1 00:00:05,480 --> 00:00:09,400 LET'S OPEN THIS JULY MEETING OF 2 00:00:09,400 --> 00:00:12,640 SACHRP. 3 00:00:12,640 --> 00:00:15,680 I'M GOING TO BEGIN WITH ROLL 4 00:00:15,680 --> 00:00:17,080 CALL, I'LL CALL EACH MEMBER'S 5 00:00:17,080 --> 00:00:19,080 NAME IF YOU WOULD BRIEFLY 6 00:00:19,080 --> 00:00:21,320 INTRODUCE YOURSELF, TELL US YOUR 7 00:00:21,320 --> 00:00:23,240 INSTITUTIONAL AFFILIATION, THAT 8 00:00:23,240 --> 00:00:25,000 WOULD BE GREAT. 9 00:00:25,000 --> 00:00:27,920 LET'S START WITH MARY ELLEN. 10 00:00:27,920 --> 00:00:30,680 >> GREETINGS, HAPPY TO BE HERE, 11 00:00:30,680 --> 00:00:34,160 EVEN THOUGH IT'S VIRTUAL, MARY 12 00:00:34,160 --> 00:00:40,000 ELLEN ALLEN, FORMER ASSOCIATE 13 00:00:40,000 --> 00:00:43,960 GENERAL COUNSEL AT GENOTECH 14 00:00:43,960 --> 00:00:48,880 ROCHE, NOW CONSULTANT IN LIFE 15 00:00:48,880 --> 00:00:50,720 SCIENCES. 16 00:00:50,720 --> 00:00:51,160 >> JODY. 17 00:00:51,160 --> 00:00:53,640 >> JYOTI ANGAL, DIRECTOR OF 18 00:00:53,640 --> 00:00:57,400 CLINICAL RESEARCH IN SOUTH 19 00:00:57,400 --> 00:00:58,720 DAKOTA. 20 00:00:58,720 --> 00:00:59,800 >> COLEMAN? 21 00:00:59,800 --> 00:01:01,680 >> GOOD MORNING, LINDA COLEMAN, 22 00:01:01,680 --> 00:01:02,920 DIRECTOR OF HUMAN RESEARCH 23 00:01:02,920 --> 00:01:08,000 PROTECTION PROGRAM AT YALE 24 00:01:08,000 --> 00:01:08,320 UNIVERSITY. 25 00:01:08,320 --> 00:01:09,440 >> JANET FREEMAN-DAILY. 26 00:01:09,440 --> 00:01:10,760 >> GOOD MORNING, LUNG CANCER 27 00:01:10,760 --> 00:01:18,000 PATIENT ADVOCATE IN THE SEATTLE 28 00:01:18,000 --> 00:01:18,280 AREA. 29 00:01:18,280 --> 00:01:20,120 >> SANDRA LEE. 30 00:01:20,120 --> 00:01:25,880 IS SANDRA HERE? 31 00:01:25,880 --> 00:01:26,720 >> NO. 32 00:01:26,720 --> 00:01:27,080 (INDISCERNIBLE). 33 00:01:27,080 --> 00:01:30,360 >> GOOD MORNING, SKIP NELSON, 34 00:01:30,360 --> 00:01:31,880 SENIOR DIRECTOR OF PEDIATRIC 35 00:01:31,880 --> 00:01:37,680 DRUG DEVELOPMENT JOHNSON & 36 00:01:37,680 --> 00:01:37,920 JOHNSON. 37 00:01:37,920 --> 00:01:39,280 >> LOIS SHEPHERD. 38 00:01:39,280 --> 00:01:41,160 >> PROFESSOR AT LAW, UNIVERSITY 39 00:01:41,160 --> 00:01:42,160 OF VIRGINIA. 40 00:01:42,160 --> 00:01:45,360 >> WALTER STRAUS. 41 00:01:45,360 --> 00:01:46,840 >> GOOD MORNING, WALTER STRAUS, 42 00:01:46,840 --> 00:01:49,800 VICE PRESIDENT OF CLINICAL 43 00:01:49,800 --> 00:01:51,400 SAFETY AT MODERNA. 44 00:01:51,400 --> 00:01:55,560 >> KEVIN LANGFORD. 45 00:01:55,560 --> 00:01:57,280 >> GOOD MORNING, KEVIN LANGFORD, 46 00:01:57,280 --> 00:01:59,160 PROFESSOR POPULATION HEALTH 47 00:01:59,160 --> 00:02:01,120 SCIENCES DUKE UNIVERSITY. 48 00:02:01,120 --> 00:02:02,880 >> CONSUELO WILKINS. 49 00:02:02,880 --> 00:02:05,120 >> I'M THE CHIEF EQUITY OFFICER, 50 00:02:05,120 --> 00:02:08,000 PROFESSOR OF MEDICINE AT 51 00:02:08,000 --> 00:02:10,440 VANDERBILT UNIVERSITY MEDICAL 52 00:02:10,440 --> 00:02:12,040 CENTER. 53 00:02:12,040 --> 00:02:13,840 >> AND I'M ALSO PRESENT, DOUG 54 00:02:13,840 --> 00:02:18,080 DIEKEMA FROM UNIVERSITY OF 55 00:02:18,080 --> 00:02:19,080 WASHINGTON, SEATTLE CHILDREN'S 56 00:02:19,080 --> 00:02:19,400 HOSPITAL. 57 00:02:19,400 --> 00:02:23,000 JERRY, DO YOU WANT TO INTRODUCE 58 00:02:23,000 --> 00:02:29,280 YOURSELF? 59 00:02:29,280 --> 00:02:34,280 >> SURE, JERRY MENIKOFF, FROM 60 00:02:34,280 --> 00:02:36,480 OHRP, DIRECTOR OF OHRP. 61 00:02:36,480 --> 00:02:41,680 >> AND JULIE GREGORY. 62 00:02:41,680 --> 00:02:45,160 >> DIFFERENCE OF POLICY PRACTICE 63 00:02:45,160 --> 00:02:45,480 OHRP. 64 00:02:45,480 --> 00:02:47,760 >> IF WE HAVE EX OFFICIO MEMBERS 65 00:02:47,760 --> 00:02:58,240 PRESENT ANNOUNCE YOURSELVES. 66 00:02:59,320 --> 00:03:06,040 >> GOOD MORNING. 67 00:03:06,040 --> 00:03:12,800 DIRECTOR OF OFFICE OF CLINICAL 68 00:03:12,800 --> 00:03:14,520 POLICY AT FDA. 69 00:03:14,520 --> 00:03:16,200 >> KEVIN PROHSKA ASSOCIATE 70 00:03:16,200 --> 00:03:17,080 DIRECTOR FDA. 71 00:03:17,080 --> 00:03:19,880 >> AND DO WE HAVE ANY EX 72 00:03:19,880 --> 00:03:27,080 OFFICIOS ONLINE WHO WANT TO 73 00:03:27,080 --> 00:03:27,840 INTRODUCE THEMSELVES? 74 00:03:27,840 --> 00:03:28,280 OKAY. 75 00:03:28,280 --> 00:03:29,400 THANK YOU VERY MUCH. 76 00:03:29,400 --> 00:03:32,200 THANK YOU FOR JOINING. 77 00:03:32,200 --> 00:03:34,160 I'M DOUG DIEKEMA, CHAIR OF 78 00:03:34,160 --> 00:03:41,120 SACHRP, AND IT IS SO GOOD TO 79 00:03:41,120 --> 00:03:42,280 ACTUALLY FINALLY MEET MY 80 00:03:42,280 --> 00:03:43,800 COMMITTEE IN PERSON, TO BE BACK 81 00:03:43,800 --> 00:03:46,080 TOGETHER MOSTLY IN THE SAME 82 00:03:46,080 --> 00:03:46,320 ROOM. 83 00:03:46,320 --> 00:03:49,080 WE HAVE A BIG MEETING TODAY, AND 84 00:03:49,080 --> 00:03:50,480 TOMORROW, WHERE WE WILL BE 85 00:03:50,480 --> 00:03:52,760 TAKING ON A NUMBER OF ITEMS THAT 86 00:03:52,760 --> 00:03:54,960 WE HOPE WE CAN ACHIEVE SOME 87 00:03:54,960 --> 00:03:59,000 FINAL APPROVAL ON IN TERMS OF 88 00:03:59,000 --> 00:03:59,280 GUIDANCE. 89 00:03:59,280 --> 00:04:02,040 AND I JUST WANT TO RECOGNIZE 90 00:04:02,040 --> 00:04:05,240 BEHIND THE SCENES DOING MUCH OF 91 00:04:05,240 --> 00:04:07,320 THE HEAVY LIFTING ON THE SORT OF 92 00:04:07,320 --> 00:04:08,160 DAY-TO-DAY WORK ON THE 93 00:04:08,160 --> 00:04:09,840 STATEMENTS WE'RE GOING TO BE 94 00:04:09,840 --> 00:04:12,800 TALKING ABOUT ARE TWO 95 00:04:12,800 --> 00:04:15,200 SUBCOMMITTEES, OUR SUBCOMMITTEE 96 00:04:15,200 --> 00:04:19,120 ON HARMONIZATION AND OUR SUBPART 97 00:04:19,120 --> 00:04:20,760 A SUBCOMMITTEE, AND I WANT TO 98 00:04:20,760 --> 00:04:23,920 RECOGNIZE THE GREAT AMOUNT OF 99 00:04:23,920 --> 00:04:25,280 WORK THAT GOES INTO PREPARATION 100 00:04:25,280 --> 00:04:26,680 FOR THESE MEETINGS. 101 00:04:26,680 --> 00:04:29,360 WE HAVE REPRESENTATIVES OF BOTH 102 00:04:29,360 --> 00:04:30,720 COMMITTEES HERE PRESENTING SOME 103 00:04:30,720 --> 00:04:32,160 OF THOSE MATERIALS AND WE'LL 104 00:04:32,160 --> 00:04:35,840 INTRODUCE THEM AT THAT TIME. 105 00:04:35,840 --> 00:04:37,200 JERRY MENIKOFF, DO YOU WANT TO 106 00:04:37,200 --> 00:04:39,400 SAY ANYTHING BEFORE WE GET 107 00:04:39,400 --> 00:04:39,960 STARTED? 108 00:04:39,960 --> 00:04:44,440 >> YES, THANK YOU, DOUG. 109 00:04:44,440 --> 00:04:49,120 IT'S A GREAT PLEASURE TO ECHO 110 00:04:49,120 --> 00:04:50,880 YOUR COMMENTS THAT WE'RE HAVING 111 00:04:50,880 --> 00:04:52,640 SOMETHING CLOSE TO THE OLD 112 00:04:52,640 --> 00:04:53,360 NORMALITY AGAIN. 113 00:04:53,360 --> 00:04:56,120 WE'RE VERY HAPPY ON BEHALF OF 114 00:04:56,120 --> 00:04:59,200 OHRP AND HHS TO BE PART OF THAT 115 00:04:59,200 --> 00:04:59,760 PROCESS. 116 00:04:59,760 --> 00:05:01,760 SO IT'S GREAT TO SEE PEOPLE HERE 117 00:05:01,760 --> 00:05:04,400 IN PERSON AND BOTH PEOPLE WHO 118 00:05:04,400 --> 00:05:05,440 ARE ONLINE. 119 00:05:05,440 --> 00:05:08,160 I ALSO WANT TO ECHO, DOUG, YOUR 120 00:05:08,160 --> 00:05:09,960 COMMENTS ABOUT ALL THE WORK THAT 121 00:05:09,960 --> 00:05:13,240 LED UP TO THIS MEETING. 122 00:05:13,240 --> 00:05:15,000 AND IN PARTICULAR, THE PEOPLE 123 00:05:15,000 --> 00:05:16,200 WHO WORKED ON THE SUBCOMMITTEES, 124 00:05:16,200 --> 00:05:18,680 THAT IS WHERE A MASSIVE AMOUNT 125 00:05:18,680 --> 00:05:23,200 OF WORK IS REGULARLY DONE. 126 00:05:23,200 --> 00:05:26,040 THE SUBCOMMITTEE CO-CHAIRS, WHO 127 00:05:26,040 --> 00:05:27,800 ARE SORT OF IN CHARGE OF A GREAT 128 00:05:27,800 --> 00:05:29,080 DEAL OF THIS WORK, COMMITTEE 129 00:05:29,080 --> 00:05:32,080 MEMBERS, THE MEMBERS OF SACHRP 130 00:05:32,080 --> 00:05:37,200 THAT INTERACT WITH THE 131 00:05:37,200 --> 00:05:38,120 SUBCOMMITTEES, EX OFFICIOS, 132 00:05:38,120 --> 00:05:39,000 MEMBERS OF FEDERAL AGENCIES THAT 133 00:05:39,000 --> 00:05:40,400 ARE PART OF THIS PROCESS. 134 00:05:40,400 --> 00:05:42,240 IT'S A MASSIVE AMOUNT OF WORK 135 00:05:42,240 --> 00:05:44,800 AND WE REMAIN VERY, VERY 136 00:05:44,800 --> 00:05:47,200 GRATEFUL FOR ALL THE EFFORT 137 00:05:47,200 --> 00:05:49,160 PEOPLE HAVE PUT IN TO MAKE THIS 138 00:05:49,160 --> 00:05:50,160 A REALITY. 139 00:05:50,160 --> 00:05:57,160 I ALSO WANT TO THANK JULIA 140 00:05:57,160 --> 00:06:00,040 GOREY, OUR OHRP, YOU KNOW, 141 00:06:00,040 --> 00:06:00,680 INCREDIBLE VALUABLE COLLEAGUES 142 00:06:00,680 --> 00:06:07,280 WHO OF COURSE VERY MUCH MAKE 143 00:06:07,280 --> 00:06:09,520 THIS A REALITY. 144 00:06:09,520 --> 00:06:11,760 YOU'RE A CRUCIAL PART OF THIS 145 00:06:11,760 --> 00:06:13,080 PROCESS, JULIA, OF COURSE. 146 00:06:13,080 --> 00:06:15,080 THANKS TO MEMBERS OF THE PUBLIC 147 00:06:15,080 --> 00:06:16,240 FOR PARTICIPATING IN THIS. 148 00:06:16,240 --> 00:06:18,840 I ALSO WANT TO JUST MENTION, 149 00:06:18,840 --> 00:06:20,080 WE'RE VERY MUCH LOOKING FORWARD 150 00:06:20,080 --> 00:06:22,680 TO THE WORK THAT'S GOING TO 151 00:06:22,680 --> 00:06:25,240 OCCUR DURING THESE TWO DAYS, 152 00:06:25,240 --> 00:06:28,440 SOME OF THAT WORK VERY DIRECTLY 153 00:06:28,440 --> 00:06:32,440 RELATES TO WORK IN PARTICULAR 154 00:06:32,440 --> 00:06:34,880 COMMENTING ON WORK OHRP HAS BEEN 155 00:06:34,880 --> 00:06:37,720 DOING BEHIND THE SCENES IN TERMS 156 00:06:37,720 --> 00:06:39,120 OF NEW GUIDANCE, REVIEWING OLD 157 00:06:39,120 --> 00:06:41,160 GUIDANCE, ET CETERA, AND I WOULD 158 00:06:41,160 --> 00:06:43,800 ENCOURAGE PEOPLE IF YOU HAVEN'T 159 00:06:43,800 --> 00:06:46,360 BEEN TO OHRP'S WEB PAGE 160 00:06:46,360 --> 00:06:50,600 RECENTLY, TAKE A LOOK AT THAT. 161 00:06:50,600 --> 00:06:51,160 YOU'LL DISCOVER JUST 162 00:06:51,160 --> 00:06:55,200 HIGHLIGHTING THE WORK OF THE 163 00:06:55,200 --> 00:06:58,040 OTHER OHRP STAFF, OUR EDUCATION 164 00:06:58,040 --> 00:07:00,320 DIVISION HAS BEEN BUSILY 165 00:07:00,320 --> 00:07:02,760 OVERTIME CREATING MORE AND MORE 166 00:07:02,760 --> 00:07:04,160 VIDEOS AND OTHER THINGS THAT ARE 167 00:07:04,160 --> 00:07:06,800 VERY USER FRIENDLY THAT COULD 168 00:07:06,800 --> 00:07:09,320 HELP PEOPLE UNDERSTAND THE 169 00:07:09,320 --> 00:07:09,840 REGULATIONS. 170 00:07:09,840 --> 00:07:12,480 OUR POLICY DIVISION HAS BEEN 171 00:07:12,480 --> 00:07:17,400 VISIBLY OVER TIME PRODUCING 172 00:07:17,400 --> 00:07:18,600 GUIDANCE, FAQs, ET CETERA. 173 00:07:18,600 --> 00:07:21,600 SO TAKE A LOOK, YOU MAY DISCOVER 174 00:07:21,600 --> 00:07:24,000 THERE'S SOME GUIDANCE ON SOME 175 00:07:24,000 --> 00:07:25,520 TOPIC THAT'S VERY HELPFUL TO 176 00:07:25,520 --> 00:07:26,200 YOU. 177 00:07:26,200 --> 00:07:29,640 ALSO MENTION OUR COMPLIANCE 178 00:07:29,640 --> 00:07:31,000 DIVISION, DOING A NUMBER OF 179 00:07:31,000 --> 00:07:32,960 THINGS, SOME OF THOSE THINGS ARE 180 00:07:32,960 --> 00:07:34,840 WORKS IN PROGRESS DUE TO THE 181 00:07:34,840 --> 00:07:36,080 NATURE OF COMPLIANCE UNTIL WE 182 00:07:36,080 --> 00:07:37,680 REACH A CERTAIN POINT WE DON'T 183 00:07:37,680 --> 00:07:39,440 GO PUBLIC BUT I JUST WANT -- 184 00:07:39,440 --> 00:07:43,400 EVERYBODY SHOULD BE AWARE OF ALL 185 00:07:43,400 --> 00:07:45,800 OF THAT WORK. 186 00:07:45,800 --> 00:07:46,760 AGAIN, WE'RE REALLY LOOKING 187 00:07:46,760 --> 00:07:48,360 FORWARD TO THESE TWO DAYS, AND 188 00:07:48,360 --> 00:07:51,360 I'LL HAND IT BACK TO DOUG. 189 00:07:51,360 --> 00:07:52,120 >> THANKS, JERRY. 190 00:07:52,120 --> 00:07:55,400 WE'LL HAVE AN OPPORTUNITY TO 191 00:07:55,400 --> 00:07:56,400 HEAR FROM YVONNE LAU A LITTLE 192 00:07:56,400 --> 00:07:58,680 LATER IN THE DAY ABOUT SOME OF 193 00:07:58,680 --> 00:07:59,560 THE INITIATIVES IN THE 194 00:07:59,560 --> 00:08:01,680 DEPARTMENT OF EDUCATION WHICH WE 195 00:08:01,680 --> 00:08:02,840 CAN LOOK FORWARD TO. 196 00:08:02,840 --> 00:08:08,000 OUR FIRST ORDER OF BUSINESS IS 197 00:08:08,000 --> 00:08:09,880 TO APPROVE MINUTES FROM MARCH 10 198 00:08:09,880 --> 00:08:11,600 AND 11 MEETING EARLIER THIS 199 00:08:11,600 --> 00:08:14,360 YEAR, CAN I GET A MOTION TO 200 00:08:14,360 --> 00:08:16,280 APPROVE THOSE MINUTES? 201 00:08:16,280 --> 00:08:17,480 >> SO MOVED. 202 00:08:17,480 --> 00:08:20,240 >> IS THERE A SECOND? 203 00:08:20,240 --> 00:08:20,680 >> SECOND. 204 00:08:20,680 --> 00:08:26,680 >> ANY COMMENTS OR AMENDMENTS TO 205 00:08:26,680 --> 00:08:27,440 THOSE MINUTES? 206 00:08:27,440 --> 00:08:32,160 SEEING NONE, ALL IN FAVOR OF 207 00:08:32,160 --> 00:08:33,720 APPROVAL? 208 00:08:33,720 --> 00:08:36,360 >> AYE. 209 00:08:36,360 --> 00:08:36,720 >> AYE. 210 00:08:36,720 --> 00:08:40,520 >> AND ANYONE OPPOSED? 211 00:08:40,520 --> 00:08:41,480 ANYBODY ABSTAIN? 212 00:08:41,480 --> 00:08:43,280 OKAY. 213 00:08:43,280 --> 00:08:45,640 THE MINUTES ARE APPROVED. 214 00:08:45,640 --> 00:08:47,080 ALL RIGHT. 215 00:08:47,080 --> 00:08:49,520 NEXT ITEM OF BUSINESS IS TO 216 00:08:49,520 --> 00:08:50,800 REVIEW OHRP DRAFT GUIDANCE ON 217 00:08:50,800 --> 00:08:54,320 THE USE OF SINGLE INSTITUTIONAL 218 00:08:54,320 --> 00:08:57,480 REVIEW BOARDS FOR COOPERATIVE 219 00:08:57,480 --> 00:09:01,400 RESEARCH, AND WE HAVE BOTH OF 220 00:09:01,400 --> 00:09:02,560 OUR -- TWO SUBCOMMITTEE CHAIRS 221 00:09:02,560 --> 00:09:04,600 HERE TO PRESENT THAT. 222 00:09:04,600 --> 00:09:06,560 DAVID BORASKY I BELIEVE IS GOING 223 00:09:06,560 --> 00:09:08,520 TO SORT OF PRESENT THIS, AND 224 00:09:08,520 --> 00:09:12,640 MARK BARNES IS HERE AT THE TABLE 225 00:09:12,640 --> 00:09:15,080 TO ASSIST WITH THAT. 226 00:09:15,080 --> 00:09:17,120 I'LL LET YOU TWO INTRODUCE 227 00:09:17,120 --> 00:09:20,520 YOURSELVES AND MOVE FORWARD. 228 00:09:20,520 --> 00:09:21,480 >> THANKS, DOUG. 229 00:09:21,480 --> 00:09:27,360 LET ME JUST MAKE SURE -- YEAH. 230 00:09:27,360 --> 00:09:29,240 I'LL INTRODUCE MYSELF. 231 00:09:29,240 --> 00:09:33,720 DAVID BORASKY, VICE PRESIDENT 232 00:09:33,720 --> 00:09:35,360 ARE COMPLIANCE WCGIRG, CO-CHAIR 233 00:09:35,360 --> 00:09:38,400 OF THE SUBPART A SUBCOMMITTEE, 234 00:09:38,400 --> 00:09:39,640 OFTEN THESE DOCUMENTS ARE GIVEN 235 00:09:39,640 --> 00:09:41,480 TO ONE COMMITTEE OR THE OTHER 236 00:09:41,480 --> 00:09:44,560 BUT WE OFTEN END UP DOING 237 00:09:44,560 --> 00:09:46,080 OVERLAPPING WORK SO THIS 238 00:09:46,080 --> 00:09:48,280 DOCUMENT WAS CO-AUTHORED BY 239 00:09:48,280 --> 00:09:50,280 MYSELF AND MARK BARNES WHO WILL 240 00:09:50,280 --> 00:09:50,960 PARTICIPATE IN DISCUSSIONS, AND 241 00:09:50,960 --> 00:09:53,440 HE'S AT THE TABLE TODAY AS WELL. 242 00:09:53,440 --> 00:09:55,720 I THINK I'VE GOT THIS PULLED UP, 243 00:09:55,720 --> 00:09:58,560 IT SAYS I'M STILL SHARING THE 244 00:09:58,560 --> 00:09:59,440 SCREEN SO HOPEFULLY EVERYBODY 245 00:09:59,440 --> 00:10:00,880 CAN SEE IT. 246 00:10:00,880 --> 00:10:01,560 APOLOGIES THAT I'M SPEAKING TO 247 00:10:01,560 --> 00:10:04,040 THE BACKS OF SOME OF YOU, THE 248 00:10:04,040 --> 00:10:05,800 WAY THE ROOM IS ARRANGED, 249 00:10:05,800 --> 00:10:11,600 ALTHOUGH I DIDN'T ARRANGE IT. 250 00:10:11,600 --> 00:10:15,200 THIS DOCUMENT IS THE 251 00:10:15,200 --> 00:10:16,240 SUBCOMMITTEE'S PROPOSED RESPONSE 252 00:10:16,240 --> 00:10:18,280 TO THE RECENTLY RELEASED 253 00:10:18,280 --> 00:10:19,720 GUIDANCE ON SINGLE IRB REVIEW 254 00:10:19,720 --> 00:10:22,480 THAT HAS COME OUT OF OHRP. 255 00:10:22,480 --> 00:10:23,240 >> EXCUSE ME. 256 00:10:23,240 --> 00:10:24,320 SORRY TO INTERRUPT. 257 00:10:24,320 --> 00:10:28,120 WE'RE NOT SEEING YOUR SLIDES ON 258 00:10:28,120 --> 00:10:28,320 ZOOM. 259 00:10:28,320 --> 00:10:30,240 >> OH, HOLD ON A SECOND. 260 00:10:30,240 --> 00:10:34,520 LET'S SEE, YOUR SCREEN SHARING 261 00:10:34,520 --> 00:10:39,000 IS PAUSED. 262 00:10:39,000 --> 00:10:40,960 >> JANET, THERE ARE NO SLIDES. 263 00:10:40,960 --> 00:10:42,040 THERE'S TEXT. 264 00:10:42,040 --> 00:10:44,000 >> YES, ARE YOU SEEING THE TEXT? 265 00:10:44,000 --> 00:10:45,600 >> NO, WE JUST SEE THE INTRODUCE 266 00:10:45,600 --> 00:10:48,240 SLIDE FOR THE MEETING. 267 00:10:48,240 --> 00:10:48,840 >> OKAY. 268 00:10:48,840 --> 00:10:50,600 JUST A MOMENT. 269 00:10:50,600 --> 00:10:53,320 >> THE GUARDIAN ANGEL IS 270 00:10:53,320 --> 00:10:53,760 APPROACHING. 271 00:10:53,760 --> 00:11:03,960 [LAUGHTER] 272 00:11:06,680 --> 00:11:08,480 >> THERE WE GO. 273 00:11:08,480 --> 00:11:10,240 THANK YOU. 274 00:11:10,240 --> 00:11:10,960 >> ALL RIGHT. 275 00:11:10,960 --> 00:11:13,360 USUALLY AFTER TWO OR THREE YEARS 276 00:11:13,360 --> 00:11:14,200 OF ZOOMING AND FACETIMING AND 277 00:11:14,200 --> 00:11:15,760 EVERYTHING YOU WOULD THINK I 278 00:11:15,760 --> 00:11:20,240 WOULD HAVE THIS FIGURED OUT. 279 00:11:20,240 --> 00:11:21,840 REGARDLESS, WE'VE GOT THIS 280 00:11:21,840 --> 00:11:29,160 GUIDANCE, THE DRAFT GUIDANCE WAS 281 00:11:29,160 --> 00:11:30,120 RELEASED RECENTLY, AND SACHRP 282 00:11:30,120 --> 00:11:31,880 HAS BEEN ASKED TO MAKE COMMENTS 283 00:11:31,880 --> 00:11:33,320 ON THAT. 284 00:11:33,320 --> 00:11:35,640 YOU KNOW, IN TERMS OF THE 285 00:11:35,640 --> 00:11:37,160 SUBCOMMITTEES, WE WERE EXCITED 286 00:11:37,160 --> 00:11:39,240 TO SEE THIS GUIDANCE, AS IT'S 287 00:11:39,240 --> 00:11:42,760 NOTED IN THE DOCUMENT THE SINGLE 288 00:11:42,760 --> 00:11:44,160 IRE MANDATES STARTED WITH THE 289 00:11:44,160 --> 00:11:46,080 NIH A FEW YEARS AGO, AND THEN IT 290 00:11:46,080 --> 00:11:49,800 WAS PUT INTO THE COMMON RULE FOR 291 00:11:49,800 --> 00:11:51,400 RESEARCH UNDER THE COMMON RULE 292 00:11:51,400 --> 00:11:53,440 MANDATING THE USE OF SINGLE IRB 293 00:11:53,440 --> 00:11:57,520 REVIEW FOR A LOT OF MULTI-SITE 294 00:11:57,520 --> 00:11:57,880 RESEARCH. 295 00:11:57,880 --> 00:12:03,280 THE CONCEPT ITSELF ISN'T NEW. 296 00:12:03,280 --> 00:12:04,960 LOTS OF FDA MULTI-SITE STUDIES 297 00:12:04,960 --> 00:12:06,920 HAVE GONE ON FOR DECADES BUT 298 00:12:06,920 --> 00:12:08,920 THIS REPRESENTED A CATCHING UP 299 00:12:08,920 --> 00:12:13,280 ON THE COMMON RULE SIDE OF THE 300 00:12:13,280 --> 00:12:13,720 HOUSE. 301 00:12:13,720 --> 00:12:15,600 AND WHY THE GUIDANCE IS NEEDED, 302 00:12:15,600 --> 00:12:18,200 EVEN THOUGH IT'S BEEN OCCURRING 303 00:12:18,200 --> 00:12:21,400 IN THE CONTEXT OF MULTI-SITE 304 00:12:21,400 --> 00:12:22,040 INDUSTRY SPONSORED CLINICAL 305 00:12:22,040 --> 00:12:23,600 TRIALS FOR DECADES THE GUIDANCE 306 00:12:23,600 --> 00:12:25,560 IS NEEDED BECAUSE UNDER THE NEW 307 00:12:25,560 --> 00:12:26,520 MANDATE LOTS OF INSTITUTIONS 308 00:12:26,520 --> 00:12:29,040 THAT ARE USED TO BEING AN 309 00:12:29,040 --> 00:12:31,640 INSTITUTIONAL LOCAL IRB ARE NOW 310 00:12:31,640 --> 00:12:32,680 TASKED WITH BEING APPOINTED OR 311 00:12:32,680 --> 00:12:34,200 BEING PART OF A PROGRAM THAT IS 312 00:12:34,200 --> 00:12:35,720 GOING TO REVIEW FOR MULTIPLE 313 00:12:35,720 --> 00:12:36,360 SITES. 314 00:12:36,360 --> 00:12:38,080 AND THERE WASN'T REALLY A LOT OF 315 00:12:38,080 --> 00:12:40,440 EXISTING GUIDANCE OUT THERE. 316 00:12:40,440 --> 00:12:41,400 THE ORGANIZATIONS THAT WERE 317 00:12:41,400 --> 00:12:43,480 DOING IT BEFORE JUST SORT OF 318 00:12:43,480 --> 00:12:45,480 GREW UP DOING IT. 319 00:12:45,480 --> 00:12:46,880 AND SO THE GUIDANCE HAS THE 320 00:12:46,880 --> 00:12:49,120 OPPORTUNITY TO BE VERY HELPFUL 321 00:12:49,120 --> 00:12:52,920 TO THAT SEGMENT OF THE IRB WORLD 322 00:12:52,920 --> 00:12:54,120 THAT IS WADING INTO THESE WATERS 323 00:12:54,120 --> 00:12:55,000 FOR THE FIRST TIME TRYING TO 324 00:12:55,000 --> 00:13:00,040 FIGURE OUT HOW TO MAKE IT ALL 325 00:13:00,040 --> 00:13:01,720 WORK IN A WAY THAT PROVIDES THE 326 00:13:01,720 --> 00:13:03,200 SORT OF EFFICIENCIES TO THE 327 00:13:03,200 --> 00:13:05,040 PROCESS THAT THE REGULATION WAS 328 00:13:05,040 --> 00:13:07,560 HOPING TO ACHIEVE AND NOT 329 00:13:07,560 --> 00:13:08,520 CREATING ADDITIONAL NEW BARRIERS 330 00:13:08,520 --> 00:13:16,120 TO TAKE THE PLACE OF ANY OF THE 331 00:13:16,120 --> 00:13:17,880 THINGS THAT WERE PART OF THE OLD 332 00:13:17,880 --> 00:13:18,280 SYSTEM. 333 00:13:18,280 --> 00:13:18,800 >> DAVID, I'M GOING TO 334 00:13:18,800 --> 00:13:19,080 INTERRUPT. 335 00:13:19,080 --> 00:13:22,160 I DON'T KNOW IF THERE'S A WAY TO 336 00:13:22,160 --> 00:13:25,200 PUT THE MICROPHONE SO THEY ARE 337 00:13:25,200 --> 00:13:26,120 MORE STRAIGHT UP. 338 00:13:26,120 --> 00:13:27,640 I'M GETTING MESSAGES ON THE 339 00:13:27,640 --> 00:13:29,040 PUBLIC FEED YOU'RE FAINT. 340 00:13:29,040 --> 00:13:30,680 I.T. PEOPLE, IF THERE'S A WAY 341 00:13:30,680 --> 00:13:32,960 YOU CAN INCREASE HIS VOLUME THAT 342 00:13:32,960 --> 00:13:33,560 WOULD BE -- 343 00:13:33,560 --> 00:13:35,440 >> I COULD STAND CLOSER. 344 00:13:35,440 --> 00:13:36,720 >> I'M SORRY FOR INTERRUPTING. 345 00:13:36,720 --> 00:13:37,520 >> NO, THAT'S OKAY. 346 00:13:37,520 --> 00:13:39,320 IT'S GOOD FOR THE PEOPLE WHO ARE 347 00:13:39,320 --> 00:13:43,840 ONLINE AND HAVING TO LISTEN TO 348 00:13:43,840 --> 00:13:46,400 BE ABLE TO HEAR ME AND 349 00:13:46,400 --> 00:13:50,080 PARTICIPATE IN THE DISCUSSIONS. 350 00:13:50,080 --> 00:13:52,600 WE HAVE THIS DOCUMENT THAT MARK 351 00:13:52,600 --> 00:13:55,000 TOOK THE LEAD ON AUTHORING BUT 352 00:13:55,000 --> 00:13:55,680 IT WENT THROUGH THE 353 00:13:55,680 --> 00:13:56,560 SUBCOMMITTEES, PART OF THE 354 00:13:56,560 --> 00:13:58,040 CHALLENGE FOR TODAY DOUG 355 00:13:58,040 --> 00:14:00,000 MENTIONED SEVERAL ITEMS FOR THE 356 00:14:00,000 --> 00:14:03,840 SACHRP MEETING THAT ARE TIME 357 00:14:03,840 --> 00:14:04,120 SENSITIVE. 358 00:14:04,120 --> 00:14:05,840 THIS IS OPEN COMMENT PERIOD. 359 00:14:05,840 --> 00:14:07,920 MARK AND I HOPE THAT WE'LL NOT 360 00:14:07,920 --> 00:14:10,200 ONLY GET GOOD FEEDBACK TODAY BUT 361 00:14:10,200 --> 00:14:11,720 HAVE THIS IN A FINAL DONE FORM 362 00:14:11,720 --> 00:14:14,560 BY THE END OF THE MEETING IF NOT 363 00:14:14,560 --> 00:14:15,280 TODAY THEN TOMORROW. 364 00:14:15,280 --> 00:14:17,480 THAT'S WHY IT'S ON THE AGENDA 365 00:14:17,480 --> 00:14:18,520 TODAY EARLY AS WELL. 366 00:14:18,520 --> 00:14:22,000 AND SO WHAT WE'LL BE DOING IS 367 00:14:22,000 --> 00:14:24,000 GOING THROUGH THIS DOCUMENT, AND 368 00:14:24,000 --> 00:14:25,200 REQUESTING FEEDBACK AND LOOKING 369 00:14:25,200 --> 00:14:28,160 FOR AREAS TO IMPROVE IT AND I 370 00:14:28,160 --> 00:14:30,360 THINK -- I'M GOING TO SEE IF THE 371 00:14:30,360 --> 00:14:31,320 TRACKING IS ON. 372 00:14:31,320 --> 00:14:35,800 IF NOT I'LL TURN THAT ON IN A 373 00:14:35,800 --> 00:14:36,160 MINUTE. 374 00:14:36,160 --> 00:14:37,600 AND SO AT A HIGH LEVEL THAT'S 375 00:14:37,600 --> 00:14:38,080 THE BACKGROUND, MARK. 376 00:14:38,080 --> 00:14:40,080 I DON'T KNOW IF YOU HAVE 377 00:14:40,080 --> 00:14:41,960 ANYTHING TO ADD WHILE I FIGURE 378 00:14:41,960 --> 00:14:42,920 OUT HOW TO -- 379 00:14:42,920 --> 00:14:43,640 >> NOT REALLY, DAVID. 380 00:14:43,640 --> 00:14:47,440 ARE YOU GOING TO GO THROUGH LIKE 381 00:14:47,440 --> 00:14:51,080 THE PRIMARY FEATURES OF OUR 382 00:14:51,080 --> 00:14:55,200 COMMENTS? 383 00:14:55,200 --> 00:14:55,800 YES. 384 00:14:55,800 --> 00:14:56,120 >> GREAT. 385 00:14:56,120 --> 00:14:57,760 >> I'LL TURN ON TRACK CHANGES, 386 00:14:57,760 --> 00:15:01,000 LET ME GET THAT. 387 00:15:01,000 --> 00:15:03,760 388 00:15:03,760 --> 00:15:05,520 389 00:15:05,520 --> 00:15:07,680 SO, IN THE REFLECTIONS FROM THE 390 00:15:07,680 --> 00:15:10,760 SUBCOMMITTEE, WHEN LOOKING AT 391 00:15:10,760 --> 00:15:13,400 THIS DOCUMENT, WE BELIEVE THAT 392 00:15:13,400 --> 00:15:16,880 THERE ARE APPROXIMATELY FIVE 393 00:15:16,880 --> 00:15:20,080 AREAS THAT CAN BENEFIT FROM -- 394 00:15:20,080 --> 00:15:21,280 THAT -- AREAS FOR IMPROVEMENT TO 395 00:15:21,280 --> 00:15:23,800 DOCUMENT TO MAKE IT MORE USEFUL 396 00:15:23,800 --> 00:15:25,240 FOR THE COMMUNITY OF FOLKS THAT 397 00:15:25,240 --> 00:15:29,040 WILL BE USING THIS AS A GUIDANCE 398 00:15:29,040 --> 00:15:30,600 DOCUMENT. 399 00:15:30,600 --> 00:15:32,440 AND ALSO TO REALLY HELP THE 400 00:15:32,440 --> 00:15:34,160 COMMUNITY ACHIEVE THE GOALS OF 401 00:15:34,160 --> 00:15:35,400 WHAT COULD BE ACCOMPLISHED 402 00:15:35,400 --> 00:15:37,240 THROUGH SINGLE IRB REVIEW AND 403 00:15:37,240 --> 00:15:43,360 ELIMINATING SOME OF THE CONCERNS 404 00:15:43,360 --> 00:15:44,800 THAT WE HAD, ONE, WE'VE EITHER 405 00:15:44,800 --> 00:15:46,120 EXPERIENCED IN THE 406 00:15:46,120 --> 00:15:48,280 IMPLEMENTATION OF SINGLE IRB OR 407 00:15:48,280 --> 00:15:50,240 THAT WE THOUGHT WERE POSSIBLE 408 00:15:50,240 --> 00:15:53,480 OUTCOMES FROM THE WAY THE 409 00:15:53,480 --> 00:15:54,240 DOCUMENT'S CURRENTLY WRITTEN. 410 00:15:54,240 --> 00:15:57,400 AND SO THERE ARE AREAS OF LOCAL 411 00:15:57,400 --> 00:15:58,480 CONTEXT, WHAT THAT MEANS, HOW 412 00:15:58,480 --> 00:16:00,800 THAT'S TO BE INTERPRETED BY THE 413 00:16:00,800 --> 00:16:01,920 IRB COMMUNITY. 414 00:16:01,920 --> 00:16:05,000 WE HAVE QUESTIONS OR COMMENTS 415 00:16:05,000 --> 00:16:08,760 ABOUT THE ROLE OF THE LOCAL 416 00:16:08,760 --> 00:16:10,880 IRBs AT THE SITES THAT CEDED 417 00:16:10,880 --> 00:16:13,080 REVIEW TO THE IRB AND WHAT THAT 418 00:16:13,080 --> 00:16:15,480 ROLE SHOULD BE, WITH A CONCERN 419 00:16:15,480 --> 00:16:16,240 THAT, AGAIN, WE DON'T WANT TO 420 00:16:16,240 --> 00:16:23,280 HAVE A SYSTEM THAT SAYS SINGLE 421 00:16:23,280 --> 00:16:29,800 IRB BUT LOCAL IRBs ARE CHIMING 422 00:16:29,800 --> 00:16:30,120 IN. 423 00:16:30,120 --> 00:16:32,040 WE THINK IT WILL BENEFIT FROM 424 00:16:32,040 --> 00:16:39,680 DEFINING ROLE OF THE SINGLE IRB 425 00:16:39,680 --> 00:16:48,120 AND ROLE CEDED TO THE IRB, 426 00:16:48,120 --> 00:16:49,200 INTERWEAVING WITH QUESTIONS 427 00:16:49,200 --> 00:16:52,600 ABOUT LOCAL CONTEXT. 428 00:16:52,600 --> 00:16:53,520 ANOTHER POTENTIAL AREA FOR 429 00:16:53,520 --> 00:16:56,240 CLARIFICATION HAS TO DO WITH 430 00:16:56,240 --> 00:16:57,440 ISSUES AROUND COMPLIANCE, AND 431 00:16:57,440 --> 00:17:00,920 WHO IS IN THE DRIVER'S SEAT WHEN 432 00:17:00,920 --> 00:17:06,720 A COMPLIANCE ISSUE ARISES AT AN 433 00:17:06,720 --> 00:17:07,920 INSTITUTION THAT HAS CEDED 434 00:17:07,920 --> 00:17:10,120 OVERSIGHT TO A SINGLE IRB AND 435 00:17:10,120 --> 00:17:12,080 HOW DOES THE SINGLE IRB INTERACT 436 00:17:12,080 --> 00:17:15,360 WITH THOSE LOCAL SITES IN 437 00:17:15,360 --> 00:17:16,720 MANAGING AND CONCLUDING ANY 438 00:17:16,720 --> 00:17:19,760 INVESTIGATIONS OR ISSUES RELATED 439 00:17:19,760 --> 00:17:20,280 TO COMPLIANCE. 440 00:17:20,280 --> 00:17:22,920 SO THAT'S CERTAINLY AN AREA FOR 441 00:17:22,920 --> 00:17:23,440 IMPROVEMENT. 442 00:17:23,440 --> 00:17:25,000 OR AN AREA WHERE MORE CLARITY 443 00:17:25,000 --> 00:17:28,040 WOULD BE HELPFUL TO THE 444 00:17:28,040 --> 00:17:30,240 COMMUNITY, AND THEN WE ALSO 445 00:17:30,240 --> 00:17:31,640 SPENT TIME TALKING ABOUT ANOTHER 446 00:17:31,640 --> 00:17:34,080 ASPECT OF LOCAL CONTEXT WHICH 447 00:17:34,080 --> 00:17:35,920 ARE STATE LAWS. 448 00:17:35,920 --> 00:17:38,440 ONE OF THE CHALLENGES TO OUR 449 00:17:38,440 --> 00:17:41,120 CURRENT SYSTEM IS THAT IN 450 00:17:41,120 --> 00:17:42,120 ADDITION TO FEDERAL REGULATIONS 451 00:17:42,120 --> 00:17:47,080 THERE ARE A NUMBER OF STATES 452 00:17:47,080 --> 00:17:48,320 WITH RESEARCH-SPECIFIC LAWS THAT 453 00:17:48,320 --> 00:17:51,680 MUST BE FOLLOWED AT VARIOUS 454 00:17:51,680 --> 00:17:53,800 SITES, IN MULTI-SITE STUDIES ARE 455 00:17:53,800 --> 00:17:54,520 OFTEN CROSSING STATE LINESES IF 456 00:17:54,520 --> 00:17:56,840 YOU HAVE A SINGLE IRB IN 457 00:17:56,840 --> 00:17:57,600 WASHINGTON STATE OVERSEEING 458 00:17:57,600 --> 00:17:58,320 RESEARCH IN NEW YORK OR VIRGINIA 459 00:17:58,320 --> 00:17:59,600 THERE MAY BE LAWS THAT THEY HAVE 460 00:17:59,600 --> 00:18:02,640 TO BE AWARE OF OR UNDERSTAND HOW 461 00:18:02,640 --> 00:18:03,000 TO IMPLEMENT. 462 00:18:03,000 --> 00:18:04,800 AND SO, YOU KNOW, THE DOCUMENT 463 00:18:04,800 --> 00:18:07,880 WAS FAIRLY SILENT ON THAT, BUT 464 00:18:07,880 --> 00:18:10,520 WE HAVE RECOMMENDATIONS FOR HOW 465 00:18:10,520 --> 00:18:13,520 THAT MIGHT BE ADDRESSED AND WHAT 466 00:18:13,520 --> 00:18:16,320 CAN BE DONE TO FACILITATE THAT 467 00:18:16,320 --> 00:18:20,600 ASPECT OF COMPLIANCE WITH STATE 468 00:18:20,600 --> 00:18:22,040 AND LOCAL LAWS. 469 00:18:22,040 --> 00:18:26,400 AND I THINK THOSE ARE THE MAIN 470 00:18:26,400 --> 00:18:28,640 BUCKET AREAS THAT WE'VE 471 00:18:28,640 --> 00:18:30,000 ADDRESSED IN THIS DOCUMENT. 472 00:18:30,000 --> 00:18:32,320 >> I WOULD JUST A COUPLE 473 00:18:32,320 --> 00:18:32,920 COMMENTS. 474 00:18:32,920 --> 00:18:34,360 DAVID, ONE IS THERE'S ALSO -- 475 00:18:34,360 --> 00:18:36,240 >> YOUR MIC IS OFF. 476 00:18:36,240 --> 00:18:38,560 YOUR LIGHT IS NOT ON. 477 00:18:38,560 --> 00:18:40,640 >> IT IS ON. 478 00:18:40,640 --> 00:18:41,280 >> OH, OKAY. 479 00:18:41,280 --> 00:18:43,800 >> ONE IS THAT WE ACTUALLY 480 00:18:43,800 --> 00:18:46,880 ADDRESS HERE THE ISSUE OF 481 00:18:46,880 --> 00:18:48,560 DEFINING ALLOWABLE -- CRITERIA 482 00:18:48,560 --> 00:18:50,800 FOR ALLOWABLE EXCEPTIONS TO THE 483 00:18:50,800 --> 00:18:55,520 SINGLE IRB REQUIREMENT, AND NEED 484 00:18:55,520 --> 00:18:58,000 TO DEFINE WHAT CRITERIA OUGHT TO 485 00:18:58,000 --> 00:18:59,760 BE FOR DETERMINING THAT SINGLE 486 00:18:59,760 --> 00:19:01,840 IRB IS NOT APPROPRIATE FOR A 487 00:19:01,840 --> 00:19:03,160 FEDERALLY FUNDED FEDERALLY 488 00:19:03,160 --> 00:19:04,080 SUPPORTED STUDY. 489 00:19:04,080 --> 00:19:05,600 AND THE -- SO THERE'S THAT AS 490 00:19:05,600 --> 00:19:08,880 WELL, IN THE LAST PART OF THIS 491 00:19:08,880 --> 00:19:09,280 DRAFT. 492 00:19:09,280 --> 00:19:11,720 THE OTHER THING THAT JUST TO BE 493 00:19:11,720 --> 00:19:13,160 CLEAR, THAT THIS COMMITTEE, 494 00:19:13,160 --> 00:19:15,320 SACHRP, AND THE SUBCOMMITTEES 495 00:19:15,320 --> 00:19:18,080 FOUR YEARS AGO MADE COMMENTS 496 00:19:18,080 --> 00:19:20,280 ABOUT THE SINGLE IRB REQUIREMENT 497 00:19:20,280 --> 00:19:25,960 AND THAT ARE LARGELY -- THESE 498 00:19:25,960 --> 00:19:27,480 ARE LARGELY CONSISTENT WERE 499 00:19:27,480 --> 00:19:28,160 MARCH 2018 COMMENTS. 500 00:19:28,160 --> 00:19:30,120 AND SO THIS COMMITTEE IS ON 501 00:19:30,120 --> 00:19:31,760 RECORD ABOUT THESE ISSUES FROM 502 00:19:31,760 --> 00:19:33,400 BEFORE, AND I WOULD -- IF I WERE 503 00:19:33,400 --> 00:19:35,400 YOU AS I LOOKED AT CERTAINLY WE 504 00:19:35,400 --> 00:19:36,400 ON THE SUBCOMMITTEES AS WE 505 00:19:36,400 --> 00:19:38,200 LOOKED AT THIS AND TRIED TO 506 00:19:38,200 --> 00:19:39,440 DRAFT THESE THINGS WE WERE 507 00:19:39,440 --> 00:19:41,440 MINDFUL OF TRYING TO CONTINUE 508 00:19:41,440 --> 00:19:43,840 THE SAME THEMES AND POINTS OF 509 00:19:43,840 --> 00:19:46,320 VIEW ARTICULATED FOUR YEARS AGO. 510 00:19:46,320 --> 00:19:47,440 >> AND SINCE THEY WERE FOUR 511 00:19:47,440 --> 00:19:48,880 YEARS AGO THEY WERE ATTACHED TO 512 00:19:48,880 --> 00:19:50,720 THE DOCUMENT SO YOU HAD A CHANCE 513 00:19:50,720 --> 00:19:51,320 TO SEE THOSE. 514 00:19:51,320 --> 00:19:53,680 I THINK MANY OF YOU WERE NOT ON 515 00:19:53,680 --> 00:19:55,880 THE SACHRP FOUR YEARS AGO. 516 00:19:55,880 --> 00:19:58,560 SO THANKS, MARK, FOR THAT 517 00:19:58,560 --> 00:19:59,400 ADDITIONAL CONTEXT. 518 00:19:59,400 --> 00:20:01,880 SO, WITH THAT, I THINK WE CAN 519 00:20:01,880 --> 00:20:04,600 START GOING THROUGH THIS 520 00:20:04,600 --> 00:20:09,000 DOCUMENT AND HOPEFULLY MAKE SOME 521 00:20:09,000 --> 00:20:10,400 PROGRESS IN GETTING THIS INTO A 522 00:20:10,400 --> 00:20:12,720 STATE THAT ALL OF YOU FIND 523 00:20:12,720 --> 00:20:13,040 ACCEPTABLE. 524 00:20:13,040 --> 00:20:14,840 AND I WILL, AS I'M GOING THROUGH 525 00:20:14,840 --> 00:20:16,760 THIS, WILL DO MY BEST TO WATCH 526 00:20:16,760 --> 00:20:19,400 THE FOLKS ON THE SCREEN FOR 527 00:20:19,400 --> 00:20:20,240 RAISED HANDS. 528 00:20:20,240 --> 00:20:21,600 THAT FUNCTION SHOULD WORK. 529 00:20:21,600 --> 00:20:25,240 I DON'T THINK -- I'M NOT GOING 530 00:20:25,240 --> 00:20:26,280 TO -- I'LL LET SOMEBODY ELSE 531 00:20:26,280 --> 00:20:27,880 WATCH THE CHAT. 532 00:20:27,880 --> 00:20:28,720 THAT'S TOO DISTRACTING. 533 00:20:28,720 --> 00:20:31,120 THE BACKGROUND IS WHAT IT IS. 534 00:20:31,120 --> 00:20:32,200 AND WE'RE TALKING ABOUT 535 00:20:32,200 --> 00:20:34,080 OBVIOUSLY THIS IS JUST THE 536 00:20:34,080 --> 00:20:36,040 BACKGROUND FOR HOW WE GOT HERE, 537 00:20:36,040 --> 00:20:40,440 STARTING WITH NIH POLICY IN 538 00:20:40,440 --> 00:20:42,200 2016, AND THE IMPLEMENTATION OF 539 00:20:42,200 --> 00:20:44,600 THE FINAL RULE THAT PUT IN THE 540 00:20:44,600 --> 00:20:47,040 SINGLE IRB REQUIREMENT IN PLACE. 541 00:20:47,040 --> 00:20:48,920 AND RIGHT HERE IN THE BEGINNING 542 00:20:48,920 --> 00:20:52,120 AS MARK NOTED, THERE ARE SOME 543 00:20:52,120 --> 00:20:53,120 BUILT-IN EXCEPTIONS TO THE 544 00:20:53,120 --> 00:20:56,720 REQUIREMENT THAT ARE BUILT INTO 545 00:20:56,720 --> 00:20:59,360 THE REGULATIONS THEMSELVES, 546 00:20:59,360 --> 00:21:02,680 RESEARCH REQUIRING REVIEW BY, 547 00:21:02,680 --> 00:21:04,720 FOR EXAMPLE, TRIBAL IRB OR FOR 548 00:21:04,720 --> 00:21:05,920 FOLLOWING TRIBAL LAW AND THEN 549 00:21:05,920 --> 00:21:06,920 SORT OF A CATCH-ALL RESEARCH 550 00:21:06,920 --> 00:21:08,760 THAT THE DEPARTMENT OR AGENCY 551 00:21:08,760 --> 00:21:12,400 CONDUCTING SAYS A SINGLE IRB IS 552 00:21:12,400 --> 00:21:12,960 NOT APPROPRIATE. 553 00:21:12,960 --> 00:21:14,480 SO, MORE ON THAT LATER AS WE GET 554 00:21:14,480 --> 00:21:17,560 TO THAT SECTION OF IT. 555 00:21:17,560 --> 00:21:20,040 AND IT'S ALSO NOTED IN HERE 556 00:21:20,040 --> 00:21:22,040 THAT, YOU KNOW, THE FDA DOES NOT 557 00:21:22,040 --> 00:21:23,760 HAVE A SIMILAR REQUIREMENT BUT 558 00:21:23,760 --> 00:21:26,280 HAS BEEN FAIRLY COMMON IN 559 00:21:26,280 --> 00:21:27,160 INDUSTRY-SPONSORED MULTI-SITE 560 00:21:27,160 --> 00:21:30,480 RESEARCH TO USE SINGLE IRBs, 561 00:21:30,480 --> 00:21:32,760 BUT THAT'S CURRENTLY AN AREA 562 00:21:32,760 --> 00:21:34,200 WHERE THERE'S NOT HARMONIZATION 563 00:21:34,200 --> 00:21:41,000 BETWEEN THE FDA REGULATIONS AND 564 00:21:41,000 --> 00:21:51,240 COMMON RULE. 565 00:21:52,560 --> 00:21:53,600 THE DISCUSSION STARTS WITH 566 00:21:53,600 --> 00:21:56,880 FURTHER BACKGROUND, WHAT IS 567 00:21:56,880 --> 00:21:58,840 HISTORY OF IRBs, THEY WERE 568 00:21:58,840 --> 00:22:00,920 INSTITUTIONALLY BASED, SET UP TO 569 00:22:00,920 --> 00:22:06,280 REVIEW RESEARCH AT THAT 570 00:22:06,280 --> 00:22:06,800 INSTITUTION. 571 00:22:06,800 --> 00:22:08,240 AND, YOU KNOW, THAT DOES HAVE 572 00:22:08,240 --> 00:22:09,640 ITS OWN STRENGTHS IN MANY WAYS, 573 00:22:09,640 --> 00:22:11,640 THOSE ARE NOTED IN THE DOCUMENT, 574 00:22:11,640 --> 00:22:12,680 FAMILIARITY WITH THE LOCAL 575 00:22:12,680 --> 00:22:14,800 CONTEXT IN TERMS OF THE 576 00:22:14,800 --> 00:22:20,320 INSTITUTION ITSELF, RESEARCHERS 577 00:22:20,320 --> 00:22:21,360 THAT WORK THERE, FAMILIARITY, IF 578 00:22:21,360 --> 00:22:24,120 YOU WILL, THAT A SINGLE IRB 579 00:22:24,120 --> 00:22:25,360 WOULD NOT SORT OF INTUITIVELY 580 00:22:25,360 --> 00:22:27,960 HAVE BECAUSE THEY ARE NOT 581 00:22:27,960 --> 00:22:29,640 LOCATED AT THAT LOCATION. 582 00:22:29,640 --> 00:22:30,760 AND THEN OBVIOUSLY NOT ONLY ON 583 00:22:30,760 --> 00:22:33,480 THE FRONT END ARE THEY ABLE TO 584 00:22:33,480 --> 00:22:35,360 HAVE A FAMILIARITY WITH LOCAL 585 00:22:35,360 --> 00:22:36,960 POLICIES AND PROCEDURES, LOCAL 586 00:22:36,960 --> 00:22:40,400 RESEARCHERS, BUT THEY ARE ON 587 00:22:40,400 --> 00:22:40,840 SITE. 588 00:22:40,840 --> 00:22:41,520 AND BEING INSTITUTIONAL BASED, 589 00:22:41,520 --> 00:22:43,680 THEY ARE IN A GOOD POSITION TO 590 00:22:43,680 --> 00:22:45,120 MONITOR THE RESEARCH FOR IRBs 591 00:22:45,120 --> 00:22:47,480 THAT HAVE TAKEN THAT ON AS A 592 00:22:47,480 --> 00:22:50,280 COMPONENT OF THEIR WORK. 593 00:22:50,280 --> 00:22:53,400 AND HAVE MORE READY ACCESS TO 594 00:22:53,400 --> 00:22:56,200 INVESTIGATORS, TO RECORDS, TO 595 00:22:56,200 --> 00:22:57,040 TEAM MEMBERS, ET CETERA. 596 00:22:57,040 --> 00:22:58,400 AND WE JUST CALL THAT OUT 597 00:22:58,400 --> 00:22:59,560 BECAUSE I THINK, YOU KNOW, I 598 00:22:59,560 --> 00:23:01,520 DON'T THINK THERE'S ANY DEBATE 599 00:23:01,520 --> 00:23:04,840 THAT THAT'S INDEED THE CASE, AND 600 00:23:04,840 --> 00:23:07,560 THEY -- AS NOTED IN THE 601 00:23:07,560 --> 00:23:08,480 PARAGRAPH STARTING AT LINE 47, 602 00:23:08,480 --> 00:23:10,600 YOU KNOW, THAT IS PART OF THE 603 00:23:10,600 --> 00:23:13,760 CONTEXT IN WHICH WE LOOK AT THE 604 00:23:13,760 --> 00:23:16,520 SINGLE IRB CONCERNS AND IN FACT 605 00:23:16,520 --> 00:23:21,360 IT IS PART OF WHAT MAKES THE 606 00:23:21,360 --> 00:23:22,640 GUIDANCE -- HIGHLIGHTS NEED FOR 607 00:23:22,640 --> 00:23:23,800 GUIDANCE AND POINTS THAT HELP 608 00:23:23,800 --> 00:23:25,480 MAKE THE GUIDANCE I THINK 609 00:23:25,480 --> 00:23:26,920 HELPFUL IS THAT THEY CAN HELP 610 00:23:26,920 --> 00:23:29,440 ADDRESS OR HELP THE COMMUNITY 611 00:23:29,440 --> 00:23:31,560 UNDERSTAND HOW TO SORT OF TREAD 612 00:23:31,560 --> 00:23:35,240 THOSE PATHS AND DO SO 613 00:23:35,240 --> 00:23:35,560 EFFECTIVELY. 614 00:23:35,560 --> 00:23:37,040 SO, I'LL MOVE INTO THE LOCAL 615 00:23:37,040 --> 00:23:37,880 CONTEXT SECTION. 616 00:23:37,880 --> 00:23:39,080 IF PEOPLE HAVE COMMENTS OR 617 00:23:39,080 --> 00:23:40,200 QUESTIONS, JUST RAISE YOUR HAND 618 00:23:40,200 --> 00:23:42,000 AND I'LL DO MY BEST TO SORT OF 619 00:23:42,000 --> 00:23:43,480 WATCH FOR THOSE ON THE SCREEN AS 620 00:23:43,480 --> 00:23:46,440 WELL AS IN THE ROOM. 621 00:23:46,440 --> 00:23:50,920 LOCAL CONTEXT IS THE FIRST BIG 622 00:23:50,920 --> 00:23:52,600 -- THE BIG BUCKET OF COMMENTS WE 623 00:23:52,600 --> 00:23:53,160 HAVE HERE. 624 00:23:53,160 --> 00:23:58,160 YOU KNOW, THIS NOTION OF LOCAL 625 00:23:58,160 --> 00:24:00,480 CONTEXT IS THE IDEA OF IRBs 626 00:24:00,480 --> 00:24:03,600 HAVING ADEQUATE KNOWLEDGE OF THE 627 00:24:03,600 --> 00:24:04,760 LOCAL CONTEXT WHERE THE RESEARCH 628 00:24:04,760 --> 00:24:06,400 WILL TAKE PLACE. 629 00:24:06,400 --> 00:24:12,960 AS MENTIONED A ABOVE, IT WAS AT 630 00:24:12,960 --> 00:24:14,800 THE INSTITUTION AND HAD A GOOD 631 00:24:14,800 --> 00:24:16,880 SENSE OF WHAT THE CONTEXT WAS 632 00:24:16,880 --> 00:24:18,200 AND WHERE THINGS LIKE, YOU KNOW, 633 00:24:18,200 --> 00:24:21,040 LOCAL LAW WOULD COME INTO PLACE, 634 00:24:21,040 --> 00:24:22,880 LOCAL IRB WOULD IN THEORY HAVE A 635 00:24:22,880 --> 00:24:28,080 GOOD UNDERSTANDING OF THAT PART 636 00:24:28,080 --> 00:24:30,560 OF THE LOCAL CONTEXT. 637 00:24:30,560 --> 00:24:35,920 WHAT WE START TALKING ABOUT AT 638 00:24:35,920 --> 00:24:37,880 LINE 64 IS SUPPLEMENTING DRAFT 639 00:24:37,880 --> 00:24:39,200 GUIDANCE WITH ADDITIONAL 640 00:24:39,200 --> 00:24:40,960 LANGUAGE ABOUT HOW THE SINGLE 641 00:24:40,960 --> 00:24:42,640 IRB SHOULD TAKE LOCAL CONTEXT 642 00:24:42,640 --> 00:24:45,760 INTO ACCOUNT, AND WHEN THE LOCAL 643 00:24:45,760 --> 00:24:47,200 CONTEXT SHOULD PREVAIL AS 644 00:24:47,200 --> 00:24:48,680 DETERMINANT IN THE APPROVAL 645 00:24:48,680 --> 00:24:50,040 DECISION FOR PROPOSED STUDY. 646 00:24:50,040 --> 00:24:53,960 AND WE HAVE AN EXAMPLE HERE OF 647 00:24:53,960 --> 00:24:55,400 MULTI-SIDE SOCIAL BEHAVIORAL 648 00:24:55,400 --> 00:24:56,840 STUDY ON PSYCHOLOGICAL 649 00:24:56,840 --> 00:24:58,480 COUNSELING INTERVENTIONS FOR 650 00:24:58,480 --> 00:25:00,360 TRANSGENDER TEENAGERS AND HOW 651 00:25:00,360 --> 00:25:02,840 THAT THE ISSUES AND IMPLICATIONS 652 00:25:02,840 --> 00:25:04,160 MAY DIFFER SUBSTANTIALLY AT 653 00:25:04,160 --> 00:25:05,760 DIFFERENT SITES DEPENDING ON 654 00:25:05,760 --> 00:25:06,640 THEIR LOCATION AND THE 655 00:25:06,640 --> 00:25:13,040 ENVIRONMENT IN WHICH THEY ARE 656 00:25:13,040 --> 00:25:13,560 LOCATED. 657 00:25:13,560 --> 00:25:20,400 AND, YOU KNOW, THE SCENARIO, 658 00:25:20,400 --> 00:25:21,480 THAT RAISES A NUMBER OF 659 00:25:21,480 --> 00:25:22,320 INTERESTING OR CHALLENGING 660 00:25:22,320 --> 00:25:23,440 POINTS THAT WOULD HAVE TO BE 661 00:25:23,440 --> 00:25:25,440 WORKED THROUGH IN THE SINGLE IRB 662 00:25:25,440 --> 00:25:27,400 CONTEXT, AND SO WE THINK THE 663 00:25:27,400 --> 00:25:32,320 GUIDANCE IS AN OPPORTUNITY TO 664 00:25:32,320 --> 00:25:33,760 TAKE EXAMPLES LIKE THAT AND 665 00:25:33,760 --> 00:25:35,800 ELABORATE FURTHER ON WHETHER OR 666 00:25:35,800 --> 00:25:40,400 NOT SINGLE IRB WOULD BE 667 00:25:40,400 --> 00:25:40,840 APPROPRIATE IN THE 668 00:25:40,840 --> 00:25:46,120 CIRCUMSTANCES, AND ANY COMMENTS 669 00:25:46,120 --> 00:25:50,040 ON THAT FIRST LONGER PARAGRAPH 670 00:25:50,040 --> 00:26:00,280 AT LINE 64? 671 00:26:01,720 --> 00:26:02,800 >> I HAVE A QUESTION. 672 00:26:02,800 --> 00:26:08,240 >> SURE? SO WHO . 673 00:26:08,240 --> 00:26:08,880 >> WHO WOULD INITIATE LOOKING 674 00:26:08,880 --> 00:26:10,320 INTO WHETHER OR NOT THE SINGLE 675 00:26:10,320 --> 00:26:12,360 IRB WOULD BE APPROPRIATE IN THAT 676 00:26:12,360 --> 00:26:16,880 CONTEXT, WOULD IT BE THE 677 00:26:16,880 --> 00:26:18,080 INSTITUTION, FUNDER, 678 00:26:18,080 --> 00:26:19,000 INVESTIGATOR, WHO WOULD THAT BE? 679 00:26:19,000 --> 00:26:20,920 >> I DON'T KNOW IF YOU HAVE 680 00:26:20,920 --> 00:26:21,440 THOUGHTS, MARK. 681 00:26:21,440 --> 00:26:23,120 >> I THINK IT'S ALL OF THE 682 00:26:23,120 --> 00:26:25,240 ABOVE, I THINK THE INVESTIGATOR 683 00:26:25,240 --> 00:26:26,520 AS A RESPONSIBILITY TO THINK 684 00:26:26,520 --> 00:26:28,720 ABOUT WHETHER THE SINGLE IRB IS 685 00:26:28,720 --> 00:26:30,280 APPROPRIATE OR NOT APPROPRIATE 686 00:26:30,280 --> 00:26:35,720 FOR THE STUDY, ESPECIALLY FOR 687 00:26:35,720 --> 00:26:38,120 MULTI-SITE STUDY. 688 00:26:38,120 --> 00:26:39,640 THIS PARAGRAPH PROPOSES OR 689 00:26:39,640 --> 00:26:44,280 POSITS COULD BE IN WIDELY 690 00:26:44,280 --> 00:26:46,920 VARYING GEOGRAPHIC AREAS WITH 691 00:26:46,920 --> 00:26:47,880 VARYING RESOURCE ALLOCATIONSES 692 00:26:47,880 --> 00:26:49,520 AVAILABLE FOR THESE KIDS 693 00:26:49,520 --> 00:26:49,840 ENROLLED. 694 00:26:49,840 --> 00:26:52,120 IT'S ALSO THE INSTITUTION WHERE 695 00:26:52,120 --> 00:26:53,680 THE INVESTIGATOR IS LOCATED 696 00:26:53,680 --> 00:26:56,320 BECAUSE THE OFFICIAL AND 697 00:26:56,320 --> 00:26:58,080 HIERARCHY, HRPP, HAS AN 698 00:26:58,080 --> 00:26:58,960 OBLIGATION, PLENARY OBLIGATION 699 00:26:58,960 --> 00:27:01,160 TO MAKE SURE THE RESEARCH IS 700 00:27:01,160 --> 00:27:04,320 BEING DONE APPROPRIATELY. 701 00:27:04,320 --> 00:27:06,280 THE FUNDER WOULD BE -- HOPEFULY 702 00:27:06,280 --> 00:27:07,920 THE FUNDER WHEN IT FUNDED THE 703 00:27:07,920 --> 00:27:09,800 PROPOSED STUDY WOULD THINK ALONG 704 00:27:09,800 --> 00:27:12,680 THE SAME LINES, IF THE FUNDER IS 705 00:27:12,680 --> 00:27:14,320 A FEDERAL AGENCY HOPEFULLY IT 706 00:27:14,320 --> 00:27:15,960 WOULD BE THINKING ALONG THOSE 707 00:27:15,960 --> 00:27:20,640 LINES AS WELL. 708 00:27:20,640 --> 00:27:23,160 ANY OF THOSE ENTITIES COULD 709 00:27:23,160 --> 00:27:25,560 BRING IT UP, AND THE LOCAL SITES 710 00:27:25,560 --> 00:27:27,520 IN A MULTI-SITE STUDY SHOULD BE 711 00:27:27,520 --> 00:27:29,160 TALKING ABOUT WHETHER THEY THINK 712 00:27:29,160 --> 00:27:32,680 THEY WANT TO SUBJECT THEMSELVES 713 00:27:32,680 --> 00:27:34,320 TO REVIEW WHEN THEY BELIEVE THEY 714 00:27:34,320 --> 00:27:35,320 HAVE UNIQUE LOCAL CIRCUMSTANCES 715 00:27:35,320 --> 00:27:37,640 THAT MIGHT NOT BE TAKEN INTO 716 00:27:37,640 --> 00:27:38,160 ACCOUNT. 717 00:27:38,160 --> 00:27:39,800 BUT THE BETTER IDEA WOULD BE TO 718 00:27:39,800 --> 00:27:40,920 USE THE SINGLE IRB BUT FIGURE 719 00:27:40,920 --> 00:27:43,320 OUT A WAY IN WHICH THE SINGLE 720 00:27:43,320 --> 00:27:45,720 IRB COULD TAKE ACCOUNT OF -- 721 00:27:45,720 --> 00:27:47,240 SUFFICIENT ACCOUNT OF THE LOCAL 722 00:27:47,240 --> 00:27:48,560 CONTEXT IN MAKING ITS 723 00:27:48,560 --> 00:27:49,560 DETERMINATIONS AND 724 00:27:49,560 --> 00:27:58,520 RECOMMENDATIONS ABOUT THE STUDY. 725 00:27:58,520 --> 00:28:01,240 >> ANY COMMENTS ON THAT PORTION? 726 00:28:01,240 --> 00:28:03,040 IN THE LAST PARAGRAPH AT LINE 727 00:28:03,040 --> 00:28:07,280 81, ONE OF THE THINGS THAT WE 728 00:28:07,280 --> 00:28:11,040 FLAGGED IN THE DRAFT GUIDANCE IS 729 00:28:11,040 --> 00:28:13,200 THE IDEA THAT -- OR THE 730 00:28:13,200 --> 00:28:14,120 SUGGESTION THE IRB MEMBERSHIP 731 00:28:14,120 --> 00:28:18,320 ITSELF AND DIVERSITY OF THAT 732 00:28:18,320 --> 00:28:20,560 MEMBERSHIP WOULD BE A MECHANISM 733 00:28:20,560 --> 00:28:23,480 FOR SOLVING LOCAL -- IS A 734 00:28:23,480 --> 00:28:26,560 MECHANISM FOR SOLVING LOCAL 735 00:28:26,560 --> 00:28:31,240 CONTEXT ISSUES, AND, YOU KNOW, 736 00:28:31,240 --> 00:28:35,520 AS WE KNOW A SINGLE IRB MAY BE 737 00:28:35,520 --> 00:28:36,680 DIVERSE IN ITS REPRESENTATION 738 00:28:36,680 --> 00:28:39,600 BUT FOLLOWING ON THE SCENARIO 739 00:28:39,600 --> 00:28:42,200 ABOVE, IT'S REALLY UNLIKELY THAT 740 00:28:42,200 --> 00:28:45,040 ANY SINGLE IRB COULD -- WOULD BE 741 00:28:45,040 --> 00:28:46,240 EXPECTED TO HAVE 742 00:28:46,240 --> 00:28:46,880 REPRESENTATIVENESS WITHIN ITS 743 00:28:46,880 --> 00:28:48,360 MEMBERSHIP TO COVER ALL OF THOSE 744 00:28:48,360 --> 00:28:51,160 ISSUES, TO HAVE THEM. 745 00:28:51,160 --> 00:28:52,240 SOME MIGHT SAY CERTAIN LOCAL 746 00:28:52,240 --> 00:28:53,360 IRBs DON'T HAVE ONE OF 747 00:28:53,360 --> 00:28:58,160 EVERYBODY ON THERE. 748 00:28:58,160 --> 00:29:02,200 SO, IT'S -- OUR CONCERN IS THAT 749 00:29:02,200 --> 00:29:04,960 THAT RELIANCE ON DIVERSITY OF 750 00:29:04,960 --> 00:29:06,480 MEMBERSHIP TO RESOLVE CONTEXT 751 00:29:06,480 --> 00:29:08,360 ISSUES IS PROBABLY SOMEWHAT 752 00:29:08,360 --> 00:29:08,760 MISPLACED. 753 00:29:08,760 --> 00:29:12,920 IT'S CERTAINLY A FACTOR BUT IT'S 754 00:29:12,920 --> 00:29:17,000 NOT-- IT IS NOT A MECHANISM THAT 755 00:29:17,000 --> 00:29:19,520 WILL BE THE SOLE WAY OF 756 00:29:19,520 --> 00:29:22,440 IDENTIFYING AND MANAGING LOCAL 757 00:29:22,440 --> 00:29:27,080 CONTEXT ISSUES. 758 00:29:27,080 --> 00:29:29,040 >> I CAN GIVE ANOTHER EXAMPLE OF 759 00:29:29,040 --> 00:29:30,680 THAT WHICH MIGHT BE AN 760 00:29:30,680 --> 00:29:31,560 INTERESTING EXAMPLE. 761 00:29:31,560 --> 00:29:34,280 THAT IS -- THIS ACTUALLY 762 00:29:34,280 --> 00:29:34,720 OCCURRED. 763 00:29:34,720 --> 00:29:36,320 KEVIN, YOU MAY HAVE BEEN 764 00:29:36,320 --> 00:29:36,800 INVOLVED. 765 00:29:36,800 --> 00:29:39,360 I FORGET. 766 00:29:39,360 --> 00:29:42,640 A STUDY FUNDED BY ONE OF THE 767 00:29:42,640 --> 00:29:44,640 INSTITUTES AT NIH OF SUBSTANCE 768 00:29:44,640 --> 00:29:46,240 ABUSE INTERVENTIONS IN MEN WHO 769 00:29:46,240 --> 00:29:48,280 HAVE SEX WITH MEN AROUND THE 770 00:29:48,280 --> 00:29:48,480 WORLD. 771 00:29:48,480 --> 00:29:49,920 SO THERE WERE FOUR OR FIVE 772 00:29:49,920 --> 00:29:55,720 DIFFERENT SITES, ONE IN 773 00:29:55,720 --> 00:29:57,920 THAILAND, TAIWAN, ONE IN PERHAPS 774 00:29:57,920 --> 00:29:58,280 NIGERIA. 775 00:29:58,280 --> 00:30:00,360 THE QUESTION THAT EMERGED IN THE 776 00:30:00,360 --> 00:30:01,840 STUDY WAS WHAT ARE THE LOCAL 777 00:30:01,840 --> 00:30:03,480 LAWS PERTAINING TO MEN WHO HAVE 778 00:30:03,480 --> 00:30:05,360 SEX WITH MEN, THE ACTIVITY OF 779 00:30:05,360 --> 00:30:07,440 MEN HAVING SEX WITH MEN, WHAT 780 00:30:07,440 --> 00:30:09,400 ARE THE LAWS IN REGARD TO 781 00:30:09,400 --> 00:30:11,160 SUBSTANCE ABUSE AND POSSESSION 782 00:30:11,160 --> 00:30:12,760 OF NARCOTICS IN THESE DIFFERENT 783 00:30:12,760 --> 00:30:14,560 COUNTRIES, AND ALL WOULD NEED TO 784 00:30:14,560 --> 00:30:17,320 BE TAKEN INTO ACCOUNT BY THE 785 00:30:17,320 --> 00:30:20,600 IRB, THIS IS INTERNATIONAL, BUT 786 00:30:20,600 --> 00:30:21,680 IT'S A COMPARABLE SITUATION. 787 00:30:21,680 --> 00:30:24,000 IF IT WERE A SINGLE IRB IT WOULD 788 00:30:24,000 --> 00:30:27,920 HAVE TO TAKE INTO ACCOUNT ALL 789 00:30:27,920 --> 00:30:29,120 THESE DIFFERENT SITUATIONS TO 790 00:30:29,120 --> 00:30:31,120 MAKE SURE SUBJECTS WERE 791 00:30:31,120 --> 00:30:32,200 APPROPRIATELY PROTECTED, PRIVACY 792 00:30:32,200 --> 00:30:33,160 PROTECTIONS WERE' APPROPRIATE 793 00:30:33,160 --> 00:30:34,560 AND ADEQUATE, THERE WAS 794 00:30:34,560 --> 00:30:35,280 AGREEMENT WITH LOCAL LAW 795 00:30:35,280 --> 00:30:38,560 ENFORCEMENT AUTHORITIES NOT TO 796 00:30:38,560 --> 00:30:41,720 USE STUDY RECORDS TO PROSECUTE 797 00:30:41,720 --> 00:30:44,000 ANYBODY CRIMINALLY, FOR EITHER 798 00:30:44,000 --> 00:30:47,960 SEXUAL ACTIVITY OR FOR THE USE 799 00:30:47,960 --> 00:30:49,160 OR POSSESSION OF CONTROLLED 800 00:30:49,160 --> 00:30:50,880 SUBSTANCES UNDER THE LOCAL 801 00:30:50,880 --> 00:30:51,360 JURISDICTION. 802 00:30:51,360 --> 00:30:53,880 AND IN THIS CASE, ALTHOUGH IT 803 00:30:53,880 --> 00:30:54,960 WAS INTERNATIONAL CONTEXT, IT 804 00:30:54,960 --> 00:30:56,920 WAS AN AMERICAN INSTITUTION THAT 805 00:30:56,920 --> 00:31:01,080 WAS THE PRIMARY -- THAT WAS THE 806 00:31:01,080 --> 00:31:04,800 PRIME AWARDEE, SO THAT IRB IN 807 00:31:04,800 --> 00:31:06,960 APPROVING THE STUDY HAVE TO TAKE 808 00:31:06,960 --> 00:31:07,960 ACCOUNT OF LOCAL CONTEXTS EVEN 809 00:31:07,960 --> 00:31:09,720 THOSE THERE WERE LOCAL IRBs 810 00:31:09,720 --> 00:31:09,960 INVOLVED. 811 00:31:09,960 --> 00:31:11,680 JUST ANOTHER EXAMPLE OF THE FACT 812 00:31:11,680 --> 00:31:13,320 THAT THERE'S NO WAY THAT 813 00:31:13,320 --> 00:31:15,840 EITHER -- THAT AN IRB WOULD HAVE 814 00:31:15,840 --> 00:31:16,760 SUFFICIENT EXPERTISE WITHIN THE 815 00:31:16,760 --> 00:31:18,360 MEMBERSHIP EVEN IF IT HAD A 816 00:31:18,360 --> 00:31:19,880 DIVERSE MEMBERSHIP TO BE ABLE TO 817 00:31:19,880 --> 00:31:28,320 UNDERSTAND ALL OF THESE FACTORS. 818 00:31:28,320 --> 00:31:28,960 >> WALTER? 819 00:31:28,960 --> 00:31:31,720 >> SO -- THANK YOU, MARK AND 820 00:31:31,720 --> 00:31:31,920 DAVID. 821 00:31:31,920 --> 00:31:35,320 TO THAT POINT, I THINK THE 822 00:31:35,320 --> 00:31:36,160 ASSUMPTION THAT HAVING DIVERSITY 823 00:31:36,160 --> 00:31:38,400 WITHIN THE IRB IS GOING TO BE 824 00:31:38,400 --> 00:31:39,800 SUFFICIENT, YOU MADE THE CASE 825 00:31:39,800 --> 00:31:41,880 THAT'S NOT GOING TO BE 826 00:31:41,880 --> 00:31:44,840 SUFFICIENT. 827 00:31:44,840 --> 00:31:47,800 WOULD IT BE CONSIDERED TO BE 828 00:31:47,800 --> 00:31:50,280 OVERLY PRESCRIPTIVE TO PROVIDE A 829 00:31:50,280 --> 00:31:52,720 POINTS TO CONSIDER FOR 830 00:31:52,720 --> 00:31:54,600 DETERMINING WHETHER OR NOT A 831 00:31:54,600 --> 00:31:56,800 CENTRAL -- YOU KNOW, A SINGLE 832 00:31:56,800 --> 00:31:59,840 IRB WOULD BE APPROPRIATE OR NOT? 833 00:31:59,840 --> 00:32:03,800 >> YEAH, I THINK SO, WALTER. 834 00:32:03,800 --> 00:32:08,360 IN FACT, YOU GET TO THE 835 00:32:08,360 --> 00:32:10,240 EXCEPTION CRITERIA ON LINE 180, 836 00:32:10,240 --> 00:32:12,080 THAT'S WHAT WE'RE TRYING TO 837 00:32:12,080 --> 00:32:12,760 ACCOMMODATE. 838 00:32:12,760 --> 00:32:14,080 THERE ARE TWO SOLUTIONS, ONE TO 839 00:32:14,080 --> 00:32:15,960 FIGURE OUT WHETHER THERE COULD 840 00:32:15,960 --> 00:32:18,560 BE EXPERTISE BROUGHT TO BEAR IN 841 00:32:18,560 --> 00:32:20,120 A SINGLE IRB THAT'S SUFFICIENT 842 00:32:20,120 --> 00:32:23,920 TO TAKE INTO ACCOUNT LOCAL 843 00:32:23,920 --> 00:32:24,880 CONTEXT, THE OTHER OPTION IS NOT 844 00:32:24,880 --> 00:32:26,200 TO HAVE A SINGLE IRB. 845 00:32:26,200 --> 00:32:32,000 THEY ARE POINTS TO CONSIDER IN 846 00:32:32,000 --> 00:32:34,240 REGARD TO BOTH ALTERNATIVES. 847 00:32:34,240 --> 00:32:34,480 >> SKIP? 848 00:32:34,480 --> 00:32:35,680 >> THE LINE WE'RE QUESTIONING IN 849 00:32:35,680 --> 00:32:37,080 THE DISCUSSION IS TOUCHING ON 850 00:32:37,080 --> 00:32:39,680 THE ONE QUESTION I HAD, WHICH 851 00:32:39,680 --> 00:32:41,480 AROSE ON THOSE THREE EXCEPTIONS 852 00:32:41,480 --> 00:32:43,000 THAT YOU PROVIDED. 853 00:32:43,000 --> 00:32:49,960 WHICH WERE -- WHICH IS PROCESS. 854 00:32:49,960 --> 00:32:52,160 I AGREE WITH EVERYTHING YOU'RE 855 00:32:52,160 --> 00:32:54,000 SAYING, I AGREE EVERYONE SHOULD 856 00:32:54,000 --> 00:32:55,000 HAVE RESPONSIBILITY BUT WHAT'S 857 00:32:55,000 --> 00:32:56,120 THE PROCESS, HOW WOULD YOU MAKE 858 00:32:56,120 --> 00:33:00,040 A DECISION? 859 00:33:00,040 --> 00:33:01,920 I WONDER IF THE INVESTIGATOR IN 860 00:33:01,920 --> 00:33:03,120 THE LEAD INSTITUTION CONSULTS 861 00:33:03,120 --> 00:33:04,720 WITH THEIR IRB OR SINGLE IRB 862 00:33:04,720 --> 00:33:06,040 THAT PERHAPS IT WOULD BE 863 00:33:06,040 --> 00:33:07,600 APPROPRIATE FOR THAT SINGLE IRB 864 00:33:07,600 --> 00:33:09,800 TO SAY, THERE'S NO WAY WE CAN 865 00:33:09,800 --> 00:33:11,880 POSSIBLY HAVE THE EXPERTISE IN 866 00:33:11,880 --> 00:33:15,120 THAT EXAMPLE, THE EXAMPLE YOU'RE 867 00:33:15,120 --> 00:33:15,480 GIVING. 868 00:33:15,480 --> 00:33:15,920 >> RIGHT. 869 00:33:15,920 --> 00:33:18,280 >> IT COULD BE JUST ONE SENTENCE 870 00:33:18,280 --> 00:33:20,600 THAT TALKS ABOUT, YOU KNOW, THAT 871 00:33:20,600 --> 00:33:20,840 PROCESS. 872 00:33:20,840 --> 00:33:23,240 I PERSONALLY WOULD BE MORE 873 00:33:23,240 --> 00:33:26,600 COMFORTABLE IF IT WAS THE, YOU 874 00:33:26,600 --> 00:33:27,960 KNOW, THE INITIAL DESIGNATION 875 00:33:27,960 --> 00:33:29,160 THE POTENTIALLY SINGLE IRB WHO 876 00:33:29,160 --> 00:33:31,600 SAID NO WAY CAN WE TOUCH ALL 877 00:33:31,600 --> 00:33:34,120 THESE ISSUES RATHER THAN THE 878 00:33:34,120 --> 00:33:35,680 INVESTIGATOR OR THE INSTITUTION. 879 00:33:35,680 --> 00:33:37,000 SO THAT'S A POINT FOR DISCUSSION 880 00:33:37,000 --> 00:33:38,760 BUT I DIDN'T SEE ANYTHING THAT 881 00:33:38,760 --> 00:33:40,080 WOULD SAY, WELL, AT THE END OF 882 00:33:40,080 --> 00:33:41,400 THE DAY THIS IS, YOU KNOW, WHO 883 00:33:41,400 --> 00:33:49,920 IS GOING TO MAKE THIS DECISION. 884 00:33:49,920 --> 00:33:53,320 >> I THINK LINDA -- 885 00:33:53,320 --> 00:33:53,720 (INDISCERNIBLE). 886 00:33:53,720 --> 00:33:55,800 >> I WAS GOING TO TRY TO ADDRESS 887 00:33:55,800 --> 00:33:57,160 YOUR COMMENT, LOOKING AT 888 00:33:57,160 --> 00:33:59,680 LINES -- LET'S MAKE SURE IT'S 889 00:33:59,680 --> 00:34:01,880 RIGHT, 102 TO 105 TALKING ABOUT 890 00:34:01,880 --> 00:34:03,760 THE RESEARCH INSTITUTION, ANY 891 00:34:03,760 --> 00:34:07,040 DECISION ABOUT CONDUCTING 892 00:34:07,040 --> 00:34:08,640 ADDITIONAL LOCAL IRB REVIEW, 893 00:34:08,640 --> 00:34:12,360 IT'S DIFFICULT TO HAVE A SINGLE 894 00:34:12,360 --> 00:34:14,120 DESCRIBED PROCESS BECAUSE THE 895 00:34:14,120 --> 00:34:15,760 DECISIONS WILL DEPEND ON CONTEXT 896 00:34:15,760 --> 00:34:16,720 OF THE STUDY. 897 00:34:16,720 --> 00:34:18,840 AND SO I AGREE MAYBE YOU MIGHT 898 00:34:18,840 --> 00:34:20,480 WANT TO MAKE A STATEMENT THAT 899 00:34:20,480 --> 00:34:22,880 STATES YOU SHOULD HAVE A DEFINED 900 00:34:22,880 --> 00:34:24,400 PROCESS BECAUSE IF YOU DON'T, 901 00:34:24,400 --> 00:34:25,920 THIS COULD GO SIDEWAYS VERY 902 00:34:25,920 --> 00:34:27,920 QUICKLY, IF YOU DON'T HAVE THAT. 903 00:34:27,920 --> 00:34:30,120 BUT I THINK THAT STARTS TO TOUCH 904 00:34:30,120 --> 00:34:34,400 UPON THE FACT THAT IT'S NOT 905 00:34:34,400 --> 00:34:36,360 GOING TO BE ONE-SIZE-FITS-ALL 906 00:34:36,360 --> 00:34:37,080 PROCESS. 907 00:34:37,080 --> 00:34:38,760 MAYBE I'M MISINTERPRETING WHAT 908 00:34:38,760 --> 00:34:39,760 YOU'RE ASKING. 909 00:34:39,760 --> 00:34:41,440 >> MAYBE I CAN CLARIFY. 910 00:34:41,440 --> 00:34:46,240 I READ THAT SENTENCE AS TALKING 911 00:34:46,240 --> 00:34:48,680 ABOUT A SITE MAKING A DECISION 912 00:34:48,680 --> 00:34:52,160 ABOUT ADDITIONAL INTERNAL IRB 913 00:34:52,160 --> 00:34:53,960 REVIEW AS OPPOSED TO, YOU KNOW, 914 00:34:53,960 --> 00:34:56,160 THE QUESTION AS TO WHETHER OR 915 00:34:56,160 --> 00:34:57,040 NOT THE RESPONSIBLE PARTY, 916 00:34:57,040 --> 00:34:59,880 HAVING COME OUT OF THE FDA, I 917 00:34:59,880 --> 00:35:01,200 THINK THERE IS THE RESPONSIBLE 918 00:35:01,200 --> 00:35:02,840 PARTY, WHETHER IT'S THE FUNDER, 919 00:35:02,840 --> 00:35:05,680 THE HOLDER OF THE FUNDS FOR THAT 920 00:35:05,680 --> 00:35:07,320 INITIAL INSTITUTION, THAT THAT 921 00:35:07,320 --> 00:35:09,200 INSTITUTION THERE BE A PROCESS 922 00:35:09,200 --> 00:35:10,400 BY WHICH THAT INSTITUTION SAYS 923 00:35:10,400 --> 00:35:16,160 WE DO NOT THINK A SINGLE IRB IS 924 00:35:16,160 --> 00:35:16,440 APPROPRIATE. 925 00:35:16,440 --> 00:35:19,040 YOU KNOW, AND THAT COULD BE AN 926 00:35:19,040 --> 00:35:20,320 IRB WHO WOULD THEN SAY, YOU 927 00:35:20,320 --> 00:35:22,160 KNOW, WE DON'T THINK A SINGLE 928 00:35:22,160 --> 00:35:23,160 IRB IS APPROPRIATE HERE. 929 00:35:23,160 --> 00:35:24,480 I AGREE WITH EVERY EXAMPLE 930 00:35:24,480 --> 00:35:24,960 YOU'VE GIVEN. 931 00:35:24,960 --> 00:35:27,760 THAT WOULD BE A DAUNTING TASK 932 00:35:27,760 --> 00:35:30,400 FOR ANY IRB TO DO ON THEIR OWN. 933 00:35:30,400 --> 00:35:32,360 SO THAT'S WHAT I WAS SUGGESTING. 934 00:35:32,360 --> 00:35:35,120 I SEE THIS MORE AS A PROCESS BY 935 00:35:35,120 --> 00:35:36,200 WHICH YOU DECIDE WHAT YOU'RE 936 00:35:36,200 --> 00:35:37,720 DOING AT YOUR INSTITUTION IF 937 00:35:37,720 --> 00:35:39,080 YOU'RE ASKED TO PARTICIPATE, 938 00:35:39,080 --> 00:35:40,360 WHICH IS DIFFERENT. 939 00:35:40,360 --> 00:35:44,560 >> YEAH, I MEAN, I AGREE. 940 00:35:44,560 --> 00:35:45,480 I THINK THAT'S CORRECT. 941 00:35:45,480 --> 00:35:46,760 IF WE COULD MAKE THAT CLEAR IN 942 00:35:46,760 --> 00:35:47,840 THE DOCUMENT THAT WOULD BE 943 00:35:47,840 --> 00:35:48,360 HELPFUL. 944 00:35:48,360 --> 00:35:51,840 I DON'T THINK THESE ARE -- THESE 945 00:35:51,840 --> 00:35:54,080 ARE EITHER/OR. 946 00:35:54,080 --> 00:35:54,680 ACCOMMODATE BOTH. 947 00:35:54,680 --> 00:35:58,960 >> NO WAY YOU'RE GOING TO GIVE 948 00:35:58,960 --> 00:36:00,600 ALL THE POINTS TO CONSIDER, THAT 949 00:36:00,600 --> 00:36:02,920 WOULD BE A DAUNTING TASK AS 950 00:36:02,920 --> 00:36:05,280 WELL. 951 00:36:05,280 --> 00:36:06,760 >> I HAD TWO COMMENTS RELATING 952 00:36:06,760 --> 00:36:09,240 TO THAT PARAGRAPH THAT ENDS IN 953 00:36:09,240 --> 00:36:10,120 LINE 90. 954 00:36:10,120 --> 00:36:11,960 AND I'LL GO TO MY SECOND LINE 955 00:36:11,960 --> 00:36:15,800 BECAUSE IT RELATES TO THIS 956 00:36:15,800 --> 00:36:16,160 CONVERSATION. 957 00:36:16,160 --> 00:36:19,080 AND WHAT I HAD -- I APPRECIATE 958 00:36:19,080 --> 00:36:21,480 THIS DISCUSSION ABOUT PROCESS TO 959 00:36:21,480 --> 00:36:25,320 KNOW HOW THEY ARE GOING TO 960 00:36:25,320 --> 00:36:28,280 DECIDE, WHETHER ADDITIONAL 961 00:36:28,280 --> 00:36:31,240 IRB -- LOCAL IRB INFORMATION IS 962 00:36:31,240 --> 00:36:32,080 IMPORTANT FOR PROVIDING 963 00:36:32,080 --> 00:36:33,400 INFORMATION ABOUT THE LOCAL 964 00:36:33,400 --> 00:36:33,640 CONTEXT. 965 00:36:33,640 --> 00:36:35,280 I WONDERED ABOUT THIS LAST, 966 00:36:35,280 --> 00:36:36,800 BEFORE, I HADN'T BEEN THINKING 967 00:36:36,800 --> 00:36:37,680 ABOUT PROCESS, JUST THINKING 968 00:36:37,680 --> 00:36:39,200 ABOUT THE KIND OF PUTTING IN A 969 00:36:39,200 --> 00:36:43,000 LITTLE BIT OF A MORE NORMATIVE 970 00:36:43,000 --> 00:36:47,400 STATEMENT IN THIS LINE BEGINNING 971 00:36:47,400 --> 00:36:47,760 89. 972 00:36:47,760 --> 00:36:50,160 NONETHELESS SACHRP AGREES WITH 973 00:36:50,160 --> 00:36:51,240 ADVISING THAT THE INSTITUTION 974 00:36:51,240 --> 00:36:54,400 CAN PROVIDE THE SINGLE IRB 975 00:36:54,400 --> 00:36:55,520 ADDITIONAL INFORMATION REGARDING 976 00:36:55,520 --> 00:36:57,920 LOCAL CONTEXT, THAT SEEMS SO 977 00:36:57,920 --> 00:37:01,320 NEUTRAL AFTER -- IT'S ALSO 978 00:37:01,320 --> 00:37:03,280 AWKWARD ADVISING THE LINE -- I 979 00:37:03,280 --> 00:37:04,600 COULDN'T FIGURE OUT WHAT IT WAS 980 00:37:04,600 --> 00:37:07,240 SAYING, WONDERED IF IT MIGHT 981 00:37:07,240 --> 00:37:12,520 SAY, YOU KNOW, SOMETHING LIKE 982 00:37:12,520 --> 00:37:14,560 THE SACHRP AGREES THAT THE 983 00:37:14,560 --> 00:37:17,000 RELYING INSTITUTION CAN PROVIDE 984 00:37:17,000 --> 00:37:18,720 AND SHOULD PROVIDE, YOU KNOW, 985 00:37:18,720 --> 00:37:21,160 AND THAT NEEDS TO BE FURTHER 986 00:37:21,160 --> 00:37:22,480 DEFINED, SHOULD PROVIDE IN 987 00:37:22,480 --> 00:37:25,200 CERTAIN CONTEXT OR SOMETHING. 988 00:37:25,200 --> 00:37:26,920 AND THEN MAYBE IF THERE NEEDS TO 989 00:37:26,920 --> 00:37:28,920 BE ANOTHER SENTENCE OR SOMETHING 990 00:37:28,920 --> 00:37:33,040 ABOUT PROCESS IT COULD GO RIGHT 991 00:37:33,040 --> 00:37:33,920 AFTER THAT. 992 00:37:33,920 --> 00:37:34,920 I HAD A SLIGHT CHANGE. 993 00:37:34,920 --> 00:37:36,920 I DON'T KNOW IF WE'RE DOWN -- 994 00:37:36,920 --> 00:37:40,320 IT'S NOT A CORRECTION. 995 00:37:40,320 --> 00:37:44,680 IT'S A SUBSTANTIVE. 996 00:37:44,680 --> 00:37:47,400 LINE 86 TALKING ABOUT THE 997 00:37:47,400 --> 00:37:47,960 SCENARIO ABOUT TRANSGENDER 998 00:37:47,960 --> 00:37:50,240 TEENAGERS I.E. SINGLE IRB IS 999 00:37:50,240 --> 00:37:53,760 REVIEWING A MULTI-SITE STUDY ON 1000 00:37:53,760 --> 00:37:55,280 TRANSGENDERED TEENAGERS AND 1001 00:37:55,280 --> 00:37:56,800 MULTIPLE COMMUNITIES WITH 1002 00:37:56,800 --> 00:37:57,800 SIGNIFICANT VARIATIONS IN 1003 00:37:57,800 --> 00:37:59,200 CULTURAL VALUES AMONG THOSE 1004 00:37:59,200 --> 00:37:59,480 COMMUNITIES. 1005 00:37:59,480 --> 00:38:02,320 I HAD AN OBJECTION TO CALLING IT 1006 00:38:02,320 --> 00:38:03,680 CULTURAL VALUES. 1007 00:38:03,680 --> 00:38:06,840 AND SO I WANTED TO SUGGEST THAT 1008 00:38:06,840 --> 00:38:08,720 WE CHANGE THAT BACK TO ACTUALLY 1009 00:38:08,720 --> 00:38:11,680 WHAT HAD BEEN SAID IN THE 1010 00:38:11,680 --> 00:38:14,400 SCENARIO, AND SAY THE 1011 00:38:14,400 --> 00:38:16,000 SIGNIFICANT VARIATIONS IN 1012 00:38:16,000 --> 00:38:17,600 ACCEPTANCE AND SUPPORT SERVICES. 1013 00:38:17,600 --> 00:38:20,200 SO WE'RE NOT CALLING -- WE'RE 1014 00:38:20,200 --> 00:38:22,120 NOT SHORTHANDING THAT 1015 00:38:22,120 --> 00:38:23,000 DESCRIPTION INTO CULTURAL 1016 00:38:23,000 --> 00:38:25,760 VALUES. 1017 00:38:25,760 --> 00:38:27,880 >> THAT'S FINE. 1018 00:38:27,880 --> 00:38:28,160 >> OKAY. 1019 00:38:28,160 --> 00:38:37,240 >> I ECHO THAT LAST POINT. 1020 00:38:37,240 --> 00:38:37,360 1021 00:38:37,360 --> 00:38:38,920 >> THANK YOU. 1022 00:38:38,920 --> 00:38:40,040 JYOTI? 1023 00:38:40,040 --> 00:38:41,560 >> SO, IF THE LOCAL IRB DOES GET 1024 00:38:41,560 --> 00:38:43,760 IN TOUCH WITH THE SINGLE IRB AND 1025 00:38:43,760 --> 00:38:47,240 SAYS HERE IS THE ISSUES, THE 1026 00:38:47,240 --> 00:38:49,240 SINGLE IRB SAYS YES, WE CAN 1027 00:38:49,240 --> 00:38:51,720 PROVIDE OR WE HAVE EXPERTISE, WE 1028 00:38:51,720 --> 00:38:55,800 DON'T KNOW WE HAVE EXPERTISE, 1029 00:38:55,800 --> 00:38:57,960 CAN YOU HELP? 1030 00:38:57,960 --> 00:38:59,840 WHAT DO WE SEE, IS THAT A 1031 00:38:59,840 --> 00:39:01,400 PERSON, AN INDIVIDUAL FROM THE 1032 00:39:01,400 --> 00:39:03,200 LOCAL IRB WOULD SERVE AS 1033 00:39:03,200 --> 00:39:03,520 CONSULTANT? 1034 00:39:03,520 --> 00:39:05,400 AM I GOING INTO THE WEEDS HERE 1035 00:39:05,400 --> 00:39:05,600 MAYBE? 1036 00:39:05,600 --> 00:39:08,160 I'M TRYING TO THINK WHAT WOULD 1037 00:39:08,160 --> 00:39:08,680 THAT LOOK LIKE. 1038 00:39:08,680 --> 00:39:10,120 >> I THINK IT COULD WORK IN A 1039 00:39:10,120 --> 00:39:11,640 NUMBER OF WAYS. 1040 00:39:11,640 --> 00:39:16,920 ONE SIMPLE ONE WOULD BE IN 1041 00:39:16,920 --> 00:39:19,240 PUTTING TOGETHER A PROCESS FOR 1042 00:39:19,240 --> 00:39:21,400 ACTING AS A SINGLE IRB THAT PART 1043 00:39:21,400 --> 00:39:23,240 OF THE INFORMATION SOLICITED 1044 00:39:23,240 --> 00:39:27,080 FROM THE RELYING SITES HAS 1045 00:39:27,080 --> 00:39:28,040 QUESTIONS ABOUT ARE THERE 1046 00:39:28,040 --> 00:39:29,920 CONTEXTUAL ISSUES RELEVANT TO 1047 00:39:29,920 --> 00:39:31,480 THE REVIEWING ISSUE AND THEY 1048 00:39:31,480 --> 00:39:34,960 SHOULD BE AWARE OF AND WHETHER 1049 00:39:34,960 --> 00:39:36,800 THAT HAS A TRIGGER WHERE IT 1050 00:39:36,800 --> 00:39:39,200 MIGHT ACTUALLY INVOLVE AN 1051 00:39:39,200 --> 00:39:41,040 IN-PERSON CONSULTATION BY THE 1052 00:39:41,040 --> 00:39:42,720 LOCAL P.I. OR REPRESENTATIVE OF 1053 00:39:42,720 --> 00:39:45,040 THE LOCAL IRB, IT WOULD DEPEND. 1054 00:39:45,040 --> 00:39:46,520 I COULD IMAGINE MECHANISMS LIKE 1055 00:39:46,520 --> 00:39:46,840 THAT. 1056 00:39:46,840 --> 00:39:49,640 CERTAINLY AT A MINIMUM HAVING 1057 00:39:49,640 --> 00:39:51,360 QUESTIONS THAT ASK ABOUT ANY 1058 00:39:51,360 --> 00:39:54,320 SITE-SPECIFIC CONCERNS THAT ARE 1059 00:39:54,320 --> 00:39:56,240 RELEVANT TO THE IRB IS -- THAT'S 1060 00:39:56,240 --> 00:39:57,360 AN EASY STARTING POINT. 1061 00:39:57,360 --> 00:39:59,560 YOU KNOW, HOW IT MIGHT ESCALATE 1062 00:39:59,560 --> 00:40:01,880 COULD TAKE A FEW DIFFERENT 1063 00:40:01,880 --> 00:40:02,440 PATHWAYS. 1064 00:40:02,440 --> 00:40:02,760 LINDA? 1065 00:40:02,760 --> 00:40:04,920 >> I WAS GOING TO SAY A NUMBER 1066 00:40:04,920 --> 00:40:06,440 OF INSTITUTIONS, I CAN'T SAY FOR 1067 00:40:06,440 --> 00:40:09,400 ALL, THERE'S A GATE KEEPER 1068 00:40:09,400 --> 00:40:09,920 PROCESS. 1069 00:40:09,920 --> 00:40:11,520 HRPP, THE GATE KEEPER. 1070 00:40:11,520 --> 00:40:13,600 WHEN INVOLVING A SINGLE IRB 1071 00:40:13,600 --> 00:40:16,200 THAT'S EXTERNAL TO THE 1072 00:40:16,200 --> 00:40:18,160 INSTITUTION, WE TYPICALLY DON'T 1073 00:40:18,160 --> 00:40:19,920 INVOLVE AN IRB STAFF AND 1074 00:40:19,920 --> 00:40:20,240 MEMBERS. 1075 00:40:20,240 --> 00:40:22,760 WE HAVE DEDICATED PEOPLE THAT 1076 00:40:22,760 --> 00:40:26,480 WORK WITH THAT EXTERNAL IRB OR 1077 00:40:26,480 --> 00:40:27,280 LOCAL IRB. 1078 00:40:27,280 --> 00:40:29,000 AND ASKING A SERIES OF 1079 00:40:29,000 --> 00:40:29,920 QUESTIONS, IF THERE'S 1080 00:40:29,920 --> 00:40:31,080 CONSULTATION IT'S NO DIFFERENT 1081 00:40:31,080 --> 00:40:33,800 THAN IF YOU NEED EXPERTISE WOULD 1082 00:40:33,800 --> 00:40:37,760 GET THE EXPERTISE, SIMILAR TO 1083 00:40:37,760 --> 00:40:39,080 INTERNATIONAL CONTEXT IF I'M 1084 00:40:39,080 --> 00:40:39,960 COMMUNICATING WITH INTERNATIONAL 1085 00:40:39,960 --> 00:40:43,200 SITES WE MAY HAVE TO GET 1086 00:40:43,200 --> 00:40:44,320 CONTEXTUAL INFORMATION TO 1087 00:40:44,320 --> 00:40:45,760 CONDUCT THE REVIEW. 1088 00:40:45,760 --> 00:40:47,520 TYPICALLY THAT'S HOW IT'S DONE. 1089 00:40:47,520 --> 00:40:53,200 YOU SHOULD HAVE A GATE KEEPER 1090 00:40:53,200 --> 00:40:53,960 PROCESS. 1091 00:40:53,960 --> 00:40:56,800 SOME INSTITUTIONS MAY HAVE THEIR 1092 00:40:56,800 --> 00:40:59,000 STRUCTURES SUCH THAT PEOPLE WEAR 1093 00:40:59,000 --> 00:41:01,640 MULTIPLE HATS, SO KEEPING 1094 00:41:01,640 --> 00:41:04,240 THOSE -- UNDERSTANDING HRPP 1095 00:41:04,240 --> 00:41:05,440 FUNCTION VERSUS IRB FUNCTION IS 1096 00:41:05,440 --> 00:41:05,800 IMPORTANT. 1097 00:41:05,800 --> 00:41:08,400 AT A LARGE INSTITUTION WHERE I 1098 00:41:08,400 --> 00:41:09,640 COME FROM WE DIFFERENTIATE THAT. 1099 00:41:09,640 --> 00:41:10,920 THAT'S HOW IT WORKS. 1100 00:41:10,920 --> 00:41:14,320 SO THERE IS A VERY ROBUST 1101 00:41:14,320 --> 00:41:15,960 PROCESS, SIMILAR TO HOW EXTERNAL 1102 00:41:15,960 --> 00:41:19,000 IRBs AND COMMERCIAL IRBs 1103 00:41:19,000 --> 00:41:19,400 OPERATE, MODEL THAT. 1104 00:41:19,400 --> 00:41:22,200 A LOT OF PEOPLE MODEL THAT. 1105 00:41:22,200 --> 00:41:22,720 >> SKIP? 1106 00:41:22,720 --> 00:41:25,560 >> BASED ON WHAT YOU JUST SAID, 1107 00:41:25,560 --> 00:41:26,880 LINDA, MODIFY MY ORIGINAL 1108 00:41:26,880 --> 00:41:27,240 COMMENTS. 1109 00:41:27,240 --> 00:41:31,360 IT WOULD BE REASONABLE THAT THE 1110 00:41:31,360 --> 00:41:33,200 RESPONSIBLE HRPP AND/OR IRB, IT 1111 00:41:33,200 --> 00:41:36,440 WOULDN'T BOTHER ME, FOR EXAMPLE, 1112 00:41:36,440 --> 00:41:38,720 IF YALE WAS THE GRANTEE AND YOU 1113 00:41:38,720 --> 00:41:40,920 MADE A DECISION IN AN HRPP 1114 00:41:40,920 --> 00:41:43,080 PROCESS TO SAY WE'LL NOT RELY ON 1115 00:41:43,080 --> 00:41:44,640 THE SINGLE IRB BECAUSE OF THIS, 1116 00:41:44,640 --> 00:41:46,720 THAT, THE OTHER REASON. 1117 00:41:46,720 --> 00:41:51,000 I DON'T THINK IT HAS TO BE THE 1118 00:41:51,000 --> 00:41:52,400 IRB PER SE. 1119 00:41:52,400 --> 00:41:54,680 >> WITHIN AN INSTITUTION, THE 1120 00:41:54,680 --> 00:41:55,720 WAY IT WORKS -- 1121 00:41:55,720 --> 00:41:57,840 >> I'M SORRY. 1122 00:41:57,840 --> 00:41:59,360 THE LIGHT AROUND THE TOP OF YOUR 1123 00:41:59,360 --> 00:42:01,560 MIC, I DON'T THINK YOUR MIC IS 1124 00:42:01,560 --> 00:42:02,560 WORKING AND I'M GETTING 1125 00:42:02,560 --> 00:42:04,560 COMPLAINTS ON THE PUBLIC FEED 1126 00:42:04,560 --> 00:42:05,280 IT'S TOO SOFT. 1127 00:42:05,280 --> 00:42:12,600 DO YOU WANT TO SIT HERE? 1128 00:42:12,600 --> 00:42:12,960 >> YEAH. 1129 00:42:12,960 --> 00:42:13,320 (INDISCERNIBLE). 1130 00:42:13,320 --> 00:42:15,400 >> I WON'T BE ABLE TO PUT THIS 1131 00:42:15,400 --> 00:42:21,960 IN FRONT OF ME. 1132 00:42:21,960 --> 00:42:32,160 >> HERE. 1133 00:42:32,840 --> 00:42:32,920 1134 00:42:32,920 --> 00:42:34,280 >> THE WAY THIS ACTUALLY WORKS, 1135 00:42:34,280 --> 00:42:36,840 THERE ARE A NUMBER OF TOLL GATES 1136 00:42:36,840 --> 00:42:38,280 AT INSTITUTIONS, IT'S THE 1137 00:42:38,280 --> 00:42:39,280 INVESTIGATOR WHO HAS TO WRITE 1138 00:42:39,280 --> 00:42:41,320 THE GRANT AND THE INVESTIGATOR 1139 00:42:41,320 --> 00:42:42,720 IS GOING TO THINK ABOUT THESE 1140 00:42:42,720 --> 00:42:45,360 THINGS WHEN HE OR SHE WRITES THE 1141 00:42:45,360 --> 00:42:46,320 GRANT TO PUT IN THERE FOR 1142 00:42:46,320 --> 00:42:48,000 EXAMPLE THEY DON'T WANT TO USE A 1143 00:42:48,000 --> 00:42:49,640 SINGLE IRB AND NEED TO PUT IN 1144 00:42:49,640 --> 00:42:51,320 REASONS WHY NOT, THAT WOULD 1145 00:42:51,320 --> 00:42:53,160 PRESUMABLY GO IN THE PROPOSAL TO 1146 00:42:53,160 --> 00:42:54,400 THE FUNDING AGENCY FOR IT TO SEE 1147 00:42:54,400 --> 00:42:56,200 THAT THAT WAS WHAT WAS PROPOSED 1148 00:42:56,200 --> 00:42:57,320 OR NOT PROPOSED. 1149 00:42:57,320 --> 00:43:00,120 AND THAT'S ONE PIECE OF IT. 1150 00:43:00,120 --> 00:43:02,920 THEN THE SUB-AWARDEE P.I.s, IF 1151 00:43:02,920 --> 00:43:04,000 THE GRANT IS APPROVED, THEY ARE 1152 00:43:04,000 --> 00:43:06,240 GOING TO HAVE TO -- IF THERE'S A 1153 00:43:06,240 --> 00:43:08,160 SINGLE IRB, WHATEVER IS SAID IN 1154 00:43:08,160 --> 00:43:10,480 THE GRANT APPLICATION AND 1155 00:43:10,480 --> 00:43:11,480 APPROVED BY FUNDING AGENCY, 1156 00:43:11,480 --> 00:43:12,320 SPECIAL AWARD TERMS AND 1157 00:43:12,320 --> 00:43:14,080 CONDITIONS, THEY ARE GOING TO 1158 00:43:14,080 --> 00:43:16,480 NEED TO MAKE SURE THAT THEY 1159 00:43:16,480 --> 00:43:19,880 AGREE AS AN ETHICAL MATTER AND 1160 00:43:19,880 --> 00:43:21,960 MORAL MATTER, BASED ON THEIR 1161 00:43:21,960 --> 00:43:23,280 PERCEPTION OF WHETHER LOCAL 1162 00:43:23,280 --> 00:43:24,760 CONTEXT CAN BE TAKEN 1163 00:43:24,760 --> 00:43:26,120 SUFFICIENTLY INTO ACCOUNT. 1164 00:43:26,120 --> 00:43:27,400 SO THERE'S THE INVESTIGATOR 1165 00:43:27,400 --> 00:43:28,280 SIDE. 1166 00:43:28,280 --> 00:43:30,160 THEN THERE'S THE HRPP SIDE OF 1167 00:43:30,160 --> 00:43:31,920 ALL THIS BECAUSE EVEN IF THE 1168 00:43:31,920 --> 00:43:33,640 INVESTIGATOR THINKS ONE THING, 1169 00:43:33,640 --> 00:43:36,040 THE HRPP AND/OR IRB IF THERE IS 1170 00:43:36,040 --> 00:43:37,960 NO HRPP AT THE INSTITUTION, THEY 1171 00:43:37,960 --> 00:43:38,480 HAVE TO AGREE. 1172 00:43:38,480 --> 00:43:40,640 THERE'S GOING TO BE A 1173 00:43:40,640 --> 00:43:42,240 CONSULTATION PROCESS BETWEEN THE 1174 00:43:42,240 --> 00:43:44,400 INVESTIGATOR AT THE CENTRAL SITE 1175 00:43:44,400 --> 00:43:47,480 AND THE INVESTIGATORS AND THEIR 1176 00:43:47,480 --> 00:43:49,440 HRPPs, IRBs AT THE LOCAL 1177 00:43:49,440 --> 00:43:49,640 SITES. 1178 00:43:49,640 --> 00:43:51,520 AND THIS IS REALLY ANSWERING 1179 00:43:51,520 --> 00:43:53,720 YOUR QUESTION, SKIP, AND 1180 00:43:53,720 --> 00:43:56,240 LEVERING WHAT LINDA SAID, A 1181 00:43:56,240 --> 00:43:57,320 CONVERSATION ABOUT THIS STUFF. 1182 00:43:57,320 --> 00:43:58,960 IT REALLY STARTS WITH THE 1183 00:43:58,960 --> 00:44:01,000 CONVERSATION THAT THE 1184 00:44:01,000 --> 00:44:01,880 INVESTIGATOR HAS WITH HERSELF 1185 00:44:01,880 --> 00:44:06,160 ABOUT WHAT SHOULD BE THE 1186 00:44:06,160 --> 00:44:07,760 PROCESS, RECOMMENDED PROCESS OF 1187 00:44:07,760 --> 00:44:08,240 ETHICAL REVIEW. 1188 00:44:08,240 --> 00:44:12,400 SO I THINK IT'S POSSIBLE TO PUT 1189 00:44:12,400 --> 00:44:14,040 THAT, ENCAPSULATE THAT PROCESS 1190 00:44:14,040 --> 00:44:16,320 IN SENTENCES BUT IT'S BY 1191 00:44:16,320 --> 00:44:24,120 DEFINITION A SOMEWHAT MESSY 1192 00:44:24,120 --> 00:44:24,720 PROCESS. 1193 00:44:24,720 --> 00:44:25,960 >> OFTERREN TIMES HRPP IS 1194 00:44:25,960 --> 00:44:27,400 WORKING WITH THE INVESTIGATOR 1195 00:44:27,400 --> 00:44:28,600 WRITING THE GRANT, WRITING 1196 00:44:28,600 --> 00:44:30,440 LETTERS OF SUPPORT AND SOMETIMES 1197 00:44:30,440 --> 00:44:31,960 WE'LL TRY TO HELP CRAFT 1198 00:44:31,960 --> 00:44:35,400 ARGUMENTS AS TO WERE SOMETHING 1199 00:44:35,400 --> 00:44:37,000 SHOULDN'T BE SUCH AS A SINGLE 1200 00:44:37,000 --> 00:44:38,840 IRB FOR WHATEVER REASON OTHER 1201 00:44:38,840 --> 00:44:39,640 EXPLAIN TO THE INVESTIGATOR 1202 00:44:39,640 --> 00:44:40,800 LIKELY NOT TO WIN THAT ARGUMENT, 1203 00:44:40,800 --> 00:44:42,920 THIS IS WHAT YOU NEED TO DO, 1204 00:44:42,920 --> 00:44:44,360 HELP WITH BUDGETING AND ALL 1205 00:44:44,360 --> 00:44:45,640 KINDS OF THINGS. 1206 00:44:45,640 --> 00:44:46,960 DIFFERENT INSTITUTIONS HANDLE IT 1207 00:44:46,960 --> 00:44:48,280 DIFFERENTLY, BUT THAT'S WHAT MY 1208 00:44:48,280 --> 00:44:49,360 EXPERIENCE HAS BEEN. 1209 00:44:49,360 --> 00:44:52,000 >> AND JUST A FINAL POINT, 1210 00:44:52,000 --> 00:44:54,960 WHATEVER IS SAID IN THIS 1211 00:44:54,960 --> 00:44:56,800 DOCUMENT, JUST REMEMBER WHAT 1212 00:44:56,800 --> 00:44:59,240 WE'RE TRYING TO COMMENT ON IS 1213 00:44:59,240 --> 00:45:01,160 DRAFT GUIDANCE OHRP ISSUED. 1214 00:45:01,160 --> 00:45:04,120 TO YOUR POINT, SKIP, OHRP 1215 00:45:04,120 --> 00:45:05,120 GUIDANCE DOESN'T TALK ABOUT THE 1216 00:45:05,120 --> 00:45:05,760 PROCESS AT ALL. 1217 00:45:05,760 --> 00:45:09,840 SOUNDS LIKE WHAT WE NEED TO SAY 1218 00:45:09,840 --> 00:45:12,440 IS THAT WE DO NEED TO SAY THERE 1219 00:45:12,440 --> 00:45:15,080 NEEDS TO BE A PROCESS DEFINED, 1220 00:45:15,080 --> 00:45:25,000 AT LEAST IN OUTLINE FORM, IN THE 1221 00:45:25,000 --> 00:45:28,640 ULTIMATE GUIDANCE DOCUMENT. 1222 00:45:28,640 --> 00:45:31,040 >> THIS FLOWS INTO THE NEXT 1223 00:45:31,040 --> 00:45:35,760 ISSUE, THIS LOCAL SITE, REVIEW 1224 00:45:35,760 --> 00:45:36,400 AND APPROVAL. 1225 00:45:36,400 --> 00:45:38,280 AND ONE OF THE THINGS THAT STOOD 1226 00:45:38,280 --> 00:45:40,000 OUT TO THE SUBCOMMITTEE WAS THAT 1227 00:45:40,000 --> 00:45:42,200 IN THIS SECTION OF THE DRAFT 1228 00:45:42,200 --> 00:45:43,280 GUIDANCE THERE WAS A LOT OF 1229 00:45:43,280 --> 00:45:45,240 DISCUSSION ABOUT THE ROLE OF THE 1230 00:45:45,240 --> 00:45:49,400 LOCAL IRB AND NOT REALLY THE 1231 00:45:49,400 --> 00:45:50,080 LOCAL HRPP. 1232 00:45:50,080 --> 00:45:53,440 I THINK COMMENTS PARTICULAR LIP 1233 00:45:53,440 --> 00:45:58,520 -- PARTICULARLY FROM LINDA 1234 00:45:58,520 --> 00:46:02,760 TALKED ABOUT WHY THAT'S AN 1235 00:46:02,760 --> 00:46:04,080 IMPORTANT DIFFERENCE. 1236 00:46:04,080 --> 00:46:07,080 WE ADVOCATE GUIDANCE SHOULD BE 1237 00:46:07,080 --> 00:46:08,560 CLEAR ABOUT RELYING 1238 00:46:08,560 --> 00:46:10,560 INSTITUTION'S HRPP BEING 1239 00:46:10,560 --> 00:46:13,080 INVOLVED AT APPROPRIATE LEVEL IN 1240 00:46:13,080 --> 00:46:15,800 THE PROCESS, AND THEN ONE OF THE 1241 00:46:15,800 --> 00:46:22,600 THINGS THAT THE GUIDANCE 1242 00:46:22,600 --> 00:46:25,040 DISCUSSED THAT IS POTENTIALLY 1243 00:46:25,040 --> 00:46:27,440 PROBLEMATIC IS SECONDARY REVIEW 1244 00:46:27,440 --> 00:46:29,360 OR LOCAL REVIEW IN ADDITION TO 1245 00:46:29,360 --> 00:46:31,520 SINGLE IRB REVIEW WHILE WE 1246 00:46:31,520 --> 00:46:33,240 BELIEVE IT'S APPROPRIATE FOR A 1247 00:46:33,240 --> 00:46:39,360 LOCAL IRB OR LOCAL HRPP BEING 1248 00:46:39,360 --> 00:46:41,760 ABLE TO ADVISE THE SINGLE IRB ON 1249 00:46:41,760 --> 00:46:46,040 LET'S SAY LOCAL CONTEXT ISSUES, 1250 00:46:46,040 --> 00:46:48,120 THE IDEA THAT THEY WOULD CONDUCT 1251 00:46:48,120 --> 00:46:50,320 THEIR OWN IRB REVIEW AND HAVE A 1252 00:46:50,320 --> 00:46:51,600 STUDY THAT'S BOTH THE IRB OF 1253 00:46:51,600 --> 00:46:52,920 RECORD IS A SINGLE IRB BUT 1254 00:46:52,920 --> 00:46:56,880 THERE'S A LOCAL IRB IN PLACE 1255 00:46:56,880 --> 00:46:58,640 THAT'S REVIEWED AND APPROVED IT 1256 00:46:58,640 --> 00:47:00,400 WOULD BE CONFUSIONING AND 1257 00:47:00,400 --> 00:47:01,480 POTENTIALLY THE CONFLICT AND 1258 00:47:01,480 --> 00:47:06,080 CERTAINLY MAKE IT LESS CLEAR 1259 00:47:06,080 --> 00:47:09,040 WHAT THE SINGLE IRB IS -- HAS 1260 00:47:09,040 --> 00:47:10,360 ACTUAL OVERSIGHT OR DOES NOT 1261 00:47:10,360 --> 00:47:13,040 HAVE ACTUAL OVERSIGHT OF. 1262 00:47:13,040 --> 00:47:16,640 AND SO IN THE LONGER -- OR 1263 00:47:16,640 --> 00:47:20,360 SHORTER PARAGRAPH LINE 106 WE 1264 00:47:20,360 --> 00:47:29,040 THINK THE GUIDANCE SHOULD BE 1265 00:47:29,040 --> 00:47:30,600 MODIFIED TO ADVISE THAT THAT 1266 00:47:30,600 --> 00:47:33,000 SHOULD REALLY BE AN EXCEPTION AN 1267 00:47:33,000 --> 00:47:37,080 THE SINGLE IRB SHOULD BE THE 1268 00:47:37,080 --> 00:47:39,400 ONLY IRB THAT'S THE IRB OF 1269 00:47:39,400 --> 00:47:44,080 RECORD REVIEWING THAT STUDY. 1270 00:47:44,080 --> 00:47:47,240 AND THAT SUGGESTING OTHERWISE IN 1271 00:47:47,240 --> 00:47:48,960 GUIDANCE IS INCONSISTENT WITH 1272 00:47:48,960 --> 00:47:51,080 THE SINGLE IRB REGULATION AND 1273 00:47:51,080 --> 00:47:54,240 WHAT IT'S TRYING TO ACHIEVE. 1274 00:47:54,240 --> 00:47:58,080 LAST DISCUSSION MAY HAVE COVERED 1275 00:47:58,080 --> 00:47:59,800 A LOT OF WHAT'S ON THE TWO 1276 00:47:59,800 --> 00:48:02,160 PARAGRAPHS THAT ARE TAKING UP 1277 00:48:02,160 --> 00:48:03,320 THE PAGE RIGHT NOW. 1278 00:48:03,320 --> 00:48:06,040 AND WE'VE GOT SOME GOOD 1279 00:48:06,040 --> 00:48:06,840 FEEDBACK. 1280 00:48:06,840 --> 00:48:08,800 BUT IF THERE'S ADDITIONAL 1281 00:48:08,800 --> 00:48:12,840 FEEDBACK ON PARAGRAPHS AT LINES 1282 00:48:12,840 --> 00:48:14,920 92 AND 106 -- 1283 00:48:14,920 --> 00:48:15,640 >> THIS IS CONSUELO. 1284 00:48:15,640 --> 00:48:16,760 I HAD MY HAND UP. 1285 00:48:16,760 --> 00:48:18,520 IS THIS A GOOD TIME? 1286 00:48:18,520 --> 00:48:18,960 >> YES. 1287 00:48:18,960 --> 00:48:23,440 >> I DO HAVE A LITTLE BIT OF 1288 00:48:23,440 --> 00:48:28,480 CONCERN ABOUT HOW POTENTIAL 1289 00:48:28,480 --> 00:48:33,200 CONFLICTS WOULD BE RESOLVED IF A 1290 00:48:33,200 --> 00:48:35,360 LOCAL SITE HAS CONCERNS AND THEY 1291 00:48:35,360 --> 00:48:39,640 ARE NOT ADDRESSED BY THE SINGLE 1292 00:48:39,640 --> 00:48:39,960 IRB. 1293 00:48:39,960 --> 00:48:44,040 DO WE THINK THAT THE LANGUAGE 1294 00:48:44,040 --> 00:48:46,440 HERE IS CLEAR ON WHAT WOULD 1295 00:48:46,440 --> 00:48:49,520 HAPPEN OR WHAT WOULD NEED TO 1296 00:48:49,520 --> 00:48:49,720 HAPPEN? 1297 00:48:49,720 --> 00:48:52,520 >> I DON'T KNOW IF THE LANGUAGE 1298 00:48:52,520 --> 00:48:54,040 ITSELF IS CLEAR. 1299 00:48:54,040 --> 00:48:56,520 I THINK, YOU KNOW, IF IT'S NOT 1300 00:48:56,520 --> 00:49:00,000 CLEAR THERE IS NO REASON THAT 1301 00:49:00,000 --> 00:49:02,080 THE GUIDANCE CANNOT REMIND THAT 1302 00:49:02,080 --> 00:49:03,480 INSTITUTIONS ALWAYS HAVE THE 1303 00:49:03,480 --> 00:49:04,440 AUTHORITY TO DISAPPROVE 1304 00:49:04,440 --> 00:49:06,640 SOMETHING THAT THE IRB HAS 1305 00:49:06,640 --> 00:49:07,000 APPROVED. 1306 00:49:07,000 --> 00:49:08,840 SO AN INSTITUTION, WHETHER AT 1307 00:49:08,840 --> 00:49:10,560 THE HRPP LEVEL OR ADMINISTRATIVE 1308 00:49:10,560 --> 00:49:12,240 LEVEL, WHATEVER, CAN ALWAYS SAY, 1309 00:49:12,240 --> 00:49:14,440 WELL, YOU KNOW, WE DON'T BELIEVE 1310 00:49:14,440 --> 00:49:15,880 THIS RESEARCH IS APPROPRIATE, 1311 00:49:15,880 --> 00:49:22,680 THE WAY IT'S DESIGNED AND BEING 1312 00:49:22,680 --> 00:49:23,320 IMPLEMENTED IS APPROPRIATE SO 1313 00:49:23,320 --> 00:49:24,760 WE'RE NOT GOING TO PARTICIPATE. 1314 00:49:24,760 --> 00:49:27,040 THAT'S ALREADY A MECHANISM IN 1315 00:49:27,040 --> 00:49:28,920 PLACE EXERCISED FROM TIME TO 1316 00:49:28,920 --> 00:49:29,240 TIME. 1317 00:49:29,240 --> 00:49:30,960 NOT JUST IN THE CONTEXT OF 1318 00:49:30,960 --> 00:49:33,360 SINGLE IRB BUT FOR AN 1319 00:49:33,360 --> 00:49:34,480 INVESTIGATOR THAT WANTS TO DO 1320 00:49:34,480 --> 00:49:36,280 SOME SORT OF STUDY THAT 1321 00:49:36,280 --> 00:49:41,000 INSTITUTION DOES NOT SUPPORT. 1322 00:49:41,000 --> 00:49:41,200 SO -- 1323 00:49:41,200 --> 00:49:43,440 >> WELL, I THINK WHERE I'M GOING 1324 00:49:43,440 --> 00:49:45,440 WITH THIS IS REALLY MORE ALONG 1325 00:49:45,440 --> 00:49:51,680 THE LINES OF IF THE ONLY OPTION 1326 00:49:51,680 --> 00:49:54,640 IS TO NOT PARTICIPATE, IS NOT TO 1327 00:49:54,640 --> 00:50:00,000 PARTICIPATE, THEN THAT'S REALLY 1328 00:50:00,000 --> 00:50:01,240 REINFORCING THE SYSTEMS OF 1329 00:50:01,240 --> 00:50:05,480 EXCLUSION SUCH THAT, YOU KNOW, 1330 00:50:05,480 --> 00:50:05,960 MINORATIZED MARGINALIZED 1331 00:50:05,960 --> 00:50:07,200 POPULATIONS WHO MIGHT HAVE 1332 00:50:07,200 --> 00:50:11,520 OBJECTIONS TO A SPECIFIC 1333 00:50:11,520 --> 00:50:13,880 APPROACH OR STRATEGY, WHO REALLY 1334 00:50:13,880 --> 00:50:16,760 NEED TO, WANT TO, SHOULD BE 1335 00:50:16,760 --> 00:50:18,440 PARTICIPATING IN THE RESEARCH, 1336 00:50:18,440 --> 00:50:20,680 IF THOSE ISSUES CAN'T BE 1337 00:50:20,680 --> 00:50:21,880 ADDRESSED THEN IF OUR ONLY 1338 00:50:21,880 --> 00:50:23,680 OPTION IS TO SAY, WELL, IF YOU 1339 00:50:23,680 --> 00:50:25,400 DON'T LIKE WHAT THE SINGLE IRB 1340 00:50:25,400 --> 00:50:28,760 SAYS, THEN YOU DON'T HAVE TO 1341 00:50:28,760 --> 00:50:29,200 PARTICIPATE. 1342 00:50:29,200 --> 00:50:31,720 >> YEAH, NO, I AGREE AND THAT'S 1343 00:50:31,720 --> 00:50:33,800 A FAIR POINT. 1344 00:50:33,800 --> 00:50:36,880 I THINK THAT OUTCOME WHERE A 1345 00:50:36,880 --> 00:50:38,960 LOCAL SITE ELECTED TO NOT 1346 00:50:38,960 --> 00:50:40,360 PARTICIPATE IN THE RESEARCH 1347 00:50:40,360 --> 00:50:41,920 WOULD BE REALLY THE EXCEPTION. 1348 00:50:41,920 --> 00:50:43,200 ONE WOULD HOPE THERE WOULD 1349 00:50:43,200 --> 00:50:44,520 ACTUALLY BE A DIALOGUE BETWEEN 1350 00:50:44,520 --> 00:50:49,440 THAT SITE AND THE SINGLE IRB, 1351 00:50:49,440 --> 00:50:52,280 MAYBE INCLUDING THE SPONSOR OR 1352 00:50:52,280 --> 00:50:53,440 FUNDER IF THEY THOUGHT SOMETHING 1353 00:50:53,440 --> 00:50:54,920 WAS FLAWED APPROVED BY THE 1354 00:50:54,920 --> 00:50:56,800 SINGLE IRB THAT COULD BE 1355 00:50:56,800 --> 00:50:58,560 ADDRESSED OR OTHERWISE MANAGED 1356 00:50:58,560 --> 00:51:00,960 BEFORE GETTING THAT EXTREME 1357 00:51:00,960 --> 00:51:05,920 FINAL POINT WHERE THERE'S A 1358 00:51:05,920 --> 00:51:06,160 BREAKAWAY. 1359 00:51:06,160 --> 00:51:08,080 AND, AGAIN, IF THE GUIDANCE CAN 1360 00:51:08,080 --> 00:51:09,720 BE IMPROVED BY COMMENTING ON 1361 00:51:09,720 --> 00:51:13,000 THAT, WE CAN PUT THAT INTO OUR 1362 00:51:13,000 --> 00:51:13,360 DOCUMENT. 1363 00:51:13,360 --> 00:51:13,640 MARK? 1364 00:51:13,640 --> 00:51:16,200 >> DAVID, WE ALSO CAN SAY IN 1365 00:51:16,200 --> 00:51:18,360 THIS DOCUMENT THAT NOT ONLY 1366 00:51:18,360 --> 00:51:20,200 SHOULD BE THERE IN CASE BE AN 1367 00:51:20,200 --> 00:51:22,200 ACTIVE COLLOQUY BETWEEN THE 1368 00:51:22,200 --> 00:51:23,960 LOCAL INSTITUTION AND THE SINGLE 1369 00:51:23,960 --> 00:51:25,480 IRB AND THE INSTITUTION THAT 1370 00:51:25,480 --> 00:51:27,800 SPONSORS IT, ALSO A COLLOQUY 1371 00:51:27,800 --> 00:51:31,280 AMONG THE LOCAL INVESTIGATOR AND 1372 00:51:31,280 --> 00:51:31,960 THE PRINCIPAL INVESTIGATOR, BUT 1373 00:51:31,960 --> 00:51:34,240 ALSO, YOU KNOW, THERE'S NO 1374 00:51:34,240 --> 00:51:36,120 REASON WHY IN THIS CASE THERE 1375 00:51:36,120 --> 00:51:38,840 REALLY IS THAT DEEP A 1376 00:51:38,840 --> 00:51:40,120 DISAGREEMENT THAT THE LOCAL 1377 00:51:40,120 --> 00:51:41,240 INSTITUTION COULDN'T SAY, YOU 1378 00:51:41,240 --> 00:51:43,320 KNOW, WE REALLY THINK THERE 1379 00:51:43,320 --> 00:51:45,360 SHOULD BE A PETITION FOR AN 1380 00:51:45,360 --> 00:51:45,880 EXCEPTION. 1381 00:51:45,880 --> 00:51:54,000 SO THAT WE CAN APPROVE IT OR NOT 1382 00:51:54,000 --> 00:51:54,840 ON LOCAL BASIS. 1383 00:51:54,840 --> 00:51:57,240 NOT SAYING IT HAS TO BE THAT 1384 00:51:57,240 --> 00:51:58,240 WAY, BUT LOCAL INSTITUTION OUGHT 1385 00:51:58,240 --> 00:52:03,560 TO BE ABLE TO ASK FOR THAT, 1386 00:52:03,560 --> 00:52:05,760 WHETHER THE LEAD P.I., PRIME 1387 00:52:05,760 --> 00:52:07,280 AWARDEE WANTS TO AGREE OR NOT IS 1388 00:52:07,280 --> 00:52:09,280 GOING TO BE UP TO THEM AND ALSO 1389 00:52:09,280 --> 00:52:11,120 THE FUNDER'S GOT TO AGREE WITH 1390 00:52:11,120 --> 00:52:13,880 IT TOO SO ... BUT IT IS AN 1391 00:52:13,880 --> 00:52:14,800 OPTION. 1392 00:52:14,800 --> 00:52:19,000 IT'S A PROCEDURAL OPTION. 1393 00:52:19,000 --> 00:52:27,880 1394 00:52:27,880 --> 00:52:29,200 >> YEAH, GO AHEAD. 1395 00:52:29,200 --> 00:52:30,400 >> IN THAT SITUATION, WOULDN'T 1396 00:52:30,400 --> 00:52:32,800 IT ALSO BE APPROPRIATE IF YOU 1397 00:52:32,800 --> 00:52:33,640 CAN'T RESOLVE A SITUATION WHERE 1398 00:52:33,640 --> 00:52:35,320 YOU MAKE THAT ARGUMENT AS TO WHY 1399 00:52:35,320 --> 00:52:37,080 THE SINGLE IRB IS NOT 1400 00:52:37,080 --> 00:52:38,040 APPROPRIATE, SO IN ADDITION TO 1401 00:52:38,040 --> 00:52:39,680 TRYING TO DO WHAT YOU SAY THAT 1402 00:52:39,680 --> 00:52:40,840 WOULD BE ONE ARGUMENT FOR WHY 1403 00:52:40,840 --> 00:52:42,520 YOU STILL WANT TO DO THE STUDY 1404 00:52:42,520 --> 00:52:45,000 BUT WE WANT TO DO IT A DIFFERENT 1405 00:52:45,000 --> 00:52:46,480 WAY, MODIFIED SUCH THAT IT COULD 1406 00:52:46,480 --> 00:52:53,040 BE DONE LOCALLY OR YOU COULD DO 1407 00:52:53,040 --> 00:52:55,200 A DUAL REVIEW BUT THAT COULD BE 1408 00:52:55,200 --> 00:52:55,680 COMPLICATED. 1409 00:52:55,680 --> 00:52:59,080 >> THE EXCEPTION FROM THE SINGLE 1410 00:52:59,080 --> 00:52:59,560 IRB. 1411 00:52:59,560 --> 00:53:01,560 >> YEAH. 1412 00:53:01,560 --> 00:53:06,640 1413 00:53:06,640 --> 00:53:07,840 >> YOU KNOW, THE BOTTOM LINE 1414 00:53:07,840 --> 00:53:09,480 POINT, THAT'S THE KIND OF DETAIL 1415 00:53:09,480 --> 00:53:11,440 THAT'S NEEDED IN THIS GUIDANCE, 1416 00:53:11,440 --> 00:53:14,080 WE THINK, THAT'S NOT IN THE -- 1417 00:53:14,080 --> 00:53:15,120 JERRY, THE GUIDANCE IS AT A 1418 00:53:15,120 --> 00:53:16,240 HIGHER LEVEL THAN WHAT WE'RE 1419 00:53:16,240 --> 00:53:16,680 TALKING ABOUT. 1420 00:53:16,680 --> 00:53:18,080 THESE ARE THE KIND OF QUESTIONS 1421 00:53:18,080 --> 00:53:19,320 THAT ACTUALLY COME UP IN THE 1422 00:53:19,320 --> 00:53:22,240 LIFE OF AN IRB, TRYING TO 1423 00:53:22,240 --> 00:53:26,520 IMPLEMENT THE SINGLE IRB POLICY. 1424 00:53:26,520 --> 00:53:27,560 SO, I MEAN, WHAT THE 1425 00:53:27,560 --> 00:53:28,800 SUBCOMMITTEES ARE TRYING TO SAY, 1426 00:53:28,800 --> 00:53:32,800 IT'S UP TO YOU AGREE OR NOT, 1427 00:53:32,800 --> 00:53:37,040 MORE DETAIL IS NEEDED FOR THE 1428 00:53:37,040 --> 00:53:39,120 REGULAR LA OF -- REGULATED 1429 00:53:39,120 --> 00:53:40,120 COMMUNITY TO PUZZLE THEIR WAY 1430 00:53:40,120 --> 00:53:46,920 THROUGH THIS. . 1431 00:53:46,920 --> 00:53:55,680 >> AND THE REMAINDER OF THIS 1432 00:53:55,680 --> 00:53:57,320 SECTION STARTING AT LINE 113 1433 00:53:57,320 --> 00:53:59,360 SIMPLY REFLECTS THE DISCUSSIONS 1434 00:53:59,360 --> 00:54:00,400 WE'VE BEEN HAVING, THAT, YOU 1435 00:54:00,400 --> 00:54:04,400 KNOW, THE ROLE OF THE RELYING 1436 00:54:04,400 --> 00:54:06,600 INSTITUTIONS HRPP HAS TO BE 1437 00:54:06,600 --> 00:54:11,400 CLEARLY DELINEATED IN THE 1438 00:54:11,400 --> 00:54:17,040 GUIDANCE AND -- YEAH, THIS 1439 00:54:17,040 --> 00:54:23,240 SECTION JUST REFLECTS WHAT 1440 00:54:23,240 --> 00:54:24,360 W E'VE BEEN TALKING ABOUT. 1441 00:54:24,360 --> 00:54:25,920 I'M GOING TO MOVE ON TO THE 1442 00:54:25,920 --> 00:54:26,600 SECTION OF COMPLIANCE 1443 00:54:26,600 --> 00:54:28,560 INVESTIGATIONS AT LOCAL SITES, A 1444 00:54:28,560 --> 00:54:34,600 FAIRLY SHORT BUT IMPORTANT ONE. 1445 00:54:34,600 --> 00:54:36,000 OBVIOUSLY, NOBODY ENJOYS 1446 00:54:36,000 --> 00:54:37,800 COMPLIANCE ISSUES BUT MULTI-SITE 1447 00:54:37,800 --> 00:54:40,600 RESEARCH CAN GET -- OR SINGLE 1448 00:54:40,600 --> 00:54:43,800 IRB RESEARCH, IT CAN BECOME 1449 00:54:43,800 --> 00:54:45,120 TRICKY BECAUSE THE 1450 00:54:45,120 --> 00:54:47,040 NON-COMPLIANCE OR THE POTENTIAL 1451 00:54:47,040 --> 00:54:47,640 NON-COMPLIANCE ISSUE AT A SITE 1452 00:54:47,640 --> 00:54:49,960 MAY NOT BE THE SITE WHERE THE 1453 00:54:49,960 --> 00:54:54,640 SINGLE IRB IS LOCATED. 1454 00:54:54,640 --> 00:54:55,400 AND ORGANIZATIONS, INSTITUTIONS, 1455 00:54:55,400 --> 00:54:59,120 WHAT HAVE YOU, TEND TO GET 1456 00:54:59,120 --> 00:55:00,880 PRICKLY WHEN IT COMES TO 1457 00:55:00,880 --> 00:55:01,520 COMPLIANCE THINGS. 1458 00:55:01,520 --> 00:55:02,960 WE WANT TO HAVE SOME INVOLVEMENT 1459 00:55:02,960 --> 00:55:05,800 IN OVERSIGHT OF THOSE THINGS SO 1460 00:55:05,800 --> 00:55:07,200 THE QUESTION THAT SORT OF WE TRY 1461 00:55:07,200 --> 00:55:09,080 TO ADDRESS IN THIS SECTION IS 1462 00:55:09,080 --> 00:55:11,520 SO, YOU KNOW, WHERE DOES THAT 1463 00:55:11,520 --> 00:55:12,240 LEAVE THE SINGLE IRB? 1464 00:55:12,240 --> 00:55:15,240 WHAT IS THE ROLE IN COMPLIANCE 1465 00:55:15,240 --> 00:55:17,280 OVERSIGHT FOR MULTI-SITE STUDIES 1466 00:55:17,280 --> 00:55:19,480 INCLUDING THE SITES WHERE THERE 1467 00:55:19,480 --> 00:55:21,880 ARE NOT QUOTE/UNQUOTE LOCAL IRB 1468 00:55:21,880 --> 00:55:24,640 BUT SERVING AS REVIEWING IRB FOR 1469 00:55:24,640 --> 00:55:25,800 ANOTHER SITE, IN GENERAL, YOU 1470 00:55:25,800 --> 00:55:26,800 KNOW, WE THINK MUCH OF THIS 1471 00:55:26,800 --> 00:55:28,760 SHOULD BE DEALT WITH THROUGH 1472 00:55:28,760 --> 00:55:30,200 RELIANCE AGREEMENTS, AND THAT IN 1473 00:55:30,200 --> 00:55:34,480 FACT IS WHAT OFTEN HAPPENS IN 1474 00:55:34,480 --> 00:55:36,000 PRACTICE NOW, BUT AGAIN FOR 1475 00:55:36,000 --> 00:55:38,200 IRBs THAT ARE GOING INTO THAT 1476 00:55:38,200 --> 00:55:42,280 ROLE OF BEING A SINGLE IRB OR 1477 00:55:42,280 --> 00:55:45,000 INSTITUTIONS NOW USING OR CEDING 1478 00:55:45,000 --> 00:55:46,840 REVIEW TO A SINGLE IRB ON A MORE 1479 00:55:46,840 --> 00:55:49,040 FREQUENT BASIS WE THINK THE 1480 00:55:49,040 --> 00:55:55,880 GUIDANCE SHOULD BE REALLY CLEAR 1481 00:55:55,880 --> 00:55:57,280 IN RECOMMENDING THE OUTLINING OF 1482 00:55:57,280 --> 00:55:59,080 THOSE TERMS IN THE RELIANCE 1483 00:55:59,080 --> 00:56:00,720 PROCESS, BEFORE IT GETS TO IRB 1484 00:56:00,720 --> 00:56:02,280 REVIEW PUTTING IN PLACE, YOU 1485 00:56:02,280 --> 00:56:04,960 KNOW, THE OLD IRB AUTHORIZATION 1486 00:56:04,960 --> 00:56:06,280 AGREEMENTS, SORT OF A MODEL OF 1487 00:56:06,280 --> 00:56:07,760 WE'LL RELY ON THE IRB FOR THIS. 1488 00:56:07,760 --> 00:56:09,520 BUT IT'S IMPORTANT TO CALL THIS 1489 00:56:09,520 --> 00:56:10,840 OUT BECAUSE WHEN THERE ARE 1490 00:56:10,840 --> 00:56:12,920 COMPLIANCE ISSUES FROM A 1491 00:56:12,920 --> 00:56:13,960 REGULATORY STANDPOINT THE 1492 00:56:13,960 --> 00:56:15,760 REVIEWING IRB HAS OBLIGATIONS, 1493 00:56:15,760 --> 00:56:17,400 AND WE DON'T -- YOU KNOW, THEY 1494 00:56:17,400 --> 00:56:19,280 DON'T WANT TO BE NUT A POSITION 1495 00:56:19,280 --> 00:56:22,120 WHERE THEIR ABILITY TO CARRY OUT 1496 00:56:22,120 --> 00:56:25,840 REGULATORY POSITIONS FOR MAKING 1497 00:56:25,840 --> 00:56:27,040 DETERMINATIONS OF NON-COMPLIANCE 1498 00:56:27,040 --> 00:56:28,360 ARE HAMPERED AND DERAILED 1499 00:56:28,360 --> 00:56:29,640 BECAUSE OF POOR COOPERATION 1500 00:56:29,640 --> 00:56:40,000 BETWEEN RELYING SITE AND 1501 00:56:40,000 --> 00:56:41,760 REVIEWING SITE. 1502 00:56:41,760 --> 00:56:45,480 IN THIS SECTION WE DISCUSS THAT 1503 00:56:45,480 --> 00:56:46,560 AND REALLY, AGAIN, FEEL THE 1504 00:56:46,560 --> 00:56:48,320 ANSWER IS JUST THE GUIDANCE 1505 00:56:48,320 --> 00:56:49,400 SHOULD BE CLEAR THAT THESE 1506 00:56:49,400 --> 00:56:50,280 ISSUES REALLY NEED TO BE 1507 00:56:50,280 --> 00:56:51,920 ADDRESSED ON THE FRONT END AND 1508 00:56:51,920 --> 00:56:53,680 NOT WAIT FOR COMPLIANCE ISSUE TO 1509 00:56:53,680 --> 00:56:57,280 ARISE TO DEAL WITH THEM. 1510 00:56:57,280 --> 00:56:58,160 1511 00:56:58,160 --> 00:57:02,080 ANY COMMENTS OR QUESTIONS ON 1512 00:57:02,080 --> 00:57:04,400 THIS SECTION? 1513 00:57:04,400 --> 00:57:05,480 YES? 1514 00:57:05,480 --> 00:57:09,200 >> I JUST HAD A -- ON THE 1515 00:57:09,200 --> 00:57:11,200 SENTENCE STARTING ON 19, 1516 00:57:11,200 --> 00:57:14,920 SLIGHTLY SUBSTANTIVE BUT MOSTLY 1517 00:57:14,920 --> 00:57:16,240 JUST WORDING. 1518 00:57:16,240 --> 00:57:17,520 LATER OR -- 1519 00:57:17,520 --> 00:57:17,880 >> GO AHEAD. 1520 00:57:17,880 --> 00:57:22,280 >> I THINK YOU HAVE A MISPLACED 1521 00:57:22,280 --> 00:57:23,480 MODIFIER IF VIOLATIONS ARE 1522 00:57:23,480 --> 00:57:26,520 FOUND, STRIKE THROUGH THAT AND 1523 00:57:26,520 --> 00:57:28,960 SAY WE'LL INCLUDE THAT LATER, 1524 00:57:28,960 --> 00:57:31,360 THE DRAFT GUIDANCE SHOULD ALSO 1525 00:57:31,360 --> 00:57:33,120 IDENTIFY THE CIRCUMSTANCES UNDER 1526 00:57:33,120 --> 00:57:39,240 WHICH THE SINGLE IRB SHOULD 1527 00:57:39,240 --> 00:57:41,680 PROVIDE ADVANCE NOTICE ABOUT 1528 00:57:41,680 --> 00:57:43,400 VIOLATIONS FOUND AT THE SITE. 1529 00:57:43,400 --> 00:57:46,560 AND THEN THE REST OF THE 1530 00:57:46,560 --> 00:57:47,560 SENTENCE WOULD CONTINUE. 1531 00:57:47,560 --> 00:57:51,960 SO IT'S A LITTLE STRONGER. 1532 00:57:51,960 --> 00:57:53,960 >> SORRY, MY KEYBOARD WAS ACTING 1533 00:57:53,960 --> 00:57:54,240 FUNNY. 1534 00:57:54,240 --> 00:57:54,800 >> SAY IT AGAIN? 1535 00:57:54,800 --> 00:57:57,080 >> I THINK I GOT IT, BUT PLACED 1536 00:57:57,080 --> 00:58:00,480 AFTER THIS INSTANCE OF HRPP? 1537 00:58:00,480 --> 00:58:03,400 >> STARTING WITH THAT SENTENCE, 1538 00:58:03,400 --> 00:58:04,960 IF VIOLATIONS ARE FOUND. 1539 00:58:04,960 --> 00:58:05,240 >> RIGHT. 1540 00:58:05,240 --> 00:58:06,280 >> THAT'S GONE. 1541 00:58:06,280 --> 00:58:10,000 THEN IT SAYS THE DRAFT GUIDANCE 1542 00:58:10,000 --> 00:58:12,280 SHOULD ALSO IDENTIFY THE 1543 00:58:12,280 --> 00:58:17,120 CIRCUMSTANCES UNDER WHICH THE 1544 00:58:17,120 --> 00:58:21,360 SINGLE IRB SHOULD PROVIDE 1545 00:58:21,360 --> 00:58:22,960 ADVANCE NOTICE TO RELYING HRPP 1546 00:58:22,960 --> 00:58:24,560 ABOUT VIOLATIONS FOUND AT THE 1547 00:58:24,560 --> 00:58:24,880 SITE. 1548 00:58:24,880 --> 00:58:27,360 AND THEN THE REST OF THE 1549 00:58:27,360 --> 00:58:31,320 SENTENCE WOULD BE THE SAME. 1550 00:58:31,320 --> 00:58:33,800 INSTEAD OF JUST -- BEFORE IF 1551 00:58:33,800 --> 00:58:35,960 VIOLATIONS ARE FOUND, THAT WAS 1552 00:58:35,960 --> 00:58:40,640 MODIFYING THE DRAFT GUIDANCE, 1553 00:58:40,640 --> 00:58:42,680 MAKES SENSE GRAMMAR-WISE OR 1554 00:58:42,680 --> 00:58:45,560 WHATEVER, BUT THE 1555 00:58:45,560 --> 00:58:46,440 APPROPRIATENESS OF ADVANCE 1556 00:58:46,440 --> 00:58:48,200 NOTICE, IT COULD GO FURTHER IN 1557 00:58:48,200 --> 00:58:49,400 IDENTIFYING THE CIRCUMSTANCES 1558 00:58:49,400 --> 00:58:52,400 UNDER WHICH THE SINGLE IRB 1559 00:58:52,400 --> 00:58:54,520 SHOULD PROVIDE ADVANCE NOTICE. 1560 00:58:54,520 --> 00:58:56,520 I GUESS ASKING FOR THE GUIDANCE 1561 00:58:56,520 --> 00:58:59,160 TO PROVIDE A LITTLE BIT MORE, 1562 00:58:59,160 --> 00:59:04,240 SORT OF SAYING IT WOULD BE 1563 00:59:04,240 --> 00:59:05,200 APPROPRIATE, IDENTIFY 1564 00:59:05,200 --> 00:59:07,200 APPROPRIATE, THAT SEEMED VAGUE. 1565 00:59:07,200 --> 00:59:08,760 I JUST SHARPENED IT A LITTLE BIT 1566 00:59:08,760 --> 00:59:12,840 I HOPE. 1567 00:59:12,840 --> 00:59:13,920 TRIED TO. 1568 00:59:13,920 --> 00:59:15,280 >> DAVID, WHAT WE'RE TALKING 1569 00:59:15,280 --> 00:59:23,120 ABOUT IS ADVANCE NOTICE BEFORE. 1570 00:59:23,120 --> 00:59:25,160 >> THAT'S HOW I READ IT. 1571 00:59:25,160 --> 00:59:27,720 >> THIS HAS BEEN THROUGH A 1572 00:59:27,720 --> 00:59:29,560 NUMBER OF HANDS. 1573 00:59:29,560 --> 00:59:31,960 >> THIS KEYBOARD KEEPS CUTTING 1574 00:59:31,960 --> 00:59:33,320 OUT ON ME. 1575 00:59:33,320 --> 00:59:37,800 >> I'M WRITING IT DOWN. 1576 00:59:37,800 --> 00:59:41,040 >> OKAY. 1577 00:59:41,040 --> 00:59:44,080 OTHER COMMENTS ON THAT SECTION? 1578 00:59:44,080 --> 00:59:49,560 THANKS, LOIS. 1579 00:59:49,560 --> 00:59:50,240 OKAY. 1580 00:59:50,240 --> 00:59:51,080 ANOTHER ISSUE THAT'S RELATIVELY 1581 00:59:51,080 --> 00:59:54,320 MINOR BUT STILL IMPORTANT IS 1582 00:59:54,320 --> 00:59:55,720 THIS NOTION OF UNFUNDED 1583 00:59:55,720 --> 00:59:56,160 COLLABORATORS. 1584 00:59:56,160 --> 00:59:58,320 IN PART BECAUSE WE'RE TALKING 1585 00:59:58,320 --> 01:00:01,640 ABOUT A COMMON RULE REQUIREMENT 1586 01:00:01,640 --> 01:00:05,440 THAT, YOU KNOW, RESEARCH THAT IS 1587 01:00:05,440 --> 01:00:07,400 LIKELY SINGLE IRB BUT THERE MAY 1588 01:00:07,400 --> 01:00:09,040 BE SCENARIOS SOME SITES ARE 1589 01:00:09,040 --> 01:00:13,200 FEDERALLY SUPPORTED AND OTHERS 1590 01:00:13,200 --> 01:00:13,880 ARE NOT. 1591 01:00:13,880 --> 01:00:17,040 AND, YOU KNOW, WE JUST THINK THE 1592 01:00:17,040 --> 01:00:19,320 GUIDANCE SHOULD CLARIFY WHAT 1593 01:00:19,320 --> 01:00:20,640 SHOULD BE THE -- WHAT'S 1594 01:00:20,640 --> 01:00:26,480 APPROPRIATE WAY TO MANAGE WHEN 1595 01:00:26,480 --> 01:00:28,440 THE SINGLE IRB IS -- A STUDY 1596 01:00:28,440 --> 01:00:30,160 THAT OTHERWISE QUALIFIES FOR 1597 01:00:30,160 --> 01:00:31,360 SINGLE IRB REVIEW BUT I DON'T 1598 01:00:31,360 --> 01:00:33,920 KNOW HOW COMMON THE SCENARIO IS 1599 01:00:33,920 --> 01:00:34,960 BUT SCENARIO THAT COULD TAKE 1600 01:00:34,960 --> 01:00:41,120 PLACE AND COULD LEAD TO SOME 1601 01:00:41,120 --> 01:00:45,200 CONFUSION BECAUSE OTHER 1602 01:00:45,200 --> 01:00:46,080 REGULATIONS ADDRESS SINGLE IRB. 1603 01:00:46,080 --> 01:00:48,720 >> I THINK THIS IS A REAL 1604 01:00:48,720 --> 01:00:49,240 SITUATION. 1605 01:00:49,240 --> 01:00:50,680 IT'S AKIN TO THE DEFINITION OF 1606 01:00:50,680 --> 01:00:52,720 WHAT IS FEDERAL SUPPORT FOR 1607 01:00:52,720 --> 01:00:53,280 THESE PURPOSES. 1608 01:00:53,280 --> 01:00:54,760 IN OTHER WORDS IF YOU HAVE ONE 1609 01:00:54,760 --> 01:00:56,600 UNFUNNED OR TWO OR THREE 1610 01:00:56,600 --> 01:00:57,960 UNFUNDED SITES FUNDED BY THE 1611 01:00:57,960 --> 01:00:59,680 GATES FOUNDATION TO DO SOMETHING 1612 01:00:59,680 --> 01:01:01,640 BUT NOT FUNDED BY NIH, THE LEAD 1613 01:01:01,640 --> 01:01:03,600 SITE IS FUNDED BY NIH AND TWO 1614 01:01:03,600 --> 01:01:06,120 OTHER SITES, HOW DOES THE SINGLE 1615 01:01:06,120 --> 01:01:08,040 IRB REQUIREMENT APPLY? 1616 01:01:08,040 --> 01:01:09,520 TO THE ENTIRE STUDY? 1617 01:01:09,520 --> 01:01:12,040 RECEIPT OF FEDERAL MONEY BY ONE 1618 01:01:12,040 --> 01:01:13,760 INSTITUTION BASICALLY AFFECT THE 1619 01:01:13,760 --> 01:01:17,480 ENTIRE STUDY WITH THE SINGLE IRB 1620 01:01:17,480 --> 01:01:17,920 REQUIREMENT OR NOT? 1621 01:01:17,920 --> 01:01:20,880 I THINK -- YOU KNOW, I DON'T 1622 01:01:20,880 --> 01:01:22,760 HAVE A STRONG -- A NORMATIVE 1623 01:01:22,760 --> 01:01:23,920 FEELING BUT IT'S A REAL 1624 01:01:23,920 --> 01:01:26,480 SITUATION THAT NEEDS TO BE 1625 01:01:26,480 --> 01:01:28,680 ANTICIPATED. 1626 01:01:28,680 --> 01:01:34,760 1627 01:01:34,760 --> 01:01:35,080 >> SKIP? 1628 01:01:35,080 --> 01:01:35,800 >> SHOULDN'T WE BASICALLY SAY 1629 01:01:35,800 --> 01:01:37,920 WHAT WE THINK WOULD BE THE BEST 1630 01:01:37,920 --> 01:01:39,200 ANSWER TO THAT QUESTION? 1631 01:01:39,200 --> 01:01:40,360 >> I THINK WE SHOULD. 1632 01:01:40,360 --> 01:01:43,560 I WAS WAITING FOR YOU TO TELL ME 1633 01:01:43,560 --> 01:01:46,160 WHAT THAT WAS. 1634 01:01:46,160 --> 01:01:47,480 >> WELL, TEN YEARS AT THE FDA 1635 01:01:47,480 --> 01:01:49,600 I'M A FAN OF HOLDING SOMEONE 1636 01:01:49,600 --> 01:01:50,000 RESPONSIBLE. 1637 01:01:50,000 --> 01:01:54,360 I'M A FAN OF THAT BEING THE LEAD 1638 01:01:54,360 --> 01:01:54,800 INSTITUTION. 1639 01:01:54,800 --> 01:01:56,120 IT'S POSSIBLE THE LEAD 1640 01:01:56,120 --> 01:01:57,320 INSTITUTION COULD BE A GATES 1641 01:01:57,320 --> 01:01:59,000 FOUNDATION FUNDED AND NOT THE 1642 01:01:59,000 --> 01:02:01,280 NIH BUT SOMEWHERE THERE'S A LEAD 1643 01:02:01,280 --> 01:02:01,800 INSTITUTION PRESUMABLY. 1644 01:02:01,800 --> 01:02:02,280 >> RIGHT. 1645 01:02:02,280 --> 01:02:03,560 >> IT WOULD BE THAT INSTITUTION, 1646 01:02:03,560 --> 01:02:07,280 I THINK I WOULD HOLD 1647 01:02:07,280 --> 01:02:11,040 RESPONSIBILITY, INDEPENDENT OF 1648 01:02:11,040 --> 01:02:12,120 COMPLEXITY OF THE FUNDING. 1649 01:02:12,120 --> 01:02:15,480 >> IF THE LEAD INSTITUTION IS 1650 01:02:15,480 --> 01:02:16,280 NOT FEDERALLY FUNDED. 1651 01:02:16,280 --> 01:02:19,360 IF IT IS, THE SINGLE IRB 1652 01:02:19,360 --> 01:02:21,600 REQUIREMENT NEEDS TO BE MET. 1653 01:02:21,600 --> 01:02:24,640 IF NOT, EVEN IF SOME SITES ARE, 1654 01:02:24,640 --> 01:02:28,040 WOULD NOT NEED TO BE MET. 1655 01:02:28,040 --> 01:02:29,840 >> IT'S A MATTER OF POLICY, YES, 1656 01:02:29,840 --> 01:02:31,880 BUT I THINK AS A MATTER OF GOOD 1657 01:02:31,880 --> 01:02:33,640 PRACTICE I WOULD ARGUE IT WOULD 1658 01:02:33,640 --> 01:02:35,160 BE APPROPRIATE TO APPLY THE SAME 1659 01:02:35,160 --> 01:02:35,720 POLICY. 1660 01:02:35,720 --> 01:02:38,600 I GUESS IT WOULDN'T APPLY THEN. 1661 01:02:38,600 --> 01:02:40,000 I THINK WE'RE DISCUSSING WHETHER 1662 01:02:40,000 --> 01:02:41,520 IT'S GOOD PRACTICE AS WELL. 1663 01:02:41,520 --> 01:02:42,440 >> YES, I AGREE. 1664 01:02:42,440 --> 01:02:43,720 I AGREE. 1665 01:02:43,720 --> 01:02:44,240 >> RIGHT. 1666 01:02:44,240 --> 01:02:51,400 >> WE COULD SAY WE THINK THAT 1667 01:02:51,400 --> 01:02:52,440 SACHRP, IN DOMESTIC STUDIES, 1668 01:02:52,440 --> 01:02:54,160 BEST PRACTICE, WHEN YOU CAN, TO 1669 01:02:54,160 --> 01:02:58,040 USE A SINGLE IRB MODEL BUT WHEN 1670 01:02:58,040 --> 01:03:00,240 THE LEAD INSTITUTION IS ACTUALLY 1671 01:03:00,240 --> 01:03:00,960 NOT FEDERALLY FUNDED THEN IT 1672 01:03:00,960 --> 01:03:03,280 WOULD BE UP TO THAT INSTITUTION 1673 01:03:03,280 --> 01:03:04,520 IN CONSULTATION WITH THE OTHER 1674 01:03:04,520 --> 01:03:05,920 SITES TO DETERMINE WHETHER A 1675 01:03:05,920 --> 01:03:07,360 SINGLE IRB IS APPROPRIATE OR 1676 01:03:07,360 --> 01:03:07,960 NOT. 1677 01:03:07,960 --> 01:03:08,240 >> YEAH. 1678 01:03:08,240 --> 01:03:11,720 I DON'T KNOW IF OTHERS AGREE, 1679 01:03:11,720 --> 01:03:13,280 THAT WOULD BE MY APPROACH. 1680 01:03:13,280 --> 01:03:15,280 >> I MEAN BASICALLY IT BECOMES A 1681 01:03:15,280 --> 01:03:17,320 DECISION FOR THE SPONSOR, WHAT 1682 01:03:17,320 --> 01:03:18,160 HAPPENS IN INDUSTRY-FUNDED 1683 01:03:18,160 --> 01:03:19,160 STUDIES ALL THE TIME. 1684 01:03:19,160 --> 01:03:21,880 SPONSOR SAYS THIS IS WHAT THE 1685 01:03:21,880 --> 01:03:32,400 IRB IS GOING TO BE FOR THIS. 1686 01:03:36,360 --> 01:03:36,560 >> OKAY. 1687 01:03:36,560 --> 01:03:37,040 >> OKAY. 1688 01:03:37,040 --> 01:03:38,640 >> ONE OF THE MORE CHALLENGING 1689 01:03:38,640 --> 01:03:40,960 ISSUES, JUST IN GENERAL WITH 1690 01:03:40,960 --> 01:03:42,360 SINGLE IRB, IS COMPLIANCE WITH 1691 01:03:42,360 --> 01:03:43,120 LOCAL LAWS. 1692 01:03:43,120 --> 01:03:46,880 I MEAN, THIS IS A REAL -- THIS 1693 01:03:46,880 --> 01:03:48,600 IS A CHALLENGE FOR ANY IRB 1694 01:03:48,600 --> 01:03:54,160 THAT'S TRYING TO WORK AS A 1695 01:03:54,160 --> 01:03:58,160 SINGLE IRB, PARTICULARLY FOR 1696 01:03:58,160 --> 01:03:58,920 INSTITUTIONAL IRBs, LOCAL 1697 01:03:58,920 --> 01:04:02,320 IRBs FOR THE FIRST TIME IT'S 1698 01:04:02,320 --> 01:04:03,120 UNCHARTERED WATERS. 1699 01:04:03,120 --> 01:04:05,160 THEY HAVEN'T GONE DOWN THE 1700 01:04:05,160 --> 01:04:08,640 PATHWAYS TO FIGURE IT OUT IN A 1701 01:04:08,640 --> 01:04:13,360 WAY THAT IS EFFICIENT AND 1702 01:04:13,360 --> 01:04:13,640 COMPLIANT. 1703 01:04:13,640 --> 01:04:17,600 AND SO THIS IS AN AREA WHERE WE 1704 01:04:17,600 --> 01:04:19,400 THINK GUIDANCE REALLY SHOULD BE 1705 01:04:19,400 --> 01:04:20,600 SAYING MORE. 1706 01:04:20,600 --> 01:04:23,960 I MEAN, WITH DRAFT GUIDANCE 1707 01:04:23,960 --> 01:04:25,840 EMPHASIZING THE SINGLE IRB MUST 1708 01:04:25,840 --> 01:04:28,120 HAVE ABILITY TO ASSESS LOCAL 1709 01:04:28,120 --> 01:04:29,440 LAWS BUT DOESN'T TALK ABOUT 1710 01:04:29,440 --> 01:04:30,880 PROCESS, HOW THAT MIGHT WORK, 1711 01:04:30,880 --> 01:04:34,360 WHAT SHOULD BE DONE IN THAT 1712 01:04:34,360 --> 01:04:34,560 CASE. 1713 01:04:34,560 --> 01:04:38,760 YOU KNOW, A LOW-HANGING FRUIT 1714 01:04:38,760 --> 01:04:40,400 EXAMPLE IS STATE PRIVACY LAWS 1715 01:04:40,400 --> 01:04:46,280 WHICH ARE MANY AND EVOLVING. 1716 01:04:46,280 --> 01:04:48,240 AND OFTEN HAVE A DIRECT IMPACT 1717 01:04:48,240 --> 01:04:49,040 ON RESEARCH ACTIVITIES. 1718 01:04:49,040 --> 01:04:52,520 HERE, YOU KNOW, THE SINGLE IRB 1719 01:04:52,520 --> 01:04:55,520 WILL NEED A WAY TO BE ABLE TO 1720 01:04:55,520 --> 01:04:57,560 PROPERLY ASSESS STATE LAWS AND 1721 01:04:57,560 --> 01:04:58,880 ENSURE THAT FOR THE VARIOUS 1722 01:04:58,880 --> 01:05:03,360 SITES THAT ARE NOW UNDER ITS IRB 1723 01:05:03,360 --> 01:05:05,720 OVERSIGHT THAT THEY ARE 1724 01:05:05,720 --> 01:05:08,000 FOLLOWING THOSE LOCAL 1725 01:05:08,000 --> 01:05:08,560 REQUIREMENTS. 1726 01:05:08,560 --> 01:05:10,840 AND TO THAT END, WE SUGGEST THAT 1727 01:05:10,840 --> 01:05:12,280 THE DRAFT GUIDANCE SHOULD TALK 1728 01:05:12,280 --> 01:05:13,800 FURTHER ABOUT THE SINGLE IRB'S 1729 01:05:13,800 --> 01:05:15,560 RESPONSIBILITY AND SCOPE OF THAT 1730 01:05:15,560 --> 01:05:17,080 RESPONSIBILITY IN TERMS OF 1731 01:05:17,080 --> 01:05:18,400 ASSESSING THE LAWS APPLICABLE TO 1732 01:05:18,400 --> 01:05:21,400 THE RESEARCH THAT IT REVIEWS AND 1733 01:05:21,400 --> 01:05:22,480 APPROVES, AND THAT ULTIMATELY 1734 01:05:22,480 --> 01:05:27,640 THE SINGLE IRB SHOULD SEEK TO 1735 01:05:27,640 --> 01:05:28,480 REVIEW LOCAL INFORMATION. 1736 01:05:28,480 --> 01:05:32,760 BUT AT THE END OF THE DAY SINGLE 1737 01:05:32,760 --> 01:05:34,600 IRB STILL HAS THAT -- HAS SOME 1738 01:05:34,600 --> 01:05:36,280 LEVEL OF RESPONSIBILITY FOR 1739 01:05:36,280 --> 01:05:37,360 ENSURING THAT THEY DID WHAT THEY 1740 01:05:37,360 --> 01:05:40,640 ARE SUPPOSED TO DO WITH RESPECT 1741 01:05:40,640 --> 01:05:41,400 TO THAT. 1742 01:05:41,400 --> 01:05:44,240 AND IN SOME WAYS IT'S A LITTLE 1743 01:05:44,240 --> 01:05:45,600 SIMILAR TO THE LOCAL CONTEXT 1744 01:05:45,600 --> 01:05:46,880 QUESTION, WHAT CAN THEY DO FROM 1745 01:05:46,880 --> 01:05:50,280 PROS TOES FIND OUT -- PROCESS 1746 01:05:50,280 --> 01:05:54,120 TO FIND OUT WHAT ARE LOCAL LAWS, 1747 01:05:54,120 --> 01:05:55,800 WITH THE INTAKE MECHANISM 1748 01:05:55,800 --> 01:05:58,080 ASSESSING OTHER CONTEXT ISSUES 1749 01:05:58,080 --> 01:05:59,840 RELATED TO IT. 1750 01:05:59,840 --> 01:06:04,120 AND THEN WE END THIS SECTION BY 1751 01:06:04,120 --> 01:06:08,920 RECOMMENDING THAT OHRP COMPILE 1752 01:06:08,920 --> 01:06:10,480 STATE LAW DATABASE THAT IS 1753 01:06:10,480 --> 01:06:11,560 COLLECTED AND MAINTAINED. 1754 01:06:11,560 --> 01:06:19,080 IT'S A LOT OF WORK BUT IT'S 1755 01:06:19,080 --> 01:06:19,440 POSSIBLE. 1756 01:06:19,440 --> 01:06:22,040 AND IT'S NOT ENTIRELY WITHOUT 1757 01:06:22,040 --> 01:06:22,400 PRECEDENT. 1758 01:06:22,400 --> 01:06:28,440 THERE'S THE INTERNATIONAL 1759 01:06:28,440 --> 01:06:29,840 COMPENDIUM THAT COULD SERVE AS A 1760 01:06:29,840 --> 01:06:32,280 MODEL BUT WE HAVE RESOURCES FOR 1761 01:06:32,280 --> 01:06:33,080 HHS TO PROVIDE THOSE RESOURCES 1762 01:06:33,080 --> 01:06:36,720 SO THE WORK CAN BE DONE. 1763 01:06:36,720 --> 01:06:42,520 1764 01:06:42,520 --> 01:06:43,600 LOIS? 1765 01:06:43,600 --> 01:06:44,760 >> THAT WAS THE SUBSTANTIVE 1766 01:06:44,760 --> 01:06:48,040 THING IN THIS DOCUMENT THAT I 1767 01:06:48,040 --> 01:06:52,520 QUESTIONED, WHETHER THAT SHOULD 1768 01:06:52,520 --> 01:06:56,720 BE WHERE OHRP AND HHS PUT THEIR 1769 01:06:56,720 --> 01:06:59,440 RESOURCES, AND, YOU KNOW, I MEAN 1770 01:06:59,440 --> 01:07:02,920 I'VE DONE KIND OF -- YOU KNOW, 1771 01:07:02,920 --> 01:07:04,560 STATEWIDE KIND OF RESEARCH, AND 1772 01:07:04,560 --> 01:07:07,200 IT IS REALLY -- THAT IS JUST A 1773 01:07:07,200 --> 01:07:10,520 LOT OF WORK. 1774 01:07:10,520 --> 01:07:11,800 AND THEN TO UPDATE, AND SO, YOU 1775 01:07:11,800 --> 01:07:15,280 KNOW, SEEMS TO ME THAT'S THE 1776 01:07:15,280 --> 01:07:16,040 COST OF DOING RESEARCH, AND 1777 01:07:16,040 --> 01:07:18,920 SHOULD BE, YOU KNOW, SHOULDERED 1778 01:07:18,920 --> 01:07:21,640 BY THE INSTITUTIONS THAT ARE 1779 01:07:21,640 --> 01:07:23,280 PERFORMING THE RESEARCH, WHETHER 1780 01:07:23,280 --> 01:07:28,040 IT'S THE SINGLE IRB TAKES IT ON, 1781 01:07:28,040 --> 01:07:32,040 IN CONSULTATION OR, YOU KNOW, 1782 01:07:32,040 --> 01:07:35,440 SAYS THAT THE LOCAL HRPPs HAVE 1783 01:07:35,440 --> 01:07:37,280 TO PROVIDE AND TAKE -- YOU KNOW, 1784 01:07:37,280 --> 01:07:39,920 I WONDER IF THERE ARE NOT OTHER 1785 01:07:39,920 --> 01:07:41,480 THINGS THAT OHRP SHOULD BE 1786 01:07:41,480 --> 01:07:44,800 DOING, AND IF THERE'S TIME AND 1787 01:07:44,800 --> 01:07:45,000 MONEY. 1788 01:07:45,000 --> 01:07:46,080 >> KEVIN? 1789 01:07:46,080 --> 01:07:48,800 >> SORT OF A NAIVE QUESTION BUT 1790 01:07:48,800 --> 01:07:52,200 I WONDER HOW HAVING SUCH A 1791 01:07:52,200 --> 01:07:55,360 RESOURCE WOULD CHANGE THE ACTUAL 1792 01:07:55,360 --> 01:08:00,360 BEHAVIOR OF SINGLE IRBs AND 1793 01:08:00,360 --> 01:08:01,440 RESPONSIBILITIES SO, FOR 1794 01:08:01,440 --> 01:08:03,560 EXAMPLE, WOULD ANY SINGLE IRB 1795 01:08:03,560 --> 01:08:05,400 JUST ONLY RELY ON THAT AND THEN 1796 01:08:05,400 --> 01:08:07,240 IF THEY ARE CALLED OUT ON 1797 01:08:07,240 --> 01:08:08,800 MISSING SOMETHING, IT WASN'T IN 1798 01:08:08,800 --> 01:08:10,640 THE DATABASE, I'M GUESSING NOT. 1799 01:08:10,640 --> 01:08:11,960 SO TO WHAT EXTENT ARE PEOPLE 1800 01:08:11,960 --> 01:08:15,040 GOING TO BE DOING THAT WORK 1801 01:08:15,040 --> 01:08:17,000 ANYWAY, JUST ANOTHER THING THAT 1802 01:08:17,000 --> 01:08:20,520 OCCURRED TO ME ABOUT THE 1803 01:08:20,520 --> 01:08:24,120 HELPFULNESS OF THIS. 1804 01:08:24,120 --> 01:08:25,320 >> WALTER? 1805 01:08:25,320 --> 01:08:27,160 >> I WAS ACTUALLY COMING FROM 1806 01:08:27,160 --> 01:08:28,440 THE OPPOSITE PERSPECTIVE WHICH 1807 01:08:28,440 --> 01:08:32,200 WAS THINKING THAT WITH ALL THE 1808 01:08:32,200 --> 01:08:34,800 EFFORT BEING MADE IN INFORMATICS 1809 01:08:34,800 --> 01:08:40,080 NOW, IT MIGHT ACTUALLY BE EASIER 1810 01:08:40,080 --> 01:08:42,480 TO PULL EVOLVING LAWS INTO A 1811 01:08:42,480 --> 01:08:45,920 COMMON DATABASE IN A WAY THAT IS 1812 01:08:45,920 --> 01:08:47,400 LESS ONEROUS THAN HAS BEEN IN 1813 01:08:47,400 --> 01:08:50,720 THE PAST. 1814 01:08:50,720 --> 01:08:52,240 I AGREE, LOIS, HISTORICALLY -- I 1815 01:08:52,240 --> 01:08:56,600 CAN SEE THIS FROM A PERSPECTIVE 1816 01:08:56,600 --> 01:08:59,680 OF A LOCAL IRB THAT'S SERVING AS 1817 01:08:59,680 --> 01:09:01,320 A COORDINATING CENTER, THAT IT'S 1818 01:09:01,320 --> 01:09:02,600 VERY -- YOU KNOW, IT'S 1819 01:09:02,600 --> 01:09:03,280 CHALLENGING. 1820 01:09:03,280 --> 01:09:07,800 THEY MAY NOT HAVE THE EXPERTISE 1821 01:09:07,800 --> 01:09:10,280 BUT THERE ARE -- THERE MUST BE 1822 01:09:10,280 --> 01:09:12,280 MECHANISMS TO PULL THIS AND 1823 01:09:12,280 --> 01:09:15,040 MAYBE, MARK, YOU CAN SPEAK FROM 1824 01:09:15,040 --> 01:09:17,760 OTHER AREAS OF THE LAW, WHERE 1825 01:09:17,760 --> 01:09:25,320 THERE ARE ADVANCES BEING MADE 1826 01:09:25,320 --> 01:09:28,560 THAT MAY FACILITATE, PULLING IN 1827 01:09:28,560 --> 01:09:29,960 AN ONGOING MANNER NEW LAWS WHICH 1828 01:09:29,960 --> 01:09:32,400 WOULD AT LEAST MAKE THE 1829 01:09:32,400 --> 01:09:32,960 RESOURCES AVAILABLE, 1830 01:09:32,960 --> 01:09:35,240 INTERPRETING THEM IS ANOTHER 1831 01:09:35,240 --> 01:09:37,360 THING BUT PULLING THEM MAY BE -- 1832 01:09:37,360 --> 01:09:40,080 THERE MAY BE AN EASIER SOLUTION 1833 01:09:40,080 --> 01:09:43,240 THAN THERE WAS FIVE YEARS AGO. 1834 01:09:43,240 --> 01:09:46,000 >> I THINK THERE PROBABLY IS. 1835 01:09:46,000 --> 01:09:48,280 ONE COULD WRITE PROGRAMS LIKE 1836 01:09:48,280 --> 01:09:51,480 A.I. PROGRAMS TO TROLL THE WEB 1837 01:09:51,480 --> 01:09:53,520 FROM STATE LEGISLATIVE 1838 01:09:53,520 --> 01:09:54,400 AUTHORITIES AND REGULATORY 1839 01:09:54,400 --> 01:09:57,800 BODIES, IT'S NOT GOING TO BE 1840 01:09:57,800 --> 01:10:00,320 FOOLPROOF, SO WE COULD 1841 01:10:00,320 --> 01:10:02,040 ELIMINATE -- THIS WAS A 1842 01:10:02,040 --> 01:10:04,560 PROCEDURAL RECOMMENDATION THE 1843 01:10:04,560 --> 01:10:06,640 SUBCOMMITTEE HAD, AND WE CAN 1844 01:10:06,640 --> 01:10:10,000 DELETE IT, WE CAN SAY WHAT 1845 01:10:10,000 --> 01:10:10,720 WALTER SAID. 1846 01:10:10,720 --> 01:10:12,360 OHRP DOES DO THIS ON THE 1847 01:10:12,360 --> 01:10:14,520 INTERNATIONAL SCENE RIGHT NOW SO 1848 01:10:14,520 --> 01:10:16,600 IT'S NOT UNPRECEDENTED AND IT'S 1849 01:10:16,600 --> 01:10:18,040 NOT FOOLPROOF BECAUSE THERE ARE 1850 01:10:18,040 --> 01:10:22,080 LOTS OF THINGS THAT ARE IN THESE 1851 01:10:22,080 --> 01:10:24,840 LOCAL, NATIONAL JURISDICTIONS 1852 01:10:24,840 --> 01:10:27,120 NOT PICKED UP BY THE OHRP 1853 01:10:27,120 --> 01:10:28,680 SERVICE IN THIS REGARD BUT A LOT 1854 01:10:28,680 --> 01:10:30,880 IS PICKED UP. 1855 01:10:30,880 --> 01:10:35,000 SO IT'S KIND OF A USEFUL 1856 01:10:35,000 --> 01:10:36,680 COMPENDIUM, BUT IT'S NOT 1857 01:10:36,680 --> 01:10:37,040 CONCLUSIVE. 1858 01:10:37,040 --> 01:10:38,480 >> I THINK PART OF WHY WE PUT 1859 01:10:38,480 --> 01:10:40,280 THIS IN HERE AT THE SUBCOMMITTEE 1860 01:10:40,280 --> 01:10:42,800 LEVEL AT LEAST WAS THE IDEA THAT 1861 01:10:42,800 --> 01:10:45,320 IF THERE'S NOW A REGULATORY 1862 01:10:45,320 --> 01:10:47,960 MANDATE TO DO SINGLE IRB AND 1863 01:10:47,960 --> 01:10:50,960 IMPLEMENT IT, THEN NOT PROVIDING 1864 01:10:50,960 --> 01:10:52,880 THOSE TOOLS DOESN'T SEEM FAIR IN 1865 01:10:52,880 --> 01:10:55,080 MANY WAYS BECAUSE IT'S NOT -- 1866 01:10:55,080 --> 01:10:58,000 FOR A LOT OF RESEARCH NOW IT'S 1867 01:10:58,000 --> 01:11:01,280 NOT AN OPTION, AND THE 1868 01:11:01,280 --> 01:11:02,280 ORGANIZATIONS OR INSTITUTIONS 1869 01:11:02,280 --> 01:11:04,120 THAT MIGHT BE TAKING ON THAT 1870 01:11:04,120 --> 01:11:05,920 ROLE HAVEN'T DONE IT 1871 01:11:05,920 --> 01:11:08,200 HISTORICALLY SO HAVEN'T BUILT UP 1872 01:11:08,200 --> 01:11:10,400 THAT EXPERIENCE OR HAVE THAT 1873 01:11:10,400 --> 01:11:12,280 INFORMATION AT THEIR FINGER 1874 01:11:12,280 --> 01:11:12,720 TIPS. 1875 01:11:12,720 --> 01:11:13,160 LINDA? 1876 01:11:13,160 --> 01:11:18,280 >> I WAS GOING TO SAY I THINK 1877 01:11:18,280 --> 01:11:19,320 THAT FROM EXPERIENCE, 1878 01:11:19,320 --> 01:11:24,040 INTERNATIONAL CONTEXT, RELY ON 1879 01:11:24,040 --> 01:11:25,080 INTERNATIONAL COMPENDIUM. 1880 01:11:25,080 --> 01:11:27,520 YOU START WITH LOCATION, STILL 1881 01:11:27,520 --> 01:11:28,600 HAVE ADDICTAL OBLIGATION TO 1882 01:11:28,600 --> 01:11:29,080 EVALUATE. 1883 01:11:29,080 --> 01:11:32,240 YOU MAY HAVE TO GET ADVICE FROM 1884 01:11:32,240 --> 01:11:35,080 OUR LEGAL COUNSEL. 1885 01:11:35,080 --> 01:11:36,800 EVEN IF YOU HAVE THIS RESOURCE 1886 01:11:36,800 --> 01:11:37,560 YOU STILL HAVE THIS OBLIGATION 1887 01:11:37,560 --> 01:11:40,120 IF YOU TAKE ON THAT 1888 01:11:40,120 --> 01:11:41,200 RESPONSIBILITY I THINK THAT'S 1889 01:11:41,200 --> 01:11:42,560 THE SCARY PART FOR 1890 01:11:42,560 --> 01:11:43,560 ORGANIZATIONS, WHAT HAPPENS IF 1891 01:11:43,560 --> 01:11:46,960 YOU MAKE A MISTAKE OR 1892 01:11:46,960 --> 01:11:47,640 MISINTERPRET LANGUAGE. 1893 01:11:47,640 --> 01:11:50,400 THAT'S THE PART THAT IS A LITTLE 1894 01:11:50,400 --> 01:11:52,600 BIT MORE PROBLEMATIC BECAUSE 1895 01:11:52,600 --> 01:11:54,080 SIMPLY HAVING A RESEARCHER GIVE 1896 01:11:54,080 --> 01:11:56,640 YOU HERE IS WHAT THE LAW SAYS, 1897 01:11:56,640 --> 01:11:58,280 HOW YOU APPLY, THAT'S THE PART 1898 01:11:58,280 --> 01:12:00,040 IN THE WEEDS, THE PART THAT IT 1899 01:12:00,040 --> 01:12:01,840 WOULD BE NICE TO FIGURE OUT A 1900 01:12:01,840 --> 01:12:04,080 SOLUTION, IF YOU COULD WORK 1901 01:12:04,080 --> 01:12:05,080 TOGETHER, THE RESEARCH COMMUNITY 1902 01:12:05,080 --> 01:12:10,120 DID HELP IN THAT REGARD, PROVIDE 1903 01:12:10,120 --> 01:12:12,200 RESOURCES AND HOW YOU APPLY, IT 1904 01:12:12,200 --> 01:12:12,960 MAKES IT EASIER. 1905 01:12:12,960 --> 01:12:15,520 HAVING EVERYONE DO IT ON THEIR 1906 01:12:15,520 --> 01:12:16,960 OWN EVEN THOUGH YOU HAVE TO DO 1907 01:12:16,960 --> 01:12:18,440 SOME OF THAT IS A LOT OF EXTRA 1908 01:12:18,440 --> 01:12:24,480 WORK AND COST TO THE 1909 01:12:24,480 --> 01:12:27,120 ORGANIZATION AS WELL. 1910 01:12:27,120 --> 01:12:30,080 >> SO, YOU KNOW, THAT'S A GREAT 1911 01:12:30,080 --> 01:12:31,640 POINT. 1912 01:12:31,640 --> 01:12:32,800 AT THE SAME TIME I DON'T KNOW IF 1913 01:12:32,800 --> 01:12:35,440 THAT NEEDS TO BE THE GOVERNMENT 1914 01:12:35,440 --> 01:12:35,720 DOING THAT. 1915 01:12:35,720 --> 01:12:39,160 YOU KNOW, WITH THE LIMITED 1916 01:12:39,160 --> 01:12:40,400 RESOURCES. 1917 01:12:40,400 --> 01:12:43,000 MAYBE SOME KIND OF COLLABORATION 1918 01:12:43,000 --> 01:12:44,720 AMONG RESEARCH INSTITUTIONS TO 1919 01:12:44,720 --> 01:12:51,640 PULL THAT TOGETHER OR SO -- I 1920 01:12:51,640 --> 01:12:53,800 JUST HAVE CONCERN. 1921 01:12:53,800 --> 01:12:54,800 WHAT'S THIS COMPUTED WITH IN 1922 01:12:54,800 --> 01:12:57,160 TERMS OF WHAT ELSE COULD BE 1923 01:12:57,160 --> 01:13:01,240 DONE, IF THERE'S, YOU KNOW, 1924 01:13:01,240 --> 01:13:03,560 RESOURCES AND STAFFING AND OTHER 1925 01:13:03,560 --> 01:13:05,000 BURNING QUESTIONS. 1926 01:13:05,000 --> 01:13:07,000 >> I THINK THAT'S -- GO AHEAD, 1927 01:13:07,000 --> 01:13:07,200 LINDA. 1928 01:13:07,200 --> 01:13:09,720 >> I WAS GOING TO SAY THE SAME 1929 01:13:09,720 --> 01:13:09,920 THING. 1930 01:13:09,920 --> 01:13:11,520 IT'S WORTH LEADING, MY OPINION, 1931 01:13:11,520 --> 01:13:13,680 IN THE DOCUMENT, THEN WE CAN 1932 01:13:13,680 --> 01:13:15,000 ALSO SUGGEST SOME OTHER OPTIONS 1933 01:13:15,000 --> 01:13:15,640 TO CONSIDER. 1934 01:13:15,640 --> 01:13:17,160 I LIKE TO HAVE OPTIONS TO 1935 01:13:17,160 --> 01:13:19,920 CONSIDER SO I UNDERSTAND YOUR 1936 01:13:19,920 --> 01:13:20,120 POINT. 1937 01:13:20,120 --> 01:13:22,400 JUST SORT OF SPEAKING FROM 1938 01:13:22,400 --> 01:13:24,760 EXPERIENCE HOW TO USE THE 1939 01:13:24,760 --> 01:13:26,960 RESOURCE, IT'S BEEN VERY 1940 01:13:26,960 --> 01:13:28,440 BENEFICIAL BUT I AGREE COULD ADD 1941 01:13:28,440 --> 01:13:29,640 SUGGESTIONS FOR SOME THINGS TO 1942 01:13:29,640 --> 01:13:30,640 CONSIDER. 1943 01:13:30,640 --> 01:13:32,040 MAYBE THAT'S A HAPPY COMPROMISE. 1944 01:13:32,040 --> 01:13:33,720 >> I THINK IN THE INTEREST OF 1945 01:13:33,720 --> 01:13:35,440 THE DOCUMENT, WE SORT OF HAVE TO 1946 01:13:35,440 --> 01:13:38,480 FIGURE OUT WHAT YOU ALL WANT TO 1947 01:13:38,480 --> 01:13:40,080 SAY TODAY. 1948 01:13:40,080 --> 01:13:43,520 AND SO I JUST SAY THAT PLAINLY 1949 01:13:43,520 --> 01:13:46,080 SO WE CAN -- THIS ONE WE CAN'T 1950 01:13:46,080 --> 01:13:48,360 TURN AROUND UNTIL THE NEXT 1951 01:13:48,360 --> 01:13:49,000 SACHRP MEETING. 1952 01:13:49,000 --> 01:13:51,120 ALONG THE LINES OF WHAT YOU'RE 1953 01:13:51,120 --> 01:13:52,600 SAYING, LINDA, ONE THING WE 1954 01:13:52,600 --> 01:13:56,920 COULD DO, USE THIS SECTION OF 1955 01:13:56,920 --> 01:14:00,720 THESE COMMENTS TO MAKE SURE IT'S 1956 01:14:00,720 --> 01:14:02,440 KNOWN AS ISSUE AND TALK ABOUT 1957 01:14:02,440 --> 01:14:04,200 MULTIPLE WAYS IT COULD BE 1958 01:14:04,200 --> 01:14:07,280 ADDRESSED, OHRP GETTING FUNDING, 1959 01:14:07,280 --> 01:14:09,160 A COLLABORATION BETWEEN RESEARCH 1960 01:14:09,160 --> 01:14:11,240 ORGANIZATIONS TO CONTRIBUTE, 1961 01:14:11,240 --> 01:14:12,040 SOME COMBINATION, OHRP SOLICITS 1962 01:14:12,040 --> 01:14:13,440 INFORMATION FROM THE PUBLIC FROM 1963 01:14:13,440 --> 01:14:14,280 INSTITUTIONS TO GET THAT BUT, 1964 01:14:14,280 --> 01:14:16,840 YOU KNOW, WE COME UP WITH A FEW 1965 01:14:16,840 --> 01:14:18,040 OPTIONS THAT ARE ON THE TABLE 1966 01:14:18,040 --> 01:14:19,680 BUT MOST IMPORTANTLY THAT IT'S 1967 01:14:19,680 --> 01:14:24,800 IN THE GUIDANCE, IN THE RESPONSE 1968 01:14:24,800 --> 01:14:27,560 TO GUIDANCE THAT IT PROBABLY 1969 01:14:27,560 --> 01:14:29,320 NEEDS TO BE MORE -- ADDRESSED 1970 01:14:29,320 --> 01:14:30,280 MORE COMPLETELY. 1971 01:14:30,280 --> 01:14:31,720 DOES THAT SOUND RIGHT, MARK? 1972 01:14:31,720 --> 01:14:33,360 >> I THINK THAT'S RIGHT. 1973 01:14:33,360 --> 01:14:35,920 I THINK WE CAN SCOPE IT OUT AS 1974 01:14:35,920 --> 01:14:38,200 AN ISSUE THAT WOULD BE USEFUL TO 1975 01:14:38,200 --> 01:14:40,120 BE SOLVED, WHETHER BY OHRP OR 1976 01:14:40,120 --> 01:14:42,120 SOMEBODY ELSE AND POINT OUT THAT 1977 01:14:42,120 --> 01:14:44,040 THE USEFULNESS OF THE 1978 01:14:44,040 --> 01:14:44,560 INTERNATIONAL RESOURCE IS 1979 01:14:44,560 --> 01:14:45,000 ALREADY AVAILABLE. 1980 01:14:45,000 --> 01:14:52,720 MAYBE THAT'S THE WAY TO HANDLE 1981 01:14:52,720 --> 01:14:53,400 IT. 1982 01:14:53,400 --> 01:14:56,360 >> GOOD. 1983 01:14:56,360 --> 01:14:59,120 >> THERE WAS AN NIH-FUNDED 1984 01:14:59,120 --> 01:15:07,440 STUDY, WHICH I WAS INVOLVED, 1985 01:15:07,440 --> 01:15:09,360 CLAYTON, SUSAN WOLF, NIH FUNDED 1986 01:15:09,360 --> 01:15:11,720 AN ENTIRE PROJECT ON TRYING TO 1987 01:15:11,720 --> 01:15:13,680 UNDERSTAND THE STATE LAWS OF 1988 01:15:13,680 --> 01:15:16,080 GENOMIC AND GENETIC PRIVACY AND 1989 01:15:16,080 --> 01:15:18,200 TESTING, AND THAT DID ASSEMBLE 1990 01:15:18,200 --> 01:15:19,560 AN ENTIRE DATABASE OF ALL THE 1991 01:15:19,560 --> 01:15:21,640 STATE LAWS BUT THE PROBLEM IS 1992 01:15:21,640 --> 01:15:24,680 NIH DID NOT PROVIDE CONTINUED 1993 01:15:24,680 --> 01:15:26,600 FUNDING SO THE LAW, RESOURCE IS 1994 01:15:26,600 --> 01:15:27,920 USEFUL, IT WAS OUTDATED ON THE 1995 01:15:27,920 --> 01:15:30,080 DAY WE PUT IT ON THE WEB. 1996 01:15:30,080 --> 01:15:33,240 SO IT IS A CHALLENGE, UNLESS ONE 1997 01:15:33,240 --> 01:15:34,600 CAN COME UP WITH AN A.I. 1998 01:15:34,600 --> 01:15:36,360 RESOURCE TO TROLL THE WEB AND 1999 01:15:36,360 --> 01:15:40,040 STILL HAS TO BE CURATED. 2000 01:15:40,040 --> 01:15:45,400 >> MARK, TO THAT POINT, 2001 01:15:45,400 --> 01:15:51,440 PRIMARILY A LOCAL IRB THAT HAS 2002 01:15:51,440 --> 01:15:53,920 RESPONSIBILITY FOR, YOU KNOW, 2003 01:15:53,920 --> 01:15:55,440 MULTI-CENTER STUDY BUT IT WOULD 2004 01:15:55,440 --> 01:15:57,000 BE -- THIS WOULD SEEM LIKE A 2005 01:15:57,000 --> 01:16:04,320 SIGNIFICANT BURDEN TO THEM TO 2006 01:16:04,320 --> 01:16:07,600 TRY TO COLLATE RELEVANT LAWS FOR 2007 01:16:07,600 --> 01:16:08,400 PARTICIPATING CENTERS SO 2008 01:16:08,400 --> 01:16:09,560 HAVING -- THE SPIRIT OF THE 2009 01:16:09,560 --> 01:16:12,000 SUGGESTION WAS IN PART TO BE 2010 01:16:12,000 --> 01:16:15,040 ABLE TO PROVIDE A REFERENCE THAT 2011 01:16:15,040 --> 01:16:17,800 COULD BE USED TO ESSENTIALLY 2012 01:16:17,800 --> 01:16:21,760 INDICATE THAT THEY HAVE INDEED 2013 01:16:21,760 --> 01:16:23,640 SOUGHT ACCESS TO ALL AVAILABLE 2014 01:16:23,640 --> 01:16:25,240 AND CURRENT DATA AS OPPOSED TO 2015 01:16:25,240 --> 01:16:28,920 THE UNCERTAINTY OF LOOKING FOR 2016 01:16:28,920 --> 01:16:33,040 IT THEMSELVES. 2017 01:16:33,040 --> 01:16:35,920 >> SO THE OTHER OPTION I WAS 2018 01:16:35,920 --> 01:16:42,440 THINKING OF IF IT SEEMS TOO 2019 01:16:42,440 --> 01:16:46,720 BURDENSOME FOR OHRP IS THAT 2020 01:16:46,720 --> 01:16:48,040 SOMETHING THE INSTITUTION CAN 2021 01:16:48,040 --> 01:16:53,520 REQUEST FUNDS FOR, THE SINGLE 2022 01:16:53,520 --> 01:16:55,600 IRB CAN THEY ADD TO GRANT 2023 01:16:55,600 --> 01:16:56,600 APPLICATIONS SAYING THEY NEED 2024 01:16:56,600 --> 01:17:02,840 THIS TO DO MORE RESEARCH TO HELP 2025 01:17:02,840 --> 01:17:04,360 WITH THAT. 2026 01:17:04,360 --> 01:17:04,840 >> (INDISCERNIBLE). 2027 01:17:04,840 --> 01:17:06,080 >> YEAH, I MEAN, THAT COULD BE 2028 01:17:06,080 --> 01:17:08,480 AN OPTION. 2029 01:17:08,480 --> 01:17:10,720 I THINK YOU HAVE -- I THINK THE 2030 01:17:10,720 --> 01:17:12,440 THINGS THAT I WOULD FIND 2031 01:17:12,440 --> 01:17:13,120 PROBLEMATIC ABOUT THAT IS THEN 2032 01:17:13,120 --> 01:17:14,720 WOULD YOU HAVE LOTS OF PEOPLE 2033 01:17:14,720 --> 01:17:16,040 PUTTING IN REQUESTS FOR GRANTS 2034 01:17:16,040 --> 01:17:20,120 TO DO THE SAME WORK OVER AND 2035 01:17:20,120 --> 01:17:21,640 OVER AGAIN. 2036 01:17:21,640 --> 01:17:23,760 AND THERE'S THE ONGOING PROBLEM 2037 01:17:23,760 --> 01:17:24,600 FOR MARK'S EXAMPLE OF THE 2038 01:17:24,600 --> 01:17:26,120 PROJECT HE WAS INVOLVED WITH 2039 01:17:26,120 --> 01:17:32,920 MAINTAINING IT, YOU KNOW, 2040 01:17:32,920 --> 01:17:33,440 DOWNSTREAM. 2041 01:17:33,440 --> 01:17:35,080 AND IT'S A GRANT TO PULL IT 2042 01:17:35,080 --> 01:17:36,200 TOGETHER BUT DOESN'T HAVE A 2043 01:17:36,200 --> 01:17:37,840 GRANT TO KEEP IT UP. 2044 01:17:37,840 --> 01:17:41,760 THERE MIGHT BE NO INCENTIVE TO 2045 01:17:41,760 --> 01:17:43,520 DO SO. 2046 01:17:43,520 --> 01:17:47,040 HOWEVER, SINCE IT'S PART OF A 2047 01:17:47,040 --> 01:17:48,240 REGULATORY MANDATE, I DON'T KNOW 2048 01:17:48,240 --> 01:17:50,120 FANTASTIC OFF THE TABLE BUT THAT 2049 01:17:50,120 --> 01:17:54,000 WOULD BE MY OFF THE CUFF TO THAT 2050 01:17:54,000 --> 01:17:54,680 APPROACH. 2051 01:17:54,680 --> 01:17:55,440 >> THE EXAMPLE OF THE 2052 01:17:55,440 --> 01:17:56,600 INTERNATIONAL STUDY OF MEN WHO 2053 01:17:56,600 --> 01:17:59,200 HAVE SEX WITH MEN AND SUBSTANCE 2054 01:17:59,200 --> 01:18:03,440 ABUSE INTERVENTIONS I THINK 2055 01:18:03,440 --> 01:18:04,440 GETTING LOCAL LEGAL OPINIONS 2056 01:18:04,440 --> 01:18:06,640 ABOUT WHAT THE LEGALITY OF THESE 2057 01:18:06,640 --> 01:18:10,040 SITUATIONS MIGHT BE IF 2058 01:18:10,040 --> 01:18:11,000 IDENTIFIED IN RESEARCH RECORDS, 2059 01:18:11,000 --> 01:18:19,200 PUT ON AS DIRECT COST OF GRANT, 2060 01:18:19,200 --> 01:18:19,480 ALLOWABLE. 2061 01:18:19,480 --> 01:18:21,880 WHAT NIH WOULD SAY FOR DOMESTIC 2062 01:18:21,880 --> 01:18:25,480 SITUATIONS THAT WOULD BE PART OF 2063 01:18:25,480 --> 01:18:28,960 THE INDIRECT LEGAL COST OF 2064 01:18:28,960 --> 01:18:31,480 THE -- INDIRECT COST, LEGAL 2065 01:18:31,480 --> 01:18:33,360 SERVICES NEGOTIATED IN IDC 2066 01:18:33,360 --> 01:18:34,000 RATES. 2067 01:18:34,000 --> 01:18:39,920 I THINK IT COULD BE POSSIBLE. 2068 01:18:39,920 --> 01:18:43,880 >> THERE COULD BE A FUNDING 2069 01:18:43,880 --> 01:18:46,280 OPPORTUNITY TO DO THIS WORK AS A 2070 01:18:46,280 --> 01:18:48,680 WAY TO KICK START IT, NOT 2071 01:18:48,680 --> 01:18:54,560 SPECIFIC TO ANY ONE STUDY. 2072 01:18:54,560 --> 01:18:55,360 >> THAT'S TRUE. 2073 01:18:55,360 --> 01:18:56,440 FUNDED BY THE NIH TO TAKE CARE 2074 01:18:56,440 --> 01:18:59,280 OF THE PROBLEM WHICH IS THE 2075 01:18:59,280 --> 01:19:02,680 STATES HAVE THIS PANOPLY OF LAWS 2076 01:19:02,680 --> 01:19:04,640 ABOUT GENOMIC TESTING, GENOMIC 2077 01:19:04,640 --> 01:19:05,640 SEQUENCING AND TESTING. 2078 01:19:05,640 --> 01:19:07,800 AND SO NIH THOUGHT IN ORDER TO 2079 01:19:07,800 --> 01:19:10,040 BE ABLE TO ALLOW RESEARCHERS TO 2080 01:19:10,040 --> 01:19:12,280 HAVE A RESOURCE IT WOULD FUND 2081 01:19:12,280 --> 01:19:14,280 THIS PROJECT, AS I SAID THAT 2082 01:19:14,280 --> 01:19:15,480 DIDN'T CONTINUE THE FUNDING. 2083 01:19:15,480 --> 01:19:18,440 BUT IF THERE IS GOING TO BE A 2084 01:19:18,440 --> 01:19:21,520 SINGLE IRB MANDATE, THEN BOTH AT 2085 01:19:21,520 --> 01:19:24,280 THE FUNDER LEVEL AT NIH AND 2086 01:19:24,280 --> 01:19:25,800 OHRP, THEN ONE COULD ARGUE THAT 2087 01:19:25,800 --> 01:19:30,280 THAT WOULD BE AN APPROPRIATE WAY 2088 01:19:30,280 --> 01:19:31,720 TO HELP THE REGULATED COMMUNITY 2089 01:19:31,720 --> 01:19:32,920 BUT THERE'S THE RESOURCE 2090 01:19:32,920 --> 01:19:34,000 ALLOCATION QUESTIONS, WHETHER 2091 01:19:34,000 --> 01:19:36,600 THAT'S BEST USE OF RESOURCES. 2092 01:19:36,600 --> 01:19:40,000 ULTIMATELY, I'LL JUST TELL YOU 2093 01:19:40,000 --> 01:19:42,560 AS AN ECONOMIC -- MACROECONOMIC 2094 01:19:42,560 --> 01:19:44,960 MATTER, HAVING THE SINGLE IRB BE 2095 01:19:44,960 --> 01:19:47,360 RESPONSIBLE REALLY DRIVES THIS 2096 01:19:47,360 --> 01:19:48,320 CENTRALIZATION OF IRBs EVEN 2097 01:19:48,320 --> 01:19:50,680 MORE BECAUSE ONLY A FEW IRBs 2098 01:19:50,680 --> 01:19:52,880 HAVE THE CAPACITY TO HAVE ACCESS 2099 01:19:52,880 --> 01:19:56,840 TO ALL THE INFORMATION THAT THEY 2100 01:19:56,840 --> 01:19:59,960 WOULD NEED SO DISINCENTIVIZES 2101 01:19:59,960 --> 01:20:00,720 SMALLER INSTITUTIONAL IRBs 2102 01:20:00,720 --> 01:20:05,120 FROM BEING SINGLE IRBs, IN 2103 01:20:05,120 --> 01:20:05,720 MULTI-SITE STUDIES, THE REAL 2104 01:20:05,720 --> 01:20:09,360 WORLD FACT OF THE WAY THIS PLAYS 2105 01:20:09,360 --> 01:20:09,560 OUT. 2106 01:20:09,560 --> 01:20:11,360 ANY REGULATED INDUSTRY, MORE 2107 01:20:11,360 --> 01:20:12,560 HIGHLY REGULATED, THE MORE 2108 01:20:12,560 --> 01:20:14,400 CENTRALIZED IT BECOMES BECAUSE 2109 01:20:14,400 --> 01:20:16,040 OF TRANSACTION COST OF DEALING 2110 01:20:16,040 --> 01:20:17,840 WITH REGULATIONS. 2111 01:20:17,840 --> 01:20:19,120 THAT'S AN ECONOMIC PHENOMENON. 2112 01:20:19,120 --> 01:20:20,560 >> I COULDN'T AGREE MORE, MARK. 2113 01:20:20,560 --> 01:20:30,120 THAT WAS THE SPIRIT OF HAVING 2114 01:20:30,120 --> 01:20:31,360 THIS SUPPORTED THROUGH OHRP. 2115 01:20:31,360 --> 01:20:36,080 LOIS, I TAKE THE POINT ABOUT 2116 01:20:36,080 --> 01:20:38,280 RESOURCING, I'M ALSO THE ETERNAL 2117 01:20:38,280 --> 01:20:41,120 OPTIMIST, HOPING I.T. COSTS WILL 2118 01:20:41,120 --> 01:20:49,040 GO DOWN FOR THIS SORT OF 2119 01:20:49,040 --> 01:20:49,640 ACTIVITY FUTURE. 2120 01:20:49,640 --> 01:20:57,080 >> MY OTHER TAKEWAY FROM READING 2121 01:20:57,080 --> 01:20:58,480 THE DOCUMENT 2122 01:20:58,480 --> 01:21:06,280 I'M NEW TO SACHRP, MY FIRST 2123 01:21:06,280 --> 01:21:06,720 IN-PERSON MEETING. 2124 01:21:06,720 --> 01:21:09,480 WHAT DO WE KNOW ABOUT HOW THINGS 2125 01:21:09,480 --> 01:21:11,400 ARE GOING WITH THE SINGLE 2126 01:21:11,400 --> 01:21:11,960 IRBs? 2127 01:21:11,960 --> 01:21:13,400 YOU KNOW, SO, MARK, YOU'RE 2128 01:21:13,400 --> 01:21:15,560 TELLING US LIKE THIS IS WHAT'S 2129 01:21:15,560 --> 01:21:16,760 HAPPENING, WHAT THE EFFECTS 2130 01:21:16,760 --> 01:21:17,640 WOULD BE, WHAT'S HAPPENING ON 2131 01:21:17,640 --> 01:21:19,760 THE GROUND. 2132 01:21:19,760 --> 01:21:21,720 I'M JUST WONDERING WHAT I WAS 2133 01:21:21,720 --> 01:21:24,040 THINKING WHEN I SAW THAT 2134 01:21:24,040 --> 01:21:25,560 PROPOSED, YOU KNOW, LOCAL IRBs 2135 01:21:25,560 --> 01:21:26,640 HAVE BEEN HAVING TO FIGURE OUT 2136 01:21:26,640 --> 01:21:31,120 WHAT THE LAWS ARE ALL THE TIME, 2137 01:21:31,120 --> 01:21:32,480 YOU KNOW. 2138 01:21:32,480 --> 01:21:33,960 AND CAN'T SINGLE AND LOCAL JUST 2139 01:21:33,960 --> 01:21:34,880 WORK THAT OUT? 2140 01:21:34,880 --> 01:21:36,920 SO THAT WAS KIND OF MY BEGINNING 2141 01:21:36,920 --> 01:21:38,920 POINT BUT MY OTHER POINT WAS 2142 01:21:38,920 --> 01:21:42,080 THINKING ABOUT WHAT OTHER KIND 2143 01:21:42,080 --> 01:21:43,520 OF THINGS WE WOULD LIKE OHRP TO 2144 01:21:43,520 --> 01:21:45,560 DO OR KNOW ABOUT OR WHAT SHOULD 2145 01:21:45,560 --> 01:21:51,200 BE FUNDED, IT SEEMS TO ME, YOU 2146 01:21:51,200 --> 01:21:53,600 KNOW, SOME KIND OF REPORT ABOUT 2147 01:21:53,600 --> 01:21:57,400 HOW THE SINGLE IRB SYSTEM IS 2148 01:21:57,400 --> 01:21:59,600 GOING, INTENDED AND UNINTENDED 2149 01:21:59,600 --> 01:22:04,280 CONSEQUENCES, AND JUST A FACTUAL 2150 01:22:04,280 --> 01:22:06,400 WHERE ARE THINGS? 2151 01:22:06,400 --> 01:22:08,280 AND, YOU KNOW, SO IF THAT 2152 01:22:08,280 --> 01:22:10,760 ALREADY EXISTS, POINT ME TO IT. 2153 01:22:10,760 --> 01:22:12,320 BUT, YOU KNOW, I PEER REVIEWED 2154 01:22:12,320 --> 01:22:14,600 SOMETHING RECENTLY, I KEPT ON 2155 01:22:14,600 --> 01:22:17,680 SAYING WHERE'S THE DATA ON WHAT 2156 01:22:17,680 --> 01:22:20,280 YOU'RE TALKING ABOUT? 2157 01:22:20,280 --> 01:22:23,200 THAT'S WHAT I -- I'M CURIOUS IF 2158 01:22:23,200 --> 01:22:26,720 ANY OF YOU KNOW, I MEAN, DO WE 2159 01:22:26,720 --> 01:22:28,920 HAVE A GOOD UNDERSTANDING -- 2160 01:22:28,920 --> 01:22:30,360 DOES OHRP HAVE A GOOD 2161 01:22:30,360 --> 01:22:32,520 UNDERSTANDING RIGHT NOW OF WHAT 2162 01:22:32,520 --> 01:22:37,320 HAS HAPPENED SINCE THE SINGLE 2163 01:22:37,320 --> 01:22:42,840 IRB MANDATE WITH RESPECT TO 2164 01:22:42,840 --> 01:22:45,760 CONSOLIDATION, WITH RESPECT TO 2165 01:22:45,760 --> 01:22:46,760 PRIVATE/PUBLIC IRBs, YOU KNOW, 2166 01:22:46,760 --> 01:22:49,160 WITH RESPECT TO THOSE CONNECTED 2167 01:22:49,160 --> 01:22:52,360 TO ACADEMIC INSTITUTIONS VERSUS 2168 01:22:52,360 --> 01:22:55,520 NOT, AND JUST KIND OF HOW'S IT 2169 01:22:55,520 --> 01:22:55,840 GOING? 2170 01:22:55,840 --> 01:22:57,200 YOU KNOW, SEEMS LIKE THAT WOULD 2171 01:22:57,200 --> 01:22:58,440 BE GOOD INFORMATION TO KNOW. 2172 01:22:58,440 --> 01:23:01,200 IF WE ALREADY KNOW IT, LET ME 2173 01:23:01,200 --> 01:23:01,520 KNOW. 2174 01:23:01,520 --> 01:23:03,440 SOMEONE POINT ME TO THAT 2175 01:23:03,440 --> 01:23:05,800 RESOURCE. 2176 01:23:05,800 --> 01:23:07,080 2177 01:23:07,080 --> 01:23:09,040 >> I MEAN, OHRP IS WELCOME TO 2178 01:23:09,040 --> 01:23:09,280 COMMENT. 2179 01:23:09,280 --> 01:23:14,480 NIH, IF IT'S IN THE ROOM OR ON 2180 01:23:14,480 --> 01:23:15,680 THE ZOOM, IS OBVIOUSLY -- WE 2181 01:23:15,680 --> 01:23:17,200 WOULD LOVE TO HEAR THE COMMENTS. 2182 01:23:17,200 --> 01:23:18,720 I DON'T THINK THERE'S BEEN A 2183 01:23:18,720 --> 01:23:19,720 COMPREHENSIVE DATA ANALYSIS OF 2184 01:23:19,720 --> 01:23:22,080 WHAT THE EFFECT IS. 2185 01:23:22,080 --> 01:23:23,960 I DO THINK WHAT I GET, MY 2186 01:23:23,960 --> 01:23:26,840 IMPRESSIONS FROM JUST BEING 2187 01:23:26,840 --> 01:23:30,000 ASKED ABOUT THINGS, I DO THINK 2188 01:23:30,000 --> 01:23:32,400 THAT THE FACT THAT INDUSTRY 2189 01:23:32,400 --> 01:23:35,400 SPONSORS OF CLINICAL RESEARCH 2190 01:23:35,400 --> 01:23:36,480 INCREASINGLY HAVE DEMANDED 2191 01:23:36,480 --> 01:23:39,240 SINGLE IRBs AS A CONDITION OF 2192 01:23:39,240 --> 01:23:41,080 A SITE BEING BROUGHT ON AS A 2193 01:23:41,080 --> 01:23:43,920 SITE, IN ADDITION TO THE NIH AND 2194 01:23:43,920 --> 01:23:46,880 THE COMMON RULE MANDATE HAS LED, 2195 01:23:46,880 --> 01:23:49,880 IN MY IMPRESSION, FOR WHAT IT'S 2196 01:23:49,880 --> 01:23:55,440 WORTH, IT HAS LED TO A LOT OF 2197 01:23:55,440 --> 01:23:57,160 OPPORTUNITY FOR THE COMMERCIAL 2198 01:23:57,160 --> 01:24:01,680 CENTRAL IRBs AS WELL AS 2199 01:24:01,680 --> 01:24:03,040 OPPORTUNITY FOR THE 2200 01:24:03,040 --> 01:24:04,400 WELL-ESTABLISHED ACADEMIC IRBs 2201 01:24:04,400 --> 01:24:05,960 IN THE LARGEST INSTITUTIONS TO 2202 01:24:05,960 --> 01:24:09,520 BECOME THE CENTRAL IRBs, BUT 2203 01:24:09,520 --> 01:24:14,240 I DON'T THINK THERE'S BEEN A 2204 01:24:14,240 --> 01:24:18,200 SURVEY DONE, JUST GIVING MY 2205 01:24:18,200 --> 01:24:18,720 EXPRESSION. 2206 01:24:18,720 --> 01:24:22,560 SKIP? 2207 01:24:22,560 --> 01:24:25,680 >> FOR MANY YEARS, MANY ACADEMIC 2208 01:24:25,680 --> 01:24:28,280 INSTITUTIONS HAVE BEEN 2209 01:24:28,280 --> 01:24:29,320 OUTSOURCING IRB REVIEWS FOR 2210 01:24:29,320 --> 01:24:30,800 PHARMACEUTICAL STUDIES FOR 2211 01:24:30,800 --> 01:24:31,040 EXAMPLE. 2212 01:24:31,040 --> 01:24:34,160 I SUSPECT THE ANSWER TO YOUR 2213 01:24:34,160 --> 01:24:35,920 QUESTION WILL DEPEND LARGELY ON 2214 01:24:35,920 --> 01:24:37,360 TYPE OF STUDY. 2215 01:24:37,360 --> 01:24:38,560 COMPLEXITY, IT'S NOT WITHOUT 2216 01:24:38,560 --> 01:24:39,880 NOTICE KINDS OF EXAMPLES GIVEN 2217 01:24:39,880 --> 01:24:44,680 HERE HAVE BEEN ABOUT WHERE THIS 2218 01:24:44,680 --> 01:24:47,840 COULD BE PROBLEMATIC, HAVE 2219 01:24:47,840 --> 01:24:50,280 BEEN -- STUDIES THAT INVOLVE 2220 01:24:50,280 --> 01:24:51,160 VULNERABLE POPULATIONS, 2221 01:24:51,160 --> 01:24:52,000 DIFFICULT TOPICS, WHERE THERE'S 2222 01:24:52,000 --> 01:24:55,960 A LOT OF LOCAL VARIABILITY IN 2223 01:24:55,960 --> 01:24:59,120 LAWS, PRACTICES, ET CETERA. 2224 01:24:59,120 --> 01:25:00,840 WHICH DOESN'T REALLY APPLY TO 2225 01:25:00,840 --> 01:25:01,480 PHARMACEUTICAL STUDIES SO I 2226 01:25:01,480 --> 01:25:03,280 THINK THE ANSWER TO THE QUESTION 2227 01:25:03,280 --> 01:25:04,840 WILL DEPEND IN LARGE PART ON 2228 01:25:04,840 --> 01:25:06,720 TYPE OF STUDY YOU'RE LOOKING AT 2229 01:25:06,720 --> 01:25:10,320 SO I DON'T THINK ONE SIZE WOULD 2230 01:25:10,320 --> 01:25:12,920 FIT ALL. 2231 01:25:12,920 --> 01:25:15,440 2232 01:25:15,440 --> 01:25:18,040 >> YES? 2233 01:25:18,040 --> 01:25:20,680 >> YEAH, PLEASE, JERRY. 2234 01:25:20,680 --> 01:25:23,280 >> YEAH, I PROBABLY AGREE WITH 2235 01:25:23,280 --> 01:25:24,880 SKIP'S POINT, IN TERMS OF 2236 01:25:24,880 --> 01:25:28,480 FEDERALLY FUNDED STUFF AND 2237 01:25:28,480 --> 01:25:29,880 NON-FEDERALLY FUNDED STUFF. 2238 01:25:29,880 --> 01:25:31,640 JUST IN TERMS OF, YOU KNOW, OHRP 2239 01:25:31,640 --> 01:25:32,720 PROBABLY DOESN'T HAVE A LOT OF 2240 01:25:32,720 --> 01:25:33,360 INFORMATION ABOUT THIS. 2241 01:25:33,360 --> 01:25:35,920 IT'S IN THE NATURE OF WHAT 2242 01:25:35,920 --> 01:25:37,360 INFORMATION ACTUALLY OHRP HAS 2243 01:25:37,360 --> 01:25:39,360 READY ACCESS TO AND BY AND LARGE 2244 01:25:39,360 --> 01:25:42,040 WE ACTUALLY DON'T, I MEAN WE 2245 01:25:42,040 --> 01:25:43,680 DON'T -- YOU KNOW, WE'VE 2246 01:25:43,680 --> 01:25:45,200 ADMINISTER RULES, BUT DAY TO DAY 2247 01:25:45,200 --> 01:25:47,600 WE DON'T CREATE IRBs OR HAVE 2248 01:25:47,600 --> 01:25:51,040 OUR OWN IRBs DOING STUFF. 2249 01:25:51,040 --> 01:25:52,560 WHETHER NIH PEOPLE HERE WANT TO 2250 01:25:52,560 --> 01:25:55,040 COMMENT ON THAT, YOU KNOW, IT'S 2251 01:25:55,040 --> 01:25:56,480 UP TO THEM. 2252 01:25:56,480 --> 01:25:57,680 IN FACT MY RECOLLECTION GOING 2253 01:25:57,680 --> 01:26:01,360 BACK TO THE COMMON RULE WAS 2254 01:26:01,360 --> 01:26:02,880 REVIEWED THERE WERE ISSUES 2255 01:26:02,880 --> 01:26:04,800 RELATING AND FOLLOW WHERE NIH 2256 01:26:04,800 --> 01:26:06,920 INDICATED AND PROBABLY HAS BEEN 2257 01:26:06,920 --> 01:26:09,880 DOING FROM TIME TO TIME, VARIOUS 2258 01:26:09,880 --> 01:26:12,600 ATTEMPTS TO SEE HOW THE SYSTEM 2259 01:26:12,600 --> 01:26:13,280 IS WORKING. 2260 01:26:13,280 --> 01:26:16,000 I'LL REMIND SOME OF YOU WHEN WE 2261 01:26:16,000 --> 01:26:17,200 WERE CRAFTING THE REVISIONS TO 2262 01:26:17,200 --> 01:26:19,600 COMMON RULE IT WAS LIKE PULLING 2263 01:26:19,600 --> 01:26:22,800 TEETH IN TERMS OF A FEW MINOR 2264 01:26:22,800 --> 01:26:24,360 THINGS OHRP WOULD LIKE THIS TINY 2265 01:26:24,360 --> 01:26:26,080 PIECE OF INFORMATION THAT WOULD 2266 01:26:26,080 --> 01:26:27,200 TAKE AN INSTITUTION FIVE MINUTES 2267 01:26:27,200 --> 01:26:29,200 A YEAR AND THESE BY AND LARGE 2268 01:26:29,200 --> 01:26:32,240 WERE PULLED OUT OF THE REVISIONS 2269 01:26:32,240 --> 01:26:34,400 TO THE RULE THAT THIS IS TOO 2270 01:26:34,400 --> 01:26:40,120 MUCH WORK SO BOTTOM LINE HORN IN 2271 01:26:40,120 --> 01:26:41,920 OHRP DOES NOT HAVE ACCESS TO 2272 01:26:41,920 --> 01:26:44,600 THE INFORMATION THAT WOULD TELL 2273 01:26:44,600 --> 01:26:47,880 YOU HOW THESE CHANGES, GOOD OR 2274 01:26:47,880 --> 01:26:50,200 BAD, AGAIN, OTHER PLAYERS MAY 2275 01:26:50,200 --> 01:26:50,640 CERTAINLY KNOW MORE, 2276 01:26:50,640 --> 01:26:55,800 PARTICULARLY IN TERMS OF NIH. 2277 01:26:55,800 --> 01:26:56,760 CERTAINLY AGREE THE MORE 2278 01:26:56,760 --> 01:26:57,840 INFORMATION YOU GET ABOUT A 2279 01:26:57,840 --> 01:26:59,160 SYSTEM, THIS WOULD BE GREAT BUT, 2280 01:26:59,160 --> 01:27:02,880 AGAIN, THIS IS PART OF WHAT 2281 01:27:02,880 --> 01:27:04,440 HAPPENED BEFORE, REVISING THE 2282 01:27:04,440 --> 01:27:05,680 COMMON RULE. 2283 01:27:05,680 --> 01:27:07,040 I THOUGHT A BIG THEME IN TERMS 2284 01:27:07,040 --> 01:27:08,480 OF OUR SIDE WE DON'T ACTUALLY 2285 01:27:08,480 --> 01:27:10,000 HAVE A LOT OF INFORMATION ABOUT 2286 01:27:10,000 --> 01:27:11,520 HOW THE SYSTEM WORKS AND WERE 2287 01:27:11,520 --> 01:27:12,880 TRYING TO COLLECT MORE AROUND 2288 01:27:12,880 --> 01:27:14,280 WEREN'T GIVEN THE AUTHORITY TO 2289 01:27:14,280 --> 01:27:15,240 DO THAT. 2290 01:27:15,240 --> 01:27:16,680 AND IT WAS NOTEWORTHY FROM MY 2291 01:27:16,680 --> 01:27:18,640 END HOW MUCH THERE WAS PUSHBACK 2292 01:27:18,640 --> 01:27:22,920 IN SAYING, YOU KNOW, EVEN IN 2293 01:27:22,920 --> 01:27:23,920 TERMS OF THINGS THAT WEREN'T 2294 01:27:23,920 --> 01:27:26,000 GOING TO TAKE OF TIME OR EFFORT 2295 01:27:26,000 --> 01:27:28,080 AT ALL WE WEREN'T ALLOWED TO DO 2296 01:27:28,080 --> 01:27:28,400 THAT. 2297 01:27:28,400 --> 01:27:29,720 THE OTHER ISSUE RAISED IN TERMS 2298 01:27:29,720 --> 01:27:34,440 OF THIS TOPIC AND PRIOR ONE, OUR 2299 01:27:34,440 --> 01:27:35,040 BUDGET. 2300 01:27:35,040 --> 01:27:35,960 WE ARE SMALL. 2301 01:27:35,960 --> 01:27:38,480 DOING MANY THINGS THAT YOU GUYS 2302 01:27:38,480 --> 01:27:41,200 HAVE TALKED ABOUT HERE ARE GOING 2303 01:27:41,200 --> 01:27:44,200 TO TURN INTO HOW SMALL THEY ARE 2304 01:27:44,200 --> 01:27:46,120 AND EFFORT THAT'S INVOLVED, 2305 01:27:46,120 --> 01:27:48,120 PEOPLE POINTED OUT INTERNATIONAL 2306 01:27:48,120 --> 01:27:49,320 COMPILATION, FOR EXAMPLE, WHICH 2307 01:27:49,320 --> 01:27:52,280 ACTUALLY IS A BIG EFFORT THAT WE 2308 01:27:52,280 --> 01:27:53,400 ACTUALLY TALK ABOUT WHETHER OR 2309 01:27:53,400 --> 01:27:56,280 NOT WE COULD MAINTAIN DOING THAT 2310 01:27:56,280 --> 01:27:58,800 BUT THAT'S RELATIVELY EASY IN 2311 01:27:58,800 --> 01:28:00,840 TERMS OF WHAT OHRP PRETTY MUCH 2312 01:28:00,840 --> 01:28:02,800 DOES, HAS CONTEXTS IN A BUNCH OF 2313 01:28:02,800 --> 01:28:04,360 COUNTRIES AND ONCE A YEAR ASK 2314 01:28:04,360 --> 01:28:08,640 THEM COULD YOU SHIP US JUST A 2315 01:28:08,640 --> 01:28:17,600 DOCUMENT, THE LAWS, THAT'S MIND 2316 01:28:17,600 --> 01:28:21,480 BOGGLING DIFFERENT AND BY AND 2317 01:28:21,480 --> 01:28:22,760 LARGE, NOT JUST OHRP BUT OTHER 2318 01:28:22,760 --> 01:28:23,960 PARTS OF THE FEDERAL GOVERNMENT 2319 01:28:23,960 --> 01:28:25,520 IN GENERAL, IT'S NOT THE 2320 01:28:25,520 --> 01:28:30,320 BUSINESS OF MOST PARTS OF THE 2321 01:28:30,320 --> 01:28:31,320 FEDERAL GOVERNMENT TO DELVE INTO 2322 01:28:31,320 --> 01:28:32,720 TELLING PEOPLE WHO ARE SUBJECT 2323 01:28:32,720 --> 01:28:34,480 TO STATE AND LOCAL LAWS HERE IS 2324 01:28:34,480 --> 01:28:35,560 THE FEDERAL GOVERNMENT HELPING 2325 01:28:35,560 --> 01:28:38,080 YOU OUT TO COMPLY WITH STATE AND 2326 01:28:38,080 --> 01:28:39,480 LOCAL LAWS. 2327 01:28:39,480 --> 01:28:41,480 WHICH OF COURSE, AGAIN, YOU 2328 01:28:41,480 --> 01:28:42,360 SHOULD MAKE WHATEVER 2329 01:28:42,360 --> 01:28:44,680 RECOMMENDATION YOU WANT BUT 2330 01:28:44,680 --> 01:28:45,440 REALISTICALLY SPEAKING I DON'T 2331 01:28:45,440 --> 01:28:46,960 SEE ANYBODY IS GOING TO GIVE US 2332 01:28:46,960 --> 01:28:48,680 A VAST AMOUNT OF MONEY THAT 2333 01:28:48,680 --> 01:28:51,000 WOULD BE REQUIRED TO DO THIS. 2334 01:28:51,000 --> 01:28:52,600 I'M CURIOUS, MARK, I SUSPECT IT 2335 01:28:52,600 --> 01:28:53,840 WASN'T A TINY MATTER OF MONEY 2336 01:28:53,840 --> 01:28:56,760 THAT WAS INVOLVED WHEN SUSAN 2337 01:28:56,760 --> 01:28:57,680 WOLFE -- 2338 01:28:57,680 --> 01:28:59,760 >> IT WAS A LARGE GRANT, A 2339 01:28:59,760 --> 01:29:04,040 FIVE-YEAR GRANT THAT TOOK A LOT 2340 01:29:04,040 --> 01:29:07,280 OF TIME AND TROUBLE. 2341 01:29:07,280 --> 01:29:08,360 >> THAT'S JUST THE REALITY OF 2342 01:29:08,360 --> 01:29:10,480 WHERE THINGS ARE AT. 2343 01:29:10,480 --> 01:29:12,360 WE CAN ENDORSE THE GOAL OF 2344 01:29:12,360 --> 01:29:13,520 GETTING MORE INFORMATION ABOUT 2345 01:29:13,520 --> 01:29:16,680 ALL OF THIS, I PERSONALLY THINK, 2346 01:29:16,680 --> 01:29:18,280 AND OHRP HAS BEEN BEHIND 2347 01:29:18,280 --> 01:29:19,480 UNDERSTANDING MORE ABOUT THIS 2348 01:29:19,480 --> 01:29:20,120 SYSTEM. 2349 01:29:20,120 --> 01:29:20,440 ABSOLUTELY. 2350 01:29:20,440 --> 01:29:22,200 IT'S JUST A QUESTION OF HOW DO 2351 01:29:22,200 --> 01:29:22,880 YOU GET THERE. 2352 01:29:22,880 --> 01:29:25,320 AND WHO IS GOING TO PAY FOR IT, 2353 01:29:25,320 --> 01:29:27,120 ET CETERA, ET CETERA. 2354 01:29:27,120 --> 01:29:28,520 AGAIN, WE'RE A RELATIVELY SMALL 2355 01:29:28,520 --> 01:29:36,120 PLAYER, JUST IN TERMS OF OUR 2356 01:29:36,120 --> 01:29:36,360 BUDGET. 2357 01:29:36,360 --> 01:29:38,800 >> LOIS, JUST TO BUILD ON WHAT 2358 01:29:38,800 --> 01:29:42,320 YOU SAID, AND WHAT JERRY SAID, I 2359 01:29:42,320 --> 01:29:44,320 THINK MY OTHER IMPRESSION IS 2360 01:29:44,320 --> 01:29:46,280 THAT IN MANY AREAS A SINGLE IRB 2361 01:29:46,280 --> 01:29:48,840 MANDATE HAS BEEN VERY USEFUL 2362 01:29:48,840 --> 01:29:50,360 BECAUSE IT HAS EXPEDITED 2363 01:29:50,360 --> 01:29:52,880 RESEARCH AND MADE REVIEW OF 2364 01:29:52,880 --> 01:29:54,840 RESEARCH MORE PROFESSIONAL, 2365 01:29:54,840 --> 01:29:56,120 HIGHLY CENTRALIZED IRBs THAT 2366 01:29:56,120 --> 01:29:57,480 HAVE SUFFICIENT STAFF TO LOOK 2367 01:29:57,480 --> 01:29:59,520 EXTREMELY CAREFULLY AT THESE 2368 01:29:59,520 --> 01:29:59,960 PROTOCOLS. 2369 01:29:59,960 --> 01:30:01,320 YOU ALSO GET ADVERSE EVENT 2370 01:30:01,320 --> 01:30:03,360 REPORTING THAT IS UNIFIED TO ONE 2371 01:30:03,360 --> 01:30:05,000 IRB WHICH MEANS THE SINGLE IRB 2372 01:30:05,000 --> 01:30:06,440 IS ABLE TO UNDERSTAND WHAT'S 2373 01:30:06,440 --> 01:30:07,640 HAPPENING ACROSS ALL THE SITES 2374 01:30:07,640 --> 01:30:09,160 RATHER THAN JUST ONE SITE IN 2375 01:30:09,160 --> 01:30:10,000 REAL TIME. 2376 01:30:10,000 --> 01:30:12,240 SO THERE'S A LOT OF ADVANTAGES 2377 01:30:12,240 --> 01:30:12,800 TO IT. 2378 01:30:12,800 --> 01:30:15,000 AND I THINK WHAT WE HAVE FOCUSED 2379 01:30:15,000 --> 01:30:18,800 ON IN THIS AS WE FOCUSED ON FOUR 2380 01:30:18,800 --> 01:30:19,800 YEARS AGO ARE CIRCUMSTANCES 2381 01:30:19,800 --> 01:30:22,080 WHICH A SINGLE IRB MAY NOT BE 2382 01:30:22,080 --> 01:30:24,400 THE OPTIMAL WAY TO GO. 2383 01:30:24,400 --> 01:30:27,040 AND SO I THINK IT'S A BIG 2384 01:30:27,040 --> 01:30:30,560 UNIVERSE OUT THERE IN SOME WAYS 2385 01:30:30,560 --> 01:30:32,800 IT'S BEEN EXTREMELY USEFUL. 2386 01:30:32,800 --> 01:30:35,200 ESPECIALLY THE COVID VACCINE 2387 01:30:35,200 --> 01:30:36,840 STUDIES AND COVID TREATMENT 2388 01:30:36,840 --> 01:30:40,480 STUDIES, THERE HAVE BEEN LIKE 25 2389 01:30:40,480 --> 01:30:42,000 OR 50 IRBs WRITING HERD THEY 2390 01:30:42,000 --> 01:30:43,760 WOULD NEVER HAVE BEEN DONE AS 2391 01:30:43,760 --> 01:30:46,960 QUICKLY AS THEY WERE DONE, TO 2392 01:30:46,960 --> 01:30:53,720 GIVE AN EXAMPLE, FOR WHAT IT'S 2393 01:30:53,720 --> 01:30:54,440 WORTH. 2394 01:30:54,440 --> 01:30:55,240 >> TWO COMMENTS. 2395 01:30:55,240 --> 01:30:58,640 ONE IS I JUST DID A QUICK SEARCH 2396 01:30:58,640 --> 01:31:01,480 TO SEE IF THERE WAS EMPIRICAL 2397 01:31:01,480 --> 01:31:02,880 LITERATURE ABOUT THE FUNCTIONING 2398 01:31:02,880 --> 01:31:04,920 OF SINGLE IRBs, IT TURNED UP 2399 01:31:04,920 --> 01:31:09,800 AN ARTICLE, WHEN IRBs SAY NO 2400 01:31:09,800 --> 01:31:11,680 TO PARTICIPATING IN RESEARCH 2401 01:31:11,680 --> 01:31:15,160 ABOUT SINGLE IRBs. 2402 01:31:15,160 --> 01:31:16,520 SO, WE DON'T APPEAR TO KNOW A 2403 01:31:16,520 --> 01:31:20,640 LOT ABOUT HOW THIS IS WORKING. 2404 01:31:20,640 --> 01:31:22,720 AND THE OTHER IS JUST I SECOND 2405 01:31:22,720 --> 01:31:24,360 WHAT JERRY SAID. 2406 01:31:24,360 --> 01:31:28,280 YOU KNOW, EVEN APART FROM OHRP 2407 01:31:28,280 --> 01:31:30,680 BEING SMALL, THE SECTION AT 172 2408 01:31:30,680 --> 01:31:33,760 AND BEYOND, AS I READ THAT I 2409 01:31:33,760 --> 01:31:35,400 THOUGHT THAT'S SO DIFFICULT FOR 2410 01:31:35,400 --> 01:31:37,600 ANYBODY TO DO, NOT ONLY BECAUSE 2411 01:31:37,600 --> 01:31:40,200 COMPILING IS DIFFICULT BUT 2412 01:31:40,200 --> 01:31:42,400 BECAUSE STATE LAW CHANGES ON A 2413 01:31:42,400 --> 01:31:44,720 DIME IN 50 DIFFERENT PLACES AND 2414 01:31:44,720 --> 01:31:46,440 STATE LAWS ARE NOT LIKE ONE 2415 01:31:46,440 --> 01:31:47,120 STATE LAW. 2416 01:31:47,120 --> 01:31:48,960 YOU HAVE TO DRAW FROM A BUNCH OF 2417 01:31:48,960 --> 01:31:49,160 THEM. 2418 01:31:49,160 --> 01:31:54,080 SO TRYING TO KEEP THESE CURRENT 2419 01:31:54,080 --> 01:31:56,000 IS ALMOST A BIGGER CHALLENGE 2420 01:31:56,000 --> 01:31:56,400 THAN COMPILING. 2421 01:31:56,400 --> 01:32:02,640 I DON'T KNOW HOW YOU WOULD DO 2422 01:32:02,640 --> 01:32:03,160 THAT. 2423 01:32:03,160 --> 01:32:06,560 THERE ARE A FEW FOUNDATIONS THAT 2424 01:32:06,560 --> 01:32:09,040 DO THAT FOR LIKE LAWS RELATED TO 2425 01:32:09,040 --> 01:32:10,280 MINORS, INFORMED CONSENT, FOR 2426 01:32:10,280 --> 01:32:11,440 EXAMPLE, BUT EVEN THOSE ARE 2427 01:32:11,440 --> 01:32:17,640 DIFFICULT TO KEEP UP TO DATE. 2428 01:32:17,640 --> 01:32:21,160 >> DOUG, A QUESTION. 2429 01:32:21,160 --> 01:32:23,200 SHOULD WE WALK LACK LINE 172, IN 2430 01:32:23,200 --> 01:32:25,200 THE INTEREST OF DAVID AND MARK 2431 01:32:25,200 --> 01:32:29,000 HAVING A FINAL DOCUMENT, BECAUSE 2432 01:32:29,000 --> 01:32:30,000 IT SAYS SACHRP RECOMMENDS, ET 2433 01:32:30,000 --> 01:32:30,840 CETERA, ET CETERA. 2434 01:32:30,840 --> 01:32:32,320 SOUND LIKE THERE'S A FAIR AMOUNT 2435 01:32:32,320 --> 01:32:33,840 OF DISCUSSION OF THE DOUBTS 2436 01:32:33,840 --> 01:32:36,120 AROUND THAT EVEN THOUGH THERE'S 2437 01:32:36,120 --> 01:32:38,320 USEFULNESS FOR SUCH A PRODUCT 2438 01:32:38,320 --> 01:32:39,960 BUT DOUBTS WE SHOULD -- WHY 2439 01:32:39,960 --> 01:32:40,720 RECOMMEND SOMETHING WE DON'T 2440 01:32:40,720 --> 01:32:42,200 THINK IS EVER GOING TO HAPPEN I 2441 01:32:42,200 --> 01:32:43,560 GUESS IS THE QUESTION. 2442 01:32:43,560 --> 01:32:46,000 >> YEAH, AND I GUESS I WOULD -- 2443 01:32:46,000 --> 01:32:47,200 YEAH, I'D BE INTERESTED TO SEE 2444 01:32:47,200 --> 01:32:48,840 WHAT OTHERS LIKE LINDA HAVE TO 2445 01:32:48,840 --> 01:32:49,280 SAY. 2446 01:32:49,280 --> 01:32:50,960 I THINK IT'S A GREAT IDEA. 2447 01:32:50,960 --> 01:32:53,440 I JUST DON'T KNOW HOW TO 2448 01:32:53,440 --> 01:32:53,760 IMPLEMENT. 2449 01:32:53,760 --> 01:32:54,440 WE PROBABLY SHOULDN'T BE 2450 01:32:54,440 --> 01:32:55,520 RECOMMENDING SOMETHING WE DON'T 2451 01:32:55,520 --> 01:32:57,920 HAVE A SUGGESTION FOR HOW TO 2452 01:32:57,920 --> 01:32:59,200 REASONABLY IMPLEMENT IT. 2453 01:32:59,200 --> 01:32:59,880 LINDA? 2454 01:32:59,880 --> 01:33:04,920 >> I WAS GOING TO SUGGEST THAT I 2455 01:33:04,920 --> 01:33:06,440 WOULD NOT RECOMMEND ELIMINATING 2456 01:33:06,440 --> 01:33:08,840 IT BUT CHANGING THE LANGUAGE TO 2457 01:33:08,840 --> 01:33:13,000 WHAT WE HAD ORIGINALLY TALKED 2458 01:33:13,000 --> 01:33:14,760 ABOUT, DAVID, YOU COULD SAY THAT 2459 01:33:14,760 --> 01:33:18,080 AGAIN, WE TALKED ABOUT WE SHOULD 2460 01:33:18,080 --> 01:33:20,320 CONSIDER SOMETHING LIKE THE 2461 01:33:20,320 --> 01:33:21,240 INTERNATIONAL COMPILATION OR 2462 01:33:21,240 --> 01:33:22,760 SOMETHING THAT LOIS HAD 2463 01:33:22,760 --> 01:33:25,160 MENTIONED, I THINK SEVERAL OF US 2464 01:33:25,160 --> 01:33:27,120 HAD MENTIONED OPTIONS THAT COULD 2465 01:33:27,120 --> 01:33:29,360 BE DONE, WE CAN'T REALLY SOLVE 2466 01:33:29,360 --> 01:33:30,320 THE PROBLEM, WHAT WE WANT TO 2467 01:33:30,320 --> 01:33:31,520 RECOMMEND IS THERE NEEDS TO BE 2468 01:33:31,520 --> 01:33:32,960 SOMETHING IN PLACE, WHAT WE WANT 2469 01:33:32,960 --> 01:33:33,720 TO RECOMMEND. 2470 01:33:33,720 --> 01:33:37,560 THIS COULD BE IN THE FORM OF 2471 01:33:37,560 --> 01:33:41,480 SUCH AS THESE THINGS, I WOULD 2472 01:33:41,480 --> 01:33:43,640 LIST IT, IT COULD SAY 2473 01:33:43,640 --> 01:33:44,560 RECOGNIZING THERE ARE FUNDING 2474 01:33:44,560 --> 01:33:46,400 AND OTHER ISSUES BUT HERE IS HOW 2475 01:33:46,400 --> 01:33:47,280 WE RECOMMEND SOMETHING BEING 2476 01:33:47,280 --> 01:33:47,920 LOOKED AT. 2477 01:33:47,920 --> 01:33:51,120 I THINK THAT'S GOING TO BE 2478 01:33:51,120 --> 01:33:51,720 REALLY IMPORTANT JUST BECAUSE 2479 01:33:51,720 --> 01:33:53,840 THOSE OF US ON THE GROUND DOING 2480 01:33:53,840 --> 01:33:56,760 THE WORK I MEAN I DON'T CARE 2481 01:33:56,760 --> 01:33:59,200 WHERE IT COMES FROM BUT I WOULD 2482 01:33:59,200 --> 01:34:02,600 THINK MOST INSTITUTIONS OR 2483 01:34:02,600 --> 01:34:06,760 ORGANIZATIONS EVEN LOCAL IRBs 2484 01:34:06,760 --> 01:34:07,600 COMMERCIAL OR OTHERWISE WOULD 2485 01:34:07,600 --> 01:34:08,280 APPRECIATE THAT. 2486 01:34:08,280 --> 01:34:12,640 IT'S NOT A QUESTION OF 2487 01:34:12,640 --> 01:34:13,640 INTERPRETING LAW, BUT GIVING 2488 01:34:13,640 --> 01:34:14,280 INFORMATION, YOU STILL HAVE A 2489 01:34:14,280 --> 01:34:15,680 DUTY TO GET IN THE WEEDS ABOUT 2490 01:34:15,680 --> 01:34:17,680 WHAT YOU LAW MEANS AND HOW TO 2491 01:34:17,680 --> 01:34:17,960 INTERPRET. 2492 01:34:17,960 --> 01:34:19,480 AGAIN, I THINK THAT YOU NEED TO 2493 01:34:19,480 --> 01:34:21,080 HAVE A STARTING POINT. 2494 01:34:21,080 --> 01:34:22,840 I THINK IT'S REALLY IMPORTANT 2495 01:34:22,840 --> 01:34:26,240 BECAUSE OTHERWISE IT COULD BE A 2496 01:34:26,240 --> 01:34:27,960 SITUATION WHERE THEN, YOU KNOW, 2497 01:34:27,960 --> 01:34:29,280 IT'S AN UNFUNDED MANDATE AND 2498 01:34:29,280 --> 01:34:32,920 YOU'RE REQUIRING THIS TO HAPPEN 2499 01:34:32,920 --> 01:34:34,200 BUT THEN YOU'RE NOT SUPPLYING 2500 01:34:34,200 --> 01:34:37,840 IDEAS HOW TO SOLVE THE PROBLEM. 2501 01:34:37,840 --> 01:34:38,760 THAT'S JUST MY RECOMMENDATION. 2502 01:34:38,760 --> 01:34:41,560 >> KEVIN HAS BEEN PATIENT. 2503 01:34:41,560 --> 01:34:42,400 MY ONLY COMMENT, WE'VE 2504 01:34:42,400 --> 01:34:44,600 RECOMMENDED MAYBE THINGS OVER 2505 01:34:44,600 --> 01:34:46,160 THE YEARS WE WERE SURE WEREN'T 2506 01:34:46,160 --> 01:34:47,040 GOING ANYWHERE, I DON'T KNOW 2507 01:34:47,040 --> 01:34:48,640 THAT SHOULD BE A DISINCENTIVE TO 2508 01:34:48,640 --> 01:34:53,520 SAYING THIS IS WHAT WE THINK. 2509 01:34:53,520 --> 01:34:55,240 THAT'S MY TWO CENTS. 2510 01:34:55,240 --> 01:34:56,000 KEVIN? 2511 01:34:56,000 --> 01:34:56,520 >> THANKS. 2512 01:34:56,520 --> 01:35:00,040 THIS IS AN INTERESTING 2513 01:35:00,040 --> 01:35:00,920 DISCUSSION. 2514 01:35:00,920 --> 01:35:03,760 IT SEEMS LIKE AT BASE WE'VE GOT 2515 01:35:03,760 --> 01:35:05,960 SOME RECOMMENDATION THAT WE'RE 2516 01:35:05,960 --> 01:35:06,720 CONSIDERING TO SAY ADDITIONAL 2517 01:35:06,720 --> 01:35:10,120 RESOURCES SHOULD BE PROVIDED BY 2518 01:35:10,120 --> 01:35:11,960 HHS TO HELP THIS OUT IN SOME 2519 01:35:11,960 --> 01:35:12,400 WAY. 2520 01:35:12,400 --> 01:35:15,680 AND I WAS THINKING ABOUT WHAT 2521 01:35:15,680 --> 01:35:18,560 MARK WAS SAYING ABOUT THE 2522 01:35:18,560 --> 01:35:21,400 MACROECONOMIC PICTURE, AM I 2523 01:35:21,400 --> 01:35:22,680 RIGHT THERE'S AN ASSUMPTION 2524 01:35:22,680 --> 01:35:24,440 WE'RE ASKING FOR RESOURCES 2525 01:35:24,440 --> 01:35:25,080 BECAUSE ADDITIONAL RESOURCES 2526 01:35:25,080 --> 01:35:27,160 WERE NOT PUSHED INTO THE SYSTEM 2527 01:35:27,160 --> 01:35:30,920 THE WAY IT'S GOING TO GO 2528 01:35:30,920 --> 01:35:33,080 NATURALLY IS LARGE COMMERCIAL 2529 01:35:33,080 --> 01:35:35,680 IRBs AND LARGE ACADEMIC 2530 01:35:35,680 --> 01:35:36,800 INSTITUTIONS THAT DO THE VOLUME 2531 01:35:36,800 --> 01:35:40,320 OF THE WORK CAN AFFORD TO DO 2532 01:35:40,320 --> 01:35:41,840 THIS THEMSELVES WILL PUSH 2533 01:35:41,840 --> 01:35:44,360 CENTRAL IRB WORK TO THOSE TYPES 2534 01:35:44,360 --> 01:35:45,120 OF PLACES. 2535 01:35:45,120 --> 01:35:48,200 SO IF I'M AT HHS THOUGH I MIGHT 2536 01:35:48,200 --> 01:35:50,040 SAY WHAT'S WRONG WITH THAT? 2537 01:35:50,040 --> 01:35:53,000 AND SO IT SEEMS LIKE THERE'S AN 2538 01:35:53,000 --> 01:35:53,880 ASSUMPTION ASKING FOR RESOURCES 2539 01:35:53,880 --> 01:35:55,840 THAT THE PICTURE OF WHAT'S GOING 2540 01:35:55,840 --> 01:35:57,240 TO HAPPEN ABSENT THE RESOURCES 2541 01:35:57,240 --> 01:35:58,400 IS A BAD PICTURE, I'M NOT SAYING 2542 01:35:58,400 --> 01:36:03,720 ALSO A GOOD -- IT'S GOOD OR BAD, 2543 01:36:03,720 --> 01:36:06,720 THAT SEEMS TO BE UNDERLYING THE 2544 01:36:06,720 --> 01:36:09,760 SUGGESTION MORE RESOURCES BE 2545 01:36:09,760 --> 01:36:11,520 PUSHED, IF THAT'S AN ASSUMPTION, 2546 01:36:11,520 --> 01:36:14,240 WHAT IS THE VALUE HAVING A LOT 2547 01:36:14,240 --> 01:36:16,960 OF VARIETY OF SITES ABLE TO 2548 01:36:16,960 --> 01:36:18,080 PARTICIPATE IN SINGLE IRBs, IS 2549 01:36:18,080 --> 01:36:20,240 THERE VALUE IN THAT OR IS THAT 2550 01:36:20,240 --> 01:36:20,720 ACTUALLY INEFFICIENT? 2551 01:36:20,720 --> 01:36:24,600 I DON'T KNOW THE ANSWER TO THAT 2552 01:36:24,600 --> 01:36:28,240 BUT IT SEEMS LIKE A CRITICAL 2553 01:36:28,240 --> 01:36:28,760 ASSUMPTION UNDERLYING THE 2554 01:36:28,760 --> 01:36:29,640 SUGGESTION MORE RESOURCES NEED 2555 01:36:29,640 --> 01:36:35,480 TO COME INTO THE SYSTEM. 2556 01:36:35,480 --> 01:36:46,080 >> ONE THING ABOUT -- I'MING A 2557 01:36:49,000 --> 01:36:50,480 -- I'M AGNOSTIC. 2558 01:36:50,480 --> 01:36:52,760 BUT THERE IS ANOTHER AUDIENCE 2559 01:36:52,760 --> 01:36:55,280 FOR A RESOURCE LIKE THAT, THAT 2560 01:36:55,280 --> 01:36:59,760 IS INVESTIGATORS TRYING TO PLAN 2561 01:36:59,760 --> 01:37:00,840 STUDIES, MULTI-SITE STUDIES, 2562 01:37:00,840 --> 01:37:03,400 BEING ABLE TO PROPOSE STUDIES 2563 01:37:03,400 --> 01:37:04,920 THAT ARE CONSISTENT WITH LOCAL 2564 01:37:04,920 --> 01:37:09,200 LAW SO THERE IS ANOTHER USER 2565 01:37:09,200 --> 01:37:11,080 POPULATION. 2566 01:37:11,080 --> 01:37:13,800 I DON'T WANT US TO LOSE SIGHT. 2567 01:37:13,800 --> 01:37:16,200 TO RESOLVE THIS WE'LL TAKE OUT 2568 01:37:16,200 --> 01:37:17,960 THAT SACHRP SHOULD DO THIS. 2569 01:37:17,960 --> 01:37:19,840 I'M PROPOSING THIS. 2570 01:37:19,840 --> 01:37:21,160 WE'LL TAKE OUT SACHRP, SHOULD 2571 01:37:21,160 --> 01:37:24,200 JUST SAY THERE'S VALUE IN HAVING 2572 01:37:24,200 --> 01:37:25,640 A CENTRALIZED RESOURCE THAT 2573 01:37:25,640 --> 01:37:27,280 WOULD BE KEPT AND UPDATED, MAY 2574 01:37:27,280 --> 01:37:32,640 BE POSSIBLE TO DO IT THROUGH 2575 01:37:32,640 --> 01:37:34,960 TROLLING OR AI MECHANISMS IN A 2576 01:37:34,960 --> 01:37:36,800 MORE EFFICIENT WAY THAN HUMANS 2577 01:37:36,800 --> 01:37:39,960 ONE BY ONE AND IT WOULD EMPOWER 2578 01:37:39,960 --> 01:37:41,640 SOME IRBs THAT MIGHT NOT 2579 01:37:41,640 --> 01:37:43,360 OTHERWISE HAVE ACCESS TO SERVE 2580 01:37:43,360 --> 01:37:44,920 AS CENTRAL IRBs AND EMPOWER 2581 01:37:44,920 --> 01:37:46,000 INVESTIGATORS AT ALL 2582 01:37:46,000 --> 01:37:47,760 INSTITUTIONS TO BE ABLE TO PLAN 2583 01:37:47,760 --> 01:37:54,440 THEIR STUDIES IN A WAY IN -- 2584 01:37:54,440 --> 01:37:56,600 MORE IN TUNE TO LOCAL 2585 01:37:56,600 --> 01:37:59,160 REQUIREMENTS, PUBLIC/PRIVATE 2586 01:37:59,160 --> 01:37:59,800 PARTNERSHIP, ENTIRELY PRIVATE, 2587 01:37:59,800 --> 01:38:03,840 NOT FOR PROFIT, ANYTHING, BUT IT 2588 01:38:03,840 --> 01:38:06,680 WOULD BE USEFUL. 2589 01:38:06,680 --> 01:38:08,320 >> WE COULD TAKE OUT OHRP. 2590 01:38:08,320 --> 01:38:10,960 YOU MEANT SACHRP. 2591 01:38:10,960 --> 01:38:12,280 >> I MEANT OHRP. 2592 01:38:12,280 --> 01:38:14,360 WOULD NOT SAY OHRP HAS TO DO IT. 2593 01:38:14,360 --> 01:38:18,040 IS THAT OKAY WITH EVERYBODY? 2594 01:38:18,040 --> 01:38:22,920 >> THAT'S WHAT WE'LL DO. 2595 01:38:22,920 --> 01:38:24,760 >> GREAT. 2596 01:38:24,760 --> 01:38:25,360 >> ALL RIGHT. 2597 01:38:25,360 --> 01:38:27,320 THE LAST SECTION OF THE DOCUMENT 2598 01:38:27,320 --> 01:38:30,160 HAS TO DO WITH EXCEPTIONS TO 2599 01:38:30,160 --> 01:38:32,240 SINGLE IRB REQUIREMENT AND AS WE 2600 01:38:32,240 --> 01:38:34,000 NOTED IN THE BEGINNING, INCLUDED 2601 01:38:34,000 --> 01:38:37,840 WITH THE DOCUMENT, WE MADE 2602 01:38:37,840 --> 01:38:40,640 RECOMMENDATIONS, WE, SACHRP, YOU 2603 01:38:40,640 --> 01:38:43,720 MADE RECOMMENDATIONS IN 2018 2604 01:38:43,720 --> 01:38:47,360 ABOUT THIS REQUIREMENT AND 2605 01:38:47,360 --> 01:38:48,560 RECOMMENDED THREE CATEGORIES, 2606 01:38:48,560 --> 01:38:51,520 THREE TYPES OF EXCEPTIONS, AS 2607 01:38:51,520 --> 01:38:52,360 POTENTIALLY APPROPRIATE RESEARCH 2608 01:38:52,360 --> 01:38:54,120 INVOLVING LIMITED NUMBER OF 2609 01:38:54,120 --> 01:38:57,200 SITES, FIVE OR FEWER, RESEARCH 2610 01:38:57,200 --> 01:38:59,360 FOR WHICH REVIEW BY SINGLE IRB 2611 01:38:59,360 --> 01:39:02,000 IS UNABLE TO MEET NEEDS AND 2612 01:39:02,000 --> 01:39:05,080 INVOLVING POLITICAL CONTROVERSY 2613 01:39:05,080 --> 01:39:07,280 OR SENSITIVE ISSUES, LOCAL 2614 01:39:07,280 --> 01:39:09,040 IRBs WOULD BETTER ADDRESS 2615 01:39:09,040 --> 01:39:12,080 THOSE CONCERNS. 2616 01:39:12,080 --> 01:39:14,400 AND SO WE BELIEVE THIS DRAFT 2617 01:39:14,400 --> 01:39:16,680 GUIDANCE WOULD BENEFIT BY HAVING 2618 01:39:16,680 --> 01:39:19,640 A DISCUSSION ABOUT EXCEPTIONS 2619 01:39:19,640 --> 01:39:20,920 AND OFFERING ADDITIONAL 2620 01:39:20,920 --> 01:39:23,040 OFF-RAMP, SO TO SPEAK, FOR 2621 01:39:23,040 --> 01:39:30,000 STUDIES OR SITES FROM THE 2622 01:39:30,000 --> 01:39:33,840 REQUIREMENT. 2623 01:39:33,840 --> 01:39:36,160 >> DAVID, THIS GOES BACK TO THE 2624 01:39:36,160 --> 01:39:38,360 PROCESS WE TALKED ABOUT, BUT 2625 01:39:38,360 --> 01:39:40,560 ALSO LOOKING AT NUMBER 3 AGAIN, 2626 01:39:40,560 --> 01:39:42,520 I WOULD SUGGEST GETTING RID OF 2627 01:39:42,520 --> 01:39:44,920 POLITICAL AND SAY CONTROVERSIAL 2628 01:39:44,920 --> 01:39:45,880 AND SENSITIVE. 2629 01:39:45,880 --> 01:39:49,200 THAT'S WHAT IT EVENTUALLY 2630 01:39:49,200 --> 01:39:50,560 BECOMES. 2631 01:39:50,560 --> 01:39:51,360 >> YOU'RE IMPOSSIBLE TO HEAR. 2632 01:39:51,360 --> 01:39:53,440 CAN YOU PLEASE SPEAK INTO YOUR 2633 01:39:53,440 --> 01:39:57,200 MIC? 2634 01:39:57,200 --> 01:39:58,360 THANK YOU. 2635 01:39:58,360 --> 01:39:59,120 >> SORRY. 2636 01:39:59,120 --> 01:40:02,000 SO NUMBER 3, I WOULD GET RID OF 2637 01:40:02,000 --> 01:40:03,520 THE WORD POLITICAL. 2638 01:40:03,520 --> 01:40:05,720 DIFFERENCES MAY THEN CREATE A 2639 01:40:05,720 --> 01:40:08,200 CONTROVERSIAL, COULD AT ITS ROOT 2640 01:40:08,200 --> 01:40:09,440 BE RELATED TO POLITICAL ISSUES 2641 01:40:09,440 --> 01:40:10,960 BUT IT DOESN'T ADD ANYTHING TO 2642 01:40:10,960 --> 01:40:12,120 THE DOCUMENT. 2643 01:40:12,120 --> 01:40:15,560 I WOULD JUST GO CONTROVERSIAL OR 2644 01:40:15,560 --> 01:40:15,800 SENSITIVE. 2645 01:40:15,800 --> 01:40:19,040 WE CAN ALL DEBATE ABOUT THE 2646 01:40:19,040 --> 01:40:20,440 POLITICS OF DIFFERENT 2647 01:40:20,440 --> 01:40:24,080 CONTROVERSIAL OR SENSITIVE 2648 01:40:24,080 --> 01:40:25,880 ISSUES. 2649 01:40:25,880 --> 01:40:27,360 >> WALTER? 2650 01:40:27,360 --> 01:40:28,840 >> I DO THINK HAVING SOME 2651 01:40:28,840 --> 01:40:31,040 GRANULARITY HERE WOULD BE 2652 01:40:31,040 --> 01:40:31,320 HELPFUL. 2653 01:40:31,320 --> 01:40:33,080 I DON'T NECESSARILY AGREE THAT 2654 01:40:33,080 --> 01:40:34,400 HAVING POLITICAL OR 2655 01:40:34,400 --> 01:40:35,600 CONTROVERSIAL OR APPROPRIATE 2656 01:40:35,600 --> 01:40:37,040 TERMS BUT I THINK SOME GRANT 2657 01:40:37,040 --> 01:40:39,160 LATER WOULD BE HELPFUL BECAUSE 2658 01:40:39,160 --> 01:40:42,600 I'M THINKING IN PARALLEL THAT IT 2659 01:40:42,600 --> 01:40:47,360 MIGHT BE HELPFUL TO PROVIDE SOME 2660 01:40:47,360 --> 01:40:50,400 GUIDANCE THAT THE IRB REVIEW 2661 01:40:50,400 --> 01:40:53,600 SHOULD BE FOCUSED OR RESTRICTED 2662 01:40:53,600 --> 01:40:56,440 TO THOSE PARTICULAR TOPICS THAT 2663 01:40:56,440 --> 01:41:00,360 MAKE THE REVIEW, THAT SUPPORT 2664 01:41:00,360 --> 01:41:02,200 THIS EXCEPTION. 2665 01:41:02,200 --> 01:41:10,000 IN ORDER TO, AS MUCH AS 2666 01:41:10,000 --> 01:41:12,320 POSSIBLE, SEE THAT THE REVIEW IS 2667 01:41:12,320 --> 01:41:13,280 RESTRICTED TO THOSE AREAS, 2668 01:41:13,280 --> 01:41:16,800 ALLOWS AN EFFICIENT WAY OF 2669 01:41:16,800 --> 01:41:18,200 DETERMINING WHETHER OR NOT THE 2670 01:41:18,200 --> 01:41:21,920 INTEGRITY OF THE STUDY IS 2671 01:41:21,920 --> 01:41:24,640 POTENTIALLY, YOU KNOW, IS 2672 01:41:24,640 --> 01:41:26,880 POTENTIALLY COMPROMISED OR 2673 01:41:26,880 --> 01:41:29,880 WHETHER IT COULD BE REMEDIATED. 2674 01:41:29,880 --> 01:41:34,840 AND THINKING MORE FROM THE 2675 01:41:34,840 --> 01:41:35,720 PRIVATE SECTOR SPONSOR 2676 01:41:35,720 --> 01:41:36,800 PERSPECTIVE WITH FOCUS ON 2677 01:41:36,800 --> 01:41:44,120 DESIGNING STUDIES THAT HAVE 2678 01:41:44,120 --> 01:41:46,320 CERTAIN LEVELS OF HOMOGENEITY 2679 01:41:46,320 --> 01:41:48,040 FOR REGULATORY PURPOSES. 2680 01:41:48,040 --> 01:41:48,240 OVER. 2681 01:41:48,240 --> 01:41:53,000 >> WALTER, LET ME PUT YOU ON THE 2682 01:41:53,000 --> 01:41:53,200 SPOT. 2683 01:41:53,200 --> 01:41:55,280 I'M GOING TO ASK YOU TO BE 2684 01:41:55,280 --> 01:41:56,600 SPECIFIC HOW YOU CHANGED THE 2685 01:41:56,600 --> 01:41:57,240 WORDING HERE. 2686 01:41:57,240 --> 01:41:59,440 IF I'M HEARING YOU, YOU WANT 2687 01:41:59,440 --> 01:42:01,720 MORE GRANULARITY WITH REGARD TO 2688 01:42:01,720 --> 01:42:04,360 ITEM 3 THERE, CONTROVERSIAL AND 2689 01:42:04,360 --> 01:42:05,040 SENSITIVE ISSUES, BUT 2690 01:42:05,040 --> 01:42:07,320 SPECIFICALLY HOW WOULD YOU ADD 2691 01:42:07,320 --> 01:42:10,480 THAT OR WORD THAT SINCE WE 2692 01:42:10,480 --> 01:42:12,320 REALLY DO NEED TO. 2693 01:42:12,320 --> 01:42:13,440 >> MIC. 2694 01:42:13,440 --> 01:42:14,440 >> SORRY. 2695 01:42:14,440 --> 01:42:18,920 >> WE TRIED CULTURAL BEFORE. 2696 01:42:18,920 --> 01:42:23,400 THAT WAS -- THERE ARE ISSUES 2697 01:42:23,400 --> 01:42:28,400 RELATED TO PERHAPS LOCAL NORMS 2698 01:42:28,400 --> 01:42:30,000 AND VALUES. 2699 01:42:30,000 --> 01:42:35,080 THERE ARE -- THOSE ARE TWO TO 2700 01:42:35,080 --> 01:42:39,480 COME TO MIND IMMEDIATELY. 2701 01:42:39,480 --> 01:42:41,120 2702 01:42:41,120 --> 01:42:41,880 >> GO AHEAD, SKIP. 2703 01:42:41,880 --> 01:42:45,520 >> I GUESS I DON'T SEE IT ADDING 2704 01:42:45,520 --> 01:42:46,280 ANY MORE SPECIFICITY. 2705 01:42:46,280 --> 01:42:48,240 I MEAN, IN OTHER WORDS, WE CAN 2706 01:42:48,240 --> 01:42:49,880 SAY TODAY THIS IS A 2707 01:42:49,880 --> 01:42:50,960 CONTROVERSIAL ISSUE, AND IT 2708 01:42:50,960 --> 01:42:54,360 COULD BE RELATED TO POLITICAL 2709 01:42:54,360 --> 01:42:54,920 DIFFERENCES, CULTURAL 2710 01:42:54,920 --> 01:42:56,560 DIFFERENCES, DIFFERENCES AT A 2711 01:42:56,560 --> 01:42:58,960 LOCAL LEVEL FOR X, Y OR Z AND 2712 01:42:58,960 --> 01:43:00,400 TEN YEARS FROM NOW THAT SAME 2713 01:43:00,400 --> 01:43:03,800 ISSUE MAY NOT BE CONTROVERSIAL 2714 01:43:03,800 --> 01:43:04,120 ANYMORE. 2715 01:43:04,120 --> 01:43:06,640 SO I'M NOT SURE WE GAIN ANY MORE 2716 01:43:06,640 --> 01:43:11,880 SPES SPECIFICITY BY ADDING 2717 01:43:11,880 --> 01:43:13,480 BUZZWORDS AROUND ROOTS OF 2718 01:43:13,480 --> 01:43:16,800 DIFFERENCES OTHER THAN TO SAY 2719 01:43:16,800 --> 01:43:18,480 CONTROVERSIAL OR SENSITIVE. 2720 01:43:18,480 --> 01:43:19,760 >> SKIP, SO I UNDERSTOOD, YOU 2721 01:43:19,760 --> 01:43:21,360 AGREED WITH THE TERM 2722 01:43:21,360 --> 01:43:22,400 CONTROVERSIAL OR DISAGREED? 2723 01:43:22,400 --> 01:43:23,520 >> I AGREE. 2724 01:43:23,520 --> 01:43:25,280 I JUST DON'T THINK POLITICAL 2725 01:43:25,280 --> 01:43:27,160 ADDS ANY DEPTH TO CONTROVERSIAL 2726 01:43:27,160 --> 01:43:27,960 OR SENSITIVE. 2727 01:43:27,960 --> 01:43:29,840 THAT'S ALL. 2728 01:43:29,840 --> 01:43:31,800 >> SO THE WORD WOULD GO LIKE IT 2729 01:43:31,800 --> 01:43:35,320 IS UP THERE -- WORDING WOULD BE 2730 01:43:35,320 --> 01:43:36,520 RESEARCH INVOLVING CONTROVERSIAL 2731 01:43:36,520 --> 01:43:39,680 OR SENSITIVE ISSUES WHICH WOULD 2732 01:43:39,680 --> 01:43:40,080 PRESUMABLY BE -- 2733 01:43:40,080 --> 01:43:45,120 >> THE ROOT COULD BE VARIABLE. 2734 01:43:45,120 --> 01:43:48,160 >> YES, THAT'S FINE, DOUG. 2735 01:43:48,160 --> 01:43:51,000 >> THANK YOU. 2736 01:43:51,000 --> 01:43:52,000 >> OTHER COMMENTS OR QUESTIONS 2737 01:43:52,000 --> 01:43:54,160 HERE? 2738 01:43:54,160 --> 01:43:57,120 2739 01:43:57,120 --> 01:43:57,400 >> LOIS? 2740 01:43:57,400 --> 01:43:58,520 >> SORRY. 2741 01:43:58,520 --> 01:44:00,200 >> I THINK ON MINE 191 YOU MIGHT 2742 01:44:00,200 --> 01:44:02,720 BE MISSING A WORD. 2743 01:44:02,720 --> 01:44:07,200 I THINK IT'S SUPPOSED TO BE 2744 01:44:07,200 --> 01:44:08,280 SINGLE IRB REVIEW. 2745 01:44:08,280 --> 01:44:10,600 THE LINES ARE DIFFERENT NOW. 2746 01:44:10,600 --> 01:44:12,960 OKAY. 2747 01:44:12,960 --> 01:44:20,600 2748 01:44:20,600 --> 01:44:24,560 >> WHAT'S THE SENTENCE? 2749 01:44:24,560 --> 01:44:25,760 >> SORRY. 2750 01:44:25,760 --> 01:44:26,280 YES. 2751 01:44:26,280 --> 01:44:28,280 THAT'S IT. 2752 01:44:28,280 --> 01:44:34,320 2753 01:44:34,320 --> 01:44:42,040 2754 01:44:42,040 --> 01:44:42,600 2755 01:44:42,600 --> 01:44:43,200 >> OTHER COMMENTS? 2756 01:44:43,200 --> 01:44:45,160 >> YEAH, GO AHEAD, SKIP. 2757 01:44:45,160 --> 01:44:48,520 >> SO MY QUESTION TO MARK AND 2758 01:44:48,520 --> 01:44:49,440 DAVID, I'M ASSUMING THIS IS 2759 01:44:49,440 --> 01:44:51,160 WHERE I WOULD ADD SOME OF THE 2760 01:44:51,160 --> 01:44:52,160 PROCESS COMMENTS. 2761 01:44:52,160 --> 01:44:54,280 I MEAN, WE HAD THAT DISCUSSION A 2762 01:44:54,280 --> 01:44:56,520 WHILE AGO BUT I THINK STIMULATED 2763 01:44:56,520 --> 01:44:58,640 AT LEAST IN MY VIEW OF ASKING 2764 01:44:58,640 --> 01:45:00,800 HOW DO YOU MAKE A DECISION AS TO 2765 01:45:00,800 --> 01:45:02,640 WHETHER THIS IS AN EXCEPTION. 2766 01:45:02,640 --> 01:45:05,320 SO THIS IS WHERE I PERSONALLY 2767 01:45:05,320 --> 01:45:08,120 WOULD ADD A COUPLE SENTENCES 2768 01:45:08,120 --> 01:45:12,640 AROUND THAT PROCESS TO THE 2769 01:45:12,640 --> 01:45:12,920 DOCUMENT. 2770 01:45:12,920 --> 01:45:15,000 I DON'T KNOW IF OTHERS SEE A 2771 01:45:15,000 --> 01:45:17,160 DIFFERENT PLACE FOR IT. 2772 01:45:17,160 --> 01:45:19,320 >> SKIP, I THINK IT COULD GO 2773 01:45:19,320 --> 01:45:21,640 HERE AND IT COULD GO -- NO 2774 01:45:21,640 --> 01:45:23,480 PROBLEM WITH PUTTING IT IN 2775 01:45:23,480 --> 01:45:25,480 TWICE, YOU KNOW. 2776 01:45:25,480 --> 01:45:25,720 >> OKAY. 2777 01:45:25,720 --> 01:45:28,720 >> FROM MY POINT OF VIEW. 2778 01:45:28,720 --> 01:45:32,040 2779 01:45:32,040 --> 01:45:34,680 >> AND I KNOW WE HAD A TIME SET 2780 01:45:34,680 --> 01:45:37,600 ASIDE AT THE END FOR PUBLIC 2781 01:45:37,600 --> 01:45:38,960 COMMENT BUT THAT DOESN'T HELP 2782 01:45:38,960 --> 01:45:41,880 MUCH IN IT'S RELATED TO THIS. 2783 01:45:41,880 --> 01:45:42,880 WE HAD ONE PUBLIC COMMENT 2784 01:45:42,880 --> 01:45:44,200 E-MAILED TO ALL OF YOU BUT I'M 2785 01:45:44,200 --> 01:45:46,200 GOING TO READ IT SO IT'S ON THE 2786 01:45:46,200 --> 01:45:51,960 RECORD AND YOU'RE AWARE OF IT. 2787 01:45:51,960 --> 01:45:53,400 AND THIS PARTICULAR PERSON I 2788 01:45:53,400 --> 01:45:55,920 THINK HAS REALLY TWO COMMENTS. 2789 01:45:55,920 --> 01:45:57,880 FIRST IS ASKING WHETHER IT'S 2790 01:45:57,880 --> 01:45:59,680 POSSIBLE FOR SACHRP TO COMMENT 2791 01:45:59,680 --> 01:46:03,160 ON OR RECOMMEND A STANDARDIZED 2792 01:46:03,160 --> 01:46:05,760 LOCAL CONTEXT FORM TO BE ADAPTED 2793 01:46:05,760 --> 01:46:07,320 TO RESEARCH BEING CONDUCTED FOR 2794 01:46:07,320 --> 01:46:08,720 USE WHEN A SINGLE IRB STRUCTURE 2795 01:46:08,720 --> 01:46:10,720 IS REQUIRED BY THE REGS, THIS 2796 01:46:10,720 --> 01:46:12,640 TYPE OF PRACTICAL DOCUMENT IS A 2797 01:46:12,640 --> 01:46:14,760 WAY FOR THE LOCAL SITE TO ENSURE 2798 01:46:14,760 --> 01:46:16,520 THAT THE REVIEWING IRB IS AWARE 2799 01:46:16,520 --> 01:46:20,240 OF ALL THE APPLICABLE LAWS AND 2800 01:46:20,240 --> 01:46:21,360 LOCAL ETHICAL CONSIDERATIONS. 2801 01:46:21,360 --> 01:46:24,640 AND THEN THE SECOND COMMENT IS A 2802 01:46:24,640 --> 01:46:27,240 COMMENT ON TIMING OF LOCAL 2803 01:46:27,240 --> 01:46:28,960 CONTEXT SCOPING, TIMING OF THE 2804 01:46:28,960 --> 01:46:31,880 DECISIONS ABOUT EXCEPTIONS, ET 2805 01:46:31,880 --> 01:46:33,480 CETERA, ALSO NEEDED, SINCE 2806 01:46:33,480 --> 01:46:34,920 APPLICATIONS SUBMITTED TO 2807 01:46:34,920 --> 01:46:36,160 FUNDING AGENCIES ARE BUDGETED 2808 01:46:36,160 --> 01:46:37,800 ACCORDING TO REVIEW STRUCTURE. 2809 01:46:37,800 --> 01:46:40,400 AND IF IT'S POSSIBLE TO ADDRESS 2810 01:46:40,400 --> 01:46:43,120 PRIOR TO AWARD, THEN FLEXIBILITY 2811 01:46:43,120 --> 01:46:45,920 IS WARRANTED FOR MOST 2812 01:46:45,920 --> 01:46:46,440 STAKEHOLDERS TO ADJUST 2813 01:46:46,440 --> 01:46:51,000 ACCORDINGLY. 2814 01:46:51,000 --> 01:46:54,520 2815 01:46:54,520 --> 01:46:55,720 >> DOUG, I WOULD NOT RECOMMEND 2816 01:46:55,720 --> 01:46:58,840 THAT YOU RECOMMEND THAT THERE BE 2817 01:46:58,840 --> 01:47:02,280 ONE FORM, BUT I THINK IT WOULD 2818 01:47:02,280 --> 01:47:05,280 BE POTENTIALLY USEFUL TO PUT IN 2819 01:47:05,280 --> 01:47:07,440 THAT ONE METHOD BY WHICH A 2820 01:47:07,440 --> 01:47:09,800 CENTRAL OR SINGLE IRB MIGHT 2821 01:47:09,800 --> 01:47:11,120 SOLICIT COMMENT AND INFORMATION 2822 01:47:11,120 --> 01:47:13,960 IS BY USING ITS OWN STANDARDIZED 2823 01:47:13,960 --> 01:47:19,680 FORM AS A BASELINE THAT WOULD BE 2824 01:47:19,680 --> 01:47:21,760 USEFUL IN SOLICITING PARTICULAR 2825 01:47:21,760 --> 01:47:23,600 INPUT ABOUT MAKING IT 2826 01:47:23,600 --> 01:47:24,800 STANDARDIZED ACROSS STUDIES. 2827 01:47:24,800 --> 01:47:26,440 THAT'S ONE THING WE COULD SAY. 2828 01:47:26,440 --> 01:47:28,640 I THINK THE SECOND THING, SECOND 2829 01:47:28,640 --> 01:47:30,400 COMMENT THE COMMENTER IS TALKING 2830 01:47:30,400 --> 01:47:32,480 ABOUT, I THINK THAT WILL 2831 01:47:32,480 --> 01:47:35,240 ACTUALLY BE PROBABLY FOLDED INTO 2832 01:47:35,240 --> 01:47:39,160 THE PROCESS POINTS THAT SKIP 2833 01:47:39,160 --> 01:47:42,120 NELSON COULD MAKE. 2834 01:47:42,120 --> 01:47:43,080 >> HOW WOULD THE STANDARDIZATION 2835 01:47:43,080 --> 01:47:45,320 PLAY INTO THE SMART IRB 2836 01:47:45,320 --> 01:47:48,480 PLATFORMS THAT ARE MOST 2837 01:47:48,480 --> 01:47:49,680 FREQUENTLY USED FOR THIS 2838 01:47:49,680 --> 01:47:50,320 MECHANISM? 2839 01:47:50,320 --> 01:47:52,760 >> THAT OF THEY WOULD NEED TO 2840 01:47:52,760 --> 01:47:55,480 THINK ABOUT WHETHER THEY COULD 2841 01:47:55,480 --> 01:47:56,920 USE AND COULD HAVE A 2842 01:47:56,920 --> 01:47:58,400 STANDARDIZED FORM AS PART OF 2843 01:47:58,400 --> 01:48:00,960 THEIR PROCESS, PART OF THE 2844 01:48:00,960 --> 01:48:05,240 ELECTRONIC APPLICATION PROCESS. 2845 01:48:05,240 --> 01:48:09,040 SO, LIKE ANYBODY COULD. 2846 01:48:09,040 --> 01:48:11,560 WCG OR ANYTHING, YOU KNOW. 2847 01:48:11,560 --> 01:48:14,480 I'LL PUT THAT IN IF YOU GUYS ARE 2848 01:48:14,480 --> 01:48:19,240 IN AGREEMENT ON THAT. 2849 01:48:19,240 --> 01:48:19,520 >> OKAY. 2850 01:48:19,520 --> 01:48:22,760 >> WE'RE AT THE END OF THIS 2851 01:48:22,760 --> 01:48:27,360 DOCUMENT. 2852 01:48:27,360 --> 01:48:29,520 >> DAVID BORASKY, I THINK WHAT 2853 01:48:29,520 --> 01:48:32,040 YOU AND I COULD TRY TO DO IS 2854 01:48:32,040 --> 01:48:34,320 OVERNIGHT TRY TO PUT THIS 2855 01:48:34,320 --> 01:48:36,080 DOCUMENT IN BETTER SHAPE, I MEAN 2856 01:48:36,080 --> 01:48:36,520 IN SHAPE. 2857 01:48:36,520 --> 01:48:38,040 THERE'S NOT MUCH TO DO. 2858 01:48:38,040 --> 01:48:41,560 THERE'S SOME TO DO BUT LOIS HAS 2859 01:48:41,560 --> 01:48:43,200 MADE SOME SPECIFIC WORDING 2860 01:48:43,200 --> 01:48:50,960 SUGGESTIONS AND AND SO HAS 2861 01:48:50,960 --> 01:48:51,320 LINDA. 2862 01:48:51,320 --> 01:48:53,600 IF IT'S OKAY WITH DOUG YOU AND I 2863 01:48:53,600 --> 01:48:55,800 COULD WORK ON THIS AND TOMORROW 2864 01:48:55,800 --> 01:48:57,200 YOU COULD PRESENT THE RED LINE 2865 01:48:57,200 --> 01:48:59,160 VERSION OF IT. 2866 01:48:59,160 --> 01:49:02,120 I WON'T BE HERE. 2867 01:49:02,120 --> 01:49:08,600 >> YEAH, I THINK THAT'S 2868 01:49:08,600 --> 01:49:08,880 REASONABLE. 2869 01:49:08,880 --> 01:49:11,640 >> OKAY. 2870 01:49:11,640 --> 01:49:13,320 >> DOUG, CAN WE TAKE A 2871 01:49:13,320 --> 01:49:14,480 FIVE-MINUTE BREAK? 2872 01:49:14,480 --> 01:49:15,720 >> YES, WAS THERE ANYTHING ELSE 2873 01:49:15,720 --> 01:49:19,920 ON THIS ITEM BEFORE WE TAKE A 2874 01:49:19,920 --> 01:49:21,080 FIVE-MINUTE BREAK? 2875 01:49:21,080 --> 01:49:23,720 IT WOULD BE NICE IF WE CAN GET 2876 01:49:23,720 --> 01:49:24,960 THIS APPROVED TOMORROW. 2877 01:49:24,960 --> 01:49:28,720 IF WE CAN'T, WE MISS THE 2878 01:49:28,720 --> 01:49:31,080 OPPORTUNITY TO COMMENT. 2879 01:49:31,080 --> 01:49:32,480 OKAY. 2880 01:49:32,480 --> 01:49:34,000 LET'S TAKE FIVE OR TEN MINUTES. 2881 01:49:34,000 --> 01:49:36,200 WE CAN JUST COME BACK AT NOON 2882 01:49:36,200 --> 01:49:40,400 WHEN THE NEXT ITEM IS SCHEDULED. 2883 01:49:40,400 --> 01:49:40,960 SO TEN-MINUTE BREAK. 2884 01:49:40,960 --> 01:49:50,880 SO, WE HAVE ABOUT AN HOUR NOW TO 2885 01:49:50,880 --> 01:49:52,480 DISCUSS INTERPRETING ENGAGEMENT 2886 01:49:52,480 --> 01:49:55,480 IN HHS CONDUCTED RESEARCH. 2887 01:49:55,480 --> 01:49:56,920 >> I'M WONDERING WHY I'M NOT 2888 01:49:56,920 --> 01:49:58,680 SEEING ZOOM MEMBERS ON ZOOM, IF 2889 01:49:58,680 --> 01:50:02,160 THAT'S AN I.T. THING. 2890 01:50:02,160 --> 01:50:03,040 >> YEAH, GOOD POINT. 2891 01:50:03,040 --> 01:50:06,360 >> WHERE ARE I.T. ANGELS WHO I'M 2892 01:50:06,360 --> 01:50:09,040 SURE HEAR ME? 2893 01:50:09,040 --> 01:50:16,200 2894 01:50:16,200 --> 01:50:19,480 WHY DON'T YOU CONTINUE AND I'LL 2895 01:50:19,480 --> 01:50:20,240 GO. 2896 01:50:20,240 --> 01:50:21,840 >> THEY DIDN'T RESPOND. 2897 01:50:21,840 --> 01:50:22,840 >> WE'RE HERE. 2898 01:50:22,840 --> 01:50:25,480 EVERYONE IS HERE. 2899 01:50:25,480 --> 01:50:26,000 >> WE'RE HERE. 2900 01:50:26,000 --> 01:50:29,640 >> WHERE DID MY ZOOM PEOPLE GO? 2901 01:50:29,640 --> 01:50:32,440 >> SO, WE DON'T HAVE THEIR 2902 01:50:32,440 --> 01:50:34,200 PICTURE UP. 2903 01:50:34,200 --> 01:50:36,120 THEY ARE APPARENTLY PRESENT. 2904 01:50:36,120 --> 01:50:37,520 >> OKAY. 2905 01:50:37,520 --> 01:50:39,400 >> THERE'S CONSUELO. 2906 01:50:39,400 --> 01:50:40,000 OKAY, GOOD. 2907 01:50:40,000 --> 01:50:40,280 >> OKAY. 2908 01:50:40,280 --> 01:50:40,880 >> ALL RIGHT. 2909 01:50:40,880 --> 01:50:43,960 WE'LL TRY TO GET THE PICTURE SO 2910 01:50:43,960 --> 01:50:45,920 WE CAN ACTUALLY SEE YOU, SO WHEN 2911 01:50:45,920 --> 01:50:48,800 YOU HAVE COMMENTS AND RAISE YOUR 2912 01:50:48,800 --> 01:50:52,440 HANDS WE KNOW IT. 2913 01:50:52,440 --> 01:50:54,320 BUT MARK BARNES IS GOING TO 2914 01:50:54,320 --> 01:50:55,520 PRESENT THIS. 2915 01:50:55,520 --> 01:50:58,840 AND WE HAVE VISITED THIS POLICY 2916 01:50:58,840 --> 01:51:01,600 SEVERAL TIMES NOW IN OUR HOPE AS 2917 01:51:01,600 --> 01:51:03,320 WITH OUR PREVIOUS ITEM, THAT WE 2918 01:51:03,320 --> 01:51:11,120 CAN GET AN APPROVAL ON THIS 2919 01:51:11,120 --> 01:51:14,640 TODAY, SO AS MARK PRESENTS THIS, 2920 01:51:14,640 --> 01:51:15,600 COMMITTEE MEMBERS MAKE COMMENTS, 2921 01:51:15,600 --> 01:51:18,680 THE MORE SPECIFIC WE CAN BE LIKE 2922 01:51:18,680 --> 01:51:20,760 DOWN TO THE LEVEL OF WORDING 2923 01:51:20,760 --> 01:51:23,720 CHANGES, THE MORE HELPFUL IT 2924 01:51:23,720 --> 01:51:28,760 WOULD BE TO GET THIS MOVING 2925 01:51:28,760 --> 01:51:29,000 FORWARD. 2926 01:51:29,000 --> 01:51:30,840 SO, MARK, WHEN YOU GET THE 2927 01:51:30,840 --> 01:51:34,160 PODIUM I'M GOING TO LET YOU TAKE 2928 01:51:34,160 --> 01:51:44,480 US THROUGH THIS. 2929 01:51:46,360 --> 01:51:46,560 GREAT. 2930 01:51:46,560 --> 01:51:47,360 THANK YOU. 2931 01:51:47,360 --> 01:51:51,360 WE CAN SEE OUR OTHER MEMBERS 2932 01:51:51,360 --> 01:52:01,440 NOW. 2933 01:52:12,920 --> 01:52:16,240 >> CAN I ASK IF PEOPLE ON THE 2934 01:52:16,240 --> 01:52:20,160 ZOOM CAN SEE THE POWERPOINT 2935 01:52:20,160 --> 01:52:21,040 WELL? 2936 01:52:21,040 --> 01:52:21,600 MARY ELLEN? 2937 01:52:21,600 --> 01:52:21,840 >> YES. 2938 01:52:21,840 --> 01:52:22,280 >> CONSUELO? 2939 01:52:22,280 --> 01:52:23,960 >> WE'RE JUST SEEING A SCREEN 2940 01:52:23,960 --> 01:52:26,000 WITH ONE SLIDE. 2941 01:52:26,000 --> 01:52:26,480 THAT'S THE -- 2942 01:52:26,480 --> 01:52:28,400 >> THAT'S ALL. 2943 01:52:28,400 --> 01:52:29,920 >> SO THE INTRO SLIDE. 2944 01:52:29,920 --> 01:52:31,080 >> THAT'S FINE. 2945 01:52:31,080 --> 01:52:33,200 I HAVEN'T CHANGED SLIDES YET. 2946 01:52:33,200 --> 01:52:35,840 >> OKAY, GOT IT. 2947 01:52:35,840 --> 01:52:36,640 >> OKAY. 2948 01:52:36,640 --> 01:52:40,960 SO, THANK YOU, DOUG. 2949 01:52:40,960 --> 01:52:41,120 SO. 2950 01:52:41,120 --> 01:52:42,560 >> WE'RE SEEING THE COMMITTEE, 2951 01:52:42,560 --> 01:52:44,120 NOT YOUR INTRO SLIDE. 2952 01:52:44,120 --> 01:52:46,600 >> YOU'RE NOT SEEING MY INTRO. 2953 01:52:46,600 --> 01:52:49,320 HOLD ON, I'M SORRY. 2954 01:52:49,320 --> 01:52:51,920 HOLD ON. 2955 01:52:51,920 --> 01:52:59,000 2956 01:52:59,000 --> 01:53:04,280 HOLD ON. 2957 01:53:04,280 --> 01:53:08,440 WHAT ARE YOU SEEING NOW? 2958 01:53:08,440 --> 01:53:08,560 2959 01:53:08,560 --> 01:53:10,720 >> STILL THE COMMITTEE SLIDE. 2960 01:53:10,720 --> 01:53:12,920 THE POWERPOINT WITH JUST ONE 2961 01:53:12,920 --> 01:53:17,240 SLIDE THAT SAYS THE INTRO. 2962 01:53:17,240 --> 01:53:24,160 2963 01:53:24,160 --> 01:53:24,840 THERE WE GO. 2964 01:53:24,840 --> 01:53:26,480 >> DO YOU SEE IT NOW? 2965 01:53:26,480 --> 01:53:27,400 >> YES. 2966 01:53:27,400 --> 01:53:29,520 >> OKAY, GREAT. 2967 01:53:29,520 --> 01:53:29,920 EXCELLENT. 2968 01:53:29,920 --> 01:53:31,800 THANK YOU, DOUG. 2969 01:53:31,800 --> 01:53:33,760 SO, LOOK, I'M NOT GOING -- I'M 2970 01:53:33,760 --> 01:53:35,040 GOING TO TELL YOU CERTAIN THINGS 2971 01:53:35,040 --> 01:53:38,120 BUT I'M NOT GOING TO GO THROUGH 2972 01:53:38,120 --> 01:53:40,720 ALL OF THE ISSUES, ALL OVER 2973 01:53:40,720 --> 01:53:41,960 AGAIN, BECAUSE WE'VE DONE THAT 2974 01:53:41,960 --> 01:53:44,800 IN THIS COMMITTEE. 2975 01:53:44,800 --> 01:53:48,000 WE'VE DONE THAT IN SPADES AT THE 2976 01:53:48,000 --> 01:53:50,120 COMMITTEE LEVEL, AT THE 2977 01:53:50,120 --> 01:53:50,680 SUBCOMMITTEE LEVEL. 2978 01:53:50,680 --> 01:53:53,520 SO, LET ME JUST HIT SOME 2979 01:53:53,520 --> 01:53:55,960 HIGHLIGHTS FOR YOU. 2980 01:53:55,960 --> 01:53:58,680 FIRST OF ALL, I'D LIKE AS A 2981 01:53:58,680 --> 01:54:00,960 CONTEXTUAL ISSUE FOR PEOPLE ON 2982 01:54:00,960 --> 01:54:02,200 THE COMMITTEE TO REMEMBER THAT 2983 01:54:02,200 --> 01:54:04,680 THIS IS NOT THE GUIDANCE 2984 01:54:04,680 --> 01:54:06,200 DOCUMENT. 2985 01:54:06,200 --> 01:54:08,520 THIS IS A RECOMMENDATION TO OHRP 2986 01:54:08,520 --> 01:54:13,240 THAT THEY THINK ABOUT THIS AS A 2987 01:54:13,240 --> 01:54:13,680 POSSIBILITY. 2988 01:54:13,680 --> 01:54:15,440 AND THERE WOULD HAVE TO BE A LOT 2989 01:54:15,440 --> 01:54:16,480 OF GESTATION AND CONSIDERATION 2990 01:54:16,480 --> 01:54:17,600 ON ANY RECOMMENDATION YOU MIGHT 2991 01:54:17,600 --> 01:54:19,480 MAKE AS A COMMITTEE BEFORE 2992 01:54:19,480 --> 01:54:21,680 ANYTHING WOULD ACTUALLY MAKE IT 2993 01:54:21,680 --> 01:54:24,600 INTO REGULATORY GUIDANCE SO 2994 01:54:24,600 --> 01:54:27,920 YOU'RE NOT VOTING ON REGULATORY 2995 01:54:27,920 --> 01:54:29,080 GUIDANCE BUT A REGULATION THERE 2996 01:54:29,080 --> 01:54:31,480 BE A DIFFERENT WAY OF THINKING 2997 01:54:31,480 --> 01:54:33,440 ABOUT THIS TO BE CONSIDERED. 2998 01:54:33,440 --> 01:54:35,000 SECOND THING, I WANT TO POINT 2999 01:54:35,000 --> 01:54:39,080 OUT AGAIN BOTH I AND THE 3000 01:54:39,080 --> 01:54:40,920 SUBCOMMITTEES ARE REALLY -- 3001 01:54:40,920 --> 01:54:43,640 WE'RE INNOCENT BYSTANDERS IN ALL 3002 01:54:43,640 --> 01:54:45,720 OF THIS BECAUSE THIS WAS NOT -- 3003 01:54:45,720 --> 01:54:47,480 THIS IDEA OF REVISITING THIS DID 3004 01:54:47,480 --> 01:54:49,120 NOT COME FROM THE SUBCOMMITTEES. 3005 01:54:49,120 --> 01:54:51,080 WE WERE ASKED BY OHRP TO TRY TO 3006 01:54:51,080 --> 01:54:54,480 LOOK AT THE EXISTING GUIDANCE 3007 01:54:54,480 --> 01:54:55,360 DOCUMENTS ON ENGAGEMENT RESEARCH 3008 01:54:55,360 --> 01:54:57,320 AND SEE IF WE COULD THINK ABOUT 3009 01:54:57,320 --> 01:55:00,000 IT IN A BLUE SKY WAY TO WHETHER 3010 01:55:00,000 --> 01:55:05,200 THERE MIGHT BE A DIFFERENT WAY 3011 01:55:05,200 --> 01:55:06,120 TO PROCEED. 3012 01:55:06,120 --> 01:55:07,520 THAT'S WHAT WE WERE ASKED TO DO. 3013 01:55:07,520 --> 01:55:08,960 THAT WAS THE CHALLENGE WE TOOK 3014 01:55:08,960 --> 01:55:10,480 UP ABOUT 18 MONTHS AGO WHEN WE 3015 01:55:10,480 --> 01:55:19,440 STARTED THE CONSIDERATION OF ALL 3016 01:55:19,440 --> 01:55:19,640 THIS. 3017 01:55:19,640 --> 01:55:21,880 IT WAS RELATED TO YOU LAST TIME 3018 01:55:21,880 --> 01:55:22,840 SUBCOMMITTEES AND YOU HAVE 3019 01:55:22,840 --> 01:55:27,680 CONSIDERED A LOT OF ALTERNATIVES 3020 01:55:27,680 --> 01:55:31,280 IN REGARD TO TO WHAT MIGHT BE 3021 01:55:31,280 --> 01:55:32,080 RECOMMENDED HERE. 3022 01:55:32,080 --> 01:55:34,040 THE LAST ROUND OF THIS, THE LAST 3023 01:55:34,040 --> 01:55:36,560 ITERATION OF ALL OF THIS 3024 01:55:36,560 --> 01:55:39,280 DISCUSSION, HAS REALLY BEEN AT 3025 01:55:39,280 --> 01:55:41,600 THAT SUBCOMMITTEE LEVEL, HAS 3026 01:55:41,600 --> 01:55:45,520 BEEN THAT WE CAN SAID DO WE JUST 3027 01:55:45,520 --> 01:55:48,040 SAY KEEP WHAT YOU'VE GOT AND 3028 01:55:48,040 --> 01:55:52,320 LET'S ADD ADDITIONAL SCENARIOS 3029 01:55:52,320 --> 01:55:54,440 THAT ARE COMMON SCENARIOS THAT 3030 01:55:54,440 --> 01:55:55,840 COME UP WITH COMMONALITY, SOME 3031 01:55:55,840 --> 01:55:58,680 FREQUENCY, JUST ASK THAT THOSE 3032 01:55:58,680 --> 01:56:00,000 ADDITIONAL SCENARIOS BE 3033 01:56:00,000 --> 01:56:01,880 ADDRESSED, AND LAYER ON A FOURTH 3034 01:56:01,880 --> 01:56:03,840 LEVEL OF GUIDANCE ON TOP OF THE 3035 01:56:03,840 --> 01:56:05,920 EXISTING THREE LEVELS OF 3036 01:56:05,920 --> 01:56:07,240 GIVEDDANCE ABOUT THIS. 3037 01:56:07,240 --> 01:56:11,160 OR DO WE DO SOMETHING BIGGER? 3038 01:56:11,160 --> 01:56:12,360 THE SUBCOMMITTEE AFTER TALKING 3039 01:56:12,360 --> 01:56:13,800 AND THINKING SAID WE REALLY WANT 3040 01:56:13,800 --> 01:56:17,080 TO DO SOMETHING THAT'S BIGGER 3041 01:56:17,080 --> 01:56:17,960 THAN THAT. 3042 01:56:17,960 --> 01:56:20,160 LET'S GO BACK TO FIRST 3043 01:56:20,160 --> 01:56:22,000 PRINCIPLES AND COME UP WITH 3044 01:56:22,000 --> 01:56:24,080 SOMETHING THAT WOULD DISTILL 3045 01:56:24,080 --> 01:56:28,440 CONVERSATIONS INTO A MORE 3046 01:56:28,440 --> 01:56:29,560 COMPREHENSIVE RECOMMENDATION TO 3047 01:56:29,560 --> 01:56:32,160 SACHRP AND ULTIMATELY TO OHRP 3048 01:56:32,160 --> 01:56:34,480 THAT WOULD NOT JUST ADD ON 3049 01:56:34,480 --> 01:56:35,320 ADDITIONAL SCENARIOS AND LAYER 3050 01:56:35,320 --> 01:56:38,840 ON TOP OF WHAT WE THINK IS 3051 01:56:38,840 --> 01:56:44,160 ALREADY CONFUSING AND IN SOME 3052 01:56:44,160 --> 01:56:44,880 CASES INCONSISTENT GUIDANCE. 3053 01:56:44,880 --> 01:56:48,920 AND YOU HAVE A COPY OF THIS, IT 3054 01:56:48,920 --> 01:56:50,880 ARRIVED IN MY MAILBOX AT THE 3055 01:56:50,880 --> 01:56:53,280 SAME TIME IN JERRY'S MAILBOX AND 3056 01:56:53,280 --> 01:56:55,240 MAYBE A COUPLE OTHER PEOPLE, 3057 01:56:55,240 --> 01:56:58,400 JULIE, MAYBE iVar AT OHRP, 3058 01:56:58,400 --> 01:57:02,800 BUT THE COMMITTEE ON GOVERNMENT 3059 01:57:02,800 --> 01:57:04,560 RELATIONS, A POLICY ADVOCACY 3060 01:57:04,560 --> 01:57:07,080 GROUP, THAT IS BASED IN 3061 01:57:07,080 --> 01:57:09,040 WASHINGTON AND CONSISTS OF 200 3062 01:57:09,040 --> 01:57:10,560 MEMBERS BASICALLY THE LEADING 3063 01:57:10,560 --> 01:57:14,920 ERST AND ACADEMIC MEDICAL 3064 01:57:14,920 --> 01:57:16,080 CENTERS RESEARCH INTENSIVE, IF I 3065 01:57:16,080 --> 01:57:17,800 GET THIS WRONG, ONE OF YOU WHO 3066 01:57:17,800 --> 01:57:19,640 KNOWS BETTER THAN I CAN CORRECT 3067 01:57:19,640 --> 01:57:24,560 ME, BUT THERE'S A RESEARCH 3068 01:57:24,560 --> 01:57:27,080 COMMITTEE OF COVR, AND THAT 3069 01:57:27,080 --> 01:57:31,680 COMMITTEE TOOK THIS ISSUE UP OF 3070 01:57:31,680 --> 01:57:33,000 ENGAGEMENT MINDFUL OF THE LAST 3071 01:57:33,000 --> 01:57:34,520 SESSION WE HAD AT SACHRP ON THIS 3072 01:57:34,520 --> 01:57:36,040 ISSUE I THINK IN MARCH AND 3073 01:57:36,040 --> 01:57:37,680 WEIGHED IN WITH THEIR OWN 3074 01:57:37,680 --> 01:57:38,040 LETTER. 3075 01:57:38,040 --> 01:57:40,480 YOU HAVE A COPY OF THE LETTER, 3076 01:57:40,480 --> 01:57:41,280 BUT THE LETTER REITERATES MANY 3077 01:57:41,280 --> 01:57:43,680 OF THE CONCERNS THAT HAVE BEEN 3078 01:57:43,680 --> 01:57:45,120 EXPRESSED BY THE SUBCOMMITTEE 3079 01:57:45,120 --> 01:57:47,320 MEMBERS AND EXPRESSED TO YOU 3080 01:57:47,320 --> 01:57:47,960 GUYS ABOUT HOW CONFUSING 3081 01:57:47,960 --> 01:57:51,520 GUIDANCE IS AND HOW IT REALLY 3082 01:57:51,520 --> 01:57:54,600 TENDS NOT TO FIT THE SOMEWHAT 3083 01:57:54,600 --> 01:57:56,680 REVOLUTIONARY NATURE OF THE 3084 01:57:56,680 --> 01:57:58,360 DECENTRALIZATION OF CLINICAL 3085 01:57:58,360 --> 01:58:00,000 TRIALS AND EMERGENCE OF SINGLE 3086 01:58:00,000 --> 01:58:02,200 IRBs THAT THEN ARE FACED WITH 3087 01:58:02,200 --> 01:58:03,600 MAKING ALL SORTS OF JUDGMENTS 3088 01:58:03,600 --> 01:58:05,400 ABOUT ALL OF THE ENTITIES OVER 3089 01:58:05,400 --> 01:58:12,720 25 OR 50 SITES THAT MAY SO 3090 01:58:12,720 --> 01:58:14,480 CALLED ENGAGED IN RESEARCH, IN 3091 01:58:14,480 --> 01:58:14,880 QUOTES. 3092 01:58:14,880 --> 01:58:17,280 I COMMEND THAT LETTER TO YOUR 3093 01:58:17,280 --> 01:58:18,400 ATTENTION BECAUSE IT'S ON THE 3094 01:58:18,400 --> 01:58:22,560 TABLE OVER HERE FOR THOSE WHO 3095 01:58:22,560 --> 01:58:23,920 AREN'T PRESENT PHYSICALLY IT'S 3096 01:58:23,920 --> 01:58:27,320 POSTED ON THE WEB. 3097 01:58:27,320 --> 01:58:29,240 >> ON THE DOCKET. 3098 01:58:29,240 --> 01:58:37,360 >> AND THAT -- I WAS GLAD TO 3099 01:58:37,360 --> 01:58:39,560 RECEIVE IT, AN ORGANIZATION 3100 01:58:39,560 --> 01:58:41,440 COMPOSED OF MANY ENTITIES 3101 01:58:41,440 --> 01:58:42,520 RESEARCH INTENSIVE SEEM TO THINK 3102 01:58:42,520 --> 01:58:44,240 IN TERMS OF THE CURRENT LAY OF 3103 01:58:44,240 --> 01:58:46,000 THE LAND THAT SEEM TO FEEL 3104 01:58:46,000 --> 01:58:48,280 SIMILARLY TO THE WAY THAT THE 3105 01:58:48,280 --> 01:58:50,400 SUBCOMMITTEE MEMBERS HAVE FELT 3106 01:58:50,400 --> 01:58:53,000 ABOUT THE CURRENT GUIDANCE. 3107 01:58:53,000 --> 01:58:54,640 I SUPPOSE PEOPLE WITHIN OHRP 3108 01:58:54,640 --> 01:58:56,280 WERE QUESTIONING AS WELL, THAT'S 3109 01:58:56,280 --> 01:58:57,480 WHY THEY ASKED US AS A 3110 01:58:57,480 --> 01:58:58,320 SUBCOMMITTEE AND YOU AS A 3111 01:58:58,320 --> 01:59:00,360 COMMITTEE TO LOOK AT THIS. 3112 01:59:00,360 --> 01:59:03,160 SO WE WENT THROUGH A LOT OF 3113 01:59:03,160 --> 01:59:05,600 DIFFERENT, AGAIN, ITERATIONS OF 3114 01:59:05,600 --> 01:59:08,640 THINGS, AND WHAT WE CAME UP WITH 3115 01:59:08,640 --> 01:59:10,640 WAS BASICALLY A RECOMMENDATION 3116 01:59:10,640 --> 01:59:12,840 WHICH IS ENSHRINED IN THE 3117 01:59:12,840 --> 01:59:14,000 LENGTHY LETTER THAT I PUT 3118 01:59:14,000 --> 01:59:16,240 TOGETHER AND WAS LOOKED AT BY 3119 01:59:16,240 --> 01:59:17,480 THE SUBCOMMITTEE TRYING TO LAY 3120 01:59:17,480 --> 01:59:21,120 OUT THIS IN A LARGER CONCEPTUAL 3121 01:59:21,120 --> 01:59:22,200 CONTEXT, OF WHAT THE 3122 01:59:22,200 --> 01:59:23,520 RECOMMENDATION WE'RE MAKING TO 3123 01:59:23,520 --> 01:59:28,680 YOU AND RECOMMENDING YOU MAKE TO 3124 01:59:28,680 --> 01:59:29,960 OHRP, WHAT IT ACTUALLY -- WHAT 3125 01:59:29,960 --> 01:59:33,440 THE BACKGROUND IS AND WHAT IT 3126 01:59:33,440 --> 01:59:36,320 MEANS. 3127 01:59:36,320 --> 01:59:40,120 LET ME GO TO THE RECOMMENDATION 3128 01:59:40,120 --> 01:59:42,000 HERE. 3129 01:59:42,000 --> 01:59:43,840 AND I'LL GO BACK. 3130 01:59:43,840 --> 01:59:49,000 SO, THE STANDARD WE'RE PROPOSING 3131 01:59:49,000 --> 01:59:51,160 IS BASICALLY THAT IN DECIDING 3132 01:59:51,160 --> 01:59:53,080 WHO IS ENGAGED IN RESEARCH FOR 3133 01:59:53,080 --> 01:59:59,280 PURPOSES OF NEEDING TO HAVE AN 3134 01:59:59,280 --> 02:00:00,280 ACTIVE FEDERAL ASSURANCE WITH 3135 02:00:00,280 --> 02:00:02,560 OHRP MEANING IT'S A PIECE OF 3136 02:00:02,560 --> 02:00:05,160 PAPER BUT IT IS AN ASSURANCE 3137 02:00:05,160 --> 02:00:06,520 THAT SUBJECTS THE ORGANIZATION 3138 02:00:06,520 --> 02:00:08,360 CONDUCTING THE RESEARCH THAT'S 3139 02:00:08,360 --> 02:00:10,560 ENGAGED IN THE RESEARCH TO THE 3140 02:00:10,560 --> 02:00:13,600 JURISDICTION OF OHRP AND ALSO 3141 02:00:13,600 --> 02:00:15,240 REQUIRES THAT THE ENTITY ENGAGED 3142 02:00:15,240 --> 02:00:17,560 IN RESEARCH HAVE ALL OF THE 3143 02:00:17,560 --> 02:00:19,520 POLICIES AND PROCEDURES IN ORDER 3144 02:00:19,520 --> 02:00:20,840 TO IMPLEMENT THE PROTECTIONS OF 3145 02:00:20,840 --> 02:00:23,440 THE COMMON RULE INCLUDING AN IRB 3146 02:00:23,440 --> 02:00:26,720 EITHER A LOCAL IRB OR IRB OF 3147 02:00:26,720 --> 02:00:30,560 RECORD THAT WOULD BE AN IRB BY 3148 02:00:30,560 --> 02:00:31,880 THE REVIEW PROCESS, RECOMMENDING 3149 02:00:31,880 --> 02:00:33,880 THAT THE DEFINITION BE REFINED 3150 02:00:33,880 --> 02:00:35,280 TO THE FOLLOWING. 3151 02:00:35,280 --> 02:00:37,920 PARTY IS ENGAGED IN RESEARCH IF 3152 02:00:37,920 --> 02:00:40,120 IT, IN GENERAL ENTITIES HERE, OR 3153 02:00:40,120 --> 02:00:42,360 ITS EMPLOYEES, STAFF OR AGENTS, 3154 02:00:42,360 --> 02:00:45,800 HAS A KEY ROLE IN DESIGNING 3155 02:00:45,800 --> 02:00:46,880 RESEARCH, CONDUCTING RESEARCH, 3156 02:00:46,880 --> 02:00:48,520 ANALYZING AND INTERPRETING THE 3157 02:00:48,520 --> 02:00:50,840 RESULTS, OR GAINING INFORMED 3158 02:00:50,840 --> 02:00:52,320 CONSENT FROM HUMAN SUBJECTS. 3159 02:00:52,320 --> 02:00:56,040 THIS IS AN ATTEMPT TO FOCUS THE 3160 02:00:56,040 --> 02:00:57,480 ENGAGED IN RESEARCH CONCEPT ON 3161 02:00:57,480 --> 02:00:59,280 THOSE WHO ARE MOST DEEPLY 3162 02:00:59,280 --> 02:01:02,400 INVOLVED IN THE RESEARCH AND WHO 3163 02:01:02,400 --> 02:01:04,080 HAVE CONTROL THE ESSENTIAL 3164 02:01:04,080 --> 02:01:06,000 ASPECTS OF THE RESEARCH, THE 3165 02:01:06,000 --> 02:01:07,160 RESEARCH DESIGN, RESEARCH 3166 02:01:07,160 --> 02:01:09,960 ANALYSIS, AND CONDUCT OF THE 3167 02:01:09,960 --> 02:01:10,360 RESEARCH. 3168 02:01:10,360 --> 02:01:12,360 SO THAT IS THE BOTTOM LINE 3169 02:01:12,360 --> 02:01:14,360 RECOMMENDATION AS TO HOW A NEW 3170 02:01:14,360 --> 02:01:15,960 STANDARD THAT MIGHT BE 3171 02:01:15,960 --> 02:01:16,400 ARTICULATED. 3172 02:01:16,400 --> 02:01:20,920 NOW, I WANT TO GIVE YOU A LITTLE 3173 02:01:20,920 --> 02:01:22,360 BIT OF BACKGROUND JUST IN THE -- 3174 02:01:22,360 --> 02:01:25,960 AND THIS IS PUT INTO THE PROSE 3175 02:01:25,960 --> 02:01:29,680 DOCUMENT YOU HAVE. 3176 02:01:29,680 --> 02:01:34,400 ONE OF THE SOURCES OF THIS 3177 02:01:34,400 --> 02:01:35,240 RECOMMENDATION, CONCEPTUAL 3178 02:01:35,240 --> 02:01:36,080 SOURCES, THE COMMITTEE, THE 3179 02:01:36,080 --> 02:01:37,280 SUBCOMMITTEES HAVE LOOKED AT THE 3180 02:01:37,280 --> 02:01:39,120 OTHER WAYS IN WHICH FEDERAL 3181 02:01:39,120 --> 02:01:42,640 INSTITUTIONS AND OTHER KINDS OF 3182 02:01:42,640 --> 02:01:44,280 ORGANIZATIONS APPROACH HOW THEY 3183 02:01:44,280 --> 02:01:46,680 APPLY THEIR STANDARDS FOR 3184 02:01:46,680 --> 02:01:48,040 PROTECTING HUMAN SUBJECTS AND 3185 02:01:48,040 --> 02:01:50,280 FOR BEING RESPONSIBLE IN THE 3186 02:01:50,280 --> 02:01:51,360 CONDUCT OF RESEARCH. 3187 02:01:51,360 --> 02:01:54,200 AND SO WE LOOKED, WE TALKED 3188 02:01:54,200 --> 02:01:56,240 ABOUT THIS I THINK AT THE 3189 02:01:56,240 --> 02:02:00,200 MEETING, THE FDA IN THE WAY IT 3190 02:02:00,200 --> 02:02:01,120 ORGANIZES ENFORCEMENT OVER 3191 02:02:01,120 --> 02:02:03,840 CLINICAL TRIALS THAT ARE UNDER 3192 02:02:03,840 --> 02:02:06,160 THE FDA JURISDICTION, MANY OF 3193 02:02:06,160 --> 02:02:07,560 WHICH ACTUALLY CAN ALSO FALL 3194 02:02:07,560 --> 02:02:09,880 UNDER AT THE SAME TIME IN A VENN 3195 02:02:09,880 --> 02:02:11,080 DIAGRAM WAY UNDER THE COMMON 3196 02:02:11,080 --> 02:02:14,120 RULE IS THAT FDA DOES NOT LOOK 3197 02:02:14,120 --> 02:02:15,760 AT EVERY VENDOR THAT MAY BE 3198 02:02:15,760 --> 02:02:17,240 COLLECTING INFORMATION IN THE 3199 02:02:17,240 --> 02:02:20,040 COURSE OF A RESEARCH, THE FDA 3200 02:02:20,040 --> 02:02:23,200 FOCUSES ON THE INVESTIGATOR AND 3201 02:02:23,200 --> 02:02:25,160 THE CO-INVESTIGATORS WHO HAVE TO 3202 02:02:25,160 --> 02:02:28,600 SIGN WHAT'S CALLED A FORM 1572, 3203 02:02:28,600 --> 02:02:29,800 IN WHICH THEY TAKE 3204 02:02:29,800 --> 02:02:32,280 RESPONSIBILITY FOR THE CONDUCT 3205 02:02:32,280 --> 02:02:34,480 OF THE STUDY INCLUDING 3206 02:02:34,480 --> 02:02:36,240 RESPONSIBILITY FOR THE 3207 02:02:36,240 --> 02:02:37,560 ACTIVITIES OF TEAM MEMBERS IN 3208 02:02:37,560 --> 02:02:39,640 THE INSTITUTION AS WELL AS THE 3209 02:02:39,640 --> 02:02:41,040 VENDORS AND CENTRAL LABS AND 3210 02:02:41,040 --> 02:02:43,400 OTHERS THAT ARE LISTED ON THE 3211 02:02:43,400 --> 02:02:45,280 1572, BUT THEY DON'T HAVE TO 3212 02:02:45,280 --> 02:02:46,840 SIGN THEIR OWN 1572. 3213 02:02:46,840 --> 02:02:48,480 THE IDEA FROM FDA'S POINT OF 3214 02:02:48,480 --> 02:02:51,120 VIEW BEING THE INVESTIGATOR IS 3215 02:02:51,120 --> 02:02:52,960 THE PRIMARY AND APPROPRIATE 3216 02:02:52,960 --> 02:02:54,080 PRESSURE POINT FOR AN ENTITY 3217 02:02:54,080 --> 02:02:56,040 THAT SHOULD BE RESPONSIBLE FOR 3218 02:02:56,040 --> 02:02:59,320 THE RESEARCH SINCE HE OR SHE IS 3219 02:02:59,320 --> 02:03:01,040 THE ONE THAT ULTIMATELY IS 3220 02:03:01,040 --> 02:03:02,040 THROUGH THEIR INSTITUTION 3221 02:03:02,040 --> 02:03:02,680 CONTROLLING THE ACTIVITIES OF 3222 02:03:02,680 --> 02:03:05,520 ALL OF THESE OTHER PARTIES TO 3223 02:03:05,520 --> 02:03:08,160 THE RESEARCH. 3224 02:03:08,160 --> 02:03:12,000 THIS IS THE WAY THAT -- OH, 3225 02:03:12,000 --> 02:03:13,640 THANK YOU. 3226 02:03:13,640 --> 02:03:18,560 I DON'T MIND BEING DAVID BORASKY 3227 02:03:18,560 --> 02:03:19,200 FOR A DAY. 3228 02:03:19,200 --> 02:03:21,480 THIS IS THE WAY FDA DOES IT. 3229 02:03:21,480 --> 02:03:24,760 THERE DON'T APPEAR TO BE 3230 02:03:24,760 --> 02:03:25,920 TERRIBLE EFFECTS, THE WORLD HAS 3231 02:03:25,920 --> 02:03:28,520 NOT GONE CRAZY IN CLINICAL 3232 02:03:28,520 --> 02:03:29,800 TRIALS BECAUSE THE FDA DOESN'T 3233 02:03:29,800 --> 02:03:35,000 REGULATE VENDORS DIRECTLY. 3234 02:03:35,000 --> 02:03:36,520 IT SEEMS TO HAVE WORKED OUT FOR 3235 02:03:36,520 --> 02:03:37,280 FDA WELL. 3236 02:03:37,280 --> 02:03:39,680 SKIP FROM THE FDA COULD, FOR 3237 02:03:39,680 --> 02:03:42,520 EXAMPLE, COMMENT ON THIS IN THE 3238 02:03:42,520 --> 02:03:45,240 DISCUSSION IF HE WANTS. 3239 02:03:45,240 --> 02:03:47,600 THAT'S ONE REGULATORY MODEL WITH 3240 02:03:47,600 --> 02:03:48,840 WHICH THE RECOMMENDATION WE'RE 3241 02:03:48,840 --> 02:03:51,640 MAKING TO YOU WOULD BE 3242 02:03:51,640 --> 02:03:52,080 CONSISTENT. 3243 02:03:52,080 --> 02:03:54,600 ANOTHER THING WHICH IS NOT 3244 02:03:54,600 --> 02:03:55,800 REALLY -- IT'S NOT DIRECTLY 3245 02:03:55,800 --> 02:03:58,120 APPLICABLE BUT IT'S IMPORTANT IS 3246 02:03:58,120 --> 02:03:59,080 THE STANDARDS THAT THE 3247 02:03:59,080 --> 02:04:01,040 INTERNATIONAL COMMITTEE OF 3248 02:04:01,040 --> 02:04:02,480 MEDICAL JOURNAL EDITORS HAVE FOR 3249 02:04:02,480 --> 02:04:04,720 WHO IS ALLOWED TO BE AN AUTHOR 3250 02:04:04,720 --> 02:04:06,720 ON A PUBLICATION. 3251 02:04:06,720 --> 02:04:08,160 REMEMBER, A PUBLICATION, 3252 02:04:08,160 --> 02:04:09,000 RESEARCH PUBLICATION, IS AN 3253 02:04:09,000 --> 02:04:14,440 ATTEMPT BY A GROUP OF PEOPLE TO 3254 02:04:14,440 --> 02:04:15,480 OFFER GENERALIZABLE KNOWLEDGE TO 3255 02:04:15,480 --> 02:04:20,880 THE LAY PUBLIC AND TO THE 3256 02:04:20,880 --> 02:04:24,560 LEARNED PUBLIC ABOUT A SET OF 3257 02:04:24,560 --> 02:04:26,880 FINDINGS, DATA, THEIR ANALYSIS 3258 02:04:26,880 --> 02:04:28,840 AND THEIR FINDINGS AND WHAT THEY 3259 02:04:28,840 --> 02:04:30,280 THINK WOULD BE -- COULD BE 3260 02:04:30,280 --> 02:04:32,120 DISTILLED FROM THE WORK THEY 3261 02:04:32,120 --> 02:04:34,360 HAVE DONE AND NOT EVERYBODY 3262 02:04:34,360 --> 02:04:35,560 UNDER THESE STANDARDS IS ALLOWED 3263 02:04:35,560 --> 02:04:38,280 TO BE AN AUTHOR BECAUSE THEY ARE 3264 02:04:38,280 --> 02:04:39,840 NOT REGARDED HAVING SUFFICIENT 3265 02:04:39,840 --> 02:04:42,800 CONTROL OF AND PARTICIPATION IN 3266 02:04:42,800 --> 02:04:45,000 THE RESEARCH. 3267 02:04:45,000 --> 02:04:48,600 INSTEAD, ICMGE AFTER A SERIES OF 3268 02:04:48,600 --> 02:04:50,040 FRANKLY ABUSES WE DON'T HAVE TO 3269 02:04:50,040 --> 02:04:51,440 TALK ABOUT HERE ADDING LOTS OF 3270 02:04:51,440 --> 02:04:53,240 PEOPLE AS AUTHORS WHO HAD VERY 3271 02:04:53,240 --> 02:04:55,280 LITTLE TO DO WITH THE STUDY 3272 02:04:55,280 --> 02:04:57,040 OTHER THAN PERHAPS HAVING HELPED 3273 02:04:57,040 --> 02:04:58,640 FUND A STUDY OR HAVING A GRANT 3274 02:04:58,640 --> 02:04:59,880 OR REFERRING SOMEBODY TO THE 3275 02:04:59,880 --> 02:05:02,400 STUDY OR BEING A FRIEND OF THE 3276 02:05:02,400 --> 02:05:06,240 SENIOR AUTHOR OR FIRST AUTHOR, A 3277 02:05:06,240 --> 02:05:10,520 SERIES OF ABUSES LIKE THAT, THE 3278 02:05:10,520 --> 02:05:13,440 ALLOCATION OF BOTH CREDIT AND 3279 02:05:13,440 --> 02:05:14,640 RESPONSIBILITY FOR THE RESEARCH 3280 02:05:14,640 --> 02:05:16,280 THAT'S BEEN PUBLISHED TO A SET 3281 02:05:16,280 --> 02:05:17,920 OF PEOPLE WHO ESSENTIALLY ARE 3282 02:05:17,920 --> 02:05:20,120 THOSE WHO MAKES SUBSTANTIAL 3283 02:05:20,120 --> 02:05:21,040 CONTRIBUTIONS TO THE CONCEPTION 3284 02:05:21,040 --> 02:05:24,920 AND DESIGN OF THE WORK, 3285 02:05:24,920 --> 02:05:25,680 ACQUISITION, ANALYSIS AND 3286 02:05:25,680 --> 02:05:27,040 INTERPRETATION OF DATA, AND 3287 02:05:27,040 --> 02:05:30,640 DRAFT THE WORK OR REVISE 3288 02:05:30,640 --> 02:05:31,840 CRITICALLY FOR INTELLECTUAL 3289 02:05:31,840 --> 02:05:33,480 CONTENT AND HAVE FINAL APPROVAL 3290 02:05:33,480 --> 02:05:35,240 OVER THE FORM OF PUBLICATION. 3291 02:05:35,240 --> 02:05:37,320 AND IT'S THOUGHT IF YOU SIGN UP 3292 02:05:37,320 --> 02:05:38,920 AS AN AUTHOR, THAT, YES, YOU GET 3293 02:05:38,920 --> 02:05:41,680 THE CREDIT WHICH GOES ON YOUR 3294 02:05:41,680 --> 02:05:43,760 ACADEMIC CV, BUT YOU ALSO ARE 3295 02:05:43,760 --> 02:05:46,160 TAKING ON THE RESPONSIBILITY FOR 3296 02:05:46,160 --> 02:05:47,600 THE ACCURACY OF THAT WHICH HAS 3297 02:05:47,600 --> 02:05:50,840 BEEN PUBLISHED UNDER YOUR NAME. 3298 02:05:50,840 --> 02:05:55,120 THIS IS HOW THE -- ICMJE IS 3299 02:05:55,120 --> 02:05:57,560 FOCUSING ON THOSE WITH THE MOST 3300 02:05:57,560 --> 02:05:59,840 INPUT AND CONTROL. 3301 02:05:59,840 --> 02:06:01,800 AND THERE'S THE OTHER BACKGROUND 3302 02:06:01,800 --> 02:06:04,080 WHICH IS ACTUALLY QUITE 3303 02:06:04,080 --> 02:06:06,600 OPERATIVE IN REGARD TO THE 3304 02:06:06,600 --> 02:06:08,800 ENGAGED IN RESEARCH SCENARIO 3305 02:06:08,800 --> 02:06:12,840 THAT HOW DO WE -- REMEMBER THAT 3306 02:06:12,840 --> 02:06:15,240 ENGAGED IN RESEARCH IS A 3307 02:06:15,240 --> 02:06:16,920 SUBPOINT UNDER THOSE ENTITIES 3308 02:06:16,920 --> 02:06:18,640 THAT ARE RECEIVING FEDERAL 3309 02:06:18,640 --> 02:06:19,440 SUPPORT, FEDERAL MONETARY 3310 02:06:19,440 --> 02:06:21,160 SUPPORT FOR THEIR RESEARCH. 3311 02:06:21,160 --> 02:06:22,680 THERE'S NOT FEDERAL MONETARY 3312 02:06:22,680 --> 02:06:25,000 SUPPORT FOR THE RESEARCH, OHRP 3313 02:06:25,000 --> 02:06:26,760 DOESN'T GET INVOLVED AND THERE'S 3314 02:06:26,760 --> 02:06:27,600 NO FWA. 3315 02:06:27,600 --> 02:06:29,040 ONLY IF THERE'S SUPPORT WHICH 3316 02:06:29,040 --> 02:06:31,240 WE'LL TALK ABOUT TOMORROW WITH 3317 02:06:31,240 --> 02:06:34,160 DAVID FORSTER DOES THE 3318 02:06:34,160 --> 02:06:37,120 INSTITUTION THEN FALL UNDER 3319 02:06:37,120 --> 02:06:38,880 POTENTIAL OHRP JURISDICTION. 3320 02:06:38,880 --> 02:06:41,920 AND BUT IT'S NOT ALL ENTITIES 3321 02:06:41,920 --> 02:06:43,800 THAT ARE RECEIVING FEDERAL FUNDS 3322 02:06:43,800 --> 02:06:45,960 BUT ULTIMATELY ARE RESPONSIBLE 3323 02:06:45,960 --> 02:06:47,840 FOR THE EXPENDITURE OF FEDERAL 3324 02:06:47,840 --> 02:06:48,480 FUNDS. 3325 02:06:48,480 --> 02:06:49,920 INSTEAD, THE FUNDING AGENCIES 3326 02:06:49,920 --> 02:07:00,400 LIKE NIH AND DoD AND DOE AND 3327 02:07:01,480 --> 02:07:03,400 NSF FOCUS ON INSTITUTIONS WITH 3328 02:07:03,400 --> 02:07:05,640 SIGNIFICANT INTELLECTUAL INPUT 3329 02:07:05,640 --> 02:07:07,880 INTO AND CONTROL OVER THE DESIGN 3330 02:07:07,880 --> 02:07:14,320 AND CONDUCT AND REPORTING OUT OF 3331 02:07:14,320 --> 02:07:14,720 STUDIES. 3332 02:07:14,720 --> 02:07:16,840 AND IN THE VARIOUS GUIDANCE 3333 02:07:16,840 --> 02:07:20,000 DOCUMENTS REGARD TO WHO IS 3334 02:07:20,000 --> 02:07:21,760 RESPONSIBLE DIRECTLY TO THE 3335 02:07:21,760 --> 02:07:22,640 FUNDING -- FEDERAL FUNDING 3336 02:07:22,640 --> 02:07:23,800 AGENCY FOR THE EXPENDITURE OF 3337 02:07:23,800 --> 02:07:26,240 FUNDS AND CONDUCT OF WHAT THEY 3338 02:07:26,240 --> 02:07:28,240 DO UNDER USING FEDERAL MONEY, IT 3339 02:07:28,240 --> 02:07:30,200 DOESN'T REST DIRECTLY ON THE 3340 02:07:30,200 --> 02:07:31,800 VENDORS. 3341 02:07:31,800 --> 02:07:32,920 IT RESTS ON THE AWARDEE WHO HAS 3342 02:07:32,920 --> 02:07:35,640 A P.I. AND THE SUB-AWARDEES 3343 02:07:35,640 --> 02:07:37,280 WOULD OF WHO HAVE THEIR OWN 3344 02:07:37,280 --> 02:07:38,240 P.I.s, THAT'S WHERE THE 3345 02:07:38,240 --> 02:07:39,720 RESPONSIBILITY LIES. 3346 02:07:39,720 --> 02:07:40,840 THERE ARE GUIDANCE DOCUMENTS AND 3347 02:07:40,840 --> 02:07:43,120 TERMS AND CONDITIONS OF GRANT 3348 02:07:43,120 --> 02:07:46,840 AWARDS THAT PLACE ONTO THE 3349 02:07:46,840 --> 02:07:49,320 AWARDEES AND SUB-AWARDEES THE 3350 02:07:49,320 --> 02:07:51,640 REQUIREMENT THAT THEY BE -- THAT 3351 02:07:51,640 --> 02:07:52,960 THEY EXERCISE DILIGENCE IN 3352 02:07:52,960 --> 02:07:55,480 SELECTING VENDORS AND THEY MAKE 3353 02:07:55,480 --> 02:07:57,760 SURE THE VENDORS ARE SPENDING 3354 02:07:57,760 --> 02:07:58,960 MONEY APPROPRIATELY AND 3355 02:07:58,960 --> 02:08:00,200 PERFORMING SERVICES THEY 3356 02:08:00,200 --> 02:08:00,880 PROMISED TO SERVE UNDER THE 3357 02:08:00,880 --> 02:08:03,200 SCOPE OF WORK OF THE VENDOR 3358 02:08:03,200 --> 02:08:04,240 AGREEMENT. 3359 02:08:04,240 --> 02:08:06,200 BUT THE DIRECTLY ANSWERABLE 3360 02:08:06,200 --> 02:08:08,160 PARTIES ARE NOT THE VENDORS THAT 3361 02:08:08,160 --> 02:08:10,680 ARE PROVIDING SERVICES TO 3362 02:08:10,680 --> 02:08:11,440 IMPLEMENT THE TRIAL, EVEN WHEN 3363 02:08:11,440 --> 02:08:14,080 THEY ARE -- OF THE STUDY, EVEN 3364 02:08:14,080 --> 02:08:16,640 WHEN LAYING HANDS ON PATIENTS, 3365 02:08:16,640 --> 02:08:17,280 THE ENTITY RESPONSIBLE DIRECTLY 3366 02:08:17,280 --> 02:08:20,320 TO THE FEDERAL GOVERNMENT ARE 3367 02:08:20,320 --> 02:08:21,640 THE AWARDEES AND SUB-AWARDEES 3368 02:08:21,640 --> 02:08:23,840 EACH OF WHICH HAS A PRINCIPAL 3369 02:08:23,840 --> 02:08:26,560 INVESTIGATOR AND OTHER NAMED 3370 02:08:26,560 --> 02:08:28,080 CO-INVESTIGATORS, KEY PERSONNEL 3371 02:08:28,080 --> 02:08:30,840 WHO ARE ENGAGED, WHO ARE ENGAGED 3372 02:08:30,840 --> 02:08:33,520 FOR THESE PURPOSES, IN THE 3373 02:08:33,520 --> 02:08:37,160 CONTROL AND CONDUCT OF THE 3374 02:08:37,160 --> 02:08:38,040 STUDY. 3375 02:08:38,040 --> 02:08:39,800 THE FEDERAL FUNDING AGENCIES 3376 02:08:39,800 --> 02:08:41,320 DOES NOT SEEK BECAUSE THEY DON'T 3377 02:08:41,320 --> 02:08:46,040 THINK THEY NEED TO SEEK TO 3378 02:08:46,040 --> 02:08:48,000 FULFILL THEIR MANDATE THEY HAVE 3379 02:08:48,000 --> 02:08:49,080 PLENARY JURISDICTION, FOCUS ON 3380 02:08:49,080 --> 02:08:50,200 THOSE WHO APPLY FOR THE MONEY 3381 02:08:50,200 --> 02:08:52,280 AND CONTROL THE MONEY AND THE 3382 02:08:52,280 --> 02:08:54,920 IMPLEMENTATION OF THE RESEARCH 3383 02:08:54,920 --> 02:08:55,120 PLAN. 3384 02:08:55,120 --> 02:08:58,840 SO, IT WAS THESE KINDS OF 3385 02:08:58,840 --> 02:09:01,360 FRAMEWORKS THAT WE HAD IN MIND 3386 02:09:01,360 --> 02:09:06,080 WHEN WE WROTE THIS REFINEMENT OF 3387 02:09:06,080 --> 02:09:08,920 THE ENGAGED IN RESEARCH 3388 02:09:08,920 --> 02:09:10,560 SCENARIO, FOR THE PURPOSE OF 3389 02:09:10,560 --> 02:09:11,800 ENGAGED IN RESEARCH. 3390 02:09:11,800 --> 02:09:13,640 NOW, ANOTHER THING I WANT TO 3391 02:09:13,640 --> 02:09:17,240 POINT OUT TO YOU IS REALLY THIS. 3392 02:09:17,240 --> 02:09:20,200 AND THAT IS THAT WE HAVE THREE 3393 02:09:20,200 --> 02:09:20,800 DIFFERENT OPERATIVE GUIDANCE 3394 02:09:20,800 --> 02:09:24,480 DOCUMENTS RIGHT NOW FROM OHRP, 3395 02:09:24,480 --> 02:09:27,400 2008, 2009, 2011, ON 3396 02:09:27,400 --> 02:09:30,920 INTERPRETING THE ENGAGED IN 3397 02:09:30,920 --> 02:09:31,440 RESEARCH. 3398 02:09:31,440 --> 02:09:33,960 NONE OF THAT STUFF IS MANDATED 3399 02:09:33,960 --> 02:09:36,160 BY REGULATION. 3400 02:09:36,160 --> 02:09:38,120 NONE OF IT IS REQUIRED, NONE OF 3401 02:09:38,120 --> 02:09:42,080 THE CONTENT OF THOSE GUIDANCE 3402 02:09:42,080 --> 02:09:43,400 DOCUMENTS IS REQUIRED BY 3403 02:09:43,400 --> 02:09:43,800 REGULATION. 3404 02:09:43,800 --> 02:09:45,680 THERE'S ONLY ONE THANK THAT IS 3405 02:09:45,680 --> 02:09:46,840 ACTUALLY IN REGULATION, AND THAT 3406 02:09:46,840 --> 02:09:49,320 IS IN THE COMMON RULE ITSELF IT 3407 02:09:49,320 --> 02:09:51,480 SAYS EACH INSTITUTION ENGAGED IN 3408 02:09:51,480 --> 02:09:54,440 RESEARCH THAT IS COVERED BY THIS 3409 02:09:54,440 --> 02:09:56,760 POLICY EXCEPT RESEARCH ELIGIBLE 3410 02:09:56,760 --> 02:09:57,800 FOR EXEMPTION AND CONDUCTED OR 3411 02:09:57,800 --> 02:10:01,720 SUPPORTED BY FEDERAL DEPARTMENT 3412 02:10:01,720 --> 02:10:05,400 OR AGENCY, AND TOMORROW WE'LL 3413 02:10:05,400 --> 02:10:08,040 GET TO FEDERAL SUPPORT BECAUSE 3414 02:10:08,040 --> 02:10:09,680 WE HAVE RECOMMENDATIONS DAVID 3415 02:10:09,680 --> 02:10:12,080 FORSTER WILL GIVE YOU, PROVIDE 3416 02:10:12,080 --> 02:10:13,720 WRITTEN ASSURANCE THAT ALMOST 3417 02:10:13,720 --> 02:10:14,600 COMPLY WITH THE REQUIREMENTS 3418 02:10:14,600 --> 02:10:17,000 WHICH WOULD BE AN FWA. 3419 02:10:17,000 --> 02:10:19,560 IT'S THEN THAT'S THE -- THERE'S 3420 02:10:19,560 --> 02:10:20,840 NO OTHER REQUIREMENT IN THE 3421 02:10:20,840 --> 02:10:22,720 REGULATION FOR WHAT IS ENGAGED 3422 02:10:22,720 --> 02:10:26,240 IN RESEARCH, JUST THIS TERM 3423 02:10:26,240 --> 02:10:30,320 THAT'S ELABORATED BY OHRP IN 3424 02:10:30,320 --> 02:10:33,000 THESE ADDITIONAL GUIDANCE 3425 02:10:33,000 --> 02:10:36,360 DOCUMENTS. 3426 02:10:36,360 --> 02:10:39,240 IF YOU LOOK AT -- THAT'S ALL 3427 02:10:39,240 --> 02:10:46,360 THERE IS THAT'S REQUIRED, RIGHT? 3428 02:10:46,360 --> 02:10:46,840 EVERYTHING ELSE IS 3429 02:10:46,840 --> 02:10:47,200 INTERPRETATION. 3430 02:10:47,200 --> 02:10:51,240 IF YOU LOOK AT THE 2008 BASELINE 3431 02:10:51,240 --> 02:10:54,000 GUIDANCE OHRP OPINED THAT THIS 3432 02:10:54,000 --> 02:10:55,960 IS THE WAY ONE DECIDES WHO IS 3433 02:10:55,960 --> 02:10:58,600 ENGAGED IN RESEARCH, WHO IS NOT. 3434 02:10:58,600 --> 02:11:02,440 IN GENERAL WHEN DATA IS OBTAINED 3435 02:11:02,440 --> 02:11:04,920 ABOUT SUBJECTS THROUGH 3436 02:11:04,920 --> 02:11:06,360 INTERVENTION, WHO OBTAINED 3437 02:11:06,360 --> 02:11:07,560 IDENTIFIABLE INFORMATION ABOUT 3438 02:11:07,560 --> 02:11:10,080 SUBJECTS OR WHO OBTAIN INFORMED 3439 02:11:10,080 --> 02:11:12,600 CONSENT, SO THAT'S THE 3440 02:11:12,600 --> 02:11:15,000 PRIMARY -- THAT'S THE FIRST 3441 02:11:15,000 --> 02:11:16,040 LEVEL OF REFINEMENT OF 3442 02:11:16,040 --> 02:11:17,960 INTERPRETATION OF WHAT IS 3443 02:11:17,960 --> 02:11:19,640 ENGAGED IN RESEARCH. 3444 02:11:19,640 --> 02:11:22,280 SO YOU HAVE THAT. 3445 02:11:22,280 --> 02:11:27,240 THEN THERE'S A SECOND LAYER OF 3446 02:11:27,240 --> 02:11:29,080 INTERPRETATION WHICH IS THAT 3447 02:11:29,080 --> 02:11:31,960 THIS THING IN GENERAL, THESE 3448 02:11:31,960 --> 02:11:34,280 LINES RIGHT HERE, STARTING IN 3449 02:11:34,280 --> 02:11:35,120 GENERAL, ENDING WITH INFORMED 3450 02:11:35,120 --> 02:11:37,840 CONSENT OF THE HUMAN SUBJECTS 3451 02:11:37,840 --> 02:11:39,080 ARE THEN INTERPRETED IN THE 3452 02:11:39,080 --> 02:11:41,720 FOLLOWING WAY, IN THE SAME 3453 02:11:41,720 --> 02:11:42,080 DOCUMENT. 3454 02:11:42,080 --> 02:11:45,200 INSTITUTIONS WHOSE EMPLOYEES OR 3455 02:11:45,200 --> 02:11:47,080 AGENTS RECEIVE AN AWARD EVEN IF 3456 02:11:47,080 --> 02:11:49,560 ALL ACTIVITIES ARE CONDUCTED BY 3457 02:11:49,560 --> 02:11:50,680 ANOTHER INSTITUTION. 3458 02:11:50,680 --> 02:11:53,960 INSTITUTIONS THAT INTERVENE FOR 3459 02:11:53,960 --> 02:11:56,360 RESEARCH PURPOSES BY PERFORMING 3460 02:11:56,360 --> 02:11:56,920 INVASIVE PROCEDURES, 3461 02:11:56,920 --> 02:11:58,400 INSTITUTIONS THAT INTERVENE FOR 3462 02:11:58,400 --> 02:11:59,840 RESEARCH PURPOSES BY 3463 02:11:59,840 --> 02:12:01,720 MANIPULATING THE ENVIRONMENT. 3464 02:12:01,720 --> 02:12:03,040 INSTITUTIONS THAT OBTAIN 3465 02:12:03,040 --> 02:12:04,440 INFORMED CONSENT, INSTITUTIONS 3466 02:12:04,440 --> 02:12:05,440 THAT OBTAIN IDENTIFIABLE PRIVATE 3467 02:12:05,440 --> 02:12:08,400 INFORMATION FROM ANY SOURCE FOR 3468 02:12:08,400 --> 02:12:09,600 THE RESEARCH. 3469 02:12:09,600 --> 02:12:11,880 NOW, SO, THE REASON I'M GIVING 3470 02:12:11,880 --> 02:12:15,400 YOU THIS IS BECAUSE THIS IS PART 3471 02:12:15,400 --> 02:12:18,560 OF THE COMPLEXITY THAT WE AND BY 3472 02:12:18,560 --> 02:12:20,760 THE WAY THE KROGER LETTER IS 3473 02:12:20,760 --> 02:12:22,080 REACTING TO WHICH IS IT'S NOT 3474 02:12:22,080 --> 02:12:25,240 JUST A SIMPLE SET OF STANDARDS. 3475 02:12:25,240 --> 02:12:26,720 IT'S A SET OF STANDARDS, SECOND 3476 02:12:26,720 --> 02:12:31,720 SET OF STANDARDS, AND IN THE 3477 02:12:31,720 --> 02:12:33,440 2009 AND 2011 GUIDANCE THERE ARE 3478 02:12:33,440 --> 02:12:35,560 EXAMPLES, I WON'T GO THROUGH 3479 02:12:35,560 --> 02:12:37,080 THIS BECAUSE WE'VE GONE THROUGH 3480 02:12:37,080 --> 02:12:38,920 IN MARCH A LOT OF THIS ANALYSIS, 3481 02:12:38,920 --> 02:12:44,400 BUT MANY OF THOSE EXAMPLES OR 3482 02:12:44,400 --> 02:12:47,320 SOME EXAMPLES ONE COULD ARGUE 3483 02:12:47,320 --> 02:12:49,520 ARE NOT ENTIRELY CONSISTENT WITH 3484 02:12:49,520 --> 02:12:51,400 THE STANDARDS ARTICULATED IN THE 3485 02:12:51,400 --> 02:12:52,960 2008 GUIDANCE, EITHER THE FIRST 3486 02:12:52,960 --> 02:12:54,680 LEVEL GUIDANCE OR SECOND LEVEL 3487 02:12:54,680 --> 02:12:56,120 GUIDANCE, AND I'M CALLING THIS 3488 02:12:56,120 --> 02:12:57,520 THE FIRST LEVEL GUIDANCE AND 3489 02:12:57,520 --> 02:13:00,600 CALLING THIS SECOND LEVEL 3490 02:13:00,600 --> 02:13:01,200 GUIDANCE. 3491 02:13:01,200 --> 02:13:03,200 AND I CAN -- I GUESS WHAT I'LL 3492 02:13:03,200 --> 02:13:04,840 DO IS FOR A MOMENT I'LL JUST 3493 02:13:04,840 --> 02:13:06,720 WALK YOU THROUGH A COUPLE OF 3494 02:13:06,720 --> 02:13:07,240 THINGS HERE. 3495 02:13:07,240 --> 02:13:10,160 YOU SEE THIS IS THE FIRST LEVEL 3496 02:13:10,160 --> 02:13:12,280 OF GUIDANCE, IN GENERAL. 3497 02:13:12,280 --> 02:13:13,320 AND INSTITUTIONS WHOSE EMPLOYEES 3498 02:13:13,320 --> 02:13:17,640 OR AGENTS -- THIS IS THE SECOND 3499 02:13:17,640 --> 02:13:19,280 LEVEL -- RECEIVING AWARD EVEN IF 3500 02:13:19,280 --> 02:13:24,000 ALL ACTIVITIES ARE CONDUCTED BY 3501 02:13:24,000 --> 02:13:24,640 ANOTHER INSTITUTION, SO A 3502 02:13:24,640 --> 02:13:27,960 FLOW-THROUGH ENTITY THAT HAS NO 3503 02:13:27,960 --> 02:13:30,920 INVOLVEMENT IN RESEARCH IS THAT 3504 02:13:30,920 --> 02:13:31,960 ENTITY OBTAINING DATA ABOUT 3505 02:13:31,960 --> 02:13:32,640 SUBJECTS? 3506 02:13:32,640 --> 02:13:33,320 NO. 3507 02:13:33,320 --> 02:13:34,400 IS IT OBTAINING IDENTIFIABLE 3508 02:13:34,400 --> 02:13:35,280 PRIVATE INFORMATION? 3509 02:13:35,280 --> 02:13:35,800 NO. 3510 02:13:35,800 --> 02:13:37,480 IS IT OBTAINING INFORMED 3511 02:13:37,480 --> 02:13:38,240 CONSENT? 3512 02:13:38,240 --> 02:13:38,400 NO. 3513 02:13:38,400 --> 02:13:39,640 MY POINT HERE, I COULD GO 3514 02:13:39,640 --> 02:13:41,280 THROUGH ALL OF THESE THINGS, IS 3515 02:13:41,280 --> 02:13:44,040 THAT THE SECOND LEVEL GUIDANCE 3516 02:13:44,040 --> 02:13:45,320 IS NOT REALLY FULLY CONSISTENT 3517 02:13:45,320 --> 02:13:48,040 WITH THE FIRST LEVEL GUIDANCE. 3518 02:13:48,040 --> 02:13:53,520 I COULD GO THROUGH THE OTHER 3519 02:13:53,520 --> 02:13:56,840 EXAMPLES, THIS IS THE PROBLEM TO 3520 02:13:56,840 --> 02:13:59,760 WHICH WE'RE REACTING. 3521 02:13:59,760 --> 02:14:01,120 AS KROGER SAID, OTHERS IN THE 3522 02:14:01,120 --> 02:14:02,760 SUBCOMMITTEES HAVE SAID TO ONE 3523 02:14:02,760 --> 02:14:05,480 ANOTHER, AND ARE SAYING TO YOU 3524 02:14:05,480 --> 02:14:07,880 IN THE RECOMMENDATION, IS THAT 3525 02:14:07,880 --> 02:14:10,040 THE REGULATED COMMUNITY IS 3526 02:14:10,040 --> 02:14:13,680 CONFUSED BY THESE LEVELS OF 3527 02:14:13,680 --> 02:14:14,280 GUIDANCE. 3528 02:14:14,280 --> 02:14:16,000 THERE'S ONE PHRASE WHICH HAS 3529 02:14:16,000 --> 02:14:17,640 FIRST LEVEL GUIDANCE, AND SECOND 3530 02:14:17,640 --> 02:14:19,960 LEVEL GUIDANCE, AND THEN TWO 3531 02:14:19,960 --> 02:14:21,040 ADDITIONAL GUIDANCES THAT GIVE 3532 02:14:21,040 --> 02:14:23,800 EXAMPLES OF WHAT'S IN AND WHAT'S 3533 02:14:23,800 --> 02:14:24,080 OUT. 3534 02:14:24,080 --> 02:14:25,640 AND THOSE, UNLESS YOU WANT ME TO 3535 02:14:25,640 --> 02:14:28,040 I WON'T GO THROUGH ALL OF THAT 3536 02:14:28,040 --> 02:14:29,680 AT ALL BUT SUFFICE IT TO SAY 3537 02:14:29,680 --> 02:14:31,120 THAT IT'S NOT -- THIS IS NOT 3538 02:14:31,120 --> 02:14:32,720 JUST MY OPINION. 3539 02:14:32,720 --> 02:14:34,400 IT'S THE OPINION OF A BROAD 3540 02:14:34,400 --> 02:14:36,480 SWATH OF THE REGULATED 3541 02:14:36,480 --> 02:14:37,160 COMMUNITY. 3542 02:14:37,160 --> 02:14:40,640 AND SO THIS IS NOT -- WE GET 3543 02:14:40,640 --> 02:14:43,480 THEN TO THE RECOMMENDATION WHICH 3544 02:14:43,480 --> 02:14:46,880 IS AS I SAID BEFORE THAT WE 3545 02:14:46,880 --> 02:14:47,520 BASICALLY -- RECOMMENDATION IS 3546 02:14:47,520 --> 02:14:52,880 DITCH ALL THAT STUFF YOU'VE GOT 3547 02:14:52,880 --> 02:14:56,280 AND CONCENTRATE ENGAGED IN 3548 02:14:56,280 --> 02:14:57,920 RESEARCH, REQUIREMENT TO HAVE 3549 02:14:57,920 --> 02:14:59,360 FWA AND REQUIREMENT TO BE 3550 02:14:59,360 --> 02:15:01,960 RESPONSIBLE FOR THE CONDUCT OF 3551 02:15:01,960 --> 02:15:03,760 THE RESEARCH, PUT THAT ON THE 3552 02:15:03,760 --> 02:15:05,280 PLACE WHERE IT BELONGS AND SO 3553 02:15:05,280 --> 02:15:07,280 THAT YOU HAVE SMART REGULATION, 3554 02:15:07,280 --> 02:15:08,800 NOT JUST MORE REGULATION, AND 3555 02:15:08,800 --> 02:15:10,120 THE SMART REGULATION IS FOCUSED 3556 02:15:10,120 --> 02:15:14,040 ON THOSE WHO ARE MOST DEEPLY 3557 02:15:14,040 --> 02:15:15,000 INVOLVED IN PARTICIPATION, 3558 02:15:15,000 --> 02:15:16,720 CONTROL, AND THEREFORE WHOSE 3559 02:15:16,720 --> 02:15:18,640 INVOLVEMENT IS ACTUALLY IN 3560 02:15:18,640 --> 02:15:21,960 GENERAL THE MUCH HIGHER THAN THE 3561 02:15:21,960 --> 02:15:25,880 VENDORS AND BEST ABLE TO 3562 02:15:25,880 --> 02:15:27,280 PARTICIPATE AND PREVENT RISK BY 3563 02:15:27,280 --> 02:15:28,680 OTHERS PERFORMING SERVICES IN 3564 02:15:28,680 --> 02:15:32,160 THE CONTEXT OF THE RESEARCH. 3565 02:15:32,160 --> 02:15:38,120 SO, A COUPLE OTHER THINGS ABOUT 3566 02:15:38,120 --> 02:15:40,040 THIS, ABOUT THIS RECOMMENDATION. 3567 02:15:40,040 --> 02:15:42,720 ONE IS THAT THE -- AS WITH THE 3568 02:15:42,720 --> 02:15:49,640 CURRENT GUIDANCE, THIS WOULD BE 3569 02:15:49,640 --> 02:15:52,280 APPLIED BY INSTITUTIONS THAT ARE 3570 02:15:52,280 --> 02:15:53,240 CONSIDERING HAVING THEIR STAFF 3571 02:15:53,240 --> 02:15:55,240 OR AGENTS OR FACULTY DO 3572 02:15:55,240 --> 02:15:58,400 RESEARCH, IT WOULD BE CONSIDERED 3573 02:15:58,400 --> 02:15:59,960 BY IRBs WHEN IT ASKS WHETHER 3574 02:15:59,960 --> 02:16:01,160 THE ENTITIES THAT ARE APPLYING 3575 02:16:01,160 --> 02:16:03,680 FOR THE RESEARCH AND THAT ARE 3576 02:16:03,680 --> 02:16:06,720 INVOLVED IN THE RESEARCH HAVE 3577 02:16:06,720 --> 02:16:12,640 FWAs OR SHOULD AND CONSIDERED 3578 02:16:12,640 --> 02:16:13,560 BY INVESTIGATOR PLANNING WHO 3579 02:16:13,560 --> 02:16:16,280 WILL HELP THEM DO THE RESEARCH. 3580 02:16:16,280 --> 02:16:18,560 THE GUIDANCE THAT THE 3581 02:16:18,560 --> 02:16:22,400 RECOMMENDATION TO OHRP IS THAT 3582 02:16:22,400 --> 02:16:23,800 THE -- THAT REASONABLE 3583 02:16:23,800 --> 02:16:25,000 DETERMINATIONS BY AN INSTITUTION 3584 02:16:25,000 --> 02:16:26,760 AND AN IRB AND AN INVESTIGATOR 3585 02:16:26,760 --> 02:16:28,440 AS TO WHO IS ENGAGED IN RESEARCH 3586 02:16:28,440 --> 02:16:31,120 AND WHO IS NOT UNDER THIS 3587 02:16:31,120 --> 02:16:33,680 STANDARD WOULD BE GIVEN A 3588 02:16:33,680 --> 02:16:34,720 PRESUMPTION VALIDITY AS LONG AS 3589 02:16:34,720 --> 02:16:36,240 THEY ARE REASONABLE AND 3590 02:16:36,240 --> 02:16:40,120 RATIONALEE FOR THE DECISION 3591 02:16:40,120 --> 02:16:42,080 MAKING HAS DOCUMENTED. 3592 02:16:42,080 --> 02:16:46,120 WE THINK -- THIS WILL NOT BE A 3593 02:16:46,120 --> 02:16:47,280 PANACEA, IF ADOPTED. 3594 02:16:47,280 --> 02:16:52,160 THERE WOULD NEED TO BE GUIDANCE 3595 02:16:52,160 --> 02:16:53,800 EXAMPLES CULLED FROM, WE HOPE, 3596 02:16:53,800 --> 02:16:56,200 THIS IS WHAT THE RECOMMENDATION 3597 02:16:56,200 --> 02:16:58,720 IS, OHRP SOLICIT COMMENT FROM 3598 02:16:58,720 --> 02:17:01,000 REGULATED COMMUNITY AS TO WHAT 3599 02:17:01,000 --> 02:17:03,520 SCENARIOS NEED TO BE ADDRESSED 3600 02:17:03,520 --> 02:17:07,480 AND FAQs ARE IN A GUIDANCE 3601 02:17:07,480 --> 02:17:08,000 DOCUMENT. 3602 02:17:08,000 --> 02:17:10,960 AND SO IT'S NOT THE -- IF OHRP 3603 02:17:10,960 --> 02:17:13,160 WERE TOMORROW TO ADOPT -- IF YOU 3604 02:17:13,160 --> 02:17:16,000 WERE TO APPROVE AND RECOMMEND 3605 02:17:16,000 --> 02:17:17,320 IT, OHRP WERE TO ADOPT, THAT'S 3606 02:17:17,320 --> 02:17:18,640 NOT THE END OF THE STORY. 3607 02:17:18,640 --> 02:17:19,760 THERE'S A LOT MORE WORK THAT 3608 02:17:19,760 --> 02:17:21,360 NEEDS TO BE DONE. 3609 02:17:21,360 --> 02:17:23,680 LET ME TELL YOU, THERE WILL BE 3610 02:17:23,680 --> 02:17:25,520 DIFFICULTIES APPLYING THE NEW 3611 02:17:25,520 --> 02:17:25,800 DEFINITION. 3612 02:17:25,800 --> 02:17:29,720 THE POINT IS WE THINK THAT THERE 3613 02:17:29,720 --> 02:17:32,360 WILL BE FEWER DIFFICULTIES AND 3614 02:17:32,360 --> 02:17:33,320 MORE STRAIGHTFORWARD AND 3615 02:17:33,320 --> 02:17:34,960 RATIONAL APPROACH TO DETERMINING 3616 02:17:34,960 --> 02:17:37,480 WHO IS ENGAGED IN RESEARCH UNDER 3617 02:17:37,480 --> 02:17:38,560 RECOMMENDED APPROACH AS OPPOSED 3618 02:17:38,560 --> 02:17:40,440 TO THE CURRENT QUITE CONFUSING 3619 02:17:40,440 --> 02:17:40,960 APPROACH. 3620 02:17:40,960 --> 02:17:43,480 IT'S NOT THE END OF THE STORY. 3621 02:17:43,480 --> 02:17:44,920 I'M NOT SAYING -- DON'T SAY THAT 3622 02:17:44,920 --> 02:17:46,560 WE SAY THERE ARE NO PROBLEMS 3623 02:17:46,560 --> 02:17:47,280 WITH THIS APPROACH. 3624 02:17:47,280 --> 02:17:49,200 THERE ARE PROBLEMS WITH THIS 3625 02:17:49,200 --> 02:17:50,840 APPROACH IN TERMS OF APPLYING IT 3626 02:17:50,840 --> 02:17:52,320 IN LOTS OF INDIVIDUAL CASES BUT 3627 02:17:52,320 --> 02:17:56,840 WE THINK THAT IT IS EASIER UNDER 3628 02:17:56,840 --> 02:17:58,360 THIS APPROACH TO APPLY IT AND TO 3629 02:17:58,360 --> 02:18:00,600 APPLY IT IN A WAY THAT IS 3630 02:18:00,600 --> 02:18:02,320 CONSISTENT ACROSS EXAMPLES AND 3631 02:18:02,320 --> 02:18:04,520 SCENARIOS, AND WE THINK THIS 3632 02:18:04,520 --> 02:18:07,840 COULD BE DONE IN A CONSTRUCTIVE 3633 02:18:07,840 --> 02:18:12,960 WAY THROUGH ENGAGEMENT WITH THE 3634 02:18:12,960 --> 02:18:15,160 REGULATED COMMUNITY. 3635 02:18:15,160 --> 02:18:17,240 SO, IN ANY CASE, I THINK THAT 3636 02:18:17,240 --> 02:18:19,640 THAT IS AS MUCH AS I WANTED 3637 02:18:19,640 --> 02:18:22,280 TO -- OH, ONE OTHER THING. 3638 02:18:22,280 --> 02:18:26,120 ONE OTHER POINT THAT IS WORTH 3639 02:18:26,120 --> 02:18:28,520 TALKING ABOUT IN THIS INITIAL 3640 02:18:28,520 --> 02:18:28,960 PRESENTATION. 3641 02:18:28,960 --> 02:18:30,800 AND THAT IS THAT THE -- THERE 3642 02:18:30,800 --> 02:18:32,560 WAS A LOT OF DISCUSSION AS TO 3643 02:18:32,560 --> 02:18:35,760 WHETHER THE SIMPLE ACT OF 3644 02:18:35,760 --> 02:18:37,040 OBTAINING INFORMED CONSENT IF AN 3645 02:18:37,040 --> 02:18:39,200 ENTITY IS NOT OTHERWISE INVOLVED 3646 02:18:39,200 --> 02:18:41,520 IN THE RESEARCH SHOULD MAKE THAT 3647 02:18:41,520 --> 02:18:43,240 ENTITY ENGAGED IN THE RESEARCH 3648 02:18:43,240 --> 02:18:44,600 UNDER EXISTING GUIDANCE IT IS. 3649 02:18:44,600 --> 02:18:48,320 THERE ARE A NUMBER OF PEOPLE AT 3650 02:18:48,320 --> 02:18:49,640 THE SUBCOMMITTEES AND I THINK 3651 02:18:49,640 --> 02:18:51,480 PROBABLY AT KROGER WHO THINK 3652 02:18:51,480 --> 02:18:54,080 THAT IF ONE'S ONLY INVOLVEMENT 3653 02:18:54,080 --> 02:18:55,120 IS OBTAINING INFORMED CONSENT 3654 02:18:55,120 --> 02:18:58,320 THAT THAT SHOULD NOT MAKE ONE 3655 02:18:58,320 --> 02:19:01,320 THE ENTITY BE ENGAGED IN 3656 02:19:01,320 --> 02:19:02,960 RESEARCH BUT WE REACHED A 3657 02:19:02,960 --> 02:19:05,080 DIFFERENT CONCLUSION IN THE 3658 02:19:05,080 --> 02:19:05,600 RECOMMENDATION. 3659 02:19:05,600 --> 02:19:14,360 WE THINK OBTAINING INFORMED 3660 02:19:14,360 --> 02:19:15,800 CONSENT SHOULD BE ENGAGED IN 3661 02:19:15,800 --> 02:19:17,320 RESEARCH BUT POSSIBLE IN LIMITED 3662 02:19:17,320 --> 02:19:19,640 CIRCUMSTANCES FOR AN IRB OR 3663 02:19:19,640 --> 02:19:21,840 INSTITUTION TO DETERMINE THE 3664 02:19:21,840 --> 02:19:24,080 ENTITY THAT IS ONLY OBTAINING 3665 02:19:24,080 --> 02:19:25,760 INFORMED CONSENT COULD BE 3666 02:19:25,760 --> 02:19:32,200 REGARDED AS NOT ENGAGED IN 3667 02:19:32,200 --> 02:19:34,080 RESEARCH IN OBTAINING LOW RISK 3668 02:19:34,080 --> 02:19:35,720 STUDIES AND OBTAINING CONSENT 3669 02:19:35,720 --> 02:19:41,760 PARTICIPANTS ARE OFFERED 3670 02:19:41,760 --> 02:19:45,200 OPPORTUNITIES TO ENGAGE IN 3671 02:19:45,200 --> 02:19:47,240 DISCUSSION WAS PRIMARY RESEARCH 3672 02:19:47,240 --> 02:19:48,960 TEAM FACILITATED BY ENTITY 3673 02:19:48,960 --> 02:19:50,240 SEEKING TO OBTAIN CONSENT. 3674 02:19:50,240 --> 02:19:54,880 WE'RE TALKING ABOUT LOW RISK, 3675 02:19:54,880 --> 02:19:55,520 NON-INTERVENTIONAL STUDIES, THE 3676 02:19:55,520 --> 02:19:57,640 PRIMARY DRIVER OF THIS IS THE 3677 02:19:57,640 --> 02:20:00,720 SCENARIO WHICH IS GIVEN TO YOU 3678 02:20:00,720 --> 02:20:03,880 IN THE MATERIALS OF A CANCER 3679 02:20:03,880 --> 02:20:07,160 HOSPITAL IN MADRID THAT IS 3680 02:20:07,160 --> 02:20:08,440 CONSENTING FOLKS, OBTAINING 3681 02:20:08,440 --> 02:20:11,520 CONSENT FROM FOLKS TO ENROLL IN 3682 02:20:11,520 --> 02:20:13,920 A NATURAL HISTORY STUDY THAT IS 3683 02:20:13,920 --> 02:20:16,440 FUNDED BY THE NIH WHICH IS 3684 02:20:16,440 --> 02:20:18,360 SOLELY STANDARD OF CARE, THE 3685 02:20:18,360 --> 02:20:19,600 ONLY PARTICIPATION OF THE 3686 02:20:19,600 --> 02:20:22,240 INDIVIDUAL WOULD BE THAT THEIR 3687 02:20:22,240 --> 02:20:25,760 DATA LONGITUDINALLY WHEN GIVEN 3688 02:20:25,760 --> 02:20:29,360 STANDARD OF CARE IN MADRID WOULD 3689 02:20:29,360 --> 02:20:35,520 BE COLLECTED AND SENT UNDER 3690 02:20:35,520 --> 02:20:36,720 AAPPROPRIATE CONDITIONS IN THE 3691 02:20:36,720 --> 02:20:38,560 U.S., THE HOSPITAL IN MADRID 3692 02:20:38,560 --> 02:20:40,440 SHOULD NOT BE SUBJECT -- 3693 02:20:40,440 --> 02:20:41,760 REGARDED AS ENGAGED IN RESEARCH 3694 02:20:41,760 --> 02:20:45,240 WHEN ALL IT'S DOING IS 3695 02:20:45,240 --> 02:20:45,840 SOLICITING CONSENT, OBTAINING 3696 02:20:45,840 --> 02:20:49,400 CONSENT, IN THE LOW RISK STUDY 3697 02:20:49,400 --> 02:20:52,440 PRIMARY RISK IS DATA COULD BE 3698 02:20:52,440 --> 02:20:55,440 COMPROMISED AND SO ANYWAY THAT 3699 02:20:55,440 --> 02:20:57,400 IS THE PRESUMPTION ACCORDING TO 3700 02:20:57,400 --> 02:20:59,040 THIS RECOMMENDED RECOMMENDATION 3701 02:20:59,040 --> 02:21:01,920 TO YOU IS THAT OBTAINING 3702 02:21:01,920 --> 02:21:03,680 INFORMED CONSENT WOULD MAKE AN 3703 02:21:03,680 --> 02:21:05,200 ENTITY ENGAGED IN RESEARCH 3704 02:21:05,200 --> 02:21:07,160 EXCEPT IN A NARROW CIRCUMSTANCE, 3705 02:21:07,160 --> 02:21:09,480 THAT WOULD BE ALLOWABLE BUT NOT 3706 02:21:09,480 --> 02:21:11,480 REQUIRED THAT AN IRB OR 3707 02:21:11,480 --> 02:21:12,480 INSTITUTION WOULD REACH THE 3708 02:21:12,480 --> 02:21:14,440 DETERMINATION THAT ENTITY IN 3709 02:21:14,440 --> 02:21:15,560 MADRID IS NOT ENGAGED IN THE 3710 02:21:15,560 --> 02:21:18,960 RESEARCH SO IT WOULD BE A WAY 3711 02:21:18,960 --> 02:21:20,920 OUT BUT NOT DISPOSITIVE. 3712 02:21:20,920 --> 02:21:21,120 OKAY? 3713 02:21:21,120 --> 02:21:22,800 I'M GOING TO STOP THERE. 3714 02:21:22,800 --> 02:21:25,160 THAT IS THE -- I COULD GO ON FOR 3715 02:21:25,160 --> 02:21:26,600 A LONG TIME. 3716 02:21:26,600 --> 02:21:28,400 THERE'S A DOCUMENT THAT HAS BEEN 3717 02:21:28,400 --> 02:21:29,800 THROUGH A LOT OF REVIEW BUT I 3718 02:21:29,800 --> 02:21:32,440 HOPE YOU'VE HAD A CHANCE TO READ 3719 02:21:32,440 --> 02:21:38,680 BUT I'LL STOP THERE. 3720 02:21:38,680 --> 02:21:39,920 >> QUESTION. 3721 02:21:39,920 --> 02:21:40,480 >> YES? 3722 02:21:40,480 --> 02:21:43,760 >> I JUST HAVE A QUESTION. 3723 02:21:43,760 --> 02:21:44,720 I LIKE THE DIRECTION YOU'RE 3724 02:21:44,720 --> 02:21:46,720 GOING AND I LIKE THE DEFINITION. 3725 02:21:46,720 --> 02:21:48,000 OBVIOUSLY AS YOU POINT OUT 3726 02:21:48,000 --> 02:21:51,000 THERE'S A LOT OF INTERPRETIVE 3727 02:21:51,000 --> 02:21:52,280 ISSUES, KEY ROLE, ET CETERA, 3728 02:21:52,280 --> 02:21:53,680 THAT'S STILL GOING TO REMAIN BUT 3729 02:21:53,680 --> 02:21:56,880 I'M CURIOUS ABOUT WHAT THE 3730 02:21:56,880 --> 02:21:58,080 PROCESS IS. 3731 02:21:58,080 --> 02:21:59,800 LET'S IMAGINE THE COMMITTEE SAYS 3732 02:21:59,800 --> 02:22:03,240 THIS LOOKS LIKE A GOOD 3733 02:22:03,240 --> 02:22:03,560 DIRECTION. 3734 02:22:03,560 --> 02:22:05,240 WHAT THEN? 3735 02:22:05,240 --> 02:22:07,160 ARE WE GOING TO, AS THE 3736 02:22:07,160 --> 02:22:08,600 SUBCOMMITTEE, THEN COME BACK 3737 02:22:08,600 --> 02:22:12,280 WITH FLESHING THIS OUT, WITH 3738 02:22:12,280 --> 02:22:12,560 EXAMPLES? 3739 02:22:12,560 --> 02:22:13,720 WOULD IT DISAPPEAR BEHIND THE 3740 02:22:13,720 --> 02:22:15,360 CLOSED DOORS OF OHRP WHO THEN 3741 02:22:15,360 --> 02:22:17,120 COME OUT WITH DRAFT GUIDANCE ON 3742 02:22:17,120 --> 02:22:18,000 THEIR OWN? 3743 02:22:18,000 --> 02:22:20,520 WHAT DO YOU IMAGINE THAT PROCESS 3744 02:22:20,520 --> 02:22:22,480 TO LOOK IKE OR IF WE ENDORSE 3745 02:22:22,480 --> 02:22:24,080 THAT WOULD IT REQUIRE OHRP TO 3746 02:22:24,080 --> 02:22:26,320 SAY BACK TO THE SUBCOMMITTEE, 3747 02:22:26,320 --> 02:22:27,640 DEVELOP EXAMPLES TO FLESH OUT 3748 02:22:27,640 --> 02:22:30,480 WHAT THIS REALLY LOOKS LIKE? 3749 02:22:30,480 --> 02:22:32,040 SO IN YOUR IDEAL WORLD WHAT 3750 02:22:32,040 --> 02:22:33,800 WOULD YOU IMAGINE THAT TO LOOK 3751 02:22:33,800 --> 02:22:34,640 LIKE? 3752 02:22:34,640 --> 02:22:36,840 >> I THINK IN AN IDEAL WORLD, 3753 02:22:36,840 --> 02:22:39,240 THE WAY IT WOULD WORK IS THAT WE 3754 02:22:39,240 --> 02:22:41,280 AS AN ADVISORY -- AS AN ADVISORY 3755 02:22:41,280 --> 02:22:44,640 COMMITTEE TO YOU, YOU AS 3756 02:22:44,640 --> 02:22:45,640 ADVISORY SUBCOMMITTEE OR 3757 02:22:45,640 --> 02:22:47,480 COMMITTEE TO OHRP WE ESSENTIALLY 3758 02:22:47,480 --> 02:22:55,480 DON'T SET OUR OWN AGENDAS, WE 3759 02:22:55,480 --> 02:22:57,000 RESPOND TO QUESTIONS THEY RAISE. 3760 02:22:57,000 --> 02:22:59,120 OHRP WOULD LOOK AT IT AND THEY 3761 02:22:59,120 --> 02:23:00,400 WOULD PRESUMABLY SAY WE LIKE 3762 02:23:00,400 --> 02:23:02,200 THIS, WE DON'T LIKE THIS, IF WE 3763 02:23:02,200 --> 02:23:05,080 THINK THIS IS A POTENTIALLY 3764 02:23:05,080 --> 02:23:06,880 POSITIVE DIRECTION, WE HAVE 3765 02:23:06,880 --> 02:23:08,520 ADDITIONAL QUESTIONS FOR THE 3766 02:23:08,520 --> 02:23:09,840 COMMITTEE AND THE SUBCOMMITTEES 3767 02:23:09,840 --> 02:23:11,040 AS TO HOW THIS WOULD BE 3768 02:23:11,040 --> 02:23:12,000 INTERPRETED IN THE FOLLOWING 3769 02:23:12,000 --> 02:23:13,680 WAYS SO PLEASE GIVE US 3770 02:23:13,680 --> 02:23:14,960 ADDITIONAL GUIDANCE ON HOW YOU 3771 02:23:14,960 --> 02:23:17,480 THINK THIS WOULD APPLY IN THESE 3772 02:23:17,480 --> 02:23:17,760 SCENARIOS. 3773 02:23:17,760 --> 02:23:20,720 IF THEY THINK IT'S TRASH THEY 3774 02:23:20,720 --> 02:23:23,520 WOULDN'T ASK US THAT. 3775 02:23:23,520 --> 02:23:24,600 AND THAT'S OKAY. 3776 02:23:24,600 --> 02:23:26,520 BUT IT WOULD BE UP TO THEM TO 3777 02:23:26,520 --> 02:23:28,320 SEE WHETHER THEY THINK THIS IS A 3778 02:23:28,320 --> 02:23:30,920 FRUITFUL AVENUE OR NOT. 3779 02:23:30,920 --> 02:23:32,560 IF THEY WANTED OUR OPINION ABOUT 3780 02:23:32,560 --> 02:23:37,040 WAYS IN WHICH WE COULD MORE 3781 02:23:37,040 --> 02:23:37,800 PARTICULARIZE THE APPLICATION 3782 02:23:37,800 --> 02:23:39,280 AND WE WOULD DO OUR WORK AND 3783 02:23:39,280 --> 02:23:40,560 WOULD COME BACK TO YOU, YOU 3784 02:23:40,560 --> 02:23:42,440 WOULD LOOK AT THE EXAMPLES AND 3785 02:23:42,440 --> 02:23:47,560 YOU WOULD GO FROM THERE. 3786 02:23:47,560 --> 02:23:48,000 >> LOIS? 3787 02:23:48,000 --> 02:23:50,720 >> HI, I REALIZE YOU JUST 3788 02:23:50,720 --> 02:23:53,320 REFERRED TO CASE EXAMPLE 3 AND 3789 02:23:53,320 --> 02:23:54,240 EXHIBIT A. 3790 02:23:54,240 --> 02:24:01,360 I DON'T KNOW IF I'VE SEEN THAT 3791 02:24:01,360 --> 02:24:11,680 EXHIBIT A SLIDES. 3792 02:24:24,560 --> 02:24:26,520 >> GO OUT ON A LIMB, MAKE A 3793 02:24:26,520 --> 02:24:30,720 MOTION WE ENDORSE THIS LET'S 3794 02:24:30,720 --> 02:24:34,560 CALL IT DIRECTION AND MY HOPE 3795 02:24:34,560 --> 02:24:36,360 OHRP WOULD SEE THIS AS A 3796 02:24:36,360 --> 02:24:39,000 PRODUCTIVE STEP AND THEN WOULD 3797 02:24:39,000 --> 02:24:41,720 ASK FOR THE SUBCOMMITTEE TO THEN 3798 02:24:41,720 --> 02:24:43,920 DO FURTHER WORK AND PRECISELY 3799 02:24:43,920 --> 02:24:46,000 APPLYING THIS DEFINITION IN SOME 3800 02:24:46,000 --> 02:24:49,320 PROBLEMATIC CASES, TO SAY HOW IT 3801 02:24:49,320 --> 02:24:51,040 WOULD WORK BECAUSE, YOU KNOW, 3802 02:24:51,040 --> 02:24:51,960 KEY ROLE IN CONDUCTING, ONE 3803 02:24:51,960 --> 02:24:56,480 COULD INTERPRET THAT TO MEAN IT 3804 02:24:56,480 --> 02:24:58,680 WOULD INCLUDE LET'S SAY A CRO 3805 02:24:58,680 --> 02:25:00,200 VENDOR OR NOT, STILL BE SOME 3806 02:25:00,200 --> 02:25:00,680 WORK. 3807 02:25:00,680 --> 02:25:03,840 I GUESS I WOULD MOVE THAT WE 3808 02:25:03,840 --> 02:25:04,440 ACCEPT THIS DOCUMENT, 3809 02:25:04,440 --> 02:25:06,440 UNDERSTANDING THE NATURE OF THE 3810 02:25:06,440 --> 02:25:09,080 DOCUMENT AND THAT IT'S REALLY A 3811 02:25:09,080 --> 02:25:10,600 WORK IN PROGRESS AND FORWARD IT 3812 02:25:10,600 --> 02:25:11,840 TO OHRP WITH A RECOMMENDATION 3813 02:25:11,840 --> 02:25:14,000 THAT FURTHER WORK BE DONE IN 3814 02:25:14,000 --> 02:25:17,000 THIS DIRECTION, I GUESS THAT 3815 02:25:17,000 --> 02:25:18,480 WOULD BE MY MOTION. 3816 02:25:18,480 --> 02:25:19,800 >> GO AHEAD. 3817 02:25:19,800 --> 02:25:20,680 >> WE HAVE A MOTION. 3818 02:25:20,680 --> 02:25:21,880 DO WE HAVE A SECOND? 3819 02:25:21,880 --> 02:25:23,400 >> I WAS GOING TO SECOND WITH 3820 02:25:23,400 --> 02:25:24,160 THE UNDERSTANDING THAT WE'RE 3821 02:25:24,160 --> 02:25:26,040 GOING TO BE ABLE TO FURTHER 3822 02:25:26,040 --> 02:25:28,360 REFINE AND GET INTO THE DETAILS. 3823 02:25:28,360 --> 02:25:28,640 >> OKAY. 3824 02:25:28,640 --> 02:25:29,080 >> OF THE DOCUMENT. 3825 02:25:29,080 --> 02:25:33,280 AS LONG AS THAT'S THE CASE, I 3826 02:25:33,280 --> 02:25:34,920 WOULD SECOND. 3827 02:25:34,920 --> 02:25:35,720 >> OKAY. 3828 02:25:35,720 --> 02:25:36,960 ANY FURTHER DISCUSSION, 3829 02:25:36,960 --> 02:25:38,000 COMMENTS, CONCERNS? 3830 02:25:38,000 --> 02:25:39,280 YES, GO AHEAD, LOIS. 3831 02:25:39,280 --> 02:25:43,760 >> I WOULD JUST LIKE TO KNOW, 3832 02:25:43,760 --> 02:25:46,080 I'M ABOUT READY TO GO WITH IT 3833 02:25:46,080 --> 02:25:46,760 TOO. 3834 02:25:46,760 --> 02:25:56,680 THERE WERE A COUPLE TYPOS BUT 3835 02:25:56,680 --> 02:26:00,720 WAS THERE A REASON TO USE THE 3836 02:26:00,720 --> 02:26:04,680 TERM LOW RISK INSTEAD OF MINIMAL 3837 02:26:04,680 --> 02:26:05,320 RISK? 3838 02:26:05,320 --> 02:26:09,280 >> WE COULD USE LOW RISK INSTEAD 3839 02:26:09,280 --> 02:26:10,560 OF MINIMAL. 3840 02:26:10,560 --> 02:26:12,560 >> WE HAVE AN IDEA, AN 3841 02:26:12,560 --> 02:26:14,120 UNDERSTANDING OF MINIMAL RISK, 3842 02:26:14,120 --> 02:26:16,960 AND NO RISK, I WONDERED IF THAT 3843 02:26:16,960 --> 02:26:17,960 WAS DELIBERATE OR -- 3844 02:26:17,960 --> 02:26:19,400 >> IT WASN'T. 3845 02:26:19,400 --> 02:26:20,400 THE ONLY DELIBERATENESS OF THE 3846 02:26:20,400 --> 02:26:22,680 USE OF THAT TERM WAS JUST THAT I 3847 02:26:22,680 --> 02:26:25,960 WAS TRYING TO CONCEPTUALIZE NOT 3848 02:26:25,960 --> 02:26:27,480 IN EXISTING REGULATORY FRAMEWORK 3849 02:26:27,480 --> 02:26:29,160 BUT IN A MORE GENERAL WAY. 3850 02:26:29,160 --> 02:26:31,000 >> IT'S GOING TO EVENTUALLY BE 3851 02:26:31,000 --> 02:26:32,200 IN -- RIGHT. 3852 02:26:32,200 --> 02:26:33,520 >> IT WILL. 3853 02:26:33,520 --> 02:26:35,480 AND I THINK THAT PARTICULAR 3854 02:26:35,480 --> 02:26:39,880 POINT COULD BE PROPERTY -- 3855 02:26:39,880 --> 02:26:41,960 BROUGHT UP HOW DOES LOW RISK 3856 02:26:41,960 --> 02:26:44,240 CORRELATE TO MINIMAL RISK. 3857 02:26:44,240 --> 02:26:44,440 SKIP? 3858 02:26:44,440 --> 02:26:47,080 >> JUST BEING AWARE OF THE 3859 02:26:47,080 --> 02:26:50,360 DISCUSSION, MINIMAL RISK IN 3860 02:26:50,360 --> 02:26:52,520 PEDIATRIC CONTEXT, I'M NOT SURE 3861 02:26:52,520 --> 02:27:02,880 IT SOLVES THE PROBLEM. 3862 02:27:03,440 --> 02:27:06,160 ICH e-6, IT'S NOT DEFINED 3863 02:27:06,160 --> 02:27:07,040 ACROSS MANY STAKEHOLDERS, WE 3864 02:27:07,040 --> 02:27:09,080 WOULD GET INTO THAT BUT IT'S NOT 3865 02:27:09,080 --> 02:27:11,280 STRAIGHTFORWARD TO USE LOW RISK 3866 02:27:11,280 --> 02:27:15,520 I THINK. 3867 02:27:15,520 --> 02:27:18,200 >> GO AHEAD, KEVIN. 3868 02:27:18,200 --> 02:27:24,520 >> ONE SPECIFIC THING, FIRST OF 3869 02:27:24,520 --> 02:27:28,000 ALL, IT WAS SUCH A WELL DRAFT, 3870 02:27:28,000 --> 02:27:28,680 OUTSTANDING, THANKS TO ALL THE 3871 02:27:28,680 --> 02:27:31,960 BACK AND FORTH IT TOOK TO GET 3872 02:27:31,960 --> 02:27:32,400 HERE. 3873 02:27:32,400 --> 02:27:37,200 RIGHT UNDER THE FIRST MENTION OF 3874 02:27:37,200 --> 02:27:38,880 THE STANDARD, WHICH I DON'T SEE 3875 02:27:38,880 --> 02:27:40,680 THE PAGE NUMBERS HERE. 3876 02:27:40,680 --> 02:27:42,000 >> FIRST PAGE, YEAH, IT WOULD BE 3877 02:27:42,000 --> 02:27:46,480 THE FIRST PAGE. 3878 02:27:46,480 --> 02:27:49,000 >> YEAH, THERE'S ABOUT A 3879 02:27:49,000 --> 02:27:51,320 SIX-LINE SENTENCE THAT BEGINS IN 3880 02:27:51,320 --> 02:27:53,160 SACHRP'S VIEW, THAT I DON'T 3881 02:27:53,160 --> 02:27:54,040 UNDERSTAND THAT SENTENCE. 3882 02:27:54,040 --> 02:27:56,120 IT SEEMS LIKE THERE'S A 3883 02:27:56,120 --> 02:27:58,560 PREDICATE CLAUSE MISSING FROM 3884 02:27:58,560 --> 02:28:01,040 THE FIRST THREE LINES SOMEWHERE. 3885 02:28:01,040 --> 02:28:05,880 WE HAVE TO FIX IT NOW THAT -- 3886 02:28:05,880 --> 02:28:08,760 STANDARD WOULD PLACE THE BURDEN 3887 02:28:08,760 --> 02:28:11,440 OF ENSURING RESEARCH SUPPORTED 3888 02:28:11,440 --> 02:28:12,920 BY FEDERAL FUNDING SOMETHING 3889 02:28:12,920 --> 02:28:15,880 RESTS ON THE ENTITIES AND 3890 02:28:15,880 --> 02:28:16,480 PERSONS. 3891 02:28:16,480 --> 02:28:21,320 I MAY HAVE MISREAD IT. 3892 02:28:21,320 --> 02:28:25,120 3893 02:28:25,120 --> 02:28:26,120 YEAH, PAGE 3. 3894 02:28:26,120 --> 02:28:28,640 >> IT'S THE LAST PARAGRAPH OF 3895 02:28:28,640 --> 02:28:31,480 THE -- WHAT'S REALLY THE 3896 02:28:31,480 --> 02:28:32,280 INTRODUCTORY SECTION. 3897 02:28:32,280 --> 02:28:33,480 >> AGAIN, WE DON'T NEED TO TAKE 3898 02:28:33,480 --> 02:28:35,120 UP DISCUSSION TIME BUT JUST LOOK 3899 02:28:35,120 --> 02:28:37,840 AT IT AGAIN. 3900 02:28:37,840 --> 02:28:40,840 IT SEEMS LIKE THERE'S SOMETHING 3901 02:28:40,840 --> 02:28:43,240 MISSING OR I NEED TO BE MORE 3902 02:28:43,240 --> 02:28:43,520 CAFFEINATED. 3903 02:28:43,520 --> 02:28:45,440 >> I CAN DIVIDE THAT INTO TWO 3904 02:28:45,440 --> 02:28:46,720 SENTENCES THAT WILL MAKE IT 3905 02:28:46,720 --> 02:28:46,960 CLEARER. 3906 02:28:46,960 --> 02:28:53,080 WHY DON'T I DO THAT? 3907 02:28:53,080 --> 02:28:55,760 >> AND THE OTHER, -- 3908 02:28:55,760 --> 02:28:59,080 >> I'M NOT UNDERSTANDING ON THE 3909 02:28:59,080 --> 02:29:09,520 SCREEN WHY IT WAS RISKY. 3910 02:29:11,200 --> 02:29:20,320 >> YOU GUYS ARE NOT SEEING IT. 3911 02:29:20,320 --> 02:29:24,560 >> FEDERAL GOVERNMENT SHUTDOWN 3912 02:29:24,560 --> 02:29:25,480 WE DIDN'T KNOW ABOUT? 3913 02:29:25,480 --> 02:29:27,720 >> SHOULD I CONTINUE TO TALK OR 3914 02:29:27,720 --> 02:29:28,920 WAIT? 3915 02:29:28,920 --> 02:29:29,040 3916 02:29:29,040 --> 02:29:34,240 >> YOU'RE GOOD. 3917 02:29:34,240 --> 02:29:34,480 >> OH. 3918 02:29:34,480 --> 02:29:38,920 YOU KNOW, A LOT OF US DO 3919 02:29:38,920 --> 02:29:40,440 RESEARCH INCREASINGLY HAS 3920 02:29:40,440 --> 02:29:41,640 PATIENTS, PATIENT COMMUNITY, 3921 02:29:41,640 --> 02:29:43,160 COMMUNITY MEMBERS, INVOLVED IN 3922 02:29:43,160 --> 02:29:48,560 DIFFERENT WAYS, CONDUCT OF THE 3923 02:29:48,560 --> 02:29:49,080 RESEARCH. 3924 02:29:49,080 --> 02:29:52,600 AND IT'S IMPORTANT TO THEM TO BE 3925 02:29:52,600 --> 02:29:53,840 RECOGNIZED FOR THAT. 3926 02:29:53,840 --> 02:29:59,080 AND SO WHATEVER GUYEDANCE WERE 3927 02:29:59,080 --> 02:30:08,920 TO COME OUT IT MAY BE USEFUL 3928 02:30:08,920 --> 02:30:11,800 USEFUL TO HAVE OTHER 3929 02:30:11,800 --> 02:30:13,120 TERMINOLOGY, IT'S A TECHNICAL 3930 02:30:13,120 --> 02:30:14,800 MATTER ENGAGED IN THE RESEARCH, 3931 02:30:14,800 --> 02:30:16,840 JUST FOR COMMUNICATING I'M 3932 02:30:16,840 --> 02:30:19,680 CALLING THAT OUT THAT THOSE 3933 02:30:19,680 --> 02:30:23,520 LANGUAGE THINGS ARE IMPORTANT TO 3934 02:30:23,520 --> 02:30:25,680 PEOPLE AND THERE MAY BE AN 3935 02:30:25,680 --> 02:30:26,880 INADVERTENT MESSAGE THAT GOES 3936 02:30:26,880 --> 02:30:28,200 OUT, SO HEADING THAT OFF AT THE 3937 02:30:28,200 --> 02:30:32,040 PASS MIGHT BE A USEFUL THING TO 3938 02:30:32,040 --> 02:30:32,280 CONSIDER. 3939 02:30:32,280 --> 02:30:39,240 THOSE ARE THE COMMENTS I HAD.. 3940 02:30:39,240 --> 02:30:41,240 >> LINDA AND WALTER? 3941 02:30:41,240 --> 02:30:43,760 >> HIS HAND WAS UP FIRST. 3942 02:30:43,760 --> 02:30:45,520 >> THANK YOU. 3943 02:30:45,520 --> 02:30:46,480 APPRECIATED THE CONTEXT, YOU 3944 02:30:46,480 --> 02:30:50,760 MADE IT CLEAR A CLEAR CASE FOR 3945 02:30:50,760 --> 02:30:53,840 THE NEED FOR A CLEAR DEFINITION 3946 02:30:53,840 --> 02:30:58,280 OF ENGAGING IN RESEARCH GIVEN 3947 02:30:58,280 --> 02:30:59,160 CONFLICTING GUIDANCES BETWEEN 3948 02:30:59,160 --> 02:31:00,240 2008 AND 2011. 3949 02:31:00,240 --> 02:31:02,680 THE ONLY AREA THAT I STUMBLED 3950 02:31:02,680 --> 02:31:04,880 OVER WAS INFORMED CONSENT ISSUE. 3951 02:31:04,880 --> 02:31:09,280 BUT I THINK YOU PROVIDED A GOOD 3952 02:31:09,280 --> 02:31:13,680 EXPLANATION FOR WHY THAT SHOULD 3953 02:31:13,680 --> 02:31:14,360 BE CAPTURED. 3954 02:31:14,360 --> 02:31:16,120 I'M SUPPORTIVE AND I THOUGHT 3955 02:31:16,120 --> 02:31:22,000 THAT SKIP DID A GOOD JOB WITH 3956 02:31:22,000 --> 02:31:23,960 RESPECT TO THE MOTION, FRAMING 3957 02:31:23,960 --> 02:31:27,600 IT IN A WAY THAT'S DIRECTIONAL 3958 02:31:27,600 --> 02:31:28,920 GUIDANCE TO THE SUBCOMMITTEE, 3959 02:31:28,920 --> 02:31:32,680 I'M FULLY SUPPORTIVE. 3960 02:31:32,680 --> 02:31:34,680 >> GO AHEAD, LINDA. 3961 02:31:34,680 --> 02:31:36,520 >> COMMENTS IN CONVERSATION, I'M 3962 02:31:36,520 --> 02:31:36,880 SORRY. 3963 02:31:36,880 --> 02:31:37,520 >> YOU'RE GOOD. 3964 02:31:37,520 --> 02:31:39,600 >> IN REGARD TO THE INFORMED 3965 02:31:39,600 --> 02:31:41,920 CONSENT SOMETIMES THAT ISSUE CAN 3966 02:31:41,920 --> 02:31:44,640 BECOME PROBLEMATIC, LOW RISK, 3967 02:31:44,640 --> 02:31:48,920 MINIMAL RISK, THIS IS A 3968 02:31:48,920 --> 02:31:49,920 DIRECTIONAL DOCUMENT, FURTHER 3969 02:31:49,920 --> 02:31:51,640 REFINE THAT, BUT THERE ARE WAYS 3970 02:31:51,640 --> 02:31:53,360 OF READYING IT SO IN ADDITION 3971 02:31:53,360 --> 02:31:54,720 TO, SAY, A SITUATION THAT'S 3972 02:31:54,720 --> 02:31:56,640 CLOSE CALL AND YOU'RE NOT SURE 3973 02:31:56,640 --> 02:31:58,400 AND IT'S IN THE MIDDLE, SO 3974 02:31:58,400 --> 02:32:00,600 THEREFORE THEY WOULD BE 3975 02:32:00,600 --> 02:32:03,360 CONSIDERED ENGAGED, THERE ARE 3976 02:32:03,360 --> 02:32:06,400 WAYS, OPERATIONALLY, TO ADDRESS 3977 02:32:06,400 --> 02:32:06,920 THAT. 3978 02:32:06,920 --> 02:32:08,360 SO, INTERNATIONAL CONTEXT WE 3979 02:32:08,360 --> 02:32:14,720 HAVE SITES YOU WOULD SIMPLY HAVE 3980 02:32:14,720 --> 02:32:15,440 MAYBE INVESTIGATORS THEN 3981 02:32:15,440 --> 02:32:16,360 VIRTUALLY CONSENT THOSE PEOPLE. 3982 02:32:16,360 --> 02:32:19,640 SO THERE ARE THINGS WE CAN MAYBE 3983 02:32:19,640 --> 02:32:22,280 ADD WHEN WE FURTHER REFINE THIS 3984 02:32:22,280 --> 02:32:23,560 TO GIVE SOME PRACTICAL EXAMPLES 3985 02:32:23,560 --> 02:32:27,080 OF HOW YOU CAN REMEDY FOR THOSE 3986 02:32:27,080 --> 02:32:28,720 PEOPLE STILL STRUGGLING WITH, 3987 02:32:28,720 --> 02:32:30,440 WELL, ARE WE ENGAGED, NOT 3988 02:32:30,440 --> 02:32:32,200 ENGAGED, CONCERNED ABOUT MAKING 3989 02:32:32,200 --> 02:32:33,760 A WRONG DECISION, THERE ARE WAYS 3990 02:32:33,760 --> 02:32:34,520 OF MANAGING THAT. 3991 02:32:34,520 --> 02:32:35,600 SOMETIMES HAVING THAT IN THERE 3992 02:32:35,600 --> 02:32:37,240 WOULD BE BENEFICIAL TO THE 3993 02:32:37,240 --> 02:32:39,320 RESEARCH COMMUNITY, SOMETIMES 3994 02:32:39,320 --> 02:32:41,280 IT'S HARD TO KNOW WHAT TO DO, 3995 02:32:41,280 --> 02:32:43,200 WHAT DO WE DO WITH THIS? 3996 02:32:43,200 --> 02:32:44,800 THAT'S MY ONLY COMMENT. 3997 02:32:44,800 --> 02:32:46,440 >> I COMPLETELY AGREE. 3998 02:32:46,440 --> 02:32:48,520 I ALMOST PUT THAT STUFF IN HERE. 3999 02:32:48,520 --> 02:32:49,040 >> OKAY. 4000 02:32:49,040 --> 02:32:52,040 >> THE IDEA OF HAVING A VIRTUAL 4001 02:32:52,040 --> 02:32:54,000 PRESENCE OF THE DIRECT PRIMARY 4002 02:32:54,000 --> 02:32:56,400 RESEARCH TEAM AS BEING A 4003 02:32:56,400 --> 02:32:56,760 SOLUTION. 4004 02:32:56,760 --> 02:32:59,360 WE CAN DEFINITELY PUT THAT IN. 4005 02:32:59,360 --> 02:33:01,120 >> IN FUTURE DOCUMENT. 4006 02:33:01,120 --> 02:33:01,440 >> EXACTLY. 4007 02:33:01,440 --> 02:33:04,280 >> WE GET INTO SOME OF THE -- 4008 02:33:04,280 --> 02:33:07,160 HOPEFULLY GET INTO IF OHRP 4009 02:33:07,160 --> 02:33:09,120 THINKS IT'S WORTH PURSUING, 4010 02:33:09,120 --> 02:33:11,280 DEFINING WHAT SUPERVISION MEANS 4011 02:33:11,280 --> 02:33:14,480 IN THE NEW WORLD OF ZOOM CALLS, 4012 02:33:14,480 --> 02:33:16,120 DISTANCE, ET CETERA. 4013 02:33:16,120 --> 02:33:18,440 THE REAL WORLD EVEN ABSENT THAT, 4014 02:33:18,440 --> 02:33:20,520 THE MOST OF THE INFORMED CONSENT 4015 02:33:20,520 --> 02:33:23,360 IN STUDIES DONE IS BY THE 4016 02:33:23,360 --> 02:33:26,200 RESEARCH COORDINATOR, NOT THE 4017 02:33:26,200 --> 02:33:27,200 PRINCIPAL INVESTIGATOR BUT THE 4018 02:33:27,200 --> 02:33:28,080 PRINCIPAL INVESTIGATOR IS HELD 4019 02:33:28,080 --> 02:33:29,320 RESPONSIBLE IF THERE'S SOMETHING 4020 02:33:29,320 --> 02:33:31,520 WRONG WITH THE PROCESS. 4021 02:33:31,520 --> 02:33:34,760 DELINEATING RESPONSIBILITY, WHEN 4022 02:33:34,760 --> 02:33:36,400 CAN YOU DELEGATE AUTHORITY, BUT 4023 02:33:36,400 --> 02:33:38,920 YOU CAN'T DELEGATE YOUR 4024 02:33:38,920 --> 02:33:39,720 RESPONSIBILITY, ET CETERA, ALL 4025 02:33:39,720 --> 02:33:47,000 WOULD HAVE TO BE PULLED INTO 4026 02:33:47,000 --> 02:33:50,800 EXAMPLES AND CLARIFIED. 4027 02:33:50,800 --> 02:33:51,800 >> ANY OTHER COMMENTS? 4028 02:33:51,800 --> 02:33:52,920 >> CAN YOU HEAR US? 4029 02:33:52,920 --> 02:33:55,200 WE DON'T SEE YOU ALL ON THE 4030 02:33:55,200 --> 02:33:55,680 SCREEN. 4031 02:33:55,680 --> 02:34:03,560 >> THERE ARE I.T. PROBLEMS THAT 4032 02:34:03,560 --> 02:34:04,880 ARE BEING WORKED ON. 4033 02:34:04,880 --> 02:34:06,680 >> ARE THEY ABLE TO HEAR US? 4034 02:34:06,680 --> 02:34:07,720 >> THEY CAN HEAR US. 4035 02:34:07,720 --> 02:34:12,000 I CAN SEE THEIR FACES ON THE 4036 02:34:12,000 --> 02:34:12,200 SCREEN. 4037 02:34:12,200 --> 02:34:13,600 >> SO I'M ASSUMING THERE ARE NO 4038 02:34:13,600 --> 02:34:16,360 COMMENTS FROM THE THREE MEMBERS 4039 02:34:16,360 --> 02:34:18,880 WHO ARE ONLINE. 4040 02:34:18,880 --> 02:34:19,240 >> CONSUELO? 4041 02:34:19,240 --> 02:34:20,640 >> I HAVE COMMENTS. 4042 02:34:20,640 --> 02:34:21,960 >> CAN YOU HEAR US. 4043 02:34:21,960 --> 02:34:24,360 >> SOMEONE HAS A COMMENT. 4044 02:34:24,360 --> 02:34:25,920 >> CONSUELO, DO YOU HAVE A 4045 02:34:25,920 --> 02:34:26,160 COMMENT? 4046 02:34:26,160 --> 02:34:26,560 >> YES. 4047 02:34:26,560 --> 02:34:29,200 CAN YOU HEAR ME? 4048 02:34:29,200 --> 02:34:30,600 >> BARELY. 4049 02:34:30,600 --> 02:34:30,880 >> OKAY. 4050 02:34:30,880 --> 02:34:35,160 SO, I JUST WANT TO REITERATE THE 4051 02:34:35,160 --> 02:34:36,080 ISSUE ABOUT ENGAGEMENT, IT CAME 4052 02:34:36,080 --> 02:34:40,000 UP IN ONE OF THE EARLIER 4053 02:34:40,000 --> 02:34:40,360 READINGS HERE. 4054 02:34:40,360 --> 02:34:43,880 I THINK IT'S VERY IMPORTANT FOR 4055 02:34:43,880 --> 02:34:47,720 US TO DEFINE ENGAGEMENT CLEARLY, 4056 02:34:47,720 --> 02:34:49,440 ENGAGEMENT IS A SCIENCE, AND 4057 02:34:49,440 --> 02:34:51,080 THERE'S A WHOLE GROUP, A 4058 02:34:51,080 --> 02:34:53,840 COMMUNITY OF PEOPLE WHO SPEND 4059 02:34:53,840 --> 02:34:55,160 THEIR TIME FOCUSED ON ENGAGEMENT 4060 02:34:55,160 --> 02:35:02,720 SO WE WANT TO BE CLEAR THAT THE 4061 02:35:02,720 --> 02:35:05,120 LANGUAGE IS ABOUT ENGAGING VIA 4062 02:35:05,120 --> 02:35:06,120 SPECIFIC TECHNICAL DEFINITION, 4063 02:35:06,120 --> 02:35:07,440 JUST REALLY WANT TO REITERATE 4064 02:35:07,440 --> 02:35:09,480 THE NEED FOR THE RIGHT 4065 02:35:09,480 --> 02:35:11,960 MESSAGING, SO WE'RE NOT TAKING 4066 02:35:11,960 --> 02:35:15,000 STEPS BACKWARDS AS RELATES TO 4067 02:35:15,000 --> 02:35:17,800 COMMUNITY AND PARTICIPANT 4068 02:35:17,800 --> 02:35:18,080 ENGAGEMENT. 4069 02:35:18,080 --> 02:35:19,880 >> MARK, CAN YOU RESTATE THAT? 4070 02:35:19,880 --> 02:35:24,760 I'M SURE THE PUBLIC DIDN'T -- 4071 02:35:24,760 --> 02:35:27,640 >> I THINK -- NOD IF I GET THIS 4072 02:35:27,640 --> 02:35:28,520 WRONG, SAYING THAT THERE ARE A 4073 02:35:28,520 --> 02:35:33,680 LOT OF PEOPLE TRYING TO APPLY 4074 02:35:33,680 --> 02:35:35,760 THIS DEFINITION AND THERE NEEDS 4075 02:35:35,760 --> 02:35:38,360 TO BE GREATER SPECIFICITY TO BE 4076 02:35:38,360 --> 02:35:39,480 MORE PREDICTABLE AND EASILY 4077 02:35:39,480 --> 02:35:40,040 APPLICABLE. 4078 02:35:40,040 --> 02:35:43,880 IS THAT ESSENTIALLY WHAT YOU 4079 02:35:43,880 --> 02:35:46,720 WERE SAYING OR NO? 4080 02:35:46,720 --> 02:35:46,880 NO? 4081 02:35:46,880 --> 02:35:49,200 >> NOT QUITE. 4082 02:35:49,200 --> 02:35:50,400 >> OH, OKAY. 4083 02:35:50,400 --> 02:35:53,040 >> MARK, IS YOUR MIC ON? 4084 02:35:53,040 --> 02:35:56,880 >> I DON'T KNOW. 4085 02:35:56,880 --> 02:35:58,960 MAYBE NOT. 4086 02:35:58,960 --> 02:36:00,960 >> WE HEAR HIM. 4087 02:36:00,960 --> 02:36:01,360 >> THERE'S NO -- 4088 02:36:01,360 --> 02:36:02,920 >> I DON'T KNOW. 4089 02:36:02,920 --> 02:36:05,520 I DIDN'T DO ANYTHING BETWEEN 4090 02:36:05,520 --> 02:36:10,440 DAVID BORASKY AND THIS. 4091 02:36:10,440 --> 02:36:14,840 >> SPEAK ROBUSTLY. 4092 02:36:14,840 --> 02:36:15,520 >> OKAY. 4093 02:36:15,520 --> 02:36:17,680 SO, AM I HEARING -- ARE THESE 4094 02:36:17,680 --> 02:36:18,960 COMMENTS REQUIRING CHANGES TO 4095 02:36:18,960 --> 02:36:21,160 THIS DOCUMENT OR IS THIS JUST 4096 02:36:21,160 --> 02:36:24,160 COMMENT ABOUT MOVING FORWARD? 4097 02:36:24,160 --> 02:36:25,680 >> IT'S A COMMENT ABOUT MOVING 4098 02:36:25,680 --> 02:36:28,720 FORWARD AND NOT ABOUT THIS 4099 02:36:28,720 --> 02:36:29,160 DOCUMENT. 4100 02:36:29,160 --> 02:36:30,680 NOW THAT I UNDERSTAND, SHE WAS 4101 02:36:30,680 --> 02:36:34,280 MAKING A POINT SIMILAR TO THE 4102 02:36:34,280 --> 02:36:36,640 POINT KEVIN WEINFURT MADE 4103 02:36:36,640 --> 02:36:37,080 BEFORE. 4104 02:36:37,080 --> 02:36:38,960 >> CONSUELO ADDED THERE'S A 4105 02:36:38,960 --> 02:36:41,040 SCIENCE OF ENGAGEMENT TOO. 4106 02:36:41,040 --> 02:36:42,880 SO THAT'S ANOTHER -- IT'S A WORD 4107 02:36:42,880 --> 02:36:45,760 THAT IS OUT THERE USED IN A 4108 02:36:45,760 --> 02:36:48,560 DIFFERENT CONTEXT TOO. 4109 02:36:48,560 --> 02:36:52,160 4110 02:36:52,160 --> 02:36:54,360 >> WOULD ANYBODY ELSE LIKE TO GO 4111 02:36:54,360 --> 02:36:54,560 AHEAD? 4112 02:36:54,560 --> 02:36:56,000 >> WONDERING BEFORE WE ACTUALLY 4113 02:36:56,000 --> 02:36:58,000 VOTE IF WE CAN KNOW WHAT THE 4114 02:36:58,000 --> 02:37:00,920 MOTION IS BECAUSE IT SEEMED TO 4115 02:37:00,920 --> 02:37:02,000 HAVE -- 4116 02:37:02,000 --> 02:37:05,360 >> DID YOU HAVE ANOTHER COMMENT? 4117 02:37:05,360 --> 02:37:05,960 OKAY, GREAT. 4118 02:37:05,960 --> 02:37:07,760 >> THIS IS BASED ON MY 4119 02:37:07,760 --> 02:37:10,480 UNDERSTANDING OF THE PROCESS. 4120 02:37:10,480 --> 02:37:12,280 SO, WHAT WE WOULD BE DOING IS -- 4121 02:37:12,280 --> 02:37:15,040 THIS IS NOT A GUIDANCE DOCUMENT. 4122 02:37:15,040 --> 02:37:17,560 THIS IS BASICALLY A DIRECTIONAL 4123 02:37:17,560 --> 02:37:21,280 DOCUMENT THAT SAYS TO OHRP THAT 4124 02:37:21,280 --> 02:37:23,000 THIS GROUP, SACHRP, WOULD 4125 02:37:23,000 --> 02:37:23,640 RECOMMEND THIS DEFINITION WHICH 4126 02:37:23,640 --> 02:37:33,680 IS AT THE TOP OF PAGE 3 AND THAT 4127 02:37:33,680 --> 02:37:35,040 WOULD GO TO OHRP. 4128 02:37:35,040 --> 02:37:38,040 THAT'S BASICALLY THE MOTION. 4129 02:37:38,040 --> 02:37:43,560 THE HOPE WHICH I GUESS WE CAN'T 4130 02:37:43,560 --> 02:37:47,120 VOTE ON A HOPE, THAT OHRP WOULD 4131 02:37:47,120 --> 02:37:49,320 CONSIDER THIS A DIRECTION WORTH 4132 02:37:49,320 --> 02:37:52,840 EXPLORING FURTHER IN WHICH CASE 4133 02:37:52,840 --> 02:37:55,240 THEY WOULD THEN CHARGE THE 4134 02:37:55,240 --> 02:37:56,760 SACHRP AND THE SUBCOMMITTEES 4135 02:37:56,760 --> 02:37:59,520 WITHIN SACHRP TO THEN DEVELOP 4136 02:37:59,520 --> 02:38:01,240 THIS FURTHER, AND THEN WITH THAT 4137 02:38:01,240 --> 02:38:03,880 OPPORTUNITY ONCE THAT WORK IS 4138 02:38:03,880 --> 02:38:05,800 DONE WOULD THEN COME BACK TO 4139 02:38:05,800 --> 02:38:07,160 THIS GROUP PRECISELY FOR THE 4140 02:38:07,160 --> 02:38:08,520 CONVERSATION WE HAD IN THE LAST 4141 02:38:08,520 --> 02:38:10,480 20 MINUTES OR SO AROUND HOW YOU 4142 02:38:10,480 --> 02:38:11,400 INTERPRET ENGAGEMENT AND MAKE 4143 02:38:11,400 --> 02:38:14,000 SURE THAT THE SCIENCE OF 4144 02:38:14,000 --> 02:38:14,520 ENGAGEMENT, COMMUNITY 4145 02:38:14,520 --> 02:38:16,120 ENGAGEMENT, HOW WE INTERPRET 4146 02:38:16,120 --> 02:38:18,280 CONSENT AND SUPERVISION, ALL OF 4147 02:38:18,280 --> 02:38:20,080 THAT WORK WOULD BE DONE IN 4148 02:38:20,080 --> 02:38:21,560 APPLYING THIS RECOMMENDED 4149 02:38:21,560 --> 02:38:22,000 DEFINITION. 4150 02:38:22,000 --> 02:38:23,960 THE VOTE REALLY IS TO SAY THIS 4151 02:38:23,960 --> 02:38:26,720 DOCUMENT AS IT IS CAN GO TO OHRP 4152 02:38:26,720 --> 02:38:27,960 AS A DIRECTIONAL RECOMMENDATION 4153 02:38:27,960 --> 02:38:30,760 FOR FURTHER WORK ON THE PART OF 4154 02:38:30,760 --> 02:38:31,840 THIS GROUP. 4155 02:38:31,840 --> 02:38:34,080 THAT'S THE MOTION. 4156 02:38:34,080 --> 02:38:36,240 >> AND LINDA HAS SECONDED. 4157 02:38:36,240 --> 02:38:37,560 >> ONE QUESTION BEFORE I DO 4158 02:38:37,560 --> 02:38:41,600 THAT, IT WOULD INCLUDE A 4159 02:38:41,600 --> 02:38:42,360 RECOMMENDATION, INCLUDING THAT 4160 02:38:42,360 --> 02:38:43,600 SACHRP WOULD LOOK AT THE 4161 02:38:43,600 --> 02:38:45,200 DEFINITION AS WELL, CORRECT? 4162 02:38:45,200 --> 02:38:47,160 IT WOULD NOT JUST BE HERE IS THE 4163 02:38:47,160 --> 02:38:48,400 DEFINITION, MOVE ON, BUT IT 4164 02:38:48,400 --> 02:38:50,760 WOULD BE A RECOMMENDATION TO 4165 02:38:50,760 --> 02:38:52,480 LOOK AT THE ENTIRE DOCUMENT, ALL 4166 02:38:52,480 --> 02:38:55,160 THE LANGUAGE IN IT. 4167 02:38:55,160 --> 02:38:56,480 >> RIGHT, PRESUMABLY OHRP WOULD 4168 02:38:56,480 --> 02:38:58,600 SEEK OUR ADVICE ON THAT. 4169 02:38:58,600 --> 02:38:59,800 >> OKAY. 4170 02:38:59,800 --> 02:39:01,640 >> I'M FAIRLY CONFIDENT THEY 4171 02:39:01,640 --> 02:39:03,040 WOULD PROBABLY DO THAT IF THEY 4172 02:39:03,040 --> 02:39:08,400 THOUGHT THERE WAS MERIT IN THIS 4173 02:39:08,400 --> 02:39:08,800 APPROACH. 4174 02:39:08,800 --> 02:39:09,600 >> ANY OTHER LAST COMMENTS 4175 02:39:09,600 --> 02:39:13,560 BEFORE WE VOTE ON THIS? 4176 02:39:13,560 --> 02:39:14,080 LET'S VOTE. 4177 02:39:14,080 --> 02:39:22,320 ALL IN FAVOR OF THE MOTION? 4178 02:39:22,320 --> 02:39:26,240 ANY OPPOSED? 4179 02:39:26,240 --> 02:39:27,520 AND ANY ABSTENTIONS? 4180 02:39:27,520 --> 02:39:32,040 SO THE MOTION PASSES. 4181 02:39:32,040 --> 02:39:33,360 ALL RIGHT. 4182 02:39:33,360 --> 02:39:35,800 WE'RE GOING TO BREAK FOR LUNCH. 4183 02:39:35,800 --> 02:39:39,520 AND FOR THOSE OF YOU WHO ARE 4184 02:39:39,520 --> 02:39:44,200 ONLINE WE WILL BE RECONVENING AT 4185 02:39:44,200 --> 02:39:45,600 2:00 EASTERN TIME. 4186 02:39:45,600 --> 02:39:46,560 >>MOST OF OUR 4187 02:39:46,560 --> 02:39:49,560 AFTERNOON DEVOTED TO THE NIH 4188 02:39:49,560 --> 02:39:53,320 POLICY FOR DATA MANAGEMENT AND 4189 02:39:53,320 --> 02:39:55,000 SHARING, PROTECTING PRIVACY ON 4190 02:39:55,000 --> 02:39:56,680 HUMAN RESEARCH PARTICIPANT DATA. 4191 02:39:56,680 --> 02:40:03,040 THIS PARTICULAR ACTIVITY IS 4192 02:40:03,040 --> 02:40:05,040 PROVIDING COMMENTS ON AN NIH 4193 02:40:05,040 --> 02:40:08,080 PROPOSAL, AND BECAUSE THERE IS A 4194 02:40:08,080 --> 02:40:09,280 DEADLINE FOR COMMENTS IF WE'RE 4195 02:40:09,280 --> 02:40:11,480 GOING TO DO THIS IT HAS TO BE 4196 02:40:11,480 --> 02:40:13,200 DONE AT THIS MEETING. 4197 02:40:13,200 --> 02:40:14,960 SO, ONCE AGAIN, THIS WILL BE -- 4198 02:40:14,960 --> 02:40:16,920 IT WILL BE IMPORTANT FOR US TO 4199 02:40:16,920 --> 02:40:20,920 MAKE VERY SPECIFIC CHANGES IF WE 4200 02:40:20,920 --> 02:40:21,640 WANT THEM. 4201 02:40:21,640 --> 02:40:23,080 WE CAN'T MAKE BIG PICTURE 4202 02:40:23,080 --> 02:40:24,960 SUGGESTIONS TO THE AUTHORS OF 4203 02:40:24,960 --> 02:40:35,480 THIS BECAUSE THERE WON'T BE TIME 4204 02:40:39,240 --> 02:40:44,240 TO IMPLEMENT THOSE. 4205 02:40:44,240 --> 02:40:46,120 TAUNTON PAINE WILL GIVE AN 4206 02:40:46,120 --> 02:40:50,360 OVERVIEW AND DAVID WILL TALK 4207 02:40:50,360 --> 02:40:51,480 THROUGH OUR COMMENTS. 4208 02:40:51,480 --> 02:40:51,760 >> GREAT. 4209 02:40:51,760 --> 02:40:52,720 CAN YOU HEAR ME? 4210 02:40:52,720 --> 02:40:56,080 IS THIS THE CORRECT MICROPHONE? 4211 02:40:56,080 --> 02:40:58,080 >> THAT'S THE CORRECT MIC BUT 4212 02:40:58,080 --> 02:41:00,040 IT'S VERY FAINT. 4213 02:41:00,040 --> 02:41:01,440 >> MAYBE I'LL TRY ADJUSTING. 4214 02:41:01,440 --> 02:41:03,200 >> SPEAK AS LOUDLY AS POSSIBLE. 4215 02:41:03,200 --> 02:41:07,200 THEY SEEM TO BE HAVING TECH 4216 02:41:07,200 --> 02:41:08,880 ISSUES WITH THAT MIC. 4217 02:41:08,880 --> 02:41:10,640 >> THANK YOU. 4218 02:41:10,640 --> 02:41:13,400 I'M TAUNTON PAINE, DIRECTOR OF 4219 02:41:13,400 --> 02:41:14,880 SCIENTIFIC DATA SHARING POLICY 4220 02:41:14,880 --> 02:41:16,800 DIVISION IN OFFICE OF SCIENCE 4221 02:41:16,800 --> 02:41:18,880 POLICY AT NIH. 4222 02:41:18,880 --> 02:41:21,920 I JUST WANTED TO GIVE YOU SOME 4223 02:41:21,920 --> 02:41:24,560 BACKGROUND ON THE DATA 4224 02:41:24,560 --> 02:41:26,440 MANAGEMENT AND SHARING POLICY, 4225 02:41:26,440 --> 02:41:27,200 AND ASSOCIATED SUPPLEMENTAL 4226 02:41:27,200 --> 02:41:28,600 INFORMATION THAT WE'VE DEVELOPED 4227 02:41:28,600 --> 02:41:31,560 WHICH IS IN DRAFT FORM THAT WE 4228 02:41:31,560 --> 02:41:32,560 PUBLISHED FOR PUBLIC COMMENT 4229 02:41:32,560 --> 02:41:34,760 EARLIER THIS YEAR. 4230 02:41:34,760 --> 02:41:41,120 JUST AS PREPARATION FOR YOUR 4231 02:41:41,120 --> 02:41:41,520 DISCUSSION. 4232 02:41:41,520 --> 02:41:43,400 AS YOU PROBABLY KNOW, WE ISSUED 4233 02:41:43,400 --> 02:41:47,120 THE DATA MANAGEMENT AND SHARING 4234 02:41:47,120 --> 02:41:50,080 POLICY IN OCTOBER 2020, AFTER A 4235 02:41:50,080 --> 02:41:51,280 LONG PERIOD OF DEVELOPMENT AND 4236 02:41:51,280 --> 02:41:53,560 PUBLIC COMMENT THROUGH SORT OF 4237 02:41:53,560 --> 02:41:55,000 ENGAGEMENT WITH STAKEHOLDERS AT 4238 02:41:55,000 --> 02:41:56,960 DIFFERENT POINTS. 4239 02:41:56,960 --> 02:41:58,960 WE ALSO CONSULTED SECRETARY'S 4240 02:41:58,960 --> 02:42:00,960 ADVISORY COMMITTEE FOR HUMAN 4241 02:42:00,960 --> 02:42:02,440 RESEARCH PROTECTIONS ON DRAFT 4242 02:42:02,440 --> 02:42:03,880 POLICY IN EARLY 2020 AND WORKED 4243 02:42:03,880 --> 02:42:05,320 TO INCORPORATE SOME OF THOSE 4244 02:42:05,320 --> 02:42:07,040 INTO THE FINAL POLICY AND INTO 4245 02:42:07,040 --> 02:42:09,440 THE DOCUMENT THAT I'LL TELL YOU 4246 02:42:09,440 --> 02:42:09,760 ABOUT TODAY. 4247 02:42:09,760 --> 02:42:11,520 AND THE POLICY IS NOT YET IN 4248 02:42:11,520 --> 02:42:11,840 EFFECT. 4249 02:42:11,840 --> 02:42:13,840 IT WAS ISSUED IN OCTOBER 2020 4250 02:42:13,840 --> 02:42:15,280 BUT WE WANTED TO GIVE PEOPLE 4251 02:42:15,280 --> 02:42:16,680 TIME TO IMPLEMENT IT. 4252 02:42:16,680 --> 02:42:19,000 SO IT'S TAKING EFFECT FOR NEW 4253 02:42:19,000 --> 02:42:21,280 AND COMPETING AWARDS BEGINNING 4254 02:42:21,280 --> 02:42:25,480 IN JANUARY 25, 2023, AND 4255 02:42:25,480 --> 02:42:25,880 AFTERWARDS. 4256 02:42:25,880 --> 02:42:28,200 SO, THE POLICY ITSELF IS 4257 02:42:28,200 --> 02:42:30,920 RELATIVELY STRAIGHT FORWARD. 4258 02:42:30,920 --> 02:42:32,960 IT ONLY HAS TWO REQUIREMENTS, 4259 02:42:32,960 --> 02:42:34,160 SUBMISSION OF DATA MANAGEMENT 4260 02:42:34,160 --> 02:42:36,640 AND SHARING PLAN FOR ALL 4261 02:42:36,640 --> 02:42:39,040 NIH-FUNDED RESEARCH, SO GRANTS, 4262 02:42:39,040 --> 02:42:40,160 CONTRACTS, COOPERATIVE 4263 02:42:40,160 --> 02:42:41,680 AGREEMENTS, THAT WOULD GENERALLY 4264 02:42:41,680 --> 02:42:44,200 DESCRIBE HOW, WHERE, AND WHEN 4265 02:42:44,200 --> 02:42:46,720 SCIENTIFIC DATA WILL BE SHARED. 4266 02:42:46,720 --> 02:42:48,240 AND IT ALSO REQUIRES COMPLIANCE 4267 02:42:48,240 --> 02:42:49,360 WITH THE VERSION OF THE PLAN 4268 02:42:49,360 --> 02:42:52,080 THAT IS APPROVED BY THE NIH 4269 02:42:52,080 --> 02:42:54,280 INSTITUTE CENTER OR OFFICE 4270 02:42:54,280 --> 02:42:55,400 FUNDING THE RESEARCH. 4271 02:42:55,400 --> 02:42:56,480 IT WILL ACTUALLY BECOME 4272 02:42:56,480 --> 02:42:58,120 EFFECTIVE FOR NEW AND COMPETING 4273 02:42:58,120 --> 02:43:00,960 AWARDS SUBMITTED FOR THE JANUARY 4274 02:43:00,960 --> 02:43:03,040 25, 2023, RECEIPT DATE AND LATER 4275 02:43:03,040 --> 02:43:04,320 AT WHICH POINT FOR THOSE AWARDS 4276 02:43:04,320 --> 02:43:05,920 IT WILL START TO REPLACE THE 4277 02:43:05,920 --> 02:43:06,880 2003 DATA SHARING POLICY FOR 4278 02:43:06,880 --> 02:43:11,160 THOSE WHO ARE FAMILIAR WITH THAT 4279 02:43:11,160 --> 02:43:11,640 ONE. 4280 02:43:11,640 --> 02:43:14,320 SO, I WON'T GO THROUGH THIS IN 4281 02:43:14,320 --> 02:43:14,680 DETAIL. 4282 02:43:14,680 --> 02:43:16,720 THE NIH HAS ISSUED SORT OF A 4283 02:43:16,720 --> 02:43:18,600 RECOMMENDED SET OF ELEMENTS OF A 4284 02:43:18,600 --> 02:43:19,440 DATA MANAGEMENT AND SHARING 4285 02:43:19,440 --> 02:43:19,920 PLAN. 4286 02:43:19,920 --> 02:43:22,840 I WANT TO DRAW YOUR ATTENTION TO 4287 02:43:22,840 --> 02:43:25,840 THE ACCESS DISTRIBUTION AND 4288 02:43:25,840 --> 02:43:26,480 REUSE CONSIDERATION SINCE 4289 02:43:26,480 --> 02:43:28,560 GENERALLY SPEAKING IF THERE ARE 4290 02:43:28,560 --> 02:43:30,000 GOING TO BE LIMITATIONS THAT CAN 4291 02:43:30,000 --> 02:43:31,720 BE ANTICIPATED FOR THE SHARING 4292 02:43:31,720 --> 02:43:34,520 OF DATA, WE WOULD EXPECT THOSE 4293 02:43:34,520 --> 02:43:36,800 TO BE DESCRIBED IN THAT SECTION. 4294 02:43:36,800 --> 02:43:38,880 SO IT IS SOMETHING WE WANT TO 4295 02:43:38,880 --> 02:43:40,320 HEAR ABOUT. 4296 02:43:40,320 --> 02:43:41,800 AND IN GENERAL, THE POLICY 4297 02:43:41,800 --> 02:43:43,240 REQUIRES THE SUBMISSION OF DATA 4298 02:43:43,240 --> 02:43:44,800 MANAGEMENT AND SHARING PLAN AND 4299 02:43:44,800 --> 02:43:46,320 COMPLIANCE WITH THAT PLAN. 4300 02:43:46,320 --> 02:43:48,040 IT DOES NOT DIRECTLY REQUIRE 4301 02:43:48,040 --> 02:43:49,040 DATA SHARING. 4302 02:43:49,040 --> 02:43:51,360 WHAT IT DOES EXPECT IS THAT IN 4303 02:43:51,360 --> 02:43:53,080 DEVELOPING THEIR DATA MANAGEMENT 4304 02:43:53,080 --> 02:43:56,920 AND SHARING PLANS, RESEARCHERS 4305 02:43:56,920 --> 02:43:57,960 WILL MAXIMIZE APPROPRIATE 4306 02:43:57,960 --> 02:43:59,760 SHARING RECOGNIZING THERE ARE 4307 02:43:59,760 --> 02:44:01,080 CERTAIN JUSTIFIABLE ETHICAL, 4308 02:44:01,080 --> 02:44:03,600 LEGAL OR TECHNICAL FACTORS THAT 4309 02:44:03,600 --> 02:44:04,440 MAY NECESSITATE LIMITING SHARING 4310 02:44:04,440 --> 02:44:07,120 TO SOME DEGREE OR IN SOME CASES 4311 02:44:07,120 --> 02:44:08,640 EVEN PRECLUDE SHARING ENTIRELY. 4312 02:44:08,640 --> 02:44:09,720 WE'VE PROVIDED SOME EXAMPLES OF 4313 02:44:09,720 --> 02:44:11,680 THESE THAT WE WOULD GENERALLY 4314 02:44:11,680 --> 02:44:13,320 CONSIDER TO BE JUSTIFIABLE SUCH 4315 02:44:13,320 --> 02:44:14,960 AS WHEN INFORMED CONSENT WILL 4316 02:44:14,960 --> 02:44:16,480 NOT PERMIT OR WOULD LIMIT THE 4317 02:44:16,480 --> 02:44:18,480 SCOPE OF SHARING OR USE, IF 4318 02:44:18,480 --> 02:44:21,400 PRIVACY OR SAFETY OF RESEARCH 4319 02:44:21,400 --> 02:44:22,520 PARTICIPANTS WOULD BE 4320 02:44:22,520 --> 02:44:23,200 COMPROMISED AND AVAILABLE 4321 02:44:23,200 --> 02:44:24,160 PROTECTIONS ARE NOT SUFFICIENT 4322 02:44:24,160 --> 02:44:26,120 OR IF THERE'S AN EXPLICIT 4323 02:44:26,120 --> 02:44:28,200 FEDERAL, STATE, LOCAL OR TRIBAL 4324 02:44:28,200 --> 02:44:29,960 LAW REGULATION OR POLICY THAT 4325 02:44:29,960 --> 02:44:31,360 WOULD PROHIBIT DISCLOSURE. 4326 02:44:31,360 --> 02:44:33,400 THESE ARE EXAMPLES OF WHAT WE 4327 02:44:33,400 --> 02:44:34,840 WOULD CONSIDER APPROPRIATE TO BE 4328 02:44:34,840 --> 02:44:36,640 STATED IN PLANS AS A JUSTIFIABLE 4329 02:44:36,640 --> 02:44:41,360 REASON FOR HAVING TO LIMIT 4330 02:44:41,360 --> 02:44:43,640 SHARING IN SOME WAY. 4331 02:44:43,640 --> 02:44:44,960 ALONGSIDE THE POLICY WE'VE 4332 02:44:44,960 --> 02:44:46,720 DEVELOPED A NUMBER OF ADDITIONAL 4333 02:44:46,720 --> 02:44:48,760 RESOURCE, SOME PUBLISHED WITH 4334 02:44:48,760 --> 02:44:50,080 THE POLICY IN OCTOBER 2020, 4335 02:44:50,080 --> 02:44:51,880 OTHERS OF WHICH WE SORT OF 4336 02:44:51,880 --> 02:44:53,200 DEVELOPED SINCE THEN. 4337 02:44:53,200 --> 02:44:55,840 SO EARLIER THIS YEAR NIH 4338 02:44:55,840 --> 02:44:57,000 ACTUALLY ISSUED A NEW RESOURCE 4339 02:44:57,000 --> 02:44:59,880 TO HELP PEOPLE THINK THROUGH HOW 4340 02:44:59,880 --> 02:45:01,640 TO ADDRESS FUTURE USE AND 4341 02:45:01,640 --> 02:45:04,440 SHARING OF DATA AND SPECIMENS IN 4342 02:45:04,440 --> 02:45:05,400 INFORMED CONSENT FORMS. 4343 02:45:05,400 --> 02:45:07,320 IT'S NOT A REQUIREMENT TO USE 4344 02:45:07,320 --> 02:45:07,600 IT. 4345 02:45:07,600 --> 02:45:09,080 IT'S MORE OF A POINTS TO 4346 02:45:09,080 --> 02:45:10,080 CONSIDER DOCUMENT WITH SUGGESTED 4347 02:45:10,080 --> 02:45:12,880 LANGUAGE THAT CAN BE MODIFIED. 4348 02:45:12,880 --> 02:45:18,720 WE ALSO ISSUED TWO DRAFT 4349 02:45:18,720 --> 02:45:22,640 DOCUMENTS, ONE IN A TRIBAL 4350 02:45:22,640 --> 02:45:24,320 CONSULTATION BEGINNING WITH A 4351 02:45:24,320 --> 02:45:25,920 DRAFT POLICY IN 2009 ON 4352 02:45:25,920 --> 02:45:28,200 RESPONSIBLE MANAGEMENT AND 4353 02:45:28,200 --> 02:45:29,640 SHARING OF DATA WHEN YOU ARE 4354 02:45:29,640 --> 02:45:31,200 DEVELOPING A DATA MANAGEMENT AND 4355 02:45:31,200 --> 02:45:32,640 SHARING PLAN IN A RESEARCH 4356 02:45:32,640 --> 02:45:37,000 PROJECT THAT INVOLVES WORKING 4357 02:45:37,000 --> 02:45:41,400 WITH AMERICAN INDIAN OR ALASKA 4358 02:45:41,400 --> 02:45:43,000 NATIVE TRIBES OR COMMUNITIES. 4359 02:45:43,000 --> 02:45:45,080 AND SO THAT WENT OUT FOR PUBLIC 4360 02:45:45,080 --> 02:45:46,520 COMMENT IN JANUARY. 4361 02:45:46,520 --> 02:45:48,240 AND WE'RE WORKING THROUGH THE 4362 02:45:48,240 --> 02:45:49,520 PUBLIC COMMENTS ON THAT NOW. 4363 02:45:49,520 --> 02:45:51,640 THE SECOND DRAFT THAT WENT OUT 4364 02:45:51,640 --> 02:45:53,040 FOR PUBLIC COMMENT WAS ISSUED IN 4365 02:45:53,040 --> 02:45:54,920 MAY THAT WE'LL BE TALKING ABOUT 4366 02:45:54,920 --> 02:45:57,200 TODAY WHICH IS THE SUPPLEMENTAL 4367 02:45:57,200 --> 02:45:58,520 INFORMATION FOR PROTECTING 4368 02:45:58,520 --> 02:46:00,400 PRIVACY WHEN SHARING HUMAN 4369 02:46:00,400 --> 02:46:01,680 RESEARCH PARTICIPANT DATA. 4370 02:46:01,680 --> 02:46:04,160 SO, I WON'T GO THROUGH IN 4371 02:46:04,160 --> 02:46:04,600 DETAIL. 4372 02:46:04,600 --> 02:46:06,200 IT'S AVAILABLE ONLINE. 4373 02:46:06,200 --> 02:46:07,400 IT'S RELATIVELY SHORT AND IN 4374 02:46:07,400 --> 02:46:08,560 GENERAL IT'S TRYING TO RESPOND 4375 02:46:08,560 --> 02:46:10,320 TO THE NEED TO UPDATE THE 4376 02:46:10,320 --> 02:46:12,640 GUIDANCE THAT WAS PROVIDED FOR 4377 02:46:12,640 --> 02:46:14,400 THE 2003 DATA SHARING POLICY ON 4378 02:46:14,400 --> 02:46:16,880 HOW TO PROTECT PRIVACY UNDER 4379 02:46:16,880 --> 02:46:18,240 THAT POLICY. 4380 02:46:18,240 --> 02:46:20,400 IT'S ALSO RESPONDING TO 4381 02:46:20,400 --> 02:46:20,920 ADDITIONAL REQUESTS FOR 4382 02:46:20,920 --> 02:46:23,120 CLARIFICATION WE'VE HEARD IN THE 4383 02:46:23,120 --> 02:46:27,400 PUBLIC COMMENTS OR SINCE THEN IN 4384 02:46:27,400 --> 02:46:28,280 OUR DISCUSSIONS WITH THE 4385 02:46:28,280 --> 02:46:29,800 RESEARCH COMMUNITY WHICH HAVE 4386 02:46:29,800 --> 02:46:32,360 BEEN ONGOING SINCE WE ISSUED THE 4387 02:46:32,360 --> 02:46:33,560 POLICY IN OCTOBER 2020. 4388 02:46:33,560 --> 02:46:36,400 AND ALSO WE WANTED TO RESPOND TO 4389 02:46:36,400 --> 02:46:37,720 CERTAIN RECOMMENDATIONS THAT 4390 02:46:37,720 --> 02:46:39,480 SACHRP MADE ON THE DRAFT POLICY 4391 02:46:39,480 --> 02:46:41,760 SUCH AS RECOMMENDATION THAT DATA 4392 02:46:41,760 --> 02:46:44,040 USE AGREEMENTS INCLUDE 4393 02:46:44,040 --> 02:46:45,040 STIPULATION THAT DATA RECIPIENTS 4394 02:46:45,040 --> 02:46:47,040 WOULD HAVE TO AGREE NOT TO 4395 02:46:47,040 --> 02:46:47,800 ATTEMPT TO REIDENTIFY 4396 02:46:47,800 --> 02:46:50,480 INDIVIDUALS WHICH WE DO ACTUALLY 4397 02:46:50,480 --> 02:46:53,960 I THINK HAVE IN THE SUPPLEMENTAL 4398 02:46:53,960 --> 02:46:55,360 INFORMATION ITSELF. 4399 02:46:55,360 --> 02:46:56,320 AND IN GENERAL, APPROACH WE'VE 4400 02:46:56,320 --> 02:46:58,880 TAKEN HERE IS TO TRY TO PROVIDE 4401 02:46:58,880 --> 02:47:01,720 GUIDANCE TO RESEARCHERS AND 4402 02:47:01,720 --> 02:47:02,920 INSTITUTIONS, IN THE GENERAL 4403 02:47:02,920 --> 02:47:05,400 SENSE OF THE WORD, WHILE 4404 02:47:05,400 --> 02:47:06,320 PRESERVING THEIR FLEXIBILITY TO 4405 02:47:06,320 --> 02:47:08,720 BE ABLE TO IMPLEMENT THIS AS 4406 02:47:08,720 --> 02:47:09,800 THEY SEE FIT. 4407 02:47:09,800 --> 02:47:10,680 RECOGNIZING THERE ARE 4408 02:47:10,680 --> 02:47:11,880 DIFFERENCES IN DISCIPLINES AND 4409 02:47:11,880 --> 02:47:13,760 IN CONTEXT THAT MAY BE IMPORTANT 4410 02:47:13,760 --> 02:47:16,240 TO TAKE INTO ACCOUNT HERE. 4411 02:47:16,240 --> 02:47:18,720 IT'S NOT INTENDED TO ESTABLISH 4412 02:47:18,720 --> 02:47:19,320 BINDING REQUIREMENTS. 4413 02:47:19,320 --> 02:47:21,280 AND SO I DO WANT TO SAY WE'VE 4414 02:47:21,280 --> 02:47:22,480 RECEIVED A NUMBER OF PUBLIC 4415 02:47:22,480 --> 02:47:24,480 COMMENTS ON THIS AND WE'VE BEEN 4416 02:47:24,480 --> 02:47:26,440 REVIEWING THOSE CAREFULLY AND WE 4417 02:47:26,440 --> 02:47:34,120 LOOK FORWARD TO SACHRP'S 4418 02:47:34,120 --> 02:47:34,960 RECOMMENDATIONS. 4419 02:47:34,960 --> 02:47:36,040 >> ANY QUESTIONS FOR TAUNTON 4420 02:47:36,040 --> 02:47:45,240 BEFORE WE TURN IT OVER TO DAVID? 4421 02:47:45,240 --> 02:47:45,440 OKAY. 4422 02:47:45,440 --> 02:47:46,920 THANK YOU. 4423 02:47:46,920 --> 02:47:48,240 ALL RIGHT. 4424 02:47:48,240 --> 02:47:49,240 DAVE BORASKY, YOU'RE GOING TO 4425 02:47:49,240 --> 02:47:55,640 TAKE US THROUGH THE SACHRP 4426 02:47:55,640 --> 02:48:05,920 COMMENTS DRAFT. 4427 02:48:17,560 --> 02:48:18,440 >> DAVID, YOU HAVE TO FIRST GO 4428 02:48:18,440 --> 02:48:20,560 TO THE ZOOM AND SHARE YOUR 4429 02:48:20,560 --> 02:48:25,560 SCREEN THROUGH THE ZOOM. 4430 02:48:25,560 --> 02:48:35,800 >> GOT IT. 4431 02:48:49,160 --> 02:48:52,040 ALL RIGHT, GREAT. 4432 02:48:52,040 --> 02:48:54,120 THANKS FOR THAT INTRODUCTION, 4433 02:48:54,120 --> 02:48:54,640 TAUNTON. 4434 02:48:54,640 --> 02:48:58,600 WE HAD THE SAME -- THE PLEASURE 4435 02:48:58,600 --> 02:49:00,400 OF GETTING SIMILAR BACKGROUND IS 4436 02:49:00,400 --> 02:49:02,680 HE SUBCOMMITTEE MEETING WHICH WE 4437 02:49:02,680 --> 02:49:05,560 FOUND HELPFUL AS WE WORKED ON 4438 02:49:05,560 --> 02:49:08,480 PULLING TOGETHER THESE 4439 02:49:08,480 --> 02:49:08,720 DOCUMENTS. 4440 02:49:08,720 --> 02:49:13,720 SO, AS DOUG ALREADY NOTED, THIS 4441 02:49:13,720 --> 02:49:17,680 IS A TIME LIMITED REQUEST TO GET 4442 02:49:17,680 --> 02:49:21,160 THIS INFORMATION BACK OUT TO NIH 4443 02:49:21,160 --> 02:49:25,240 AND SO WE'LL DO OUR BEST TO I 4444 02:49:25,240 --> 02:49:26,400 THINK WORK THROUGH THIS DOCUMENT 4445 02:49:26,400 --> 02:49:28,200 EFFICIENTLY AND THEN IF THERE 4446 02:49:28,200 --> 02:49:33,200 ARE ANY CHANGES OR CORRECTIONS 4447 02:49:33,200 --> 02:49:34,440 WE WILL -- I'M HERE TOMORROW SO 4448 02:49:34,440 --> 02:49:36,080 WE'LL BE ABLE TO USE THE 4449 02:49:36,080 --> 02:49:37,280 OVERNIGHT TO GET THINGS CLEANED 4450 02:49:37,280 --> 02:49:41,640 UP AND PUT BACK BEFORE YOU IF 4451 02:49:41,640 --> 02:49:41,920 NECESSARY. 4452 02:49:41,920 --> 02:49:43,160 SO TAUNTON GAVE THE BACKGROUND 4453 02:49:43,160 --> 02:49:44,360 ON THE DOCUMENT. 4454 02:49:44,360 --> 02:49:45,560 THAT'S WHAT'S IN THE BACKGROUND 4455 02:49:45,560 --> 02:49:47,560 SECTION ON THIS. 4456 02:49:47,560 --> 02:49:49,640 I WOULD SAY OVERALL, AS YOU SAW 4457 02:49:49,640 --> 02:49:51,040 WHEN YOU HOPEFULLY READ THROUGH 4458 02:49:51,040 --> 02:49:53,000 THE DOCUMENT AHEAD OF TIME, BUT 4459 02:49:53,000 --> 02:49:54,880 THE WAY THE DOCUMENT IS 4460 02:49:54,880 --> 02:49:56,000 ORGANIZED FIRST OF ALL I THINK 4461 02:49:56,000 --> 02:49:58,400 WE'RE ALL GOING TO SAY WE AGREE 4462 02:49:58,400 --> 02:50:00,680 PROTECTING THE PRIVACY OF 4463 02:50:00,680 --> 02:50:02,320 RESEARCH PARTICIPANTS IS 4464 02:50:02,320 --> 02:50:04,960 IMPORTANT, AND THAT IT IS USEFUL 4465 02:50:04,960 --> 02:50:06,240 FOR THE IMPACTED COMMUNITY TO 4466 02:50:06,240 --> 02:50:10,240 HAVE GUIDANCE ON HOW TO FOLLOW 4467 02:50:10,240 --> 02:50:13,160 AND COMPLY WITH THE NIH POLICY 4468 02:50:13,160 --> 02:50:16,320 ALTHOUGH THE NIH IS CLEAR THIS 4469 02:50:16,320 --> 02:50:18,320 IS NOT A GUIDANCE DOCUMENT, BUT 4470 02:50:18,320 --> 02:50:19,720 IT IS MEANT TO HELP THAT 4471 02:50:19,720 --> 02:50:20,600 COMMUNITY OF RESEARCHERS WORKING 4472 02:50:20,600 --> 02:50:25,200 WITH THIS DATA AND SHARING IT 4473 02:50:25,200 --> 02:50:26,640 AND ARE RECIPIENTS OF IT. 4474 02:50:26,640 --> 02:50:28,840 WITH THAT IN MIND, YOU KNOW, WE 4475 02:50:28,840 --> 02:50:29,480 AGREE IT'S IMPORTANT BUT THERE 4476 02:50:29,480 --> 02:50:31,320 ARE A NUMBER OF AREAS WHERE WE 4477 02:50:31,320 --> 02:50:33,440 THINK THE DOCUMENT COULD BE 4478 02:50:33,440 --> 02:50:33,920 IMPROVED. 4479 02:50:33,920 --> 02:50:35,040 ITS CURRENT STRUCTURE IS BROKEN 4480 02:50:35,040 --> 02:50:42,320 DOWN BETWEEN POINTS TO CONSIDER, 4481 02:50:42,320 --> 02:50:44,040 BEST PRACTICES, AND WHATEVER THE 4482 02:50:44,040 --> 02:50:45,640 THIRD BUCKET IS. 4483 02:50:45,640 --> 02:50:47,120 AND WE THINK THERE'S SOME 4484 02:50:47,120 --> 02:50:49,520 OPPORTUNITY TO REFINE THOSE AND 4485 02:50:49,520 --> 02:50:51,080 MAYBE REORGANIZE AND SCENARIOS 4486 02:50:51,080 --> 02:50:52,920 WHERE WE BELIEVE ADDITIONAL 4487 02:50:52,920 --> 02:50:54,760 INFORMATION WOULD BE BENEFICIAL 4488 02:50:54,760 --> 02:50:57,240 TO THE INTENDED COMMUNITY OF 4489 02:50:57,240 --> 02:50:58,440 RECIPIENTS OF THIS DOCUMENT. 4490 02:50:58,440 --> 02:51:00,360 SO, I'LL START WITH JUST THE 4491 02:51:00,360 --> 02:51:01,680 GENERAL OBSERVATIONS BEFORE WE 4492 02:51:01,680 --> 02:51:04,200 GET INTO THE SPECIFICS OF THE 4493 02:51:04,200 --> 02:51:05,080 DOCUMENT. 4494 02:51:05,080 --> 02:51:06,480 AND, YOU KNOW, HERE I THINK ONE 4495 02:51:06,480 --> 02:51:07,920 OF THE BIGGEST THINGS THE 4496 02:51:07,920 --> 02:51:09,000 SUBCOMMITTEE MEMBERS NOTED AS WE 4497 02:51:09,000 --> 02:51:13,520 STARTED TO LOOK AT THE DOCUMENT 4498 02:51:13,520 --> 02:51:14,920 WAS THAT THERE ARE A NUMBER OF 4499 02:51:14,920 --> 02:51:17,120 TERMS THAT ARE SORT OF USED 4500 02:51:17,120 --> 02:51:22,600 THROUGHOUT THAT DON'T MAKE IT 4501 02:51:22,600 --> 02:51:23,800 CLEAR WHAT IS EXPECTED OR, YOU 4502 02:51:23,800 --> 02:51:25,680 KNOW, WHAT MIGHT BE REQUIRED BY 4503 02:51:25,680 --> 02:51:27,120 THE POLICIES, REFLECTED IN THIS 4504 02:51:27,120 --> 02:51:28,400 DOCUMENT, WHAT IS REALLY A BEST 4505 02:51:28,400 --> 02:51:30,600 PRACTICE OR WHAT IS SOMETHING TO 4506 02:51:30,600 --> 02:51:32,760 JUST THINK ABOUT AND I THINK WE 4507 02:51:32,760 --> 02:51:36,600 THINK THAT THAT SORT OF SOWS 4508 02:51:36,600 --> 02:51:38,600 CONFUSION KEEPING TRACK OF WHICH 4509 02:51:38,600 --> 02:51:40,240 ARE OBLIGATIONS, AND WHICH ARE 4510 02:51:40,240 --> 02:51:42,440 SOMETHING THAT'S MAYBE NICE TO 4511 02:51:42,440 --> 02:51:42,640 DO. 4512 02:51:42,640 --> 02:51:45,960 WE ALSO IN THE PARAGRAPH AT LINE 4513 02:51:45,960 --> 02:51:49,760 31 HAD CONCERNS ABOUT STATEMENTS 4514 02:51:49,760 --> 02:51:50,880 AROUND CERTIFICATES OF 4515 02:51:50,880 --> 02:51:52,080 CONFIDENTIALITY AND THE WAY THEY 4516 02:51:52,080 --> 02:51:53,400 WERE DESCRIBED IN THIS DOCUMENT, 4517 02:51:53,400 --> 02:51:55,600 AND WHEN WE GET TO THAT SECTION 4518 02:51:55,600 --> 02:51:58,120 LATER IT WILL BE MORE CLEAR, BUT 4519 02:51:58,120 --> 02:51:59,840 THAT WAS ANOTHER POINT OF 4520 02:51:59,840 --> 02:52:01,840 CONCERN WITH THE DOCUMENT. 4521 02:52:01,840 --> 02:52:03,720 AND THEN IN GENERAL THE DOCUMENT 4522 02:52:03,720 --> 02:52:06,800 OFTEN TALKS ABOUT USING 4523 02:52:06,800 --> 02:52:08,840 STANDARDIZED TEMPLATES FOR DATA 4524 02:52:08,840 --> 02:52:09,120 SHARING. 4525 02:52:09,120 --> 02:52:10,880 BUT DOESN'T REALLY TALK ABOUT 4526 02:52:10,880 --> 02:52:11,600 THE NIH DEVELOPING ONE. 4527 02:52:11,600 --> 02:52:13,560 SO THAT WILL BE ALSO A THEME YOU 4528 02:52:13,560 --> 02:52:16,200 SAW IN THE DOCUMENT WHICH IS YOU 4529 02:52:16,200 --> 02:52:18,680 SEEM TO THINK TEMPLATES ARE A 4530 02:52:18,680 --> 02:52:20,120 GREAT IDEA, MAYBE YOU SHOULD 4531 02:52:20,120 --> 02:52:21,440 CREATE ONE THAT MEETS THE 4532 02:52:21,440 --> 02:52:22,960 REQUIREMENTS OF THE POLICY SO 4533 02:52:22,960 --> 02:52:24,720 THAT'S ALSO A FAMILIAR THEME 4534 02:52:24,720 --> 02:52:26,800 THROUGHOUT THE DOCUMENT. 4535 02:52:26,800 --> 02:52:28,880 AND THEN THE FINAL GENERAL 4536 02:52:28,880 --> 02:52:30,080 OBSERVATION IS THAT WE'RE 4537 02:52:30,080 --> 02:52:32,280 TALKING ABOUT DATA PRIVACY AND 4538 02:52:32,280 --> 02:52:32,920 IDENTIFIABLE PRIVATE 4539 02:52:32,920 --> 02:52:35,320 INFORMATION, AND THAT IS 4540 02:52:35,320 --> 02:52:38,440 SOMETHING THAT RECEIVED ITS OWN 4541 02:52:38,440 --> 02:52:39,360 DEFINITION IN REVISED COMMON 4542 02:52:39,360 --> 02:52:41,200 RULE WITH THE REQUIREMENT THAT 4543 02:52:41,200 --> 02:52:46,280 DEFINITION BE EXAMINED ON A 4544 02:52:46,280 --> 02:52:47,560 PERIODIC BASIS, THAT AS FAR AS 4545 02:52:47,560 --> 02:52:50,080 WE KNOW HAS NOT BEEN INITIATED 4546 02:52:50,080 --> 02:52:50,560 YET. 4547 02:52:50,560 --> 02:52:52,360 SO THERE'S ALSO A -- WHILE MOST 4548 02:52:52,360 --> 02:52:55,880 COMMENTS ARE DIRECTED AT NIH 4549 02:52:55,880 --> 02:52:57,960 THERE'S A RECOMMENDATION THAT 4550 02:52:57,960 --> 02:53:00,720 THAT REVIEW PROCESS FOR THE 4551 02:53:00,720 --> 02:53:02,120 DEFINITION OF IDENTIFIABLE 4552 02:53:02,120 --> 02:53:05,720 PRIVATE INFORMATION BE INITIATED 4553 02:53:05,720 --> 02:53:06,080 BY OHRP. 4554 02:53:06,080 --> 02:53:14,000 SO ANY QUESTIONS OR COMMENTS ON 4555 02:53:14,000 --> 02:53:14,800 THIS GENERAL OBSERVATION 4556 02:53:14,800 --> 02:53:15,000 SECTION? 4557 02:53:15,000 --> 02:53:15,360 ALL RIGHT. 4558 02:53:15,360 --> 02:53:18,320 I'M GOING TO MOVE TO THE 4559 02:53:18,320 --> 02:53:19,200 OPERATIONAL PRINCIPLES SECTION 4560 02:53:19,200 --> 02:53:21,800 AND WATCH HANDS ON THE SCREEN 4561 02:53:21,800 --> 02:53:22,240 TOO. 4562 02:53:22,240 --> 02:53:23,200 THE OPERATIONAL PRINCIPLES IS 4563 02:53:23,200 --> 02:53:24,840 THE FIRST CHUNK OF THE DOCUMENT 4564 02:53:24,840 --> 02:53:26,200 WHERE THEY BREAK THINGS DOWN. 4565 02:53:26,200 --> 02:53:27,520 WE DIDN'T HAVE COMMENTS ON ALL. 4566 02:53:27,520 --> 02:53:30,600 THAT'S WHY YOU DON'T SEE NUMBER 4567 02:53:30,600 --> 02:53:31,440 1 HERE. 4568 02:53:31,440 --> 02:53:33,040 THERE ARE ACCEPT OPERATIONAL 4569 02:53:33,040 --> 02:53:34,280 PRINCIPLES IN THE DOCUMENT. 4570 02:53:34,280 --> 02:53:36,280 I DON'T THINK THERE'S ANYTHING 4571 02:53:36,280 --> 02:53:36,920 OBJECTIONABLE. 4572 02:53:36,920 --> 02:53:38,880 WE JUST HAVE CRITICAL COMMENTS 4573 02:53:38,880 --> 02:53:42,160 ABOUT A HANDFUL OF THEM. 4574 02:53:42,160 --> 02:53:47,600 SO THE SECOND PRINCIPLE TALKS 4575 02:53:47,600 --> 02:53:48,720 ABOUT APPROPRIATE PROTECTIONS, 4576 02:53:48,720 --> 02:53:50,920 AND SO ON. 4577 02:53:50,920 --> 02:53:53,880 AND HERE THE THEME THAT CAME OUT 4578 02:53:53,880 --> 02:53:55,760 OF THE SUBCOMMITTEE DISCUSSIONS 4579 02:53:55,760 --> 02:53:57,640 WAS THIS IDEA THE SECOND 4580 02:53:57,640 --> 02:53:58,480 OPERATIONAL PRINCIPLE SOUNDS 4581 02:53:58,480 --> 02:54:00,080 MORE LIKE A BEST PRACTICE AS IT 4582 02:54:00,080 --> 02:54:01,760 DESCRIBES THE ACTIONS TO BE 4583 02:54:01,760 --> 02:54:03,720 TAKEN BY RESEARCHERS AND THE 4584 02:54:03,720 --> 02:54:04,840 INSTITUTION, BUT AS A BEST 4585 02:54:04,840 --> 02:54:07,240 PRACTICE IT'S STILL NOT CLEAR TO 4586 02:54:07,240 --> 02:54:09,200 THE SUBCOMMITTEES WHAT THE 4587 02:54:09,200 --> 02:54:09,680 INSTITUTIONAL -- WHAT 4588 02:54:09,680 --> 02:54:11,520 INSTITUTIONAL COMPONENT OR 4589 02:54:11,520 --> 02:54:13,120 COMPONENTS WOULD BE EXPECTED TO 4590 02:54:13,120 --> 02:54:13,480 DO THIS WORK. 4591 02:54:13,480 --> 02:54:15,240 THAT COULD HAVE BEEN IN THE 4592 02:54:15,240 --> 02:54:16,360 BACKGROUND, THAT'S ALSO A THEME 4593 02:54:16,360 --> 02:54:17,640 THAT THERE'S OFTEN TALK ABOUT 4594 02:54:17,640 --> 02:54:19,760 DOING CERTAIN TIMES OF REVIEWS 4595 02:54:19,760 --> 02:54:21,480 OR CERTIFICATIONS BUT NOT A 4596 02:54:21,480 --> 02:54:23,600 CLEAR INDICATION OF WHO MIGHT BE 4597 02:54:23,600 --> 02:54:31,200 DOING THAT OR LEADING IT WITHIN 4598 02:54:31,200 --> 02:54:36,920 RESEARCH PROGRAM AT AN 4599 02:54:36,920 --> 02:54:39,520 INSTITUTION IT APPLIES. 4600 02:54:39,520 --> 02:54:40,080 THERE'S VARIABILITY AMONG 4601 02:54:40,080 --> 02:54:42,280 INSTITUTIONS, SOME ARE LARGE 4602 02:54:42,280 --> 02:54:44,240 WITH ROBUST HRPPs WITH 4603 02:54:44,240 --> 02:54:45,320 MULTIPLE COMPONENTS THAT MAY OR 4604 02:54:45,320 --> 02:54:47,000 MAY NOT INCLUDE THE IRB THAT 4605 02:54:47,000 --> 02:54:48,520 WOULD BE INVOLVED IN THIS, IN 4606 02:54:48,520 --> 02:54:51,800 OTHER PLACES MAY BE ORGANIZED 4607 02:54:51,800 --> 02:54:52,120 DIFFERENTLY. 4608 02:54:52,120 --> 02:54:54,560 SOME CLARITY AROUND, YOU KNOW, 4609 02:54:54,560 --> 02:54:56,200 WHAT ENTITY WITHIN AN 4610 02:54:56,200 --> 02:54:58,600 INSTITUTION WOULD BE DOING THESE 4611 02:54:58,600 --> 02:55:04,040 ASSESSMENTS, WOULD BE I THINK 4612 02:55:04,040 --> 02:55:05,040 HELPFUL TO INSTITUTIONS 4613 02:55:05,040 --> 02:55:11,720 ATTEMPTING TO FOLLOW THE POLICY. 4614 02:55:11,720 --> 02:55:12,360 LOIS? 4615 02:55:12,360 --> 02:55:15,880 >> IT SEEMED THAT -- I'M SORRY. 4616 02:55:15,880 --> 02:55:18,320 SO THERE ARE DIFFERENT WAYS THAT 4617 02:55:18,320 --> 02:55:19,720 LARGER INSTITUTIONS ARE SET UP 4618 02:55:19,720 --> 02:55:21,360 AND HAVE MULTIPLE COMPONENTS AND 4619 02:55:21,360 --> 02:55:23,960 IT MIGHT BE DIFFERENT IN 4620 02:55:23,960 --> 02:55:25,400 DIFFERENT PLACES BUT WHERE THEY 4621 02:55:25,400 --> 02:55:28,040 WOULD BE MOST LOGICALLY LOCATED. 4622 02:55:28,040 --> 02:55:33,160 I WONDER IF AT ISSUE IS MORE 4623 02:55:33,160 --> 02:55:35,120 THAT INSTITUTIONS HAVE A 4624 02:55:35,120 --> 02:55:37,200 RESPONSIBILITY FOR IDENTIFYING 4625 02:55:37,200 --> 02:55:40,400 WHICH OF THEIR INSTITUTIONAL 4626 02:55:40,400 --> 02:55:44,120 COMPONENT OR COMPONENTS WILL 4627 02:55:44,120 --> 02:55:45,760 UNDERTAKE THE ASSESSMENT. 4628 02:55:45,760 --> 02:55:46,440 >> FAIR POINT. 4629 02:55:46,440 --> 02:55:49,120 >> SO I HAD A LITTLE LANGUAGE ON 4630 02:55:49,120 --> 02:55:50,280 THAT IF YOU WANT. 4631 02:55:50,280 --> 02:55:51,920 >> THAT WOULD BE GREAT. 4632 02:55:51,920 --> 02:55:53,120 LANGUAGE IS DEFINITELY HELPFUL. 4633 02:55:53,120 --> 02:55:54,760 >> WANT ME TO GIVE IT TO YOU 4634 02:55:54,760 --> 02:55:54,920 NOW? 4635 02:55:54,920 --> 02:55:56,520 >> SURE. 4636 02:55:56,520 --> 02:55:57,600 >> JUST ONE SENTENCE. 4637 02:55:57,600 --> 02:55:58,560 IT COULD BE ADDED. 4638 02:55:58,560 --> 02:56:00,000 I DON'T THINK IT'S INCONSISTENT 4639 02:56:00,000 --> 02:56:02,080 WITH ANYTHING YOU SAID. 4640 02:56:02,080 --> 02:56:03,920 TO ME, IT WAS A LOGICAL 4641 02:56:03,920 --> 02:56:07,240 CULMINATION OF WHAT YOU HAD SAID 4642 02:56:07,240 --> 02:56:08,760 BEFORE, TO CONSIDER THIS 4643 02:56:08,760 --> 02:56:10,920 SENTENCE AT THE END AFTER PLUS 4644 02:56:10,920 --> 02:56:13,680 OTHERS, WHICH WOULD BE 4645 02:56:13,680 --> 02:56:16,160 INSTITUTIONS HAVE A 4646 02:56:16,160 --> 02:56:17,720 RESPONSIBILITY TO IDENTIFY THE 4647 02:56:17,720 --> 02:56:18,840 INSTITUTIONAL COMPONENT OR 4648 02:56:18,840 --> 02:56:20,280 COMPONENTS, USING YOUR LANGUAGE 4649 02:56:20,280 --> 02:56:22,200 FROM ABOVE, THAT UNDERTAKE SUCH 4650 02:56:22,200 --> 02:56:23,880 ASSESSMENTS AND TO CHARGE SUCH 4651 02:56:23,880 --> 02:56:27,360 COMPONENT OR COMPONENTS WITH 4652 02:56:27,360 --> 02:56:28,360 DOING SO. 4653 02:56:28,360 --> 02:56:30,320 THAT'S MORE LIKE GUIDANCE 4654 02:56:30,320 --> 02:56:31,160 LANGUAGE RATHER THAN THINKING 4655 02:56:31,160 --> 02:56:34,400 NIH NEEDS TO THINK ABOUT THIS SO 4656 02:56:34,400 --> 02:56:35,600 I WROTE IT. 4657 02:56:35,600 --> 02:56:39,080 >> JUST SO YOU KNOW, THIS IS THE 4658 02:56:39,080 --> 02:56:40,840 KEYBOARD, I CAN SPELL AND TYPE. 4659 02:56:40,840 --> 02:56:44,040 THE KEYBOARD IS A LITTLE -- 4660 02:56:44,040 --> 02:56:54,400 >> OH. 4661 02:56:54,400 --> 02:56:56,600 I'LL READ IT AGAIN. 4662 02:56:56,600 --> 02:56:58,320 INSTITUTIONS HAVE A 4663 02:56:58,320 --> 02:57:00,680 RESPONSIBILITY TO IDENTIFY THE 4664 02:57:00,680 --> 02:57:01,200 INSTITUTIONAL COMPONENT OR 4665 02:57:01,200 --> 02:57:06,120 COMPONENTS THAT WOULD UNDERTAKE 4666 02:57:06,120 --> 02:57:08,080 SUCH ASSESSMENTS AND TO CHARGE 4667 02:57:08,080 --> 02:57:10,480 SUCH COMPONENT OR COMPONENTS 4668 02:57:10,480 --> 02:57:14,120 WITH DOING SO. 4669 02:57:14,120 --> 02:57:17,960 WE MIGHT WANT TO SOFTEN THAT. 4670 02:57:17,960 --> 02:57:21,000 I JUST DRAFTED, THE COMMENTS, WE 4671 02:57:21,000 --> 02:57:23,840 WERE WRITING THE GUIDANCE 4672 02:57:23,840 --> 02:57:25,360 OURSELVES WHICH WE'RE NOT, SO, 4673 02:57:25,360 --> 02:57:30,400 YOU KNOW, NIH MIGHT WANT TO 4674 02:57:30,400 --> 02:57:31,040 CONSIDER REQUIRING INSTITUTIONS 4675 02:57:31,040 --> 02:57:34,560 TO IDENTIFY, SOMETHING LIKE 4676 02:57:34,560 --> 02:57:43,880 THAT. 4677 02:57:43,880 --> 02:57:45,600 I MEAN, UNLESS ANYBODY SEES A 4678 02:57:45,600 --> 02:57:47,840 PROBLEM WITH THAT. 4679 02:57:47,840 --> 02:57:48,360 OKAY. 4680 02:57:48,360 --> 02:57:55,160 >> NO, I THINK THAT'S QUITE 4681 02:57:55,160 --> 02:57:56,880 HELPFUL ACTUALLY, IN TERMS OF 4682 02:57:56,880 --> 02:57:58,440 GIVING NIH SOME GUIDANCE, YOU 4683 02:57:58,440 --> 02:58:01,320 KNOW, AS TO HOW WE THINK PART OF 4684 02:58:01,320 --> 02:58:11,720 THIS COULD BE RESOLVED. 4685 02:58:21,480 --> 02:58:22,400 ALL RIGHT. 4686 02:58:22,400 --> 02:58:23,920 INSTITUTIONS HAVE RESPONSIBILITY 4687 02:58:23,920 --> 02:58:26,160 TO IDENTIFY THE INSTITUTIONAL 4688 02:58:26,160 --> 02:58:36,560 COMPONENT OR COMPONENTS. 4689 02:58:38,840 --> 02:58:41,480 >> THAT WILL UNDERTAKE SUCH 4690 02:58:41,480 --> 02:58:51,720 ASSESSMENTS. 4691 02:58:54,240 --> 02:58:55,840 COULD CHARGE SUCH COMPONENT OR 4692 02:58:55,840 --> 02:59:06,280 COMPONENTS WITH DOING SO. 4693 02:59:34,760 --> 02:59:39,720 >> OKAY. 4694 02:59:39,720 --> 02:59:42,040 >> LIKE I SAID, I MEAN, AS YOU 4695 02:59:42,040 --> 02:59:43,640 GUYS GO BACK, IF YOU'RE GOING 4696 02:59:43,640 --> 02:59:48,960 BACK YOU MIGHT WANT TO SAY 4697 02:59:48,960 --> 02:59:51,760 INSTEAD THAT NIH MIGHT CONSIDER 4698 02:59:51,760 --> 02:59:54,280 MAKING CLEAR THAT, AND THEN YOU 4699 02:59:54,280 --> 02:59:56,200 COULD PUT THAT RIGHT BEFORE THE 4700 02:59:56,200 --> 02:59:58,760 WHOLE THING. 4701 02:59:58,760 --> 03:00:08,400 4702 03:00:08,400 --> 03:00:11,480 >> I'LL TELL YOU WHAT. 4703 03:00:11,480 --> 03:00:15,080 I'M-- THIS KEYBOARD IS HIGHLY 4704 03:00:15,080 --> 03:00:15,800 UNCOOPERATIVE. 4705 03:00:15,800 --> 03:00:17,640 I CAN REMEMBER WHAT THE REST OF 4706 03:00:17,640 --> 03:00:25,960 THAT IS. 4707 03:00:25,960 --> 03:00:28,200 >> YEAH, SURE. 4708 03:00:28,200 --> 03:00:37,400 >> OKAY. 4709 03:00:37,400 --> 03:00:41,120 THE THIRD PRINCIPLE HAS -- 4710 03:00:41,120 --> 03:00:46,600 DISCUSSES HAVING A ROBUST 4711 03:00:46,600 --> 03:00:48,800 CONSENT PROCESS, AND IT 4712 03:00:48,800 --> 03:00:50,760 INDICATES THAT THE DMS POLICY 4713 03:00:50,760 --> 03:00:52,560 DOES NOT REQUIRE SHARING OF DATA 4714 03:00:52,560 --> 03:00:54,960 IN ORDER TO PARTICIPATE. 4715 03:00:54,960 --> 03:00:56,680 AND DON'T DISAGREE WITH THAT BUT 4716 03:00:56,680 --> 03:01:00,080 WE NOTED THAT THE POLICY ALSO 4717 03:01:00,080 --> 03:01:01,600 DOESN'T PROHIBIT REQUIRING DATA 4718 03:01:01,600 --> 03:01:05,880 SHARING IN ORDER TO PARTICIPATE, 4719 03:01:05,880 --> 03:01:07,080 AND SOME SUBCOMMITTEE NOTED -- 4720 03:01:07,080 --> 03:01:09,480 SEVERAL NOTED THERE MAY BE 4721 03:01:09,480 --> 03:01:11,920 VALUABLE REASONS AND OTHER 4722 03:01:11,920 --> 03:01:20,600 POLICIES AND/OR REGULATORY 4723 03:01:20,600 --> 03:01:22,600 REQUIREMENTS FOR DATA TO BE 4724 03:01:22,600 --> 03:01:23,680 SHARED. 4725 03:01:23,680 --> 03:01:24,920 PRETTY STRAIGHTFORWARD. 4726 03:01:24,920 --> 03:01:26,480 SKIP? 4727 03:01:26,480 --> 03:01:28,880 >> IS THERE AN AMBIGUITY IN HERE 4728 03:01:28,880 --> 03:01:29,960 BETWEEN THE INSTITUTION MAKING A 4729 03:01:29,960 --> 03:01:32,520 DECISION TO SHARE THE DATA AND 4730 03:01:32,520 --> 03:01:34,360 WHETHER OR NOT THE CONSENT TO 4731 03:01:34,360 --> 03:01:37,520 SHARING THAT DATA IS A 4732 03:01:37,520 --> 03:01:39,000 REQUIREMENT FOR PARTICIPATION? 4733 03:01:39,000 --> 03:01:39,800 WHAT'S THE INTENT HERE? 4734 03:01:39,800 --> 03:01:41,240 IN OTHER WORDS, IF THERE'S A 4735 03:01:41,240 --> 03:01:44,840 TRIAL THAT OFFERS ME THE 4736 03:01:44,840 --> 03:01:46,400 POSSIBILITY OF DIRECT BENEFIT, 4737 03:01:46,400 --> 03:01:49,680 COULD I NOT ENTER THAT STUDY, IF 4738 03:01:49,680 --> 03:01:52,640 THERE WAS A REASON TO SAY YOUR 4739 03:01:52,640 --> 03:01:55,360 DATA HAD TO BE SHARED? 4740 03:01:55,360 --> 03:01:58,080 I READ THIS TO SAY THAT, YOU 4741 03:01:58,080 --> 03:01:59,560 KNOW, WHO IS IT THAT'S BEING 4742 03:01:59,560 --> 03:02:00,840 REQUIRED TO SHARE THE DATA, IS 4743 03:02:00,840 --> 03:02:01,960 IT THE INSTITUTION OR 4744 03:02:01,960 --> 03:02:03,800 PARTICIPANT MUST AGREE TO 4745 03:02:03,800 --> 03:02:06,960 SHARING OF DATA IN ORDER TO BE 4746 03:02:06,960 --> 03:02:08,760 IN THE TRIAL, I INTERPRET NIH 4747 03:02:08,760 --> 03:02:10,360 POLICY TO IMPLY YOU WOULDN'T 4748 03:02:10,360 --> 03:02:11,680 WANT TO REQUIRE SHARING OF DATA 4749 03:02:11,680 --> 03:02:15,840 TO BE IN A TRIAL. 4750 03:02:15,840 --> 03:02:18,360 BUT SEEING AMBIGUITY, TAUNTON IS 4751 03:02:18,360 --> 03:02:21,080 SHAKING HIS HEAD, THAT RAISES AN 4752 03:02:21,080 --> 03:02:23,600 ETHICAL QUESTION IN MY MIND 4753 03:02:23,600 --> 03:02:27,760 WHETHER WE REQUIRE A PARTICIPANT 4754 03:02:27,760 --> 03:02:34,120 TO BE IN A TRIAL THAT REQUIRES 4755 03:02:34,120 --> 03:02:36,400 DATA SHARING TO BE A BENEFIT. 4756 03:02:36,400 --> 03:02:40,120 >> I DON'T HAVE A READY EXAMPLE 4757 03:02:40,120 --> 03:02:44,480 OF THAT, BUT TRIALS IMPOSE ALL 4758 03:02:44,480 --> 03:02:48,480 TYPES OF BURDENS OR REQUIREMENTS 4759 03:02:48,480 --> 03:02:51,440 UPON SUBJECTS AS A CONDITION OF 4760 03:02:51,440 --> 03:02:54,280 PARTICIPATION WITHOUT REGARD TO 4761 03:02:54,280 --> 03:02:56,400 THE DIRECT BENEFIT COMPONENT OF 4762 03:02:56,400 --> 03:02:58,120 IT. 4763 03:02:58,120 --> 03:03:00,800 I COULDN'T SEE WHAT TAUNTON -- 4764 03:03:00,800 --> 03:03:02,160 HE'S BEHIND THIS PILLAR. 4765 03:03:02,160 --> 03:03:08,400 HE'S WELCOME TO COMMENT IN TERMS 4766 03:03:08,400 --> 03:03:14,080 OF AMBIGUITY, THEIR END OR OURS. 4767 03:03:14,080 --> 03:03:15,000 >> WHAT THIS BASICALLY SAYS, DMS 4768 03:03:15,000 --> 03:03:15,960 POLICY DOES NOT REQUIRE SHARING 4769 03:03:15,960 --> 03:03:17,440 OF DATA IN ORDER TO PARTICIPATE 4770 03:03:17,440 --> 03:03:21,120 SO I INTERPRET THAT TO BE THE 4771 03:03:21,120 --> 03:03:23,760 NIH WOULD NOT THAT A FILE THAT 4772 03:03:23,760 --> 03:03:24,840 OFFERS POSSIBLY DIRECT BENEFIT 4773 03:03:24,840 --> 03:03:28,480 THATTED -- THAT IN ORDER FOR ME 4774 03:03:28,480 --> 03:03:30,200 TO PARTICIPATE I DON'T HAVE TO 4775 03:03:30,200 --> 03:03:31,840 SHARE MY DATA, YOU BASICALLY 4776 03:03:31,840 --> 03:03:33,040 IMPLY THEN THERE COULD BE 4777 03:03:33,040 --> 03:03:34,000 REASONS THAT WOULD BE 4778 03:03:34,000 --> 03:03:36,080 APPROPRIATE TO SAY I CAN'T 4779 03:03:36,080 --> 03:03:36,880 PARTICIPATE UNTIL OF IN THE 4780 03:03:36,880 --> 03:03:39,160 TRIAL IF I DON'T AGREE TO 4781 03:03:39,160 --> 03:03:40,800 SHARING THE DATA WHICH IS 4782 03:03:40,800 --> 03:03:43,440 DIRECTED TO THE PARTICIPANT, NOT 4783 03:03:43,440 --> 03:03:46,120 THE INSTITUTION. 4784 03:03:46,120 --> 03:03:46,960 THAT'S THE AMBIGUITY. 4785 03:03:46,960 --> 03:03:48,480 I'M NOT SURE I WOULD AGREE WITH 4786 03:03:48,480 --> 03:03:50,400 THE IDEA IF THERE'S A TRIAL, IT 4787 03:03:50,400 --> 03:03:55,560 GETS INTO WHETHER THERE ARE 4788 03:03:55,560 --> 03:03:56,600 OTHER OPTIONS, ET CETERA. 4789 03:03:56,600 --> 03:04:00,360 >> YEAH, I DON'T KNOW HOW TO 4790 03:04:00,360 --> 03:04:01,320 RESOLVE IT. 4791 03:04:01,320 --> 03:04:03,480 I DON'T KNOW, LINDA IS YOUR HAND 4792 03:04:03,480 --> 03:04:03,840 UP? 4793 03:04:03,840 --> 03:04:07,000 IF OTHERS HAVE THOUGHTS ON THAT? 4794 03:04:07,000 --> 03:04:09,920 >> CAN I ASK TAUNTON A QUESTION? 4795 03:04:09,920 --> 03:04:13,320 >> IS THE INTENT TO SAY YOU 4796 03:04:13,320 --> 03:04:14,760 WOULD NOT REQUIRE A PARTICIPANT 4797 03:04:14,760 --> 03:04:18,560 TO SHARE DATA AS A CONDITION IN 4798 03:04:18,560 --> 03:04:19,400 PARTICIPATION OR DIRECT BENEFIT 4799 03:04:19,400 --> 03:04:21,520 OR ARE YOU TALKING ABOUT THE 4800 03:04:21,520 --> 03:04:22,680 INSTITUTION I GUESS? 4801 03:04:22,680 --> 03:04:25,000 >> THE INTENT IS TO CLARIFY WHAT 4802 03:04:25,000 --> 03:04:25,600 THE POLICY IS. 4803 03:04:25,600 --> 03:04:28,240 >> I DON'T THINK THAT MIC IS ON. 4804 03:04:28,240 --> 03:04:28,720 SPEAK LOUDLY. 4805 03:04:28,720 --> 03:04:31,120 >> I THINK THE INTENT IS TO 4806 03:04:31,120 --> 03:04:33,240 CLARIFY WHAT THE EXPECTATION OF 4807 03:04:33,240 --> 03:04:34,640 THE POLICY IS. 4808 03:04:34,640 --> 03:04:36,400 BECAUSE I THINK WE DON'T WANT A 4809 03:04:36,400 --> 03:04:38,240 SITUATION WHERE PEOPLE ARE 4810 03:04:38,240 --> 03:04:39,560 SUGGESTING THAT IT'S THE POLICY 4811 03:04:39,560 --> 03:04:41,720 THAT IS REQUIRING THEM TO DO A 4812 03:04:41,720 --> 03:04:49,640 CERTAIN THING, IF THE POLICY 4813 03:04:49,640 --> 03:04:50,280 DOESN'T ACTUALLY DOES NOT 4814 03:04:50,280 --> 03:04:51,800 ESTABLISH THAT. 4815 03:04:51,800 --> 03:04:53,360 IT DOESN'T TAKE A STANCE WHETHER 4816 03:04:53,360 --> 03:04:55,040 CONSENT HAS TO BE OBTAINED IN 4817 03:04:55,040 --> 03:04:55,880 CERTAIN CONDITIONS OR NOT. 4818 03:04:55,880 --> 03:04:57,600 IT DOES A LOT OF REMINDING 4819 03:04:57,600 --> 03:04:59,400 PEOPLE ABOUT IMPORTANCE OF 4820 03:04:59,400 --> 03:05:00,760 CONSENT BUT IT DOES NOT REQUIRE 4821 03:05:00,760 --> 03:05:02,120 -- YOU KNOW, SET THIS 4822 03:05:02,120 --> 03:05:02,960 EXPECTATION HERE. 4823 03:05:02,960 --> 03:05:04,960 SO WHAT WE WANT TO AVOID IS A 4824 03:05:04,960 --> 03:05:08,280 SITUATION WHERE PEOPLE SAY DATA 4825 03:05:08,280 --> 03:05:09,320 MANAGEMENT AND SHARING POLICY IS 4826 03:05:09,320 --> 03:05:10,760 REQUIRING US TO DO THIS 4827 03:05:10,760 --> 03:05:21,440 PARTICULAR THING BECAUSE IT'S 4828 03:05:21,440 --> 03:05:23,120 NOT. 4829 03:05:23,120 --> 03:05:25,000 >> I MEAN, AS OUR -- THE 4830 03:05:25,000 --> 03:05:26,200 STATEMENT HERE IS CONSISTENT 4831 03:05:26,200 --> 03:05:27,400 WITH THE VIEW THE POLICY DOES 4832 03:05:27,400 --> 03:05:30,160 NOT REQUIRE NOR DOES THE POLICY 4833 03:05:30,160 --> 03:05:31,000 PROHIBIT, SO FROM LOGICAL POINT 4834 03:05:31,000 --> 03:05:32,760 OF VIEW THE STATEMENT IS TRUE 4835 03:05:32,760 --> 03:05:38,240 BUT IT IS A DIFFERENT TONE 4836 03:05:38,240 --> 03:05:38,800 BASICALLY. 4837 03:05:38,800 --> 03:05:40,560 SO THE STATEMENT IS TRUE BUT 4838 03:05:40,560 --> 03:05:47,040 IT'S A VERY DIFFERENT TONE. 4839 03:05:47,040 --> 03:05:48,240 >> YEAH, NO, I AGREE. 4840 03:05:48,240 --> 03:05:50,520 YOU KNOW, I DON'T KNOW -- SO 4841 03:05:50,520 --> 03:05:51,720 PART IS WHAT'S THE PLEASURE OF 4842 03:05:51,720 --> 03:05:53,920 SACHRP HERE? 4843 03:05:53,920 --> 03:05:57,160 WE DON'T HAVE TO INCLUDE THIS 4844 03:05:57,160 --> 03:05:59,480 RESPONSE TO PRINCIPAL 3, THE 4845 03:05:59,480 --> 03:06:00,360 SUBCOMMITTEE'S THOUGHTS ON IT, 4846 03:06:00,360 --> 03:06:04,000 AND I THINK IN THE GRAND SCHEME 4847 03:06:04,000 --> 03:06:05,520 OF THINGS IT'S NOT -- IT'S 4848 03:06:05,520 --> 03:06:06,960 CERTAINLY NOT THE MOST IMPORTANT 4849 03:06:06,960 --> 03:06:08,920 PIECE OF THIS DOCUMENT I DON'T 4850 03:06:08,920 --> 03:06:09,240 THINK. 4851 03:06:09,240 --> 03:06:11,640 SO I HAVE NO PROBLEM WITH IF 4852 03:06:11,640 --> 03:06:17,640 CONSENSUS IS IT'S NOT ADDING ANY 4853 03:06:17,640 --> 03:06:19,120 VALUE TO THE OVERALL DISCUSSION 4854 03:06:19,120 --> 03:06:20,360 IT CAN COME OUT. 4855 03:06:20,360 --> 03:06:24,320 I JUST NEED TO KNOW WHAT ALL OF 4856 03:06:24,320 --> 03:06:26,000 YOU THINK ABOUT IT. 4857 03:06:26,000 --> 03:06:27,920 >> I THINK IT WOULD BE -- I 4858 03:06:27,920 --> 03:06:31,440 AGREE WITH THE TONE ISSUE. 4859 03:06:31,440 --> 03:06:32,160 I UNDERSTAND TAUNTON'S ANSWER, 4860 03:06:32,160 --> 03:06:34,160 WE'RE NOT SAYING ANYTHING ABOUT 4861 03:06:34,160 --> 03:06:37,640 THIS, BUT ESPECIALLY FOR SOME 4862 03:06:37,640 --> 03:06:43,280 REASON WITH PROHIBIT, IT HAS 4863 03:06:43,280 --> 03:06:48,760 THIS TONE OF, YOU KNOW, APPROVAL 4864 03:06:48,760 --> 03:06:50,480 OR WE THINK IT'S -- I'M 4865 03:06:50,480 --> 03:06:53,200 OVERSTATING BUT WE THINK ITS 4866 03:06:53,200 --> 03:06:57,680 JUST FINE AND GOOD FOR PEOPLE 4867 03:06:57,680 --> 03:07:00,120 TO -- OR INVESTIGATORS AND 4868 03:07:00,120 --> 03:07:03,800 INSTITUTIONS TO REQUIRE DATA 4869 03:07:03,800 --> 03:07:05,400 SHARING EVEN THOUGH THE STUDY 4870 03:07:05,400 --> 03:07:08,800 CARRIES POSSIBILITY OF A DIRECT 4871 03:07:08,800 --> 03:07:09,080 BENEFIT. 4872 03:07:09,080 --> 03:07:11,600 SO, I AGREE. 4873 03:07:11,600 --> 03:07:13,040 IT MADE ME UNCOMFORTABLE WHEN I 4874 03:07:13,040 --> 03:07:15,640 READ IT THE FIRST TIME. 4875 03:07:15,640 --> 03:07:17,640 WELL, THE POLICY DOESN'T SAY 4876 03:07:17,640 --> 03:07:19,040 THIS BUT I AGREE, I THINK 4877 03:07:19,040 --> 03:07:29,520 THERE'S A QUESTION OF TONE. 4878 03:07:29,960 --> 03:07:34,000 >> IF I CAN MAKE A SUGGESTION 4879 03:07:34,000 --> 03:07:36,960 HAVING RAISED THE ISSUE, AT 4880 03:07:36,960 --> 03:07:38,600 MINIMUM PROHIBIT COULDN'T BE 4881 03:07:38,600 --> 03:07:38,920 ITALICIZED. 4882 03:07:38,920 --> 03:07:40,360 ONE COULD HAVE A SENTENCE ALONG 4883 03:07:40,360 --> 03:07:42,120 THE LINES THIS WOULD BE A PRETTY 4884 03:07:42,120 --> 03:07:44,280 HIGH BAR, THERE WOULD HAVE TO BE 4885 03:07:44,280 --> 03:07:45,920 PRETTY DARN GOOD REASONS TO 4886 03:07:45,920 --> 03:07:46,160 REQUIRE. 4887 03:07:46,160 --> 03:07:47,840 YOU SAY THERE MAY BE VALUABLE 4888 03:07:47,840 --> 03:07:49,840 REASONS, IT'S HARD TO IMAGINE 4889 03:07:49,840 --> 03:07:53,800 WHAT THOSE MIGHT BE FRANKLY. 4890 03:07:53,800 --> 03:07:55,320 AND I COULD LIVE WITH THAT. 4891 03:07:55,320 --> 03:07:57,960 THE OTHER OPTION IS TO TAKE IT 4892 03:07:57,960 --> 03:07:59,160 OUT, BUT I WOULD DEFER TO THE 4893 03:07:59,160 --> 03:08:02,440 REST OF THE GROUP IF THEY FEEL 4894 03:08:02,440 --> 03:08:02,760 STRONGLY. 4895 03:08:02,760 --> 03:08:06,360 IT'S A HIGH BAR TO MAKE A 4896 03:08:06,360 --> 03:08:09,200 CONDITION OF PARTICIPATION 4897 03:08:09,200 --> 03:08:10,000 RELEASE OF RECORDS. 4898 03:08:10,000 --> 03:08:13,040 >> LET ME MAKE ONE POINT IN THIS 4899 03:08:13,040 --> 03:08:13,360 REGARD. 4900 03:08:13,360 --> 03:08:15,000 I'M AGNOSTIC WHETHER YOU GUYS 4901 03:08:15,000 --> 03:08:17,320 DECIDE TO KEEP THIS IN OR NOT 4902 03:08:17,320 --> 03:08:19,800 BUT ASIDE FROM NIH DATA SHARING 4903 03:08:19,800 --> 03:08:21,160 POLICY, LEAVING THAT ASIDE, WHEN 4904 03:08:21,160 --> 03:08:23,320 YOU HAVE FUNDED RESEARCH AND THE 4905 03:08:23,320 --> 03:08:25,200 INVESTIGATOR WANTS TO PUBLISH 4906 03:08:25,200 --> 03:08:27,880 THAT RESEARCH IN MANY OF THE 4907 03:08:27,880 --> 03:08:29,360 JOURNALS LIKE BMJ FOR EXAMPLE 4908 03:08:29,360 --> 03:08:31,520 YOU'RE ACTUALLY REQUIRED TO MAKE 4909 03:08:31,520 --> 03:08:34,160 THE BASELINE DATA IN AN 4910 03:08:34,160 --> 03:08:35,280 ANONYMIZED FORM AVAILABLE AND TO 4911 03:08:35,280 --> 03:08:36,240 SHARE THE DATA. 4912 03:08:36,240 --> 03:08:37,520 SO IF YOU HAVE PEOPLE WHO WANT 4913 03:08:37,520 --> 03:08:40,640 TO BE IN THE STUDY, WHETHER 4914 03:08:40,640 --> 03:08:42,360 DIRECT BENEFIT OR NOT, DON'T 4915 03:08:42,360 --> 03:08:43,600 WANT THEIR ANONYMIZED OR 4916 03:08:43,600 --> 03:08:45,760 DE-IDENTIFIED DATA TO BE SHARED, 4917 03:08:45,760 --> 03:08:47,080 THAT'S GOING TO PREVENT THE 4918 03:08:47,080 --> 03:08:48,920 SHARING OF THOSE DATA FOR THE 4919 03:08:48,920 --> 03:08:51,800 PURPOSE OF FULFILLING THE 4920 03:08:51,800 --> 03:08:56,400 MANDATES BY JOURNALS, DATA BE 4921 03:08:56,400 --> 03:08:59,240 MADE AVAILABLE EITHER ON THE 4922 03:08:59,240 --> 03:09:00,920 WEBSITE OR BY REQUEST. 4923 03:09:00,920 --> 03:09:04,880 LEAVING NIH ASIDE, THAT IS A 4924 03:09:04,880 --> 03:09:05,360 PROBLEM. 4925 03:09:05,360 --> 03:09:05,880 >> FAIR POINT. 4926 03:09:05,880 --> 03:09:09,640 I MEAN IN THE PRINCIPLE IT 4927 03:09:09,640 --> 03:09:10,920 DOESN'T TALK ABOUT DE-IDENTIFIED 4928 03:09:10,920 --> 03:09:11,520 DATA. 4929 03:09:11,520 --> 03:09:12,800 SO IF YOU ADDED DE-IDENTIFIED IN 4930 03:09:12,800 --> 03:09:15,000 FRONT OF DATA IT WOULD CERTAINLY 4931 03:09:15,000 --> 03:09:17,400 -- AND GOT RID OF ITALICS ON 4932 03:09:17,400 --> 03:09:19,240 PROHIBIT THAT WOULD MAKE IT A 4933 03:09:19,240 --> 03:09:20,360 MUCH DIFFERENT TONE. 4934 03:09:20,360 --> 03:09:21,880 >> JUST TO BE CLEAR, MY 4935 03:09:21,880 --> 03:09:22,880 UNDERSTANDING OF THE WHOLE 4936 03:09:22,880 --> 03:09:24,960 DOCUMENT WE'RE TALKING ABOUT 4937 03:09:24,960 --> 03:09:26,040 DE-IDENTIFIED OR ANONYMIZED 4938 03:09:26,040 --> 03:09:28,040 DATA, NOT TALKING ABOUT SHARING. 4939 03:09:28,040 --> 03:09:28,840 >> THAT'S FINE. 4940 03:09:28,840 --> 03:09:32,280 I WAS READING IT IN ISOLATION 4941 03:09:32,280 --> 03:09:35,680 BUT IF YOU ADD DE-IDENTIFIED IN 4942 03:09:35,680 --> 03:09:41,120 FRONT OF DATA THAT'S CERTAINLY 4943 03:09:41,120 --> 03:09:47,520 REINFORCING THAT. 4944 03:09:47,520 --> 03:09:50,120 MUCH LESS CONCERNING. 4945 03:09:50,120 --> 03:09:56,680 4946 03:09:56,680 --> 03:09:59,600 4947 03:09:59,600 --> 03:10:00,880 >> OTHER COMMENTS OR 4948 03:10:00,880 --> 03:10:01,200 SUGGESTIONS? 4949 03:10:01,200 --> 03:10:02,640 FOURTH PRINCIPLE HAS TO DO WITH 4950 03:10:02,640 --> 03:10:04,360 INSTITUTIONAL REVIEW OF THE 4951 03:10:04,360 --> 03:10:11,480 CONDITIONS FOR DATA SHARING. 4952 03:10:11,480 --> 03:10:13,120 AND THE PLACEMENT OF LIMITATIONS 4953 03:10:13,120 --> 03:10:13,920 ON FUTURE USE. 4954 03:10:13,920 --> 03:10:15,560 AND THIS IS ANOTHER ONE WHERE 4955 03:10:15,560 --> 03:10:18,400 THE BASIC THEME HERE WAS JUST 4956 03:10:18,400 --> 03:10:19,840 THE NOTION ABOUT INSTITUTIONAL 4957 03:10:19,840 --> 03:10:22,200 REVIEW AND WHO WOULD DO THAT. 4958 03:10:22,200 --> 03:10:23,960 SO, THE SUGGESTION THAT CAME OUT 4959 03:10:23,960 --> 03:10:26,160 OF THE COMMITTEE WAS TO CHANGE 4960 03:10:26,160 --> 03:10:28,280 INSTITUTIONAL REVIEW TO REVIEW 4961 03:10:28,280 --> 03:10:29,000 BY APPROPRIATE INSTITUTIONAL 4962 03:10:29,000 --> 03:10:31,200 COMPONENTS. 4963 03:10:31,200 --> 03:10:41,240 4964 03:10:43,120 --> 03:10:46,080 >> WHEN I WAS READING I HAD THE 4965 03:10:46,080 --> 03:10:49,720 SAME COMMENT AS BEFORE, MAYBE 4966 03:10:49,720 --> 03:11:00,200 ONE INSTEAD OF -- I THINK WHAT 4967 03:11:01,800 --> 03:11:04,720 SEEMS TO -- THAT NEEDS TO HAPPEN 4968 03:11:04,720 --> 03:11:08,760 IS THAT THERE'S AN 4969 03:11:08,760 --> 03:11:10,040 IDENTIFIABLE -- SOMEONE'S GOING 4970 03:11:10,040 --> 03:11:11,360 TO REVIEW IT, THE INSTITUTION 4971 03:11:11,360 --> 03:11:12,680 HAS TO TAKE RESPONSIBILITY FOR 4972 03:11:12,680 --> 03:11:14,320 FIGURING OUT SOMEBODY'S GOING TO 4973 03:11:14,320 --> 03:11:16,520 REVIEW IT, IT'S THEM IN THIS 4974 03:11:16,520 --> 03:11:17,960 INSTITUTION, AND THAT 4975 03:11:17,960 --> 03:11:18,840 INSTITUTION IT'S ANOTHER PLACE, 4976 03:11:18,840 --> 03:11:20,240 SAME COMMENT I HAD BEFORE IF YOU 4977 03:11:20,240 --> 03:11:23,960 WANT TO JUST LOOK AT THAT. 4978 03:11:23,960 --> 03:11:25,000 >> YEAH. 4979 03:11:25,000 --> 03:11:25,240 AND -- 4980 03:11:25,240 --> 03:11:27,760 >> INSTEAD OF NIH -- INSTEAD OF 4981 03:11:27,760 --> 03:11:29,880 SAYING NIH NEEDS TO IDENTIFY 4982 03:11:29,880 --> 03:11:30,960 WHICH INSTITUTIONAL COMPONENT 4983 03:11:30,960 --> 03:11:33,480 COULD DO THIS IT SEEMS INSTEAD 4984 03:11:33,480 --> 03:11:35,560 NIH SHOULD SAY TO INSTITUTIONS, 4985 03:11:35,560 --> 03:11:37,200 YOU FIGURE OUT WHICH 4986 03:11:37,200 --> 03:11:38,320 INSTITUTIONAL COMPONENT WILL DO 4987 03:11:38,320 --> 03:11:44,080 THIS BUT MAKE SURE THERE IS ONE. 4988 03:11:44,080 --> 03:11:44,400 >> RIGHT. 4989 03:11:44,400 --> 03:11:47,160 >> YEAH, THIS ONE THE WORDING IS 4990 03:11:47,160 --> 03:11:50,320 DIFFERENT, SWITCHED TO REVIEW BY 4991 03:11:50,320 --> 03:11:50,880 APPROPRIATE INSTITUTIONAL 4992 03:11:50,880 --> 03:11:52,920 COMPONENTS WOULD SORT OF PUSH 4993 03:11:52,920 --> 03:12:00,240 THAT QUESTION BACK TO THE 4994 03:12:00,240 --> 03:12:03,720 INSTITUTION HOLDING THE DATA. 4995 03:12:03,720 --> 03:12:04,920 >> YOU MIGHT BE RIGHT. 4996 03:12:04,920 --> 03:12:06,440 I'LL KEEP LOOKING AT IT. 4997 03:12:06,440 --> 03:12:10,800 YOU CAN MOVE ON. 4998 03:12:10,800 --> 03:12:11,080 >> OKAY. 4999 03:12:11,080 --> 03:12:11,800 FIFTH PRINCIPLE ADDRESSED 5000 03:12:11,800 --> 03:12:14,560 COLLECTION OF DATA FROM WHAT THE 5001 03:12:14,560 --> 03:12:18,600 DOCUMENT CALLS NON-TRADITIONAL 5002 03:12:18,600 --> 03:12:20,760 RESEARCH SETTINGS, EXAMPLES ARE 5003 03:12:20,760 --> 03:12:22,720 CONSUMER REPORTS, PUBLIC HEALTH 5004 03:12:22,720 --> 03:12:24,520 SURVEILLANCE, NOTE THEY MAY 5005 03:12:24,520 --> 03:12:27,600 WARRANT -- ALSO WARRANT STRICT 5006 03:12:27,600 --> 03:12:31,320 PRIVACY CONSIDERATIONS, THE 5007 03:12:31,320 --> 03:12:32,680 SUBCOMMITTEE HAD DIFFICULTY. 5008 03:12:32,680 --> 03:12:34,680 WE DIDN'T SENSE CLEAR DIRECTION 5009 03:12:34,680 --> 03:12:35,440 COMING FROM IT AND THAT PERHAPS 5010 03:12:35,440 --> 03:12:37,320 SOME OF THE ELEMENTS OF THIS 5011 03:12:37,320 --> 03:12:38,080 PRINCIPLE SHOULD MOVE TO THE 5012 03:12:38,080 --> 03:12:41,560 BEGINNING OF THE DOCUMENT AND 5013 03:12:41,560 --> 03:12:43,000 TALK ABOUT THE EVOLVING NATURE 5014 03:12:43,000 --> 03:12:45,200 OF SOURCES OF DATA THAT MAY BE 5015 03:12:45,200 --> 03:12:46,880 IDENTIFIABLE AND PROMOTE PRIVACY 5016 03:12:46,880 --> 03:12:51,440 PROTECTIONS REGARDLESS OF THE 5017 03:12:51,440 --> 03:12:51,640 SOURCE. 5018 03:12:51,640 --> 03:12:53,760 AND TAKE IT OUT OF THESE 5019 03:12:53,760 --> 03:12:57,240 PRINCIPLES IN THAT SENSE. 5020 03:12:57,240 --> 03:13:01,120 AND THERE WAS SOME CONCERN SOME 5021 03:13:01,120 --> 03:13:06,000 OF THE SOURCES THAT ARE 5022 03:13:06,000 --> 03:13:07,720 IDENTIFIED HERE AREN'T 5023 03:13:07,720 --> 03:13:09,800 APPROPRIATELY CATEGORIZED AS 5024 03:13:09,800 --> 03:13:12,200 NON-TRADITIONAL PUBLIC HEALTH 5025 03:13:12,200 --> 03:13:13,760 SURVEILLANCE WAS EXPLICITLY 5026 03:13:13,760 --> 03:13:16,120 NOTED, THAT'S IN THE SUBSEQUENT 5027 03:13:16,120 --> 03:13:16,920 PARAGRAPH AT 98. 5028 03:13:16,920 --> 03:13:19,560 BUT EVEN THE MOBILE HEALTH 5029 03:13:19,560 --> 03:13:21,320 DEVICES AND SOCIAL MEDIA ARE 5030 03:13:21,320 --> 03:13:22,160 BECOMING MAINSTREAM SOURCES OF 5031 03:13:22,160 --> 03:13:25,360 DATA FOR A LOT OF RESEARCH, SO 5032 03:13:25,360 --> 03:13:30,720 WE HAD SOME CHALLENGES WITH THIS 5033 03:13:30,720 --> 03:13:33,240 PARTICULAR PRINCIPLE AND ALSO 5034 03:13:33,240 --> 03:13:37,720 CALLED OUT PREVIOUS 5035 03:13:37,720 --> 03:13:41,000 RECOMMENDATIONS BY SACHRP ON 5036 03:13:41,000 --> 03:13:42,760 ISSUES RELATED TO END USER 5037 03:13:42,760 --> 03:13:48,560 AGREEMENTS IN TERMS OF USE FOR 5038 03:13:48,560 --> 03:13:50,000 MOBILE DEVICES, CONSUMER DEVICES 5039 03:13:50,000 --> 03:13:51,120 THAT RECORD IDENTIFIABLE PRIVATE 5040 03:13:51,120 --> 03:13:53,240 DATA. 5041 03:13:53,240 --> 03:13:57,720 5042 03:13:57,720 --> 03:13:59,160 >> I REALLY LIKE THIS ONE, HOW 5043 03:13:59,160 --> 03:14:01,800 IT'S WORDED. 5044 03:14:01,800 --> 03:14:02,520 >> OH GOOD. 5045 03:14:02,520 --> 03:14:04,120 I WASN'T SURE IF YOU SAID REALLY 5046 03:14:04,120 --> 03:14:05,480 LIKE OR NOT LIKE. 5047 03:14:05,480 --> 03:14:07,880 YOU WERE NODDING SO I HOPE IT 5048 03:14:07,880 --> 03:14:09,240 WAS THE LIKE PART. 5049 03:14:09,240 --> 03:14:18,840 ANY OTHER COMMENTS OR 5050 03:14:18,840 --> 03:14:24,680 SUGGESTIONS FOR IMPROVEMENT? 5051 03:14:24,680 --> 03:14:26,320 PRINCIPLE 6 TALKS ABOUT 5052 03:14:26,320 --> 03:14:27,520 JUSTIFIABLE EXCEPTIONS TO 5053 03:14:27,520 --> 03:14:33,200 SHARING DATA REGARDLESS OF THE 5054 03:14:33,200 --> 03:14:35,520 SUFFICIENCY OF CONTROL AN 5055 03:14:35,520 --> 03:14:38,480 TECHNIQUE, RESEARCHERS SHOULD 5056 03:14:38,480 --> 03:14:39,560 OUTLINE JUSTIFICATIONS. 5057 03:14:39,560 --> 03:14:44,160 SUBCOMMITTEES, WE AGREED WITH 5058 03:14:44,160 --> 03:14:45,200 PRINCIPLES POINT THAT THERE WAS 5059 03:14:45,200 --> 03:14:49,200 EXCEPTION THAT NEEDS TO BE MADE. 5060 03:14:49,200 --> 03:14:51,600 HOWEVER, IN TERMS OF BEING A 5061 03:14:51,600 --> 03:14:54,440 GUIDANCE DOCUMENT IT DIDN'T SEEM 5062 03:14:54,440 --> 03:14:57,040 HELPFUL TO NOT SAY HERE ARE SOME 5063 03:14:57,040 --> 03:15:01,120 EXAMPLES WHAT THE JUSTIFICATIONS 5064 03:15:01,120 --> 03:15:02,080 MIGHT BE. 5065 03:15:02,080 --> 03:15:04,200 AND HOW AN INSTITUTIONAL 5066 03:15:04,200 --> 03:15:05,240 COMPONENT THAT'S REVIEWING THIS 5067 03:15:05,240 --> 03:15:13,040 MIGHT DETERMINE WHETHER OR NOT 5068 03:15:13,040 --> 03:15:16,120 THEY ARE JUSTIFIED. 5069 03:15:16,120 --> 03:15:16,520 SKIP? 5070 03:15:16,520 --> 03:15:18,280 >> THE QUESTION, CAN WE COME UP 5071 03:15:18,280 --> 03:15:20,360 WITH SOME IDEAS WHAT THAT MIGHT 5072 03:15:20,360 --> 03:15:22,160 BE OR IS THIS SIMPLY A STATEMENT 5073 03:15:22,160 --> 03:15:23,120 THAT WE DON'T KNOW EVERYTHING 5074 03:15:23,120 --> 03:15:26,600 AND MAYBE THERE'S SOMETHING WE 5075 03:15:26,600 --> 03:15:27,800 DON'T KNOW? 5076 03:15:27,800 --> 03:15:30,440 THIS GROUP CAN'T COME WITH AN 5077 03:15:30,440 --> 03:15:31,320 EXCEPTION, MAYBE NIH COULD. 5078 03:15:31,320 --> 03:15:34,360 DO YOU HAVE ONE IN MIND THAT I'M 5079 03:15:34,360 --> 03:15:36,880 NOT SAYING PUT IT IN BUT WHAT IN 5080 03:15:36,880 --> 03:15:38,440 YOUR MIND MIGHT BE ONE? 5081 03:15:38,440 --> 03:15:40,720 >> MY MEMORY OF THE SUBCOMMITTEE 5082 03:15:40,720 --> 03:15:45,200 MEETING WE DID NOT COME UP WITH 5083 03:15:45,200 --> 03:15:51,560 ANY OFF THE TOP OF OUR HEAD 5084 03:15:51,560 --> 03:15:53,080 EXAMPLES OF THIS. 5085 03:15:53,080 --> 03:15:55,480 >> THIS WOULD BE ASIDE FROM THE 5086 03:15:55,480 --> 03:15:58,360 TRIBAL EXCEPTION, THIS IS 5087 03:15:58,360 --> 03:15:59,040 DIFFERENT? 5088 03:15:59,040 --> 03:15:59,600 >> RIGHT. 5089 03:15:59,600 --> 03:16:01,080 >> THIS MAY OPEN THE DOOR TO SAY 5090 03:16:01,080 --> 03:16:02,760 WE MAY NOT KNOW EVERYTHING, IF 5091 03:16:02,760 --> 03:16:04,480 YOU THINK THERE'S EXCEPTION PUT 5092 03:16:04,480 --> 03:16:05,600 ANYTIME THE DOCUMENT. 5093 03:16:05,600 --> 03:16:05,840 >> YEAH. 5094 03:16:05,840 --> 03:16:08,320 >> IF A GROUP OF SMART PEOPLE 5095 03:16:08,320 --> 03:16:10,240 HAS NO EXCEPTION AT THE MOMENT 5096 03:16:10,240 --> 03:16:12,840 THIS MAY BE -- SO IT'S FINE TO 5097 03:16:12,840 --> 03:16:16,320 LEAVE IT IN BUT I CAN'T -- MAY 5098 03:16:16,320 --> 03:16:18,600 OR MAY NOT HAVE ONE IN OUR OWN 5099 03:16:18,600 --> 03:16:18,840 MIND. 5100 03:16:18,840 --> 03:16:22,360 IF WE DO SHOULD ADD AN EXAMPLE. 5101 03:16:22,360 --> 03:16:24,640 >> AGAIN, I THINK AT THE 5102 03:16:24,640 --> 03:16:25,720 SUBCOMMITTEE LEVEL WE DIDN'T, 5103 03:16:25,720 --> 03:16:29,760 AND THE NIH DOCUMENT CLEARLY 5104 03:16:29,760 --> 03:16:34,800 DOESN'T, BUT ALSO SEEMS TO 5105 03:16:34,800 --> 03:16:37,760 ACCEPT THE FACT MAY BE 5106 03:16:37,760 --> 03:16:39,600 JUSTIFIABLE EXCEPTIONS, SO 5107 03:16:39,600 --> 03:16:46,720 ANTICIPATING IT BUT WE DIDN'T 5108 03:16:46,720 --> 03:16:47,320 HAVE ANY EXAMPLES. 5109 03:16:47,320 --> 03:16:48,880 >> IT STRIKES ME AS LANGUAGE YOU 5110 03:16:48,880 --> 03:16:51,160 SEE IN ALL THE FDA GUIDANCE 5111 03:16:51,160 --> 03:16:52,880 DOCUMENTS WHICH SAY IF YOU HAVE 5112 03:16:52,880 --> 03:17:03,360 A BETTER IDEA PLEASE TELL US, 5113 03:17:04,000 --> 03:17:04,560 BASICALLY. 5114 03:17:04,560 --> 03:17:05,360 >> ALL RIGHT. 5115 03:17:05,360 --> 03:17:10,000 FOR NOW I'LL LEAVE IT AS IT IS. 5116 03:17:10,000 --> 03:17:16,640 AND THEN LINE 107 THE SEVENTH 5117 03:17:16,640 --> 03:17:19,160 PRINCIPLE OF DATA SHARING 5118 03:17:19,160 --> 03:17:21,680 PRACTICES, THIS MAKES SENSE FOR 5119 03:17:21,680 --> 03:17:22,640 THE SUBCOMMITTEE BUT WOULD SAY 5120 03:17:22,640 --> 03:17:24,720 PUT THIS IN THE BEGINNING, IN 5121 03:17:24,720 --> 03:17:27,240 THE INTRODUCTION, BECAUSE IT'S 5122 03:17:27,240 --> 03:17:28,680 JUST TALKING ABOUT RESPONSIBLE 5123 03:17:28,680 --> 03:17:31,400 DATA SHARING PRACTICES REQUIRE 5124 03:17:31,400 --> 03:17:31,720 COMMITMENT. 5125 03:17:31,720 --> 03:17:39,200 I MEAN, WE DIDN'T THINK IT FIT 5126 03:17:39,200 --> 03:17:46,240 WELL IN THE PRINCIPLES. 5127 03:17:46,240 --> 03:17:48,040 >> DO YOU WANT TO SAY ANYTHING 5128 03:17:48,040 --> 03:17:49,440 ABOUT THE NIH COMMITMENT TO 5129 03:17:49,440 --> 03:17:52,480 ENFORCE THE TERMS OF DATA USE 5130 03:17:52,480 --> 03:17:52,960 AGREEMENTS? 5131 03:17:52,960 --> 03:17:54,040 IS THERE ANYTHING THAT NIH WOULD 5132 03:17:54,040 --> 03:17:57,480 LIKE TO SAY MORE ABOUT HOW THEY 5133 03:17:57,480 --> 03:17:58,720 MAY DO IT? 5134 03:17:58,720 --> 03:18:00,040 DOES THE RESEARCH COMMUNITY NEED 5135 03:18:00,040 --> 03:18:02,560 TO KNOW THAT IS WHAT I'M ASKING. 5136 03:18:02,560 --> 03:18:04,800 >> WELL, I DON'T KNOW THE 5137 03:18:04,800 --> 03:18:05,120 ANSWER. 5138 03:18:05,120 --> 03:18:06,320 TAUNTON MIGHT KNOW. 5139 03:18:06,320 --> 03:18:07,600 I KNOW THAT WAS SOMETHING THAT 5140 03:18:07,600 --> 03:18:08,800 BRIEFLY CAME UP IN THE 5141 03:18:08,800 --> 03:18:10,160 SUBCOMMITTEE CALL BUT DIDN'T 5142 03:18:10,160 --> 03:18:11,040 MAKE IT INTO THIS DOCUMENT. 5143 03:18:11,040 --> 03:18:12,120 I DON'T REMEMBER WHY. 5144 03:18:12,120 --> 03:18:14,080 I THINK BECAUSE WE DIDN'T HAVE 5145 03:18:14,080 --> 03:18:15,600 AN ANSWER WE JUST SAID DOES 5146 03:18:15,600 --> 03:18:16,800 ANYBODY KNOW ANYTHING ABOUT THE 5147 03:18:16,800 --> 03:18:18,880 NIH HOW THEY INTEND TO ENFORCE 5148 03:18:18,880 --> 03:18:21,840 OR WHAT THE MECHANISM IS, AND WE 5149 03:18:21,840 --> 03:18:22,920 DIDN'T KNOW. 5150 03:18:22,920 --> 03:18:24,680 IF YOU THINK THERE'S A STATEMENT 5151 03:18:24,680 --> 03:18:28,640 TO PUT IN HERE THAT POINTS TO 5152 03:18:28,640 --> 03:18:34,680 THAT, I'M HAPPY TO TYPE IT OUT. 5153 03:18:34,680 --> 03:18:36,280 >> I DON'T HAVE. 5154 03:18:36,280 --> 03:18:38,160 >> THIS IS A REQUIREMENT TO 5155 03:18:38,160 --> 03:18:43,120 SUBMIT YOUR DATA SHARING PLAN AS 5156 03:18:43,120 --> 03:18:46,760 PART OF YOUR APPLICATION. 5157 03:18:46,760 --> 03:18:48,640 WHY WOULD COMPLIANCE BE 5158 03:18:48,640 --> 03:18:50,200 DIVERSITY ANY DIFFERENTLY THAN 5159 03:18:50,200 --> 03:18:50,440 THE GRANT? 5160 03:18:50,440 --> 03:18:51,400 IT'S A DOCUMENT THAT GOES IN 5161 03:18:51,400 --> 03:18:52,200 WITH THE GRANT. 5162 03:18:52,200 --> 03:18:54,200 IF YOU'RE OUT OF COMPLIANCE WITH 5163 03:18:54,200 --> 03:18:56,080 SOME PORTION OF THE GRANT NIH 5164 03:18:56,080 --> 03:18:58,480 CAN DO WHATEVER NIH DOES, I 5165 03:18:58,480 --> 03:19:00,040 DON'T KNOW WHY IT WOULD BE 5166 03:19:00,040 --> 03:19:02,120 UNIQUE TO THIS. 5167 03:19:02,120 --> 03:19:05,400 I DON'T DO THIS, FOR THOSE 5168 03:19:05,400 --> 03:19:07,680 INVOLVED IN ADMINISTRATION OF 5169 03:19:07,680 --> 03:19:08,960 GRANTS I ASSUME IT WOULD BE 5170 03:19:08,960 --> 03:19:10,880 DEALT WITH IN THE SAME WAY. 5171 03:19:10,880 --> 03:19:15,560 IS THAT A REASONABLE ASSUMPTION? 5172 03:19:15,560 --> 03:19:18,000 5173 03:19:18,000 --> 03:19:20,360 >> I THINK IT IS. 5174 03:19:20,360 --> 03:19:23,440 >> NEXT SECTION WAS BEST 5175 03:19:23,440 --> 03:19:23,800 PRACTICES. 5176 03:19:23,800 --> 03:19:26,200 IN THIS WE DO HAVE A SECTION ON 5177 03:19:26,200 --> 03:19:27,280 THE VARIOUS BEST PRACTICES BUT 5178 03:19:27,280 --> 03:19:33,040 ONE OF THE THINGS THE 5179 03:19:33,040 --> 03:19:35,040 SUBCOMMITTEE STRUGGLED WITH WAS, 5180 03:19:35,040 --> 03:19:37,760 YOU KNOW, LOOKING AT THEM IN 5181 03:19:37,760 --> 03:19:39,520 ISOLATION VERSUS LOOKING AT THEM 5182 03:19:39,520 --> 03:19:41,720 AS A BUNDLED SET OF BEST 5183 03:19:41,720 --> 03:19:43,320 PRACTICES BECAUSE GUIDANCE 5184 03:19:43,320 --> 03:19:45,320 DOCUMENT ITSELF SAYS THESE ARE 5185 03:19:45,320 --> 03:19:50,800 MEANT TO ALL WORK TOGETHER TO 5186 03:19:50,800 --> 03:19:51,960 ENCOURAGE BEST PRACTICES, BUT WE 5187 03:19:51,960 --> 03:19:54,120 COULDN'T HELP BUT LOOKING AT 5188 03:19:54,120 --> 03:19:58,360 THEM ON SORT OF A POINT-BY-POINT 5189 03:19:58,360 --> 03:19:59,000 BASIS. 5190 03:19:59,000 --> 03:20:00,960 I THINK THAT JUST HAS TO BE KEPT 5191 03:20:00,960 --> 03:20:02,640 IN MIND WHEN LOOKING AT THE 5192 03:20:02,640 --> 03:20:04,240 PROPOSED COMMENTS ON EACH BEST 5193 03:20:04,240 --> 03:20:05,160 PRACTICE, BUT WE COULDN'T COME 5194 03:20:05,160 --> 03:20:09,720 UP WITH A GOOD WAY TO SORT OF 5195 03:20:09,720 --> 03:20:14,760 TAKE OUR POINT-BY-POINT PIECES 5196 03:20:14,760 --> 03:20:18,400 AND PACKAGE THEM AS AN 5197 03:20:18,400 --> 03:20:19,560 OVERARCHING BULK RECOMMENDATION 5198 03:20:19,560 --> 03:20:20,120 ABOUT THEM. 5199 03:20:20,120 --> 03:20:22,360 WE MIGHT HAVE WITH MORE TIME BUT 5200 03:20:22,360 --> 03:20:24,840 THIS WAS A -- WE DIDN'T HAVE AS 5201 03:20:24,840 --> 03:20:26,680 MUCH TIME AS USUAL WITH THE PREP 5202 03:20:26,680 --> 03:20:29,320 OF THIS DOCUMENT. 5203 03:20:29,320 --> 03:20:31,600 FIRST BEST PRACTICE ENSURING 5204 03:20:31,600 --> 03:20:32,360 APPROPRIATE DE-IDENTIFICATION 5205 03:20:32,360 --> 03:20:34,000 AND WE START OFF BY, AGAIN, 5206 03:20:34,000 --> 03:20:35,760 NOTING THAT THE DOCUMENT ITSELF 5207 03:20:35,760 --> 03:20:39,480 WHEN IT TALKS IN THIS SECTION 5208 03:20:39,480 --> 03:20:45,080 THEY EXPLICITTY CITE COMMON RULE 5209 03:20:45,080 --> 03:20:46,480 AND HIPAA AS STANDARDS FOR 5210 03:20:46,480 --> 03:20:47,880 IDENTIFIABLE, ANOTHER PLACE 5211 03:20:47,880 --> 03:20:50,440 WHETHER WE NOTED, ONE, THERE'S 5212 03:20:50,440 --> 03:20:55,560 DIFFERENCES BETWEEN THE TWO, AND 5213 03:20:55,560 --> 03:20:58,360 IT'S NOT CLEAR WHETHER THE NIH 5214 03:20:58,360 --> 03:21:02,000 EXPECTS BOTH TO BE FOLLOWED 5215 03:21:02,000 --> 03:21:03,000 REGARDLESS OF APPLICABILITY, AND 5216 03:21:03,000 --> 03:21:05,080 THE PREVIOUS NOTE THAT WAS 5217 03:21:05,080 --> 03:21:05,800 MENTIONED THAT THE DEFINITION 5218 03:21:05,800 --> 03:21:08,600 WITHIN THE COMMON RULE IS 5219 03:21:08,600 --> 03:21:12,960 SUBJECT TO REEVALUATION AND 5220 03:21:12,960 --> 03:21:14,160 POSSIBLY CHANGE. 5221 03:21:14,160 --> 03:21:16,680 SO THAT'S THE FIRST PARAGRAPH. 5222 03:21:16,680 --> 03:21:19,480 THE SECOND PARAGRAPH TALKS ABOUT 5223 03:21:19,480 --> 03:21:20,920 IDENTIFYING, YOU KNOW, WOULD BE 5224 03:21:20,920 --> 03:21:21,920 HELPFUL TO IDENTIFY CURRENT BEST 5225 03:21:21,920 --> 03:21:24,760 PRACTICES OR LINK TO RELEVANT 5226 03:21:24,760 --> 03:21:26,920 RESOURCES, FOR THE RESEARCH 5227 03:21:26,920 --> 03:21:28,800 COMMUNITY, AND THAT THE NIH 5228 03:21:28,800 --> 03:21:32,560 SHOULD CLARIFY WHO HAS THE 5229 03:21:32,560 --> 03:21:33,760 RESPONSIBILITY FOR EVALUATING 5230 03:21:33,760 --> 03:21:37,560 ADEQUACY OF METHODS EMPLOYED BY 5231 03:21:37,560 --> 03:21:38,640 DATA HOLDERS. 5232 03:21:38,640 --> 03:21:41,520 AND THEN WE NOTE IF 5233 03:21:41,520 --> 03:21:42,240 RE-IDENTIFICATION IS POSSIBLE 5234 03:21:42,240 --> 03:21:43,600 ANY INFORMATION REGARDING DATA 5235 03:21:43,600 --> 03:21:45,000 SHARING PROVIDED TO PARTICIPANTS 5236 03:21:45,000 --> 03:21:47,040 SHOULD INCLUDE INFORMATION ABOUT 5237 03:21:47,040 --> 03:21:48,400 THE POSSIBILITY OF 5238 03:21:48,400 --> 03:21:49,040 RE-IDENTIFICATION. 5239 03:21:49,040 --> 03:21:50,800 AND THERE'S A SENTENCE IN THE 5240 03:21:50,800 --> 03:21:52,440 SECTION THAT WE RECOMMENDED 5241 03:21:52,440 --> 03:21:53,720 DELETING, THAT STATES IN THOSE 5242 03:21:53,720 --> 03:21:54,840 CASES DATA SHARING MAY BE 5243 03:21:54,840 --> 03:21:56,520 SUBJECT TO PARTICULAR RULES AND 5244 03:21:56,520 --> 03:21:58,280 RESEARCHERS SHOULD ALSO CONSIDER 5245 03:21:58,280 --> 03:22:00,800 WHETHER OTHER RELEVANT 5246 03:22:00,800 --> 03:22:02,560 PROTECTION SHOULD BE EMPLOYED. 5247 03:22:02,560 --> 03:22:10,960 WE RECOMMENDED TAKING THAT OUT 5248 03:22:10,960 --> 03:22:21,240 OF THE GUIDANCE. 5249 03:22:23,080 --> 03:22:24,640 LOIS THIS GETS TO YOUR IDEA, THE 5250 03:22:24,640 --> 03:22:25,840 THEME OF DOES THE NIH SAY WHO 5251 03:22:25,840 --> 03:22:30,240 DOES THIS OR THAT IT'S AN 5252 03:22:30,240 --> 03:22:31,000 INSTITUTIONAL -- INSTITUTIONS 5253 03:22:31,000 --> 03:22:31,760 HAVE REQUIREMENTS TO DO THIS AND 5254 03:22:31,760 --> 03:22:33,520 THEY CAN FIGURE IT OUT, THEY 5255 03:22:33,520 --> 03:22:41,880 JUST HAVE TO DO IT. 5256 03:22:41,880 --> 03:22:44,200 WE'LL MAKE SURE WE'VE USED 5257 03:22:44,200 --> 03:22:44,840 CONSISTENTLY LANGUAGE ALONG 5258 03:22:44,840 --> 03:22:47,680 THOSE LINES AT EACH OF THE 5259 03:22:47,680 --> 03:22:58,080 PLACES WE'VE MADE THAT COMMENT. 5260 03:22:58,080 --> 03:22:58,360 >> WALTER? 5261 03:22:58,360 --> 03:22:58,720 >> STANDARDS FOR 5262 03:22:58,720 --> 03:23:00,680 DE-IDENTIFICATION ARE A BIT OF A 5263 03:23:00,680 --> 03:23:05,520 MOVING TARGET, AND SO THERE 5264 03:23:05,520 --> 03:23:09,360 MIGHT BE A STATEMENT IN THE -- 5265 03:23:09,360 --> 03:23:15,960 IN THE DOCUMENT INDICATING THIS 5266 03:23:15,960 --> 03:23:18,360 IS FLUID TO CURRENT STANDARDS 5267 03:23:18,360 --> 03:23:20,080 ONE COULD REFERENCE THESE ARE 5268 03:23:20,080 --> 03:23:20,360 EVOLVEING 5269 03:23:20,360 --> 03:23:22,840 >> WALTER, IS THAT SOMETHING YOU 5270 03:23:22,840 --> 03:23:24,560 SEE FALLING HERE OR IS IT MORE 5271 03:23:24,560 --> 03:23:26,440 BACKGROUND IN THE BEGINNING OF 5272 03:23:26,440 --> 03:23:27,960 THE DOCUMENT WHEN IT'S 5273 03:23:27,960 --> 03:23:33,440 ESTABLISHING THE LANDSCAPE? 5274 03:23:33,440 --> 03:23:37,480 WE'VE TALKED ABOUT, FOR EXAMPLE, 5275 03:23:37,480 --> 03:23:38,400 ALTERNATE COLLECTION METHODS, 5276 03:23:38,400 --> 03:23:41,640 MOVING IT TO THE FRONT. 5277 03:23:41,640 --> 03:23:43,520 >> I'M AGNOSTIC ON IT, DAVID. 5278 03:23:43,520 --> 03:23:46,480 >> LET'S PUT A NOTE HERE IN 5279 03:23:46,480 --> 03:23:56,640 MYSELF. 5280 03:24:11,320 --> 03:24:12,000 >> ANOTHER BEST PRACTICE 5281 03:24:12,000 --> 03:24:16,280 ESTABLISHING SCIENTIFIC DATA 5282 03:24:16,280 --> 03:24:21,840 SHARING AND USE AGREEMENTS. 5283 03:24:21,840 --> 03:24:22,520 YOU KNOW, PERHAPS OBVIOUSLY THIS 5284 03:24:22,520 --> 03:24:24,240 IS ONE OF THE AREAS WHERE WE 5285 03:24:24,240 --> 03:24:26,080 SAID, WELL, IF IT'S A GREAT IDEA 5286 03:24:26,080 --> 03:24:28,640 PERHAPS THE NIH SHOULD COME UP 5287 03:24:28,640 --> 03:24:29,600 WITH ONE THAT INCLUDES 5288 03:24:29,600 --> 03:24:31,680 EVERYTHING THAT'S REQUIRED BY 5289 03:24:31,680 --> 03:24:32,320 THE POLICY. 5290 03:24:32,320 --> 03:24:35,840 AND THEN THIS BEST PRACTICE ALSO 5291 03:24:35,840 --> 03:24:38,160 TALKS ABOUT THAT THE AGREEMENT 5292 03:24:38,160 --> 03:24:40,680 SHOULD CLEARLY INCLUDE 5293 03:24:40,680 --> 03:24:42,080 CERTIFICATION FROM INSTITUTIONAL 5294 03:24:42,080 --> 03:24:42,560 OFFICIAL. 5295 03:24:42,560 --> 03:24:45,440 AND A NUMBER OF SUBCOMMITTEE 5296 03:24:45,440 --> 03:24:46,720 MEMBERS WERE CONCERNED THAT 5297 03:24:46,720 --> 03:24:48,640 CERTIFICATION HAS A LOT OF 5298 03:24:48,640 --> 03:24:51,240 IMPLICATIONS IN TERMS OF WHAT 5299 03:24:51,240 --> 03:24:53,880 SOMEBODY'S DOING AND IF IT'S 5300 03:24:53,880 --> 03:24:54,880 REALLY A REQUIREMENT, IT 5301 03:24:54,880 --> 03:24:56,200 SHOULDN'T BE CALLED OUT AS A 5302 03:24:56,200 --> 03:24:57,800 BEST PRACTICE, IT SHOULD BE 5303 03:24:57,800 --> 03:24:58,640 IDENTIFIED AS A REQUIREMENT 5304 03:24:58,640 --> 03:25:00,640 EITHER WITHIN THE POLICY OR IN 5305 03:25:00,640 --> 03:25:03,640 THE GUIDANCE ON IMPLEMENTING THE 5306 03:25:03,640 --> 03:25:08,240 POLICY OR IN CONTEXT OF A 5307 03:25:08,240 --> 03:25:09,000 STANDARDIZED AGREEMENT. 5308 03:25:09,000 --> 03:25:11,080 WE WEREN'T SURE HOW THAT FIT IN 5309 03:25:11,080 --> 03:25:14,120 AS A BEST PRACTICE. 5310 03:25:14,120 --> 03:25:24,160 . 5311 03:25:25,960 --> 03:25:26,080 OKAY. 5312 03:25:26,080 --> 03:25:28,720 AND THE LAST BEST PRACTICE -- 5313 03:25:28,720 --> 03:25:29,400 SORRY, SKIP. 5314 03:25:29,400 --> 03:25:32,360 >> MIGHT BE A TYPO IN THE LAST 5315 03:25:32,360 --> 03:25:34,320 SENTENCE BUT SACHRP RECOMMENDS 5316 03:25:34,320 --> 03:25:37,160 NIH WILL REQUIRE CERTIFICATION 5317 03:25:37,160 --> 03:25:41,440 THAT THIS BE INCLUDED OR THAT IT 5318 03:25:41,440 --> 03:25:43,000 BE INCLUDED? 5319 03:25:43,000 --> 03:25:45,720 EITHER THIS OR IT. 5320 03:25:45,720 --> 03:25:48,000 >> YEAH. 5321 03:25:48,000 --> 03:25:50,400 5322 03:25:50,400 --> 03:25:53,680 >> WHEN YOU GO TO THE FIRST PAGE 5323 03:25:53,680 --> 03:26:03,200 YOU TALK ABOUT THIS CONCEPT OF 5324 03:26:03,200 --> 03:26:03,880 CERTIFICATION, INSTITUTIONAL 5325 03:26:03,880 --> 03:26:06,080 CERTIFICATION, AND I'M TRYING TO 5326 03:26:06,080 --> 03:26:08,680 FIND IT. 5327 03:26:08,680 --> 03:26:09,840 5328 03:26:09,840 --> 03:26:12,720 >> IT MIGHT BE IN THE, YEAH, 5329 03:26:12,720 --> 03:26:15,040 AROUND LINE 33. 5330 03:26:15,040 --> 03:26:15,800 >> INSTITUTIONAL CERTIFICATION 5331 03:26:15,800 --> 03:26:17,360 ACTION THAT SHOULD ONLY BE 5332 03:26:17,360 --> 03:26:20,040 RAISED AS A REQUIREMENT NOT AS 5333 03:26:20,040 --> 03:26:20,960 ASPIRATIONAL GOAL. 5334 03:26:20,960 --> 03:26:21,280 OKAY. 5335 03:26:21,280 --> 03:26:23,120 THEN I GUESS YOU'RE CORRECT. 5336 03:26:23,120 --> 03:26:27,920 LATER ON YOU SAY THE SAME THING. 5337 03:26:27,920 --> 03:26:29,920 MY ONLY QUESTION IS, MAYBE IT 5338 03:26:29,920 --> 03:26:31,600 MAKES SENSE THE INSTITUTIONAL 5339 03:26:31,600 --> 03:26:33,480 OFFICIAL OR DESIGNEE, ARE YOU 5340 03:26:33,480 --> 03:26:36,600 ASSUMING IT HAS TO BE -- ARE YOU 5341 03:26:36,600 --> 03:26:38,680 DIRECTING TO INSTITUTIONAL 5342 03:26:38,680 --> 03:26:41,320 OFFICIAL OR IS IT -- IS THERE 5343 03:26:41,320 --> 03:26:42,920 SOME LATITUDE THERE THAT IS 5344 03:26:42,920 --> 03:26:43,840 GIVEN THERE? 5345 03:26:43,840 --> 03:26:45,040 WHAT ARE YOUR THOUGHTS AND 5346 03:26:45,040 --> 03:26:51,880 PRACTICE HOW THAT WOULD WORK? 5347 03:26:51,880 --> 03:26:53,680 COULD THAT BE DELEGATED? 5348 03:26:53,680 --> 03:26:54,720 I JUST DON'T REMEMBER. 5349 03:26:54,720 --> 03:26:57,040 I KNOW WE TALKED ABOUT THAT. 5350 03:26:57,040 --> 03:26:58,080 >> WE TALKED ABOUT IT. 5351 03:26:58,080 --> 03:27:05,560 AS SOMEONE WHO DOES NOT DO 5352 03:27:05,560 --> 03:27:09,120 RESEARCH ADMINISTRATION, YOU 5353 03:27:09,120 --> 03:27:12,520 KNOW, I SUSPECT THAT THE 5354 03:27:12,520 --> 03:27:14,240 SUBCOMMITTEE WOULD SAY THAT, YOU 5355 03:27:14,240 --> 03:27:16,120 KNOW, ABSENT A VERY SPECIFIC 5356 03:27:16,120 --> 03:27:19,840 REQUIREMENT IN THE POLICY, THAT 5357 03:27:19,840 --> 03:27:22,480 INSTITUTIONS SHOULD HAVE 5358 03:27:22,480 --> 03:27:24,880 FLEXIBILITY IN DECIDING HOW TO 5359 03:27:24,880 --> 03:27:25,480 DO THAT. 5360 03:27:25,480 --> 03:27:29,160 >> I WANT TO SAY ON LINE 33, 5361 03:27:29,160 --> 03:27:30,040 DESCRIBES AN INSTITUTIONAL 5362 03:27:30,040 --> 03:27:32,120 CERTIFICATION AND ACTION THAT 5363 03:27:32,120 --> 03:27:34,640 SHOULD ONLY -- OKAY, THAT PART I 5364 03:27:34,640 --> 03:27:37,040 SEE BUT WE USE THE WORD 5365 03:27:37,040 --> 03:27:37,680 INSTITUTIONAL OFFICIAL LATER. 5366 03:27:37,680 --> 03:27:38,360 >> I CAN'T REMEMBER. 5367 03:27:38,360 --> 03:27:40,560 >> IF YOU COULD TAKE A LOOK TO 5368 03:27:40,560 --> 03:27:41,960 SEE WHETHER YOU INTENDED IT TO 5369 03:27:41,960 --> 03:27:45,920 BE VERY SPECIFIC OR DID YOU JUST 5370 03:27:45,920 --> 03:27:47,440 MEAN INSTITUTIONAL, WITHOUT THE 5371 03:27:47,440 --> 03:27:50,960 OFFICIAL SIFICATION, THAT'S THE 5372 03:27:50,960 --> 03:27:53,800 QUESTION I HAVE. 5373 03:27:53,800 --> 03:27:58,320 >> WE DECIDED NOT TO USE IT. 5374 03:27:58,320 --> 03:28:00,480 >> IT'S IN THE QUOTE. 5375 03:28:00,480 --> 03:28:05,840 LINE 138, IT'S IN THE QUOTE. 5376 03:28:05,840 --> 03:28:08,920 IT'S THE NIH, ASSUMING THAT'S A 5377 03:28:08,920 --> 03:28:12,320 QUOTE FROM THE NIH. 5378 03:28:12,320 --> 03:28:13,480 THAT'S WHERE THERE'S AMBIGUITY. 5379 03:28:13,480 --> 03:28:15,000 YOU COULD ADD THAT POINT. 5380 03:28:15,000 --> 03:28:17,280 IT DOESN'T HAVE TO BE THE 5381 03:28:17,280 --> 03:28:17,760 INSTITUTION FOR SURE. 5382 03:28:17,760 --> 03:28:19,240 >> BASICALLY CLARIFY WHAT YOU 5383 03:28:19,240 --> 03:28:24,720 DID ON LINE 33. 5384 03:28:24,720 --> 03:28:25,040 THANK YOU. 5385 03:28:25,040 --> 03:28:27,440 >> YEAH, THAT ALSO FITS IN WITH 5386 03:28:27,440 --> 03:28:29,000 LOIS' THEME OF PUTTING THAT 5387 03:28:29,000 --> 03:28:30,000 RESPONSIBILITY BACK ON THE 5388 03:28:30,000 --> 03:28:32,960 INSTITUTION TO FIGURE OUT HOW TO 5389 03:28:32,960 --> 03:28:36,560 COMPLY AND USING -- WHICH 5390 03:28:36,560 --> 03:28:40,840 INSTITUTIONAL MECHANISMS TO USE 5391 03:28:40,840 --> 03:28:45,240 TO BE COMPLIANT, YEAH. 5392 03:28:45,240 --> 03:28:46,680 ALL RIGHT. 5393 03:28:46,680 --> 03:28:48,640 LAST BEST PRACTICE IS 5394 03:28:48,640 --> 03:28:49,680 UNDERSTANDING LEGAL PROTECTION 5395 03:28:49,680 --> 03:28:51,720 AGAINST DISCLOSURE AND MISUSE. 5396 03:28:51,720 --> 03:28:55,560 A FOCUS OF THIS ONE WAS 5397 03:28:55,560 --> 03:28:56,840 CERTIFICATES OF CONFIDENTIALITY. 5398 03:28:56,840 --> 03:28:58,640 SOME OF THE SUBCOMMITTEE MEMBERS 5399 03:28:58,640 --> 03:29:01,640 WERE CONCERNED IT MADE IT SOUND 5400 03:29:01,640 --> 03:29:08,360 LIKE THAT WAS THE ONLY LEGAL 5401 03:29:08,360 --> 03:29:09,440 PROTECTIONS AGAINST DISCLOSURE 5402 03:29:09,440 --> 03:29:12,760 MISUSE. 5403 03:29:12,760 --> 03:29:14,040 WHERE CLEARLY IT ISN'T. 5404 03:29:14,040 --> 03:29:17,120 THERE ARE RELEVANT LAWS SUCH AS 5405 03:29:17,120 --> 03:29:24,840 HIPAA BUT STATE LAWS MY APPLY 5406 03:29:24,840 --> 03:29:26,160 LIMITATIONS ON RESEARCHERS, IT'S 5407 03:29:26,160 --> 03:29:27,840 A POINT OF CONCERN, GUIDANCE 5408 03:29:27,840 --> 03:29:30,120 MAKE IT SOUND LIKE ALL YOU HAD 5409 03:29:30,120 --> 03:29:33,640 TO WORRY ABOUT WERE CERTIFICATES 5410 03:29:33,640 --> 03:29:37,480 OF CONFIDENTIALITY, AND IN IF 5411 03:29:37,480 --> 03:29:39,240 THAT'S THE FOCUS THE PARAGRAPH 5412 03:29:39,240 --> 03:29:42,520 AT 146 WE WOULD SAY THAT THEN 5413 03:29:42,520 --> 03:29:44,640 MAKE IT A BEST PRACTICE THAT'S 5414 03:29:44,640 --> 03:29:52,160 CLEARLY ABOUT THAT AND RENAME IT 5415 03:29:52,160 --> 03:29:53,360 SOMETHING LIKE COMMUNICATE 5416 03:29:53,360 --> 03:29:54,160 PROTECTIONS AFFORDED BY 5417 03:29:54,160 --> 03:29:55,360 CERTIFICATE, FOCUSED ON THAT AND 5418 03:29:55,360 --> 03:30:02,240 CLEAR THE FOCUS IS ON THAT 5419 03:30:02,240 --> 03:30:03,240 PARTICULAR ONE, AND, YOU KNOW, 5420 03:30:03,240 --> 03:30:05,760 CERTAINLY COULD BE A PLACE WHERE 5421 03:30:05,760 --> 03:30:07,600 OTHER ONES ARE MENTIONED BUT OUR 5422 03:30:07,600 --> 03:30:12,480 FEELING WAS THE INTENT OF NIH 5423 03:30:12,480 --> 03:30:14,000 WAS TO ESSENTIALLY REMIND THE 5424 03:30:14,000 --> 03:30:15,640 COMMUNITY ABOUT CERTIFICATES OF 5425 03:30:15,640 --> 03:30:20,320 CONFIDENTIALITY AND TO MAKE SURE 5426 03:30:20,320 --> 03:30:22,040 THEY ARE APPROPRIATELY 5427 03:30:22,040 --> 03:30:32,280 COMMUNICATED. 5428 03:30:43,280 --> 03:30:45,160 THE THIRD SECTION OF THE 5429 03:30:45,160 --> 03:30:50,200 DOCUMENT WAS POINTS TO CONSIDER. 5430 03:30:50,200 --> 03:30:52,840 AND WE DIDN'T HAVE A LOT OF 5431 03:30:52,840 --> 03:30:54,480 COMMENTS THERE BUT WE DID 5432 03:30:54,480 --> 03:30:55,920 RECOMMEND THE NIH INCLUDE 5433 03:30:55,920 --> 03:30:56,520 EXAMPLES OF ACCESS CONTROL 5434 03:30:56,520 --> 03:30:57,960 MEASURES THAT WOULD BE 5435 03:30:57,960 --> 03:30:59,640 ACCEPTABLE TO THE NIH AND 5436 03:30:59,640 --> 03:31:02,560 CLARIFY HOW COMPLIANCE WITH ANY 5437 03:31:02,560 --> 03:31:04,880 LIMITATIONS OR PROHIBITIONS 5438 03:31:04,880 --> 03:31:05,960 WOULD BE MONITORED. 5439 03:31:05,960 --> 03:31:09,880 AND IN THE FOURTH POINT TO 5440 03:31:09,880 --> 03:31:14,640 CONSIDER, WE WANTED TO ADD THE 5441 03:31:14,640 --> 03:31:15,720 PHRASE, APPROACHES THAT BECOME 5442 03:31:15,720 --> 03:31:18,680 KNOWN, AFTER A PHRASE THAT 5443 03:31:18,680 --> 03:31:20,320 CURRENTLY READS PREVIOUSLY 5444 03:31:20,320 --> 03:31:23,040 UNANTICIPATED APPROACHES. 5445 03:31:23,040 --> 03:31:24,560 AND THEN FINALLY IT'S NOT CLEAR 5446 03:31:24,560 --> 03:31:25,720 WHO IS EXPECTED TO COMMUNICATE 5447 03:31:25,720 --> 03:31:27,080 NECESSARY CHANGES TO THE DATA 5448 03:31:27,080 --> 03:31:30,280 MANAGEMENT SHARING PLANS TO THE 5449 03:31:30,280 --> 03:31:31,800 NIH OR HOW NEW INFORMATION 5450 03:31:31,800 --> 03:31:34,320 SHOULD BE COMMUNICATED, THAT MAY 5451 03:31:34,320 --> 03:31:35,160 FALL BACK ON SKIP'S COMMENT THIS 5452 03:31:35,160 --> 03:31:38,720 IS PART OF THE ACTIVITIES OF 5453 03:31:38,720 --> 03:31:40,400 OBTAINING AND MAINTAINING A 5454 03:31:40,400 --> 03:31:42,120 GRANT, AND SO, YOU KNOW, IT MAY 5455 03:31:42,120 --> 03:31:43,640 BE ALREADY BUILT INTO THE SYSTEM 5456 03:31:43,640 --> 03:31:48,840 THAT THIS IS GOING TO HAPPEN. 5457 03:31:48,840 --> 03:31:57,520 BUT THIS IS WHERE WE LANDED AS 5458 03:31:57,520 --> 03:31:58,640 THE SUBCOMMITTEE. 5459 03:31:58,640 --> 03:32:00,080 >> AGAIN, ANOTHER TYPO, THE 5460 03:32:00,080 --> 03:32:01,360 PHRASE APPROACHES HAVE BECOME 5461 03:32:01,360 --> 03:32:02,960 KNOWN, IS THAT SUPPOSED TO BE 5462 03:32:02,960 --> 03:32:04,160 SIMPLY THAT BECOME KNOWN? 5463 03:32:04,160 --> 03:32:07,000 TAKE APPROACHES OUT OF THE QUOTE 5464 03:32:07,000 --> 03:32:11,120 BECAUSE YOU DON'T WANT TO READ 5465 03:32:11,120 --> 03:32:11,680 PREVIOUSLY UNANTICIPATED 5466 03:32:11,680 --> 03:32:15,280 APPROACHES THAT BECOME KNOWN, 5467 03:32:15,280 --> 03:32:15,480 RIGHT? 5468 03:32:15,480 --> 03:32:19,720 PREVIOUSLY UNANTICIPATED 5469 03:32:19,720 --> 03:32:21,520 APPROACHES THAT BECOME KNOWN. 5470 03:32:21,520 --> 03:32:22,280 FIRST LINE OF 158. 5471 03:32:22,280 --> 03:32:23,720 >> I'M LOOKING AND TRYING TO 5472 03:32:23,720 --> 03:32:24,120 REMEMBER. 5473 03:32:24,120 --> 03:32:25,600 I DON'T HAVE THE GUIDANCE 5474 03:32:25,600 --> 03:32:26,880 DOCUMENT SO I CAN'T LOOK BACK 5475 03:32:26,880 --> 03:32:28,240 AND SEE WHAT THE CURRENT 5476 03:32:28,240 --> 03:32:29,000 LANGUAGE IS. 5477 03:32:29,000 --> 03:32:31,200 BUT I WILL PUT A NOTE IN THERE. 5478 03:32:31,200 --> 03:32:32,920 >> DOUBLE CHECK. 5479 03:32:32,920 --> 03:32:35,800 IT LOOKS LIKE YOU HAVE APPROACH 5480 03:32:35,800 --> 03:32:44,200 APPROACH AFTER EACH OTHER. 5481 03:32:44,200 --> 03:32:44,520 >> RIGHT. 5482 03:32:44,520 --> 03:32:47,160 AND I DON'T REMEMBER WHY WE 5483 03:32:47,160 --> 03:32:49,120 THOUGHT PREVIOUSLY UNANTICIPATED 5484 03:32:49,120 --> 03:32:51,960 APPROACHES DIDN'T -- MIGHT HAVE 5485 03:32:51,960 --> 03:32:53,040 BEEN UNANTICIPATED BUT IF THEY 5486 03:32:53,040 --> 03:32:54,360 ARE NOW KNOWN THEY HAVE BECOME 5487 03:32:54,360 --> 03:32:54,600 KNOWN. 5488 03:32:54,600 --> 03:33:05,040 I'LL TAKE A LOOK AT THAT. 5489 03:33:08,760 --> 03:33:10,760 WHEN I DO THAT I'LL LOOK AT THE 5490 03:33:10,760 --> 03:33:11,880 GUIDANCE DOCUMENT ITSELF SO THAT 5491 03:33:11,880 --> 03:33:15,640 I CAN TRY TO REMEMBER WHAT LED 5492 03:33:15,640 --> 03:33:23,040 TO THAT. 5493 03:33:23,040 --> 03:33:24,800 THE CONCLUSION IS 5494 03:33:24,800 --> 03:33:28,160 STRAIGHTFORWARD. 5495 03:33:28,160 --> 03:33:31,680 IT MIGHT BE A PLACE TO SORT OF 5496 03:33:31,680 --> 03:33:34,520 PUT AN EXPLANATION POINT OR FINE 5497 03:33:34,520 --> 03:33:36,840 POINT ON LOIS' THEME OF, YOU 5498 03:33:36,840 --> 03:33:40,760 KNOW, NIH SHOULD BASICALLY TELL 5499 03:33:40,760 --> 03:33:42,200 INSTITUTIONS TO DO WHAT THEY ARE 5500 03:33:42,200 --> 03:33:47,440 SUPPOSED TO DO. 5501 03:33:47,440 --> 03:33:52,160 I'VE GOT A FEW - SOME LANGUAGE 5502 03:33:52,160 --> 03:33:53,000 TO CLEAN UP. 5503 03:33:53,000 --> 03:33:58,720 I'LL WORK ON GOING THROUGH AND 5504 03:33:58,720 --> 03:34:01,360 PUTTING IN THE CHANGES TO THE 5505 03:34:01,360 --> 03:34:06,920 INSTITUTIONAL COMPONENT LANGUAGE 5506 03:34:06,920 --> 03:34:08,360 THAT WE'VE DISCUSSED. 5507 03:34:08,360 --> 03:34:10,080 AND CAN BRING IT BACK TOMORROW 5508 03:34:10,080 --> 03:34:12,320 FOR A QUICK REVIEW. 5509 03:34:12,320 --> 03:34:14,800 AND LOIS, I MIGHT RUN THE 5510 03:34:14,800 --> 03:34:19,600 LANGUAGE BY YOU BY E-MAIL BEFORE 5511 03:34:19,600 --> 03:34:23,680 JUST TO -- SO IT MAKES SENSE TO 5512 03:34:23,680 --> 03:34:25,880 SOMEBODY BESIDES ME. 5513 03:34:25,880 --> 03:34:32,840 WE'RE AHEAD OF SCHEDULE, JULIA, 5514 03:34:32,840 --> 03:34:40,680 BUT THAT'S IT FOR THIS. 5515 03:34:40,680 --> 03:34:43,160 >> ANYTHING ELSE FROM COMMITTEE 5516 03:34:43,160 --> 03:34:43,400 MEMBERS? 5517 03:34:43,400 --> 03:34:45,120 IF HE MAKES THOSE CHANGES WE'RE 5518 03:34:45,120 --> 03:34:49,400 READY TO MOVE FORWARD WITH IT. 5519 03:34:49,400 --> 03:34:50,160 ALL RIGHT. 5520 03:34:50,160 --> 03:34:50,960 THANKS, DAVID. 5521 03:34:50,960 --> 03:34:57,080 >> THANKS TO ALL OF YOU. 5522 03:34:57,080 --> 03:34:58,280 >> SO YOU'RE GOING TO MAKE THOSE 5523 03:34:58,280 --> 03:35:00,400 CHANGES AND BRING IT BACK? 5524 03:35:00,400 --> 03:35:00,880 >> YEAH. 5525 03:35:00,880 --> 03:35:01,440 >> TODAY OR TOMORROW? 5526 03:35:01,440 --> 03:35:03,280 >> I WILL MAKE THE CHANGES THIS 5527 03:35:03,280 --> 03:35:05,480 EVENING, BRING THEM BACK 5528 03:35:05,480 --> 03:35:05,920 TOMORROW. 5529 03:35:05,920 --> 03:35:06,200 >> OKAY. 5530 03:35:06,200 --> 03:35:09,560 >> CAN YOU TELL ME HOW I CAN GET 5531 03:35:09,560 --> 03:35:10,560 THIS TRACK DOCUMENT? 5532 03:35:10,560 --> 03:35:17,320 >> I WILL WORK ON IT. 5533 03:35:17,320 --> 03:35:17,800 5534 03:35:17,800 --> 03:35:19,520 >> THAT'S FINE. 5535 03:35:19,520 --> 03:35:19,720 OKAY. 5536 03:35:19,720 --> 03:35:21,040 >> MAKE SURE IT'S SAVED. 5537 03:35:21,040 --> 03:35:29,480 >> I JUST CLICKED THE SAVE 5538 03:35:29,480 --> 03:35:29,720 BUTTON. 5539 03:35:29,720 --> 03:35:30,240 >> OKAY, OKAY. 5540 03:35:30,240 --> 03:35:38,240 >> I'M GOING TO LEAVE THE PODIUM 5541 03:35:38,240 --> 03:35:38,440 THEN. 5542 03:35:38,440 --> 03:35:38,680 >> OKAY. 5543 03:35:38,680 --> 03:35:41,080 >> MICHAEL, ARE YOU READY TO GO 5544 03:35:41,080 --> 03:35:41,840 EARLY? 5545 03:35:41,840 --> 03:35:42,720 >> YES, SIR. 5546 03:35:42,720 --> 03:35:45,240 >> THE LAST OFFICIAL ITEM IS AN 5547 03:35:45,240 --> 03:35:47,720 UPDATE FROM THE OHRP DIVISION OF 5548 03:35:47,720 --> 03:35:48,240 EDUCATION. 5549 03:35:48,240 --> 03:35:53,320 YVONNE IS NOT HERE BUT MICHAEL 5550 03:35:53,320 --> 03:36:00,920 GRIPALDI AGREED TO DO THIS. 5551 03:36:00,920 --> 03:36:11,240 WELCOME, MICHAEL. 5552 03:36:23,320 --> 03:36:25,200 >> GOOD AFTERNOON. 5553 03:36:25,200 --> 03:36:26,640 AS WAS MENTIONED, UNFORTUNATELY 5554 03:36:26,640 --> 03:36:28,280 YVONNE COULDN'T BE HERE, DR. 5555 03:36:28,280 --> 03:36:29,720 YVONNE LAU, SHE'S UNDER THE 5556 03:36:29,720 --> 03:36:31,200 WEATHER SO I'M GOING TO DO MY 5557 03:36:31,200 --> 03:36:35,160 BEST TO FILL IN FOR HER AND TALK 5558 03:36:35,160 --> 03:36:35,760 LOUDLY. 5559 03:36:35,760 --> 03:36:36,680 UNFORTUNATELY, BEING TALL IS 5560 03:36:36,680 --> 03:36:41,040 DIFFICULT AT THIS TIME SO I'LL 5561 03:36:41,040 --> 03:36:42,400 DO MY BEST TO PROJECT. 5562 03:36:42,400 --> 03:36:44,560 I'M HERE TO TALK ABOUT UPCOMING 5563 03:36:44,560 --> 03:36:49,160 EVENTS THAT OHRP IS GOING TO BE 5564 03:36:49,160 --> 03:36:49,480 HAVING. 5565 03:36:49,480 --> 03:36:51,120 IN SEPTEMBER ON THE 15th 5566 03:36:51,120 --> 03:36:55,200 HOSTING OUR FIFTH ANNUAL 5567 03:36:55,200 --> 03:37:01,320 EXPLORATORY WORKSHOP, BEYOND AL 5568 03:37:01,320 --> 03:37:03,960 ALTRUISM, EXPLORING PAYMENT, A 5569 03:37:03,960 --> 03:37:05,480 TOPIC SACHRP TOOK ON A FEW YEARS 5570 03:37:05,480 --> 03:37:09,200 AGO SO WE'RE BRINGING IT BACK. 5571 03:37:09,200 --> 03:37:10,520 IT'S TWO-SESSION, FREE 5572 03:37:10,520 --> 03:37:11,280 LIVESTREAMING EVENT. 5573 03:37:11,280 --> 03:37:12,280 FIRST SESSION WILL CONSIST OF 5574 03:37:12,280 --> 03:37:15,560 MORE OF THE ETHICAL AND 5575 03:37:15,560 --> 03:37:17,440 THEORETICAL FRAMEWORKS OF PAYING 5576 03:37:17,440 --> 03:37:19,520 PARTICIPANTS, WE'LL HAVE 5577 03:37:19,520 --> 03:37:21,400 SESSIONS INTRODUCING THE TOPIC, 5578 03:37:21,400 --> 03:37:23,120 TALKING ABOUT USING PAYMENT AS A 5579 03:37:23,120 --> 03:37:26,000 FORM TO ADVANCE JUSTICE, EQUITY, 5580 03:37:26,000 --> 03:37:28,960 INCLUSION. 5581 03:37:28,960 --> 03:37:31,920 WE'LL HAVE A SESSION ON IRB 5582 03:37:31,920 --> 03:37:33,200 PERSPECTIVES AND RESEARCHER 5583 03:37:33,200 --> 03:37:34,440 PERSPECTIVES, AS TO POSSIBLE 5584 03:37:34,440 --> 03:37:38,160 RELUCTANCE WHY THEY ARE DOING 5585 03:37:38,160 --> 03:37:39,160 THIS. 5586 03:37:39,160 --> 03:37:41,560 WE'LL HAVE PARTICIPANT 5587 03:37:41,560 --> 03:37:42,400 PERSPECTIVES, THREE RESEARCHERS 5588 03:37:42,400 --> 03:37:45,400 DISCUSSING RESEARCH THAT THEY 5589 03:37:45,400 --> 03:37:48,320 HAVE DONE WITH POPULATIONS AND 5590 03:37:48,320 --> 03:37:49,840 HOW THEY FEEL, WHAT THEIR 5591 03:37:49,840 --> 03:37:50,440 CONTRIBUTIONS ARE. 5592 03:37:50,440 --> 03:37:54,120 AND ONE OF WHICH IS A GROUP IN 5593 03:37:54,120 --> 03:37:55,000 NORTHERN PHILADELPHIA. 5594 03:37:55,000 --> 03:37:56,240 >> I'M SORRY, WE'RE NOT SEEING 5595 03:37:56,240 --> 03:37:57,000 YOUR SLIDES. 5596 03:37:57,000 --> 03:37:58,880 WE'RE STILL SEEING THE PREVIOUS 5597 03:37:58,880 --> 03:38:01,800 DOCUMENT IN THE ZOOM. 5598 03:38:01,800 --> 03:38:07,840 5599 03:38:07,840 --> 03:38:15,360 5600 03:38:15,360 --> 03:38:18,120 >> HOW ABOUT NOW, JANET? 5601 03:38:18,120 --> 03:38:21,920 >> YES, THANK YOU. 5602 03:38:21,920 --> 03:38:22,280 >> APOLOGIES. 5603 03:38:22,280 --> 03:38:24,040 AND SO THEN WE'LL -- THERE'S A 5604 03:38:24,040 --> 03:38:26,440 RESEARCHER TALKING ABOUT THEIR 5605 03:38:26,440 --> 03:38:28,960 EXPERIENCE WORKING WITH AN 5606 03:38:28,960 --> 03:38:29,680 HIV-POSITIVE POPULATION, ALSO 5607 03:38:29,680 --> 03:38:32,680 USES DRUGS AND HOW THEY VIEW 5608 03:38:32,680 --> 03:38:33,880 THEIR PARTICIPATION. 5609 03:38:33,880 --> 03:38:35,080 THEN BECAUSE PHASE 1 TRIALS ARE 5610 03:38:35,080 --> 03:38:37,720 A BIT OF A DIFFERENT BEAST 5611 03:38:37,720 --> 03:38:40,880 ALTOGETHER WE'RE GOING HAVE A 5612 03:38:40,880 --> 03:38:42,720 SPEAKER TALK ABOUT MOTIVATION 5613 03:38:42,720 --> 03:38:44,800 FOR PARTICIPATING IN PHASE 1 5614 03:38:44,800 --> 03:38:46,760 WHICH PRIMARILY SOMETIMES IS THE 5615 03:38:46,760 --> 03:38:47,320 MONEY. 5616 03:38:47,320 --> 03:38:51,920 AND WHAT KEEPS THEM COMING BACK. 5617 03:38:51,920 --> 03:38:56,120 THEN ALSO WITH KIND ECONOMY, 5618 03:38:56,120 --> 03:38:59,800 MANY PEOPLE HAVE MULTIPLE JOBS, 5619 03:38:59,800 --> 03:39:02,440 DOING UBER AND DOOR DASH AND 5620 03:39:02,440 --> 03:39:03,880 PARTICIPATING IN RESEARCH, DO 5621 03:39:03,880 --> 03:39:05,480 THEY DESERVE MORE RIGHTS, 5622 03:39:05,480 --> 03:39:06,080 POSSIBLY EMPLOYMENT RIGHTS, 5623 03:39:06,080 --> 03:39:07,240 THINGS LIKE THAT. 5624 03:39:07,240 --> 03:39:11,720 WHAT MAKES TH EXPLORATORY 5625 03:39:11,720 --> 03:39:16,360 WORKSHOP UNIQUE, EACH SESSION IS 5626 03:39:16,360 --> 03:39:18,320 15 MINUTES WITH 45-MINUTE 5627 03:39:18,320 --> 03:39:19,080 MODERATED DISCUSSION, AN 5628 03:39:19,080 --> 03:39:20,280 OPPORTUNITY FOR PANELISTS TO GET 5629 03:39:20,280 --> 03:39:21,680 TOGETHER AND DISCUSS THESE 5630 03:39:21,680 --> 03:39:24,560 ISSUES, WITH QUESTIONS THROWN 5631 03:39:24,560 --> 03:39:24,960 OUT. 5632 03:39:24,960 --> 03:39:28,680 THE AFTERNOON SESSION IS MORE 5633 03:39:28,680 --> 03:39:30,120 ABOUT THE PRACTICALITY OF 5634 03:39:30,120 --> 03:39:30,720 PAYING. 5635 03:39:30,720 --> 03:39:32,640 SO WE'LL HAVE DISCUSSIONS ABOUT 5636 03:39:32,640 --> 03:39:34,840 WHETHER IT REALLY IS JUST 5637 03:39:34,840 --> 03:39:35,600 SEMANTICS FOR PARTICIPANTS, 5638 03:39:35,600 --> 03:39:37,880 WHETHER WE CALL IT REIMBURSEMENT 5639 03:39:37,880 --> 03:39:41,640 OR WHETHER IT IS PAYMENT OR IF 5640 03:39:41,640 --> 03:39:43,280 IT'S COMPENSATION. 5641 03:39:43,280 --> 03:39:45,120 ALSO TALK ABOUT LOGISTICS OF 5642 03:39:45,120 --> 03:39:45,360 PAYING. 5643 03:39:45,360 --> 03:39:47,960 SOMETIMES IT CAN BE A BIT OF A 5644 03:39:47,960 --> 03:39:49,160 HINDRANCE FOR SOMEONE TO RECEIVE 5645 03:39:49,160 --> 03:39:51,680 A CHECK IF THEY DON'T HAVE A 5646 03:39:51,680 --> 03:39:52,080 CHECKING ACCOUNT. 5647 03:39:52,080 --> 03:39:53,440 ALSO IF YOU HAVE TO DISCLOSE 5648 03:39:53,440 --> 03:39:54,440 YOUR SOCIAL SECURITY NUMBER, 5649 03:39:54,440 --> 03:39:55,400 MAYBE THAT'S SOMETHING YOU'RE 5650 03:39:55,400 --> 03:39:56,280 CONCERNED ABOUT. 5651 03:39:56,280 --> 03:39:59,800 WE'LL ALSO HAVE A SPEAKER 5652 03:39:59,800 --> 03:40:02,320 TALKING ABOUT SOCIAL BEHAVIORAL 5653 03:40:02,320 --> 03:40:04,040 AND EDUCATION RESEARCH, 5654 03:40:04,040 --> 03:40:05,480 SOMETIMES PRESENT UNIQUE ISSUES 5655 03:40:05,480 --> 03:40:07,360 DOING ONLINE RESEARCH AND IT'S 5656 03:40:07,360 --> 03:40:07,920 ANONYMOUS. 5657 03:40:07,920 --> 03:40:09,240 WE'LL HAVE PEOPLE WHO HAVE GONE 5658 03:40:09,240 --> 03:40:13,280 THROUGH AND DONE THIS TYPE OF 5659 03:40:13,280 --> 03:40:15,680 WORK DISCUSSING THINGS. 5660 03:40:15,680 --> 03:40:17,880 WE'LL ALSO HAVE A CONCLUSION 5661 03:40:17,880 --> 03:40:21,560 TALKING ABOUT IS PAYMENT REALLY 5662 03:40:21,560 --> 03:40:24,360 THE SILVER BULLET FOR HAVING AN 5663 03:40:24,360 --> 03:40:25,920 INCREASE IN DIVERSITY, EQUITY, 5664 03:40:25,920 --> 03:40:28,480 AND INCLUSION IN RESEARCH. 5665 03:40:28,480 --> 03:40:32,400 AGAIN, THE SESSIONS, IT'S A 5666 03:40:32,400 --> 03:40:34,200 FREEZE-FRAMING ONE DAY FROM 10 5667 03:40:34,200 --> 03:40:36,800 TO 4, A UNIQUE OPPORTUNITY TO 5668 03:40:36,800 --> 03:40:39,080 HAVE EXPERTS COME IN, GIVE THEIR 5669 03:40:39,080 --> 03:40:41,200 SPIEL AND HAVE A GROUP 5670 03:40:41,200 --> 03:40:41,520 DISCUSSION. 5671 03:40:41,520 --> 03:40:43,920 WE'RE PARTICULARLY EXCITED ABOUT 5672 03:40:43,920 --> 03:40:44,120 THIS. 5673 03:40:44,120 --> 03:40:45,680 FIFTH ANNUAL ONE, IF YOU 5674 03:40:45,680 --> 03:40:46,960 ATTENDED THE PREVIOUS ONES THEY 5675 03:40:46,960 --> 03:40:48,200 ARE PRETTY GOOD. 5676 03:40:48,200 --> 03:40:51,560 YOU LEAVE AWAY WITH A LOT OF 5677 03:40:51,560 --> 03:40:52,920 FOOD FOR THOUGHT. 5678 03:40:52,920 --> 03:40:55,440 SO, WE HAVE SOMETHING THAT'S 5679 03:40:55,440 --> 03:40:57,280 CALLED RESEARCH COMMUNITY FORUM. 5680 03:40:57,280 --> 03:40:58,480 AND FOR THE LAST FEW YEARS 5681 03:40:58,480 --> 03:41:00,640 BECAUSE OF THE PANDEMIC THESE 5682 03:41:00,640 --> 03:41:01,880 HAVE ALL BEEN VIRTUAL. 5683 03:41:01,880 --> 03:41:04,760 WE HAD ONE WITH NORTHWELL HEALTH 5684 03:41:04,760 --> 03:41:06,280 IN MAY, LOOKING FORWARD TO 5685 03:41:06,280 --> 03:41:07,240 RETURNING TO IN-PERSON EVENTS. 5686 03:41:07,240 --> 03:41:11,080 THE FIRST ONE IS ABOUT A WEEK 5687 03:41:11,080 --> 03:41:13,840 AFTER THE WORKSHOP, IT'S THE 5688 03:41:13,840 --> 03:41:17,360 20th AND 21st IN INDIANA, 5689 03:41:17,360 --> 03:41:20,360 PARTNERING WITH INDIANA 5690 03:41:20,360 --> 03:41:20,920 UNIVERSITY. 5691 03:41:20,920 --> 03:41:23,560 AND IT'S CALLED NEW FRONTIERS IN 5692 03:41:23,560 --> 03:41:25,000 HUMAN SUBJECTS RESEARCH. 5693 03:41:25,000 --> 03:41:29,400 SO DAY 1 CONSISTS OF A WORKSHOP, 5694 03:41:29,400 --> 03:41:30,840 OHRP-LED EVENTS. 5695 03:41:30,840 --> 03:41:34,400 WE'LL BE CONDUCTING CASE STUDIES 5696 03:41:34,400 --> 03:41:35,840 AND HAVING AUDIENCE INTERACTION 5697 03:41:35,840 --> 03:41:41,320 ASKING YOU TO MAKE JUDGMENTS 5698 03:41:41,320 --> 03:41:42,760 ABOUT THINGS, APPLY REGULATIONS, 5699 03:41:42,760 --> 03:41:45,040 A SESSION TALKING ABOUT USING 5700 03:41:45,040 --> 03:41:45,840 COMMUNITY ENGAGEMENT RESOURCES, 5701 03:41:45,840 --> 03:41:47,400 HOW WE CAN USE THOSE. 5702 03:41:47,400 --> 03:41:48,560 AGAIN, EVERYTHING ON THE WEBSITE 5703 03:41:48,560 --> 03:41:49,120 IS FREE. 5704 03:41:49,120 --> 03:41:50,680 I'LL GET MORE INTO THAT LATER. 5705 03:41:50,680 --> 03:41:53,680 BUT WE'RE HERE FOR THE 5706 03:41:53,680 --> 03:41:54,000 POPULATION. 5707 03:41:54,000 --> 03:41:57,720 >> COULD YOU PUT YOUR SLIDES IN 5708 03:41:57,720 --> 03:41:59,200 PRESENTATION? 5709 03:41:59,200 --> 03:42:01,080 >> PRESENTATION MODE. 5710 03:42:01,080 --> 03:42:03,760 >> I'LL DO IT. 5711 03:42:03,760 --> 03:42:11,880 5712 03:42:11,880 --> 03:42:12,920 >> THERE WE GO. 5713 03:42:12,920 --> 03:42:13,920 THANK YOU. 5714 03:42:13,920 --> 03:42:16,240 >> ALL RIGHT, SECOND APOLOGIES. 5715 03:42:16,240 --> 03:42:17,680 AND THEN WE'LL HAVE, AGAIN, THIS 5716 03:42:17,680 --> 03:42:20,520 IS DAY OF THE WORKSHOP, INDIANA 5717 03:42:20,520 --> 03:42:20,840 UNIVERSITY. 5718 03:42:20,840 --> 03:42:25,880 WE'LL TALK ABOUT HOW TO USE HRPP 5719 03:42:25,880 --> 03:42:26,880 RESOURCES EQUITABLY, DON'T WANT 5720 03:42:26,880 --> 03:42:28,280 TO BE USING A LOT OF MONEY OR 5721 03:42:28,280 --> 03:42:30,600 TIME ON SOMETHING THAT'S NOT 5722 03:42:30,600 --> 03:42:32,480 NECESSARILY WORTH IT, KIND OF 5723 03:42:32,480 --> 03:42:34,360 HOW TO USE THEM, LOW-HANGING 5724 03:42:34,360 --> 03:42:34,560 FRUIT. 5725 03:42:34,560 --> 03:42:37,760 DAY 1 IS A WORKSHOP, MEANT FOR 5726 03:42:37,760 --> 03:42:41,720 PEOPLE WORKING IN THE IRB 5727 03:42:41,720 --> 03:42:44,320 OFFICE, HRPP PROFESSIONALS, 5728 03:42:44,320 --> 03:42:47,200 PEOPLE LIKE THAT. 5729 03:42:47,200 --> 03:42:49,800 DAY 2, OH, IN THE AFTERNOON, IN 5730 03:42:49,800 --> 03:42:51,040 THE MORNING WE'LL TALK -- 5731 03:42:51,040 --> 03:42:54,280 COLLECT IDEAS FROM THE AUDIENCE 5732 03:42:54,280 --> 03:42:56,800 ABOUT THINGS THAT PEOPLE ARE 5733 03:42:56,800 --> 03:42:58,480 LOOKING FORWARD TO TALKING 5734 03:42:58,480 --> 03:42:59,280 ABOUT, MAYBE PROBLEMS THEY HAVE 5735 03:42:59,280 --> 03:43:01,080 RUN INTO AND HOW THEY SOLVE 5736 03:43:01,080 --> 03:43:01,280 THEM. 5737 03:43:01,280 --> 03:43:02,200 WE'LL COLLECT IDEAS IN THE 5738 03:43:02,200 --> 03:43:03,840 MORNING AND THEN IN THE 5739 03:43:03,840 --> 03:43:05,920 AFTERNOON WE'LL HAVE A 5740 03:43:05,920 --> 03:43:12,360 DISCUSSION WHERE IT'S 5741 03:43:12,360 --> 03:43:14,440 REGULATORILY APPLICABLE, A 5742 03:43:14,440 --> 03:43:16,560 UNIQUE OPPORTUNITY FOR HRPP 5743 03:43:16,560 --> 03:43:18,040 OFFICES AND IRB OFFICES TO HELP 5744 03:43:18,040 --> 03:43:19,720 EACH OTHER OUT. 5745 03:43:19,720 --> 03:43:21,440 ODDS ARE IF YOU'VE SEEN 5746 03:43:21,440 --> 03:43:22,600 SOMETHING, SOMETHING ELSE WILL 5747 03:43:22,600 --> 03:43:26,320 SEE IT SOON OR THEY HAVE ALREADY 5748 03:43:26,320 --> 03:43:28,160 SEEN IT. 5749 03:43:28,160 --> 03:43:28,600 OOPS. 5750 03:43:28,600 --> 03:43:31,520 SO, DAY 2 IS THE ACTUAL 5751 03:43:31,520 --> 03:43:32,280 CONFERENCE. 5752 03:43:32,280 --> 03:43:34,840 SO THE KEYNOTE LEADS OFF TALKING 5753 03:43:34,840 --> 03:43:36,840 ABOUT PERSPECTIVES FROM THE VICE 5754 03:43:36,840 --> 03:43:38,760 PRESIDENT OF RESEARCH OFFICES. 5755 03:43:38,760 --> 03:43:45,960 WHEN IMPLEMENTING NEW COMPLIANCE 5756 03:43:45,960 --> 03:43:49,720 IDEAS WHO IS IN CHARGE, IRB, 5757 03:43:49,720 --> 03:43:51,040 INSTITUTIONAL LEVEL, OR SOMEONE 5758 03:43:51,040 --> 03:43:53,560 LOWER LIKE THE RESEARCHER 5759 03:43:53,560 --> 03:43:54,520 THEMSELVES? 5760 03:43:54,520 --> 03:43:55,600 A TALK ABOUT NEW CHALLENGES FOR 5761 03:43:55,600 --> 03:43:58,280 THE IRB THAT THEY ARE FACING AS 5762 03:43:58,280 --> 03:44:01,840 FAR AS GLOBAL RESEARCH. 5763 03:44:01,840 --> 03:44:03,040 ALSO RETURNING RESULTS, 5764 03:44:03,040 --> 03:44:04,880 NAVIGATING SINGLE IRB IF IT IS 5765 03:44:04,880 --> 03:44:06,680 DOMESTIC, THINGS LIKE THAT. 5766 03:44:06,680 --> 03:44:12,040 IT'S WE'LL HAVE A SESSION ABOUT 5767 03:44:12,040 --> 03:44:15,360 OPPORTUNITIES FOR IRB TO PROMOTE 5768 03:44:15,360 --> 03:44:18,280 DIVERSITY, EQUITY, AND 5769 03:44:18,280 --> 03:44:18,560 INCLUSION. 5770 03:44:18,560 --> 03:44:21,160 IN THE AFTERNOON THERE'S, AGAIN, 5771 03:44:21,160 --> 03:44:24,160 IT'S RESEARCH AND NEW FRONTIERS, 5772 03:44:24,160 --> 03:44:27,560 A SESSION ON ARTIFICIAL 5773 03:44:27,560 --> 03:44:28,240 INTELLIGENCE RESEARCH FROM 5774 03:44:28,240 --> 03:44:29,640 RESEARCHER AND JUST THE 5775 03:44:29,640 --> 03:44:31,480 CHALLENGES THAT THEY FACE AS 5776 03:44:31,480 --> 03:44:32,760 WELL AS HOW THEY HAVE SOLVED 5777 03:44:32,760 --> 03:44:33,840 SOME OF THIS. 5778 03:44:33,840 --> 03:44:36,440 THERE'S GOING TO BE ENSURING 5779 03:44:36,440 --> 03:44:37,280 RESEARCH INTEGRITY ONLINE 5780 03:44:37,280 --> 03:44:39,520 SESSION, AS WELL AS HOW THE IRB 5781 03:44:39,520 --> 03:44:41,680 CAN KIND OF GO FORWARD WITH DATA 5782 03:44:41,680 --> 03:44:42,080 SHARING. 5783 03:44:42,080 --> 03:44:43,920 WE WANT TO BE ABLE THAT THIS 5784 03:44:43,920 --> 03:44:44,760 IS -- THAT WE'RE SHARING THE 5785 03:44:44,760 --> 03:44:46,840 DATA THAT WE HAVE WITH OTHER 5786 03:44:46,840 --> 03:44:50,160 RESEARCHERS SO THEY CAN USE IT, 5787 03:44:50,160 --> 03:44:51,960 ALSO MAINTAINING PRIVACY AND 5788 03:44:51,960 --> 03:44:54,160 CONFIDENTIALITY OF THE SUBJECTS 5789 03:44:54,160 --> 03:44:56,360 WHO CONTRIBUTE TO THE RESEARCH. 5790 03:44:56,360 --> 03:44:58,320 LASTLY, AT THE END OF THE DAY 5791 03:44:58,320 --> 03:45:00,400 THERE'S GOING TO BE A SESSION 5792 03:45:00,400 --> 03:45:03,240 TALKING ABOUT WORKING WITH 5793 03:45:03,240 --> 03:45:03,640 SPONSORS. 5794 03:45:03,640 --> 03:45:04,680 OFTENTIMES A LOCAL SITE MIGHT 5795 03:45:04,680 --> 03:45:09,160 HAVE A CONFLICT WITH A SPONSOR'S 5796 03:45:09,160 --> 03:45:12,600 DOCUMENT, HOW TO NAVIGATE THAT 5797 03:45:12,600 --> 03:45:13,040 REALM. 5798 03:45:13,040 --> 03:45:15,960 AND THEN WE'RE ACTUALLY HAVING A 5799 03:45:15,960 --> 03:45:18,080 SECOND IN-PERSON RCF IN RENO, 5800 03:45:18,080 --> 03:45:25,160 NEVADA, AT THE END OF OCTOBER, 5801 03:45:25,160 --> 03:45:26,360 25TH TO 26th. 5802 03:45:26,360 --> 03:45:27,720 SIERRA NEVADA MOUNTAINS ARE IN 5803 03:45:27,720 --> 03:45:29,680 THE BACKGROUND, IT'S CLOSE TO 5804 03:45:29,680 --> 03:45:32,320 LAKE TAHOE WHICH I'VE BEEN TO, 5805 03:45:32,320 --> 03:45:33,280 IT'S ABSOLUTELY GORGEOUS. 5806 03:45:33,280 --> 03:45:35,800 IT REALLY IS AN OUTDOORS 5807 03:45:35,800 --> 03:45:40,040 PARADISE, IF YOU LIKE HIKING, 5808 03:45:40,040 --> 03:45:41,200 THE TRUCKEE RIVER I BELIEVE RUNS 5809 03:45:41,200 --> 03:45:42,960 RIGHT THROUGH THE TOWN. 5810 03:45:42,960 --> 03:45:43,840 IT'S A BEAUTIFUL LOCATION. 5811 03:45:43,840 --> 03:45:45,680 IT'S AT THE END OF OCTOBER. 5812 03:45:45,680 --> 03:45:46,760 IF YOU'RE AN EAST COAST PERSON 5813 03:45:46,760 --> 03:45:49,680 IT COULD BE NICE TO ESCAPE THE 5814 03:45:49,680 --> 03:45:53,120 COLD AND GO OUT TO SOME OF THE 5815 03:45:53,120 --> 03:45:53,520 WARMTH. 5816 03:45:53,520 --> 03:45:55,200 KEEPING WITH THE TWO-DAY FORMAT, 5817 03:45:55,200 --> 03:45:56,840 FIRST DAY IS THE WORKSHOP DAY, 5818 03:45:56,840 --> 03:46:01,200 SO A LOT OF OHRP-LED EVENTS. 5819 03:46:01,200 --> 03:46:02,880 WE'LL HAVE THE CASE STUDY. 5820 03:46:02,880 --> 03:46:05,600 WE'RE ALSO GOING TO BE TALKING 5821 03:46:05,600 --> 03:46:08,760 ABOUT RESEARCH WITH INDIVIDUALS 5822 03:46:08,760 --> 03:46:10,480 WHO HAD REDUCED FREEDOMS. 5823 03:46:10,480 --> 03:46:12,880 THERE'S ALSO GOING TO BE FROM 5824 03:46:12,880 --> 03:46:16,400 ONE OF THE CO-HOSTS DISCUSSION 5825 03:46:16,400 --> 03:46:18,280 ON MITIGATING RISK OF VULNERABLE 5826 03:46:18,280 --> 03:46:18,920 POPULATIONS. 5827 03:46:18,920 --> 03:46:19,880 THE NAME OF THE CONFERENCE WHICH 5828 03:46:19,880 --> 03:46:22,000 I SHOULD HAVE SAID EARLIER IS 5829 03:46:22,000 --> 03:46:23,520 TRUST TECHNOLOGY AND CONSENT. 5830 03:46:23,520 --> 03:46:27,720 YOU'LL SEE THE THREE THEMES 5831 03:46:27,720 --> 03:46:28,120 RUNNING THROUGHOUT. 5832 03:46:28,120 --> 03:46:29,760 DAY 2, AGAIN, IS THE ACTUAL 5833 03:46:29,760 --> 03:46:32,080 CONFERENCE WHERE THIS IS MORE 5834 03:46:32,080 --> 03:46:34,280 APPLICABLE TO RESEARCHERS AND 5835 03:46:34,280 --> 03:46:35,480 IRB MEMBERS, BASICALLY ANYONE IN 5836 03:46:35,480 --> 03:46:36,160 THE COMMUNITY. 5837 03:46:36,160 --> 03:46:40,080 IT'S GOING TO BE LED OFF BY 5838 03:46:40,080 --> 03:46:42,440 KEYNOTE TALKING ABOUT BUILDING 5839 03:46:42,440 --> 03:46:45,080 TRUST, INFRASTRUCTURE, WITH 5840 03:46:45,080 --> 03:46:46,520 PERVASIVE DIGITAL DEVICES. 5841 03:46:46,520 --> 03:46:47,720 OFTENTIMES SOMEONE MIGHT NOT 5842 03:46:47,720 --> 03:46:49,760 EVEN BE AWARE THEIR DATA IS 5843 03:46:49,760 --> 03:46:51,680 BEING COLLECTED SO IT'S KIND OF 5844 03:46:51,680 --> 03:46:54,160 TAKING A LOOK AT HOW AS A 5845 03:46:54,160 --> 03:46:55,600 RESEARCHER LESSONS THEY HAVE 5846 03:46:55,600 --> 03:46:57,560 LEARNED AND ALSO PROVIDING IRB 5847 03:46:57,560 --> 03:46:59,120 PERSPECTIVES ON HOW YOU CAN 5848 03:46:59,120 --> 03:47:03,120 BUILD TRUST WITH THIS COMMUNITY. 5849 03:47:03,120 --> 03:47:04,440 ANOTHER PARTNER WITH UNIVERSITY 5850 03:47:04,440 --> 03:47:06,560 OF NEVADA IN RENO IS THE 5851 03:47:06,560 --> 03:47:07,880 UNIVERSITY OF CALIFORNIA AT 5852 03:47:07,880 --> 03:47:08,080 DAVIS. 5853 03:47:08,080 --> 03:47:10,720 THEY ARE GOING TO BE HAVING A 5854 03:47:10,720 --> 03:47:13,560 SESSION TALKING ABOUT HOW THEY 5855 03:47:13,560 --> 03:47:16,200 HAVE SUCCESSFULLY PAIRED WITH 5856 03:47:16,200 --> 03:47:17,640 SOME COMMUNITY INSTITUTIONS SO 5857 03:47:17,640 --> 03:47:18,840 THEY PAIRED RESEARCHERS AND HAVE 5858 03:47:18,840 --> 03:47:21,640 BEEN ABLE TO GO OUT AND GET THE 5859 03:47:21,640 --> 03:47:25,280 COMMUNITY ONBOARD, AGAIN 5860 03:47:25,280 --> 03:47:26,280 BUILDING TRUST. 5861 03:47:26,280 --> 03:47:36,520 WE'LL HAVE AN OHRP SESSION. 5862 03:47:36,520 --> 03:47:38,240 DR. YVONNE LAU, OPPORTUNITIES 5863 03:47:38,240 --> 03:47:42,480 UNDER THE COMMON RULE. 5864 03:47:42,480 --> 03:47:44,840 SO THEN TURNING TO THE AFTERNOON 5865 03:47:44,840 --> 03:47:46,520 THERE'S GOING TO BE A TALK, ONE 5866 03:47:46,520 --> 03:47:49,400 OF THE HIGHLIGHTS ON MOBILE 5867 03:47:49,400 --> 03:47:51,360 APPS, CONNECTED DEVICES, WHAT 5868 03:47:51,360 --> 03:47:52,120 REGULATIONS CURRENTLY EXIST, 5869 03:47:52,120 --> 03:47:54,240 WHAT KIND OF OVERSIGHT IS THERE 5870 03:47:54,240 --> 03:47:57,080 FOR THESE TYPES OF DEVICES AND 5871 03:47:57,080 --> 03:47:58,800 HOW THAT DOVETAILS WITH THE 5872 03:47:58,800 --> 03:47:59,240 RESEARCH. 5873 03:47:59,240 --> 03:48:03,520 AS WELL AS IRB PERSPECTIVES ON 5874 03:48:03,520 --> 03:48:06,200 HOW TO COVER AND REVIEW RESEARCH 5875 03:48:06,200 --> 03:48:06,560 LIKE THIS. 5876 03:48:06,560 --> 03:48:08,240 SOMETHING I THINK THAT'S 5877 03:48:08,240 --> 03:48:08,760 PARTICULARLY INTERESTING, 5878 03:48:08,760 --> 03:48:12,440 THERE'S GOING TO BE A SESSION ON 5879 03:48:12,440 --> 03:48:14,840 USING VIRTUAL REALITY TO HELP 5880 03:48:14,840 --> 03:48:15,760 PAIN MANAGEMENT WITH VETERANS. 5881 03:48:15,760 --> 03:48:19,480 I THINK THAT'S SUCH A UNIQUE 5882 03:48:19,480 --> 03:48:21,160 THING THAT I'M INTERESTED IN 5883 03:48:21,160 --> 03:48:21,400 ATTENDING. 5884 03:48:21,400 --> 03:48:27,480 TO CLOSE OFF THE DAY THERE WILL 5885 03:48:27,480 --> 03:48:29,680 BE DISCUSSION ON RESEARCH WITH 5886 03:48:29,680 --> 03:48:31,080 BORDER AND REFUGEE POPULATIONS, 5887 03:48:31,080 --> 03:48:33,920 JUST IRB CONSIDERATIONS FOR 5888 03:48:33,920 --> 03:48:36,320 MAKING SURE THAT PRIVACY IS 5889 03:48:36,320 --> 03:48:40,440 PROTECTED, AS WELL AS INCLUDING 5890 03:48:40,440 --> 03:48:42,760 THEM IN THE RESEARCH. 5891 03:48:42,760 --> 03:48:47,600 SO, I THINK IT MIGHT HAVE BEEN 5892 03:48:47,600 --> 03:48:49,800 JERRY EARLIER MENTIONED BEING 5893 03:48:49,800 --> 03:48:51,240 HARD AT WORK PRODUCING RESOURCES 5894 03:48:51,240 --> 03:48:55,600 SO I'LL HIGHLIGHT A CUP THE 5895 03:48:55,600 --> 03:48:56,200 THINGS. 5896 03:48:56,200 --> 03:48:59,680 CREATED THIS ONE SHEET BIFOLD, 5897 03:48:59,680 --> 03:49:01,840 ALSO A POSTER THAT TALKS IN 5898 03:49:01,840 --> 03:49:05,280 PLAIN LANGUAGE ABOUT WHAT 5899 03:49:05,280 --> 03:49:08,240 RESEARCH IS, HOW RESEARCH WORKS. 5900 03:49:08,240 --> 03:49:10,000 ALSO QUESTIONS FOR POTENTIAL 5901 03:49:10,000 --> 03:49:11,080 PARTICIPANTS TO ASK SUCH AS 5902 03:49:11,080 --> 03:49:12,280 WHAT'S GOING TO HAPPEN IN THE 5903 03:49:12,280 --> 03:49:13,720 RESEARCH, WHY ARE YOU DOING THE 5904 03:49:13,720 --> 03:49:14,360 RESEARCH? 5905 03:49:14,360 --> 03:49:17,840 THIS IS SOMETHING THAT 5906 03:49:17,840 --> 03:49:18,400 INSTITUTIONS CAN HAVE AND 5907 03:49:18,400 --> 03:49:19,960 DISTRIBUTE, EITHER AS I 5908 03:49:19,960 --> 03:49:23,440 MENTIONED AS A ONE SHEET, FRONT 5909 03:49:23,440 --> 03:49:26,600 AND BACK, OR BIFOLD, AND 11 X 17 5910 03:49:26,600 --> 03:49:27,000 POSTER. 5911 03:49:27,000 --> 03:49:28,760 THIS IS ON OUR WEBSITE. 5912 03:49:28,760 --> 03:49:32,440 IT'S FREE, ALL OF OUR RESOURCES 5913 03:49:32,440 --> 03:49:36,000 ARE FREE, WE IMPLORE YOU TO USE 5914 03:49:36,000 --> 03:49:37,320 AND SPREAD THEM. 5915 03:49:37,320 --> 03:49:41,160 IT'S GOOD FOR GENERAL PUBLIC TO 5916 03:49:41,160 --> 03:49:42,360 JUST INTRALEVEL WHAT IS 5917 03:49:42,360 --> 03:49:44,680 RESEARCH, WHY ARE YOU TALKING TO 5918 03:49:44,680 --> 03:49:46,920 ME AND HOW IF I AM INTERESTED 5919 03:49:46,920 --> 03:49:49,360 HOW DO I FIGURE OUT THE NEXT 5920 03:49:49,360 --> 03:49:49,600 STEPS. 5921 03:49:49,600 --> 03:49:51,560 THIS IS AVAILABLE IN SPANISH. 5922 03:49:51,560 --> 03:49:56,360 A LOT OF RESOURCES HAVE BEEN 5923 03:49:56,360 --> 03:49:58,800 TRANSLATED INTO SPANISH. 5924 03:49:58,800 --> 03:50:01,400 WE ALSO CREATED A RESOURCE FOR 5925 03:50:01,400 --> 03:50:03,480 COMMUNITY MEMBERS CHECK LIST. 5926 03:50:03,480 --> 03:50:06,400 SO AS FAR AS SOME OF THE THEMES 5927 03:50:06,400 --> 03:50:07,240 TALKING ABOUT COMMUNITY 5928 03:50:07,240 --> 03:50:09,360 ENGAGEMENT THIS IS SOMETHING 5929 03:50:09,360 --> 03:50:11,320 THAT YOU CAN USE TO WORK WITH 5930 03:50:11,320 --> 03:50:14,160 EITHER PEOPLE WHO ARE INTERESTED 5931 03:50:14,160 --> 03:50:18,320 IN RESEARCH OR POSSIBLY THAT 5932 03:50:18,320 --> 03:50:19,640 COMMUNITY MEMBER. 5933 03:50:19,640 --> 03:50:22,400 STARTS AT BASIC LEVEL, AS I 5934 03:50:22,400 --> 03:50:25,160 MENTIONED USING THE PREVIOUS 5935 03:50:25,160 --> 03:50:27,120 RESOURCE THAT WE'VE CREATED TO 5936 03:50:27,120 --> 03:50:29,200 INTRODUCE WHAT RESEARCH IS, GOES 5937 03:50:29,200 --> 03:50:32,800 THROUGH SOME PREVIOUSLY CREATED 5938 03:50:32,800 --> 03:50:34,080 DOCUMENTS, WHICH USE 5939 03:50:34,080 --> 03:50:36,400 INFOGRAPHICS TO WALK THROUGH THE 5940 03:50:36,400 --> 03:50:38,920 GENERAL PUBLIC, SOME RESEARCH 5941 03:50:38,920 --> 03:50:39,120 TERMS. 5942 03:50:39,120 --> 03:50:40,920 AND ALSO TALKS ABOUT LIKE WHAT 5943 03:50:40,920 --> 03:50:43,680 IS MEDICAL RESEARCH, HOW IS THIS 5944 03:50:43,680 --> 03:50:44,680 DIFFERENT FROM SOCIAL BEHAVIORAL 5945 03:50:44,680 --> 03:50:44,960 RESEARCH. 5946 03:50:44,960 --> 03:50:47,360 THIS IS SOMETHING THAT CAN BE 5947 03:50:47,360 --> 03:50:49,040 USED TO ENGAGE PEOPLE THAT ARE 5948 03:50:49,040 --> 03:50:50,240 INTERESTED IN RESEARCH, AS WELL 5949 03:50:50,240 --> 03:50:51,640 AS IF YOU'RE INTERESTED IN 5950 03:50:51,640 --> 03:50:53,080 GETTING THAT NEW PERSON ONTO 5951 03:50:53,080 --> 03:50:54,400 YOUR IRB. 5952 03:50:54,400 --> 03:50:56,240 WE HAVE RECENTLY UPDATED ANOTHER 5953 03:50:56,240 --> 03:50:58,680 CHECK LIST THAT IS FOR PEOPLE 5954 03:50:58,680 --> 03:51:00,200 WHO ARE WORKING WITH IRBs, SO 5955 03:51:00,200 --> 03:51:02,560 THIS IS A LITTLE MORE DETAILED. 5956 03:51:02,560 --> 03:51:04,840 WE DO GET INTO MORE OF THE 5957 03:51:04,840 --> 03:51:06,240 REGULATIONS AND MORE OF WHILE 5958 03:51:06,240 --> 03:51:08,440 THIS DOES COVER SOME HISTORY 5959 03:51:08,440 --> 03:51:11,400 LIKE THE BELMONT REPORT, BUT THE 5960 03:51:11,400 --> 03:51:14,920 ONE FOR PEOPLE WORKING WITH 5961 03:51:14,920 --> 03:51:16,880 IRBs DOES GET MORE INTO THE 5962 03:51:16,880 --> 03:51:18,640 REGULATIONS AND COVERS SOME 5963 03:51:18,640 --> 03:51:18,880 GUIDANCE. 5964 03:51:18,880 --> 03:51:20,480 IT'S ACTUALLY A GOOD TRAINING 5965 03:51:20,480 --> 03:51:23,680 DOCUMENT THAT YOU GO THROUGH AT 5966 03:51:23,680 --> 03:51:25,640 YOUR SPEED IN THE ORDER WE 5967 03:51:25,640 --> 03:51:28,120 LISTED, A GREAT REVIEW FOR 5968 03:51:28,120 --> 03:51:30,200 ANYONE WHO IS INTERESTED IN 5969 03:51:30,200 --> 03:51:32,120 BONING UP ON PREVIOUS THINGS 5970 03:51:32,120 --> 03:51:33,960 THAT PERHAPS THAT THEY HAVE 5971 03:51:33,960 --> 03:51:35,160 FORGOTTEN BECAUSE THEY DON'T 5972 03:51:35,160 --> 03:51:40,360 FREQUENTLY REVIEW THAT TYPE OF 5973 03:51:40,360 --> 03:51:43,080 RESEARCH, NOT DOING PART C OR 5974 03:51:43,080 --> 03:51:46,000 PART D. 5975 03:51:46,000 --> 03:51:52,240 AND SO WE HAVE OUR ABOUT 5976 03:51:52,240 --> 03:51:52,880 PARTICIPATION BRANDED MATERIALS. 5977 03:51:52,880 --> 03:51:55,680 THIS IS AS I MENTIONED LIKE 5978 03:51:55,680 --> 03:51:57,360 BASIC LEVEL THINGS FOR 5979 03:51:57,360 --> 03:51:59,600 INTERACTING WITH THE GENERAL 5980 03:51:59,600 --> 03:52:00,840 PUBLIC AND THE COMMUNITY. 5981 03:52:00,840 --> 03:52:03,720 I BELIEVE ALL OF THEM HAVE BEEN 5982 03:52:03,720 --> 03:52:05,760 TRANSLATED, IF NOT ALL MOST HAVE 5983 03:52:05,760 --> 03:52:07,640 BEEN TRANSLATED INTO SPANISH SO 5984 03:52:07,640 --> 03:52:09,760 THAT'S A GREAT RESOURCE TO REACH 5985 03:52:09,760 --> 03:52:10,840 OUT TO AN ADDITIONAL GROUP 5986 03:52:10,840 --> 03:52:12,200 THAT'S INTERESTED IN LEARNING 5987 03:52:12,200 --> 03:52:13,680 ABOUT RESEARCH OR HAS QUESTIONS 5988 03:52:13,680 --> 03:52:15,120 ABOUT RESEARCH. 5989 03:52:15,120 --> 03:52:17,840 WE DO HAVE SOMETHING THAT CAN BE 5990 03:52:17,840 --> 03:52:21,880 PRINTED OFF, QUESTIONS TO BRING 5991 03:52:21,880 --> 03:52:25,200 WHEN YOU'RE HAVING INFORMED 5992 03:52:25,200 --> 03:52:25,880 CONSENT DONE, POTENTIAL 5993 03:52:25,880 --> 03:52:26,920 PARTICIPANT CAN WALK THROUGH 5994 03:52:26,920 --> 03:52:27,200 QUESTIONS. 5995 03:52:27,200 --> 03:52:30,760 A LOT OF US HAVE THAT WHITE COAT 5996 03:52:30,760 --> 03:52:31,720 NERVOUSNESS, ALSO TRANSLATES TO 5997 03:52:31,720 --> 03:52:33,920 THE GENERAL PUBLIC WHEN THEY ARE 5998 03:52:33,920 --> 03:52:34,920 GOING TO PARTICIPATE. 5999 03:52:34,920 --> 03:52:36,360 SO IT GIVES THEM THINGS THEY CAN 6000 03:52:36,360 --> 03:52:38,200 GO THROUGH AND ASK. 6001 03:52:38,200 --> 03:52:41,280 WE ALSO HAVE VIDEOS, RECENTLY 6002 03:52:41,280 --> 03:52:43,280 WE'VE POSTED VOICES OF 6003 03:52:43,280 --> 03:52:45,440 PARTICIPANT SERIES WHERE OHRP 6004 03:52:45,440 --> 03:52:48,000 HAS INTERVIEWED ACTUAL RESEARCH 6005 03:52:48,000 --> 03:52:50,400 PARTICIPANTS AND ASKED THEM 6006 03:52:50,400 --> 03:52:52,880 ABOUT EXPERIENCES, RESOURCES YOU 6007 03:52:52,880 --> 03:52:54,440 CAN SHARE WITHIN YOUR 6008 03:52:54,440 --> 03:52:55,320 INSTITUTION, WITHIN YOUR 6009 03:52:55,320 --> 03:52:56,040 RESEARCH COMMUNITY, ALSO SHARE 6010 03:52:56,040 --> 03:52:57,280 WITH THE PUBLIC. 6011 03:52:57,280 --> 03:53:01,480 AGAIN, THEY ARE ALL FREE. 6012 03:53:01,480 --> 03:53:04,080 THANK YOU. 6013 03:53:04,080 --> 03:53:07,760 6014 03:53:07,760 --> 03:53:13,040 >> WE'RE GOING TO TAKE 6015 03:53:13,040 --> 03:53:13,320 QUESTIONS. 6016 03:53:13,320 --> 03:53:16,480 >> COULD YOU -- 6017 03:53:16,480 --> 03:53:17,840 >> DON'T ESCAPE SO FAST. 6018 03:53:17,840 --> 03:53:21,440 WONDERED IF YOU COULD SPEAK TO 6019 03:53:21,440 --> 03:53:25,280 EDUCATIONAL LEVEL WHICH THE 6020 03:53:25,280 --> 03:53:26,840 INFORMATION FOR POTENTIAL 6021 03:53:26,840 --> 03:53:28,120 RESEARCH PARTICIPANTS IS 6022 03:53:28,120 --> 03:53:28,640 TARGETED. 6023 03:53:28,640 --> 03:53:30,640 >> WE'VE TRIED OUR BEST. 6024 03:53:30,640 --> 03:53:31,960 YOU HEAR EIGHTH GRADE LEVEL. 6025 03:53:31,960 --> 03:53:34,680 WE'VE TRIED TO GET THAT DOWN TO 6026 03:53:34,680 --> 03:53:36,480 MAYBE SIXTH GRADE LEVEL. 6027 03:53:36,480 --> 03:53:39,720 IT'S A COMBINATION OF REALLY 6028 03:53:39,720 --> 03:53:41,920 GOING THROUGH AND WE'RE 6029 03:53:41,920 --> 03:53:43,440 DELIBERATE WITH OUR WORD CHOICE, 6030 03:53:43,440 --> 03:53:46,520 AND WHERE WE CAN USE A SIMPLE 6031 03:53:46,520 --> 03:53:48,360 WORD AS OPPOSED TO A TEN DOLLAR 6032 03:53:48,360 --> 03:53:49,680 WORD, WE DO. 6033 03:53:49,680 --> 03:53:53,200 AND THEN ALSO WE HAVE KIND OF 6034 03:53:53,200 --> 03:53:56,720 TESTED THEM WITHIN OUR OWN 6035 03:53:56,720 --> 03:53:57,800 GROUP, TAKING RECOMMENDATIONS 6036 03:53:57,800 --> 03:53:59,880 FROM OHRP LEADERSHIP AS WELL AS 6037 03:53:59,880 --> 03:54:02,240 EVEN SOME OF YOU REVIEWED OUR 6038 03:54:02,240 --> 03:54:04,040 DOCUMENTS IN THE PAST. 6039 03:54:04,040 --> 03:54:10,040 >> AND THEN AS A FOLLOW-UP, 6040 03:54:10,040 --> 03:54:14,240 ESTIMATED APPROXIMATELY HALF THE 6041 03:54:14,240 --> 03:54:15,520 POPULATION IS FUNCTIONALLY 6042 03:54:15,520 --> 03:54:15,880 ILLITERATE. 6043 03:54:15,880 --> 03:54:19,040 AND SO THAT POPULATION IS GOING 6044 03:54:19,040 --> 03:54:22,280 TO BE MORE -- GRAVITATE MORE 6045 03:54:22,280 --> 03:54:24,920 TOWARDS VIDEOS, AND HAS A 6046 03:54:24,920 --> 03:54:26,760 DIFFERENT STRATEGY BEEN TAKEN 6047 03:54:26,760 --> 03:54:29,920 FOR VIDEOS THAN FOR THE WRITTEN 6048 03:54:29,920 --> 03:54:31,560 MATERIAL? 6049 03:54:31,560 --> 03:54:34,000 >> WELL, I THINK WE'VE TRIED TO 6050 03:54:34,000 --> 03:54:35,200 BE PRETTY INCLUSIVE KEEPING IT 6051 03:54:35,200 --> 03:54:38,560 KIND OF TO A BASIC LEVEL OF 6052 03:54:38,560 --> 03:54:39,480 UNDERSTANDING. 6053 03:54:39,480 --> 03:54:41,960 AND SO WE DO HAVE VIDEOS AS I 6054 03:54:41,960 --> 03:54:44,160 MENTIONED THAT EXPLAIN WHAT IS 6055 03:54:44,160 --> 03:54:44,440 RESEARCH. 6056 03:54:44,440 --> 03:54:47,120 WE HAVE ONE THAT TALKS ABOUT 6057 03:54:47,120 --> 03:54:50,080 RANDOMIZATION, KIND OF THINGS 6058 03:54:50,080 --> 03:54:52,240 THAT MIGHT BE -- POSE A BIT OF 6059 03:54:52,240 --> 03:54:55,400 AN ISSUE TO SOMEONE WHO IS NEW 6060 03:54:55,400 --> 03:54:56,400 TO RESEARCH. 6061 03:54:56,400 --> 03:54:59,040 WE ARE CREATING MORE VIDEOS ALL 6062 03:54:59,040 --> 03:54:59,800 THE TIME. 6063 03:54:59,800 --> 03:55:06,560 IT'S JUST A DIFFERENT WAY TO 6064 03:55:06,560 --> 03:55:08,440 DISTRIBUTE THE KNOWLEDGE THAT 6065 03:55:08,440 --> 03:55:13,360 WE'RE -- THAT WE'VE TOLD 6066 03:55:13,360 --> 03:55:14,880 TOGETHER, AND, YEAH, I WOULDN'T 6067 03:55:14,880 --> 03:55:16,680 SAY IT'S NECESSARILY A DIFFERENT 6068 03:55:16,680 --> 03:55:17,960 APPROACH, THE SAME APPROACH, WE 6069 03:55:17,960 --> 03:55:19,400 UNDERSTAND PEOPLE LEARN IN 6070 03:55:19,400 --> 03:55:21,280 DIFFERENT MANNERS SO THAT'S WHY 6071 03:55:21,280 --> 03:55:22,120 WE HAVE THE SELF-GUIDED CHECK 6072 03:55:22,120 --> 03:55:23,520 LISTS YOU CAN GO THROUGH. 6073 03:55:23,520 --> 03:55:25,080 IN THOSE THERE ARE A LOT OF 6074 03:55:25,080 --> 03:55:27,560 VIDEOS AS WELL AS THEIR OWN 6075 03:55:27,560 --> 03:55:30,120 DOCUMENTS BUT I DO BELIEVE IT IS 6076 03:55:30,120 --> 03:55:32,000 MORE IMPORTANT TO HAVE A MORE 6077 03:55:32,000 --> 03:55:34,280 INTERACTIVE VIDEO, IF YOU WILL, 6078 03:55:34,280 --> 03:55:35,800 FOR SOMEONE WHO IS, YOU KNOW, 6079 03:55:35,800 --> 03:55:38,240 NEW TO THE SUBJECT, JUST SO THEY 6080 03:55:38,240 --> 03:55:40,640 HAVE THE OPPORTUNITY TO BE 6081 03:55:40,640 --> 03:55:42,240 SELF-GUIDED, GUIDED THROUGH THAT 6082 03:55:42,240 --> 03:55:46,800 BY THE VIDEO AS OPPOSED TO 6083 03:55:46,800 --> 03:55:47,840 READING DOCUMENTS WHICH A LOT OF 6084 03:55:47,840 --> 03:55:49,800 PEOPLE CAN BE BORED BY, 6085 03:55:49,800 --> 03:55:50,280 REPETITIVE. 6086 03:55:50,280 --> 03:55:52,200 >> THANKS. 6087 03:55:52,200 --> 03:55:53,440 >> YOU'RE WELCOME. 6088 03:55:53,440 --> 03:55:54,120 >> YES? 6089 03:55:54,120 --> 03:55:56,920 >> HAS THOUGHT BEEN GIVEN TO 6090 03:55:56,920 --> 03:55:58,600 ADDITIONAL LANGUAGES BESIDES 6091 03:55:58,600 --> 03:55:58,840 SPANISH? 6092 03:55:58,840 --> 03:56:00,760 OR IF IT'S A SITUATION WHERE 6093 03:56:00,760 --> 03:56:02,120 SOMEONE LEARNED TO USE A 6094 03:56:02,120 --> 03:56:03,640 CHECKLIST OR MATERIALS, THEY 6095 03:56:03,640 --> 03:56:06,040 WANTED TO TRANSLATE THAT WOULD 6096 03:56:06,040 --> 03:56:07,680 BE PERMISSIBLE, IS THERE A 6097 03:56:07,680 --> 03:56:10,000 PROCESS FOR GETTING PERMISSION 6098 03:56:10,000 --> 03:56:11,080 TO DO THAT. 6099 03:56:11,080 --> 03:56:13,240 >> ALL OF OUR MATERIALS WERE 6100 03:56:13,240 --> 03:56:14,280 FULLY DISTRIBUTIVE, LIKE YOU CAN 6101 03:56:14,280 --> 03:56:17,480 TAKE IT AND DO WHAT YOU WOULD 6102 03:56:17,480 --> 03:56:18,480 LIKE WITH IT. 6103 03:56:18,480 --> 03:56:23,160 AT THIS TIME I DON'T BELIEVE WE 6104 03:56:23,160 --> 03:56:25,240 HAVE PLANS TO TRANSLATE INTO 6105 03:56:25,240 --> 03:56:26,680 OTHER LANGUAGES BUT IF AN 6106 03:56:26,680 --> 03:56:28,120 INSTITUTION WANTS TO TAKE THAT 6107 03:56:28,120 --> 03:56:30,760 ON CERTAINLY I KNOW THERE'S 6108 03:56:30,760 --> 03:56:33,000 HUBS, IF YOU WILL, IN DIFFERENT 6109 03:56:33,000 --> 03:56:36,600 CITIES WHERE THEY SPEAK 6110 03:56:36,600 --> 03:56:45,040 DIFFERENT LANGUAGES, MIGHT 6111 03:56:45,040 --> 03:56:48,080 BEHOOVE THEM TO DO THAT. 6112 03:56:48,080 --> 03:56:49,040 >> THAT'S PERMISSIBLE. 6113 03:56:49,040 --> 03:56:49,440 >> YEAH, RIGHT. 6114 03:56:49,440 --> 03:56:49,840 >> THANK YOU. 6115 03:56:49,840 --> 03:56:50,720 >> YOU'RE WELCOME. 6116 03:56:50,720 --> 03:56:54,840 >> WE HAVE A QUESTION IN THE 6117 03:56:54,840 --> 03:56:57,080 ZOOM ROOM. 6118 03:56:57,080 --> 03:56:58,720 >> YES. 6119 03:56:58,720 --> 03:56:59,800 >> HI. 6120 03:56:59,800 --> 03:57:02,000 I WANTED TO CLARIFY, IS THERE 6121 03:57:02,000 --> 03:57:03,960 TRAINING OR ARE THERE MATERIALS 6122 03:57:03,960 --> 03:57:08,560 AVAILABLE THAT COULD BE USED 6123 03:57:08,560 --> 03:57:11,520 TO -- AS ALTERNATIVE TO 6124 03:57:11,520 --> 03:57:13,920 TYPICALLY TRAINING FOR COMMUNITY 6125 03:57:13,920 --> 03:57:14,800 RESEARCHERS? 6126 03:57:14,800 --> 03:57:20,160 >> SO, WE DO HAVE A FIVE-PART 6127 03:57:20,160 --> 03:57:21,840 HUMAN RESEARCH PROTECTION 6128 03:57:21,840 --> 03:57:25,840 FUNDAMENTAL SERIES THAT IS FREE. 6129 03:57:25,840 --> 03:57:28,160 IT'S PRETTY THOROUGH. 6130 03:57:28,160 --> 03:57:32,120 IT COULD BE USED INSTEAD OF 6131 03:57:32,120 --> 03:57:35,960 CITY, BUT I THINK INSTITUTIONS 6132 03:57:35,960 --> 03:57:38,000 HAVE THEIR OWN REQUIREMENTS FOR 6133 03:57:38,000 --> 03:57:41,640 WHAT TRAINING IRB MEMBERS OR HRP 6134 03:57:41,640 --> 03:57:42,720 PROFESSIONALS MUST HAVE BUT 6135 03:57:42,720 --> 03:57:44,160 CERTAINLY THAT'S A FREE RESOURCE 6136 03:57:44,160 --> 03:57:45,920 WE HAVE ON OUR SITE. 6137 03:57:45,920 --> 03:57:47,560 YOU CAN TAKE THE TRAINING. 6138 03:57:47,560 --> 03:57:48,600 THERE'S FIVE PARTS. 6139 03:57:48,600 --> 03:57:51,360 AFTER EACH ONE YOU RECEIVE A 6140 03:57:51,360 --> 03:57:51,800 CERTIFICATE. 6141 03:57:51,800 --> 03:57:53,840 WE DO NOT KNOW WHO TAKES THE 6142 03:57:53,840 --> 03:57:54,320 TRAINING. 6143 03:57:54,320 --> 03:57:56,400 WE DON'T SAVE THE CERTIFICATES. 6144 03:57:56,400 --> 03:57:57,680 BUT CERTAINLY IT'S SOMETHING 6145 03:57:57,680 --> 03:58:00,240 THAT AN INSTITUTION COULD DECIDE 6146 03:58:00,240 --> 03:58:02,400 TO USE THAT FIVE-PART SERIES, 6147 03:58:02,400 --> 03:58:03,920 AND SAY HEY, WE'D LIKE YOU TO 6148 03:58:03,920 --> 03:58:05,920 COMPLETE THIS AND THEN AN 6149 03:58:05,920 --> 03:58:07,320 INDIVIDUAL CAN GO THROUGH AND, 6150 03:58:07,320 --> 03:58:09,640 AGAIN, UPON COMPLETION THEY HAVE 6151 03:58:09,640 --> 03:58:11,400 A PDF WHICH THEY CAN PUT THEIR 6152 03:58:11,400 --> 03:58:14,760 OWN NAME BUT THAT'S SOMETHING WE 6153 03:58:14,760 --> 03:58:17,400 DO NOT MANAGE WHO COMPLETES OR 6154 03:58:17,400 --> 03:58:19,240 TAKE DOWN ANY INFORMATION LIKE 6155 03:58:19,240 --> 03:58:19,440 THAT. 6156 03:58:19,440 --> 03:58:23,560 >> THANK YOU. 6157 03:58:23,560 --> 03:58:26,080 >> YOU'RE WELCOME. 6158 03:58:26,080 --> 03:58:28,840 >> ANY OTHER QUESTIONS? 6159 03:58:28,840 --> 03:58:30,000 6160 03:58:30,000 --> 03:58:31,200 >> IF NO OTHER QUESTIONS I NEED 6161 03:58:31,200 --> 03:58:32,400 TWO OR THREE MINUTES TO GET 6162 03:58:32,400 --> 03:58:35,120 THINGS ON AND OFF THE PODIUM 6163 03:58:35,120 --> 03:58:38,120 SYSTEM AND WE CAN TRANSITION TO 6164 03:58:38,120 --> 03:58:38,360 REVIEWING. 6165 03:58:38,360 --> 03:58:45,880 >> WE'RE GOING TO GO BACK TO THE 6166 03:58:45,880 --> 03:58:47,600 SINGLE IRB REVIEW DRAFT BECAUSE 6167 03:58:47,600 --> 03:58:48,520 OF CHANGES. 6168 03:58:48,520 --> 03:58:52,200 WE'LL TRY TO DO THAT TODAY. 6169 03:58:52,200 --> 03:58:53,800 >> CAN WE WALK AROUND. 6170 03:58:53,800 --> 03:58:56,560 >> TAKE THREE MINUTES, FIVE 6171 03:58:56,560 --> 03:59:05,840 MINUTES. 6172 03:59:05,840 --> 03:59:07,240 THANKS TO MARK AND DAVID FOR 6173 03:59:07,240 --> 03:59:11,560 TURNING THIS DOCUMENT AROUND TO 6174 03:59:11,560 --> 03:59:12,920 HOPEFULLY FINISH IT TODAY. 6175 03:59:12,920 --> 03:59:17,640 SO, WE'RE GOING BACK TO SINGLE 6176 03:59:17,640 --> 03:59:19,400 INSTITUTIONAL REVIEW BOARD FOR 6177 03:59:19,400 --> 03:59:22,480 OHRP DRAFT GUIDANCE, I'M GOING 6178 03:59:22,480 --> 03:59:27,360 TO TURN IT OVER TO YOU, DAVID. 6179 03:59:27,360 --> 03:59:27,800 >> THANKS. 6180 03:59:27,800 --> 03:59:35,400 AND HONESTLY, MARK DID THE HEAVY 6181 03:59:35,400 --> 03:59:39,680 LIFTING GETTING THIS -- OH, COME 6182 03:59:39,680 --> 03:59:48,200 ON NOW. 6183 03:59:48,200 --> 03:59:51,240 >> ARE WE SUPPOSED TO BE SEEING 6184 03:59:51,240 --> 03:59:53,000 SOMETHING OTHER THAN THE SLIDES 6185 03:59:53,000 --> 03:59:53,800 FROM THE LAST -- 6186 03:59:53,800 --> 03:59:55,520 >> I'M WORKING ON IT. 6187 03:59:55,520 --> 03:59:55,960 >> THANK YOU. 6188 03:59:55,960 --> 03:59:58,560 >> THERE WE GO. 6189 03:59:58,560 --> 04:00:00,320 OKAY. 6190 04:00:00,320 --> 04:00:01,040 ALL RIGHT. 6191 04:00:01,040 --> 04:00:04,240 SO, IN THE -- YEAH, THANKS TO 6192 04:00:04,240 --> 04:00:05,000 MARK REALLY FOR CHURNING THIS 6193 04:00:05,000 --> 04:00:07,320 OUT OVER THE LAST COUPLE SESSION 6194 04:00:07,320 --> 04:00:09,400 WHILE OTHER PEOPLE WERE 6195 04:00:09,400 --> 04:00:09,840 SPEAKING. 6196 04:00:09,840 --> 04:00:10,920 WE'RE GOING TO JUMP THROUGH THE 6197 04:00:10,920 --> 04:00:13,560 CHANGES AND NOT GO BACK THROUGH 6198 04:00:13,560 --> 04:00:16,640 THE ENTIRE DOCUMENT. 6199 04:00:16,640 --> 04:00:20,280 HERE IN THE DISCUSSION SECTION 6200 04:00:20,280 --> 04:00:27,800 WE'VE GOT THIS ADDED LANGUAGE 6201 04:00:27,800 --> 04:00:38,080 ABOUT PROCESS. 6202 04:00:56,360 --> 04:00:58,600 DOES THAT WORK FOR EVERYBODY? 6203 04:00:58,600 --> 04:01:02,920 >> HOW DOES THAT LOOK FOR FOLKS? 6204 04:01:02,920 --> 04:01:08,360 I'M SEEING GENERAL AGREEMENT. 6205 04:01:08,360 --> 04:01:10,760 I DON'T SEE DISSENT. 6206 04:01:10,760 --> 04:01:13,520 >> WORKING ON IT. 6207 04:01:13,520 --> 04:01:14,960 6208 04:01:14,960 --> 04:01:17,240 >> I'M SORRY, I NEED TO PULL THE 6209 04:01:17,240 --> 04:01:18,400 DOCUMENT. 6210 04:01:18,400 --> 04:01:26,520 IS THE ISSUE THAT WE WANT THE 6211 04:01:26,520 --> 04:01:28,280 GUIDANCE ACTUALLY HAVE SPECIFIC 6212 04:01:28,280 --> 04:01:33,000 PROCESSES OR GIVE GUIDANCE ON 6213 04:01:33,000 --> 04:01:34,880 THE FACT THAT YOU SHOULD HAVE A 6214 04:01:34,880 --> 04:01:36,160 PROCESS AND SOME ELEMENTS YOU 6215 04:01:36,160 --> 04:01:36,840 SHOULD CONSIDER? 6216 04:01:36,840 --> 04:01:38,720 I DON'T REMEMBER WHAT WE TALKED 6217 04:01:38,720 --> 04:01:45,920 ABOUT THIS MORNING, I NEED TO 6218 04:01:45,920 --> 04:01:47,240 PULL THE ORIGINAL. 6219 04:01:47,240 --> 04:01:52,480 THAT WAS MY COMMENT. 6220 04:01:52,480 --> 04:01:53,240 >> RIGHT. 6221 04:01:53,240 --> 04:01:56,480 THIS IS NEW TEXT, ORIGINAL TEXT 6222 04:01:56,480 --> 04:02:00,120 IS WHAT PRECEDES IT. 6223 04:02:00,120 --> 04:02:00,400 >> OKAY. 6224 04:02:00,400 --> 04:02:05,080 >> THIS IS IN ADDITION, NOT A 6225 04:02:05,080 --> 04:02:06,920 CHANGE, CORRECT. 6226 04:02:06,920 --> 04:02:17,160 >> OKAY. 6227 04:02:23,800 --> 04:02:26,880 >> WHILE YOU'RE THINKING, LET ME 6228 04:02:26,880 --> 04:02:28,280 THINK OUT LOUD. 6229 04:02:28,280 --> 04:02:31,360 GENERALLY THINK YOU CAN MAKE AN 6230 04:02:31,360 --> 04:02:32,080 OBSERVATION THAT SOMETHING'S 6231 04:02:32,080 --> 04:02:33,200 MISSING IT'S NICE TO SAY WHAT 6232 04:02:33,200 --> 04:02:35,000 YOU WANT THERE WHEN YOU SAY IT'S 6233 04:02:35,000 --> 04:02:35,520 MISSING. 6234 04:02:35,520 --> 04:02:37,680 I THINK THE QUESTION IS DO WE 6235 04:02:37,680 --> 04:02:39,280 WANT THE GUIDANCE TO 6236 04:02:39,280 --> 04:02:40,800 SPECIFICALLY TALK ABOUT WHAT 6237 04:02:40,800 --> 04:02:46,160 THAT PROCESS OUGHT TO BE OR TO 6238 04:02:46,160 --> 04:02:47,720 SIMPLY SAY THAT IRBs THAT 6239 04:02:47,720 --> 04:02:51,840 FUNCTIONEL AS SINGLE IRB OUGHT 6240 04:02:51,840 --> 04:02:55,000 TO HAVE APPROPRIATE PROCESS IN 6241 04:02:55,000 --> 04:02:56,640 PLACE, SO THOSE RELYING 6242 04:02:56,640 --> 04:02:58,400 INSTITUTIONS WOULD KNOW WHAT 6243 04:02:58,400 --> 04:02:59,200 THAT PROCESS IS? 6244 04:02:59,200 --> 04:03:00,680 NOT THAT WE'RE GOING TO SAY THIS 6245 04:03:00,680 --> 04:03:02,120 IS THE PROCESS YOU SHOULD HAVE 6246 04:03:02,120 --> 04:03:03,880 BUT IF I'M GOING TO RELY ON YOU 6247 04:03:03,880 --> 04:03:07,720 I WANT TO KNOW WHAT THE PROCESS 6248 04:03:07,720 --> 04:03:07,880 IS. 6249 04:03:07,880 --> 04:03:09,680 >> SO WHY DON'T WE PARKING LOT 6250 04:03:09,680 --> 04:03:11,680 THAT FOR THE MOMENT BECAUSE MARK 6251 04:03:11,680 --> 04:03:16,520 WAS JUST WHISPERING PROCESS IS 6252 04:03:16,520 --> 04:03:19,280 MENTIONED IN OTHER PLACES. 6253 04:03:19,280 --> 04:03:20,960 NEW LANGUAGE, THERE'S PROCESS -- 6254 04:03:20,960 --> 04:03:22,640 >> GREAT. 6255 04:03:22,640 --> 04:03:24,040 THANK YOU. 6256 04:03:24,040 --> 04:03:24,760 >> PUT IN. 6257 04:03:24,760 --> 04:03:32,920 YEAH, LET'S -- ALL RIGHT. 6258 04:03:32,920 --> 04:03:41,320 HERE WE JUST HAVE WHAT WAS 6259 04:03:41,320 --> 04:03:51,840 SUGGESTED FOR THIS PARAGRAPH. 6260 04:03:57,440 --> 04:04:00,160 >> IS THAT SERVICES OR IS THE S 6261 04:04:00,160 --> 04:04:01,600 CROSSED OUT? 6262 04:04:01,600 --> 04:04:09,400 >> NO, THAT IS THERE. 6263 04:04:09,400 --> 04:04:10,920 >> OKAY. 6264 04:04:10,920 --> 04:04:17,200 >> IT IS NOW, THAT'S FOR SURE. 6265 04:04:17,200 --> 04:04:23,200 6266 04:04:23,200 --> 04:04:26,280 6267 04:04:26,280 --> 04:04:28,320 >> THAT'S THE RESPONSE TO THE 6268 04:04:28,320 --> 04:04:31,040 PUBLIC COMMENT WE HAD. 6269 04:04:31,040 --> 04:04:31,320 >> YES. 6270 04:04:31,320 --> 04:04:32,200 >> OKAY, THAT'S GOOD. 6271 04:04:32,200 --> 04:04:40,080 >> LOCAL SITE REVIEW AND 6272 04:04:40,080 --> 04:04:50,600 APPROVAL THIS ADDED LANGUAGE. 6273 04:05:04,000 --> 04:05:05,800 >> ONE OF THE THINGS WE TALKED 6274 04:05:05,800 --> 04:05:08,600 ABOUT THIS MORNING ALSO ON LINE 6275 04:05:08,600 --> 04:05:11,480 117 IN ADDITION TO THOSE EXTREME 6276 04:05:11,480 --> 04:05:13,840 CIRCUMSTANCES NOT BEING IN THE 6277 04:05:13,840 --> 04:05:16,400 STUDY, THAT COULD BE AN ARGUMENT 6278 04:05:16,400 --> 04:05:18,400 FOR WHY YOU WOULD SEEK AN 6279 04:05:18,400 --> 04:05:18,640 EXCEPTION. 6280 04:05:18,640 --> 04:05:21,560 WE DID TALK ABOUT THAT AS WELL. 6281 04:05:21,560 --> 04:05:23,840 SO JUST ADD SOMETHING TO THE END 6282 04:05:23,840 --> 04:05:26,080 OF THE SENTENCE TO SAY, OR WITH 6283 04:05:26,080 --> 04:05:28,560 THE SINGLE IRB'S JUDGMENT 6284 04:05:28,560 --> 04:05:29,320 REGARDING THAT PROTOCOL HAS 6285 04:05:29,320 --> 04:05:30,880 OPTION OF NOT BEING A SITE IN 6286 04:05:30,880 --> 04:05:32,720 THE STUDY, I DON'T KNOW WHAT THE 6287 04:05:32,720 --> 04:05:36,360 LANGUAGE SHOULD BE, OR THEY 6288 04:05:36,360 --> 04:05:37,640 COULD CONSIDER SUBMITTING -- 6289 04:05:37,640 --> 04:05:38,840 REQUESTING REQUEST FOR EXCEPTION 6290 04:05:38,840 --> 04:05:46,640 BECAUSE OF -- YOU KNOW, 6291 04:05:46,640 --> 04:05:48,360 SOMETHING ALONG THOSE LINES. 6292 04:05:48,360 --> 04:05:49,680 >> I'M ASSUMING IF YOU REQUEST 6293 04:05:49,680 --> 04:05:52,000 EXCEPTION IT MEANS THE PROTOCOL 6294 04:05:52,000 --> 04:05:54,280 COULD HAVE A LOCAL AMENDMENT OR 6295 04:05:54,280 --> 04:05:56,360 LOCAL MODIFICATION. 6296 04:05:56,360 --> 04:05:58,480 THE PROTOCOL WOULD HAVE TO BE 6297 04:05:58,480 --> 04:06:00,120 CONSISTENT ACROSS THE SITES. 6298 04:06:00,120 --> 04:06:02,360 I'M CONFUSED WHAT THE EXCEPTION 6299 04:06:02,360 --> 04:06:12,600 WOULD BE FOR. 6300 04:06:14,520 --> 04:06:15,960 >> IMPLYING, CONSUELO RAISED A 6301 04:06:15,960 --> 04:06:17,800 CONCERN PEOPLE NOT BEING ABLE TO 6302 04:06:17,800 --> 04:06:20,400 BE IN THE STUDY, IF YOU CAN'T BE 6303 04:06:20,400 --> 04:06:21,840 IN THE STUDY THAT'S NOT GOOD 6304 04:06:21,840 --> 04:06:22,760 EITHER, BEING ABLE TO DO THE 6305 04:06:22,760 --> 04:06:25,080 STUDY WOULD BE TO GET AN 6306 04:06:25,080 --> 04:06:26,360 EXCEPTION TO ALLOW YOU TO HAVE 6307 04:06:26,360 --> 04:06:29,200 YOUR OWN LOCAL IRB OR YOUR OWN 6308 04:06:29,200 --> 04:06:31,280 IRB OF CHOICE DO THE REVIEW SO 6309 04:06:31,280 --> 04:06:32,520 THAT YOU COULD STILL PARTICIPATE 6310 04:06:32,520 --> 04:06:34,560 IN THE STUDY. 6311 04:06:34,560 --> 04:06:38,320 I THINK THAT'S WHAT WE SAID. 6312 04:06:38,320 --> 04:06:39,840 >> LOGICALLY THAT ASSUMES 6313 04:06:39,840 --> 04:06:42,480 WHATEVER PROTOCOL THE LOCAL IRB 6314 04:06:42,480 --> 04:06:44,120 APPROVES IS CONSISTENT AS THE 6315 04:06:44,120 --> 04:06:46,640 OTHER PROTOCOL. 6316 04:06:46,640 --> 04:06:49,160 >> IT'S THE SAME STUDY BUT WITH 6317 04:06:49,160 --> 04:06:51,880 LOCAL MODIFICATIONS SIMILAR FOR 6318 04:06:51,880 --> 04:06:54,920 THE SINGLE IRB MANDATE WHERE YOU 6319 04:06:54,920 --> 04:06:57,560 WOULD HAVE SITUATIONS WHERE YOU 6320 04:06:57,560 --> 04:06:59,440 MIGHT HAVE A STUDY AND -- 6321 04:06:59,440 --> 04:07:04,120 CURRENTLY YOUR LOCAL IRB COULD 6322 04:07:04,120 --> 04:07:05,760 HAVE MADE CHANGES, ADDING THINGS 6323 04:07:05,760 --> 04:07:06,520 TO THE CONSENT FORM. 6324 04:07:06,520 --> 04:07:10,120 >> I'M LOCKED INTO THE 6325 04:07:10,120 --> 04:07:11,160 PHARMACEUTICAL MODEL. 6326 04:07:11,160 --> 04:07:13,400 YOU COULDN'T DO THAT. 6327 04:07:13,400 --> 04:07:15,400 THE NEW CLINICAL TRIAL 6328 04:07:15,400 --> 04:07:17,040 REGULATIONS DON'T ALLOW SPECIFIC 6329 04:07:17,040 --> 04:07:18,240 AMENDMENTS SO IT'S VERY 6330 04:07:18,240 --> 04:07:18,640 INTERESTING. 6331 04:07:18,640 --> 04:07:20,480 >> I WANT TO MAKE SURE THAT'S -- 6332 04:07:20,480 --> 04:07:22,400 >> THAT'S FINE. 6333 04:07:22,400 --> 04:07:24,680 I AGREE BECAUSE OF SOME 6334 04:07:24,680 --> 04:07:26,160 CIRCUMSTANCES. 6335 04:07:26,160 --> 04:07:27,440 >> I DON'T KNOW, CONSUELO, IF 6336 04:07:27,440 --> 04:07:28,960 YOU HAD THOUGHTS THERE. 6337 04:07:28,960 --> 04:07:30,160 >> WHAT LINDA SUGGESTED IS ALONG 6338 04:07:30,160 --> 04:07:35,680 THE LINES OF WHAT I HAD IN MIND 6339 04:07:35,680 --> 04:07:39,680 AFTER THE LAST DISCUSSION. 6340 04:07:39,680 --> 04:07:42,120 THE ISSUES SPECIFICALLY ABOUT 6341 04:07:42,120 --> 04:07:46,480 HAVING LOCAL REVIEW, PEOPLE NEED 6342 04:07:46,480 --> 04:07:50,160 TO -- THERE ARE GOING TO BE 6343 04:07:50,160 --> 04:07:51,280 NUANCES AROUND ENGAGING, 6344 04:07:51,280 --> 04:07:53,800 INVOLVING CERTAIN COMMUNITIES IN 6345 04:07:53,800 --> 04:07:55,000 RESEARCH, AND YOU REALLY NEED TO 6346 04:07:55,000 --> 04:07:57,120 BE ABLE TO HAVE THAT LOCAL 6347 04:07:57,120 --> 04:07:59,160 PERSPECTIVE IN THE REVIEW. 6348 04:07:59,160 --> 04:08:01,560 NOW, THERE COULD BE ACTUALLY NO 6349 04:08:01,560 --> 04:08:04,440 DIFFERENCE ONCE THEY HAVE A 6350 04:08:04,440 --> 04:08:06,840 REVIEW BUT IF THERE ARE CONCERNS 6351 04:08:06,840 --> 04:08:10,080 THEN THOSE NEED TO BE 6352 04:08:10,080 --> 04:08:11,400 APPROPRIATELY ADDRESSED OR ELSE 6353 04:08:11,400 --> 04:08:13,280 WE'LL CONTINUE TO HAVE ISSUES 6354 04:08:13,280 --> 04:08:16,520 AROUND LACK OF REPRESENTATION IN 6355 04:08:16,520 --> 04:08:19,080 THE TRIALS. 6356 04:08:19,080 --> 04:08:19,720 6357 04:08:19,720 --> 04:08:24,840 >> SO I JUST WANT TO MAKE SURE, 6358 04:08:24,840 --> 04:08:26,840 TO THAT POINT I GUESS IT COULD 6359 04:08:26,840 --> 04:08:29,360 BE A SITUATION WHERE IT'S THE 6360 04:08:29,360 --> 04:08:30,880 SAME PROTOCOL BUT THERE ARE 6361 04:08:30,880 --> 04:08:32,000 CERTAIN ASPECTS THAT WOULD HAVE 6362 04:08:32,000 --> 04:08:33,960 TO BE REVIEWED BY THE LOCAL IRB 6363 04:08:33,960 --> 04:08:35,600 AND YOU MIGHT MAKE SOME 6364 04:08:35,600 --> 04:08:36,440 MODIFICATIONS TO CERTAIN THINGS 6365 04:08:36,440 --> 04:08:38,840 LIKE HOW TO RECRUIT OR CERTAIN 6366 04:08:38,840 --> 04:08:40,720 ASPECTS THAT WOULDN'T HAPPEN 6367 04:08:40,720 --> 04:08:41,000 OTHERWISE. 6368 04:08:41,000 --> 04:08:42,560 IS THAT WHAT WE'RE SAYING? 6369 04:08:42,560 --> 04:08:47,160 >> I THINK SO. 6370 04:08:47,160 --> 04:08:49,120 I MEAN, I THINK WHAT WE'RE NOT 6371 04:08:49,120 --> 04:08:50,920 DOING IS RULING ANYTHING OUT. 6372 04:08:50,920 --> 04:08:52,960 I WOULD SEE SOME OF THIS, WELL, 6373 04:08:52,960 --> 04:08:58,800 THE LAST RESORT WOULD BE THE NOT 6374 04:08:58,800 --> 04:09:03,720 PARTICIPATING IN THE STUDY BUT, 6375 04:09:03,720 --> 04:09:05,600 YOU KNOW, PRESUMABLY THERE WOULD 6376 04:09:05,600 --> 04:09:08,000 BE -- IF THERE WERE TO BE LOCAL 6377 04:09:08,000 --> 04:09:09,520 SITE DIFFERENCES THOSE WOULD BE 6378 04:09:09,520 --> 04:09:10,600 CAREFULLY NEGOTIATED AND WORKED 6379 04:09:10,600 --> 04:09:13,040 OUT SO THEY AREN'T HAVING AN 6380 04:09:13,040 --> 04:09:15,000 OVERALL IMPACT ON THE INTEGRITY 6381 04:09:15,000 --> 04:09:16,400 OF THE STUDY. 6382 04:09:16,400 --> 04:09:20,240 >> I GUESS MAYBE TWO THINGS. 6383 04:09:20,240 --> 04:09:24,360 WE DO WANT PEOPLE, IF -- THIS IS 6384 04:09:24,360 --> 04:09:26,240 IN REGARDS TO WHEN THERE ARE 6385 04:09:26,240 --> 04:09:28,880 DISAGREEMENTS THAT CAN'T BE 6386 04:09:28,880 --> 04:09:32,280 RESOLVED, SOMETIMES THAT MIGHT 6387 04:09:32,280 --> 04:09:34,360 INVOLVE A LOCAL REVIEW WITH 6388 04:09:34,360 --> 04:09:38,000 MODIFICATIONS BUT THEN ALSO IF 6389 04:09:38,000 --> 04:09:39,040 THAT IS UNACCEPTABLE, THEN I DO 6390 04:09:39,040 --> 04:09:41,960 THINK WE WANT TO HAVE AN 6391 04:09:41,960 --> 04:09:43,760 OPPORTUNITY FOR THERE TO BE 6392 04:09:43,760 --> 04:09:50,680 EXCEPTIONS TO THE SINGLE IRB. 6393 04:09:50,680 --> 04:09:52,280 >> SKIP? 6394 04:09:52,280 --> 04:09:53,880 >> I'M JUST WONDERING IF -- I 6395 04:09:53,880 --> 04:09:56,040 AGREE WITH WHAT'S BEEN SAID, 6396 04:09:56,040 --> 04:09:57,040 LOOKING AT THE WORDING 6397 04:09:57,040 --> 04:09:59,880 REQUESTING EXCEPTION TO THE 6398 04:09:59,880 --> 04:10:01,960 SINGLE IRB REQUIREMENTS TO ALLOW 6399 04:10:01,960 --> 04:10:03,720 FOR LOCAL REVIEW AND 6400 04:10:03,720 --> 04:10:07,520 MODIFICATIONS AS APPROPRIATE, 6401 04:10:07,520 --> 04:10:10,960 SOMETHING LIKE THAT. 6402 04:10:10,960 --> 04:10:13,160 JUST TO PROVIDE CONTEXT WHY YOU 6403 04:10:13,160 --> 04:10:14,440 WANT THAT. 6404 04:10:14,440 --> 04:10:17,520 I'M NOT WEDDED TO THAT LANGUAGE 6405 04:10:17,520 --> 04:10:21,160 BUT SOMETHING ALONG THOSE LINES. 6406 04:10:21,160 --> 04:10:26,840 >> I'LL PUT IT THERE TO SEE WHAT 6407 04:10:26,840 --> 04:10:29,080 PEOPLE THINK. 6408 04:10:29,080 --> 04:10:30,720 >> SOMEONE MORE VERSED IN IRB 6409 04:10:30,720 --> 04:10:32,200 LANGUAGE WILL HAVE TO WEIGH IN 6410 04:10:32,200 --> 04:10:34,560 BUT I PRESUME YOU DON'T NEED AN 6411 04:10:34,560 --> 04:10:38,360 EXCEPTION TO THE SINGLE IRB IF 6412 04:10:38,360 --> 04:10:41,560 IT'S JUST MODIFICATIONS. 6413 04:10:41,560 --> 04:10:45,160 BUT YOU WOULD NEED AN EXCEPTION 6414 04:10:45,160 --> 04:10:47,320 IF -- IF FOR THE FOR EXAMPLE 6415 04:10:47,320 --> 04:10:48,560 GIVEN EARLIER, IF FOUR OF THE 6416 04:10:48,560 --> 04:10:50,400 FIVE SITES WERE UNDER THE SINGLE 6417 04:10:50,400 --> 04:10:52,680 IRB AND ANOTHER SITE WANTED TO 6418 04:10:52,680 --> 04:10:53,480 HAVE A SEPARATE. 6419 04:10:53,480 --> 04:10:55,280 >> THE EXCEPTION WOULD BE TO 6420 04:10:55,280 --> 04:10:56,840 MAKE ONE OF THE SITES -- ALLOW 6421 04:10:56,840 --> 04:10:58,800 ONE OF THE SITES TO HAVE ITS 6422 04:10:58,800 --> 04:11:01,440 LOCAL IRB BE THE IRB OF RECORD 6423 04:11:01,440 --> 04:11:03,720 FOR THAT PROTOCOL AT THAT SITE. 6424 04:11:03,720 --> 04:11:04,720 >> RIGHT, RIGHT. 6425 04:11:04,720 --> 04:11:08,520 >> BUT THE REASON IS SO THEY CAN 6426 04:11:08,520 --> 04:11:09,440 MAKE MODIFICATIONS. 6427 04:11:09,440 --> 04:11:09,720 >> YEAH. 6428 04:11:09,720 --> 04:11:12,280 >> YEAH, AND I DON'T THINK THE 6429 04:11:12,280 --> 04:11:15,200 MODIFICATION APPLIES TO 6430 04:11:15,200 --> 04:11:17,200 PROTOCOL, LIKE AN AMENDMENT. 6431 04:11:17,200 --> 04:11:22,120 >> I'M BEING VERY AMBIGUOUS ON 6432 04:11:22,120 --> 04:11:30,200 THAT. 6433 04:11:30,200 --> 04:11:30,720 >> YEAH. 6434 04:11:30,720 --> 04:11:31,440 >> MAYBE REQUESTING AN EXCEPTION 6435 04:11:31,440 --> 04:11:38,120 TO THE SINGLE IRB REQUIREMENT TO 6436 04:11:38,120 --> 04:11:41,800 ALLOW FOR -- THAT'S WHAT I'M 6437 04:11:41,800 --> 04:11:42,560 TRYING TO SAY. 6438 04:11:42,560 --> 04:11:45,200 IT'S NOT BECAUSE OF LOCAL -- IF 6439 04:11:45,200 --> 04:11:46,520 YOU HAVE AN EXCEPTION SINGLE IRB 6440 04:11:46,520 --> 04:11:48,600 REQUIREMENT THAT IMPLIES YOU CAN 6441 04:11:48,600 --> 04:11:50,240 HAVE LOCAL REVIEW SO I'M NOT 6442 04:11:50,240 --> 04:11:52,320 SURE IF THAT ADDS ANYTHING. 6443 04:11:52,320 --> 04:11:54,440 IT'S REALLY BECAUSE YOU CAN'T -- 6444 04:11:54,440 --> 04:11:56,720 OR REQUEST AN EXCEPTION TO THE 6445 04:11:56,720 --> 04:11:58,040 SINGLE IRB REQUIREMENT BECAUSE 6446 04:11:58,040 --> 04:11:59,480 YOU CAN'T RESOLVE THE DISPUTE. 6447 04:11:59,480 --> 04:12:01,880 IT'S GOING TO DEPEND ON WHAT THE 6448 04:12:01,880 --> 04:12:03,880 DISPUTE WAS IN TERMS OF WHAT IT 6449 04:12:03,880 --> 04:12:05,400 IS YOU'RE ASKING FOR AND COULD 6450 04:12:05,400 --> 04:12:06,720 BE FOR DIFFERENT REASONS SO 6451 04:12:06,720 --> 04:12:07,360 MAYBE JUST -- 6452 04:12:07,360 --> 04:12:10,120 >> IT COULD BE. 6453 04:12:10,120 --> 04:12:11,640 I THINK TO SKIP'S EARLIER 6454 04:12:11,640 --> 04:12:14,840 CONCERN, I THINK, YOU KNOW, 6455 04:12:14,840 --> 04:12:17,280 WHAT'S NOT KNOWN HERE IS, AGAIN, 6456 04:12:17,280 --> 04:12:19,360 WHETHER A SPONSOR WOULD BE 6457 04:12:19,360 --> 04:12:20,320 WILLING TO ACCEPT VARIATIONS AT 6458 04:12:20,320 --> 04:12:21,640 THE LOCAL SITE. 6459 04:12:21,640 --> 04:12:24,800 IT MAY BE OUT OF A SINGLE IRB'S 6460 04:12:24,800 --> 04:12:27,480 HANDS OR LOCAL IRB'S HANDS, IF 6461 04:12:27,480 --> 04:12:29,920 THE SPONSOR SAYS WE'RE NOT 6462 04:12:29,920 --> 04:12:31,840 ALLOWING, YOU KNOW, ONE OF SEVEN 6463 04:12:31,840 --> 04:12:35,720 SITES TO GO THEIR OWN WAY. 6464 04:12:35,720 --> 04:12:39,240 >> LET ME GIVE AN EXAMPLE JUST 6465 04:12:39,240 --> 04:12:44,400 EWING THE -- USING THE NEW 6466 04:12:44,400 --> 04:12:45,440 CLINICAL TRIAL. 6467 04:12:45,440 --> 04:12:48,480 A SPONSOR WANTS TO DO 16 AND UP, 6468 04:12:48,480 --> 04:12:50,240 FINE IN COUNTRIES LIKE SCOTLAND, 6469 04:12:50,240 --> 04:12:51,400 YOU'RE AN ADULT AT 16. 6470 04:12:51,400 --> 04:12:52,840 BUT THERE ARE SOME OTHERS WHO 6471 04:12:52,840 --> 04:12:55,040 SAY, NO, WE'RE NOT GOING TO LET 6472 04:12:55,040 --> 04:12:56,120 YOU ENROLL CHILDREN, SO IT'S 6473 04:12:56,120 --> 04:12:58,360 GOING TO BE 18 AND UP. 6474 04:12:58,360 --> 04:13:00,040 WHAT DO YOU DO? 6475 04:13:00,040 --> 04:13:04,880 IF YOU CAN'T ALLOW FOR LOCAL 6476 04:13:04,880 --> 04:13:05,960 MODIFICATION, THAT SITE THAT 6477 04:13:05,960 --> 04:13:08,480 SAYS 18 AND UP ONLY WOULDN'T BE 6478 04:13:08,480 --> 04:13:10,480 ABLE TO PARTICIPATE. 6479 04:13:10,480 --> 04:13:11,440 SO, THAT'S A MODIFICATION THAT 6480 04:13:11,440 --> 04:13:13,840 DOESN'T HAVE ANY BIG IMPACT ON 6481 04:13:13,840 --> 04:13:15,280 THE PROTOCOL ITSELF. 6482 04:13:15,280 --> 04:13:16,280 AND SO THERE'S SOME 6483 04:13:16,280 --> 04:13:18,520 MODIFICATIONS THAT CAN BE DONE, 6484 04:13:18,520 --> 04:13:19,360 OTHERS THAT CAN'T. 6485 04:13:19,360 --> 04:13:22,720 AND I WAS JUST TRYING TO CAPTURE 6486 04:13:22,720 --> 04:13:25,320 LANGUAGE THAT MODIFICATIONS AS 6487 04:13:25,320 --> 04:13:27,400 APPROPRIATE IS TRYING TO BE 6488 04:13:27,400 --> 04:13:28,480 VAGUE AROUND THAT SO -- 6489 04:13:28,480 --> 04:13:31,600 OTHERWISE WE'RE GOING TO GET 6490 04:13:31,600 --> 04:13:32,880 INTO THE WEEDS VERY QUICKLY. 6491 04:13:32,880 --> 04:13:42,000 >> THAT'S A REALLY GOOD EXAMPLE 6492 04:13:42,000 --> 04:13:43,200 THAT -- REAL WORLD EXAMPLE, 6493 04:13:43,200 --> 04:13:46,600 HELPFUL TO THINK ABOUT A 6494 04:13:46,600 --> 04:13:48,360 DIFFERENCE BETWEEN SITES. 6495 04:13:48,360 --> 04:13:49,800 NOT SURE THAT'S AN EXAMPLE IN A 6496 04:13:49,800 --> 04:13:51,120 WOULD TAKE YOU TO THE POINT OF 6497 04:13:51,120 --> 04:13:52,960 SAYING WE NEED A LOCAL IRB TO 6498 04:13:52,960 --> 04:13:54,280 REVIEW THIS BUT YOU KNOW WHAT 6499 04:13:54,280 --> 04:13:55,480 I'M SAYING, YOU CAN IMAGINE 6500 04:13:55,480 --> 04:14:00,080 THERE'S MULTIPLE TYPES OF 6501 04:14:00,080 --> 04:14:02,200 EXCEPTIONS THAT MIGHT BE 6502 04:14:02,200 --> 04:14:04,560 APPROPRIATE. 6503 04:14:04,560 --> 04:14:06,080 I'M NOT COMING UP WITH ANYTHING 6504 04:14:06,080 --> 04:14:15,880 BETTER MYSELF. 6505 04:14:15,880 --> 04:14:18,400 >> IT'S GOOD ENOUGH FOR 6506 04:14:18,400 --> 04:14:19,280 GOVERNMENT WORK. 6507 04:14:19,280 --> 04:14:20,480 >> I'M GOING TO MOVE ON. 6508 04:14:20,480 --> 04:14:25,640 AND IF WE HAVE TIME AND ENERGY 6509 04:14:25,640 --> 04:14:27,160 AND INTEREST AND WE CAN LOOK AT 6510 04:14:27,160 --> 04:14:28,960 IT AGAIN. 6511 04:14:28,960 --> 04:14:39,440 SO THE COMPLIANCE SECTION ... 6512 04:14:51,240 --> 04:15:01,680 >> LINE 146 AT THE BEGINNING. 6513 04:15:07,120 --> 04:15:07,600 >> IT'S GOOD. 6514 04:15:07,600 --> 04:15:12,000 OKAY, THAT WAS MORE 6515 04:15:12,000 --> 04:15:16,880 STRAIGHTFORWARD. 6516 04:15:16,880 --> 04:15:17,560 THE UNFUNDED COLLABORATOR 6517 04:15:17,560 --> 04:15:20,960 SECTION WE'VE GOT SOME LANGUAGE 6518 04:15:20,960 --> 04:15:31,080 HERE. 6519 04:15:51,680 --> 04:15:52,080 GOOD. 6520 04:15:52,080 --> 04:15:54,320 OKAY. 6521 04:15:54,320 --> 04:16:04,360 6522 04:16:07,360 --> 04:16:08,240 >> GO BACK, DAVID. 6523 04:16:08,240 --> 04:16:11,360 THERE'S A WORD, INSTEAD OF 6524 04:16:11,360 --> 04:16:14,240 ATTACH, HOW ABOUT APPLIED? 6525 04:16:14,240 --> 04:16:15,440 TO BE APPLIED. 6526 04:16:15,440 --> 04:16:25,640 APPLIED TO. 6527 04:16:33,280 --> 04:16:37,320 >> JUST APPLY, RIGHT? 6528 04:16:37,320 --> 04:16:41,120 NOT APPLIED. 6529 04:16:41,120 --> 04:16:49,720 >> APPLY, APPLIED, EITHER WAY. 6530 04:16:49,720 --> 04:16:49,960 6531 04:16:49,960 --> 04:16:54,880 >> THE SECOND SENTENCE THERE, 6532 04:16:54,880 --> 04:16:55,600 NON-FEDERAL FUNDERS MIGHT 6533 04:16:55,600 --> 04:16:55,840 REQUIRE? 6534 04:16:55,840 --> 04:16:58,520 >> IT'S JUST A CALL OUT TO THAT, 6535 04:16:58,520 --> 04:17:00,600 THAT FACT, THAT SPONSORS ALREADY 6536 04:17:00,600 --> 04:17:04,880 CAN AND DO MANDATE USE OF A 6537 04:17:04,880 --> 04:17:05,640 SINGLE IRB. 6538 04:17:05,640 --> 04:17:09,560 >> I GUESS COULD YOU ADD 6539 04:17:09,560 --> 04:17:11,360 NON-FEDERAL IN FRONT OF FUNDER? 6540 04:17:11,360 --> 04:17:15,520 >> WHETHER THEY ARE FEDERAL OR 6541 04:17:15,520 --> 04:17:16,440 NON-FEDERAL MIGHT REQUIRE, IT'S 6542 04:17:16,440 --> 04:17:22,040 A FOLLOW-UP FROM THE FIRST 6543 04:17:22,040 --> 04:17:22,400 SENTENCE. 6544 04:17:22,400 --> 04:17:25,440 SOUNDS LIKE IT'S TRYING TO MAKE 6545 04:17:25,440 --> 04:17:26,840 CLARIFICATION BUT IT'S NOT AS 6546 04:17:26,840 --> 04:17:29,200 CLEAR. 6547 04:17:29,200 --> 04:17:39,240 6548 04:17:41,880 --> 04:17:44,000 >> ALL RIGHT. 6549 04:17:44,000 --> 04:17:46,400 IS THAT GOOD, WALTER? 6550 04:17:46,400 --> 04:17:47,360 JUST SAY IT'S GOOD. 6551 04:17:47,360 --> 04:17:50,360 THERE IT IS. 6552 04:17:50,360 --> 04:17:52,160 >> THAT'S FINE. 6553 04:17:52,160 --> 04:18:02,400 >> OKAY. 6554 04:18:19,240 --> 04:18:25,200 >> MINOR POINT, COMPILATION OF? 6555 04:18:25,200 --> 04:18:28,040 YOU COULD PUT OF. 6556 04:18:28,040 --> 04:18:29,800 >> WHICH LINE? 6557 04:18:29,800 --> 04:18:30,040 >> 194. 6558 04:18:30,040 --> 04:18:35,240 COMPILATION WITH UPDATES OF A 6559 04:18:35,240 --> 04:18:39,640 SET. 6560 04:18:39,640 --> 04:18:40,680 NO, NO. 6561 04:18:40,680 --> 04:18:43,160 RIGHT THERE. 6562 04:18:43,160 --> 04:18:53,360 OF, YEAH. 6563 04:19:00,200 --> 04:19:02,600 >> OKAY. 6564 04:19:02,600 --> 04:19:06,360 >> IT WAS A TYPO. 6565 04:19:06,360 --> 04:19:06,640 >> OHRP. 6566 04:19:06,640 --> 04:19:10,400 >> EAGLE EYES HERE, OKAY. 6567 04:19:10,400 --> 04:19:14,080 I FORGOT HOW MUCH FUN IT WAS TO 6568 04:19:14,080 --> 04:19:18,200 STAND AND TYPE IN FRONT OF 6569 04:19:18,200 --> 04:19:19,080 EVERYBODY. 6570 04:19:19,080 --> 04:19:20,800 MUCH BETTER KEY BOARD. 6571 04:19:20,800 --> 04:19:22,480 THE WORD POLITICAL IS STILL 6572 04:19:22,480 --> 04:19:22,920 HERE. 6573 04:19:22,920 --> 04:19:24,120 AFTER THE DISCUSSION ONE 6574 04:19:24,120 --> 04:19:25,720 SUBCOMMITTEE MEMBER, I'M GOING 6575 04:19:25,720 --> 04:19:31,360 TO READ THE E-MAIL, IT'S FROM 6576 04:19:31,360 --> 04:19:32,080 SUSAN STAYN, HARMONIZATION 6577 04:19:32,080 --> 04:19:35,680 SUBCOMMITTEE, OFFERED MARK AND A 6578 04:19:35,680 --> 04:19:38,200 GOOD REMINDER. 6579 04:19:38,200 --> 04:19:39,400 SHE NOTED THAT THIS GROUP MAY 6580 04:19:39,400 --> 04:19:43,680 NOT RECALL THE REASON THE 6581 04:19:43,680 --> 04:19:44,800 SUBCOMMITTEE ADDED POLITICAL TO 6582 04:19:44,800 --> 04:19:47,440 2018, WE HAD DISCUSSION ABOUT 6583 04:19:47,440 --> 04:19:47,840 THIS. 6584 04:19:47,840 --> 04:19:48,520 POLITICAL RESEARCH PRIMARILY 6585 04:19:48,520 --> 04:19:50,040 MEANING RESEARCH RELATED TO 6586 04:19:50,040 --> 04:19:51,040 POLITICAL ELECTIONS IS A 6587 04:19:51,040 --> 04:19:53,000 SENSITIVE TYPE OF RESEARCH FOR 6588 04:19:53,000 --> 04:19:54,840 WHICH LOCAL IRB REVIEW IN 6589 04:19:54,840 --> 04:19:57,240 COORDINATION WITH MANY 6590 04:19:57,240 --> 04:19:58,680 INSTITUTIONAL STAKEHOLDERS IS 6591 04:19:58,680 --> 04:20:01,160 HIGHLY ADVANTAGEOUS, SERIOUS TAX 6592 04:20:01,160 --> 04:20:05,360 EXEMPTI FOR NON-PROFIT RESEARCH 6593 04:20:05,360 --> 04:20:06,680 INSTITUTIONS, STATE LAWS, STATE 6594 04:20:06,680 --> 04:20:08,720 OPINIONS AND RELATED ISSUES THAT 6595 04:20:08,720 --> 04:20:09,520 MAKE INSTITUTIONAL RISK 6596 04:20:09,520 --> 04:20:10,960 TOLERANCE AND IMPORTANT SOURCE 6597 04:20:10,960 --> 04:20:13,120 OF INPUT FOR A LOCAL IRB. 6598 04:20:13,120 --> 04:20:17,680 THESE ISSUES EXTEND WELL BEYOND 6599 04:20:17,680 --> 04:20:19,040 THE HRPP HYPOTHETICALLY 6600 04:20:19,040 --> 04:20:19,880 CONSIDERED REALTIME INTERVENTION 6601 04:20:19,880 --> 04:20:21,320 RELATED TO POLITICAL CAMPAIGN 6602 04:20:21,320 --> 04:20:22,080 ACTIVITIES OR RESEARCH WITH 6603 04:20:22,080 --> 04:20:24,600 LARGE SOCIAL MEDIA COMPANIES 6604 04:20:24,600 --> 04:20:28,200 WITH PROPOSED DECEPTION AND 6605 04:20:28,200 --> 04:20:29,080 INTERVENTIONS PRIOR TO VOTING, 6606 04:20:29,080 --> 04:20:31,120 MUCH MORE FOR LOCAL INSTITUTIONS 6607 04:20:31,120 --> 04:20:32,120 WHOSE TAX EXEMPT STATUS MAY BE 6608 04:20:32,120 --> 04:20:32,600 AT ISSUE. 6609 04:20:32,600 --> 04:20:34,440 IN OTHER WORDS, THIS IS NOT 6610 04:20:34,440 --> 04:20:35,600 SIMPLY RESEARCH ON POLITICAL 6611 04:20:35,600 --> 04:20:37,760 ISSUES, THAT MAY NOT HAVE BEEN 6612 04:20:37,760 --> 04:20:42,160 CLEAR FROM THE SUBCOMMITTEE'S 6613 04:20:42,160 --> 04:20:44,960 SUCCINCT PRIOR WORDING. 6614 04:20:44,960 --> 04:20:55,000 >> GOOD POINT. 6615 04:20:55,000 --> 04:20:56,280 ANYBODY HAVE AN OBJECTION TO 6616 04:20:56,280 --> 04:21:00,760 KEEPING IT IN THERE? 6617 04:21:00,760 --> 04:21:02,760 >> IS SUSAN STILL WATCHING? 6618 04:21:02,760 --> 04:21:04,520 THANKS, SUSAN. 6619 04:21:04,520 --> 04:21:05,520 THAT'S HELPFUL. 6620 04:21:05,520 --> 04:21:11,960 WE HAVE ADDED TEXT HERE. 6621 04:21:11,960 --> 04:21:14,200 >> ACTUALLY, SKIP, IS THE WORD 6622 04:21:14,200 --> 04:21:16,000 POLITICAL STILL TOO CHARGED? 6623 04:21:16,000 --> 04:21:19,920 THE ISSUE THAT WAS RAISED WAS 6624 04:21:19,920 --> 04:21:25,360 THAT THERE MAY BE -- TOPICS MAY 6625 04:21:25,360 --> 04:21:27,200 HAVE LIKE TAX IMPLICATIONS. 6626 04:21:27,200 --> 04:21:30,840 >> NO, I THOUGHT ALL OF THOSE 6627 04:21:30,840 --> 04:21:32,560 DETAILED WERE VERY HELPFUL, 6628 04:21:32,560 --> 04:21:33,520 FRANKLY. 6629 04:21:33,520 --> 04:21:35,840 IT'S NOT JUST A RED STATE/BUT 6630 04:21:35,840 --> 04:21:44,280 STATE -- RED STATE-BLUE STATE 6631 04:21:44,280 --> 04:21:45,360 THING. 6632 04:21:45,360 --> 04:21:49,000 IT WAS NOT AN UNINTENDED 6633 04:21:49,000 --> 04:21:49,440 POLITICAL STATEMENT. 6634 04:21:49,440 --> 04:21:54,880 >> PARDON MY LACK OF KNOWLEDGE 6635 04:21:54,880 --> 04:22:00,480 BUT WOULD -- ARE WE TALKING 6636 04:22:00,480 --> 04:22:02,040 ABOUT CLINICAL RESEARCH OR -- 6637 04:22:02,040 --> 04:22:03,000 >> ANY. 6638 04:22:03,000 --> 04:22:05,600 >> NO, I MEAN FOR THE PURPOSE OF 6639 04:22:05,600 --> 04:22:07,920 THE SINGLE IRB REQUIREMENT IT'S 6640 04:22:07,920 --> 04:22:09,520 NOT SPECIFICALLY FOR CLINICAL 6641 04:22:09,520 --> 04:22:10,400 RESEARCH. 6642 04:22:10,400 --> 04:22:13,040 IT'S NO OF ANY MULTI-SITE 6643 04:22:13,040 --> 04:22:13,480 RESEARCH. 6644 04:22:13,480 --> 04:22:15,680 >> BUT THIS DOCUMENT IS NOT 6645 04:22:15,680 --> 04:22:19,760 SPECIFICALLY ABOUT CLINICAL 6646 04:22:19,760 --> 04:22:20,160 RESEARCH, RIGHT? 6647 04:22:20,160 --> 04:22:22,680 >> CORRECT. 6648 04:22:22,680 --> 04:22:30,240 >> SO IF WE'RE GOING TO REALLY 6649 04:22:30,240 --> 04:22:31,560 SPECIFICALLY HAVE EMPHASIS ON 6650 04:22:31,560 --> 04:22:33,520 POLITICAL IT SEEMS THERE ARE A 6651 04:22:33,520 --> 04:22:36,680 LOT OF OTHER RESEARCH TOPIC 6652 04:22:36,680 --> 04:22:40,520 AREAS THAT ALSO HAVE 6653 04:22:40,520 --> 04:22:43,120 IMPLICATIONS RELATED TO 6654 04:22:43,120 --> 04:22:44,440 COMMUNITY TRUST AND STIGMA, SO I 6655 04:22:44,440 --> 04:22:46,640 WANT TO MAKE SURE WE'RE GIVING 6656 04:22:46,640 --> 04:22:49,920 THE APPROPRIATE AMOUNT OF WEIGHT 6657 04:22:49,920 --> 04:23:00,240 TO POLITICAL HERE. 6658 04:23:04,880 --> 04:23:06,760 >> I DON'T KNOW IF OTHERS IN THE 6659 04:23:06,760 --> 04:23:07,960 ROOM HAVE COMMENTS. 6660 04:23:07,960 --> 04:23:12,680 IS THERE LANGUAGE THAT YOU THINK 6661 04:23:12,680 --> 04:23:15,120 IS MISSING THAT YOU HAVE IN MIND 6662 04:23:15,120 --> 04:23:19,480 THAT WE COULD TRY OUT HERE? 6663 04:23:19,480 --> 04:23:21,120 >> I DON'T KNOW THAT THERE'S 6664 04:23:21,120 --> 04:23:22,640 ANYTHING THAT'S MISSING. 6665 04:23:22,640 --> 04:23:27,800 MY CONCERN IS MORE ABOUT USING 6666 04:23:27,800 --> 04:23:29,120 THE SPECIFIC POLITICAL CONTEXT 6667 04:23:29,120 --> 04:23:32,000 AS JUSTIFICATION FOR THE 6668 04:23:32,000 --> 04:23:42,440 LANGUAGE IN THIS SECTION. 6669 04:23:45,680 --> 04:23:52,080 >> THE WAY I HEARD THE 6670 04:23:52,080 --> 04:23:54,160 JUSTIFICATION THAT WAS GIVEN 6671 04:23:54,160 --> 04:23:56,000 FROM LISTENING ONLINE PUTS THIS 6672 04:23:56,000 --> 04:23:58,120 ISSUE OF POLITICAL IN MY MIND 6673 04:23:58,120 --> 04:23:59,840 SIMILAR TO KNOW WHAT STATE LAWS 6674 04:23:59,840 --> 04:24:01,280 EXIST AROUND RESEARCH AND 6675 04:24:01,280 --> 04:24:01,960 EDUCATIONAL INSTITUTIONS AND 6676 04:24:01,960 --> 04:24:03,600 SCHOOLS AND THAT SORT OF THING, 6677 04:24:03,600 --> 04:24:07,960 I MEAN WHICH CAN ALSO HAVE 6678 04:24:07,960 --> 04:24:10,440 SPECIFIC LAWS IN THE LOCAL 6679 04:24:10,440 --> 04:24:11,440 CONTEXT, COULD HAVE IMPACT, ET 6680 04:24:11,440 --> 04:24:12,440 CETERA, ABOUT THE KINDS OF 6681 04:24:12,440 --> 04:24:14,840 THINGS YOU CAN DO WITH SCHOOL 6682 04:24:14,840 --> 04:24:16,040 KIDS WITHOUT PARENTS, BLAH, 6683 04:24:16,040 --> 04:24:16,680 BLAH, BLAH. 6684 04:24:16,680 --> 04:24:20,080 SO I SEE IT AS LESS -- AS MORE 6685 04:24:20,080 --> 04:24:22,840 OF A, YOU KNOW, THE READER MAY 6686 04:24:22,840 --> 04:24:26,120 NOT KNOW ALL OF THAT, BUT I 6687 04:24:26,120 --> 04:24:28,880 DON'T SEE THE WORD POLITICAL AS 6688 04:24:28,880 --> 04:24:29,800 PROBLEMATIC IN THAT LIGHT. 6689 04:24:29,800 --> 04:24:32,960 WHETHER WE NEED TO ADD ANYTHING 6690 04:24:32,960 --> 04:24:34,280 ELSE, I MEAN, BUT I THINK THEN 6691 04:24:34,280 --> 04:24:36,920 WE GET INTO A LAUNDRY LIST OF A 6692 04:24:36,920 --> 04:24:37,800 LIST OF CONTROVERSIAL OR 6693 04:24:37,800 --> 04:24:38,440 SENSITIVE ISSUES. 6694 04:24:38,440 --> 04:24:42,040 I'M NOT SURE WE NEED TO GO 6695 04:24:42,040 --> 04:24:42,400 THERE. 6696 04:24:42,400 --> 04:24:43,840 >> YEAH, THAT'S ALWAYS FROM 6697 04:24:43,840 --> 04:24:45,880 PREVIOUS WORK WITH SACHRP, 6698 04:24:45,880 --> 04:24:48,960 THAT'S ALWAYS A RABBIT HOLE WE 6699 04:24:48,960 --> 04:24:50,840 SOMETIMES GO DOWN, COMING UP 6700 04:24:50,840 --> 04:24:52,000 WITH EXAMPLES AND SUDDENLY 6701 04:24:52,000 --> 04:25:02,160 IT'S -- 6702 04:25:12,800 --> 04:25:14,320 ANY ADDITIONAL INPUT ON CHANGING 6703 04:25:14,320 --> 04:25:21,680 OR GO WITH IT? 6704 04:25:21,680 --> 04:25:26,960 >> I THINK IT SEEMS PROBLEMATIC 6705 04:25:26,960 --> 04:25:29,120 TO ME, WHAT SITE'S LEADERSHIP, 6706 04:25:29,120 --> 04:25:33,960 HOW IS IT INTERPRETED, WHAT ARE 6707 04:25:33,960 --> 04:25:43,560 WE TALKING ABOUT? 6708 04:25:43,560 --> 04:25:48,000 >> THIS IS ONLINE 221. 6709 04:25:48,000 --> 04:25:51,040 CONSULTATION WITH SITE AND 6710 04:25:51,040 --> 04:25:52,160 AMBIGUOUS ON LEADERSHIP? 6711 04:25:52,160 --> 04:25:54,640 >> WHAT WAS INTENDED BY 6712 04:25:54,640 --> 04:25:58,720 LEADERSHIP? 6713 04:25:58,720 --> 04:25:59,800 >> ASSUMING LOCAL P.I. OR 6714 04:25:59,800 --> 04:26:03,320 SOMEONE WHO WOULD KNOW THAT 6715 04:26:03,320 --> 04:26:03,960 LOCAL. 6716 04:26:03,960 --> 04:26:05,280 JUST SITE. 6717 04:26:05,280 --> 04:26:07,760 IT MAKES IT -- 6718 04:26:07,760 --> 04:26:11,640 >> YEAH, I GUESS COMPLICATING 6719 04:26:11,640 --> 04:26:14,040 FEATURE WITHIN THE STATEMENT IS 6720 04:26:14,040 --> 04:26:15,000 EMBEDDED THE NOTION NOT ALL 6721 04:26:15,000 --> 04:26:19,760 SITES HAVE A LOCAL P.I., SOME 6722 04:26:19,760 --> 04:26:22,880 SITES ARE DOING OTHER 6723 04:26:22,880 --> 04:26:33,080 ACTIVITIES. 6724 04:26:55,240 --> 04:26:56,800 >> YOU'RE SAYING OF PROCESS, 6725 04:26:56,800 --> 04:26:58,240 LEAD HERSHIP THAT WOULD WEIGH 6726 04:26:58,240 --> 04:26:58,640 IN? 6727 04:26:58,640 --> 04:27:05,480 I WAND TO MAKE SURE I UNDERSTAND 6728 04:27:05,480 --> 04:27:06,960 WHAT THAT WORD MEANS. 6729 04:27:06,960 --> 04:27:08,360 >> I WAS THINKING IF AN 6730 04:27:08,360 --> 04:27:10,760 INVESTIGATOR IS GOING TO PROPOSE 6731 04:27:10,760 --> 04:27:12,640 A MULTI-SITE STUDY, THE 6732 04:27:12,640 --> 04:27:15,600 INVESTIGATOR THINKS, GOSH, THIS 6733 04:27:15,600 --> 04:27:22,800 MAY BE A SENSITIVE SET OF ISSUES 6734 04:27:22,800 --> 04:27:23,720 REQUIRING INTENSE LOCAL REVIEW, 6735 04:27:23,720 --> 04:27:25,560 INVESTIGATOR WOULD SAY TO THE 6736 04:27:25,560 --> 04:27:32,440 OTHER P.I.s AT THE SITES, 6737 04:27:32,440 --> 04:27:33,520 SITE'S LEADERSHIP, WHAT DO YOU 6738 04:27:33,520 --> 04:27:33,720 THINK? 6739 04:27:33,720 --> 04:27:35,400 DO YOU THINK THIS MERITS A 6740 04:27:35,400 --> 04:27:36,600 SINGLE IRB EXCEPTION AND WOULD 6741 04:27:36,600 --> 04:27:40,960 YOU BE SUPPORTIVE OF THAT? 6742 04:27:40,960 --> 04:27:42,400 THAT INVESTIGATOR WOULD TALK TO 6743 04:27:42,400 --> 04:27:43,400 THE INSTITUTIONAL OFFICIAL AT 6744 04:27:43,400 --> 04:27:48,840 THAT SITE TO MAKE SURE EVERYBODY 6745 04:27:48,840 --> 04:27:50,400 WAS ON BOARD. 6746 04:27:50,400 --> 04:27:51,720 CONSULTATIVE PROCESS FOR ALL THE 6747 04:27:51,720 --> 04:27:56,960 INVESTIGATORS AND SITES TO TALK 6748 04:27:56,960 --> 04:27:57,840 AMONGST EACH OTHER. 6749 04:27:57,840 --> 04:28:01,320 >> WOULD IT BE HELPFUL TO PUT 6750 04:28:01,320 --> 04:28:04,040 THE WORD "OTHER"? 6751 04:28:04,040 --> 04:28:05,480 JUST PUT OTHER, OR OTHER 6752 04:28:05,480 --> 04:28:07,120 POTENTIAL SITES? 6753 04:28:07,120 --> 04:28:15,480 IT'S A PROPOSAL, OTHER PROPOSED 6754 04:28:15,480 --> 04:28:25,600 SITES? 6755 04:28:31,080 --> 04:28:33,200 >> ONE MORE CLARIFICATION. 6756 04:28:33,200 --> 04:28:34,720 IS THIS SPEAKING TO WHAT THE 6757 04:28:34,720 --> 04:28:37,320 BEGINNING OF THE PARAGRAPH IS 6758 04:28:37,320 --> 04:28:39,000 ABOUT WHICH IS RELATED TO A 6759 04:28:39,000 --> 04:28:40,280 STUDY WITH A SMALL NUMBER OF 6760 04:28:40,280 --> 04:28:45,160 SITES OR ARE WE NOW TALKING 6761 04:28:45,160 --> 04:28:46,280 ABOUT MORE BROADLY SITES? 6762 04:28:46,280 --> 04:28:47,520 STUDIES THAT ARE NOT JUST 6763 04:28:47,520 --> 04:28:54,240 INCLUDING A SMALL NUMBER OF 6764 04:28:54,240 --> 04:29:00,560 SITES? 6765 04:29:00,560 --> 04:29:01,960 >> YEAH, I MEAN WE'RE ALL 6766 04:29:01,960 --> 04:29:03,600 LOOKING AT THE LANGUAGE FOR THE 6767 04:29:03,600 --> 04:29:04,040 FIRST TIME. 6768 04:29:04,040 --> 04:29:06,880 SO I THINK THAT THIS IS IN THE 6769 04:29:06,880 --> 04:29:11,160 SECTION THAT IS ABOUT HAVING 6770 04:29:11,160 --> 04:29:11,880 EXCEPTIONS. 6771 04:29:11,880 --> 04:29:14,080 AND SO THE EXCEPTIONS WOULD BE 6772 04:29:14,080 --> 04:29:15,720 AS DEFINED ABOVE, COULD EITHER 6773 04:29:15,720 --> 04:29:18,240 BE BASED ON IF YOU GO UP, DAVID, 6774 04:29:18,240 --> 04:29:21,520 A LITTLE BIT, COULD BE BASED ON 6775 04:29:21,520 --> 04:29:24,320 HAVING FIVE OR FEWER SITES OR 6776 04:29:24,320 --> 04:29:25,760 THE EXCEPTION COULD BE RESEARCH 6777 04:29:25,760 --> 04:29:27,320 FOR WHICH A SINGLE IRB CAN'T 6778 04:29:27,320 --> 04:29:30,840 MEET NEEDS OF THE POPULATION OR 6779 04:29:30,840 --> 04:29:31,680 INVOLVING POLITICAL OR SENSITIVE 6780 04:29:31,680 --> 04:29:33,200 ISSUE, ANY OF THOSE SITUATIONS 6781 04:29:33,200 --> 04:29:35,400 NOT LIMITED TO JUST FIVE OR 6782 04:29:35,400 --> 04:29:37,560 FEWER SITES BUT THE INVESTIGATOR 6783 04:29:37,560 --> 04:29:39,600 MIGHT SAY, GOSH, I THINK THAT 6784 04:29:39,600 --> 04:29:41,360 THERE ARE THINGS ABOUT THIS 6785 04:29:41,360 --> 04:29:43,760 STUDY THAT WOULD MERIT EXCEPTION 6786 04:29:43,760 --> 04:29:46,640 AND GO THROUGH A CONSULTATIVE 6787 04:29:46,640 --> 04:29:50,240 PROCESS, I THINK THAT'S WHAT IT 6788 04:29:50,240 --> 04:29:50,920 MEANS. 6789 04:29:50,920 --> 04:29:54,600 >> YEAH, I SEE CONSUELO'S POINT, 6790 04:29:54,600 --> 04:29:58,960 THE BEGINNING OF THE PARAGRAPH 6791 04:29:58,960 --> 04:30:01,720 GOES BACK TO SMALL SITE NUMBERS 6792 04:30:01,720 --> 04:30:08,400 MAKING IT INEFFICIENT AND JUMPS 6793 04:30:08,400 --> 04:30:11,440 INTO PROCESS. 6794 04:30:11,440 --> 04:30:13,760 >> WELL, WHY DON'T WE BREAK A 6795 04:30:13,760 --> 04:30:17,640 NEW PARAGRAPH IN FRONT OF "IN 6796 04:30:17,640 --> 04:30:18,320 MANY CASES." 6797 04:30:18,320 --> 04:30:18,720 >> OKAY. 6798 04:30:18,720 --> 04:30:20,960 >> IT TAKES IT AWAY FROM THE 6799 04:30:20,960 --> 04:30:22,920 REFERENCE TO THE FEW SITES. 6800 04:30:22,920 --> 04:30:23,200 >> OKAY. 6801 04:30:23,200 --> 04:30:24,880 >> I DON'T KNOW IF THAT WOULD BE 6802 04:30:24,880 --> 04:30:28,040 HELPFUL OR MAKE IT CONFUSING TO 6803 04:30:28,040 --> 04:30:29,840 PUT THE TEXT BENEATH. 6804 04:30:29,840 --> 04:30:33,000 PUT THE NUMBER IT'S REFERRING 6805 04:30:33,000 --> 04:30:33,760 TO. 6806 04:30:33,760 --> 04:30:35,880 >> I WAS GOING TO SUGGEST THAT 6807 04:30:35,880 --> 04:30:39,160 BEFORE BUT THEY DON'T CORRESPOND 6808 04:30:39,160 --> 04:30:40,160 EXACTLY. 6809 04:30:40,160 --> 04:30:40,440 SORRY. 6810 04:30:40,440 --> 04:30:43,840 YOU'VE GOT THE FIRST SENTENCE 6811 04:30:43,840 --> 04:30:46,240 ELABORATES ON NUMBER 1, BUT THE 6812 04:30:46,240 --> 04:30:48,120 REMAINING BLOCK TEXT KIND OF 6813 04:30:48,120 --> 04:30:51,240 COVERS 2 AND 3, THAT'S WHY I 6814 04:30:51,240 --> 04:30:52,600 DIDN'T SUGGEST DOING THAT. 6815 04:30:52,600 --> 04:30:56,280 BUT THE TEXT THAT FOLLOWS IS 6816 04:30:56,280 --> 04:30:57,960 JUST ELABORATION OF 1, 2 AND 3. 6817 04:30:57,960 --> 04:31:00,280 YOU HAVE TO BREAK THAT OUT, 6818 04:31:00,280 --> 04:31:02,680 SEEMS LIKE YOU WOULD BREAK IT AS 6819 04:31:02,680 --> 04:31:04,520 A MATTER OF PROCESS IS THE NEW 6820 04:31:04,520 --> 04:31:05,720 PARAGRAPH, IN MANY CASES 6821 04:31:05,720 --> 04:31:07,480 ELABORATION OF 2 AND 3 AS I'M 6822 04:31:07,480 --> 04:31:08,560 UNDERSTANDING THAT. 6823 04:31:08,560 --> 04:31:10,360 >> BASICALLY THE ORIGINAL TEXT 6824 04:31:10,360 --> 04:31:12,120 COVERS 1, 2, AND 3. 6825 04:31:12,120 --> 04:31:12,440 >> RIGHT. 6826 04:31:12,440 --> 04:31:18,120 >> THAT IS PROCESS. 6827 04:31:18,120 --> 04:31:18,400 >> RIGHT. 6828 04:31:18,400 --> 04:31:20,080 >> OKAY. 6829 04:31:20,080 --> 04:31:25,080 >> ONE OTHER POINT, AND AFTER 2. 6830 04:31:25,080 --> 04:31:26,480 IS THERE ANY MISINTERPRETATION 6831 04:31:26,480 --> 04:31:27,400 FOLLOWING CATEGORIES? 6832 04:31:27,400 --> 04:31:29,360 DO YOU REALLY NEED IT? 6833 04:31:29,360 --> 04:31:31,440 IS IT OR, OR, OR, NOT AND? 6834 04:31:31,440 --> 04:31:32,520 YOU DON'T WANT SOMEONE TO 6835 04:31:32,520 --> 04:31:34,160 INTERPRET THIS TO MEAN THEY BOTH 6836 04:31:34,160 --> 04:31:35,840 HAVE TO APPLY. 6837 04:31:35,840 --> 04:31:38,360 >> YOU COULD PUT AND/OR. 6838 04:31:38,360 --> 04:31:40,440 THAT'S FINE, A CLARIFICATION. 6839 04:31:40,440 --> 04:31:43,200 >> OR GET RID OF "AND" AND JUST 6840 04:31:43,200 --> 04:31:44,880 PUT "OR." 6841 04:31:44,880 --> 04:31:53,640 >> OKAY. 6842 04:31:53,640 --> 04:31:55,640 6843 04:31:55,640 --> 04:31:57,520 >> SHOULD BE AND. 6844 04:31:57,520 --> 04:31:58,920 ALL THINGS THAT WERE 6845 04:31:58,920 --> 04:31:59,440 RECOMMENDED. 6846 04:31:59,440 --> 04:32:07,800 >> RIGHT BUT THEY ARE 6847 04:32:07,800 --> 04:32:08,320 DISJUNCTIVE. 6848 04:32:08,320 --> 04:32:13,520 PUT A CATEGORY AS INDEPENDENT 6849 04:32:13,520 --> 04:32:14,000 POTENTIALLY APPROPRIATE 6850 04:32:14,000 --> 04:32:14,320 EXCEPTIONS. 6851 04:32:14,320 --> 04:32:19,760 >> IF YOU LOOK AT THE LEAD-IN 6852 04:32:19,760 --> 04:32:21,720 SENTENCE, ALL THREE THINGS 6853 04:32:21,720 --> 04:32:22,680 SACHRP RECOMMENDED. 6854 04:32:22,680 --> 04:32:24,480 IT DIDN'T RECOMMEND ONLY ONE OF 6855 04:32:24,480 --> 04:32:25,320 THOSE THINGS. 6856 04:32:25,320 --> 04:32:25,680 >> RIGHT. 6857 04:32:25,680 --> 04:32:28,360 >> OR ANOTHER OR ANOTHER. 6858 04:32:28,360 --> 04:32:30,240 IT RECOMMENDED ALL THREE. 6859 04:32:30,240 --> 04:32:31,040 >> YES. 6860 04:32:31,040 --> 04:32:32,440 >> I AGREE WITH THAT. 6861 04:32:32,440 --> 04:32:34,080 MY CONCERN IS THAT SOMEONE MIGHT 6862 04:32:34,080 --> 04:32:36,600 READ THAT TO MEAN YOU HAVE TO 6863 04:32:36,600 --> 04:32:38,000 MEET BOTH 2 AND 3 IN ORDER FOR 6864 04:32:38,000 --> 04:32:40,400 IT TO BE AN EXCEPTION BY THE 6865 04:32:40,400 --> 04:32:41,600 WORD "AND," NOT THAT IT'S 6866 04:32:41,600 --> 04:32:43,360 RECOMMENDING ALL THREE. 6867 04:32:43,360 --> 04:32:48,840 I'M NOT THE LEGAL -- YOU KNOW. 6868 04:32:48,840 --> 04:32:52,120 >> SOUND LIKE YOU'RE CHANNELED 6869 04:32:52,120 --> 04:32:57,920 AN ENGLISH TEACHER. 6870 04:32:57,920 --> 04:33:00,000 FOLLOWING THREE CATEGORIES AS 6871 04:33:00,000 --> 04:33:00,640 POTENTIALLY APPROPRIATE 6872 04:33:00,640 --> 04:33:01,400 EXCEPTIONS. 6873 04:33:01,400 --> 04:33:06,440 >> ONE OF THE FOLLOWING THREE 6874 04:33:06,440 --> 04:33:09,680 INDEPENDENT CATEGORIES. 6875 04:33:09,680 --> 04:33:11,280 >> OKAY. 6876 04:33:11,280 --> 04:33:13,600 THAT'S FINE, OKAY. 6877 04:33:13,600 --> 04:33:18,240 >> THAT DOESN'T SOLVE IT. 6878 04:33:18,240 --> 04:33:20,440 >> YEAH, WE'RE RECOMMENDING ALL 6879 04:33:20,440 --> 04:33:21,560 THREE ARE CATEGORIES. 6880 04:33:21,560 --> 04:33:23,760 WE'RE NOT RECOMMENDING ONE OR 6881 04:33:23,760 --> 04:33:26,240 MORE OF THE FOLLOWING. 6882 04:33:26,240 --> 04:33:29,920 IT'S THE ISSUE, YOU'RE MODIFYING 6883 04:33:29,920 --> 04:33:34,120 RECOMMENDATION, NOT MODIFYING 6884 04:33:34,120 --> 04:33:35,560 CATEGORIES. 6885 04:33:35,560 --> 04:33:42,400 >> LET'S GET RID OF IT. 6886 04:33:42,400 --> 04:33:45,360 >> ONE OF WHICH WOULD BE A 6887 04:33:45,360 --> 04:33:46,000 POTENTIALLY APPROPRIATE 6888 04:33:46,000 --> 04:33:46,280 EXCEPTION. 6889 04:33:46,280 --> 04:33:49,320 >> GET RID OF THE WORD "AND" 6890 04:33:49,320 --> 04:33:52,600 IT'S SOLVED, IN MY MIND. 6891 04:33:52,600 --> 04:33:54,040 >> WHAT ABOUT RECOMMENDED 6892 04:33:54,040 --> 04:33:56,560 CATEGORIES, COMMA, ANY WOULD BE 6893 04:33:56,560 --> 04:33:57,080 A POTENTIALLY APPROPRIATE 6894 04:33:57,080 --> 04:33:59,200 EXCEPTION TO THE SINGLE IRB 6895 04:33:59,200 --> 04:34:01,360 REQUIREMENT, HOW ABOUT THAT? 6896 04:34:01,360 --> 04:34:04,040 ANY ONE OF WHICH WOULD BE 6897 04:34:04,040 --> 04:34:06,240 POTENTIALLY APPROPRIATE 6898 04:34:06,240 --> 04:34:12,360 EXCEPTION TO THE SINGLE IRB 6899 04:34:12,360 --> 04:34:12,640 REQUIREMENT. 6900 04:34:12,640 --> 04:34:21,400 >> NOW YOU'RE -- 6901 04:34:21,400 --> 04:34:22,560 >> ACTUALLY AN APPROPRIATE 6902 04:34:22,560 --> 04:34:27,320 EXCEPTION TO THE SINGLE IRB 6903 04:34:27,320 --> 04:34:27,960 REQUIREMENT. 6904 04:34:27,960 --> 04:34:28,360 >> VERY GOOD. 6905 04:34:28,360 --> 04:34:31,360 >> TAKE OUT THE S. 6906 04:34:31,360 --> 04:34:32,640 THERE YOU GO. 6907 04:34:32,640 --> 04:34:42,840 HOW'S THAT? 6908 04:34:43,920 --> 04:34:44,080 >> GOOD. 6909 04:34:44,080 --> 04:34:51,040 >> LAST THING WE DIDN'T FULLY 6910 04:34:51,040 --> 04:34:57,320 RESOLVE WAS THE -- THIS ONE, 6911 04:34:57,320 --> 04:34:57,520 LINDA? 6912 04:34:57,520 --> 04:34:57,720 >> YEAH. 6913 04:34:57,720 --> 04:35:00,680 >> THIS WAS MEANT TO BE GENERIC 6914 04:35:00,680 --> 04:35:02,880 REFERENCE TO -- ELABORATED BY 6915 04:35:02,880 --> 04:35:06,920 THE ADDITIONAL REFERENCES TO 6916 04:35:06,920 --> 04:35:12,600 PROCESS. 6917 04:35:12,600 --> 04:35:15,040 >> PERSONALLY I THINK WITH ALL 6918 04:35:15,040 --> 04:35:18,720 OF THE OTHER TEXT THAT I THINK 6919 04:35:18,720 --> 04:35:20,880 THIS IS FUN PERSONALLY. 6920 04:35:20,880 --> 04:35:23,480 SEEING IT IN THE OVERALL 6921 04:35:23,480 --> 04:35:23,720 CONTEXT. 6922 04:35:23,720 --> 04:35:26,240 >> WHY DON'T WE CHANGE SHOULD TO 6923 04:35:26,240 --> 04:35:31,680 COULD SO IT'S NOT PRESCRIPTIVE 6924 04:35:31,680 --> 04:35:32,520 BUT COULD. 6925 04:35:32,520 --> 04:35:33,560 >> [OFF MICROPHONE]. 6926 04:35:33,560 --> 04:35:34,360 >> EXACTLY. 6927 04:35:34,360 --> 04:35:39,800 HOW DOES THAT SOUND? 6928 04:35:39,800 --> 04:35:40,680 OKAY. 6929 04:35:40,680 --> 04:35:41,000 >> THANKS. 6930 04:35:41,000 --> 04:35:41,440 >> YOU'RE WELCOME. 6931 04:35:41,440 --> 04:35:45,600 >> THOSE ARE ALL OF THE CHANGES, 6932 04:35:45,600 --> 04:35:47,240 DOUG. 6933 04:35:47,240 --> 04:35:49,160 >> ALL RIGHT. 6934 04:35:49,160 --> 04:35:51,880 THOSE ARE THE CHANGES. 6935 04:35:51,880 --> 04:35:53,040 EVERYBODY HAPPY WITH THEM? 6936 04:35:53,040 --> 04:35:57,360 ANYBODY NOT HAPPY WITH THEM? 6937 04:35:57,360 --> 04:35:58,560 IS THERE A MOTION? 6938 04:35:58,560 --> 04:35:59,520 >> LET'S HAVE A MOTION. 6939 04:35:59,520 --> 04:36:06,240 >> I MOVE I'M HAPPY WITH IT. 6940 04:36:06,240 --> 04:36:06,520 [LAUGHTER] 6941 04:36:06,520 --> 04:36:06,760 >> OKAY. 6942 04:36:06,760 --> 04:36:07,040 >> SORRY. 6943 04:36:07,040 --> 04:36:10,120 >> I THINK THAT WAS A MOTION TO 6944 04:36:10,120 --> 04:36:13,040 APPROVE, LET ME REPHRASE SKIP'S 6945 04:36:13,040 --> 04:36:13,520 MOTION. 6946 04:36:13,520 --> 04:36:17,640 >> I SECOND. 6947 04:36:17,640 --> 04:36:19,040 >> ANY FURTHER DISCUSSION? 6948 04:36:19,040 --> 04:36:21,600 LET'S VOTE. 6949 04:36:21,600 --> 04:36:25,840 ALL IN FAVOR? 6950 04:36:25,840 --> 04:36:29,560 ALL OPPOSED? 6951 04:36:29,560 --> 04:36:31,280 ABSTAIN? 6952 04:36:31,280 --> 04:36:32,320 OKAY. 6953 04:36:32,320 --> 04:36:33,760 THE MOTION PASSES. 6954 04:36:33,760 --> 04:36:34,200 >> THANKS, EVERYONE. 6955 04:36:34,200 --> 04:36:38,040 >> THANK YOU FOR YOUR HARD WORK 6956 04:36:38,040 --> 04:36:40,560 ON THAT, ALONG WITH THE 6957 04:36:40,560 --> 04:36:41,320 SUBCOMMITTEE. 6958 04:36:41,320 --> 04:36:42,240 ALL RIGHT. 6959 04:36:42,240 --> 04:36:43,440 THAT I THINK BRINGS US TO THE 6960 04:36:43,440 --> 04:36:45,320 END OF THE DAY. 6961 04:36:45,320 --> 04:36:47,080 WE'VE HAD A PRODUCTIVE DAY. 6962 04:36:47,080 --> 04:36:48,320 WE'VE APPROVED TWO ITEMS. 6963 04:36:48,320 --> 04:36:50,560 WE HAVE ANOTHER ONE SORT OF 6964 04:36:50,560 --> 04:36:54,440 LINED UP FOR LIKELY APPROVAL 6965 04:36:54,440 --> 04:36:55,360 TOMORROW. 6966 04:36:55,360 --> 04:37:00,480 AND TOMORROW WE WILL BE 6967 04:37:00,480 --> 04:37:02,040 VISITING - TWO -- THREE FAIRLY 6968 04:37:02,040 --> 04:37:02,800 SIGNIFICANT ISSUES. 6969 04:37:02,800 --> 04:37:04,000 WE'LL GO BACK TO ONE OF THE 6970 04:37:04,000 --> 04:37:05,280 ITEMS WE'VE BEEN WORKING ON FOR 6971 04:37:05,280 --> 04:37:08,320 A LONG TIME, THAT IS THE 6972 04:37:08,320 --> 04:37:09,360 INTERPRETATION OF HHS SUPPORT. 6973 04:37:09,360 --> 04:37:11,920 WE'LL START THE MORNING WITH 6974 04:37:11,920 --> 04:37:14,080 THAT AND THEN STEPHEN IS GOING 6975 04:37:14,080 --> 04:37:18,680 TO BE JOINING US TO BRING US 6976 04:37:18,680 --> 04:37:20,120 THROUGH THE ARTIFICIAL 6977 04:37:20,120 --> 04:37:21,000 INTELLIGENCE DOCUMENT. 6978 04:37:21,000 --> 04:37:23,040 I THINK HIS HOPE IS THAT WE MAY 6979 04:37:23,040 --> 04:37:25,560 BE ABLE TO APPROVE THAT 6980 04:37:25,560 --> 04:37:25,800 TOMORROW. 6981 04:37:25,800 --> 04:37:27,840 AND WE'LL FINISH THE DAY WITH 6982 04:37:27,840 --> 04:37:29,480 DISCUSSION OF SOCIAL MEDIA USE 6983 04:37:29,480 --> 04:37:34,080 ON HUMAN SUBJECTS RESEARCH AND 6984 04:37:34,080 --> 04:37:35,440 THE IMPACT. 6985 04:37:35,440 --> 04:37:37,280 >> IS THERE AN UPDATE, IS THERE 6986 04:37:37,280 --> 04:37:39,040 DOCUMENT FOR REVIEW FOR 6987 04:37:39,040 --> 04:37:39,800 ARTIFICIAL INTELLIGENCE? 6988 04:37:39,800 --> 04:37:44,280 THERE WASN'T A FEW DAYS AGO. 6989 04:37:44,280 --> 04:37:45,720 >> YEAH, THERE SHOULD BE. 6990 04:37:45,720 --> 04:37:48,480 >> IT SHOULD BE IN THE DOCKET, 6991 04:37:48,480 --> 04:37:49,920 I'LL CIRCULATE IT AGAIN, YEAH. 6992 04:37:49,920 --> 04:37:52,200 >> IT'S NOT IN THE PAPERWORK. 6993 04:37:52,200 --> 04:37:54,200 >> NO, THOSE ARE ALL DAY 1. 6994 04:37:54,200 --> 04:37:56,240 ACTUALLY WE SHOULD HAVE COPIES 6995 04:37:56,240 --> 04:37:59,720 OF THAT, BEFORE YOU LEAVE 6996 04:37:59,720 --> 04:38:02,160 TONIGHT, A HARD COPY. 6997 04:38:02,160 --> 04:38:02,800 >> YES, SKIP? 6998 04:38:02,800 --> 04:38:04,240 >> YOUR PREROGATIVE AS CHAIR, IF 6999 04:38:04,240 --> 04:38:06,000 WE HOPE TO APPROVE THE A.I. 7000 04:38:06,000 --> 04:38:07,520 DOCUMENT DO WE WANT TO START 7001 04:38:07,520 --> 04:38:09,960 WITH THAT IN CASE STEVE NEEDS TO 7002 04:38:09,960 --> 04:38:11,560 DO MODIFICATION WHILE WE DO THE 7003 04:38:11,560 --> 04:38:12,840 SECOND AGENDA ITEM AND COME BACK 7004 04:38:12,840 --> 04:38:14,720 WITH THE REVISION? 7005 04:38:14,720 --> 04:38:19,560 >> I THINKING STARTING WITH HHS 7006 04:38:19,560 --> 04:38:19,800 SUPPORT. 7007 04:38:19,800 --> 04:38:21,200 LONGER AND FOR THE SAME REASON. 7008 04:38:21,200 --> 04:38:21,760 >> OH, OKAY. 7009 04:38:21,760 --> 04:38:23,160 >> IN CASE THAT NEEDS TO BE 7010 04:38:23,160 --> 04:38:24,720 WORKED ON. 7011 04:38:24,720 --> 04:38:26,760 >> NO PROBLEM. 7012 04:38:26,760 --> 04:38:28,320 >> AND WHO KNOWS, THAT MAY NOT 7013 04:38:28,320 --> 04:38:31,040 TAKE 45 MINUTES. 7014 04:38:31,040 --> 04:38:33,080 WE'LL SEE. 7015 04:38:33,080 --> 04:38:37,080 YEAH, THANKS FOR THAT. 7016 04:38:37,080 --> 04:38:37,720 OKAY. 7017 04:38:37,720 --> 04:38:39,720 >> WE NEED TO FORMALLY CALL FOR 7018 04:38:39,720 --> 04:38:41,120 PUBLIC COMMENT, EVEN IF THERE IS 7019 04:38:41,120 --> 04:38:45,680 NO PUBLIC COMMENT. 7020 04:38:45,680 --> 04:38:45,920 >> OKAY. 7021 04:38:45,920 --> 04:38:47,600 >> WE HAVE CALLS. 7022 04:38:47,600 --> 04:38:49,560 FOR THE RECORD THERE WAS NONE 7023 04:38:49,560 --> 04:38:49,920 SUBMITTED. 7024 04:38:49,920 --> 04:38:53,840 >> WE'VE GOTTEN A FEW LATE 7025 04:38:53,840 --> 04:38:56,360 QUERIES BY E-MAIL THAT WE'VE 7026 04:38:56,360 --> 04:38:58,200 CIRCULATED TO THE GROUP, SOME 7027 04:38:58,200 --> 04:39:00,160 HAVE BEEN INCORPORATED INTO THE 7028 04:39:00,160 --> 04:39:02,680 DOCUMENTS ALREADY. 7029 04:39:02,680 --> 04:39:03,240 ANYTHING ELSE, JULIE? 7030 04:39:03,240 --> 04:39:06,240 >> I JUST NOTE THAT TOMORROW WE 7031 04:39:06,240 --> 04:39:08,640 DO START AT 9:00, NOT 10:00. 7032 04:39:08,640 --> 04:39:11,040 IF EVERYONE CAN GET HERE 7033 04:39:11,040 --> 04:39:12,240 ACCORDINGLY AND THE SAME 7034 04:39:12,240 --> 04:39:14,840 PROCESSES WILL BE IN PLACE 7035 04:39:14,840 --> 04:39:16,280 TOMORROW FOR LUNCH. 7036 04:39:16,280 --> 04:39:17,560 IF THERE'S ANYTHING ELSE YOU 7037 04:39:17,560 --> 04:39:22,080 COME ACROSS THIS EVENING YOU 7038 04:39:22,080 --> 04:39:24,360 WANT TO BRING TOMORROW, FOR 7039 04:39:24,360 --> 04:39:26,560 NOURISHMENT, FEEL FREE. 7040 04:39:26,560 --> 04:39:26,760 OKAY. 7041 04:39:26,760 --> 04:39:27,120 THANK YOU. 7042 04:39:27,120 --> 04:39:28,080 THANK YOU ALL VERY MUCH. 7043 04:39:28,080 --> 04:39:29,680 >> ALL RIGHT. 7044 04:39:29,680 --> 00:00:00,000 WE'RE ADJOURNED.