1 00:00:05,071 --> 00:00:05,171 >> OKAY. 2 00:00:05,238 --> 00:00:06,673 WELCOME, EVERYONE, TO THE 3 00:00:06,740 --> 00:00:08,942 SECRETARY'S ADVISORY COMMITTEE 4 00:00:09,008 --> 00:00:12,879 ON HUMAN RESEARCH PROTECTIONS ON 5 00:00:12,946 --> 00:00:14,848 MARCH 20, 2024. 6 00:00:14,914 --> 00:00:24,524 MY NAME IS JULIE GOREY, ROLL 7 00:00:24,591 --> 00:00:24,758 CALL. 8 00:00:24,824 --> 00:00:25,925 DR. HOUSE? 9 00:00:25,992 --> 00:00:26,259 >> PRESENT. 10 00:00:26,326 --> 00:00:28,128 >> STATE YOUR AFFILIATION AS 11 00:00:28,194 --> 00:00:30,430 WELL PLEASE. 12 00:00:30,497 --> 00:00:35,135 >> I'M WITH NYU SCHOOL OF 13 00:00:35,201 --> 00:00:37,971 MEDICINE. 14 00:00:38,037 --> 00:00:39,272 >> DR. NEIL DICKERT. 15 00:00:39,339 --> 00:00:42,142 >> EMORY UNIVERSITY SCHOOL OF 16 00:00:42,208 --> 00:00:42,475 MEDICINE. 17 00:00:42,542 --> 00:00:45,645 >> DR. DOUGLAS DIEKEMA. 18 00:00:45,712 --> 00:00:48,047 >> HI, UNIVERSITY OF WASHINGTON, 19 00:00:48,114 --> 00:00:50,550 SEATTLE CHILDREN'S HOSPITAL. 20 00:00:50,617 --> 00:00:54,287 >> DR. SANDRA LEE. 21 00:00:54,354 --> 00:00:58,458 >> GOOD MORNING, AT COLUMBIA 22 00:00:58,525 --> 00:00:58,758 UNIVERSITY. 23 00:00:58,825 --> 00:00:59,125 >> ERIC MAH. 24 00:00:59,192 --> 00:01:04,564 >> UNIVERSITY OF CALIFORNIA SAN 25 00:01:04,631 --> 00:01:04,764 DIEGO. 26 00:01:04,831 --> 00:01:05,999 >> MINDY READER. 27 00:01:06,065 --> 00:01:08,735 >> UNIVERSITY OF ILLINOIS, 28 00:01:08,802 --> 00:01:12,338 COLLEGE OF MEDICINE, PEORIA. 29 00:01:12,405 --> 00:01:15,308 >> LOIS SHEPARD? 30 00:01:15,375 --> 00:01:20,313 >> UNIVERSITY OF VIRGINIA. 31 00:01:20,380 --> 00:01:24,751 >> DR. KEVIN WEINFURT. 32 00:01:24,818 --> 00:01:28,688 >> DUKE UNIVERSITY. 33 00:01:28,755 --> 00:01:30,023 >> DR. YEARBY. 34 00:01:30,089 --> 00:01:31,524 >> THE OHIO STATE UNIVERSITY. 35 00:01:31,591 --> 00:01:37,864 >> THANK YOU. 36 00:01:37,931 --> 00:01:43,369 AND NOW BRUCE LEE, EX OFFICIO 37 00:01:43,436 --> 00:01:44,571 MEMBERS. 38 00:01:44,637 --> 00:01:44,971 >> HOPE IS HERE. 39 00:01:45,038 --> 00:01:46,873 >> CENTER FOR DISEASE CONTROL 40 00:01:46,940 --> 00:01:48,508 AND PREVENTION? 41 00:01:48,575 --> 00:01:51,644 >> MICAH BASS IS HERE. 42 00:01:51,711 --> 00:01:52,979 >> THANK YOU. 43 00:01:53,046 --> 00:01:56,049 FOOD AND DRUG ADMINISTRATION? 44 00:01:56,115 --> 00:02:00,320 >> GOOD MORNING, ANN MEEKER 45 00:02:00,386 --> 00:02:00,854 O'CONNELL. 46 00:02:00,920 --> 00:02:04,357 >> AND KEVIN PARASKA, FDA. 47 00:02:04,424 --> 00:02:06,359 >> HEALTH ADMINISTRATIONS 48 00:02:06,426 --> 00:02:09,162 SERVICE RESOURCE ADMINISTRATION, 49 00:02:09,229 --> 00:02:09,529 KATHY VAN ARDEN. 50 00:02:09,596 --> 00:02:12,799 >> NATIONAL INSTITUTES OF 51 00:02:12,866 --> 00:02:13,166 HEALTH. 52 00:02:13,233 --> 00:02:14,868 >> ADAM BERGER HERE. 53 00:02:14,934 --> 00:02:17,737 >> OFFICE FOR CIVIL RIGHTS? 54 00:02:17,804 --> 00:02:21,107 >> GOOD MORNING, PAYTON ISAAC IS 55 00:02:21,174 --> 00:02:21,641 ON. 56 00:02:21,708 --> 00:02:23,376 >> OFFICE OF NATIONAL 57 00:02:23,443 --> 00:02:27,847 COORDINATOR FOR HEALTH 58 00:02:27,914 --> 00:02:29,849 INFORMATION TECHNOLOGY. 59 00:02:29,916 --> 00:02:32,352 INDIAN HEALTH SERVICE. 60 00:02:32,418 --> 00:02:32,685 OKAY. 61 00:02:32,752 --> 00:02:36,189 THAT IS ALL FROM ME. 62 00:02:36,256 --> 00:02:38,324 AND, DOUG, I'M HAPPY TO TURN IT 63 00:02:38,391 --> 00:02:39,826 OVER TO YOU. 64 00:02:39,893 --> 00:02:41,995 >> THANK YOU, JULIA. 65 00:02:42,061 --> 00:02:43,663 WELCOME, EVERYONE, TO THE SPRING 66 00:02:43,730 --> 00:02:45,298 MEETING OF THE SECRETARY'S 67 00:02:45,365 --> 00:02:49,369 ADVISORY COMMITTEE ON HUMAN 68 00:02:49,435 --> 00:02:50,470 RESEARCH PROTECTIONS. 69 00:02:50,537 --> 00:02:54,507 I AM VERY GRATEFUL TO THOSE WHO 70 00:02:54,574 --> 00:02:56,576 HAVE DONE WORK SINCE OUR LAST 71 00:02:56,643 --> 00:03:00,313 MEETING TO MAKE SURE THIS 72 00:03:00,380 --> 00:03:04,117 MEETING GOES OFF SMOOTHLY AND OF 73 00:03:04,183 --> 00:03:05,985 COURSE THAT IS LARGELY DUE TO 74 00:03:06,052 --> 00:03:10,557 THE EFFORTS OF JULIE GOREY, AND 75 00:03:10,623 --> 00:03:12,892 I'D LIKE TO THANK THE BOTH WORK 76 00:03:12,959 --> 00:03:14,527 THE SUBCOMMITTEES HAVE DONE IN 77 00:03:14,594 --> 00:03:17,297 THE INTERIM TO PREPARE DOCUMENTS 78 00:03:17,363 --> 00:03:21,000 FOR OUR CONSIDERATION TODAY. 79 00:03:21,067 --> 00:03:23,937 AND THIS MEETING IS FAIRLY 80 00:03:24,003 --> 00:03:24,504 FOCUSED. 81 00:03:24,571 --> 00:03:26,773 WE HAVE TWO ITEMS WHICH WE'LL BE 82 00:03:26,839 --> 00:03:28,641 TAKING UP THIS MORNING, FIRST OF 83 00:03:28,708 --> 00:03:31,044 WHICH IS THE INTERPRETATION OF 84 00:03:31,110 --> 00:03:32,378 BEST-INTERESTS STANDARD FOR 85 00:03:32,445 --> 00:03:34,547 RETENTION OF SUBJECTS IN HUMAN 86 00:03:34,614 --> 00:03:38,818 SUBJECTS RESEARCH, THAT HAS BEEN 87 00:03:38,885 --> 00:03:40,587 HALTED OR SUSPENDED, AND THIS 88 00:03:40,653 --> 00:03:44,390 AFTERNOON ETHICAL AND REGULATORY 89 00:03:44,457 --> 00:03:48,461 CONSIDERATIONS FOR INCLUSION OF 90 00:03:48,528 --> 00:03:51,397 LGBTQI+ POPULATIONS IN HHS HUMAN 91 00:03:51,464 --> 00:03:52,966 SUBJECTS RESEARCH. 92 00:03:53,032 --> 00:03:58,738 I'M GOING TO TURN IT OVER TO THE 93 00:03:58,805 --> 00:04:00,173 ACTING DIRECTOR OF OHRP FOR A 94 00:04:00,239 --> 00:04:01,708 FEW WORDS. 95 00:04:01,774 --> 00:04:04,110 >> THANK YOU, DOUG. 96 00:04:04,177 --> 00:04:05,078 WELCOME, EVERYONE. 97 00:04:05,144 --> 00:04:08,147 GREAT TO BE MEETING LIKE THIS 98 00:04:08,214 --> 00:04:09,582 TODAY AGAIN. 99 00:04:09,649 --> 00:04:12,885 ALSO WANT TO ECHO MY THANKS TO 100 00:04:12,952 --> 00:04:14,320 THE SUBCOMMITTEES IN PARTICULAR, 101 00:04:14,387 --> 00:04:16,089 AS DOUG MENTIONED, WHO DO SO 102 00:04:16,155 --> 00:04:19,492 MUCH WORK IN BETWEEN MEETINGS. 103 00:04:19,559 --> 00:04:21,995 WE'RE GRATEFUL FOR ALL THAT YOU 104 00:04:22,061 --> 00:04:24,497 DO TO HELP US PREPARE FOR THESE 105 00:04:24,564 --> 00:04:33,906 LARGER MEETINGS WITH THE FULL 106 00:04:33,973 --> 00:04:36,175 COMMITTEE. 107 00:04:36,242 --> 00:04:40,980 WE DO HAVE ADDITIONAL SACHRP 108 00:04:41,047 --> 00:04:42,281 MEMBERS PENDING APPROVAL AND 109 00:04:42,348 --> 00:04:44,017 HOPE TO HAVE NEWS IN THAT REGARD 110 00:04:44,083 --> 00:04:46,986 SOON BUT DON'T QUITE YET. 111 00:04:47,053 --> 00:04:49,288 SO STAY TUNED. 112 00:04:49,355 --> 00:04:50,657 THAT'S IT FOR ME. 113 00:04:50,723 --> 00:04:52,759 I'LL TURN IT BACK TO YOU. 114 00:04:52,825 --> 00:04:55,862 THANK YOU. 115 00:04:55,928 --> 00:04:56,829 >> THANK YOU, JULIE. 116 00:04:56,896 --> 00:04:58,965 FIRST ITEM WE HAVE BEFORE WE 117 00:04:59,032 --> 00:05:01,000 LAUNCH INTO OUR CORE OF OUR WORK 118 00:05:01,067 --> 00:05:04,504 IS TO APPROVE THE MINUTES FROM 119 00:05:04,570 --> 00:05:08,341 OUR OCTOBER 18 AND 19 MEETING IN 120 00:05:08,408 --> 00:05:08,541 2023. 121 00:05:08,608 --> 00:05:13,279 WERE THERE ANY CHANGES TO THOSE 122 00:05:13,346 --> 00:05:14,981 MINUTES, MEETING MINUTES? 123 00:05:15,048 --> 00:05:20,420 IF NOT, CAN I HAVE A MOTION TO 124 00:05:20,486 --> 00:05:21,621 APPROVE THEM? 125 00:05:21,688 --> 00:05:23,389 >> MOTION TO APPROVE. 126 00:05:23,456 --> 00:05:26,325 >> I'LL SECOND. 127 00:05:26,392 --> 00:05:27,660 >> WE HAVE A MOTION AND SECOND. 128 00:05:27,727 --> 00:05:28,528 ALL IN FAVOR? 129 00:05:28,594 --> 00:05:34,434 WE'LL DO A RAISE OF HANDS. 130 00:05:34,500 --> 00:05:38,438 AND OPPOSED? 131 00:05:40,073 --> 00:05:40,907 AND ANY ABSTENTIONS? 132 00:05:40,973 --> 00:05:42,775 ALL RIGHT. 133 00:05:42,842 --> 00:05:46,579 THOSE MINUTES ARE APPROVED. 134 00:05:46,646 --> 00:05:47,046 OKAY. 135 00:05:47,113 --> 00:05:49,949 AS I MENTIONED BEFORE OUR FIRST 136 00:05:50,016 --> 00:05:52,719 ITEM TODAY IS TO TAKE UP OUR 137 00:05:52,785 --> 00:05:54,020 WORK ON THE INTERPRETATION OF 138 00:05:54,087 --> 00:05:56,622 THE BEST INTEREST STANDARD FOR 139 00:05:56,689 --> 00:05:58,157 RETENTION OF SUBJECTS IN HUMAN 140 00:05:58,224 --> 00:06:00,493 SUBJECTS RESEARCH THAT'S BEEN 141 00:06:00,560 --> 00:06:02,662 HALTED OR SUSPENDED. 142 00:06:02,729 --> 00:06:05,431 AND DAVE BORASKY, CO-CHAIR OF 143 00:06:05,498 --> 00:06:07,166 OUR SUBPART A SUBCOMMITTEE WILL 144 00:06:07,233 --> 00:06:08,367 TAKE US THROUGH THIS. 145 00:06:08,434 --> 00:06:09,335 >> ALL RIGHT. 146 00:06:09,402 --> 00:06:11,003 THANKS, DOUG. 147 00:06:11,070 --> 00:06:12,739 YOURS TRULY BACK AGAIN WITH THIS 148 00:06:12,805 --> 00:06:13,005 DOCUMENT. 149 00:06:13,072 --> 00:06:15,808 HAPPY TO HAVE IT BACK. 150 00:06:15,875 --> 00:06:18,845 IT'S BEEN PRODUCTIVE SEVERAL 151 00:06:18,911 --> 00:06:20,413 MONTHS OF GOING THROUGH 152 00:06:20,480 --> 00:06:24,450 ITERATIONS OF THIS DOCUMENT WITH 153 00:06:24,517 --> 00:06:25,618 THE SUBCOMMITTEE, HAD PRETTY 154 00:06:25,685 --> 00:06:29,021 ACTIVE PARTICIPATION IN THAT 155 00:06:29,088 --> 00:06:30,123 PROCESS, INCLUDING SOME OF THE 156 00:06:30,189 --> 00:06:31,657 SACHRP MEMBERS ON THE CALL 157 00:06:31,724 --> 00:06:32,191 TODAY. 158 00:06:32,258 --> 00:06:36,462 I'M GOING TO GO AHEAD AND SHARE 159 00:06:36,529 --> 00:06:38,331 MY SCREEN WITH THAT DOCUMENT. 160 00:06:38,397 --> 00:06:48,941 FOR ME, THE GOAL TODAY IS TO -- 161 00:06:49,942 --> 00:06:52,011 LET ME GO AHEAD AND MAKE THE 162 00:06:52,078 --> 00:06:52,912 GALLERY BIGGER TO LOOK FOR 163 00:06:52,979 --> 00:06:53,679 RAISED HANDS. 164 00:06:53,746 --> 00:06:56,749 MY PERSONAL GOAL IS THAT WE GOAT 165 00:06:56,816 --> 00:07:02,989 A POINT OF APPROVABILITY OF 166 00:07:03,055 --> 00:07:03,956 THESE RECOMMENDATIONS, AND IF WE 167 00:07:04,023 --> 00:07:06,692 CAN'T GET THERE THAT WE LEAVE 168 00:07:06,759 --> 00:07:10,296 THE MEETING WITH SOME CLEAR 169 00:07:10,363 --> 00:07:12,498 UNDERSTANDING OF WHAT ARE THE 170 00:07:12,565 --> 00:07:16,235 LAST OBSTACLES TO GET IT TO 171 00:07:16,302 --> 00:07:17,236 APPROVABILITY IN JULY. 172 00:07:17,303 --> 00:07:19,205 BUT WE'LL SEE WHERE WE GET. 173 00:07:19,272 --> 00:07:21,507 SO, I'VE PULLED UP THE DOCUMENT. 174 00:07:21,574 --> 00:07:23,810 HOPEFULLY EVERYBODY CAN SEE IT. 175 00:07:23,876 --> 00:07:26,546 AND IT IS BIG ENOUGH. 176 00:07:26,612 --> 00:07:29,148 AND WE HAVE SEEN IT A FEW TIMES 177 00:07:29,215 --> 00:07:33,352 NOW AT SACHRP SO I WON'T WALK 178 00:07:33,419 --> 00:07:34,754 THROUGH LINE BY LINE. 179 00:07:34,821 --> 00:07:36,389 I'LL GO SECTION BY SECTION BUT 180 00:07:36,455 --> 00:07:37,356 ENCOURAGE PEOPLE TO STOP ME AND 181 00:07:37,423 --> 00:07:38,891 HAPPY TO BOUNCE AROUND THE 182 00:07:38,958 --> 00:07:40,893 DOCUMENT AS NEEDED. 183 00:07:40,960 --> 00:07:46,666 AGAIN, JUST AS BACKGROUND, 184 00:07:46,732 --> 00:07:47,333 SACHRP ASKED -- OHRP ASKED 185 00:07:47,400 --> 00:07:49,101 SACHRP TO COMMENT ON THE TOPIC 186 00:07:49,168 --> 00:07:52,572 OR IDEA THAT RESEARCH IS 187 00:07:52,638 --> 00:07:53,206 SUSPENDED OR TERMINATED ALL THE 188 00:07:53,272 --> 00:07:57,176 TIME FOR A VARIETY OF REASONS, 189 00:07:57,243 --> 00:08:00,279 AND THAT THE -- THERE MAY BE 190 00:08:00,346 --> 00:08:04,050 TIMES WHERE IT'S IN THE BEST 191 00:08:04,116 --> 00:08:05,818 INTERESTS OF PARTICIPANTS, 192 00:08:05,885 --> 00:08:07,019 EITHER GROUPS OR INDIVIDUALS, 193 00:08:07,086 --> 00:08:08,454 FOR THAT RESEARCH TO CONTINUE. 194 00:08:08,521 --> 00:08:11,591 BUT WE'RE TALKING ABOUT 195 00:08:11,657 --> 00:08:13,259 SOMETHING THAT DOESN'T REALLY 196 00:08:13,326 --> 00:08:15,661 HAVE A FOUNDATION IN THE 197 00:08:15,728 --> 00:08:18,297 REGULATIONS OR REALLY NOT TOO 198 00:08:18,364 --> 00:08:20,700 MUCH EVEN IN EXISTING GUIDANCE 199 00:08:20,766 --> 00:08:22,235 SO INSTITUTIONS AND IRBs AND 200 00:08:22,301 --> 00:08:25,404 EVEN REGULATORS ARE SORT OF LEFT 201 00:08:25,471 --> 00:08:27,807 TO FORGE THEIR OWN PATHS HERE 202 00:08:27,874 --> 00:08:28,908 WHEN DECIDING WHAT'S 203 00:08:28,975 --> 00:08:29,308 APPROPRIATE. 204 00:08:29,375 --> 00:08:32,378 THE HOPE OBVIOUSLY IS THIS 205 00:08:32,445 --> 00:08:36,983 DOCUMENT WILL HELP PUTSOME 206 00:08:37,049 --> 00:08:39,418 BOUNDARIES AROUND THAT OR AT 207 00:08:39,485 --> 00:08:40,620 LEAST GIVE VARYING CONSTITUENTS 208 00:08:40,686 --> 00:08:41,921 IDEAS HOW TO APPROACH THE 209 00:08:41,988 --> 00:08:44,924 PROBLEM WHEN FACED WITH IT. 210 00:08:44,991 --> 00:08:48,261 AND SO A LOT OF WHAT I SAID IS 211 00:08:48,327 --> 00:08:50,229 IN THE BACKGROUND HERE, THIS 212 00:08:50,296 --> 00:08:52,098 IDEA BEST INTEREST ISN'T 213 00:08:52,164 --> 00:08:54,300 DEFINED, NOT REALLY A REGULATORY 214 00:08:54,367 --> 00:08:55,268 ISSUE PER SE. 215 00:08:55,334 --> 00:08:57,937 AND YET WE HAVE THIS PROBLEM 216 00:08:58,004 --> 00:08:59,238 THAT RESEARCH CAN STOP FOR A 217 00:08:59,305 --> 00:09:01,107 NUMBER OF REASONS. 218 00:09:01,173 --> 00:09:03,509 WE'VE GOT FROM LINES 14-26, A 219 00:09:03,576 --> 00:09:05,945 NUMBER OF THOSE REASONS BULLETED 220 00:09:06,012 --> 00:09:06,245 OUT. 221 00:09:06,312 --> 00:09:14,353 IT'S NOT ALL INCLUSIVE BUT IS 222 00:09:14,420 --> 00:09:15,254 REPRESENTATIVE OF COMMON REASONS 223 00:09:15,321 --> 00:09:18,190 RESEARCH ENDS EARLY OR IS 224 00:09:18,257 --> 00:09:18,958 SUSPENDED, RUNNING THE GAMUT, 225 00:09:19,025 --> 00:09:21,594 RESPONSIBLE SONS THAT BECOME 226 00:09:21,661 --> 00:09:22,795 INSOLVENT OR DISAPPEAR OR STOP 227 00:09:22,862 --> 00:09:25,298 FOR A VARIETY OF REASONS. 228 00:09:25,364 --> 00:09:26,732 SIGNALS RELATED TO THINGS LIKE 229 00:09:26,799 --> 00:09:34,273 SUBJECT SAFETY OUT OF A DSMB 230 00:09:34,340 --> 00:09:34,807 MEETING, COMPLIANCE-DRIVEN 231 00:09:34,874 --> 00:09:38,644 ISSUES, WHETHER DRIVEN BY AN IRB 232 00:09:38,711 --> 00:09:39,979 DECISION TO SUSPEND OR HALT A 233 00:09:40,046 --> 00:09:42,248 STUDY OR AN ACTION THAT AFFECTS 234 00:09:42,315 --> 00:09:44,250 AN ENTIRE INSTITUTION THROUGH A 235 00:09:44,317 --> 00:09:48,921 REGULATORY ACTION TO SUSPEND A 236 00:09:48,988 --> 00:09:49,588 FEDERAL-WIDE ASSURANCE. 237 00:09:49,655 --> 00:09:51,924 SO, THERE ARE A VARIETY OF 238 00:09:51,991 --> 00:09:53,559 REASONS WHY RESEARCH CAN STOP. 239 00:09:53,626 --> 00:09:55,761 IT'S BIG AND SMALL, CAN BE VERY 240 00:09:55,828 --> 00:09:58,130 SPECIFIC ISSUE, A VERY BROAD 241 00:09:58,197 --> 00:09:58,464 ISSUE. 242 00:09:58,531 --> 00:10:00,666 IN ANY CASE, THERE WILL BE 243 00:10:00,733 --> 00:10:06,238 PEOPLE THAT ARE NOW LEFT 244 00:10:06,305 --> 00:10:07,440 TRIAL-LESS OR STUDYLESS AND FOR 245 00:10:07,506 --> 00:10:10,743 SOME THERE MAY BE AN INTEREST IN 246 00:10:10,810 --> 00:10:12,044 CONTINUING SOMEHOW TO RECEIVE 247 00:10:12,111 --> 00:10:13,012 THE INTERVENTION OR PARTICIPATE 248 00:10:13,079 --> 00:10:15,481 IN SOME ASPECT OF THE STUDY AND 249 00:10:15,548 --> 00:10:18,651 SO THE QUESTION IS WHAT -- HOW 250 00:10:18,718 --> 00:10:19,952 WE DECIDE IF IT'S REALLY IN 251 00:10:20,019 --> 00:10:21,387 THEIR BEST INTEREST TO DO SO. 252 00:10:21,454 --> 00:10:24,757 SINCE WE LAST TALKED THE 253 00:10:24,824 --> 00:10:26,292 DOCUMENT'S GONE THROUGH MAINLY 254 00:10:26,359 --> 00:10:26,659 REFINEMENTS. 255 00:10:26,726 --> 00:10:29,595 THERE ARE NO HUGE BIG NEW 256 00:10:29,662 --> 00:10:29,862 SECTIONs. 257 00:10:29,929 --> 00:10:32,732 IT WAS A LOT OF ITERATIVE WORK. 258 00:10:32,798 --> 00:10:34,734 THE PLACE WITH THE MOST NEW TEXT 259 00:10:34,800 --> 00:10:36,135 IS AROUND INFORMED CONSENT WHICH 260 00:10:36,202 --> 00:10:38,871 WE'LL GET TO IN A FEW MINUTES. 261 00:10:38,938 --> 00:10:41,173 OTHERWISE, IT REALLY IS MORE OF 262 00:10:41,240 --> 00:10:43,242 A REFINEMENT OF WHAT YOU'VE SEEN 263 00:10:43,309 --> 00:10:43,609 BEFORE. 264 00:10:43,676 --> 00:10:46,112 I'M GOING ASSUME THAT IN GENERAL 265 00:10:46,178 --> 00:10:48,948 THE BACKGROUND SECTION IS PRETTY 266 00:10:49,015 --> 00:10:49,148 CLEAR. 267 00:10:49,215 --> 00:10:50,616 I'LL KEEP WATCHING, I'M WATCHING 268 00:10:50,683 --> 00:10:52,218 FOR HANDS ON THE SCREEN WHEN I 269 00:10:52,284 --> 00:10:54,086 TURN THIS WAY. 270 00:10:54,153 --> 00:10:55,621 DEFINING BEST INTERESTS AGAIN 271 00:10:55,688 --> 00:11:00,593 HAS LARGELY STAYED THE SAME. 272 00:11:00,659 --> 00:11:02,795 AND, YOU KNOW, HERE PART OF IT 273 00:11:02,862 --> 00:11:04,730 IS SORT OF TRYING TO COME UP 274 00:11:04,797 --> 00:11:06,966 WITH THIS IDEA OF WHAT 275 00:11:07,033 --> 00:11:08,934 REPRESENTS A BEST INTEREST, AND 276 00:11:09,001 --> 00:11:10,770 IN DOING SO, YOU KNOW, WE LOOKED 277 00:11:10,836 --> 00:11:14,807 AT A NUMBER OF DOCUMENTS SUCH AS 278 00:11:14,874 --> 00:11:16,042 DECLARATION OF HELSINKI, LOOKED 279 00:11:16,108 --> 00:11:19,311 AT GUIDANCES LIKE FDA GUIDANCE 280 00:11:19,378 --> 00:11:21,180 ON DISRUPTIONS AND ONGOING 281 00:11:21,247 --> 00:11:23,349 RESEARCH TO GET A SENSE OF 282 00:11:23,416 --> 00:11:24,617 WHERE -- EVEN IF A DOCUMENT 283 00:11:24,683 --> 00:11:26,185 WASN'T DIRECTLY ABOUT THIS IDEA 284 00:11:26,252 --> 00:11:28,954 OF BEST INTERESTS, WHERE THEY 285 00:11:29,021 --> 00:11:31,924 SORT OF POINTED PEOPLE IN TERMS 286 00:11:31,991 --> 00:11:34,527 OF DISRUPTIONS AND RESEARCH. 287 00:11:34,593 --> 00:11:36,062 AND WE ACKNOWLEDGE THAT THIS IS 288 00:11:36,128 --> 00:11:37,930 NOT JUST AN ISSUE IN BIOMEDICAL 289 00:11:37,997 --> 00:11:38,197 RESEARCH. 290 00:11:38,264 --> 00:11:40,332 WE THINK OF CLINICAL TRIALS BUT 291 00:11:40,399 --> 00:11:47,907 IT'S NOT LIMITED TO THAT IN ANY 292 00:11:47,973 --> 00:11:48,774 WAY. 293 00:11:48,841 --> 00:11:50,409 AND, YEAH, SO KEVIN? 294 00:11:50,476 --> 00:11:52,611 >> YEAH, THANKS. 295 00:11:52,678 --> 00:11:56,315 JUST A MINOR THING. 296 00:11:56,382 --> 00:11:59,485 LINE 63 THERE, SAYS PERSONS WHO 297 00:11:59,552 --> 00:12:02,321 RESPONDED POSITIVELY TO THE 298 00:12:02,388 --> 00:12:03,489 INTERVENTION. 299 00:12:03,556 --> 00:12:05,958 THAT CONNOTES A CAUSAL EFFECT, 300 00:12:06,025 --> 00:12:07,026 I'M JUST WONDERING WHETHER IT 301 00:12:07,093 --> 00:12:09,995 WOULD BE MORE PRUDENT TO SAY 302 00:12:10,062 --> 00:12:11,230 PERSONS WHOSE HEALTH IMPROVED 303 00:12:11,297 --> 00:12:13,299 WHILE RECEIVING THE INTERVENTION 304 00:12:13,365 --> 00:12:15,034 BECAUSE WE DON'T ACTUALLY KNOW 305 00:12:15,101 --> 00:12:16,235 AT THAT POINT WHETHER THAT 306 00:12:16,302 --> 00:12:25,544 CHANGE IS DUE TO THE 307 00:12:25,611 --> 00:12:27,947 INTERVENTION OR NOT. 308 00:12:28,013 --> 00:12:28,781 >> ANY OBJECTION THERE IS? 309 00:12:28,848 --> 00:12:32,885 >> ONE QUESTION, CHANGE OF 310 00:12:32,952 --> 00:12:35,721 HEALTH, IT COULD BE A CONDITION, 311 00:12:35,788 --> 00:12:38,557 COULD BE A MEASUREMENT. 312 00:12:38,624 --> 00:12:40,993 BROADEN IT, GIVE IT SOME 313 00:12:41,060 --> 00:12:42,728 FLEXIBILITY, I OFFER THAT AS A 314 00:12:42,795 --> 00:12:42,862 -- 315 00:12:42,928 --> 00:12:44,163 >> SURE. 316 00:12:44,230 --> 00:12:45,998 >> NOT DISAGREEMENT NECESSARILY 317 00:12:46,065 --> 00:12:47,333 BUT FURTHER CONSIDERATION. 318 00:12:47,399 --> 00:12:48,734 >> YEAH, NO, I THINK THAT'S 319 00:12:48,801 --> 00:12:48,934 WISE. 320 00:12:49,001 --> 00:12:52,805 I'M TRYING TO THINK OF WHAT IS 321 00:12:52,872 --> 00:12:54,907 THE BEST SIMPLE WAY TO DO THAT 322 00:12:54,974 --> 00:13:01,213 EVEN THOUGH THERE MAY BE PERSONS 323 00:13:01,280 --> 00:13:07,953 WHO, YOU KNOW, HAD A -- 324 00:13:08,020 --> 00:13:09,221 >> SAY IMPROVED? 325 00:13:09,288 --> 00:13:10,990 >> KEVIN, AM I TOUCHING ON WHAT 326 00:13:11,056 --> 00:13:12,391 YOU'RE CONCERNED ABOUT, MAYBE 327 00:13:12,458 --> 00:13:15,995 THE PERCEPTION OF A POSITIVE 328 00:13:16,061 --> 00:13:16,328 RESPONSE? 329 00:13:16,395 --> 00:13:18,164 IS THAT WHAT YOU'RE GETTING AT? 330 00:13:18,230 --> 00:13:23,135 >> I JUST WANT TO MAKE SURE THAT 331 00:13:23,202 --> 00:13:24,336 WE'RE NOT STATING WE KNOW 332 00:13:24,403 --> 00:13:26,305 SOMETHING WE DON'T KNOW. 333 00:13:26,372 --> 00:13:26,572 >> YEAH. 334 00:13:26,639 --> 00:13:29,375 >> SO WHAT WE KNOW IS THAT 335 00:13:29,441 --> 00:13:32,178 SOMEONE WHO WAS RANDOMIZED TO 336 00:13:32,244 --> 00:13:34,914 INTERVENTION ARM HAS EXPERIENCED 337 00:13:34,980 --> 00:13:38,684 SOME IMPROVEMENT, BUT TO USE THE 338 00:13:38,751 --> 00:13:39,785 WORD "RESPONDED" SOUNDS LIKE 339 00:13:39,852 --> 00:13:40,853 WE'RE DESCRIBING A SITUATION 340 00:13:40,920 --> 00:13:45,591 WHERE WE KNOW THAT THIS PERSON 341 00:13:45,658 --> 00:13:46,559 IS GETTING IMPROVED BECAUSE OF 342 00:13:46,625 --> 00:13:48,227 THE DRUG WHICH SEEMS LIKE THAT 343 00:13:48,294 --> 00:13:49,195 WOULD CHANGE THE CONSIDERATION 344 00:13:49,261 --> 00:13:50,529 OF HOW WE THINK ABOUT THE 345 00:13:50,596 --> 00:13:51,297 SITUATION. 346 00:13:51,363 --> 00:13:53,365 SO I WANT TO BE SURE ABOUT WHAT 347 00:13:53,432 --> 00:13:54,133 WE KNOW. 348 00:13:54,200 --> 00:13:57,403 >> SO WHAT I'VE DONE IS I'VE 349 00:13:57,469 --> 00:13:59,271 GOTTEN RID OF RESPONDED 350 00:13:59,338 --> 00:14:02,875 POSITIVELY AND SAYS PERSONS WHO 351 00:14:02,942 --> 00:14:03,542 BELIEVE INTERVENTION, I COULD 352 00:14:03,609 --> 00:14:04,643 SAY BENEFITED FROM PARTICIPATION 353 00:14:04,710 --> 00:14:08,013 IN THE RESEARCH OR FROM THE 354 00:14:08,080 --> 00:14:08,347 STUDY. 355 00:14:08,414 --> 00:14:09,715 >> THAT'S FINE WITH ME. 356 00:14:09,782 --> 00:14:13,219 >> YEAH, I THINK THAT'S EVEN 357 00:14:13,285 --> 00:14:14,386 BETTER. 358 00:14:14,453 --> 00:14:16,689 >> YEP, YEP. 359 00:14:16,755 --> 00:14:17,556 >> OKAY. 360 00:14:17,623 --> 00:14:18,757 ALLISON AND THEN LOIS? 361 00:14:18,824 --> 00:14:19,091 ALLISON? 362 00:14:19,158 --> 00:14:21,827 >> JUST TO BEAT THAT HORSE A 363 00:14:21,894 --> 00:14:24,563 LITTLE BIT FURTHER, YOU KNOW, WE 364 00:14:24,630 --> 00:14:25,864 TYPICALLY DON'T ALLOW JUST 365 00:14:25,931 --> 00:14:26,966 PARTICIPANT TO SAY I THINK IT 366 00:14:27,032 --> 00:14:30,236 HELPED ME AND LET THAT BE THE 367 00:14:30,302 --> 00:14:34,073 BAR. 368 00:14:34,139 --> 00:14:37,042 WE REQUIRE THAT THE PARTICIPANTS 369 00:14:37,109 --> 00:14:40,412 INVOLVED CLINICIAN AGREE THERE 370 00:14:40,479 --> 00:14:48,087 WAS BENEFITS. 371 00:14:48,153 --> 00:14:50,723 >> SO IS THERE A NEAT WAY TO 372 00:14:50,789 --> 00:14:53,626 NEST THAT IN? 373 00:14:57,229 --> 00:14:59,932 >> EVEN THOUGH THERE MAY BE 374 00:14:59,999 --> 00:15:10,476 PERSONS WHO -- CHOOSE HEALTH 375 00:15:14,613 --> 00:15:16,582 CARE -- WHOSE HEALTH CARE 376 00:15:16,649 --> 00:15:27,192 PROVIDERS BELIEVE THEY BENEFITED 377 00:15:33,966 --> 00:15:34,033 FROM. 378 00:15:34,099 --> 00:15:35,501 >> . 379 00:15:35,567 --> 00:15:35,968 >> SORRY. 380 00:15:36,035 --> 00:15:36,602 CLARIFICATION, I'M NOT FOLLOWING 381 00:15:36,669 --> 00:15:38,137 WHAT YOU'RE SAYING. 382 00:15:38,203 --> 00:15:39,772 >> WE DON'T LET ALLISON SAY, 383 00:15:39,838 --> 00:15:42,308 HEY, I IMPROVED, AND GO, OKAY, 384 00:15:42,374 --> 00:15:43,676 ALLISON HAD THE DRUG. 385 00:15:43,742 --> 00:15:46,312 WE HAVE ALLISON'S DOCTOR SAY, 386 00:15:46,378 --> 00:15:47,946 YES, I AGREED THAT ALLISON 387 00:15:48,013 --> 00:15:50,249 IMPROVED AND SO SO WE WILL 388 00:15:50,316 --> 00:15:51,016 CONSIDER ALLISON'S REQUEST TO 389 00:15:51,083 --> 00:15:52,451 CONTINUE ON THE DRUG. 390 00:15:52,518 --> 00:15:54,620 IF THERE'S A DIFFERENCE OF 391 00:15:54,687 --> 00:15:58,223 OPINION, IF ALLISON SAYS, I GOT 392 00:15:58,290 --> 00:15:59,658 BETTER, ALLISON'S DOCTOR SAYS, 393 00:15:59,725 --> 00:16:02,394 LOOK, I DON'T AGREE WITH THAT, 394 00:16:02,461 --> 00:16:03,395 IT'S ALLISON'S DOCTOR'S OPINION 395 00:16:03,462 --> 00:16:05,164 WHO IS GOING TO CARRY THE DAY, 396 00:16:05,230 --> 00:16:07,499 NOT MINE. 397 00:16:16,275 --> 00:16:17,943 >> SO THERE'S A WHOLE BUNCH OF 398 00:16:18,010 --> 00:16:19,812 OTHER HANDS THAT POPPED UP. 399 00:16:19,878 --> 00:16:23,549 I DON'T KNOW IF THIS HELPS, BUT 400 00:16:23,615 --> 00:16:26,819 I ADDED THIS COMMENT ABOUT 401 00:16:26,885 --> 00:16:28,253 HEALTH CARE PROVIDERS SORT OF 402 00:16:28,320 --> 00:16:30,456 AGREEING WITH THEIR I'LL CALL IT 403 00:16:30,522 --> 00:16:30,956 SUBJECTIVE BELIEF THEY 404 00:16:31,023 --> 00:16:31,390 BENEFITED. 405 00:16:31,457 --> 00:16:33,525 I DON'T KNOW IF WE WANT TO SAY 406 00:16:33,592 --> 00:16:35,260 THEY HAVE TO PROVE THEY 407 00:16:35,327 --> 00:16:36,995 BENEFITED BUT, YOU KNOW, OFTEN 408 00:16:37,062 --> 00:16:41,934 IT IS SORT OF A BELIEF THAT THEY 409 00:16:42,000 --> 00:16:42,501 DID. 410 00:16:42,568 --> 00:16:44,103 AND EVEN THOUGH THE SECOND -- 411 00:16:44,169 --> 00:16:49,308 LAST TWO LINES OF THE SECTION 412 00:16:49,375 --> 00:16:51,810 TALK ABOUT STUDY DRUG, WE MADE A 413 00:16:51,877 --> 00:16:53,011 POINT BEFORE ABOUT TALKING ABOUT 414 00:16:53,078 --> 00:16:54,313 THAT THIS ISN'T JUST FOR 415 00:16:54,380 --> 00:16:55,314 BIOLOGICAL THINGS SO I ALSO 416 00:16:55,381 --> 00:16:59,551 DON'T KNOW IF THE END OF THIS 417 00:16:59,618 --> 00:17:00,986 NEEDS TO BE -- YOU KNOW, NEEDS 418 00:17:01,053 --> 00:17:03,055 TO BE TWEAKED TO TALK ABOUT A 419 00:17:03,122 --> 00:17:04,823 STUDY MORE BROADLY AND HAVE AN 420 00:17:04,890 --> 00:17:06,558 EXAMPLE OF IT, YOU KNOW, THERE 421 00:17:06,625 --> 00:17:08,093 ARE CIRCUMSTANCES SUCH AS 422 00:17:08,160 --> 00:17:09,561 INVESTIGATIONAL PRODUCT, NO 423 00:17:09,628 --> 00:17:10,062 LONGER AVAILABLE. 424 00:17:10,129 --> 00:17:10,496 >> RIGHT. 425 00:17:10,562 --> 00:17:11,730 THAT'S WHERE I WAS GETTING HUNG 426 00:17:11,797 --> 00:17:13,031 UP A LITTLE BIT. 427 00:17:13,098 --> 00:17:19,138 JUST THAT IT'S SUCH A VARIETY OF 428 00:17:19,204 --> 00:17:19,471 CIRCUMSTANCES. 429 00:17:19,538 --> 00:17:21,273 >> LOIS, WAS YOUR HAND RAISED TO 430 00:17:21,340 --> 00:17:21,573 THIS POINT? 431 00:17:21,640 --> 00:17:26,712 >> WELL, IT WAS A COUPLE THINGS. 432 00:17:26,779 --> 00:17:28,547 I WONDER IF WE MIGHT SAY EVEN 433 00:17:28,614 --> 00:17:31,750 THOUGH THERE MAY BE PERSONS 434 00:17:31,817 --> 00:17:33,051 WHOSE BELIEVE AND WHOSE HEALTH 435 00:17:33,118 --> 00:17:38,757 CARE PROVIDERS AGREE THAT THEY 436 00:17:38,824 --> 00:17:39,625 MAY HAVE BENEFITED. 437 00:17:39,691 --> 00:17:45,464 THAT MAKES IT EVEN -- 438 00:17:45,531 --> 00:17:46,298 >> RIGHT. 439 00:17:46,365 --> 00:17:49,468 >> NOT PUTTING THE CAUSAL IN 440 00:17:49,535 --> 00:17:49,668 THERE. 441 00:17:49,735 --> 00:17:50,836 YOU'RE MISSING AT THE BEGINNING 442 00:17:50,903 --> 00:17:52,871 OF THE SENTENCE, IT IS 443 00:17:52,938 --> 00:17:54,273 INEVITABLE THERE WILL BE, SO 444 00:17:54,339 --> 00:17:56,375 YOU'RE MISSING A WORD THERE. 445 00:17:56,442 --> 00:17:59,378 AND THEN I JUST WONDERED DID WE 446 00:17:59,445 --> 00:18:00,078 NEED THE PARENTHETICAL AT THE 447 00:18:00,145 --> 00:18:01,447 END OF THE SENTENCE? 448 00:18:01,513 --> 00:18:02,581 IT JUST GOT HARD TO READ AND I 449 00:18:02,648 --> 00:18:08,620 DON'T KNOW IF IT REALLY ADDS 450 00:18:08,687 --> 00:18:10,355 ANYTHING TO THIS AS AN EXAMPLE 451 00:18:10,422 --> 00:18:20,699 OF THE KINDS OF THINGS. 452 00:18:20,766 --> 00:18:22,100 SEEMS LIKE IT'S GOING TO ANOTHER 453 00:18:22,167 --> 00:18:23,001 TOPIC TO ME. 454 00:18:23,068 --> 00:18:25,170 IT'S NOT A BIG DEAL. 455 00:18:25,237 --> 00:18:27,039 I'M NOT OPPOSED TO IT. 456 00:18:27,105 --> 00:18:28,240 IT JUST MADE THAT HARD TO 457 00:18:28,307 --> 00:18:30,008 UNDERSTAND WHAT THE MAIN POINT 458 00:18:30,075 --> 00:18:30,142 -- 459 00:18:30,209 --> 00:18:33,045 >> IF WE GOT RID OF THAT, LET ME 460 00:18:33,111 --> 00:18:34,246 CHANGE THIS TO INTERVENTION, NOT 461 00:18:34,313 --> 00:18:37,115 JUST LIMITED TO DRUG STUDIES, SO 462 00:18:37,182 --> 00:18:38,016 THAT ACTUALLY HELPS ME MAKE 463 00:18:38,083 --> 00:18:40,152 SENSE OF IT ALL. 464 00:18:40,219 --> 00:18:50,729 I DON'T KNOW HOW OTHERS FEEL. 465 00:18:53,532 --> 00:18:53,599 NEIL? 466 00:18:53,665 --> 00:18:56,902 >> I HAVE TWO QUESTIONS ABOUT 467 00:18:56,969 --> 00:18:58,337 THE PARAGRAPH THAT I MEANING 468 00:18:58,403 --> 00:19:00,405 MIGHT BE HELPFUL FOR SOME OF 469 00:19:00,472 --> 00:19:03,575 THIS DISCUSSION. 470 00:19:03,642 --> 00:19:08,847 SO MOST CONCRETELY, I THINK 471 00:19:08,914 --> 00:19:10,015 WE'RE TALKING ABOUT SITUATIONS 472 00:19:10,082 --> 00:19:12,451 WHERE ISSUES ARE CONSIDERED AND 473 00:19:12,518 --> 00:19:14,419 NOT CRITERIA FOR WHICH THEY ARE 474 00:19:14,486 --> 00:19:15,153 DETERMINATIVE. 475 00:19:15,220 --> 00:19:16,054 SOME OF THE LANGUAGE WE'RE 476 00:19:16,121 --> 00:19:17,789 TALKING ABOUT IS WHEN WE THINK 477 00:19:17,856 --> 00:19:19,558 IT SHOULD TRIGGER DOING THIS, IN 478 00:19:19,625 --> 00:19:20,425 REALITY THE PARAGRAPH IS 479 00:19:20,492 --> 00:19:21,960 INTENDED TO BE AN INTRODUCTION 480 00:19:22,027 --> 00:19:24,463 OF TIMES WHERE YOU MIGHT THINK 481 00:19:24,530 --> 00:19:25,397 ABOUT IT. 482 00:19:25,464 --> 00:19:26,298 AND I THINK -- 483 00:19:26,365 --> 00:19:26,865 >> CORRECT. 484 00:19:26,932 --> 00:19:27,866 >> I THINK THAT'S IMPORTANT TO 485 00:19:27,933 --> 00:19:29,835 REMEMBER WHEN WE'RE TRYING TO 486 00:19:29,902 --> 00:19:34,740 REFINE THE LANGUAGE. 487 00:19:34,806 --> 00:19:36,942 SECOND PIECE IS ONE THAT IT MAY 488 00:19:37,009 --> 00:19:38,710 BE CLEAR, THE PARAGRAPH STARTS 489 00:19:38,777 --> 00:19:39,711 WITH DISCUSSION OF PSYCHOLOGICAL 490 00:19:39,778 --> 00:19:42,114 BENEFIT, I HAD A HARD TIME 491 00:19:42,180 --> 00:19:43,649 TELLING WHETHER THE PARAGRAPH IS 492 00:19:43,715 --> 00:19:45,250 ABOUT MULTIPLE TYPES OF BENEFITS 493 00:19:45,317 --> 00:19:48,053 OR THIS IS A SUBSET OF 494 00:19:48,120 --> 00:19:49,321 PSYCHOLOGICAL BENEFIT. 495 00:19:49,388 --> 00:19:52,190 AND SO IF WE'RE TALKING ABOUT 496 00:19:52,257 --> 00:19:54,993 MULTIPLE TYPES OF BENEFITS THIS 497 00:19:55,060 --> 00:19:56,962 MAY SOUND PICKY BUT MIGHT BE 498 00:19:57,029 --> 00:19:58,096 HELP FOLLOW HAVE OPENING 499 00:19:58,163 --> 00:19:59,398 SENTENCE BE MULTIPLE TIMES OF 500 00:19:59,464 --> 00:20:02,801 BENEFITS THAT MIGHT GET 501 00:20:02,868 --> 00:20:05,337 TRIGGERED, ONE PSYCHOLOGICAL, 502 00:20:05,404 --> 00:20:08,273 THE OTHER PEOPLE BELIEVE THEY 503 00:20:08,340 --> 00:20:09,708 MAY HAVE BENEFITED, MAY NOT BE 504 00:20:09,775 --> 00:20:11,343 PSYCHOLOGICAL, I WANT TO MAKE 505 00:20:11,410 --> 00:20:13,946 SURE WE DON'T -- THE LAST 506 00:20:14,012 --> 00:20:15,914 SECTION, AS I READ IT, NOT 507 00:20:15,981 --> 00:20:18,016 INTENDED TO BE ABOUT 508 00:20:18,083 --> 00:20:18,784 PSYCHOLOGICAL BENEFIT. 509 00:20:18,850 --> 00:20:22,287 THERE'S A STATE WHERE PEOPLE 510 00:20:22,354 --> 00:20:23,488 BELIEVE THEY BENEFITED FOR 511 00:20:23,555 --> 00:20:25,223 POTENTIALLY A NUMBER OF REASONS. 512 00:20:25,290 --> 00:20:26,758 IT'S A MINOR EDIT BUT MIGHT HELP 513 00:20:26,825 --> 00:20:27,960 THE PARAGRAPH TO BE CLEARER IN 514 00:20:28,026 --> 00:20:30,095 TERMS OF WHAT WE'RE INTENDING 515 00:20:30,162 --> 00:20:32,030 THE SCOPE TO BE. 516 00:20:32,097 --> 00:20:33,765 >> SO IS YOUR SUGGESTION -- IF 517 00:20:33,832 --> 00:20:34,866 I'M HEARING YOU CORRECTLY, I 518 00:20:34,933 --> 00:20:37,169 THINK I AM, IS THE SIMPLE ANSWER 519 00:20:37,235 --> 00:20:42,307 THEN TO DELETE THAT FIRST 520 00:20:42,374 --> 00:20:42,574 SENTENCE? 521 00:20:42,641 --> 00:20:45,377 >> NOT IF WE THINK THAT'S ONE OF 522 00:20:45,444 --> 00:20:46,378 THE TYPES OF BENEFITS. 523 00:20:46,445 --> 00:20:47,613 I WOULD ADD A FIRST SENTENCE, 524 00:20:47,679 --> 00:20:50,315 THERE'S A NUMBER OF TYPES OF 525 00:20:50,382 --> 00:20:54,786 BENEFITS THAT MIGHT TRIGGER 526 00:20:54,853 --> 00:20:55,654 CONSIDERATION OF THIS. 527 00:20:55,721 --> 00:20:57,556 ONE WOULD BE PSYCHOLOGICAL 528 00:20:57,623 --> 00:20:59,925 BENEFITS IN DETERMINING BEST 529 00:20:59,992 --> 00:21:00,926 INTERESTS, TALK ABOUT THE 530 00:21:00,993 --> 00:21:04,229 PLACEBO PIECE. 531 00:21:04,296 --> 00:21:05,731 SECOND IT'S INEVITABLE THERE ARE 532 00:21:05,797 --> 00:21:07,599 SITUATIONS WHERE WE FIND THAT 533 00:21:07,666 --> 00:21:09,901 THE STUDY WAS STOPPED BECAUSE IT 534 00:21:09,968 --> 00:21:11,236 DIDN'T LOOK HELPFUL BUT THERE 535 00:21:11,303 --> 00:21:14,940 ARE PEOPLE WHO GOT BETTER AND WE 536 00:21:15,007 --> 00:21:22,848 NEED TO -- THAT'S NOT 537 00:21:22,914 --> 00:21:26,885 NECESSARILY A PSYCHOLOGICAL 538 00:21:26,952 --> 00:21:27,986 STATE. 539 00:21:28,053 --> 00:21:28,286 >> RIGHT. 540 00:21:28,353 --> 00:21:30,288 >> THIS IS WHAT GETS THIS ON THE 541 00:21:30,355 --> 00:21:34,092 TABLE RATHER THAN BEING WHAT THE 542 00:21:34,159 --> 00:21:35,627 CRITERIA FOR SUFFICIENCY OF 543 00:21:35,694 --> 00:21:46,238 DETERMINING BEST INTERESTS ARE 544 00:21:53,645 --> 00:21:55,113 ADVANCED BY CONTINUING. 545 00:21:55,180 --> 00:21:56,548 DURING PARTICIPATION RESEARCH 546 00:21:56,615 --> 00:21:58,316 THAT MIGHT TRIGGER BEST INTEREST 547 00:21:58,383 --> 00:22:01,953 CONSIDERATIONS OR SOMETHING LIKE 548 00:22:02,020 --> 00:22:04,389 THAT. 549 00:22:24,843 --> 00:22:24,943 >> OKAY. 550 00:22:25,010 --> 00:22:26,878 OTHER SUGGESTIONS OR CHANGES 551 00:22:26,945 --> 00:22:28,213 BEFORE I SCROLL DOWN? 552 00:22:28,280 --> 00:22:31,416 I'LL LEAVE IT UP FOR A SECOND. 553 00:22:38,557 --> 00:22:38,990 MINDY? 554 00:22:39,057 --> 00:22:44,196 >> I WAS WONDERING, IN THAT 555 00:22:44,262 --> 00:22:46,031 SENTENCE AT 64, WHERE IT SAYS 556 00:22:46,098 --> 00:22:47,566 PERSONS WHO BELIEVE, COULD YOU 557 00:22:47,632 --> 00:22:50,335 JUST SAY EVEN THOUGH THERE MAY 558 00:22:50,402 --> 00:22:53,472 BE PERCEIVED BENEFIT? 559 00:22:53,538 --> 00:22:54,573 FROM THE STUDY? 560 00:22:54,639 --> 00:22:56,308 EVEN SAYING HEALTH CARE 561 00:22:56,374 --> 00:22:58,510 PROVIDERS, I MEAN, ARE ALL 562 00:22:58,577 --> 00:22:59,177 STUDIES INVOLVING HEALTH CARE 563 00:22:59,244 --> 00:23:03,115 PROVIDERS THAT MIGHT BE STOPPED? 564 00:23:03,181 --> 00:23:05,317 I MEAN -- I'M JUST NOT SURE. 565 00:23:05,383 --> 00:23:08,286 >> YEAH. 566 00:23:19,698 --> 00:23:21,566 IT'S A PRETTY LONG LAST 567 00:23:21,633 --> 00:23:22,067 SENTENCE. 568 00:23:22,134 --> 00:23:23,235 MY ONLY CONCERN CHANGING IT THAT 569 00:23:23,301 --> 00:23:25,170 WAY THIS LAST SENTENCE WAS AN 570 00:23:25,237 --> 00:23:26,404 EXAMPLE OF STUDIES THAT ARE 571 00:23:26,471 --> 00:23:29,941 STOPPED DUE TO NEGATIVE OVERALL 572 00:23:30,008 --> 00:23:38,083 RESULTS. 573 00:23:42,687 --> 00:23:45,791 I'M SEEING IF IT WORKS TO CHOP 574 00:23:45,857 --> 00:23:51,163 THAT DOWN TO -- 575 00:23:51,229 --> 00:23:53,131 >> EVEN THOUGH THERE MAY BE 576 00:23:53,198 --> 00:23:57,803 PERCEIVED BENEFITS. 577 00:23:59,037 --> 00:24:04,442 THEN THAT COULD BE FROM THE 578 00:24:04,509 --> 00:24:05,944 SUBJECT, FROM THEIR PROVIDER, 579 00:24:06,011 --> 00:24:07,312 ALL THOSE THINGS. 580 00:24:07,379 --> 00:24:07,612 >> RIGHT. 581 00:24:07,679 --> 00:24:11,983 THAT WOULD -- WOULD YOU END THE 582 00:24:12,050 --> 00:24:12,350 SENTENCE THERE? 583 00:24:12,417 --> 00:24:16,655 >> EVEN THOUGH THERE MAY BE 584 00:24:16,721 --> 00:24:26,565 PERCEIVED BENEFIT, WHERE IS IT? 585 00:24:26,631 --> 00:24:28,733 FROM THE INTERVENTION? 586 00:24:28,800 --> 00:24:31,136 EVEN THOUGH THERE MAY BE 587 00:24:31,203 --> 00:24:32,237 PERCEIVED BENEFIT FROM THE 588 00:24:32,304 --> 00:24:33,205 INTERVENTION RECEIVED DURING THE 589 00:24:33,271 --> 00:24:41,279 STUDY OR SOMETHING LIKE THAT. 590 00:24:41,613 --> 00:24:43,849 >> MAY BE PERCEIVED BENEFITS, 591 00:24:43,915 --> 00:24:45,650 BENEFIT -- 592 00:24:45,717 --> 00:24:49,020 >> FROM THE STUDY'S INTERVENTION 593 00:24:49,087 --> 00:24:53,592 OR FROM THE INTERVENTION PERIOD. 594 00:24:53,658 --> 00:25:00,932 >> STUDY/INTERVENTION, YEAH. 595 00:25:00,999 --> 00:25:02,801 >> ALTHOUGH I DID LIKE THE IDEA 596 00:25:02,868 --> 00:25:05,303 KEEPING THAT PART ABOUT THE IDEA 597 00:25:05,370 --> 00:25:07,973 THAT PERSONS MIGHT WANT TO 598 00:25:08,039 --> 00:25:08,940 CONTINUE, RIGHT? 599 00:25:09,007 --> 00:25:10,909 I WONDER IF WE COULD SAY EVEN 600 00:25:10,976 --> 00:25:14,579 THOUGH THERE MAY BE PERCEIVED 601 00:25:14,646 --> 00:25:21,753 BENEFIT TO PERSON WHO WANT TO 602 00:25:21,820 --> 00:25:22,721 CONTINUE, YOU KNOW, PERCEIVED 603 00:25:22,787 --> 00:25:24,089 BENEFIT FROM THE STUDY TO 604 00:25:24,155 --> 00:25:25,724 PERSONS WHO WANT TO CONTINUE ON 605 00:25:25,790 --> 00:25:27,225 THE INTERVENTION. 606 00:25:27,292 --> 00:25:30,929 I THOUGHT THAT WAS AN IMPORTANT 607 00:25:30,996 --> 00:25:34,332 PART OF WHAT THE THING -- WHAT 608 00:25:34,399 --> 00:25:35,667 THE PARAGRAPH WAS SAYING. 609 00:25:35,734 --> 00:25:39,604 SOME PEOPLE WANT TO CONTINUE. 610 00:25:39,671 --> 00:25:41,172 IF WE LOSE THAT -- 611 00:25:41,239 --> 00:25:51,716 >> YEAH, SO IF I DID THAT -- 612 00:25:52,183 --> 00:25:53,919 TRACKING MAKES IT MESSY. 613 00:25:53,985 --> 00:25:55,754 THAT'S WHAT IT WOULD LOOK LIKE 614 00:25:55,820 --> 00:25:57,522 CHOPPED DOWN SO I DON'T KNOW IF 615 00:25:57,589 --> 00:25:59,758 THAT SORT OF PRESERVES WHAT YOU 616 00:25:59,824 --> 00:26:01,726 WERE CONCERNED ABOUT, LOIS. 617 00:26:01,793 --> 00:26:04,095 THAT ADDRESSES MINDY'S CONCERN. 618 00:26:04,162 --> 00:26:08,600 >> I'M HAPPY WITH THAT. 619 00:26:08,667 --> 00:26:10,001 >> ALL RIGHT. 620 00:26:10,068 --> 00:26:12,203 WELL, LET ME SCROLL THEN. 621 00:26:12,270 --> 00:26:13,738 I THINK WE'RE GOING TO HAVE TIME 622 00:26:13,805 --> 00:26:16,675 IF WE WANT TO COME BACK TO THIS 623 00:26:16,741 --> 00:26:18,109 PIECE, EITHER IN THIS SECTION OR 624 00:26:18,176 --> 00:26:19,945 EVEN LATER TODAY WE CAN. 625 00:26:20,011 --> 00:26:21,846 I'M NOT SEEING ANY OTHER 626 00:26:21,913 --> 00:26:30,355 OBJECTIONS TO IT. 627 00:26:33,725 --> 00:26:34,859 THESE OTHER TWO PARAGRAPHS 628 00:26:34,926 --> 00:26:35,794 REALLY AREN'T ALL THAT DIFFERENT 629 00:26:35,860 --> 00:26:39,898 THAN THEY HAVE BEEN ALL ALONG, 630 00:26:39,965 --> 00:26:40,565 SO KEVIN? 631 00:26:40,632 --> 00:26:42,400 >> I PROMISE I WON'T HAVE A LOT 632 00:26:42,467 --> 00:26:46,905 OF COMMENTS ON THIS DOCUMENT. 633 00:26:46,972 --> 00:26:47,238 >> IT'S 634 00:26:47,305 --> 00:26:50,842 >> 75, WHEN I READ IT, THIS, 635 00:26:50,909 --> 00:26:52,711 THIS IS AN EXPRESSION, IT SOUNDS 636 00:26:52,777 --> 00:26:54,679 LIKE THAT'S REFERRING TO WHEN A 637 00:26:54,746 --> 00:26:56,548 PROVIDER HAS PUT HIS OR HER OWN 638 00:26:56,614 --> 00:26:57,949 INTERESTS ABOVE THE INTEREST OF 639 00:26:58,016 --> 00:27:00,919 THE PATIENT, WHICH I DON'T THINK 640 00:27:00,986 --> 00:27:02,020 IS INTENDED. 641 00:27:02,087 --> 00:27:04,089 SO MAYBE THIS EXPRESSES A 642 00:27:04,155 --> 00:27:06,291 CONCERN ABOUT THE FIDUCIARY DUTY 643 00:27:06,358 --> 00:27:10,695 OR SOMETHING LIKE THAT. 644 00:27:10,762 --> 00:27:18,837 >> OKAY. 645 00:27:22,874 --> 00:27:26,745 THAT'S HOW THAT WOULD LOOK 646 00:27:26,811 --> 00:27:27,545 FOLLOWING YOUR SUGGESTION, WHICH 647 00:27:27,612 --> 00:27:29,481 IS FINE WITH ME. 648 00:27:29,547 --> 00:27:29,714 LOIS? 649 00:27:29,781 --> 00:27:34,519 >> I HAVE A LITTLE THING IN THE 650 00:27:34,586 --> 00:27:37,122 LAST SENTENCE OF THE PARAGRAPH. 651 00:27:37,188 --> 00:27:39,758 HOWEVER THEY. 652 00:27:39,824 --> 00:27:41,292 THE "THEY" WAS REFERRING BACK 653 00:27:41,359 --> 00:27:43,628 TOO MANY SENTENCES BEFORE FOR 654 00:27:43,695 --> 00:27:44,162 ME. 655 00:27:44,229 --> 00:27:46,398 SO WE MIGHT SAY -- 656 00:27:46,464 --> 00:27:47,799 >> RESEARCHERS? 657 00:27:47,866 --> 00:27:48,600 >> RESEARCHERS OR INVESTIGATORS, 658 00:27:48,666 --> 00:27:56,841 EITHER ONE. 659 00:28:00,011 --> 00:28:02,313 >> OKAY. 660 00:28:03,882 --> 00:28:07,285 ARE WE OKAY WITH THAT? 661 00:28:07,352 --> 00:28:10,989 NOT SEEING ANY OBJECTIONS, I'LL 662 00:28:11,056 --> 00:28:14,392 SCROLL DOWN TO OUR ANALYSIS 663 00:28:14,459 --> 00:28:14,726 SECTION. 664 00:28:14,793 --> 00:28:17,328 AND, AGAIN, OVER THE LAST FEW 665 00:28:17,395 --> 00:28:19,898 MONTHS, A LOT OF TAILORING TO 666 00:28:19,964 --> 00:28:21,399 THIS, BUT I DON'T KNOW THAT 667 00:28:21,466 --> 00:28:22,600 THERE'S BEEN REALLY SIGNIFICANT 668 00:28:22,667 --> 00:28:33,211 CHANGES SINCE YOU LAST SAW IT. 669 00:28:40,385 --> 00:28:42,854 AGAIN, SOME FACTORS THAT SHOULD 670 00:28:42,921 --> 00:28:44,155 BE CONSIDERED, MAKING BEST 671 00:28:44,222 --> 00:28:46,357 INTEREST, AS IS OFTEN THE CASE 672 00:28:46,424 --> 00:28:47,525 IN THESE DOCUMENTS. 673 00:28:47,592 --> 00:28:48,726 WE'RE SORT OF WALKING A FINE 674 00:28:48,793 --> 00:28:50,495 LINE, DON'T WANT PEOPLE TO THINK 675 00:28:50,562 --> 00:28:52,597 THESE ARE THE ONLY ONES OR THAT 676 00:28:52,664 --> 00:28:58,403 THIS IS ALL INCLUSIVE LIST, BUT 677 00:28:58,470 --> 00:29:03,308 THESE WERE THE EXAMPLES THAT 678 00:29:03,374 --> 00:29:04,843 THE -- BOTH PREVIOUS THIS 679 00:29:04,909 --> 00:29:05,777 COMMITTEE AND THE SUBCOMMITTEE'S 680 00:29:05,844 --> 00:29:07,312 THOUGHT WAS A REASONABLE LIST TO 681 00:29:07,378 --> 00:29:17,755 PUT IN THE DOCUMENT. 682 00:29:19,424 --> 00:29:20,191 KEVIN? 683 00:29:20,258 --> 00:29:25,864 >> SORRY, A TINY THING. 684 00:29:25,930 --> 00:29:29,167 106, WE SAY EARLIER IN 74 AND 685 00:29:29,234 --> 00:29:31,903 75, IT IS DEBATED, SOMEONE MIGHT 686 00:29:31,970 --> 00:29:35,406 READ IF THERE'S A FIDUCIARY DUTY 687 00:29:35,473 --> 00:29:37,041 AS A LOGICAL STATEMENT, NOT IF 688 00:29:37,108 --> 00:29:38,676 YOU BELIEVE THAT. 689 00:29:38,743 --> 00:29:41,646 SHOULD WE SAY IF IT'S DETERMINED 690 00:29:41,713 --> 00:29:43,615 THERE IS A FIDUCIARY DUTY OR 691 00:29:43,681 --> 00:29:45,150 SOMETHING LIKE THAT, JUST TO 692 00:29:45,216 --> 00:29:48,386 KEEP IT CLEAR THAT THAT IS STILL 693 00:29:48,453 --> 00:29:50,288 SOMETHING THAT'S DEBATED. 694 00:29:50,355 --> 00:29:50,655 >> OKAY. 695 00:29:50,722 --> 00:29:54,225 >> THANKS. 696 00:29:54,292 --> 00:29:55,426 >> DAVE, TALKING ABOUT FIDUCIARY 697 00:29:55,493 --> 00:29:57,295 DUTY I DON'T REMEMBER THIS PART. 698 00:29:57,362 --> 00:30:00,031 I'M SORRY. 699 00:30:00,098 --> 00:30:01,466 >> GO AHEAD, ERIC. 700 00:30:01,533 --> 00:30:03,401 YOU GOT THE FLOOR. 701 00:30:03,468 --> 00:30:04,068 >> THANKS. 702 00:30:04,135 --> 00:30:05,937 I JUST DON'T REMEMBER, I'M 703 00:30:06,004 --> 00:30:08,006 TRYING TO ENVISION A FIDUCIARY 704 00:30:08,072 --> 00:30:09,440 DUTY BY RESEARCHERS. 705 00:30:09,507 --> 00:30:11,176 CAN YOU EXPRESS WHAT THE 706 00:30:11,242 --> 00:30:15,346 SUBCOMMITTEE WAS THINKING ABOUT 707 00:30:15,413 --> 00:30:15,547 THIS? 708 00:30:15,613 --> 00:30:18,416 I CAN'T -- A LITTLE UNUSUAL FOR 709 00:30:18,483 --> 00:30:20,852 ME, TO THINK OF FIDUCIARY DUTY 710 00:30:20,919 --> 00:30:24,889 FOR RESEARCHER. 711 00:30:24,956 --> 00:30:28,826 >> OFF THE TOP OF MY HEAD, NO. 712 00:30:28,893 --> 00:30:30,128 WE HAVEN'T TALKED ABOUT THIS, 713 00:30:30,195 --> 00:30:33,965 THIS PART OF THIS SECTION IN A 714 00:30:34,032 --> 00:30:37,702 WHILE. 715 00:30:37,769 --> 00:30:38,169 >> OKAY. 716 00:30:38,236 --> 00:30:39,204 I'LL NOODLE ON IT. 717 00:30:39,270 --> 00:30:41,539 I'M A LITTLE CONCERNED ABOUT IT. 718 00:30:41,606 --> 00:30:52,116 IT DOESN'T POP OUT TO ME WHAT 719 00:30:53,585 --> 00:30:53,785 THIS MEANS. 720 00:30:53,851 --> 00:30:56,087 >> WE CAN THINK ABOUT THAT. 721 00:30:56,154 --> 00:30:56,387 ALLISON? 722 00:30:56,454 --> 00:31:00,458 >> A SCENARIO THAT KEPT COMING 723 00:31:00,525 --> 00:31:02,627 TO MY MIND, THAT I THOUGHT IT 724 00:31:02,694 --> 00:31:05,797 SHOULD PERHAPS BE CALLED OUT. 725 00:31:05,863 --> 00:31:08,333 IT'S THE SITUATION IN WHICH -- 726 00:31:08,399 --> 00:31:11,402 WELL, IT SEEMS LIKE WE'RE 727 00:31:11,469 --> 00:31:16,074 TALKING A LOT ABOUT RESEARCH 728 00:31:16,140 --> 00:31:17,308 SCENARIOS IN WHICH AN 729 00:31:17,375 --> 00:31:19,043 INTERVENTION MOST LIKELY A DRUG 730 00:31:19,110 --> 00:31:21,346 IS BEING PROVIDED TO THE 731 00:31:21,412 --> 00:31:23,948 PATIENT, AND WHEN THE RESEARCH 732 00:31:24,015 --> 00:31:25,383 IS RESUMED WE'RE RESUMING GIVING 733 00:31:25,450 --> 00:31:27,552 THAT DRUG BACK TO THE PATIENT OR 734 00:31:27,619 --> 00:31:28,453 OTHER PATIENTS. 735 00:31:28,519 --> 00:31:32,657 BUT I CAN VERY EASILY FORESEE A 736 00:31:32,724 --> 00:31:36,327 SITUATION IN WHICH RATHER THAN 737 00:31:36,394 --> 00:31:37,895 GETTING A DRUG AFTER RESUMPTION 738 00:31:37,962 --> 00:31:39,297 OF RESEARCH, WHAT IS BEING 739 00:31:39,364 --> 00:31:42,567 RESUMED FOR AT LEAST A NUMBER OF 740 00:31:42,634 --> 00:31:45,770 PATIENTS IS JUST FOLLOW-UP 741 00:31:45,837 --> 00:31:46,537 MONITORING BECAUSE THE 742 00:31:46,604 --> 00:31:51,376 MONITORING, THE FUNDING FOR THAT 743 00:31:51,442 --> 00:31:53,611 IS BUILT INTO RESEARCH PROTOCOL. 744 00:31:53,678 --> 00:31:54,746 PEOPLE AREN'T NECESSARILY 745 00:31:54,812 --> 00:31:56,014 GETTING DOSED OR REDOSED OR 746 00:31:56,080 --> 00:31:57,815 WHATEVER ELSE BUT THEY ARE BEING 747 00:31:57,882 --> 00:31:58,816 TRACKED AND FOLLOWED. 748 00:31:58,883 --> 00:32:00,652 I DON'T REALLY SEE THAT BEING 749 00:32:00,718 --> 00:32:06,157 CALLED OUT AS A SCENARIO. 750 00:32:06,224 --> 00:32:07,892 AND I THINK THAT THAT'S ONE THAT 751 00:32:07,959 --> 00:32:11,262 I THINK HAS, YOU KNOW, A VERY 752 00:32:11,329 --> 00:32:14,899 SORT OF DIFFERENT CALCULUS. 753 00:32:14,966 --> 00:32:16,901 >> SO, I PRESUME YOU'RE TALKING 754 00:32:16,968 --> 00:32:17,969 ABOUT THE BULLETED LIST. 755 00:32:18,036 --> 00:32:18,469 >> YES. 756 00:32:18,536 --> 00:32:20,171 >> COULD ONE BE ADDED THAT SAYS, 757 00:32:20,238 --> 00:32:25,209 YOU KNOW, THAT A FACTOR THAT MAY 758 00:32:25,276 --> 00:32:27,045 BE CONSIDERED IS THE NEED FOR 759 00:32:27,111 --> 00:32:29,514 THE ONGOING COLLECTION OF SAFETY 760 00:32:29,580 --> 00:32:32,216 DATA? 761 00:32:32,283 --> 00:32:34,118 >> SAFETY DATA OR, YOU KNOW, 762 00:32:34,185 --> 00:32:35,186 JUST PATIENT MONITORING. 763 00:32:35,253 --> 00:32:37,722 I MEAN NOT PATIENT MONITORING, 764 00:32:37,789 --> 00:32:48,199 PARTICIPANT MONITORING. 765 00:33:02,246 --> 00:33:04,849 YES, THANK YOU, DAVE. 766 00:33:04,916 --> 00:33:09,654 SUBJECT MONITORING. 767 00:33:09,721 --> 00:33:10,755 >> LOIS? 768 00:33:10,822 --> 00:33:13,491 >> I WANTED TO SPEAK TO THAT 769 00:33:13,558 --> 00:33:17,428 PARAGRAPH THAT BEGINS ON 107 770 00:33:17,495 --> 00:33:17,895 NOW. 771 00:33:17,962 --> 00:33:18,329 >> UH-HUH. 772 00:33:18,396 --> 00:33:20,064 >> BECAUSE THIS IS -- I STUMBLED 773 00:33:20,131 --> 00:33:21,165 ON THIS TOO BECAUSE I DON'T 774 00:33:21,232 --> 00:33:23,901 THINK WE NEED TO GET INTO THE 775 00:33:23,968 --> 00:33:29,307 DEBATE REALLY ABOUT WHETHER OR 776 00:33:29,374 --> 00:33:31,109 NOT RESEARCHERS, PHYSICIANS IN 777 00:33:31,175 --> 00:33:32,210 PARTICULAR, RESEARCHERS WHO 778 00:33:32,276 --> 00:33:35,146 ENROLL THEIR OWN PATIENTS IN 779 00:33:35,213 --> 00:33:36,814 THEIR RESEARCH OWE A FIDUCIARY 780 00:33:36,881 --> 00:33:40,184 DUTY OR IF THE FIDUCIARY DUTY 781 00:33:40,251 --> 00:33:42,687 THAT'S BEEN ALTERED BY THE 782 00:33:42,754 --> 00:33:44,756 INFORMED CONSENT PROCESS, AND 783 00:33:44,822 --> 00:33:46,758 GETTING CONSENT, I WONDER IF WE 784 00:33:46,824 --> 00:33:49,260 MIGHT JUST LEAVE IT MORE -- I 785 00:33:49,327 --> 00:33:50,895 LIKE THE DISCUSSION OF FIDUCIARY 786 00:33:50,962 --> 00:33:53,097 DUTY ABOVE WHICH IS JUST TALKING 787 00:33:53,164 --> 00:33:54,298 ABOUT DIFFERENT WAYS OF 788 00:33:54,365 --> 00:33:56,968 UNDERSTANDING BEST INTERESTS, 789 00:33:57,034 --> 00:33:59,437 BUT MAYBE WE SHOULD JUST -- THE 790 00:33:59,504 --> 00:34:08,246 POINT IT SEEMS TO BE IS IN SOME 791 00:34:08,312 --> 00:34:09,213 CIRCUMSTANCES, LEAVING A BLANK 792 00:34:09,280 --> 00:34:10,748 FOR WHAT THAT IS, BUT IN SOME 793 00:34:10,815 --> 00:34:13,484 CIRCUMSTANCES, YOU KNOW, THERE 794 00:34:13,551 --> 00:34:18,089 MAY BE AN OBLIGATION TO 795 00:34:18,156 --> 00:34:20,091 TRANSITION PATIENT SUBJECTS INTO 796 00:34:20,158 --> 00:34:23,027 OTHER CLINICAL CARE. 797 00:34:23,094 --> 00:34:28,299 AND SO, YOU KNOW, ESPECIALLY 798 00:34:28,366 --> 00:34:29,500 BECAUSE IT'S A RESEARCHER 799 00:34:29,567 --> 00:34:31,369 PHYSICIAN, IF IT IS, SO I'M 800 00:34:31,436 --> 00:34:34,405 WONDERING IF WE CAN LEAVE IT 801 00:34:34,472 --> 00:34:38,042 VAGUE, IN SOME INSTANCES THERE 802 00:34:38,109 --> 00:34:41,412 MAY BE PROFESSIONAL OR, YOU 803 00:34:41,479 --> 00:34:42,713 KNOW, THERE -- I DON'T KNOW HOW 804 00:34:42,780 --> 00:34:45,249 TO SAY IT BUT NOT FOCUSING IT ON 805 00:34:45,316 --> 00:34:46,751 THIS, IF IT IS DETERMINED, 806 00:34:46,818 --> 00:34:47,985 BECAUSE THERE MIGHT BE AN 807 00:34:48,052 --> 00:34:51,355 OBLIGATION TO DO THIS EVEN IF 808 00:34:51,422 --> 00:34:54,992 THERE'S NOT A FIDUCIARY DUTY BUT 809 00:34:55,059 --> 00:34:57,195 A SPECIAL RELATIONSHIP OR -- YOU 810 00:34:57,261 --> 00:34:58,496 KNOW, LEGALLY IT CAN GO A NUMBER 811 00:34:58,563 --> 00:34:59,163 OF WAYS. 812 00:34:59,230 --> 00:35:01,232 MAYBE THE BEST THING IS NOT TO 813 00:35:01,299 --> 00:35:07,271 GET INTO THAT DEBATE BUT JUST 814 00:35:07,338 --> 00:35:07,805 ACKNOWLEDGE THAT IN SOME 815 00:35:07,872 --> 00:35:09,340 CIRCUMSTANCES, YOU KNOW, THERE 816 00:35:09,407 --> 00:35:10,875 MAY BE AN OBLIGATION BUT I DON'T 817 00:35:10,942 --> 00:35:13,411 KNOW IF THAT'S SAYING THAT TOO 818 00:35:13,478 --> 00:35:14,178 STRONGLY BECAUSE WE'RE NOT 819 00:35:14,245 --> 00:35:16,247 SAYING WHEN IT IS BUT WE'RE 820 00:35:16,314 --> 00:35:18,282 ACKNOWLEDGING THAT SOMETIMES 821 00:35:18,349 --> 00:35:21,819 THERE MAY BE. 822 00:35:21,886 --> 00:35:23,254 >> YEAH, SO I'M CURIOUS, YOU 823 00:35:23,321 --> 00:35:26,858 KNOW, I THINK THE FIRST HALF OF 824 00:35:26,924 --> 00:35:30,795 IT CAN BE NARROWED DOWN OR 825 00:35:30,862 --> 00:35:32,663 SHIFTED AWAY FROM THE FIDUCIARY 826 00:35:32,730 --> 00:35:43,274 DUTY ASPECT TO SIMPLY NOTE THAT 827 00:35:43,741 --> 00:35:45,576 THERE CAN BE CIRCUMSTANCES WHERE 828 00:35:45,643 --> 00:35:51,182 THE NEEDS FOR THE SUBJECT'S 829 00:35:51,249 --> 00:35:53,150 CLINICAL CARE SORT OF CREATE 830 00:35:53,217 --> 00:35:57,321 THAT THERE'S AN -- THAT 831 00:35:57,388 --> 00:35:59,490 RESEARCHERS HAVE A -- MAY HAVE 832 00:35:59,557 --> 00:36:01,993 AN OBLIGATION OR PROFESSIONAL 833 00:36:02,059 --> 00:36:05,496 ETHICAL, WHATEVER OBLIGATION TO 834 00:36:05,563 --> 00:36:07,031 ENSURE THE TRANSITION OF 835 00:36:07,098 --> 00:36:09,433 SUBJECTS FROM THEIR STATUS AS 836 00:36:09,500 --> 00:36:10,535 SUBJECT BACK INTO APPROPRIATE 837 00:36:10,601 --> 00:36:12,203 CLINICAL CARE. 838 00:36:12,270 --> 00:36:13,404 IT'S MESSY, AND IT'S COMING 839 00:36:13,471 --> 00:36:15,273 TOGETHER IN MY HEAD BUT WOULD 840 00:36:15,339 --> 00:36:17,108 SORT OF PUSH OFF THIS FIDUCIARY 841 00:36:17,174 --> 00:36:18,743 DUTY THING AND FOCUS ON THAT 842 00:36:18,809 --> 00:36:18,943 PIECE. 843 00:36:19,010 --> 00:36:23,147 ERIC, I DON'T KNOW IF THAT WOULD 844 00:36:23,214 --> 00:36:23,648 HELP. 845 00:36:23,714 --> 00:36:25,116 >> I'M WONDERING IF IT'S 846 00:36:25,182 --> 00:36:25,783 REDUNDANT POSSIBLY. 847 00:36:25,850 --> 00:36:28,219 >> IT MAY BE. 848 00:36:28,286 --> 00:36:30,421 >> YOU TALK ABOUT THAT IN 103 TO 849 00:36:30,488 --> 00:36:31,689 106. 850 00:36:31,756 --> 00:36:35,092 IF YOU LOOK AT 103 AND 106 AND 851 00:36:35,159 --> 00:36:37,061 COMPARE TO 107 AND 110, TO ME 852 00:36:37,128 --> 00:36:38,362 THEY ARE VERY SIMILAR. 853 00:36:38,429 --> 00:36:38,663 >> YEAH. 854 00:36:38,729 --> 00:36:40,765 >> I'LL LEAVE IT TO YOU. 855 00:36:40,831 --> 00:36:44,502 I DON'T THINK WE NEED IT 856 00:36:44,569 --> 00:36:47,071 NECESSARILY IS WHERE I'M 857 00:36:47,138 --> 00:36:47,305 LANDING. 858 00:36:47,371 --> 00:36:53,811 I THINK IT'S COVERED IN 103 TO 859 00:36:53,878 --> 00:36:55,112 106, OTHER PARTS WE GO INTO 860 00:36:55,179 --> 00:36:55,613 THIS. 861 00:36:55,680 --> 00:36:58,182 THE FIDUCIARY WORD IS TRIGGERING 862 00:36:58,249 --> 00:37:00,484 FOR ME, MAYBE WE WANT TO TAKE IT 863 00:37:00,551 --> 00:37:00,918 OUT. 864 00:37:00,985 --> 00:37:05,823 >> AS YOU SAY THAT, ERIC, 865 00:37:05,890 --> 00:37:07,758 PARTICULARLY -- THAT PART C OF 866 00:37:07,825 --> 00:37:11,862 THAT SECTION YOU WERE QUOTING, I 867 00:37:11,929 --> 00:37:12,964 MEAN IT DOES -- MANAGEMENT -- 868 00:37:13,030 --> 00:37:14,832 I'M HAPPY TO LEAVE THAT AND 869 00:37:14,899 --> 00:37:16,801 STRIKE THAT LAST PARAGRAPH IF 870 00:37:16,867 --> 00:37:18,536 THAT'S NOT PROBLEMATIC FOR LOIS 871 00:37:18,603 --> 00:37:19,203 OR OTHERS. 872 00:37:19,270 --> 00:37:21,272 >> I THINK THAT WOULD BE MY 873 00:37:21,339 --> 00:37:21,572 INCLINATION. 874 00:37:21,639 --> 00:37:25,443 ALWAYS BETTER TO TRIM OUR 875 00:37:25,509 --> 00:37:26,944 DOCUMENTS WHENEVER POSSIBLE. 876 00:37:27,011 --> 00:37:27,278 >> SANDRA? 877 00:37:27,345 --> 00:37:32,450 >> IF I COULD ADD TO THAT, YOU 878 00:37:32,516 --> 00:37:35,519 KNOW, THE SECTION FROM 103 TO 879 00:37:35,586 --> 00:37:38,689 106 FOCUSES ON THE SUBJECT. 880 00:37:38,756 --> 00:37:42,526 BUT I THINK WHAT 107 DOES, IT 881 00:37:42,593 --> 00:37:46,130 STARTS TO INTRODUCE THE 882 00:37:46,197 --> 00:37:47,098 RELATIONSHIP BETWEEN RESEARCHERS 883 00:37:47,164 --> 00:37:49,100 AND SUBJECTS AND WHATEVER 884 00:37:49,166 --> 00:37:50,735 ETHICAL OBLIGATIONS THERE ARE TO 885 00:37:50,801 --> 00:37:52,803 CARE, TO CONTINUE CARE FOR THE 886 00:37:52,870 --> 00:37:54,238 SUBJECT BECAUSE OF THAT 887 00:37:54,305 --> 00:37:54,672 RELATIONSHIP. 888 00:37:54,739 --> 00:37:56,974 AND I GUESS I WOULD LOVE TO 889 00:37:57,041 --> 00:37:58,509 LEARN MORE FROM YOUR DISCUSSIONS 890 00:37:58,576 --> 00:38:00,478 WITH THE SUBCOMMITTEE IF THAT 891 00:38:00,544 --> 00:38:02,980 WAS SOMETHING THAT WAS IMPORTANT 892 00:38:03,047 --> 00:38:04,215 TO INCLUDE. 893 00:38:04,281 --> 00:38:10,254 I DO THINK THE LANGUAGE AROUND 894 00:38:10,321 --> 00:38:12,123 FIDUCIARY DUTY RAISES MORE 895 00:38:12,189 --> 00:38:14,091 QUESTIONS AND DOES NEED TO BE 896 00:38:14,158 --> 00:38:17,061 EXPLAINED IF IT'S LEFT IN. 897 00:38:17,128 --> 00:38:19,130 BUT I DO THINK THERE'S SOMETHING 898 00:38:19,196 --> 00:38:21,666 LOST IF YOU WOULD TAKE OUT THAT 899 00:38:21,732 --> 00:38:24,135 WHOLE SECTION IN TERMS OF 900 00:38:24,201 --> 00:38:27,238 OBLIGATIONS WITH RESPECT TO THE 901 00:38:27,304 --> 00:38:28,973 RELATIONSHIP, WITH RESEARCHERS. 902 00:38:29,040 --> 00:38:29,273 >> YEAH. 903 00:38:29,340 --> 00:38:31,275 AS I SAID, IT'S BEEN A WHILE 904 00:38:31,342 --> 00:38:32,810 SINCE THE SUBCOMMITTEE I THINK 905 00:38:32,877 --> 00:38:37,381 TALKED ABOUT THIS PART OF THIS 906 00:38:37,448 --> 00:38:37,848 SECTION. 907 00:38:37,915 --> 00:38:39,917 I THINK THAT IF THE FIRST HALF 908 00:38:39,984 --> 00:38:46,290 OF THAT FIRST SENTENCE AT 107 IS 909 00:38:46,357 --> 00:38:47,391 WHAT IS CREATING CONFUSION MY 910 00:38:47,458 --> 00:38:49,126 BEST MEMORY OF WHAT THE 911 00:38:49,193 --> 00:38:51,028 SUBCOMMITTEE WAS COMING DOWN 912 00:38:51,095 --> 00:38:54,632 WITH THIS PART OF IT WAS, YOU 913 00:38:54,699 --> 00:38:57,835 KNOW, MAKING IT CLEAR THAT THERE 914 00:38:57,902 --> 00:39:01,105 IS SOME SORT OF EXPECTATION, 915 00:39:01,172 --> 00:39:04,208 OBLIGATION, AGAIN WHETHER IT'S 916 00:39:04,275 --> 00:39:05,342 PROFESSIONAL OR WHETHER IT'S 917 00:39:05,409 --> 00:39:10,181 ETHICAL OR HAS MULTIPLE FACETS 918 00:39:10,247 --> 00:39:13,250 WHERE THE RESEARCHERS OR 919 00:39:13,317 --> 00:39:15,553 INVESTIGATORS OWE IT TO THEIR 920 00:39:15,619 --> 00:39:17,555 SUBJECTS TO -- IF THE STUDY 921 00:39:17,621 --> 00:39:19,724 SENDING TO MAKE SURE THEY ARE 922 00:39:19,790 --> 00:39:21,025 APPROPRIATELY TRANSITIONED TO 923 00:39:21,092 --> 00:39:22,793 WHATEVER POST-RESEARCH CARE IS 924 00:39:22,860 --> 00:39:26,263 NECESSARY TO ENSURE THEIR 925 00:39:26,330 --> 00:39:26,931 WELL-BEING. 926 00:39:26,997 --> 00:39:27,498 >> UH-HUH. 927 00:39:27,565 --> 00:39:28,799 >> NOW, WHETHER THAT CREATES 928 00:39:28,866 --> 00:39:31,535 PROBLEMS LATER WHEN WE TALK 929 00:39:31,602 --> 00:39:32,870 ABOUT LIMITS, YOU KNOW, WELL WE 930 00:39:32,937 --> 00:39:34,071 CAN GET TO THAT LATER. 931 00:39:34,138 --> 00:39:36,474 TO ME THAT'S AT THE CORE OF 932 00:39:36,540 --> 00:39:39,443 THIS, WAS BASICALLY NOT SAYING, 933 00:39:39,510 --> 00:39:40,845 WELL, RESEARCH IS DONE, TO FIND 934 00:39:40,911 --> 00:39:45,883 YOUR WAY BACK TO THE HEALTH CARE 935 00:39:45,950 --> 00:39:46,684 SYSTEM. 936 00:39:46,751 --> 00:39:47,752 >> IF THAT'S THE CASE, IF THERE 937 00:39:47,818 --> 00:39:50,488 NEEDS TO BE A STATEMENT RATHER 938 00:39:50,554 --> 00:39:51,989 THAN THE WAY IN WHICH THIS IS 939 00:39:52,056 --> 00:39:53,891 SET UP NOW. 940 00:39:53,958 --> 00:39:57,061 IT'S ALMOST AS IF THERE'S A TEST 941 00:39:57,128 --> 00:39:59,363 THAT NEEDS TO BE MET BECAUSE IF 942 00:39:59,430 --> 00:40:02,099 IT IS DETERMINED THAT THERE'S A 943 00:40:02,166 --> 00:40:07,104 FIDUCIARY DUTY IT SEEMS LIKE 944 00:40:07,171 --> 00:40:07,838 WE'RE ADJUDICATING SOMETHING 945 00:40:07,905 --> 00:40:13,911 DIFFERENT THAT NEEDS TO BE 946 00:40:13,978 --> 00:40:15,312 EXPLAINED NOW. 947 00:40:15,379 --> 00:40:18,849 ANYWAY, THAT'S -- IF THAT'S THE 948 00:40:18,916 --> 00:40:21,252 THINKING FOR THIS SUBCOMMITTEE. 949 00:40:21,318 --> 00:40:22,787 I'M WORRIED ABOUT -- I GUESS I 950 00:40:22,853 --> 00:40:26,490 WOULD STRIKE THE FIDUCIARY DUTY 951 00:40:26,557 --> 00:40:28,225 HERE AND LEAVE IT MORE GENERAL 952 00:40:28,292 --> 00:40:29,527 THAN SPECIFIC BECAUSE I THINK 953 00:40:29,593 --> 00:40:33,264 THAT THAT ACTUALLY INTRODUCES A 954 00:40:33,330 --> 00:40:37,535 WHOLE HOST OF QUESTIONS. 955 00:40:37,601 --> 00:40:38,335 >> LOIS? 956 00:40:38,402 --> 00:40:41,238 >> YES, I AGREE WITH SANDRA 957 00:40:41,305 --> 00:40:41,672 THERE. 958 00:40:41,739 --> 00:40:44,108 THAT THERE'S SOMETHING IMPORTANT 959 00:40:44,175 --> 00:40:45,709 IN THIS PARAGRAPH THAT'S 960 00:40:45,776 --> 00:40:47,478 DIFFERENT FROM I THINK WHAT'S 961 00:40:47,545 --> 00:40:47,678 ABOVE. 962 00:40:47,745 --> 00:40:49,346 NOW, I HAVEN'T LOOKED AT THE 963 00:40:49,413 --> 00:40:50,548 WHOLE DOCUMENT AGAIN IN THE 964 00:40:50,614 --> 00:40:51,649 CONTEXT OF THIS CONVERSATION SO 965 00:40:51,715 --> 00:40:56,987 IT MIGHT BE COVERED ELSEWHERE. 966 00:40:57,054 --> 00:40:59,623 BUT IN 103 AND 104 IT'S TALKING 967 00:40:59,690 --> 00:41:00,624 ABOUT CONTINUATION MAY BE 968 00:41:00,691 --> 00:41:01,926 APPROPRIATE AND I THINK THERE'S 969 00:41:01,992 --> 00:41:05,663 A STATEMENT EARLY OTHER IN THE 970 00:41:05,729 --> 00:41:07,097 DOCUMENT ABOUT WHEN WE'RE SAYING 971 00:41:07,164 --> 00:41:09,633 IT MAY BE APPROPRIATE WE'RE NOT 972 00:41:09,700 --> 00:41:11,836 SAYING THAT IT'S REQUIRED. 973 00:41:11,902 --> 00:41:16,207 AND SO THAT WORD, APPROPRIATE, 974 00:41:16,273 --> 00:41:19,009 IN 104 IS DOING SOME WORK BUT 975 00:41:19,076 --> 00:41:21,846 NOT GOING TO COVER THE IDEA 976 00:41:21,912 --> 00:41:24,582 THERE MAY BE OBLIGATIONS TO 977 00:41:24,648 --> 00:41:26,884 TRANSITION, YOU KNOW, INTO 978 00:41:26,951 --> 00:41:29,420 MEDICAL CARE. 979 00:41:29,486 --> 00:41:31,255 SO ANYWAY, I THOUGHT YOUR 980 00:41:31,322 --> 00:41:35,559 SOLUTION WAS A GOOD ONE. 981 00:41:35,626 --> 00:41:35,826 >> OKAY. 982 00:41:35,893 --> 00:41:37,628 >> I COULD ALSO BE IN FAVOR OF 983 00:41:37,695 --> 00:41:41,131 KEEPING SOME WAY OF SAYING THIS. 984 00:41:41,198 --> 00:41:41,432 >> OKAY. 985 00:41:41,498 --> 00:41:42,333 >> THAT'S IN THAT PARAGRAPH. 986 00:41:42,399 --> 00:41:46,704 >> I THINK I CAN DO THAT. 987 00:41:46,770 --> 00:41:48,172 I'LL I WON'T TRY TO FIGURE THAT 988 00:41:48,239 --> 00:41:52,509 RIGHT NOW BUT I'VE GOT A NOTE TO 989 00:41:52,576 --> 00:41:55,145 MYSELF THIS MAY BE SOMETHING TO 990 00:41:55,212 --> 00:41:57,248 COME BACK TO AT THE BREAK AND 991 00:41:57,314 --> 00:41:59,116 PUT SOMETHING, LOOK LATER IN THE 992 00:41:59,183 --> 00:42:02,887 AGENDA. 993 00:42:04,755 --> 00:42:05,756 OKAY. 994 00:42:05,823 --> 00:42:16,200 I'LL GO TO ADDITIONAL 995 00:42:20,571 --> 00:42:22,506 CONSIDERATION SECTION. 996 00:42:22,573 --> 00:42:26,577 HERE SOME OF THIS, SOME OF THE 997 00:42:26,644 --> 00:42:27,778 PRACTICAL MEASURES IN THE FIRST 998 00:42:27,845 --> 00:42:29,647 PARAGRAPH TALKING ABOUT THE FACT 999 00:42:29,713 --> 00:42:32,149 THAT, YOU KNOW, ON ONE END YOU 1000 00:42:32,216 --> 00:42:35,953 CAN SAY BEST INTEREST BUT OTHER 1001 00:42:36,020 --> 00:42:39,790 THINGS MAY NEED TO BE MANAGED, 1002 00:42:39,857 --> 00:42:42,993 INTERVENTION TO RESUME, ACCESS 1003 00:42:43,060 --> 00:42:45,396 TO INTERVENTION TO RESUME. 1004 00:42:45,462 --> 00:42:48,432 FOR EXAMPLE LEGAL, CONTRACTUAL, 1005 00:42:48,499 --> 00:42:49,099 FINANCIAL BARRIERS. 1006 00:42:49,166 --> 00:42:51,502 AND IN A WAY DIFFERENT THAN WHAT 1007 00:42:51,568 --> 00:42:55,873 ALLISON WAS TALKING ABOUT, THE 1008 00:42:55,940 --> 00:42:58,242 END OF LINE 114 INTO 115 THIS 1009 00:42:58,309 --> 00:43:01,512 WOULD HAVE TO BE RESOURCED 1010 00:43:01,578 --> 00:43:06,450 OBVIOUSLY TO ALLOW IT TO GO 1011 00:43:06,517 --> 00:43:06,917 FORWARD. 1012 00:43:06,984 --> 00:43:13,157 116 IS INVESTIGATOR LEVEL 1013 00:43:13,223 --> 00:43:14,992 COMPLIANCE ISSUES, WHEN THOSE 1014 00:43:15,059 --> 00:43:17,428 THINGS HAPPEN THERE WILL BE A 1015 00:43:17,494 --> 00:43:21,031 DISCUSSION WHAT'S APPROPRIATE TO 1016 00:43:21,098 --> 00:43:21,598 RESUME. 1017 00:43:21,665 --> 00:43:22,933 AND THEN THIS GOES BACK A WHILE 1018 00:43:23,000 --> 00:43:25,102 SINCE THE FIRST TIME THAT YOU 1019 00:43:25,169 --> 00:43:27,738 ALL LOOKED AT THIS DOCUMENT, THE 1020 00:43:27,805 --> 00:43:28,706 OTHER REALITY IS MENTIONED AT 1021 00:43:28,772 --> 00:43:30,474 THE BEGINNING OF THE DOCUMENT, 1022 00:43:30,541 --> 00:43:33,310 THAT THERE'S ALSO SITUATIONS 1023 00:43:33,377 --> 00:43:34,945 WHERE RESEARCHERS SUSPENDED OR 1024 00:43:35,012 --> 00:43:36,146 TERMINATED AT INSTITUTIONAL 1025 00:43:36,213 --> 00:43:42,720 LEVEL SUCH AS SUSPENSION OF 1026 00:43:42,786 --> 00:43:44,154 FEDERAL-WIDE ASSURANCE THAT 1027 00:43:44,221 --> 00:43:46,523 AFFECTS ALL RESEARCH UNDER A 1028 00:43:46,590 --> 00:43:47,558 FEDERAL-WIDE ASSURANCE EVEN WHEN 1029 00:43:47,624 --> 00:43:49,526 THERE'S BEEN NO PARTICULAR 1030 00:43:49,593 --> 00:43:52,162 ISSUES OR PROBLEMS WITH 1031 00:43:52,229 --> 00:43:55,866 INDIVIDUAL STUDIES THAT ARE 1032 00:43:55,933 --> 00:43:59,169 UNDER THAT FWA, AND HERE IT 1033 00:43:59,236 --> 00:44:01,605 DOESN'T GIVE THE SILVER BULLET 1034 00:44:01,672 --> 00:44:05,876 SOLUTION BUT NOTES THIS IS A 1035 00:44:05,943 --> 00:44:09,279 CASE WHERE CONSIDERATION HAS TO 1036 00:44:09,346 --> 00:44:14,518 BE GIVEN TO RESUMPTION OF 1037 00:44:14,585 --> 00:44:15,819 RESEARCH AND BEST INTEREST CAN 1038 00:44:15,886 --> 00:44:22,226 BE PART OF THAT DISCUSSION. 1039 00:44:22,359 --> 00:44:23,460 127 PARAGRAPH IS DIFFERENT THAN 1040 00:44:23,527 --> 00:44:26,096 WHAT I'LL CALL A FOR-CAUSE 1041 00:44:26,163 --> 00:44:28,599 SUSPENSION BUT DOES HAPPEN WHERE 1042 00:44:28,665 --> 00:44:32,136 INVESTIGATORS OR RESEARCH TEAMS 1043 00:44:32,202 --> 00:44:33,103 OR RESEARCH THROUGH INSTITUTIONS 1044 00:44:33,170 --> 00:44:35,305 DECIDE THEY NO LONGER WANT TO BE 1045 00:44:35,372 --> 00:44:36,940 INVOLVED IN THE RESEARCH, AND 1046 00:44:37,007 --> 00:44:43,614 WHAT HAS HAPPENED IN THOSE 1047 00:44:43,680 --> 00:44:45,082 CASES, AND THEN 133 PARAGRAPH, 1048 00:44:45,149 --> 00:44:48,485 THIS HAS TO DO WITH A LACK OF 1049 00:44:48,552 --> 00:44:48,786 FUNDING. 1050 00:44:48,852 --> 00:44:52,089 IT CAN AND DOES HAPPEN THAT 1051 00:44:52,156 --> 00:44:53,057 SPONSORS PARTICULARLY, YOU KNOW, 1052 00:44:53,123 --> 00:44:55,559 SOMETIMES IN THE CASES OF SMALL 1053 00:44:55,626 --> 00:44:58,996 BIOTECH THEY RUN OUT OF MONEY. 1054 00:44:59,063 --> 00:45:01,298 AND THAT BECOMES A LITTLE 1055 00:45:01,365 --> 00:45:03,534 TRICKIER BECAUSE, YOU KNOW, IT 1056 00:45:03,600 --> 00:45:06,070 SAYS IRBs DON'T HAVE AUTHORITY 1057 00:45:06,136 --> 00:45:12,009 TO COMPEL A SPONSOR TO CONTINUE 1058 00:45:12,076 --> 00:45:14,311 A TRIAL, BEST INTERESTS, 1059 00:45:14,378 --> 00:45:18,482 PATIENTS' OR PARTICIPANTS AS 1060 00:45:18,549 --> 00:45:22,886 BEST INTEREST IN THE RESEARCH, 1061 00:45:22,953 --> 00:45:26,890 BUT THERE'S -- THAT CAN BE A 1062 00:45:26,957 --> 00:45:29,293 PROBLEMATIC SCENARIO. 1063 00:45:29,359 --> 00:45:33,163 AND THEN FINALLY THIS LAST 1064 00:45:33,230 --> 00:45:34,598 PARAGRAPH AT 142 TALKS ABOUT 1065 00:45:34,665 --> 00:45:35,499 EXPANDED ACCESS. 1066 00:45:35,566 --> 00:45:37,434 AGAIN THIS DOCUMENT ISN'T ABOUT 1067 00:45:37,501 --> 00:45:39,069 EXPANDED ACCESS. 1068 00:45:39,136 --> 00:45:41,905 WE ENDED UP ADDING A FOOTNOTE 1069 00:45:41,972 --> 00:45:44,741 HERE TO DESCRIBE THIS AS A 1070 00:45:44,808 --> 00:45:44,975 PATHWAY. 1071 00:45:45,042 --> 00:45:46,810 WE TRIED TO EMBED IT INTO THE 1072 00:45:46,877 --> 00:45:50,614 DOCUMENT BUT IT QUICKLY GOT OUT 1073 00:45:50,681 --> 00:45:51,315 OF HAND. 1074 00:45:51,381 --> 00:45:53,784 SO THAT BECAME A FOOTNOTE. 1075 00:45:53,851 --> 00:45:56,353 I SEE A HAND UP? 1076 00:45:56,420 --> 00:45:56,787 >> YEAH. 1077 00:45:56,854 --> 00:46:06,864 I WANTED TO GO TO YOUR LINE 138. 1078 00:46:06,930 --> 00:46:07,131 >> OKAY. 1079 00:46:07,197 --> 00:46:09,166 >> AND I WOULD SAY WE NEED TO 1080 00:46:09,233 --> 00:46:10,167 REWORD THAT SENTENCE. 1081 00:46:10,234 --> 00:46:14,671 IT STARTS AT THE SAME TIME MAY 1082 00:46:14,738 --> 00:46:16,540 BE IN PARTICIPANTS' BEST 1083 00:46:16,607 --> 00:46:18,442 INTERESTS FOR INSOLVENT SPONSOR. 1084 00:46:18,509 --> 00:46:19,276 TWO THINGS. 1085 00:46:19,343 --> 00:46:25,849 WE USE A WORD THAT I'M NOT SURE 1086 00:46:25,916 --> 00:46:30,220 MANY PEOPLE WILL KNOW, AFTER 1087 00:46:30,287 --> 00:46:33,724 COPIES, 139, I WOULD SUGGEST 1088 00:46:33,790 --> 00:46:35,058 USING A DIFFERENT WORD. 1089 00:46:35,125 --> 00:46:36,560 ALSO WE START OFF TALKING ABOUT 1090 00:46:36,627 --> 00:46:38,996 IT MAY BE IN THE PARTICIPANTS' 1091 00:46:39,062 --> 00:46:42,299 BEST INTEREST, AND THEN WIND UP 1092 00:46:42,366 --> 00:46:44,134 TALKING ABOUT THAT THE MATERIALS 1093 00:46:44,201 --> 00:46:47,971 WILL BE PROVIDED TO THE 1094 00:46:48,038 --> 00:46:48,505 RESEARCHERS. 1095 00:46:48,572 --> 00:46:50,607 AND SO I WANT TO ADD SOME 1096 00:46:50,674 --> 00:46:52,576 LANGUAGE ABOUT WHY WOULD IT BE 1097 00:46:52,643 --> 00:46:55,746 IN THE BEST INTEREST OF THE 1098 00:46:55,812 --> 00:46:58,148 PATIENT, EITHER IN THAT SENTENCE 1099 00:46:58,215 --> 00:46:59,349 OR A SEPARATE SENTENCE THAT 1100 00:46:59,416 --> 00:47:04,488 FOLLOWS RIGHT AFTER THAT. 1101 00:47:04,555 --> 00:47:04,922 >> OKAY. 1102 00:47:04,988 --> 00:47:06,990 >> LIKE IS THERE -- MAYBE IN THE 1103 00:47:07,057 --> 00:47:07,925 BEST INTEREST BECAUSE 1104 00:47:07,991 --> 00:47:11,028 RESEARCHERS WILL THEN TURN THAT 1105 00:47:11,094 --> 00:47:13,130 MATERIAL OVER TO THE PATIENT OR 1106 00:47:13,197 --> 00:47:15,632 TO THEIR PROVIDERS, JUST WANTED 1107 00:47:15,699 --> 00:47:16,967 A CLOSER NEXUS. 1108 00:47:17,034 --> 00:47:18,035 >> THAT'S FINE. 1109 00:47:18,101 --> 00:47:20,003 I DON'T THINK MARK BARNES IS ON 1110 00:47:20,070 --> 00:47:20,671 THE CALL. 1111 00:47:20,737 --> 00:47:22,873 HE CAME UP WITH THIS LANGUAGE TO 1112 00:47:22,940 --> 00:47:24,074 START WITH. 1113 00:47:24,141 --> 00:47:28,679 I'M TRYING TO REMEMBER HIS 1114 00:47:28,745 --> 00:47:30,314 RATIONALE FOR -- OR IF HE GAVE 1115 00:47:30,380 --> 00:47:34,551 EXAMPLE OF HOW HE THOUGHT THE 1116 00:47:34,618 --> 00:47:38,188 RETURN OF COPIES OR SAMPLES TO 1117 00:47:38,255 --> 00:47:42,960 THE RESEARCHERS BY THE SPONSORS 1118 00:47:43,026 --> 00:47:43,493 WOULD PRODUCE VALUE. 1119 00:47:43,560 --> 00:47:49,833 I DON'T THINK HE GAVE A SPECIFIC 1120 00:47:49,900 --> 00:47:51,802 EXAMPLE BUT I CAN CHANGE THE 1121 00:47:51,868 --> 00:47:53,470 WORD ALIQUOT TO SOMETHING MORE 1122 00:47:53,537 --> 00:47:55,305 GENERIC IS EASY ENOUGH. 1123 00:47:55,372 --> 00:48:02,412 I'LL SEE IF I CAN COME UP AN 1124 00:48:02,479 --> 00:48:02,713 EXAMPLE. 1125 00:48:02,779 --> 00:48:07,317 I'LL COME UP WITH AN EXAMPLE OF 1126 00:48:07,384 --> 00:48:10,621 WHAT MAY BE FOR THE RESEARCH 1127 00:48:10,687 --> 00:48:13,123 TEAM TO GET THOSE BACK FROM A 1128 00:48:13,190 --> 00:48:13,357 SPONSOR. 1129 00:48:13,423 --> 00:48:16,526 >> YEAH, THAT WOULD BE GREAT. 1130 00:48:16,593 --> 00:48:19,596 MAYBE EVEN SAYING INCLUDING 1131 00:48:19,663 --> 00:48:22,299 COPIES SAMPLES TO THE 1132 00:48:22,366 --> 00:48:26,470 RESEARCHERS AND AFTER THE 1133 00:48:26,536 --> 00:48:31,174 RESEARCHERS YOU JUST SAY WHO CAN 1134 00:48:31,241 --> 00:48:34,244 PROVIDE IT TO THE PARTICIPANTS 1135 00:48:34,311 --> 00:48:35,646 OR THEIR PROVIDERS. 1136 00:48:35,712 --> 00:48:43,553 SOMETHING TO THAT EXTENT. 1137 00:48:43,620 --> 00:48:43,820 >> OKAY. 1138 00:48:43,887 --> 00:48:45,389 I CAN WORK ON THAT. 1139 00:48:45,455 --> 00:48:49,693 I WON'T TRY TO WORDSMITH THAT 1140 00:48:49,760 --> 00:48:49,926 NOW. 1141 00:48:49,993 --> 00:48:53,530 I'LL PULL THAT TOGETHER AT 1142 00:48:53,597 --> 00:48:57,034 WHATEVER BREAK TIME IS. 1143 00:48:57,100 --> 00:48:59,536 OTHER QUESTIONS OR SUGGESTIONS 1144 00:48:59,603 --> 00:49:03,273 IN THIS SECTION? 1145 00:49:03,340 --> 00:49:06,209 THE NEXT SECTION FOCUSES ON 1146 00:49:06,276 --> 00:49:07,744 INFORMED CONSENT. 1147 00:49:07,811 --> 00:49:11,148 IT USED TO BE -- IT WASN'T 1148 00:49:11,214 --> 00:49:12,549 ALWAYS CALLED OUT. 1149 00:49:12,616 --> 00:49:13,650 LAST TIME YOU SAW IT I DON'T 1150 00:49:13,717 --> 00:49:15,519 BELIEVE IT WAS. 1151 00:49:15,585 --> 00:49:16,620 AS ISSUES RELATED TO CONSENT 1152 00:49:16,687 --> 00:49:20,123 POPPED UP IN A FEW SECTIONS, THE 1153 00:49:20,190 --> 00:49:23,193 SUBCOMMITTEE ULTIMATELY DECIDED 1154 00:49:23,260 --> 00:49:24,928 WE WOULD PULL IT INTO JUST A 1155 00:49:24,995 --> 00:49:26,363 SECTION OF THE DOCUMENT THAT 1156 00:49:26,430 --> 00:49:34,871 SORT OF FOCUSES ON INFORMED 1157 00:49:34,938 --> 00:49:35,105 CONSENT. 1158 00:49:35,172 --> 00:49:40,110 AND THE NEED TO HELP MANAGE 1159 00:49:40,177 --> 00:49:40,711 SUSPENSIONS AND TERMINATIONS, 1160 00:49:40,777 --> 00:49:43,080 ASPECTS THAT RELATED TO STOPPING 1161 00:49:43,146 --> 00:49:45,015 AND STARTING RESEARCH AND 1162 00:49:45,082 --> 00:49:45,916 APPROPRIATELY NOTIFYING MEMBERS 1163 00:49:45,982 --> 00:49:47,451 OF THE SUBJECT COMMUNITY ABOUT 1164 00:49:47,517 --> 00:49:52,222 WHAT'S GOING ON OR WHAT'S 1165 00:49:52,289 --> 00:49:53,690 CHANGING ARE CAPTURED IN HERE. 1166 00:49:53,757 --> 00:49:55,025 I DON'T KNOW IF FOLKS HAD A 1167 00:49:55,092 --> 00:50:01,598 CHANCE TO LOOK AT THIS IN 1168 00:50:01,665 --> 00:50:04,534 ADVANCE AND HAVE ANY QUESTIONS 1169 00:50:04,601 --> 00:50:07,571 OR CONCERNS OR CHANGES. 1170 00:50:44,775 --> 00:50:44,875 >> NEIL? 1171 00:50:44,941 --> 00:50:47,010 >> PEOPLE SHOULD LEARN ABOUT 1172 00:50:47,077 --> 00:50:49,613 WHAT THEY SHOULD TELL PEOPLE, 1173 00:50:49,679 --> 00:50:50,947 THIS COUNTER TO THAT 1174 00:50:51,014 --> 00:50:53,250 UNDERSTANDING, AND WHAT NOT, 1175 00:50:53,316 --> 00:50:54,985 IT'S DIFFICULT TO FOLLOW. 1176 00:50:55,051 --> 00:51:01,425 I THINK IT'S RESTATING THE 1177 00:51:01,491 --> 00:51:02,426 SENTENCE BEFORE. 1178 00:51:02,492 --> 00:51:06,129 I THOUGHT IT WAS CONFUSING AND 1179 00:51:06,196 --> 00:51:06,797 DIDN'T HELP. 1180 00:51:06,863 --> 00:51:09,099 >> ON MY SCREEN THE SENTENCE 1181 00:51:09,166 --> 00:51:14,438 THAT STARTS WITH THE WORDS IN 1182 00:51:14,504 --> 00:51:14,905 175. 1183 00:51:14,971 --> 00:51:15,772 >> SORRY FOR THE DOG. 1184 00:51:15,839 --> 00:51:17,541 >> IT'S ALL RIGHT. 1185 00:51:17,607 --> 00:51:21,044 I BANISHED MINE FROM MY OFFICE 1186 00:51:21,111 --> 00:51:22,145 FOR THIS MEETING. 1187 00:51:22,212 --> 00:51:23,447 THERE MAY BE REDUNDANCY THERE. 1188 00:51:23,513 --> 00:51:33,190 I THINK THE IDEA THAT WE'VE GOT 1189 00:51:33,256 --> 00:51:35,525 IN THOSE LINES PROBABLY IS 1190 00:51:35,592 --> 00:51:36,693 EXPRESSED THROUGHOUT THE 1191 00:51:36,760 --> 00:51:37,027 SESSION. 1192 00:51:37,093 --> 00:51:38,795 >> I THINK THE CONFUSING PART IS 1193 00:51:38,862 --> 00:51:39,863 THE NOTION OF NEW INFORMATION 1194 00:51:39,930 --> 00:51:41,731 THAT COMES TO LIGHT THAT IS 1195 00:51:41,798 --> 00:51:42,699 COUNTER TO THAT UNDERSTANDING, 1196 00:51:42,766 --> 00:51:47,737 IT'S NOT CLEAR WHAT THAT "THAT 1197 00:51:47,804 --> 00:51:49,172 UNDERSTANDING" IS, ESPECIALLY 1198 00:51:49,239 --> 00:51:52,209 SINCE THE ONE BEFORE SAYS YOU'RE 1199 00:51:52,275 --> 00:51:55,078 OBLIGATED TO TELL PEOPLE ABOUT 1200 00:51:55,145 --> 00:51:58,682 THE INTERRUPTION, THE REASON, 1201 00:51:58,748 --> 00:51:59,783 IT'S ALL THERE. 1202 00:51:59,850 --> 00:52:01,318 SO COUNTER TO THAT UNDERSTANDING 1203 00:52:01,384 --> 00:52:03,386 I ASSUME THAT MEANS COUNTER TO 1204 00:52:03,453 --> 00:52:05,255 THE INITIAL AGREEMENT, INITIAL 1205 00:52:05,322 --> 00:52:07,357 CONSENT, WHAT PEOPLE ARE -- IT'S 1206 00:52:07,424 --> 00:52:09,659 FINE IF YOU WANT TO -- JUST 1207 00:52:09,726 --> 00:52:14,498 SEEMS RESTATING THE FIRST FEW 1208 00:52:14,564 --> 00:52:15,031 SENTENCES, MIGHT BREED 1209 00:52:15,098 --> 00:52:15,532 CONFUSION. 1210 00:52:15,599 --> 00:52:16,566 >> I DON'T THINK YOU'RE WRONG. 1211 00:52:16,633 --> 00:52:20,737 I DON'T HAVE A PROBLEM WITH 1212 00:52:20,804 --> 00:52:22,339 LIMITING. 1213 00:52:22,405 --> 00:52:23,940 THE IDEA REALLY IS NOT JUST IN 1214 00:52:24,007 --> 00:52:26,009 THIS PARAGRAPH BUT I MEAN I 1215 00:52:26,076 --> 00:52:27,444 THINK IT'S IN DIFFERENT WAYS 1216 00:52:27,511 --> 00:52:29,513 STATED IN EARLIER PARTS OF THE 1217 00:52:29,579 --> 00:52:31,248 SECTION AS WELL. 1218 00:52:31,314 --> 00:52:32,349 SO UNLESS OTHERS DISAGREE OR 1219 00:52:32,415 --> 00:52:34,751 FEEL STRONGLY OR HAVE A 1220 00:52:34,818 --> 00:52:37,254 SUGGESTION FOR HOW TO CHANGE 1221 00:52:37,320 --> 00:52:38,889 THAT SENTENCE OR CHANGE EVEN THE 1222 00:52:38,955 --> 00:52:40,123 PHRASE THAT IS COUNTER TO THAT 1223 00:52:40,190 --> 00:52:41,958 UNDERSTANDING BECAUSE I THINK 1224 00:52:42,025 --> 00:52:43,393 YOU'RE RIGHT, NEIL, WHAT WAS 1225 00:52:43,460 --> 00:52:45,262 MEANT TO BE UNDERSTOOD HERE, NO 1226 00:52:45,328 --> 00:52:51,067 PUN INTENDED, IT'S COUNTER TO 1227 00:52:51,134 --> 00:52:52,269 WHAT WAS PREVIOUSLY -- WHAT 1228 00:52:52,335 --> 00:53:01,144 SUBJECTS WERE PREVIOUSLY TOLD. 1229 00:53:01,211 --> 00:53:03,880 I'M GOING TO LEAVE THAT STRUCK 1230 00:53:03,947 --> 00:53:06,750 UNLESS SOMEBODY WANTS TO DEFEND 1231 00:53:06,816 --> 00:53:13,056 IT OR HAS A SUGGESTION FOR 1232 00:53:13,123 --> 00:53:15,859 IMPROVEMENT. 1233 00:53:15,926 --> 00:53:18,128 ALL RIGHT. 1234 00:53:18,194 --> 00:53:19,863 OTHER QUESTIONS ABOUT -- OR 1235 00:53:19,930 --> 00:53:21,831 COMMENTS ON THE CONSENT SECTION 1236 00:53:21,898 --> 00:53:27,337 BUT WE MOVE ON TO THE QUESTIONS 1237 00:53:27,404 --> 00:53:27,871 FROM OHRP? 1238 00:53:27,938 --> 00:53:29,739 >> DAVE, I WANT TO SAY I THOUGHT 1239 00:53:29,806 --> 00:53:32,175 THE CONSENT SECTION WAS REALLY 1240 00:53:32,242 --> 00:53:32,375 GOOD. 1241 00:53:32,442 --> 00:53:34,110 >> WELL, THANKS, LOIS. 1242 00:53:34,177 --> 00:53:37,314 I APPRECIATE THE FEEDBACK. 1243 00:53:37,380 --> 00:53:39,382 I KNOW THE GROUP WILL AS WELL. 1244 00:53:39,449 --> 00:53:40,684 ALL RIGHT. 1245 00:53:40,750 --> 00:53:41,184 AND THEN -- 1246 00:53:41,251 --> 00:53:43,753 >> ONE SMALL THING. 1247 00:53:43,820 --> 00:53:48,792 THERE'S A PERIOD IN ONE OF THE 1248 00:53:48,858 --> 00:53:53,663 SENTENCES, ON YOUR LINE 169. 1249 00:53:53,730 --> 00:53:54,364 >> THANK YOU. 1250 00:53:54,431 --> 00:53:55,165 ALL RIGHT. 1251 00:53:55,231 --> 00:53:57,334 WE MOVE TO THE SECTION, THESE 1252 00:53:57,400 --> 00:54:02,138 ARE THE QUESTIONS FROM THE 1253 00:54:02,205 --> 00:54:07,077 ORIGINAL CHARGE FROM OHRP FOR 1254 00:54:07,143 --> 00:54:09,245 SACHRP TO CONSIDER. 1255 00:54:09,312 --> 00:54:11,781 AND WE CAN DISCUSS THEM ONE BY 1256 00:54:11,848 --> 00:54:12,048 ONE. 1257 00:54:12,115 --> 00:54:16,353 I KNOW THERE'S PROBABLY AT LEAST 1258 00:54:16,419 --> 00:54:19,556 ONE OR TWO THAT WILL -- WHERE 1259 00:54:19,623 --> 00:54:20,857 THEY HAVE BEEN DISCUSSED AT 1260 00:54:20,924 --> 00:54:25,462 SUBCOMMITTEE AND WE'LL PROBABLY 1261 00:54:25,528 --> 00:54:28,632 HAVE SOME DISCUSSION HERE. 1262 00:54:28,698 --> 00:54:30,934 I THINK THE RESPONSE IN THE 1263 00:54:31,001 --> 00:54:33,770 FIRST -- GO AHEAD, NEIL. 1264 00:54:33,837 --> 00:54:35,705 >> SUPER MINOR. 1265 00:54:35,772 --> 00:54:37,474 FRIENDLY AMENDMENT ON 185, 1266 00:54:37,540 --> 00:54:39,442 RELATED TO WHAT SOMEONE BROUGHT 1267 00:54:39,509 --> 00:54:39,876 UP EARLIER. 1268 00:54:39,943 --> 00:54:42,612 IT MAY OR MAY NOT BE AN 1269 00:54:42,679 --> 00:54:48,418 EXPERIMENTAL INTERVENTION. 1270 00:54:48,485 --> 00:54:49,185 IT'S JUST SOMETHING THAT'S 1271 00:54:49,252 --> 00:54:51,588 AVAILABLE. 1272 00:54:51,655 --> 00:54:54,557 I DON'T KNOW THE RIGHT WORD, 1273 00:54:54,624 --> 00:54:56,326 PROCEDURE, INTERVENTION, 1274 00:54:56,393 --> 00:54:57,293 WHATEVER LANGUAGE YOU MAY WANT 1275 00:54:57,360 --> 00:54:59,062 TO USE. 1276 00:54:59,129 --> 00:55:01,131 >> IS THAT BETTER? 1277 00:55:01,197 --> 00:55:03,533 >> SURE. 1278 00:55:03,600 --> 00:55:09,673 >> OKAY. 1279 00:55:09,739 --> 00:55:10,874 QUESTION 2 SUMMARIZES I THINK 1280 00:55:10,940 --> 00:55:12,308 THINGS THAT HAVE BEEN ALREADY 1281 00:55:12,375 --> 00:55:13,443 EXPRESSED IN THE DOCUMENT BUT 1282 00:55:13,510 --> 00:55:16,446 ARE HERE BECAUSE IT WAS THE -- 1283 00:55:16,513 --> 00:55:20,383 PART OF THE LIST OF QUESTIONS 1284 00:55:20,450 --> 00:55:21,017 FROM SACHRP. 1285 00:55:21,084 --> 00:55:27,023 THIS ONE I THINK IS PRETTY 1286 00:55:27,090 --> 00:55:29,359 STRAIGHTFORWARD. 1287 00:55:34,197 --> 00:55:35,665 >> I'M DISTINGUISHING MYSELF AS 1288 00:55:35,732 --> 00:55:37,534 A PAIN IN THE NECK. 1289 00:55:37,600 --> 00:55:39,602 I RAISED CONCERN ABOUT LINE 200. 1290 00:55:39,669 --> 00:55:43,306 I LOOKED AT THE MINUTES, SO I 1291 00:55:43,373 --> 00:55:43,640 KNOW THAT. 1292 00:55:43,707 --> 00:55:46,509 THERE WAS SOMETHING ABOUT -- I 1293 00:55:46,576 --> 00:55:47,610 DON'T UNDERSTAND. 1294 00:55:47,677 --> 00:55:48,678 CONSIDER THE WILLINGNESS OF 1295 00:55:48,745 --> 00:55:50,346 SUBJECTS TO GIVE THEIR CONSENT 1296 00:55:50,413 --> 00:55:51,848 TO ONGOING PARTICIPATION. 1297 00:55:51,915 --> 00:55:56,453 I DON'T KNOW, THAT SOUNDS LIKE 1298 00:55:56,519 --> 00:55:57,554 PROBABILISTIC ASSESSMENT OF 1299 00:55:57,620 --> 00:55:58,555 WHETHER PEOPLE ARE LIKELY TO SAY 1300 00:55:58,621 --> 00:55:58,955 YES. 1301 00:55:59,022 --> 00:56:04,994 I DON'T KNOW WHAT THAT MEANS. 1302 00:56:05,061 --> 00:56:07,497 WE'VE ALREADY SAID YOU NEED TO 1303 00:56:07,564 --> 00:56:10,567 GET CONSENT. 1304 00:56:10,633 --> 00:56:15,939 I'M NOT SURE WHAT THE 1305 00:56:16,005 --> 00:56:18,975 WILLINGNESS -- IT SEEMS LIKE A 1306 00:56:19,042 --> 00:56:20,310 PREDICTIVE ASSESSMENT THAT I 1307 00:56:20,376 --> 00:56:26,349 DON'T UNDERSTAND THE PURPOSE OF. 1308 00:56:26,416 --> 00:56:28,184 IF YOU THINK IT'S IMPORTANT, YOU 1309 00:56:28,251 --> 00:56:28,451 ASK THEM. 1310 00:56:28,518 --> 00:56:30,386 I DON'T KNOW WHY WE WOULD MAKE 1311 00:56:30,453 --> 00:56:31,721 AN ASSESSMENT WHETHER WE THINK 1312 00:56:31,788 --> 00:56:34,858 THEY WOULD BE LIKELY TO DO IT. 1313 00:56:34,924 --> 00:56:36,760 >> YEAH, I MEAN I DON'T KNOW IF 1314 00:56:36,826 --> 00:56:38,328 THIS HELPS. 1315 00:56:38,394 --> 00:56:47,504 ONE OPTION WOULD BE IF IT SAID 1316 00:56:47,570 --> 00:56:49,706 THE ABILITY TO OBTAIN CONSENT. 1317 00:56:49,773 --> 00:56:51,641 >> IS IT ABOUT FEASIBILITY? 1318 00:56:51,708 --> 00:56:54,077 LIKE WE COULD GET CONSENT FOR 1319 00:56:54,144 --> 00:56:54,711 ONGOING PARTICIPATION? 1320 00:56:54,778 --> 00:56:56,913 OR IS IT ABOUT THE NOTION OF IT 1321 00:56:56,980 --> 00:56:58,882 WOULD BE LIKELY PEOPLE WOULD SAY 1322 00:56:58,948 --> 00:56:59,649 YES? 1323 00:56:59,716 --> 00:57:05,455 >> I THINK IT'S THE LATTER. 1324 00:57:05,522 --> 00:57:07,290 AND MY MEMORY IS IT'S THE 1325 00:57:07,357 --> 00:57:08,324 LATTER. 1326 00:57:08,391 --> 00:57:10,360 IF IT'S THE LATTER THEN YOUR 1327 00:57:10,426 --> 00:57:12,996 ARGUMENT FOR WHY IT SORT OF IS A 1328 00:57:13,062 --> 00:57:23,606 STRANGE FIT HERE MAY BE VALID. 1329 00:57:26,242 --> 00:57:27,777 BUT I'M STRUGGLING WITH HOW TO 1330 00:57:27,844 --> 00:57:29,746 -- IF MY MEMORY IS CORRECT THAT 1331 00:57:29,813 --> 00:57:32,182 IT'S ABOUT THE LATTER CONCERN. 1332 00:57:32,248 --> 00:57:33,917 I'M NOT -- I'M STRUGGLING WITH 1333 00:57:33,983 --> 00:57:35,552 HOW TO MODIFY IN A WAY THAT 1334 00:57:35,618 --> 00:57:38,388 MAKES IT SEEM LIKE A REASONABLE 1335 00:57:38,454 --> 00:57:41,891 -- HOW TO TURN IT INTO A 1336 00:57:41,958 --> 00:57:45,395 CONSIDERATION VERSUS JUST A 1337 00:57:45,461 --> 00:57:45,662 STATEMENT. 1338 00:57:45,728 --> 00:57:47,730 MAYBE IT SHOULDN'T BE HERE AND 1339 00:57:47,797 --> 00:57:49,332 IT'S PRESUMED OBVIOUSLY YOU'LL 1340 00:57:49,399 --> 00:57:53,403 HAVE TO OBTAIN CONSENT TO DO 1341 00:57:53,469 --> 00:57:56,673 THIS AND IF PEOPLE WANT TO GIVE 1342 00:57:56,739 --> 00:57:57,874 CONSENT THEY CONTINUE ON, IF NOT 1343 00:57:57,941 --> 00:58:00,210 THEY SAY I'M OUT. 1344 00:58:00,276 --> 00:58:01,477 THERE'S NOT AN ASSESSMENT, IT'S 1345 00:58:01,544 --> 00:58:04,314 JUST THE REALITY OF IT. 1346 00:58:04,380 --> 00:58:06,850 >> I'M NOT GOING TO -- THIS IS 1347 00:58:06,916 --> 00:58:08,718 NOT ONE I FEEL SUPER STRONGLY B 1348 00:58:08,785 --> 00:58:12,956 I -- ABOUT. 1349 00:58:13,022 --> 00:58:14,490 IT'S HELPFUL TO UNDERSTAND WHY 1350 00:58:14,557 --> 00:58:16,192 SOMETHING'S THERE. 1351 00:58:16,259 --> 00:58:18,361 ESPECIALLY IF IT'S ONE THAT 1352 00:58:18,428 --> 00:58:19,863 COULD BE INTERPRETED MULTIPLE 1353 00:58:19,929 --> 00:58:20,630 DIRECTIONS. 1354 00:58:20,697 --> 00:58:22,065 IF OTHERS DON'T HAVE CONCERNS I 1355 00:58:22,131 --> 00:58:23,466 DON'T THINK IT CAUSES PROBLEMS, 1356 00:58:23,533 --> 00:58:25,435 I JUST DON'T REALLY KNOW WHAT IT 1357 00:58:25,501 --> 00:58:25,802 DOES. 1358 00:58:25,869 --> 00:58:27,637 >> NEIL, I'M IN AGREEMENT. 1359 00:58:27,704 --> 00:58:31,140 I DO THINK IT'S AWKWARD. 1360 00:58:31,207 --> 00:58:32,775 DAVE, WHAT YOU'RE GETTING AT, OR 1361 00:58:32,842 --> 00:58:38,448 BOTH GETTING AT, PRACTICALITY IS 1362 00:58:38,514 --> 00:58:41,117 MAYBE WHAT WE WERE GOING AT, OF 1363 00:58:41,184 --> 00:58:42,752 OBTAINING CONSENT BUT IT DOESN'T 1364 00:58:42,819 --> 00:58:44,053 ADD ANYTHING NECESSARILY. 1365 00:58:44,120 --> 00:58:49,626 I THINK WE PROBABLY COULD TAKE 1366 00:58:49,692 --> 00:58:50,627 IT OUT. 1367 00:58:50,693 --> 00:58:52,595 >> THIS TALKS ABOUT THE NEED TO 1368 00:58:52,662 --> 00:58:54,464 KEEP INDIVIDUALS INFORMED ABOUT 1369 00:58:54,530 --> 00:58:55,231 THE STATUS OF PARTICIPATION, IF 1370 00:58:55,298 --> 00:58:58,935 YOU GET RID OF THAT IT DOESN'T 1371 00:58:59,002 --> 00:59:02,338 DEGRADE THE DOCUMENT IN ANY WAY. 1372 00:59:02,405 --> 00:59:02,906 >> I AGREE. 1373 00:59:02,972 --> 00:59:03,673 >> PEOPLE FEEL LIKE THERE'S 1374 00:59:03,740 --> 00:59:05,375 SOMETHING THAT NEEDS TO BE 1375 00:59:05,441 --> 00:59:06,876 THERE, YOU COULD SAY SOMETHING 1376 00:59:06,943 --> 00:59:08,378 LIKE DO SUBJECTS WANT TO 1377 00:59:08,444 --> 00:59:14,384 CONTINUE TO HAVE ACCESS, RIGHT? 1378 00:59:14,450 --> 00:59:15,718 THAT'S SORT -- IF IT'S LIKELY 1379 00:59:15,785 --> 00:59:16,719 PEOPLE MIGHT WANT WHAT'S 1380 00:59:16,786 --> 00:59:17,887 PROVIDED THAT'S DIFFERENT FROM 1381 00:59:17,954 --> 00:59:19,756 SOMETHING ABOUT WILLINGNESS TO 1382 00:59:19,822 --> 00:59:22,592 GIVE CONSENT, YOU KNOW WHAT I 1383 00:59:22,659 --> 00:59:23,459 MEAN? 1384 00:59:23,526 --> 00:59:23,927 >> UH-HUH. 1385 00:59:23,993 --> 00:59:24,894 >> THAT'S THE CRITERION IF IT'S 1386 00:59:24,961 --> 00:59:26,529 SOMETHING SEEN AS VALUABLE TO 1387 00:59:26,596 --> 00:59:28,298 THE SUBJECTS, I WOULDN'T HAVE A 1388 00:59:28,364 --> 00:59:29,933 PROBLEM WITH A STATEMENT LIKE 1389 00:59:29,999 --> 00:59:30,233 THAT. 1390 00:59:30,300 --> 00:59:31,868 THAT'S NOT ABOUT THEIR 1391 00:59:31,935 --> 00:59:33,736 WILLINGNESS TO GIVE CONSENT, 1392 00:59:33,803 --> 00:59:39,342 JUST DO THEY WANT WHATEVER WOULD 1393 00:59:39,409 --> 00:59:40,310 BE OFFERED. 1394 00:59:40,376 --> 00:59:40,743 >> YEAH. 1395 00:59:40,810 --> 00:59:43,613 I THINK I'LL GO WITH STRIKE. 1396 00:59:43,680 --> 00:59:43,880 LOIS? 1397 00:59:43,947 --> 00:59:45,348 >> LOOKS AS IF YOU WERE GOING TO 1398 00:59:45,415 --> 00:59:46,549 STRIKE IT. 1399 00:59:46,616 --> 00:59:48,351 THAT ACTUALLY I THOUGHT WAS AN 1400 00:59:48,418 --> 00:59:49,085 IMPORTANT POINT. 1401 00:59:49,152 --> 00:59:50,820 WE'RE WE'RE GIVING LIKE WHAT ARE 1402 00:59:50,887 --> 00:59:52,488 THE ISSUES AN IRB SHOULD 1403 00:59:52,555 --> 00:59:54,557 CONSIDER, SEEMS LIKE ONE OF THEM 1404 00:59:54,624 --> 00:59:57,093 THAT THEY SHOULD CONSIDER IS, 1405 00:59:57,160 --> 01:00:00,463 YOU KNOW, WHAT ARE 1406 01:00:00,530 --> 01:00:02,231 INVESTIGATORS, YOU KNOW, HEARING 1407 01:00:02,298 --> 01:00:03,967 FROM SUBJECTS WITH RESPECT TO 1408 01:00:04,033 --> 01:00:06,169 THEIR DESIRE TO CONTINUE 1409 01:00:06,235 --> 01:00:09,672 PARTICIPATING BECAUSE THEY 1410 01:00:09,739 --> 01:00:13,810 PERCEIVE A BENEFIT OR MAYBE EVEN 1411 01:00:13,876 --> 01:00:14,811 THEIR PROVIDER HAS TOLD THEM 1412 01:00:14,877 --> 01:00:18,748 THEY HAVE A BENEFIT. 1413 01:00:18,815 --> 01:00:21,684 SO IT SEEMS IF THIS IS A LIST OF 1414 01:00:21,751 --> 01:00:24,754 THE THINGS AT A MINIMUM 1415 01:00:24,821 --> 01:00:27,590 STAKEHOLDERS SHOULD CONSIDER IT 1416 01:00:27,657 --> 01:00:30,226 SEEMS, YOU KNOW, INDICATIONS OF 1417 01:00:30,293 --> 01:00:32,395 THE, YOU KNOW, SUBJECT'S DESIRES 1418 01:00:32,462 --> 01:00:33,629 TO CONSIDER PARTICIPATING FOR 1419 01:00:33,696 --> 01:00:36,399 THEIR OWN BENEFIT OR SOMETHING 1420 01:00:36,466 --> 01:00:37,433 LIKE THAT. 1421 01:00:37,500 --> 01:00:41,170 I THINK THERE MIGHT BE SOMETHING 1422 01:00:41,237 --> 01:00:42,705 VALUABLE ABOUT KEEPING IT BUT 1423 01:00:42,772 --> 01:00:44,240 NOT IN THE WAY IT IS. 1424 01:00:44,307 --> 01:00:48,711 BUT MORE LIKE WHAT YOU WERE JUST 1425 01:00:48,778 --> 01:00:49,178 SAYING. 1426 01:00:49,245 --> 01:00:49,512 >> MINDY? 1427 01:00:49,579 --> 01:00:51,781 >> YEAH, SOMETHING MAYBE ABOUT 1428 01:00:51,848 --> 01:00:52,648 THE PERCEIVED VALUE. 1429 01:00:52,715 --> 01:00:56,719 I THINK SOMEBODY JUST SAID 1430 01:00:56,786 --> 01:00:58,654 SOMETHING, MIGHT HAVE BEEN LOIS, 1431 01:00:58,721 --> 01:01:00,990 THE VALUE OF WHAT PEOPLE WOULD 1432 01:01:01,057 --> 01:01:03,159 GET FROM ONGOING PARTICIPATION 1433 01:01:03,226 --> 01:01:04,660 WHICH GOES TO ERIC'S COMMENT IN 1434 01:01:04,727 --> 01:01:06,596 A SUBCOMMITTEE ABOUT, YOU KNOW, 1435 01:01:06,662 --> 01:01:08,731 THE VALUE OF WHAT SOME PEOPLE 1436 01:01:08,798 --> 01:01:10,400 ARE RECEIVING BECAUSE THEY WERE 1437 01:01:10,466 --> 01:01:13,903 IN THE RESEARCH, BE IT NEIL, ALL 1438 01:01:13,970 --> 01:01:17,306 THAT KIND OF THING, KIND OF A 1439 01:01:17,373 --> 01:01:18,741 SLIPPERY SLOPE BUT JUST 1440 01:01:18,808 --> 01:01:23,746 PERCEPTION OF VALUE TO ONGOING 1441 01:01:23,813 --> 01:01:24,080 PARTICIPATION. 1442 01:01:24,147 --> 01:01:27,917 I DON'T KNOW IF THAT HELPS OR IS 1443 01:01:27,984 --> 01:01:28,584 WORSE. 1444 01:01:28,651 --> 01:01:31,521 >> IT WOULD BE LIKE I DON'T KNOW 1445 01:01:31,587 --> 01:01:31,854 -- 1446 01:01:31,921 --> 01:01:35,591 >> IF YOU JUST SAID SUBJECT'S 1447 01:01:35,658 --> 01:01:38,761 INTEREST OR DESIRE FOR ONGOING 1448 01:01:38,828 --> 01:01:39,829 PARTICIPATION MAY BE SUFFICIENT. 1449 01:01:39,896 --> 01:01:41,564 IF THE POINT IS TO GET THE 1450 01:01:41,631 --> 01:01:43,232 SUBJECT'S INTEREST ON THE TABLE, 1451 01:01:43,299 --> 01:01:44,434 WHAT THEY CARE ABOUT, I THINK 1452 01:01:44,500 --> 01:01:46,969 SOMETHING REALLY SIMPLE WOULD BE 1453 01:01:47,036 --> 01:01:47,703 GOOD. 1454 01:01:47,770 --> 01:01:48,805 IT JUST GETS CONVOLUTED WHEN YOU 1455 01:01:48,871 --> 01:01:50,640 TALK ABOUT WILLINGNESS TO GIVE 1456 01:01:50,706 --> 01:01:53,076 CONSENT IN TERMS THAT ARE 1457 01:01:53,142 --> 01:01:56,045 DIFFERENT FROM INITIAL -- YOU 1458 01:01:56,112 --> 01:01:57,680 KNOW, MAYBE SUBJECT'S DESIRE FOR 1459 01:01:57,747 --> 01:01:59,549 ONGOING PARTICIPATION. 1460 01:01:59,615 --> 01:02:01,517 >> SO I'M WONDERING IF THIS IS 1461 01:02:01,584 --> 01:02:03,286 IN ADDITION TO UNDERSTANDING THE 1462 01:02:03,352 --> 01:02:05,354 WILLINGNESS OF SUBJECTS TO GIVE 1463 01:02:05,421 --> 01:02:09,525 CONSENT, IS THIS ALSO TRYING TO 1464 01:02:09,592 --> 01:02:12,862 GET AT THE ABILITY TO ACTUALLY 1465 01:02:12,929 --> 01:02:20,403 ADMINISTER CONSENT ON THIS 1466 01:02:20,470 --> 01:02:21,571 CONTINUING EFFORT? 1467 01:02:21,637 --> 01:02:23,873 >> MY MEMORY IS, NO, IT'S NOT 1468 01:02:23,940 --> 01:02:24,674 THAT BECAUSE THERE WAS 1469 01:02:24,740 --> 01:02:27,276 ASSUMPTION THAT IF INDIVIDUALS 1470 01:02:27,343 --> 01:02:30,546 WANTED ACCESS TO INTERVENTION 1471 01:02:30,613 --> 01:02:31,781 MUST BE ACCESSIBLE TO THE 1472 01:02:31,848 --> 01:02:34,617 INVESTIGATORS TO BE ABLE TO 1473 01:02:34,684 --> 01:02:35,585 CONTINUE ADMINISTRATION OR 1474 01:02:35,651 --> 01:02:36,586 PROVIDING THE INTERVENTION, 1475 01:02:36,652 --> 01:02:37,787 WHATEVER IT MIGHT BE. 1476 01:02:37,854 --> 01:02:39,856 AND SO THAT IF THEY WERE ABLE TO 1477 01:02:39,922 --> 01:02:42,725 HAVE CONTACT IN ORDER TO 1478 01:02:42,792 --> 01:02:44,127 IMPLEMENT STUDY PROCEDURES THEN 1479 01:02:44,193 --> 01:02:46,863 THAT'S SUFFICIENT CONTACT TO BE 1480 01:02:46,929 --> 01:02:53,002 ABLE TO OBTAIN REVISED CONSENT 1481 01:02:53,069 --> 01:02:54,537 TO THOSE MODIFIED PROCEDURES, TO 1482 01:02:54,604 --> 01:02:56,873 THE MODIFIED -- TO THE STUDY AS 1483 01:02:56,939 --> 01:03:02,411 MODIFIED AS A RESULT OF 1484 01:03:02,478 --> 01:03:03,179 SUSPENSION OR TERMINATION. 1485 01:03:03,246 --> 01:03:06,349 I 1486 01:03:06,415 --> 01:03:07,316 >> I SEE. 1487 01:03:07,383 --> 01:03:07,550 THANKS. 1488 01:03:07,617 --> 01:03:08,518 >> I LIKE NEIL'S INTEREST. 1489 01:03:08,584 --> 01:03:11,053 AND I THINK THAT'S GREAT. 1490 01:03:11,120 --> 01:03:20,997 I THINK THAT CAPTURES A LOT. 1491 01:03:21,063 --> 01:03:26,702 >> LOIS, TO YOUR POINT, I MEAN, 1492 01:03:26,769 --> 01:03:29,739 SO I'M FINE WITH THIS BULLET THE 1493 01:03:29,805 --> 01:03:30,740 WAY IT'S CHANGED. 1494 01:03:30,806 --> 01:03:32,708 IF YOU STILL THINK THERE SHOULD 1495 01:03:32,775 --> 01:03:34,210 BE ONE ABOUT CONSENT -- 1496 01:03:34,277 --> 01:03:36,412 >> NO, I DON'T THINK I WAS 1497 01:03:36,479 --> 01:03:37,180 MAKING THAT. 1498 01:03:37,246 --> 01:03:37,613 >> OH, OKAY. 1499 01:03:37,680 --> 01:03:47,590 >> I THINK THIS IS A GOOD FIX. 1500 01:03:47,657 --> 01:03:49,125 >> OKAY. 1501 01:03:49,192 --> 01:03:50,760 NUMBER 3 IS ABOUT, YOU KNOW, 1502 01:03:50,826 --> 01:03:54,564 BALANCING THIS IDEA OF BEST 1503 01:03:54,630 --> 01:03:58,734 INTEREST OR JUSTIFYING BEST 1504 01:03:58,801 --> 01:04:01,037 INTEREST WHEN THE SAME CARE OR 1505 01:04:01,103 --> 01:04:03,806 TREATMENT IS AVAILABLE OUTSIDE 1506 01:04:03,873 --> 01:04:06,209 THE RESEARCH AND WHAT ABOUT 1507 01:04:06,275 --> 01:04:10,680 ACCESS TO CARE OR BARRIERS TO 1508 01:04:10,746 --> 01:04:14,784 ACCESS, WHERE DOES THAT FIT INTO 1509 01:04:14,850 --> 01:04:21,190 THE DISCUSSION. 1510 01:04:21,257 --> 01:04:23,492 AND SO THIS ONE HAS HAD QUITE A 1511 01:04:23,559 --> 01:04:24,560 BIT OF DISCUSSION, SO WHAT'S 1512 01:04:24,627 --> 01:04:32,034 HERE IS SORT OF THE CONSENSUS 1513 01:04:32,101 --> 01:04:32,301 STATEMENT. 1514 01:04:32,368 --> 01:04:34,103 SO I'M CURIOUS TO GET FEEDBACK. 1515 01:04:34,170 --> 01:04:36,172 THERE WERE A VARIETY OF OPINIONS 1516 01:04:36,239 --> 01:04:39,575 ON IT. 1517 01:04:39,642 --> 01:04:41,344 >> SO, DAVE, I DO HAVE A 1518 01:04:41,410 --> 01:04:44,280 QUESTION, JUST IN TERMS OF WHAT 1519 01:04:44,347 --> 01:04:46,782 THE COMMITTEE HAD DISCUSSED. 1520 01:04:46,849 --> 01:04:48,684 THE LANGUAGE AROUND IF SUBJECTS 1521 01:04:48,751 --> 01:04:50,486 CAN OBTAIN THE SAME CARE OR 1522 01:04:50,553 --> 01:04:53,356 TREATMENT OUTSIDE OF THE 1523 01:04:53,422 --> 01:04:55,224 RESEARCH, THAT'S INCLUSIVE OF 1524 01:04:55,291 --> 01:04:56,359 THEIR FINANCIAL ABILITY TO 1525 01:04:56,425 --> 01:04:56,926 OBTAIN THE CARE? 1526 01:04:56,993 --> 01:05:00,196 >> THAT WAS ONE OF THE POINTS OF 1527 01:05:00,263 --> 01:05:00,429 DEBATE. 1528 01:05:00,496 --> 01:05:05,268 HOW FAR DOES OBLIGATIONS OF THE 1529 01:05:05,334 --> 01:05:07,570 RESEARCH TEAM EXTEND TO USING 1530 01:05:07,637 --> 01:05:11,941 THE RESEARCH AS A VESSEL OR 1531 01:05:12,008 --> 01:05:13,609 MECHANISM TO CONTINUE TO PROVIDE 1532 01:05:13,676 --> 01:05:14,343 CARE THAT'S ALSO AVAILABLE 1533 01:05:14,410 --> 01:05:17,847 OUTSIDE THE RESEARCH BUT IS 1534 01:05:17,913 --> 01:05:21,684 MAYBE BEYOND THE FINANCIAL MEANS 1535 01:05:21,751 --> 01:05:23,085 OR THE POPULATION, WHATEVER THE 1536 01:05:23,152 --> 01:05:25,521 CASE MAY BE, BUT THEY HAVE 1537 01:05:25,588 --> 01:05:27,590 ACCESS, IT'S THERE, BUT NOT 1538 01:05:27,657 --> 01:05:31,294 EVERYBODY HAS OPEN ACCESS TO IT. 1539 01:05:31,360 --> 01:05:33,396 HOW DO YOU BEST -- THIS IS WHERE 1540 01:05:33,462 --> 01:05:37,633 THE COMMITTEE I THINK DEBATED A 1541 01:05:37,700 --> 01:05:38,968 BIT. 1542 01:05:39,035 --> 01:05:39,168 ERIC? 1543 01:05:39,235 --> 01:05:40,569 >> SORRY, SANDRA, WERE YOU GOOD? 1544 01:05:40,636 --> 01:05:43,339 >> I JUST WANTED TO MAKE THE 1545 01:05:43,406 --> 01:05:46,942 POINT THAT, YOU KNOW, THIS 1546 01:05:47,009 --> 01:05:48,377 DOESN'T ADDRESS UNEVEN ACCESS 1547 01:05:48,444 --> 01:05:49,578 WITHIN A STUDY POPULATION SO I'M 1548 01:05:49,645 --> 01:05:54,183 WORRIED ABOUT ISSUES WITH 1549 01:05:54,250 --> 01:05:55,184 RESPECT TO EQUITY. 1550 01:05:55,251 --> 01:05:56,919 >> SO I'M GENERALLY IN FAVOR, 1551 01:05:56,986 --> 01:05:59,555 WONDERING IF NUMBER 3 IS ONE 1552 01:05:59,622 --> 01:06:03,926 THAT DESERVES A QUALIFIER LIKE 1553 01:06:03,993 --> 01:06:06,762 USUALLY NO INSTEAD OF SAYING NO 1554 01:06:06,829 --> 01:06:09,365 TO GIVE SOME WIGGLE ROOM. 1555 01:06:09,432 --> 01:06:11,534 I THINKS THE TENSION IF I 1556 01:06:11,600 --> 01:06:13,002 REMEMBER THE LAST MEETING 1557 01:06:13,069 --> 01:06:14,737 CORRECTLY, I WASN'T ADVOCATING 1558 01:06:14,804 --> 01:06:17,039 FOR THIS NECESSARILY BUT 1559 01:06:17,106 --> 01:06:19,108 UNDERSTANDING I THINK WAS THAT 1560 01:06:19,175 --> 01:06:22,178 LET'S SAY RESEARCHER WAS WORKING 1561 01:06:22,244 --> 01:06:24,046 WITH UNHOUSED POPULATION, AND TO 1562 01:06:24,113 --> 01:06:26,582 SUDDENLY CUT OFF THE RESEARCH 1563 01:06:26,649 --> 01:06:28,317 WHEN THE RESEARCH MIGHT THEN 1564 01:06:28,384 --> 01:06:30,519 RESTART TWO MONTHS LATER WOULD 1565 01:06:30,586 --> 01:06:33,122 BE DAMAGING TO THE RESEARCH 1566 01:06:33,189 --> 01:06:33,322 STUDY. 1567 01:06:33,389 --> 01:06:35,624 SO CAN YOU CONTINUE CERTAIN 1568 01:06:35,691 --> 01:06:38,828 ASPECTS OF THE STUDY TO MAINTAIN 1569 01:06:38,894 --> 01:06:41,764 THAT RELATIONSHIP AT THE 1570 01:06:41,831 --> 01:06:43,632 DETRIMENT OF, YOU KNOW, OH, 1571 01:06:43,699 --> 01:06:45,301 WE'RE FOLLOWING THE RULES, CAN 1572 01:06:45,368 --> 01:06:47,136 WE CONTINUE THAT VISIT BUT MAYBE 1573 01:06:47,203 --> 01:06:49,872 NOT THROUGH DO THE INTERVENTION, 1574 01:06:49,939 --> 01:06:53,476 I THOUGHT SOME MEMBERS OF THE 1575 01:06:53,542 --> 01:06:55,010 COMMITTEE WANTED SOME 1576 01:06:55,077 --> 01:06:57,213 FLEXIBILITY HERE, AND IN CERTAIN 1577 01:06:57,279 --> 01:06:57,513 CASES. 1578 01:06:57,580 --> 01:07:01,150 AND SO IF THERE'S ONE OF THESE 1579 01:07:01,217 --> 01:07:03,919 THAT I THINK A USUALLY QUALIFIER 1580 01:07:03,986 --> 01:07:04,854 COULD BE APPROPRIATE THIS MIGHT 1581 01:07:04,920 --> 01:07:06,055 BE ONE. 1582 01:07:06,122 --> 01:07:07,590 THAT'S THE ONLY SUGGESTION I 1583 01:07:07,656 --> 01:07:11,727 HAVE BUT OPEN TO OTHERS. 1584 01:07:11,794 --> 01:07:13,929 >> YEAH, THIS WAS A CHALLENGING 1585 01:07:13,996 --> 01:07:15,131 ONE FOR THE GROUP. 1586 01:07:15,197 --> 01:07:16,832 USUALLY IT'S AN EASY FIX FOR ME 1587 01:07:16,899 --> 01:07:19,835 BUT WE HAD A LOT OF DEBATE. 1588 01:07:19,902 --> 01:07:23,773 IT WAS HARD TO PICK THE -- WE 1589 01:07:23,839 --> 01:07:25,408 DIDN'T GET TO A UNANIMOUS 1590 01:07:25,474 --> 01:07:26,108 PATHWAY HERE. 1591 01:07:26,175 --> 01:07:30,546 IT WAS LIKE I SAID MORE OF A 1592 01:07:30,613 --> 01:07:31,881 CONSENSUS POINT. 1593 01:07:31,947 --> 01:07:39,555 >> I AGREE WITH ERIC, ADDING THE 1594 01:07:39,622 --> 01:07:41,190 USUALLY NO BECAUSE IT'S A 1595 01:07:41,257 --> 01:07:42,625 SUMMARY OF WHAT ELSE IS IN THE 1596 01:07:42,691 --> 01:07:43,826 PARAGRAPH, SORT OF NO BUT THEN 1597 01:07:43,893 --> 01:07:46,695 YOU GO ON TO GIVE EXAMPLES OF 1598 01:07:46,762 --> 01:07:52,935 WHY IT COULD BE YES. 1599 01:07:53,002 --> 01:07:53,402 >> OKAY. 1600 01:07:53,469 --> 01:07:55,571 I THINK, AND I APPRECIATE ERIC'S 1601 01:07:55,638 --> 01:07:57,640 BEEN PARTICULARLY A CHAMPION FOR 1602 01:07:57,706 --> 01:07:59,175 GETTING THE LANGUAGE RIGHT IN 1603 01:07:59,241 --> 01:08:01,143 THIS SECTION IN THE SUBCOMMITTEE 1604 01:08:01,210 --> 01:08:01,710 CALLS. 1605 01:08:01,777 --> 01:08:04,146 STARTING NEAR THE END OF LINE 1606 01:08:04,213 --> 01:08:06,549 209 HERE WE DID TRY TO FIGURE 1607 01:08:06,615 --> 01:08:15,191 OUT HOW TO THREAD THE NEEDLE AND 1608 01:08:15,257 --> 01:08:18,594 HIGHLIGHT, YOU KNOW, LEGITIMATE 1609 01:08:18,661 --> 01:08:22,398 ISSUES AROUND ACCESS TO CARE, 1610 01:08:22,465 --> 01:08:23,599 AND ESSENTIALLY SAYING THAT 1611 01:08:23,666 --> 01:08:24,800 THERE'S NOTHING WRONG WITH 1612 01:08:24,867 --> 01:08:26,669 CONSIDERING THOSE BUT STOPPING 1613 01:08:26,735 --> 01:08:27,903 SHORT OF SAYING THERE'S ALSO, 1614 01:08:27,970 --> 01:08:29,738 YOU KNOW, WE ALSO DIDN'T SAY 1615 01:08:29,805 --> 01:08:30,706 THERE'S AN OBLIGATION YOU HAVE 1616 01:08:30,773 --> 01:08:32,374 TO FIGURE OUT HOW TO CONTINUE IT 1617 01:08:32,441 --> 01:08:35,744 BECAUSE OF THOSE BARRIERS TO 1618 01:08:35,811 --> 01:08:36,212 ACCESS. 1619 01:08:36,278 --> 01:08:39,048 SO LIKE I SAID USUALLY IS A FINE 1620 01:08:39,114 --> 01:08:42,751 FIX FOR ME BECAUSE I THINK THE 1621 01:08:42,818 --> 01:08:46,589 ANSWER ITSELF SORT OF TRIES TO 1622 01:08:46,655 --> 01:08:51,126 SHED LIGHT ON BOTH SIDES OF THE 1623 01:08:51,193 --> 01:08:55,231 COIN. 1624 01:08:58,734 --> 01:08:59,668 ALL RIGHT. 1625 01:08:59,735 --> 01:09:02,404 NUMBER 4, THIS ONE I DON'T THINK 1626 01:09:02,471 --> 01:09:06,108 HAS REALLY CHANGED A WHOLE LOT. 1627 01:09:06,175 --> 01:09:08,210 SHOULD BEST INTERESTS BE MADE ON 1628 01:09:08,277 --> 01:09:09,812 INDIVIDUAL GROUP OR STUDY-WIDE 1629 01:09:09,879 --> 01:09:11,680 BASIS, THE ANSWER WAS SORT OF 1630 01:09:11,747 --> 01:09:20,489 DEPENDS BUT COULD BE ANY OF 1631 01:09:20,556 --> 01:09:23,959 THOSE. 1632 01:09:24,026 --> 01:09:24,159 LOIS? 1633 01:09:24,226 --> 01:09:27,162 >> I JUST THOUGHT THE SECOND 1634 01:09:27,229 --> 01:09:29,031 SENTENCE WAS DIFFICULT TO 1635 01:09:29,098 --> 01:09:29,265 FOLLOW. 1636 01:09:29,331 --> 01:09:31,867 THE PRIMARY INTENT OF THE BEST 1637 01:09:31,934 --> 01:09:32,968 INTEREST DETERMINATION IS TO 1638 01:09:33,035 --> 01:09:35,905 PREVENT HARM AND EXTEND DIRECT 1639 01:09:35,971 --> 01:09:38,741 BENEFIT TO SUBJECTS AT THE 1640 01:09:38,807 --> 01:09:40,409 INDIVIDUAL LEVEL THAT RESULT 1641 01:09:40,476 --> 01:09:42,244 FROM SUSPENSION OR TERMINATION 1642 01:09:42,311 --> 01:09:42,811 OF RESEARCH. 1643 01:09:42,878 --> 01:09:44,880 AND I THINK THE LAST PART, THAT 1644 01:09:44,947 --> 01:09:46,749 RESULT FROM SUSPENSION OR 1645 01:09:46,815 --> 01:09:48,617 TERMINATION OF RESEARCH, SHOULD 1646 01:09:48,684 --> 01:09:51,554 COME AFTER IS TO PREVENT HARM 1647 01:09:51,620 --> 01:09:53,622 BECAUSE IT'S NOT -- DOESN'T 1648 01:09:53,689 --> 01:09:55,824 APPLY TO THE EXTENT DIRECT 1649 01:09:55,891 --> 01:09:56,692 BENEFIT TO SUBJECTS, RIGHT? 1650 01:09:56,759 --> 01:09:58,427 SO I THINK IT'S THE PRIMARY 1651 01:09:58,494 --> 01:10:01,931 INTENT OF THE BEST INTEREST 1652 01:10:01,997 --> 01:10:03,465 DETERMINATION TO PREVENT HARM, 1653 01:10:03,532 --> 01:10:05,467 MAYBE PREVENT HARM THAT RESULTS 1654 01:10:05,534 --> 01:10:08,070 FROM SUSPENSION OR TERMINATION 1655 01:10:08,137 --> 01:10:11,607 OF RESEARCH AND EXTEND DIRECT 1656 01:10:11,674 --> 01:10:12,074 BENEFIT. 1657 01:10:12,141 --> 01:10:15,744 >> THAT WOULD LOOK LIKE THIS. 1658 01:10:15,811 --> 01:10:17,947 >> THAT MIGHT NOT RESOLVE IT ALL 1659 01:10:18,013 --> 01:10:19,348 BUT THE THOUGHT THE LAST PART 1660 01:10:19,415 --> 01:10:22,985 WAS NOT IN THE RIGHT PLACE. 1661 01:10:23,052 --> 01:10:24,520 BECAUSE OTHERWISE IT WAS SAYING 1662 01:10:24,587 --> 01:10:25,955 EXTEND DIRECT BENEFIT TO 1663 01:10:26,021 --> 01:10:28,891 SUBJECTS AT THE INDIVIDUAL LEVEL 1664 01:10:28,958 --> 01:10:31,293 THAT RESULT FROM THE SUSPENSION. 1665 01:10:31,360 --> 01:10:33,596 SO THAT DIDN'T MAKE SENSE TO ME. 1666 01:10:33,662 --> 01:10:36,465 >> YEAH. 1667 01:10:36,532 --> 01:10:39,435 THIS IS WHAT IT WOULD -- 1668 01:10:39,501 --> 01:10:40,369 TRACKING TURNED OFF, THIS IS 1669 01:10:40,436 --> 01:10:42,137 WHAT IT WOULD LOOK LIKE CHANGED. 1670 01:10:42,204 --> 01:10:43,973 THE THOUGHT BEHIND THIS, THE 1671 01:10:44,039 --> 01:10:53,515 THOUGHT BEHIND THE ANSWER IS 1672 01:10:53,582 --> 01:10:54,183 THAT -- WELL, YEAH. 1673 01:10:54,250 --> 01:10:55,718 I WOULD HAVE TO REMEMBER WAY 1674 01:10:55,784 --> 01:10:55,918 BACK. 1675 01:10:55,985 --> 01:10:57,353 I DON'T WANT TO BE WRONG. 1676 01:10:57,419 --> 01:11:01,290 WHAT WE WERE TRYING TO SAY, YOU 1677 01:11:01,357 --> 01:11:05,894 KNOW, TO SOME EXTENT, YOU KNOW, 1678 01:11:05,961 --> 01:11:07,529 THE WAY -- I'M NOT THINKING OFF 1679 01:11:07,596 --> 01:11:09,064 THE CUFF GOOD ON THIS ONE. 1680 01:11:09,131 --> 01:11:13,102 I DON'T HAVE A PROBLEM WITH THIS 1681 01:11:13,168 --> 01:11:13,435 CHANGE. 1682 01:11:13,502 --> 01:11:14,737 I THINK THAT AT THE END OF THE 1683 01:11:14,803 --> 01:11:19,675 DAY I THINK WE'RE CLEAR THAT YOU 1684 01:11:19,742 --> 01:11:21,043 CAN MAKE THESE DETERMINATIONS AS 1685 01:11:21,110 --> 01:11:23,379 APPROPRIATE WHETHER IT'S ON THE 1686 01:11:23,445 --> 01:11:24,279 INDIVIDUAL LEVEL OR, YOU KNOW, 1687 01:11:24,346 --> 01:11:26,248 ONE ARM OF THE STUDY OR THE 1688 01:11:26,315 --> 01:11:31,186 WHOLE STUDY AND THAT'S OKAY. 1689 01:11:31,253 --> 01:11:31,654 >> RIGHT. 1690 01:11:31,720 --> 01:11:33,822 I KNOW THIS IS JUST A WORDING 1691 01:11:33,889 --> 01:11:34,023 THING. 1692 01:11:34,089 --> 01:11:36,892 PUT AN S ON THE END OF HARM 1693 01:11:36,959 --> 01:11:40,429 THOUGH FOR YOUR VERBS TO WORK. 1694 01:11:40,496 --> 01:11:49,304 >> THANK YOU. 1695 01:11:49,672 --> 01:11:50,973 NUMBER 5, THIS ONE I DON'T THINK 1696 01:11:51,040 --> 01:11:51,640 HAS CHANGED. 1697 01:11:51,707 --> 01:11:53,842 CAN YOU THINK ABOUT BEST 1698 01:11:53,909 --> 01:11:54,843 INTERESTS IN STUDIES THAT 1699 01:11:54,910 --> 01:11:55,711 HAVEN'T STARTED. 1700 01:11:55,778 --> 01:11:57,346 WE SAID NO, THE STUDY HASN'T 1701 01:11:57,413 --> 01:11:59,748 STARTED SO IT'S HARD TO SAY THAT 1702 01:11:59,815 --> 01:12:02,384 NOT STARTING THE STUDY THAT 1703 01:12:02,451 --> 01:12:04,219 NEVER STARTED IS CREATING A BEST 1704 01:12:04,286 --> 01:12:04,787 INTEREST PROBLEM. 1705 01:12:04,853 --> 01:12:05,754 THERE MAY HAVE BEEN PEOPLE THAT 1706 01:12:05,821 --> 01:12:08,090 WANTED TO BE IN THE STUDY BUT 1707 01:12:08,157 --> 01:12:11,593 THERE HASN'T BEEN EXPOSURE TO 1708 01:12:11,660 --> 01:12:12,194 INTERVENTION, NOTHING YOU'VE 1709 01:12:12,261 --> 01:12:19,902 STOPPED IN ITS TRACKS THERE. 1710 01:12:19,968 --> 01:12:22,871 LOIS, IS THAT YOUR HAND UP 1711 01:12:22,938 --> 01:12:23,272 FRESH? 1712 01:12:23,338 --> 01:12:24,173 >> IT'S FRESH, UNFORTUNATELY. 1713 01:12:24,239 --> 01:12:27,576 I THINK WE'RE MISSING A WORD. 1714 01:12:27,643 --> 01:12:27,910 >> OKAY. 1715 01:12:27,976 --> 01:12:31,080 >> 224, I THINK THE RESEARCH 1716 01:12:31,146 --> 01:12:33,148 WILL NOT BE ALLOWED, I THINK 1717 01:12:33,215 --> 01:12:43,025 YOU'RE JUST MISSING A "BE." 1718 01:12:43,092 --> 01:12:49,031 >> THANK YOU. 1719 01:12:49,098 --> 01:12:50,332 QUESTION 6 ALSO TOOK OR LED TO 1720 01:12:50,399 --> 01:12:51,433 DISCUSSION ON THE PART OF THE 1721 01:12:51,500 --> 01:12:53,402 SUBCOMMITTEE AS WE TALKED 1722 01:12:53,469 --> 01:12:54,169 THROUGH THIS. 1723 01:12:54,236 --> 01:12:55,337 AND SOME OF IT I THINK WAS 1724 01:12:55,404 --> 01:12:57,639 TRYING TO FIGURE OUT WHAT THE 1725 01:12:57,706 --> 01:12:59,074 QUESTION IS ASKING. 1726 01:12:59,141 --> 01:13:01,610 A COUPLE TIMES WE STARTED TO GO 1727 01:13:01,677 --> 01:13:03,345 QUITE FAR DOWN RABBIT HOLES, IN 1728 01:13:03,412 --> 01:13:04,913 MY OPINION, SORT OF DEVIATED 1729 01:13:04,980 --> 01:13:06,849 FROM WHAT THE QUESTION WAS 1730 01:13:06,915 --> 01:13:07,116 ASKING. 1731 01:13:07,182 --> 01:13:08,851 BUT THIS IS SORT OF WHERE WE 1732 01:13:08,917 --> 01:13:09,952 ENDED UP. 1733 01:13:10,018 --> 01:13:13,222 THE QUESTION IS WHETHER THE 1734 01:13:13,288 --> 01:13:15,524 DETERMINATION IS EVER JUSTIFIED 1735 01:13:15,591 --> 01:13:17,059 FOR PLACEBO-CONTROLLED STUDY 1736 01:13:17,126 --> 01:13:22,865 WHERE PLACEBO IS ABSENCE OF 1737 01:13:22,931 --> 01:13:23,398 POTENTIALLY BENEFICIAL 1738 01:13:23,465 --> 01:13:24,099 INTERVENTIONS. 1739 01:13:24,166 --> 01:13:33,675 SO THE ANSWER STARTS OFF BY 1740 01:13:33,742 --> 01:13:36,245 SAYING, WELL, YOU KNOW, THE 1741 01:13:36,311 --> 01:13:37,146 BEST -- TELLING SOMEBODY OR 1742 01:13:37,212 --> 01:13:39,948 SAYING THAT PEOPLE IN THE 1743 01:13:40,015 --> 01:13:47,055 PLACEBO ARM, THAT THERE'S A BEST 1744 01:13:47,122 --> 01:13:48,223 INTEREST ARGUMENT, ISN'T 1745 01:13:48,290 --> 01:13:56,064 APPROPRIATE BECAUSE BY -- WHILE 1746 01:13:56,131 --> 01:14:00,536 THERE'S A PLACEBO EFFECT, THE 1747 01:14:00,602 --> 01:14:02,638 THOUGHT IS THAT THERE'S NOT -- 1748 01:14:02,704 --> 01:14:08,110 IT'S NOT THE INTERVENTION THAT'S 1749 01:14:08,177 --> 01:14:10,312 CAUSING AN EFFECT. 1750 01:14:10,379 --> 01:14:12,514 AND THEREFORE IT'S EXCLUDED FROM 1751 01:14:12,581 --> 01:14:19,621 A BEST INTEREST DISCUSSION. 1752 01:14:19,688 --> 01:14:21,924 AND WE CALLED OUT THE PEDIATRIC 1753 01:14:21,990 --> 01:14:24,226 GUIDES IN THE FDA FOR COMPONENT 1754 01:14:24,293 --> 01:14:25,861 ANALYSIS SAYS IF IT'S A PLACEBO 1755 01:14:25,928 --> 01:14:27,462 INTERVENTION OR PROCEDURE YOU 1756 01:14:27,529 --> 01:14:30,666 CAN'T SAY THERE'S A PROSPECT OF 1757 01:14:30,732 --> 01:14:31,733 DIRECT BENEFIT. 1758 01:14:31,800 --> 01:14:33,502 WHICH IS PROBABLY AS CLOSE AS WE 1759 01:14:33,569 --> 01:14:35,704 GOT TO A REGULATION IN A LOT OF 1760 01:14:35,771 --> 01:14:40,075 THIS DOCUMENT, BUT THERE IT IS. 1761 01:14:40,142 --> 01:14:43,478 THE SECOND HALF OF THIS WE 1762 01:14:43,545 --> 01:14:47,950 TALKED A BOUGHT WILL BEHAVIORAL 1763 01:14:48,016 --> 01:14:51,119 RESEARCH STUDIES WITHOUT 1764 01:14:51,186 --> 01:14:52,120 LIFESTYLE COMPONENTS. 1765 01:14:52,187 --> 01:14:53,188 ANYHOW, THIS, AGAIN, WAS ONE OF 1766 01:14:53,255 --> 01:14:57,359 THE ONES WHERE WE GOT A 1767 01:14:57,426 --> 01:15:07,970 CONSENSUS ANSWER FOR YOU ALL TO 1768 01:15:09,304 --> 01:15:10,706 THINK ABOUT, AND I'LL OPEN IT UP 1769 01:15:10,772 --> 01:15:11,573 FOR DISCUSSION. 1770 01:15:11,640 --> 01:15:17,813 IF IT'S CLEAR, THAT'S GREAT. 1771 01:15:17,880 --> 01:15:18,013 NEIL? 1772 01:15:18,080 --> 01:15:19,781 >> YEAH, THE ONLY VERY MINOR 1773 01:15:19,848 --> 01:15:22,184 THING I MIGHT CONSIDER IS I GOT 1774 01:15:22,251 --> 01:15:24,052 STUCK ON THE STATEMENT THAT 1775 01:15:24,119 --> 01:15:25,888 CONTINUATION OF PLACEBO IS NOT 1776 01:15:25,954 --> 01:15:27,856 ALIGNED WITH THE SUBJECT'S BEST 1777 01:15:27,923 --> 01:15:29,958 INTEREST. 1778 01:15:30,025 --> 01:15:31,927 IT MIGHT BE ALIGNED BUT MORE OF 1779 01:15:31,994 --> 01:15:37,165 THE SECOND SENTENCE THAT WE 1780 01:15:37,232 --> 01:15:40,202 GENERALLY DON'T DO PLACEBO 1781 01:15:40,269 --> 01:15:41,904 TREATMENT BASED ON, YOU KNOW, SO 1782 01:15:41,970 --> 01:15:45,540 I FELT LIKE IT MIGHT BE MORE 1783 01:15:45,607 --> 01:15:47,476 STRAIGHTFORWARD TO SAY SOMETHING 1784 01:15:47,542 --> 01:15:49,111 LESS CONTENTIOUS, CONTINUATION 1785 01:15:49,177 --> 01:15:53,282 OF PLACEBO IS NOT CONSISTENT 1786 01:15:53,348 --> 01:15:54,049 WITH TYPICAL CLINICAL PRACTICE 1787 01:15:54,116 --> 01:15:55,484 OR SOMETHING LIKE THAT. 1788 01:15:55,550 --> 01:16:01,490 THE WHOLE POINT IS IT'S ALL 1789 01:16:01,556 --> 01:16:02,057 ABOUT CLINICAL INDICATIONS 1790 01:16:02,124 --> 01:16:04,760 REALLY AND SO I COULD SEE 1791 01:16:04,826 --> 01:16:05,761 SOMEBODY PICKING AT THINGS THE 1792 01:16:05,827 --> 01:16:07,963 POINT WHETHER IT IS OR ISN'T IN 1793 01:16:08,030 --> 01:16:08,830 SOMEONE'S BEST INTEREST. 1794 01:16:08,897 --> 01:16:15,504 THE POINT IS WE JUST DON'T DO 1795 01:16:15,570 --> 01:16:15,671 IT. 1796 01:16:15,737 --> 01:16:17,706 >> YEAH. 1797 01:16:17,773 --> 01:16:19,808 >> SOMETHING LIKE CONTINUATION 1798 01:16:19,875 --> 01:16:23,745 OF PLACEBO FOR CLINICAL PURPOSES 1799 01:16:23,812 --> 01:16:26,715 IS NOT CONSISTENT WITH TYPICAL 1800 01:16:26,782 --> 01:16:27,115 CLINICAL PRACTICE. 1801 01:16:27,182 --> 01:16:33,288 I DON'T KNOW. 1802 01:16:33,355 --> 01:16:35,223 JUST SEEMS LESS -- LESS 1803 01:16:35,290 --> 01:16:35,490 TECHNICAL. 1804 01:16:35,557 --> 01:16:37,092 >> LET'S SEE WHAT PEOPLE THINK. 1805 01:16:37,159 --> 01:16:40,896 >> OR CONTINUATION OF PLACEBO IS 1806 01:16:40,963 --> 01:16:48,270 NOT ALIGNED WITH STANDARD OF 1807 01:16:48,337 --> 01:16:48,603 CARE. 1808 01:16:48,670 --> 01:16:49,905 I COMPLETELY AGREE WITH NEIL. 1809 01:16:49,972 --> 01:16:52,441 WHEN YOU TRIED TO TELL PEOPLE 1810 01:16:52,507 --> 01:16:56,144 YOU CAN'T DO A 1811 01:16:56,211 --> 01:16:56,812 PLACEBO-CONTROLLED TRIAL IF WE 1812 01:16:56,878 --> 01:16:59,982 KNEW THE PLACEBO WAS GOING TO 1813 01:17:00,048 --> 01:17:01,616 HURT PEOPLE AND THERE'S A LINE 1814 01:17:01,683 --> 01:17:03,785 THAT SAYS PLACEBO IS NOT ALIGNED 1815 01:17:03,852 --> 01:17:04,920 WITH SUBJECT'S BEST INTEREST, I 1816 01:17:04,987 --> 01:17:10,258 WOULDN'T WANT TO SEE THAT IN 1817 01:17:10,325 --> 01:17:10,926 PARENTHESES. 1818 01:17:10,993 --> 01:17:11,226 >> RIGHT. 1819 01:17:11,293 --> 01:17:14,062 >> IT SEEMS FINE FOR ME. 1820 01:17:14,129 --> 01:17:24,639 LESS LIKELY TO CAUSE A FOIBLE. 1821 01:17:26,742 --> 01:17:26,975 >> OKAY. 1822 01:17:27,042 --> 01:17:28,343 LET ME LOOK AT THAT FOR A SECOND 1823 01:17:28,410 --> 01:17:31,580 BEFORE I SCROLL ON. 1824 01:17:37,686 --> 01:17:38,520 ALL RIGHT. 1825 01:17:38,587 --> 01:17:41,923 NUMBER 7, CONSIDERATIONS SUCH AS 1826 01:17:41,990 --> 01:17:43,759 LOST TIME OR EFFORT, LOST 1827 01:17:43,825 --> 01:17:44,626 RESEARCH COMPENSATION. 1828 01:17:44,693 --> 01:17:45,293 >> SORRY, DAVE. 1829 01:17:45,360 --> 01:17:46,695 GO BACK. 1830 01:17:46,762 --> 01:17:50,766 THERE'S A REFERENCE TO PLACEBO 1831 01:17:50,832 --> 01:17:53,835 EFFECT, AND MAYBE MAY 1832 01:17:53,902 --> 01:17:59,074 EXPERIENCE, 233, MAYBE I'M 1833 01:17:59,141 --> 01:17:59,841 OVERREADING IT. 1834 01:17:59,908 --> 01:18:00,942 WHILE THERE MAY BE INDIVIDUAL 1835 01:18:01,009 --> 01:18:02,844 SUBJECTS WHO EXPERIENCE A 1836 01:18:02,911 --> 01:18:06,748 PLACEBO EFFECT, IS THAT WHAT YOU 1837 01:18:06,815 --> 01:18:09,051 WANT TO SAY? 1838 01:18:09,117 --> 01:18:10,252 >> YEAH, THE GROUP SAID, LOOK, 1839 01:18:10,318 --> 01:18:12,187 THERE ARE PEOPLE THAT RESPOND TO 1840 01:18:12,254 --> 01:18:15,090 PLACEBO, AT LEAST IN A CLINICAL 1841 01:18:15,157 --> 01:18:16,491 TRIAL WORLD. 1842 01:18:16,558 --> 01:18:21,129 THAT'S EXPECTED. 1843 01:18:21,196 --> 01:18:23,865 IT'S GOING TO HAPPEN. 1844 01:18:23,932 --> 01:18:24,266 >> OKAY. 1845 01:18:24,332 --> 01:18:26,802 >> THAT WAS INTENTIONAL. 1846 01:18:26,868 --> 01:18:27,069 >> OKAY. 1847 01:18:27,135 --> 01:18:28,203 >> ALL RIGHT. 1848 01:18:28,270 --> 01:18:29,538 NUMBER 7, THIS IS ONE WHERE THE 1849 01:18:29,604 --> 01:18:30,872 SHORT ANSWER WAS NO. 1850 01:18:30,939 --> 01:18:38,413 I THINK THESE ARE REALITIES BUT 1851 01:18:38,480 --> 01:18:41,983 IN AND OF THEMSELVES DON'T 1852 01:18:42,050 --> 01:18:45,387 REPRESENT THE BASIS FOR A BEST 1853 01:18:45,454 --> 01:18:45,787 INTEREST ARGUMENT. 1854 01:18:45,854 --> 01:18:48,723 THIS HASN'T CHANGED IN QUITE 1855 01:18:48,790 --> 01:18:57,065 SOME TIME. 1856 01:19:02,003 --> 01:19:04,573 >> ON 252 I THINK THERE'S A BE 1857 01:19:04,639 --> 01:19:08,210 IN BETWEEN SHOULD AND NOT. 1858 01:19:08,276 --> 01:19:15,884 SHOULD NOT -- I'M SORRY, SHOULD 1859 01:19:15,951 --> 01:19:18,220 NOT BE DETERMINATIVE. 1860 01:19:18,286 --> 01:19:19,154 >> QUESTION 8 IS THE -- YOU 1861 01:19:19,221 --> 01:19:21,556 KNOW, WHAT ABOUT WHEN THERE'S A 1862 01:19:21,623 --> 01:19:24,626 THERAPEUTIC RELATIONSHIP BETWEEN 1863 01:19:24,693 --> 01:19:27,028 THE RESEARCHERS AND THE 1864 01:19:27,095 --> 01:19:27,362 PARTICIPANTS. 1865 01:19:27,429 --> 01:19:30,732 I THINK THIS IS ONE WHERE WE 1866 01:19:30,799 --> 01:19:32,601 SORT OF STAKED OUT THIS ANSWER 1867 01:19:32,667 --> 01:19:37,672 QUITE SOME TIME AGO AND IT 1868 01:19:37,739 --> 01:19:39,875 REALLY HASN'T CHANGED. 1869 01:19:39,941 --> 01:19:41,643 >> THE ONLY THING I HAVE A 1870 01:19:41,710 --> 01:19:48,150 CONCERN WITH ABOUT 8 WAS THAT IT 1871 01:19:48,216 --> 01:19:50,018 STRIKES ME AS NARROWLY 1872 01:19:50,085 --> 01:19:51,219 CONSTRUCTED AROUND PREEXISTING 1873 01:19:51,286 --> 01:19:52,454 RELATIONSHIPS, AND I WASN'T 1874 01:19:52,521 --> 01:19:54,189 PRESENT WHEN THE CHARGE WAS 1875 01:19:54,256 --> 01:19:59,861 CREATED OR WHEN THIS FIRST GOT 1876 01:19:59,928 --> 01:20:02,164 ASKED BUT IT SEEMS THERE ARE TWO 1877 01:20:02,230 --> 01:20:03,398 CIRCUMSTANCES THERAPEUTIC 1878 01:20:03,465 --> 01:20:04,900 RELATIONSHIPS CAN BECOME 1879 01:20:04,966 --> 01:20:05,567 RELEVANT. 1880 01:20:05,634 --> 01:20:07,002 ONE WHEN THERE'S A PREEXISTING 1881 01:20:07,068 --> 01:20:09,604 RELATIONSHIP WHICH IS COVERED. 1882 01:20:09,671 --> 01:20:11,573 SECOND IS WHEN THERAPEUTIC 1883 01:20:11,640 --> 01:20:15,177 RELATIONSHIP IS ESTABLISHED IN 1884 01:20:15,243 --> 01:20:19,481 THE CONTEXT OF RESEARCH 1885 01:20:19,548 --> 01:20:21,016 PARTICIPATION WHICH DOES HAPPEN, 1886 01:20:21,082 --> 01:20:25,287 AND I JUST WASN'T SURE IF THIS 1887 01:20:25,353 --> 01:20:27,789 WAS THE RIGHT -- IF THIS WAS TOO 1888 01:20:27,856 --> 01:20:31,092 NARROW A SCOPE. 1889 01:20:31,159 --> 01:20:36,565 >> YEAH, I DON'T KNOW. 1890 01:20:36,631 --> 01:20:37,199 WE HAVEN'T FOCUSED ON 1891 01:20:37,265 --> 01:20:41,269 SUBCOMMITTEE LEVEL IN A WHILE 1892 01:20:41,336 --> 01:20:48,510 IT'S FUNNY BECAUSE THE SENTENCE, 1893 01:20:48,577 --> 01:20:53,648 THE SECOND MAIN SENTENCE, ALMOST 1894 01:20:53,715 --> 01:20:56,818 REDUNDANT, PREEXISTING CLINICAL 1895 01:20:56,885 --> 01:20:58,887 CARE PROVIDER ... I'LL THINK 1896 01:20:58,954 --> 01:21:00,989 ABOUT THAT FOR A MINUTE. 1897 01:21:01,056 --> 01:21:01,189 LOIS? 1898 01:21:01,256 --> 01:21:03,291 >> WELL, I THINK NEIL'S POINT IS 1899 01:21:03,358 --> 01:21:04,359 A GREAT ONE. 1900 01:21:04,426 --> 01:21:07,429 AND I THINK WE SHOULD BROADEN 1901 01:21:07,495 --> 01:21:08,530 IT. 1902 01:21:08,597 --> 01:21:09,431 IN FACT THE SENTENCE, THE 1903 01:21:09,497 --> 01:21:11,933 QUESTION IS ABOUT A THERAPEUTIC 1904 01:21:12,000 --> 01:21:12,467 RELATIONSHIP. 1905 01:21:12,534 --> 01:21:14,669 IT'S NOT ABOUT WHETHER IT'S 1906 01:21:14,736 --> 01:21:16,738 ESTABLISHED BEFORE OR DURING 1907 01:21:16,805 --> 01:21:17,105 RESEARCH. 1908 01:21:17,172 --> 01:21:21,776 SO, I THINK IT'S JUST A WORDING 1909 01:21:21,843 --> 01:21:24,346 THING BUT IT COULD BE 1910 01:21:24,412 --> 01:21:25,714 THERAPEUTIC RELATIONSHIP, YOU 1911 01:21:25,780 --> 01:21:31,286 KNOW, IT COULD BE WHETHER 1912 01:21:31,353 --> 01:21:32,120 ESTABLISHED BEFORE OR DURING 1913 01:21:32,187 --> 01:21:33,588 RESEARCH, YOU KNOW, SHOULD NOT 1914 01:21:33,655 --> 01:21:34,289 BE DETERMINING, OR SOMETHING 1915 01:21:34,356 --> 01:21:35,223 LIKE THAT. 1916 01:21:35,290 --> 01:21:35,557 >> YEAH. 1917 01:21:35,624 --> 01:21:42,264 >> AND JUST GET RID OF 1918 01:21:42,330 --> 01:21:43,765 PREEXISTING IN LINE 254. 1919 01:21:43,832 --> 01:21:46,735 I DID NOT FIND THE SECOND 1920 01:21:46,801 --> 01:21:47,469 SENTENCE TOO REPETITIVE. 1921 01:21:47,535 --> 01:21:50,538 I THOUGHT IT WAS HELPFUL, FOR 1922 01:21:50,605 --> 01:21:51,640 ME, BECAUSE THIS RELATIONSHIP IS 1923 01:21:51,706 --> 01:21:53,942 NOT IN AND OF ITSELF. 1924 01:21:54,009 --> 01:21:57,779 IT SAID THERE'S A ROLE HERE 1925 01:21:57,846 --> 01:22:00,148 THAT'S IMPORTANT. 1926 01:22:00,215 --> 01:22:00,448 >> RIGHT. 1927 01:22:00,515 --> 01:22:04,986 >> SO IF WE CAN GO BACK THEN, I 1928 01:22:05,053 --> 01:22:07,589 WANT TO MAKE SURE I'M GETTING IT 1929 01:22:07,656 --> 01:22:08,189 RIGHT, NEIL. 1930 01:22:08,256 --> 01:22:10,025 IS THE WAY THE SENTENCE START 1931 01:22:10,091 --> 01:22:11,559 WHAT'S WRONG? 1932 01:22:11,626 --> 01:22:13,395 I SEE JULIE HAS A HAND UP. 1933 01:22:13,461 --> 01:22:16,698 DO YOU HAVE A CLARIFICATION FROM 1934 01:22:16,765 --> 01:22:17,565 OHRP SIDE? 1935 01:22:17,632 --> 01:22:17,966 >> YEAH. 1936 01:22:18,033 --> 01:22:18,767 HI, DAVID. 1937 01:22:18,833 --> 01:22:21,269 YEAH, I JUST WANTED TO MENTION 1938 01:22:21,336 --> 01:22:24,439 THAT WHEN WE PUBLISHED THIS 1939 01:22:24,506 --> 01:22:25,540 QUESTION IT WAS ACTUALLY NOT IN 1940 01:22:25,607 --> 01:22:29,177 THE CONTEXT OF WHERE THERE WAS A 1941 01:22:29,244 --> 01:22:32,013 PREEXISTING RELATIONSHIP BETWEEN 1942 01:22:32,080 --> 01:22:34,182 THE HEALTH CARE PROVIDER AND THE 1943 01:22:34,249 --> 01:22:35,717 NOW RESEARCH PARTICIPANT BUT 1944 01:22:35,784 --> 01:22:38,219 ACTUALLY WHERE THAT RELATIONSHIP 1945 01:22:38,286 --> 01:22:39,654 WAS DEVELOPED AS PART OF THE 1946 01:22:39,721 --> 01:22:41,122 PARTICIPATION IN THE RESEARCH 1947 01:22:41,189 --> 01:22:42,090 ITSELF. 1948 01:22:42,157 --> 01:22:45,593 AND THAT THAT WAS THE RATIONALE 1949 01:22:45,660 --> 01:22:50,298 FOR THE CONTINUATION OF 1950 01:22:50,365 --> 01:22:51,833 PARTICIPATION IN THE RESEARCH. 1951 01:22:51,900 --> 01:22:55,804 I HOPE THAT'S HELPFUL. 1952 01:22:55,870 --> 01:22:58,039 >> IF THAT'S THE CASE, I THINK 1953 01:22:58,106 --> 01:23:01,743 WHAT WOULD NEED TO GET -- THE 1954 01:23:01,810 --> 01:23:03,078 HELPFUL CHANGE WOULD BE TO ADD A 1955 01:23:03,144 --> 01:23:07,349 SENTENCE EITHER BEFORE OR 1956 01:23:07,415 --> 01:23:08,550 AFTERWARDS WHICH COULD SAY NO, 1957 01:23:08,616 --> 01:23:10,385 THERAPEUTIC RELATIONSHIPS MAY BE 1958 01:23:10,452 --> 01:23:15,023 ESTABLISHED IN THE CONTEXT OF 1959 01:23:15,090 --> 01:23:17,525 RESEARCH PARTICIPATION OR IN 1960 01:23:17,592 --> 01:23:20,595 ADDITION TO PREEXISTING 1961 01:23:20,662 --> 01:23:24,199 RELATIONSHIPS MAY BE PRESENT. 1962 01:23:24,265 --> 01:23:27,635 AND I THINK THEN THE SECTION 1963 01:23:27,702 --> 01:23:28,937 ABOUT WHEN THE INVESTIGATOR'S 1964 01:23:29,003 --> 01:23:31,439 ALSO A CLINICAL CARE PROVIDER 1965 01:23:31,506 --> 01:23:40,281 MAY HAVE INPUT TO AID, IT FEELS 1966 01:23:40,348 --> 01:23:42,117 LIKE THE POINT THAT WE'RE TRYING 1967 01:23:42,183 --> 01:23:44,986 TO MAKE IS THAT DOESN'T 1968 01:23:45,053 --> 01:23:45,754 NECESSARILY JUSTIFY CONTINUED 1969 01:23:45,820 --> 01:23:46,855 RESEARCH PARTICIPATION BUT THAT 1970 01:23:46,921 --> 01:23:49,557 WE HAVE TO FIND WAYS TO NAVIGATE 1971 01:23:49,624 --> 01:23:51,326 THE CLINICAL RELATIONSHIPS THAT 1972 01:23:51,393 --> 01:23:54,929 HAVE BEEN -- THAT EXIST, WHETHER 1973 01:23:54,996 --> 01:23:55,930 PREEXISTING OR DE NOVO. 1974 01:23:55,997 --> 01:23:56,364 >> OKAY. 1975 01:23:56,431 --> 01:23:57,899 THIS WILL BE ONE I'LL WORK ON AT 1976 01:23:57,966 --> 01:23:58,900 THE BREAK AS WELL. 1977 01:23:58,967 --> 01:24:00,301 IT WILL TAKE A LITTLE BIT OF 1978 01:24:00,368 --> 01:24:02,070 THOUGHT BUT HOPEFULLY I CAN COME 1979 01:24:02,137 --> 01:24:03,338 BACK WITH SOMETHING WE CAN LOOK 1980 01:24:03,405 --> 01:24:06,307 AT LATER IN THE AGENDA TODAY. 1981 01:24:06,374 --> 01:24:07,609 >> SORRY TO THROW A WRENCH IN 1982 01:24:07,675 --> 01:24:08,510 THE WORKS. 1983 01:24:08,576 --> 01:24:11,112 IT'S IMPORTANT TO BE CLEAR, 1984 01:24:11,179 --> 01:24:12,213 BECAUSE I THINK THERAPEUTIC 1985 01:24:12,280 --> 01:24:13,081 RELATIONSHIPS THAT GET 1986 01:24:13,148 --> 01:24:14,516 ESTABLISHED IN THE CONTEXT -- 1987 01:24:14,582 --> 01:24:16,050 TRUTH IS ONCE THEY GET 1988 01:24:16,117 --> 01:24:17,685 ESTABLISHED IN CONTEXT OF 1989 01:24:17,752 --> 01:24:18,787 RESEARCH PARTICIPATION WHERE 1990 01:24:18,853 --> 01:24:19,888 THERE ISN'T SOMETHING 1991 01:24:19,954 --> 01:24:25,260 PREEXISTING ARE PROBABLY MORE 1992 01:24:25,326 --> 01:24:26,995 IMPORTANT AND MORE CHALLENGING 1993 01:24:27,061 --> 01:24:29,097 THAN ONES PREEXISTING BECAUSE 1994 01:24:29,164 --> 01:24:30,498 PREEXISTING ONES YOU JUST -- THE 1995 01:24:30,565 --> 01:24:31,933 ANSWER IS GO BACK TO WHAT YOU 1996 01:24:32,000 --> 01:24:36,738 WERE DOING BEFORE. 1997 01:24:36,805 --> 01:24:37,038 >> RIGHT. 1998 01:24:37,105 --> 01:24:47,515 OKAY, I'LL WORK ON THAT. 1999 01:24:50,084 --> 01:24:51,986 AND NUMBER 9 -- OH, MINDY, DID 2000 01:24:52,053 --> 01:24:53,455 YOU HAVE A COMMENT ON 8? 2001 01:24:53,521 --> 01:24:55,256 >> I DO. 2002 01:24:55,323 --> 01:24:57,859 DOES THIS FIX THE FIDUCIARY DUTY 2003 01:24:57,926 --> 01:24:59,294 THING BACK IN 104? 2004 01:24:59,360 --> 01:25:01,830 BECAUSE WE'RE TALKING ABOUT A 2005 01:25:01,896 --> 01:25:02,931 THERAPEUTIC OBLIGATION, AND I 2006 01:25:02,997 --> 01:25:05,967 DON'T WANT TO -- YOU CAN LOOK AT 2007 01:25:06,034 --> 01:25:07,735 THIS AT THE BREAK, BUT WHEN WE 2008 01:25:07,802 --> 01:25:13,408 ALL HAD PROBLEMS IS THERE A 2009 01:25:13,475 --> 01:25:15,610 FIDUCIARY DUTY OWED TO SUBJECTS 2010 01:25:15,677 --> 01:25:17,679 BY RESEARCHERS, IF THERE'S A 2011 01:25:17,745 --> 01:25:18,680 THERAPEUTIC OBLIGATION TO 2012 01:25:18,746 --> 01:25:21,449 SUBJECTS BY RESEARCHERS? 2013 01:25:21,516 --> 01:25:25,386 I'M WONDERING IF THIS SECTION 2014 01:25:25,453 --> 01:25:30,758 KIND OF ANSWERS OUR DISLIKE OF 2015 01:25:30,825 --> 01:25:34,028 FIDUCIARY DUTY IN 104, MIGHT BE 2016 01:25:34,095 --> 01:25:36,231 HELPFUL FOR THE LANGUAGE TO BE 2017 01:25:36,297 --> 01:25:37,866 REPLACED, FIDUCIARY THERE. 2018 01:25:37,932 --> 01:25:38,533 SOMETHING TO THINK ABOUT. 2019 01:25:38,600 --> 01:25:40,702 >> OKAY, THANKS. 2020 01:25:40,768 --> 01:25:42,437 AND NUMBER 9 WHEN A BEST 2021 01:25:42,504 --> 01:25:44,205 INTEREST DETERMINATION IS MADE 2022 01:25:44,272 --> 01:25:45,306 TO ALLOW ONE OR MORE 2023 01:25:45,373 --> 01:25:46,708 PARTICIPANTS TO CONTINUE IN THE 2024 01:25:46,774 --> 01:25:48,576 RESEARCH SHOULD DATA COLLECTION 2025 01:25:48,643 --> 01:25:50,311 TOWARD THE SCIENTIFIC OBJECTIVES 2026 01:25:50,378 --> 01:25:50,578 CONTINUE? 2027 01:25:50,645 --> 01:25:53,281 WHAT ABOUT OTHER ANCILLARY 2028 01:25:53,348 --> 01:25:56,618 RESEARCH PROCEDURES? 2029 01:26:11,099 --> 01:26:12,867 I THINK LAST TWO LINES SUM UP 2030 01:26:12,934 --> 01:26:15,303 THE SUBCOMMITTEE'S FEELINGS, 2031 01:26:15,370 --> 01:26:16,804 WHEN THE STUDY IS BEING 2032 01:26:16,871 --> 01:26:18,673 TERMINATED OR EXPECTED TO BE 2033 01:26:18,740 --> 01:26:19,774 TERMINATED COLLECTING ADDITIONAL 2034 01:26:19,841 --> 01:26:21,409 DATA AND CONDUCTING OTHER 2035 01:26:21,476 --> 01:26:22,844 ANCILLARY PROCEDURES THAT DON'T 2036 01:26:22,911 --> 01:26:24,312 HAVE IMPACT, DIRECT IMPACT ON 2037 01:26:24,379 --> 01:26:26,648 SUBJECT BEST INTEREST SHOULD BE 2038 01:26:26,714 --> 01:26:27,282 DISCONTINUED. 2039 01:26:27,348 --> 01:26:27,515 ALLISON? 2040 01:26:27,582 --> 01:26:30,485 OR NEIL IS YOUR HAND UP? 2041 01:26:30,552 --> 01:26:32,353 JUST UP FROM BEFORE? 2042 01:26:32,420 --> 01:26:33,888 YEAH, ALLISON? 2043 01:26:33,955 --> 01:26:34,556 SORRY. 2044 01:26:34,622 --> 01:26:35,256 >> WELL, I THINK, YOU KNOW, WHAT 2045 01:26:35,323 --> 01:26:38,026 DO YOU MEAN BY DO NOT HAVE A 2046 01:26:38,092 --> 01:26:39,360 DIRECT IMPACT ON SUBJECT'S BEST 2047 01:26:39,427 --> 01:26:39,627 INTEREST? 2048 01:26:39,694 --> 01:26:41,329 I'VE ALREADY COME OUT IN FAVOR 2049 01:26:41,396 --> 01:26:43,398 OF SAYING YOU SHOULD CONTINUE 2050 01:26:43,464 --> 01:26:44,532 COLLECTING SAFETY DATA BECAUSE 2051 01:26:44,599 --> 01:26:48,303 IF SOMETHING ELSE COMES UP YOU 2052 01:26:48,369 --> 01:26:50,638 MAY END UP, EVEN THE PART OF THE 2053 01:26:50,705 --> 01:26:57,078 RESEARCH THAT YOU HAD RESUMED. 2054 01:27:05,153 --> 01:27:11,526 >> YEAH, I THINK THAT'S AN 2055 01:27:11,593 --> 01:27:13,294 EXCELLENT POINT. 2056 01:27:13,361 --> 01:27:14,862 >> I AGREE COLLECTING ANCILLARY 2057 01:27:14,929 --> 01:27:16,931 RESEARCH PROCEDURES, THAT'S A 2058 01:27:16,998 --> 01:27:18,232 NO-GO BUT -- 2059 01:27:18,299 --> 01:27:18,499 >> RIGHT. 2060 01:27:18,566 --> 01:27:20,301 I THINK IT WILL BE PRETTY EASY 2061 01:27:20,368 --> 01:27:22,170 TO WEAVE IN A SENTENCE THAT SORT 2062 01:27:22,236 --> 01:27:24,339 OF CARVES OUT THIS IDEA THAT 2063 01:27:24,405 --> 01:27:25,773 THERE WILL BE DATA SUCH AS 2064 01:27:25,840 --> 01:27:31,679 SAFETY DATA THAT'S IMPORTANT TO 2065 01:27:31,746 --> 01:27:33,014 KEEP COLLECTING AND IS I THINK 2066 01:27:33,081 --> 01:27:34,816 YOU COULD MAKE AN ARGUMENT IT 2067 01:27:34,882 --> 01:27:36,618 PROBABLY IS IN THE SUBJECT'S 2068 01:27:36,684 --> 01:27:39,320 BEST INTEREST TO CONTINUE 2069 01:27:39,387 --> 01:27:42,523 COLLECTING SAFETY DATA, 2070 01:27:42,590 --> 01:27:44,792 POTENTIAL FOR DIRECT IMPACT ON 2071 01:27:44,859 --> 01:27:46,561 THEM AS THEY WERE EXPOSED TO THE 2072 01:27:46,628 --> 01:27:48,396 INTERVENTION OR WHATEVER THE 2073 01:27:48,463 --> 01:27:50,598 RESEARCH PROCEDURE WAS. 2074 01:27:50,665 --> 01:27:52,667 >> AND THEN, YOU KNOW, THAT 2075 01:27:52,734 --> 01:27:54,569 RAISES THE QUESTION WHAT DO WE 2076 01:27:54,636 --> 01:27:55,770 MEAN BY SAFETY DATA? 2077 01:27:55,837 --> 01:27:58,640 CERTAIN TIMES OF GENE THERAPY, 2078 01:27:58,706 --> 01:28:00,675 FDA ASKED FOR 15 YEARS OF 2079 01:28:00,742 --> 01:28:00,942 FOLLOW-UP. 2080 01:28:01,009 --> 01:28:02,443 ARE WE GOING TO SAY IT'S IN THE 2081 01:28:02,510 --> 01:28:03,945 PATIENT'S BEST INTEREST TO HAVE 2082 01:28:04,012 --> 01:28:07,382 15 YEARS OF FOLLOW-UP IN THIS 2083 01:28:07,448 --> 01:28:10,585 CASE OR WHAT? 2084 01:28:20,995 --> 01:28:22,130 >> I'LL THINK ABOUT WHAT I CAN 2085 01:28:22,196 --> 01:28:24,065 DO TO PUT THAT IN THERE IN A WAY 2086 01:28:24,132 --> 01:28:25,833 THAT'S REASONABLE. 2087 01:28:25,900 --> 01:28:31,005 >> ARE YOU THINKING LIKE MAYBE 2088 01:28:31,072 --> 01:28:33,508 ONE IDEA IS -- THE FOCUS HERE IS 2089 01:28:33,574 --> 01:28:35,376 ON INDIVIDUAL INTERESTS, 2090 01:28:35,443 --> 01:28:37,578 INDIVIDUAL BENEFIT, OR NOT 2091 01:28:37,645 --> 01:28:38,513 NECESSARILY STUDY BENEFIT? 2092 01:28:38,579 --> 01:28:40,848 OR YOU'RE OKAY WITH A MIXTURE OF 2093 01:28:40,915 --> 01:28:41,082 BOTH? 2094 01:28:41,149 --> 01:28:46,988 >> I'M OKAY WITH A MIXTURE OF 2095 01:28:47,055 --> 01:28:48,956 BOTH IN THEORY, PARTICULARLY IF 2096 01:28:49,023 --> 01:28:50,792 IT'S A RARE POPULATION ONLY A 2097 01:28:50,858 --> 01:28:52,126 FEW PEOPLE HAVE BEEN EXPOSED TO 2098 01:28:52,193 --> 01:28:53,227 THE WHATEVER, I THINK IT WOULD 2099 01:28:53,294 --> 01:28:55,530 BE A SHAME TO LOSE THAT 2100 01:28:55,596 --> 01:28:57,498 OPPORTUNITY TO LEARN ABOUT IT. 2101 01:28:57,565 --> 01:28:59,467 BUT IF YOU'RE JUST TALKING 2102 01:28:59,534 --> 01:29:00,568 PRAGMATICALLY AND THINGS ARE 2103 01:29:00,635 --> 01:29:02,637 BEING CLOSED DOWN BECAUSE OF 2104 01:29:02,704 --> 01:29:04,172 MONEY OR WHAT HAVE YOU, I JUST 2105 01:29:04,238 --> 01:29:05,707 DON'T SEE HOW THERE'S GOING TO 2106 01:29:05,773 --> 01:29:09,310 BE RESOURCES TO DO THAT. 2107 01:29:09,377 --> 01:29:13,815 I THINK NEEDS TO BE A BALANCE, 2108 01:29:13,881 --> 01:29:15,550 FIRST OFF WE'RE INTERESTED IN 2109 01:29:15,616 --> 01:29:20,922 THE SUBJECT'S SAFETY, AND SECOND 2110 01:29:20,988 --> 01:29:23,791 ALSO IF IT'S POSSIBLE TO GET 2111 01:29:23,858 --> 01:29:25,193 MORE SAFETY DATA FOR 2112 01:29:25,259 --> 01:29:27,729 POPULATIONAL USE, GREAT. 2113 01:29:27,795 --> 01:29:30,031 BUT THAT'S NOT OUR PRIMARY 2114 01:29:30,098 --> 01:29:30,698 CONCERN AT THIS MOMENT. 2115 01:29:30,765 --> 01:29:32,166 ALTHOUGH IT WOULD BE WONDERFUL 2116 01:29:32,233 --> 01:29:41,743 TO GET IT IF WE COULD. 2117 01:29:41,809 --> 01:29:43,478 >> I'LL THINK ABOUT IT WHEN THE 2118 01:29:43,544 --> 01:29:45,346 NEXT DOCUMENT IS BEING 2119 01:29:45,413 --> 01:29:45,613 PRESENTED. 2120 01:29:45,680 --> 01:29:49,951 IT ALSO MAY BE SOMETHING THAT IF 2121 01:29:50,017 --> 01:29:52,019 WE WANT TO COMMENT ON THE NOTION 2122 01:29:52,086 --> 01:29:54,122 THAT THERE'S SORT OF ADDITIONAL 2123 01:29:54,188 --> 01:29:56,491 SCIENTIFIC DATA BUT THEN THERE'S 2124 01:29:56,557 --> 01:29:58,793 SPECIFIC SAFETY DATA THAT IT 2125 01:29:58,860 --> 01:30:00,862 MIGHT EITHER WORK AS GOING INTO 2126 01:30:00,928 --> 01:30:03,331 THE PARAGRAPH AS A FOOTNOTE. 2127 01:30:03,397 --> 01:30:04,932 I'LL PLAY AROUND WITH THAT. 2128 01:30:04,999 --> 01:30:11,973 I THINK IT'S AN IMPORTANT THING 2129 01:30:12,039 --> 01:30:12,607 TO DISTINGUISH. 2130 01:30:12,673 --> 01:30:13,040 YEAH. 2131 01:30:13,107 --> 01:30:14,475 >> THIS IS TO WALK OFF A PLANK 2132 01:30:14,542 --> 01:30:16,210 NO ONE NEEDS TO WALK OFF OF SO 2133 01:30:16,277 --> 01:30:19,180 I'LL JUST SAY IT AND LIKE RUN 2134 01:30:19,247 --> 01:30:19,380 AWAY. 2135 01:30:19,447 --> 01:30:21,883 WHEN WE TALK ABOUT PATIENT'S 2136 01:30:21,949 --> 01:30:23,518 BEST INTEREST COULD BE 2137 01:30:23,584 --> 01:30:25,520 PSYCHOLOGICAL, ET CETERA, THERE 2138 01:30:25,586 --> 01:30:26,687 ARE PEOPLE WHO PARTICIPATE IN 2139 01:30:26,754 --> 01:30:28,189 TRIALS KNOWING THAT THEY ARE NOT 2140 01:30:28,256 --> 01:30:31,626 GOING TO HAVE ANY DIRECT BENEFIT 2141 01:30:31,692 --> 01:30:32,560 WHATSOEVER AND THEY ARE TRYING 2142 01:30:32,627 --> 01:30:33,995 TO ADVANCE THE KNOWLEDGE IN THIS 2143 01:30:34,061 --> 01:30:35,630 PARTICULAR AREA. 2144 01:30:35,696 --> 01:30:37,431 SO IF WE SAY, YOU KNOW, HEY, YOU 2145 01:30:37,498 --> 01:30:39,934 CAN CONTINUE BUT WE'RE NOT 2146 01:30:40,001 --> 01:30:41,135 COLLECTING ANY DATA, YOU KNOW, 2147 01:30:41,202 --> 01:30:42,336 THAT'S NOT GOING TO ADVANCE 2148 01:30:42,403 --> 01:30:44,772 THEIR BEST INTEREST AT ALL. 2149 01:30:44,839 --> 01:30:47,175 OR AT LEAST NOT ADVANCE WHAT WAS 2150 01:30:47,241 --> 01:30:48,810 THEIR MAIN INTEREST IN 2151 01:30:48,876 --> 01:30:50,812 PARTICIPATING IN THE TRIAL. 2152 01:30:50,878 --> 01:30:52,180 I'M NOW RUNNING BACKWARDS OFF 2153 01:30:52,246 --> 01:30:52,780 THAT PLANK. 2154 01:30:52,847 --> 01:30:59,253 I DON'T THINK WE NEED TO TALK 2155 01:30:59,320 --> 01:30:59,854 ABOUT THAT BUT -- 2156 01:30:59,921 --> 01:31:03,124 >> ALL RIGHT. THERE WERE 2157 01:31:03,191 --> 01:31:03,791 ADDITIONAL SCENARIOS ALSO 2158 01:31:03,858 --> 01:31:12,700 PROPOSED. 2159 01:31:19,173 --> 01:31:20,441 FIRST, DEVICE INVESTIGATIONS 2160 01:31:20,508 --> 01:31:21,843 WHERE EXPLANTING OR REMOVING 2161 01:31:21,909 --> 01:31:24,178 POSES MORE RISK THAN CONTINUING 2162 01:31:24,245 --> 01:31:26,948 THE RESEARCH. 2163 01:31:34,322 --> 01:31:34,689 KEVIN? 2164 01:31:34,755 --> 01:31:35,857 >> DAVE, IN THAT PARAGRAPH THERE 2165 01:31:35,923 --> 01:31:40,561 THREE CASES WHERE YOU MEAN 2166 01:31:40,628 --> 01:31:41,896 EXPLANTATION BUT IT'S 2167 01:31:41,963 --> 01:31:42,663 EXPLANATION. 2168 01:31:42,730 --> 01:31:44,198 >> OH, THANK YOU, SPELLCHECKER. 2169 01:31:44,265 --> 01:31:50,037 YES, I THINK YOU'RE RIGHT. 2170 01:31:50,371 --> 01:31:59,013 I'LL FIX THOSE. 2171 01:32:07,355 --> 01:32:08,489 I REMEMBER THE SPELLCHECKER 2172 01:32:08,556 --> 01:32:09,690 DIDN'T LIKE THAT WORD NOW. 2173 01:32:09,757 --> 01:32:12,226 I MUST HAVE -- YEAH, WHEN I WENT 2174 01:32:12,293 --> 01:32:13,327 THROUGH ACCEPTING CHANGES I MUST 2175 01:32:13,394 --> 01:32:18,232 HAVE LET IT FIX A FEW OF THOSE. 2176 01:32:18,299 --> 01:32:20,635 >> YOU CAN PUT EXPLANT IF YOU 2177 01:32:20,701 --> 01:32:22,503 WANT. 2178 01:32:22,570 --> 01:32:25,206 I'M NOT SURE EXPLANTATION IS -- 2179 01:32:25,273 --> 01:32:27,208 IF YOU SAID HIGH RISK EXPLANT 2180 01:32:27,275 --> 01:32:28,175 PROCEDURE THAT MIGHT BE -- I 2181 01:32:28,242 --> 01:32:28,843 DON'T KNOW. 2182 01:32:28,910 --> 01:32:32,179 THAT'S THE WAY WE SAY IT BUT I 2183 01:32:32,246 --> 01:32:39,020 DON'T KNOW IF IT'S -- I DON'T 2184 01:32:39,086 --> 01:32:40,755 KNOW IF THE "ATION" IS IMPORTANT 2185 01:32:40,821 --> 01:32:41,555 OR NOT. 2186 01:32:41,622 --> 01:32:43,691 I DEFER TO OTHERS. 2187 01:32:43,758 --> 01:32:53,134 THE OTHER THING ON 184, SUCH AS 2188 01:32:53,200 --> 01:32:53,668 BEHAVIORAL OR EDUCATIONAL 2189 01:32:53,734 --> 01:32:57,738 RESEARCH, I THINK WHAT YOU MEAN 2190 01:32:57,805 --> 01:33:01,008 IS THAT NON-BIOMEDICAL TRIAL 2191 01:33:01,075 --> 01:33:01,275 SCENARIOS. 2192 01:33:01,342 --> 01:33:03,244 TECHNICALLY MANY OF THOSE MIGHT 2193 01:33:03,311 --> 01:33:05,746 BE CLINICAL TRIALS AND CLINICAL 2194 01:33:05,813 --> 01:33:11,419 RESEARCH BUT NOT BIOMEDICAL. 2195 01:33:11,485 --> 01:33:12,286 >> RIGHT. 2196 01:33:12,353 --> 01:33:22,830 >> AGAIN, JUST TO PREVENT 2197 01:33:23,164 --> 01:33:24,465 CONFUSION. 2198 01:33:24,532 --> 01:33:25,866 >> IN GENERAL THE OTHER 2199 01:33:25,933 --> 01:33:27,301 SCENARIOS HAVE NOT REALLY 2200 01:33:27,368 --> 01:33:29,170 CHANGED A LOT SINCE YOU SAW THEM 2201 01:33:29,236 --> 01:33:30,805 SO I DON'T HAVE ANY BIG THINGS 2202 01:33:30,871 --> 01:33:36,077 TO POINT OUT WHERE WE HAD 2203 01:33:36,143 --> 01:33:37,712 CHALLENGES AT THE SUBCOMMITTEE 2204 01:33:37,778 --> 01:33:37,945 LEVEL. 2205 01:33:38,012 --> 01:33:40,247 I THINK SINCE THE LAST TIME YOU 2206 01:33:40,314 --> 01:33:45,353 SAW THIS THAT THE LAST ONE I 2207 01:33:45,419 --> 01:33:47,054 BELIEVE YOU ALL ASKED TO HAVE IT 2208 01:33:47,121 --> 01:33:49,857 ADDED I BELIEVE AT THE LAST 2209 01:33:49,924 --> 01:33:52,827 MEETING, THAT'S JUST DEALING 2210 01:33:52,893 --> 01:33:57,732 WITH THE FWA SORT OF 2211 01:33:57,798 --> 01:33:58,399 ORGANIZATION-WIDE SUSPENSION AND 2212 01:33:58,466 --> 01:34:00,868 CONSIDERATIONS THERE. 2213 01:34:13,280 --> 01:34:15,049 BUT OTHERWISE THIS IS THE END OF 2214 01:34:15,116 --> 01:34:16,484 THE DOCUMENTS. 2215 01:34:16,550 --> 01:34:17,752 WE'RE MAKING PRETTY GOOD TIME. 2216 01:34:17,818 --> 01:34:21,655 IF PEOPLE WANT TO BOW BACK -- GO 2217 01:34:21,722 --> 01:34:23,524 BACK TO A CERTAIN SECTION, WE 2218 01:34:23,591 --> 01:34:23,958 CAN. 2219 01:34:24,025 --> 01:34:25,726 I'M ALSO HAPPY TO TURN THE 2220 01:34:25,793 --> 01:34:28,329 AGENDA BACK OVER TO DOUG AND 2221 01:34:28,396 --> 01:34:30,965 START WORKING ON TRYING TO CLEAN 2222 01:34:31,032 --> 01:34:32,500 UP SOME OF THE -- IT WILL GIVE 2223 01:34:32,566 --> 01:34:34,168 US TIME TO THINK THROUGH OFFLINE 2224 01:34:34,235 --> 01:34:36,137 SO I DEFER TO DOUG. 2225 01:34:36,203 --> 01:34:38,272 MINDY, DID YOU HAVE A QUESTION? 2226 01:34:38,339 --> 01:34:41,175 >> YEAH, JUST ON NUMBER 3, BACK 2227 01:34:41,242 --> 01:34:44,178 ON LINE 210, WHICH MAY HAVE 2228 01:34:44,245 --> 01:34:45,312 CHANGED A LITTLE BIT. 2229 01:34:45,379 --> 01:34:48,082 DO WE WANT TO SAY IMPACT OF 2230 01:34:48,149 --> 01:34:50,284 LOSING PHYSICAL ACCESS? 2231 01:34:50,351 --> 01:34:52,653 I DON'T LIKE PHYSICAL. 2232 01:34:52,720 --> 01:34:57,825 IMPACT OF LOSING ACCESS, LET'S 2233 01:34:57,892 --> 01:34:59,927 SAY SOMEONE'S RECEIVING LIKE 2234 01:34:59,994 --> 01:35:01,295 ONLINE COUNSELING OR SOMETHING. 2235 01:35:01,362 --> 01:35:06,133 AND THEN THE NEGATIVE IMPACT OF 2236 01:35:06,200 --> 01:35:07,435 LOSING THAT RELATIONSHIP OR 2237 01:35:07,501 --> 01:35:10,171 WHATEVER, DOES IT HAVE TO BE 2238 01:35:10,237 --> 01:35:10,438 PHYSICAL? 2239 01:35:10,504 --> 01:35:11,839 LIKE TELEMEDICINE OR SOMETHING 2240 01:35:11,906 --> 01:35:13,574 LIKE THAT? 2241 01:35:13,641 --> 01:35:16,744 WOULD YOU GUYS CONSIDER THAT TO 2242 01:35:16,811 --> 01:35:20,481 BE PHYSICAL ACCESS? 2243 01:35:20,548 --> 01:35:22,917 >> I COULD JUST GET RID OF 2244 01:35:22,983 --> 01:35:24,118 PHYSICAL, I SUPPOSE. 2245 01:35:24,185 --> 01:35:26,087 I DON'T KNOW THAT THAT CREATES 2246 01:35:26,153 --> 01:35:26,821 ANY PROBLEM 2247 01:35:26,887 --> 01:35:29,390 >> I JUST THOUGHT IT WAS 2248 01:35:29,457 --> 01:35:29,657 LIMITING. 2249 01:35:29,723 --> 01:35:30,291 THAT'S ALL. 2250 01:35:30,357 --> 01:35:32,393 THANK YOU. 2251 01:35:38,365 --> 01:35:44,972 >> ANYTHING ELSE ANYBODY WOULD 2252 01:35:45,039 --> 01:35:46,474 LIKE TO ADD HERE BEFORE WE CLEAN 2253 01:35:46,540 --> 01:35:48,275 THIS UP AND BRING IT BACK IN A 2254 01:35:48,342 --> 01:35:54,482 COUPLE HOURS? 2255 01:35:54,548 --> 01:35:56,117 IF YOU HAVE ANYTHING, NOW IS THE 2256 01:35:56,183 --> 01:35:57,551 BEST TIME TO GET IT IN THERE. 2257 01:35:57,618 --> 01:36:00,187 >> I DO APPRECIATE ALL THE FEED 2258 01:36:00,254 --> 01:36:02,923 BANK. 2259 01:36:02,990 --> 01:36:03,891 IT'S BEEN HELPFUL. 2260 01:36:03,958 --> 01:36:06,861 AND I SHOULD GIVE A SHOUT OUT TO 2261 01:36:06,927 --> 01:36:08,395 THE SUBCOMMITTEE MEMBERS WHO PUT 2262 01:36:08,462 --> 01:36:10,464 QUITE A BIT OF TIME GOING INTO 2263 01:36:10,531 --> 01:36:11,699 THIS DOCUMENT, MANY TIMES. 2264 01:36:11,765 --> 01:36:13,334 SO GLAD TO SEE IT'S MAKING 2265 01:36:13,400 --> 01:36:16,937 PROGRESS. 2266 01:36:17,004 --> 01:36:17,304 >> OKAY. 2267 01:36:17,371 --> 01:36:23,110 WE'LL PLAN ON COMING BACK TO 2268 01:36:23,177 --> 01:36:24,712 THIS LATER THIS AFTERNOON. 2269 01:36:24,778 --> 01:36:26,413 WE STILL HAVE A FEW MINUTES 2270 01:36:26,480 --> 01:36:29,350 BEFORE A SCHEDULED BREAK. 2271 01:36:29,416 --> 01:36:32,319 I WONDER, YVONNE, WOULD YOU BE 2272 01:36:32,386 --> 01:36:36,457 READY TO DO YOUR EDUCATIONAL 2273 01:36:36,524 --> 01:36:36,690 UPDATE. 2274 01:36:36,757 --> 01:36:38,125 >> YES, I CAN DO THAT. 2275 01:36:38,192 --> 01:36:42,930 LET ME GET MY VIDEO ON. 2276 01:36:42,997 --> 01:36:44,365 THANK YOU FOR THE OPPORTUNITY. 2277 01:36:44,431 --> 01:36:47,401 >> THIS WAS NOT ON THE AGENDA 2278 01:36:47,468 --> 01:36:52,339 BUT WE USUALLY DO GET AN UPDATE 2279 01:36:52,406 --> 01:36:53,774 ON EDUCATION FROM OHRP, AND THIS 2280 01:36:53,841 --> 01:36:55,376 SEEMS LIKE A GOOD TIME TO PUT 2281 01:36:55,442 --> 01:36:58,212 THAT IN SO WE CAN HAVE A CLEAN 2282 01:36:58,279 --> 01:37:00,314 BREAK AND THEN COME BACK TO A 2283 01:37:00,381 --> 01:37:03,050 NEW TOPIC AFTER THE BREAK. 2284 01:37:03,117 --> 01:37:06,420 YVONNE LAU FROM OHRP IS GOING TO 2285 01:37:06,487 --> 01:37:14,662 SHARE A FEW THINGS WITH US. 2286 01:37:14,728 --> 01:37:17,498 >> I HOPE YOU CAN SEE THE 2287 01:37:17,565 --> 01:37:17,831 SCREEN. 2288 01:37:17,898 --> 01:37:19,233 I'M YVONNE LAU, DIRECTOR FOR 2289 01:37:19,300 --> 01:37:21,101 DIVISION OF EDUCATION AND 2290 01:37:21,168 --> 01:37:22,203 DEVELOPMENT AT OHRP. 2291 01:37:22,269 --> 01:37:25,072 I JUST WANT TO SHARE WITH YOU A 2292 01:37:25,139 --> 01:37:26,240 COUPLE ANNOUNCEMENTS FROM OHRP. 2293 01:37:26,307 --> 01:37:30,211 FIRST OF ALL IT IS A SAVE THE 2294 01:37:30,277 --> 01:37:37,551 DATE, ON JULY 12, FRIDAY, AT 2295 01:37:37,618 --> 01:37:39,286 AROUND NOONTIME AN EVENT TO 2296 01:37:39,353 --> 01:37:40,821 COMMEMORATE THE 50th 2297 01:37:40,888 --> 01:37:41,555 ANNIVERSARY OF THE NATIONAL 2298 01:37:41,622 --> 01:37:43,257 RESEARCH ACT. 2299 01:37:43,324 --> 01:37:47,628 THIS WILL BE A 2.5 HOUR VIRTUAL 2300 01:37:47,695 --> 01:37:48,896 EVENT PEOPLE CAN LIVESTREAM, AND 2301 01:37:48,963 --> 01:37:54,268 PEOPLE CAN WATCH FROM LAPTOP. 2302 01:37:54,335 --> 01:37:58,005 THIS EVENT IS TO COMMEMORATE THE 2303 01:37:58,072 --> 01:37:59,773 50th ANNIVERSARY, DIVIDED INTO 2304 01:37:59,840 --> 01:38:01,075 THREE SEGMENTS. 2305 01:38:01,141 --> 01:38:04,245 FIRST SEGMENT WILL BE REFLECTION 2306 01:38:04,311 --> 01:38:06,080 ON WHAT HAPPENED RIGHT AFTER THE 2307 01:38:06,146 --> 01:38:07,615 NATIONAL RESEARCH ACT WAS 2308 01:38:07,681 --> 01:38:10,684 ENACTED, SO A BIT OF HISTORY. 2309 01:38:10,751 --> 01:38:14,088 AND THE MIDDLE SEGMENT IS TO 2310 01:38:14,154 --> 01:38:16,190 SHOWCASE WHAT RESEARCH IS -- HOW 2311 01:38:16,257 --> 01:38:21,395 RESEARCH IS BEING DONE TODAY, 2312 01:38:21,462 --> 01:38:23,364 PARTICULARLY GO OFF SHOWCASING 2313 01:38:23,430 --> 01:38:25,299 HOW, YOU KNOW, RESEARCH SUBJECTS 2314 01:38:25,366 --> 01:38:28,202 ARE NOT SO MUCH SUBJECTS ANYMORE 2315 01:38:28,269 --> 01:38:31,338 AND THEY NOW ACTUALLY TAKE ON 2316 01:38:31,405 --> 01:38:33,774 MORE OF A ROLE OF PARTNER IN 2317 01:38:33,841 --> 01:38:37,411 RESEARCH, SO WE'RE TRYING TO USE 2318 01:38:37,478 --> 01:38:39,380 THIS SEGMENT TO SHOWCASE ROLES 2319 01:38:39,446 --> 01:38:40,781 THAT RESEARCH PARTICIPANTS ARE 2320 01:38:40,848 --> 01:38:41,782 NOW TAKING. 2321 01:38:41,849 --> 01:38:44,318 AND THEN THE THIRD SEGMENT IS 2322 01:38:44,385 --> 01:38:46,487 PROJECTION INTO THE FUTURE, SO 2323 01:38:46,553 --> 01:38:49,690 LOOKING INTO THE NEXT 10, 20 2324 01:38:49,757 --> 01:38:51,325 YEARS THE CHALLENGES THAT WE'LL 2325 01:38:51,392 --> 01:38:53,694 BE SEEING FROM THE NEW 2326 01:38:53,761 --> 01:38:55,462 BIOTECHNOLOGIES THAT WILL BE 2327 01:38:55,529 --> 01:38:58,732 COMING OUR WAY, AND THAT WILL BE 2328 01:38:58,799 --> 01:39:01,702 USED IN HEALTH RESEARCH, THE 2329 01:39:01,769 --> 01:39:02,569 OTHER THING IS ALSO THE QUESTION 2330 01:39:02,636 --> 01:39:03,904 OF PUBLIC TRUST. 2331 01:39:03,971 --> 01:39:05,205 SO PLEASE SAVE THE DATE. 2332 01:39:05,272 --> 01:39:09,043 PUT IT ON YOUR CALENDAR. 2333 01:39:09,109 --> 01:39:11,245 THIS IS WILL BE AN EVENT OHRP 2334 01:39:11,312 --> 01:39:12,546 WILL BE PUTTING UP. 2335 01:39:12,613 --> 01:39:17,484 LET ME MOVE MY SLIDES. 2336 01:39:17,551 --> 01:39:20,988 NEXT IS I WANT TO JUST REMIND 2337 01:39:21,055 --> 01:39:24,692 EVERYBODY THAT OHRP HAS ACTUALLY 2338 01:39:24,758 --> 01:39:26,660 RELEASED A NEW INTERACTIVE 2339 01:39:26,727 --> 01:39:34,234 TRAINING PROGRAM, IT'S CALLED 2340 01:39:34,301 --> 01:39:35,069 PARTICIPANT CENTERED INFORMED 2341 01:39:35,135 --> 01:39:35,736 CONSENT TRAINING. 2342 01:39:35,803 --> 01:39:37,504 THIS IS THE OHRP WEBSITE. 2343 01:39:37,571 --> 01:39:40,541 AT THE TOP YOU SEE EDUCATION AND 2344 01:39:40,607 --> 01:39:41,375 OUTREACH. 2345 01:39:41,442 --> 01:39:43,644 ON THE SIDE NAVIGATION BAR, YOU 2346 01:39:43,711 --> 01:39:45,279 SEE HUMAN RESEARCH PROTECTION 2347 01:39:45,346 --> 01:39:45,779 TRAINING. 2348 01:39:45,846 --> 01:39:48,115 THIS IS AN OPPORTUNITY FOR ME TO 2349 01:39:48,182 --> 01:39:51,552 REMIND YOU ALL THAT OHRP HAS NOW 2350 01:39:51,618 --> 01:39:56,256 GOT A FAIRLY COMPREHENSIVE 2351 01:39:56,323 --> 01:39:58,759 PROGRAM ON PROVIDING A TRAINING 2352 01:39:58,826 --> 01:40:01,695 ON VARIOUS ASPECTS OF ETHICS AND 2353 01:40:01,762 --> 01:40:03,030 REGULATIONS FOR HUMAN SUBJECTS 2354 01:40:03,097 --> 01:40:03,530 RESEARCH. 2355 01:40:03,597 --> 01:40:07,301 THERE ARE SEVERAL PARTS IN THIS 2356 01:40:07,368 --> 01:40:07,735 PARTICULAR PROGRAM. 2357 01:40:07,801 --> 01:40:12,806 AND THEN ONE OF THEM NOW IS THE 2358 01:40:12,873 --> 01:40:14,074 PARTICIPANT-CENTERED INFORMED 2359 01:40:14,141 --> 01:40:14,641 CONSENT TRAINING. 2360 01:40:14,708 --> 01:40:16,910 SO IF YOU CLICK ON THAT PAGE 2361 01:40:16,977 --> 01:40:19,346 THIS IS WHAT YOU SEE. 2362 01:40:19,413 --> 01:40:22,082 IT IS AN INTERACTIVE TRAINING 2363 01:40:22,149 --> 01:40:22,850 PROGRAM. 2364 01:40:22,916 --> 01:40:25,152 THERE ARE SIX MODULES TO IT. 2365 01:40:25,219 --> 01:40:27,020 WE CALL IT PARTICIPANT CENTERED 2366 01:40:27,087 --> 01:40:31,625 BECAUSE IT IS WHAT THE GOAL OF 2367 01:40:31,692 --> 01:40:33,127 THIS IS. 2368 01:40:33,193 --> 01:40:35,662 TRYING TO PROVIDE INFORMATION OF 2369 01:40:35,729 --> 01:40:40,167 WHAT IT MEANS BY BEING -- BY 2370 01:40:40,234 --> 01:40:43,937 DOING A PARTICIPANT-CENTERED -- 2371 01:40:44,004 --> 01:40:44,538 CREATING PARTICIPANT-CENTERED 2372 01:40:44,605 --> 01:40:45,739 CONSENT FORM. 2373 01:40:45,806 --> 01:40:47,674 WE RECOMMEND PEOPLE ACTUALLY 2374 01:40:47,741 --> 01:40:50,677 OPEN UP THE PAGE TO VIEW THE 2375 01:40:50,744 --> 01:40:52,980 ENTIRE PROGRAM IN ITS FULL 2376 01:40:53,046 --> 01:40:54,248 FORMAT. 2377 01:40:54,314 --> 01:40:56,483 THERE ARE SIX MODULES TO THIS 2378 01:40:56,550 --> 01:41:00,521 TRAINING PROGRAM, AND IT'S EASY 2379 01:41:00,587 --> 01:41:02,389 ENOUGH TO NAVIGATE. 2380 01:41:02,456 --> 01:41:03,590 ONCE YOU'RE IN IT, YOU'LL SEE 2381 01:41:03,657 --> 01:41:04,458 THE WELCOMING PAGE. 2382 01:41:04,525 --> 01:41:09,396 ON THIS SLIDE IF YOU CAN SEE THE 2383 01:41:09,463 --> 01:41:12,800 MENU, AND IT'S JUST NAVIGATION, 2384 01:41:12,866 --> 01:41:14,568 THERE'S SIX MODULES, MODULE 1 IS 2385 01:41:14,635 --> 01:41:17,838 HOW WE CAN IMPROVE CONSENT 2386 01:41:17,905 --> 01:41:19,373 FORMS, TALKS ABOUT ETHICS, 2387 01:41:19,440 --> 01:41:22,342 BACKGROUND OF THE REGULATIONS, 2388 01:41:22,409 --> 01:41:27,815 MODULE 2 IS ABOUT WHAT THE 2389 01:41:27,881 --> 01:41:28,582 PARTICIPANT-CENTERED APPROACH 2390 01:41:28,649 --> 01:41:29,983 MEANS. 2391 01:41:30,050 --> 01:41:32,419 WE TALK ABOUT PROVIDING 2392 01:41:32,486 --> 01:41:35,589 CONTEXTUAL INFORMATION TO HELP 2393 01:41:35,656 --> 01:41:36,190 PARTICIPANTS, POTENTIAL 2394 01:41:36,256 --> 01:41:36,757 PARTICIPANTS UNDERSTAND THE 2395 01:41:36,824 --> 01:41:40,093 INFORMATION THAT THEY ARE 2396 01:41:40,160 --> 01:41:42,896 RECEIVING ABOUT THE RESEARCH. 2397 01:41:42,963 --> 01:41:47,501 MODULE 3, 4, HOW TO WRITE THESE 2398 01:41:47,568 --> 01:41:51,138 CONSENT FORMS USING WORDS, 2399 01:41:51,205 --> 01:41:53,607 PAYING ATTENTION TO READABILITY. 2400 01:41:53,674 --> 01:41:55,476 MODULE 4 HOW TO ORGANIZE CONSENT 2401 01:41:55,542 --> 01:41:58,745 FORM INFORMATION SO THERE'S A 2402 01:41:58,812 --> 01:42:01,515 COHERENT NARRATIVE AND NOT 2403 01:42:01,582 --> 01:42:02,583 PIECES OF INFORMATION ALL OVER 2404 01:42:02,649 --> 01:42:03,350 THE PLACE. 2405 01:42:03,417 --> 01:42:06,353 THERE IS ALSO A SEGMENT WHERE WE 2406 01:42:06,420 --> 01:42:10,023 MENTION A LITTLE BIT ABOUT KEY 2407 01:42:10,090 --> 01:42:10,691 INFORMATION, AND PROVIDE 2408 01:42:10,757 --> 01:42:12,659 POSSIBLE EXAMPLE OF WHAT THAT 2409 01:42:12,726 --> 01:42:14,194 MAY LOOK LIKE. 2410 01:42:14,261 --> 01:42:16,396 AND THEN MODULE 5 IS HOW TO 2411 01:42:16,463 --> 01:42:18,031 DESIGN AND FORMAT AND DISPLAY 2412 01:42:18,098 --> 01:42:20,567 THE INFORMATION AND FINALLY 2413 01:42:20,634 --> 01:42:24,304 MODULE 6 IS A RECAP OF THE 2414 01:42:24,371 --> 01:42:24,805 TRAINING. 2415 01:42:24,872 --> 01:42:26,406 THERE ALSO -- I WANT TO DRAW 2416 01:42:26,473 --> 01:42:27,708 YOUR ATTENTION TO THE RESOURCE 2417 01:42:27,774 --> 01:42:31,745 TAB AT THE TOP WHERE IT WOULD BE 2418 01:42:31,812 --> 01:42:35,182 VERY EASY TO ACCESS CERTAIN 2419 01:42:35,249 --> 01:42:36,917 DOCUMENTS THAT PROVIDE, FOR 2420 01:42:36,984 --> 01:42:39,319 EXAMPLE, LIST OF COMMONLY USED 2421 01:42:39,386 --> 01:42:40,854 WORDS IN PLAIN LANGUAGE, THAT 2422 01:42:40,921 --> 01:42:43,257 RESEARCHERS CAN OPT TO USE 2423 01:42:43,323 --> 01:42:48,095 INSTEAD OF COMPLICATED MEDICAL 2424 01:42:48,161 --> 01:42:48,328 TERMS. 2425 01:42:48,395 --> 01:42:52,165 THERE'S ALSO A -- WE PROVIDED 2426 01:42:52,232 --> 01:42:53,667 WHAT A KEY INFORMATION SECTION 2427 01:42:53,734 --> 01:42:54,801 MIGHT LOOK LIKE FOR CONSENT 2428 01:42:54,868 --> 01:42:56,737 FORM, SOMETHING YOU CAN ALSO 2429 01:42:56,803 --> 01:42:58,071 ACCESS FROM THE RESOURCE TAB. 2430 01:42:58,138 --> 01:43:01,775 SO WITH THAT, I HOPE THAT 2431 01:43:01,842 --> 01:43:02,809 EVERYBODY WILL TRY AND PLAY WITH 2432 01:43:02,876 --> 01:43:08,048 THIS PROGRAM A LITTLE BIT AND 2433 01:43:08,115 --> 01:43:09,616 ENCOURAGE INVESTIGATORS AND 2434 01:43:09,683 --> 01:43:10,551 INSTITUTIONS, TRIAL COORDINATORS 2435 01:43:10,617 --> 01:43:12,185 TO TAKE A LOOK AT THIS TRAINING 2436 01:43:12,252 --> 01:43:15,489 AND HOPEFULLY YOU'LL FIND THIS 2437 01:43:15,556 --> 01:43:16,590 TRAINING TO BE HELPFUL. 2438 01:43:16,657 --> 01:43:23,130 THANK YOU SO MUCH. 2439 01:43:23,196 --> 01:43:24,264 >> THANK YOU, YVONNE. 2440 01:43:24,331 --> 01:43:27,834 THAT WAS VERY HELPFUL. 2441 01:43:27,901 --> 01:43:29,803 WELL, WE'RE ABOUT 15 MINUTES 2442 01:43:29,870 --> 01:43:30,137 AHEAD. 2443 01:43:30,203 --> 01:43:32,172 IT SEEMS RATHER THAN DOING 15 2444 01:43:32,239 --> 01:43:35,509 MINUTES OF OUR NEXT TOPIC, IT 2445 01:43:35,576 --> 01:43:37,911 SEEMS TO MAKE SENSE TO DO AN 2446 01:43:37,978 --> 01:43:41,515 EARLY BREAK IF THAT'S OKAY WITH 2447 01:43:41,582 --> 01:43:41,848 EVERYBODY. 2448 01:43:41,915 --> 01:43:45,686 SO, WHY DON'T WE TAKE A 2449 01:43:45,752 --> 01:43:48,622 30-MINUTE BREAK, WHICH MEANS 2450 01:43:48,689 --> 01:43:55,529 BEING BACK HERE AT ABOUT 10:15. 2451 01:43:56,630 --> 01:43:58,865 SHARP. 2452 01:43:58,932 --> 01:44:01,234 WE'LL TAKE UP OUR SECOND TOPIC 2453 01:44:01,301 --> 01:44:03,437 OF THE MORNING. 2454 01:44:03,503 --> 01:44:05,906 >> OR 1:15 FOR THOSE -- 2455 01:44:05,973 --> 01:44:07,274 >> YEAH, SORRY. 2456 01:44:07,341 --> 01:44:08,241 >> WE'RE BACK AT 1:15. 2457 01:44:08,308 --> 01:44:10,544 EVERYBODY PLEASE BE BACK AND 2458 01:44:10,611 --> 01:44:11,945 READY TO GO AT 1:15. 2459 01:44:12,012 --> 01:44:12,279 ALL RIGHT? 2460 01:44:12,346 --> 01:44:12,846 TERRIFIC. 2461 01:44:12,913 --> 01:44:16,583 THANK YOU SO MUCH. 2462 01:44:16,650 --> 01:44:17,217 WELCOME BACK. 2463 01:44:17,284 --> 01:44:20,621 WE'RE GOING TO TURN THIS OVER TO 2464 01:44:20,687 --> 01:44:21,922 LINDA COLEMAN, SUBPART A 2465 01:44:21,989 --> 01:44:23,790 COMMITTEE CO-CHAIR, AND SHE'S 2466 01:44:23,857 --> 01:44:25,759 GOING TO LEAD US THROUGH OUR 2467 01:44:25,826 --> 01:44:27,628 SECOND MAJOR AGENDA ITEM, WHICH 2468 01:44:27,694 --> 01:44:29,930 IS THE ETHICAL AND REGULATORY 2469 01:44:29,997 --> 01:44:35,302 CONSIDERATIONS FOR THE INCLUSION 2470 01:44:35,369 --> 01:44:38,138 OF LGBTQI+ POPULATIONS IN HAST 2471 01:44:38,205 --> 01:44:40,273 HUMAN SUBJECTS RESEARCH. 2472 01:44:40,340 --> 01:44:41,642 THIS STATEMENT IS NOT AS FAR 2473 01:44:41,708 --> 01:44:43,744 ALONG AS THE BEST INTEREST 2474 01:44:43,810 --> 01:44:51,184 STATEMENT BUT I WOULD HOPE 2475 01:44:51,251 --> 01:44:55,222 WE CAN GIVE LINDA AND 2476 01:44:55,288 --> 01:44:57,424 SUBCOMMITTEE ENOUGH GUIDANCE. 2477 01:44:57,491 --> 01:44:59,593 >> THANK YOU, DOUG. 2478 01:44:59,660 --> 01:45:00,794 SO, AS DOUG MENTIONED, WE'RE 2479 01:45:00,861 --> 01:45:02,996 GOING TO FOCUS ON THE 2480 01:45:03,063 --> 01:45:05,732 RECOMMENDATIONS FOR THE ETHICAL 2481 01:45:05,799 --> 01:45:08,468 REVIEW AND INCLUSION OF LGBTQI+ 2482 01:45:08,535 --> 01:45:10,003 PARTICIPANTS IN HUMAN SUBJECTS 2483 01:45:10,070 --> 01:45:10,604 RESEARCH. 2484 01:45:10,671 --> 01:45:12,639 WANT TO THANK SUBCOMMITTEE 2485 01:45:12,706 --> 01:45:15,042 MEMBERS FOR WORK ON THIS CHARGE 2486 01:45:15,108 --> 01:45:16,777 DOCUMENT, THIS IS NOT THE 2487 01:45:16,843 --> 01:45:17,978 RECOMMENDATION DOCUMENT, THIS IS 2488 01:45:18,045 --> 01:45:21,048 JUST A CHARGE. 2489 01:45:21,114 --> 01:45:24,351 AND I ALSO WANTED TO ACKNOWLEDGE 2490 01:45:24,418 --> 01:45:28,288 OUR WORKING GROUP MEMBERS, 2491 01:45:28,355 --> 01:45:30,691 LESLIE WOLF, CHERYL, COURTNEY, 2492 01:45:30,757 --> 01:45:32,759 MINDY, AND DAVID WHO WILL BE 2493 01:45:32,826 --> 01:45:34,194 ASSISTING THE SUBCOMMITTEE AND 2494 01:45:34,261 --> 01:45:36,496 THIS GROUP GETTING THE 2495 01:45:36,563 --> 01:45:37,664 RECOMMENDATIONS FINALIZED. 2496 01:45:37,731 --> 01:45:39,533 AS I MENTIONED, WHAT I DID WAS 2497 01:45:39,599 --> 01:45:40,967 PUT TOGETHER -- YOU HAVE THE 2498 01:45:41,034 --> 01:45:42,402 DOCUMENT IN FRONT OF YOU, YOU DO 2499 01:45:42,469 --> 01:45:43,270 HAVE THE DOCUMENT. 2500 01:45:43,336 --> 01:45:46,440 I THOUGHT IT WOULD BE HELPFUL TO 2501 01:45:46,506 --> 01:45:48,642 WALK THROUGH THE ENTIRE DOCUMENT 2502 01:45:48,709 --> 01:45:51,378 FIRST AND THEN GO BACK SO THAT 2503 01:45:51,445 --> 01:46:01,955 WE CAN THEN GET YOUR THOUGHTS. 2504 01:46:03,457 --> 01:46:06,159 I PUT THIS INTO A POWERPOINT TO 2505 01:46:06,226 --> 01:46:07,027 BE EASIER. 2506 01:46:07,094 --> 01:46:14,367 I'M GOING TO SHARE MY SCREEN. 2507 01:46:14,434 --> 01:46:16,770 CAN YOU SEE THAT? 2508 01:46:16,837 --> 01:46:17,104 >> YES. 2509 01:46:17,170 --> 01:46:18,739 >> I CAN SEE YOU, I NEED TO BE 2510 01:46:18,805 --> 01:46:22,375 ABLE TO DO THAT. 2511 01:46:22,442 --> 01:46:23,643 OKAY, PERFECT. 2512 01:46:23,710 --> 01:46:24,411 OKAY. 2513 01:46:24,478 --> 01:46:26,179 SO, I THINK THE FIRST PART OF 2514 01:46:26,246 --> 01:46:28,448 THE INTRODUCTION WE ALL KNOW 2515 01:46:28,515 --> 01:46:30,117 WHAT THIS CHARGE -- WHAT THE 2516 01:46:30,183 --> 01:46:32,319 FOCUS IS IN REGARD TO THIS 2517 01:46:32,385 --> 01:46:32,552 CHARGE. 2518 01:46:32,619 --> 01:46:34,488 THE ONE THING I WANTED TO CALL 2519 01:46:34,554 --> 01:46:40,060 OUT THOUGH IS THAT WHEN WE'RE 2520 01:46:40,127 --> 01:46:40,961 CONSIDERING RECOMMENDATIONS, 2521 01:46:41,027 --> 01:46:42,329 THAT WE'RE INCLUDING ADULT AND 2522 01:46:42,395 --> 01:46:43,897 MINOR PARTICIPANTS. 2523 01:46:43,964 --> 01:46:47,300 I THINK THAT'S IMPORTANT PART. 2524 01:46:47,367 --> 01:46:49,169 I ALSO -- WHAT'S NOT IN THE 2525 01:46:49,236 --> 01:46:50,704 CHARGE BUT I WANTED TO MENTION 2526 01:46:50,771 --> 01:46:53,974 WE WERE TALKING ABOUT LGBTQI+ 2527 01:46:54,040 --> 01:46:55,909 PARTICIPANTS IN GENERAL, THERE'S 2528 01:46:55,976 --> 01:46:57,511 LIKE THREE CATEGORIES THAT YOU 2529 01:46:57,577 --> 01:47:01,414 COULD PROBABLY THINK ABOUT. 2530 01:47:01,481 --> 01:47:03,517 SO, THE FIRST CATEGORY WOULD BE 2531 01:47:03,583 --> 01:47:06,019 RESEARCH WHERE SOMEONE FROM ONE 2532 01:47:06,086 --> 01:47:08,088 OF THESE COMMUNITIES 2533 01:47:08,155 --> 01:47:09,422 PARTICIPATES IN A RESEARCH 2534 01:47:09,489 --> 01:47:09,823 STUDY. 2535 01:47:09,890 --> 01:47:14,461 BUT THE RESEARCH IS NOT FOCUSED 2536 01:47:14,528 --> 01:47:16,496 ON LGBTQI+ RESEARCH QUESTIONS. 2537 01:47:16,563 --> 01:47:19,599 THAT MIGHT BE ONE CATEGORY. 2538 01:47:19,666 --> 01:47:21,535 ANOTHER CATEGORY MIGHT BE 2539 01:47:21,601 --> 01:47:24,704 RESEARCH THAT FOCUSES ON 2540 01:47:24,771 --> 01:47:27,207 SPECIFIC LGBTQI+ RESEARCH 2541 01:47:27,274 --> 01:47:27,674 QUESTIONS THEMSELVES. 2542 01:47:27,741 --> 01:47:29,976 THIRD MIGHT BE A SITUATION WHERE 2543 01:47:30,043 --> 01:47:32,579 ONE OR MORE OF THESE COMMUNITIES 2544 01:47:32,646 --> 01:47:33,914 MIGHT HAVE A RESEARCH QUESTION 2545 01:47:33,980 --> 01:47:36,349 OR AN AREA THAT MIGHT BE OF 2546 01:47:36,416 --> 01:47:40,887 PARTICULAR INTEREST TO THEM. 2547 01:47:40,954 --> 01:47:42,222 FOR EXAMPLE, ONTOLOGY, MENTAL 2548 01:47:42,289 --> 01:47:45,292 HEALTH, ANOTHER AREA WHERE 2549 01:47:45,358 --> 01:47:46,827 THERE'S RESEARCH THAT'S 2550 01:47:46,893 --> 01:47:47,928 OCCURRING WHERE OTHER 2551 01:47:47,994 --> 01:47:49,629 INDIVIDUALS MIGHT BE INCLUDED 2552 01:47:49,696 --> 01:47:52,065 BUT THIS WOULD BE PARTICULAR 2553 01:47:52,132 --> 01:47:52,999 INTEREST POTENTIALLY FOR SOMEONE 2554 01:47:53,066 --> 01:47:59,873 FROM ONE OF THESE COMMUNITIES. 2555 01:47:59,940 --> 01:48:03,577 IN TERMS OF MOTIVATION, BY THREE 2556 01:48:03,643 --> 01:48:05,779 OBJECTIVES, TO ENSURE ETHICAL 2557 01:48:05,846 --> 01:48:07,280 PROTECTION OF LGBTQI+ 2558 01:48:07,347 --> 01:48:09,382 PARTICIPANTS INVOLVED IN 2559 01:48:09,449 --> 01:48:14,421 RESEARCH, OF COURSE ALIGNING 2560 01:48:14,487 --> 01:48:20,760 WITH APPLICABLE REGULATIONS, TO 2561 01:48:20,827 --> 01:48:21,862 ADVANCE RESEARCH AND REDUCE 2562 01:48:21,928 --> 01:48:23,163 HEALTH DISPARITIES AND 2563 01:48:23,230 --> 01:48:24,931 CONTRIBUTE TO ADVANCEMENT OF 2564 01:48:24,998 --> 01:48:27,133 KNOWLEDGE AND CULTURAL 2565 01:48:27,200 --> 01:48:27,400 AWARENESS. 2566 01:48:27,467 --> 01:48:28,535 ANOTHER COUPLE POINTS TO CALL 2567 01:48:28,602 --> 01:48:30,637 OUT IN TERMS OF THE SCOPE OF THE 2568 01:48:30,704 --> 01:48:32,606 DOCUMENT IT'S NOT JUST FOCUSED 2569 01:48:32,672 --> 01:48:33,139 ON IRBs. 2570 01:48:33,206 --> 01:48:36,643 I THINK IT IS FOCUSED ON ALL 2571 01:48:36,710 --> 01:48:39,813 STAKEHOLDERS, A NUMBER OF 2572 01:48:39,880 --> 01:48:41,014 STAKEHOLDERS INCLUDING 2573 01:48:41,081 --> 01:48:42,249 INVESTIGATORS, SPONSORS, IRBs, 2574 01:48:42,315 --> 01:48:43,116 RESEARCH INSTITUTIONS, AND MIGHT 2575 01:48:43,183 --> 01:48:44,851 BE OTHERS THAT WE MIGHT WANT TO 2576 01:48:44,918 --> 01:48:45,619 CALL OUT. 2577 01:48:45,685 --> 01:48:47,254 AGAIN, I ALREADY TALKED ABOUT 2578 01:48:47,320 --> 01:48:49,456 THE FACT WE'RE CONSIDERING ADULT 2579 01:48:49,522 --> 01:48:56,663 AND MINOR PARTICIPANTS, AND I 2580 01:48:56,730 --> 01:48:57,430 THINK ONE IMPORTANT COMMENT, 2581 01:48:57,497 --> 01:49:00,400 THIS IS NOT JUST ONE GROUP. 2582 01:49:00,467 --> 01:49:01,034 THIS REPRESENTS DISTINCT 2583 01:49:01,101 --> 01:49:04,437 COMMUNITIES, EACH WITH ITS OWN 2584 01:49:04,504 --> 01:49:07,173 SET OF SENSITIVITIES, HEALTH 2585 01:49:07,240 --> 01:49:08,174 DISPARITY, POTENTIAL HEALTH 2586 01:49:08,241 --> 01:49:09,042 DISPARITIES, AND SPECIFIC 2587 01:49:09,109 --> 01:49:10,777 RESEARCH NEEDS. 2588 01:49:10,844 --> 01:49:11,878 AGAIN, IT'S NOT A 2589 01:49:11,945 --> 01:49:12,279 ONE-SIZE-FITS-ALL. 2590 01:49:12,345 --> 01:49:13,847 IT'S REALLY IMPORTANT THAT WE 2591 01:49:13,914 --> 01:49:21,388 KEEP THAT POINT IN MIND. 2592 01:49:21,454 --> 01:49:22,389 QUESTIONS FOR CONSIDERATION, 2593 01:49:22,455 --> 01:49:24,157 IT'S DIVIDED INTO THREE MAIN 2594 01:49:24,224 --> 01:49:24,557 SECTIONS. 2595 01:49:24,624 --> 01:49:28,395 THE REASON FOR THAT BEING THAT 2596 01:49:28,461 --> 01:49:31,131 AS WE'RE DEVELOPING OR WRITING 2597 01:49:31,197 --> 01:49:33,667 THE RECOMMENDATIONS, IT MIGHT BE 2598 01:49:33,733 --> 01:49:36,069 A USEFUL SORT OF FRAMEWORK FOR 2599 01:49:36,136 --> 01:49:38,238 HOW WE WRITE THE DOCUMENT 2600 01:49:38,305 --> 01:49:39,105 ITSELF. 2601 01:49:39,172 --> 01:49:40,874 OF COURSE, AS WE DELVE INTO THIS 2602 01:49:40,941 --> 01:49:44,110 A BIT MORE WE MAY DECIDE YOU AS 2603 01:49:44,177 --> 01:49:45,578 A SACHRP COMMITTEE MAY DECIDE TO 2604 01:49:45,645 --> 01:49:48,315 REORDER SOME OF THESE THINGS OR 2605 01:49:48,381 --> 01:49:50,150 MIGHT LOOK DIFFERENT BUT I THINK 2606 01:49:50,216 --> 01:49:53,019 FOR THE PURPOSES OF THE CHARGE 2607 01:49:53,086 --> 01:49:54,354 AND STARTING THIS CONVERSATION 2608 01:49:54,421 --> 01:49:56,957 THERE'S THREE MAIN SECTIONS. 2609 01:49:57,023 --> 01:49:59,926 FIRST IS MORE OVERARCHING, 2610 01:49:59,993 --> 01:50:01,995 LEGAL, REGULATORY, ETHICAL 2611 01:50:02,062 --> 01:50:02,963 CONSIDERATION WHICH MAKES SENSE, 2612 01:50:03,029 --> 01:50:04,597 YOU WANT TO START WITH THAT. 2613 01:50:04,664 --> 01:50:09,436 SECOND IS FOCUSING MORE ON HOW 2614 01:50:09,502 --> 01:50:11,504 TO ESTABLISH INCLUSIVE AND 2615 01:50:11,571 --> 01:50:12,105 CULTURALLY SENSITIVE RESEARCH 2616 01:50:12,172 --> 01:50:15,875 ENVIRONMENT AS A WHOLE TO FOSTER 2617 01:50:15,942 --> 01:50:18,278 THIS RESEARCH. 2618 01:50:18,345 --> 01:50:20,347 THIRD GETS INTO CONSIDERATIONS 2619 01:50:20,413 --> 01:50:22,215 SPECIFIC TO DESIGN, REVIEW, 2620 01:50:22,282 --> 01:50:22,749 CONDUCT, DISSEMINATION OF 2621 01:50:22,816 --> 01:50:24,951 RESULTS IN TERMS OF RESEARCH. 2622 01:50:25,018 --> 01:50:28,455 SO THE ENTIRE RESEARCH LIFE 2623 01:50:28,521 --> 01:50:29,089 CYCLE. 2624 01:50:29,155 --> 01:50:31,091 SO THE FIRST QUESTION, FIRST 2625 01:50:31,157 --> 01:50:32,625 SECTION, THERE ARE TWO QUESTIONS 2626 01:50:32,692 --> 01:50:34,027 THAT WERE ASKED. 2627 01:50:34,094 --> 01:50:35,996 THIS IS A LEGAL, REGULATORY, 2628 01:50:36,062 --> 01:50:37,097 ETHICAL CONSIDERATIONS. 2629 01:50:37,163 --> 01:50:39,232 AGAIN, THE FIRST QUESTION IS 2630 01:50:39,299 --> 01:50:40,467 FAIRLY HIGH LEVEL IN TERMS OF 2631 01:50:40,533 --> 01:50:45,739 HOW DO WE SEEK TO ENSURE 2632 01:50:45,805 --> 01:50:46,940 ADEQUATE INCLUSION OF LGBTQI+ 2633 01:50:47,007 --> 01:50:48,375 PARTICIPANTS, PROTECTING THEIR 2634 01:50:48,441 --> 01:50:50,877 RIGHTS AND WELFARE, AND THEN 2635 01:50:50,944 --> 01:50:53,747 SECOND QUESTION FOCUSES A LOT ON 2636 01:50:53,813 --> 01:50:56,449 THE ISSUES RELATED TO 2637 01:50:56,516 --> 01:50:58,451 COMPLEXITIES OF APPLICABLE LAWS, 2638 01:50:58,518 --> 01:50:59,285 REGULATIONS, GUIDELINES, 2639 01:50:59,352 --> 01:51:00,954 DIRECTIVES, STANDARDS. 2640 01:51:01,021 --> 01:51:03,023 A LOT OF THIS, THERE'S A LOT 2641 01:51:03,089 --> 01:51:05,225 HERE THAT I'M ASSUMING YOU'LL 2642 01:51:05,291 --> 01:51:06,993 HAVE COMMENTS ON, BECAUSE 2643 01:51:07,060 --> 01:51:09,162 WE'RE -- BECAUSE OF ISSUES 2644 01:51:09,229 --> 01:51:11,264 RELATED TO THINGS LIKE DIFFERENT 2645 01:51:11,331 --> 01:51:12,766 VIEWPOINTS ON THIS TOPIC, 2646 01:51:12,832 --> 01:51:13,666 POLITICAL AND SOCIAL 2647 01:51:13,733 --> 01:51:14,968 DETERMINANTS OF HEALTH, AND THE 2648 01:51:15,035 --> 01:51:18,138 FACT THAT WHEN YOU'RE LOOKING AT 2649 01:51:18,204 --> 01:51:20,340 HE'S REGULATIONS AND GUIDELINES, 2650 01:51:20,407 --> 01:51:24,377 DIRECTIVES AND STANDARDS IT'S 2651 01:51:24,444 --> 01:51:25,578 NOT JUST 45 CFR 46 REGULATIONS, 2652 01:51:25,645 --> 01:51:27,313 THERE'S SO MUCH TO CONSIDER WHEN 2653 01:51:27,380 --> 01:51:28,448 CONDUCTING RESEARCH WHETHER YOU 2654 01:51:28,515 --> 01:51:30,283 ARE DOING RESEARCH AT ONE SITE 2655 01:51:30,350 --> 01:51:31,818 OR DOING MULTIPLE SITE RESEARCH, 2656 01:51:31,885 --> 01:51:34,454 THERE'S A LOT OF COMPLEXITY HERE 2657 01:51:34,521 --> 01:51:36,423 IN TERMS OF HOW TO NAVIGATE SOME 2658 01:51:36,489 --> 01:51:37,857 OF THE ISSUES IN REGARD TO WHAT 2659 01:51:37,924 --> 01:51:41,561 WE'RE GOING TO BE TALKING ABOUT 2660 01:51:41,628 --> 01:51:41,761 TODAY. 2661 01:51:41,828 --> 01:51:44,330 THE SECOND BUCKET WOULD BE THIS 2662 01:51:44,397 --> 01:51:45,932 ISSUE OF ESTABLISHING INCLUSIVE 2663 01:51:45,999 --> 01:51:47,033 AND CULTURALLY SENSITIVE 2664 01:51:47,100 --> 01:51:48,468 RESEARCH ENVIRONMENT, SO, AGAIN, 2665 01:51:48,535 --> 01:51:51,771 THIS GETS INTO WHAT CAN WE DO TO 2666 01:51:51,838 --> 01:51:56,009 SEEK TO ENSURE THAT WE ARE 2667 01:51:56,076 --> 01:51:58,778 ACTIVELY OR IN A MEANINGFUL WAY 2668 01:51:58,845 --> 01:51:59,979 ENGAGING WITH COMMUNITY, WHAT 2669 01:52:00,046 --> 01:52:01,614 DOES THAT LOOK LIKE, YOU KNOW, 2670 01:52:01,681 --> 01:52:04,684 HOW DO WE DO THIS? 2671 01:52:04,751 --> 01:52:06,853 HOW DO YOU INCORPORATE THIS 2672 01:52:06,920 --> 01:52:10,457 THROUGHOUT THE LIFE CYCLE OF A 2673 01:52:10,523 --> 01:52:12,992 STUDY, YOU KNOW, WHAT'S 2674 01:52:13,059 --> 01:52:13,693 APPROPRIATE CALIBRATION FOR THIS 2675 01:52:13,760 --> 01:52:15,095 THIS, ET CETERA. 2676 01:52:15,161 --> 01:52:16,830 SO THAT'S WHAT THIS HAS TO DO 2677 01:52:16,896 --> 01:52:17,130 WITH. 2678 01:52:17,197 --> 01:52:20,767 AND THEN IN TERMS OF 2679 01:52:20,834 --> 01:52:22,202 COMPOSITION, I THINK WE'VE -- A 2680 01:52:22,268 --> 01:52:24,070 LOT OF TIMES WE FOCUS ON THE 2681 01:52:24,137 --> 01:52:25,905 IRB, BUT I THINK THE 2682 01:52:25,972 --> 01:52:26,506 SUBCOMMITTEE FELT IMPORTANT, 2683 01:52:26,573 --> 01:52:29,976 FELT IT WAS IMPORTANT TO ALSO 2684 01:52:30,043 --> 01:52:32,045 INCLUDE OTHER STAKEHOLDERS SUCH 2685 01:52:32,112 --> 01:52:33,947 AS STUDY TEAM, ORGANIZATIONAL 2686 01:52:34,013 --> 01:52:38,618 LEADERSHIP, IN TERMS OF HOW DO 2687 01:52:38,685 --> 01:52:40,587 WE PROMOTE DIVERSE AND INCLUSIVE 2688 01:52:40,653 --> 01:52:42,889 REPRESENTATION DURING THE 2689 01:52:42,956 --> 01:52:45,191 RESEARCH PROCESS. 2690 01:52:45,258 --> 01:52:48,228 AND THEN THE THIRD TOPIC OR 2691 01:52:48,294 --> 01:52:50,530 THIRD QUESTION OR AREA HAS TO DO 2692 01:52:50,597 --> 01:52:52,499 WITH CULTURAL COMPETENCE, AND 2693 01:52:52,565 --> 01:52:57,337 THIS GETS INTO ISSUES OF 2694 01:52:57,403 --> 01:52:59,906 CULTURAL AWARENESS, CULTURAL 2695 01:52:59,973 --> 01:53:01,274 COMPETENCE, CULTURAL HUMILITY. 2696 01:53:01,341 --> 01:53:03,543 FOR EXAMPLE WHEN WE'RE TALKING 2697 01:53:03,610 --> 01:53:07,480 ABOUT THESE TYPES OF ISSUES FOR 2698 01:53:07,547 --> 01:53:08,948 EXAMPLE IT WOULD BE SOMETHING 2699 01:53:09,015 --> 01:53:11,151 LIKE WHAT TYPE OF MAYBE 2700 01:53:11,217 --> 01:53:14,687 EDUCATION AND TRAINING MIGHT BE 2701 01:53:14,754 --> 01:53:16,156 NECESSARY ACROSS, YOU KNOW, 2702 01:53:16,222 --> 01:53:21,628 VARIOUS -- IN TERMS OF VARIOUS 2703 01:53:21,694 --> 01:53:22,929 STAKEHOLDERS IN THE RESEARCH 2704 01:53:22,996 --> 01:53:25,031 PROCESS, HOW DO WE INCLUDE 2705 01:53:25,098 --> 01:53:26,232 SEXUAL ORIENTATION AND GENDER 2706 01:53:26,299 --> 01:53:27,367 IDENTITY OPTIONS WHEN THINKING 2707 01:53:27,433 --> 01:53:30,370 ABOUT RESEARCH, HOW DO YOU MAKE 2708 01:53:30,436 --> 01:53:33,673 YOUR ENVIRONMENT MORE LGBTQI+ 2709 01:53:33,740 --> 01:53:34,040 FRIENDLY. 2710 01:53:34,107 --> 01:53:35,408 THERE'S A LOT OF LITERATURE ON 2711 01:53:35,475 --> 01:53:36,643 THE TOPIC, AND I WOULD IMAGINE 2712 01:53:36,709 --> 01:53:38,711 THERE WOULD BE A LOT OF 2713 01:53:38,778 --> 01:53:39,812 CONVERSATION WHAT DOES THIS MEAN 2714 01:53:39,879 --> 01:53:41,881 AND HOW DO WE ACTUALLY 2715 01:53:41,948 --> 01:53:42,982 ACCOMPLISH THIS. 2716 01:53:43,049 --> 01:53:45,151 SO, THAT'S WHAT THIS QUESTION IS 2717 01:53:45,218 --> 01:53:45,385 ABOUT. 2718 01:53:45,451 --> 01:53:47,987 AND THEN THE ISSUE OF 2719 01:53:48,054 --> 01:53:48,988 INTERSECTIONALITY, THIS REALLY 2720 01:53:49,055 --> 01:53:54,360 GETS TO THE FACT THAT WHEN 2721 01:53:54,427 --> 01:53:56,329 THINKING ABOUT LGBTQ+ 2722 01:53:56,396 --> 01:53:59,899 PARTICIPANTS, THAT THERE ARE 2723 01:53:59,966 --> 01:54:00,500 OTHER CHARACTERISTICS AND, YOU 2724 01:54:00,567 --> 01:54:08,408 KNOW, OTHER ISSUES THAT WE NEED 2725 01:54:08,474 --> 01:54:09,809 TO. 2726 01:54:09,876 --> 01:54:14,847 RACE, ETHNICITY, THIS IS WHAT 2727 01:54:14,914 --> 01:54:15,448 INTERSECTIONALITY COMES INTO 2728 01:54:15,515 --> 01:54:15,748 PLAY. 2729 01:54:15,815 --> 01:54:17,150 HOW ARE WE GOING TO ADDRESS 2730 01:54:17,217 --> 01:54:17,584 THAT? 2731 01:54:17,650 --> 01:54:21,521 THE THIRD AREA HAS TO DO WITH 2732 01:54:21,588 --> 01:54:22,789 THE DESIGN, REVIEW, CONDUCT, 2733 01:54:22,855 --> 01:54:23,923 DISSEMINATION OF RESULTS. 2734 01:54:23,990 --> 01:54:27,527 AGAIN, THE FIRST ONE IS REALLY 2735 01:54:27,594 --> 01:54:30,163 ABOUT HOW DO WE DESIGN AND 2736 01:54:30,230 --> 01:54:31,798 ANALYZE RESEARCH, GETS INTO WHAT 2737 01:54:31,864 --> 01:54:34,200 ARE THE RESEARCH QUESTIONS, 2738 01:54:34,267 --> 01:54:39,138 METHODS, HOW RESEARCH IS BEING 2739 01:54:39,205 --> 01:54:40,340 CONDUCTED, INCLUSION/EXCLUSION 2740 01:54:40,406 --> 01:54:41,307 CRITERIA, THE COLLECTION 2741 01:54:41,374 --> 01:54:43,710 ANALYSIS OF SEXUAL ORIENTATION 2742 01:54:43,776 --> 01:54:45,912 AND GENDER IDENTITY DATA, AND 2743 01:54:45,979 --> 01:54:47,680 THOSE TYPES OF ISSUES. 2744 01:54:47,747 --> 01:54:49,749 AND THEN ACCESS AND INCLUSION. 2745 01:54:49,816 --> 01:54:51,718 AGAIN, WHAT STRATEGIES TO BE 2746 01:54:51,784 --> 01:54:53,786 EMPLOYED IN THE DEVELOPMENT, 2747 01:54:53,853 --> 01:54:56,889 EVALUATION OF RECRUITMENT PLANS, 2748 01:54:56,956 --> 01:54:59,392 FOR EXAMPLE, FOR LGBTQI+ 2749 01:54:59,459 --> 01:54:59,993 PARTICIPANTS TO PROMOTE 2750 01:55:00,059 --> 01:55:03,529 RESEARCH, THERE'S MORE WE CAN 2751 01:55:03,596 --> 01:55:10,236 ADD HERE BUT THAT'S ONE OF THE 2752 01:55:10,303 --> 01:55:12,572 QUESTIONS THAT WAS INCLUDED. 2753 01:55:12,639 --> 01:55:21,047 INFORMED CONSENT GETS TO THE 2754 01:55:21,114 --> 01:55:29,822 ISSUE OF THE PROCESS, NEEDS AND 2755 01:55:29,889 --> 01:55:34,827 INTERESTS OF COMMUNITIES, THAT 2756 01:55:34,894 --> 01:55:36,262 GETS TO WHAT TERMINOLOGY IS 2757 01:55:36,329 --> 01:55:42,201 BEING USED, TYING INTO OTHER 2758 01:55:42,268 --> 01:55:43,069 ISSUES SUCH AS CULTURAL 2759 01:55:43,136 --> 01:55:44,037 SENSITIVITY ISSUES WE TALKED 2760 01:55:44,103 --> 01:55:51,277 ABOUT AND HOW DOES THAT PROCESS 2761 01:55:51,344 --> 01:55:51,911 LOOK. 2762 01:55:51,978 --> 01:55:57,784 PRIVACY AND CONFIDENTIALITY, 2763 01:55:57,850 --> 01:55:59,585 STIGMA FOR HARM, OTHER ISSUES 2764 01:55:59,652 --> 01:56:02,655 THAT COULD BE CONSIDERED, AND, 2765 01:56:02,722 --> 01:56:06,159 AGAIN, HERE WE ADDED INCLUDING 2766 01:56:06,225 --> 01:56:08,661 NOT JUST THE LGBTQI+ RESEARCH 2767 01:56:08,728 --> 01:56:12,398 PARTICIPANTS THEMSELVES BUT ALSO 2768 01:56:12,465 --> 01:56:13,599 POTENTIALLY NON-RESEARCH -- 2769 01:56:13,666 --> 01:56:14,801 NON-SUBJECTS, FOR EXAMPLE, AS 2770 01:56:14,867 --> 01:56:17,537 YOU KNOW THERE WAS A 2771 01:56:17,603 --> 01:56:18,938 RECOMMENDATIONS WRITTEN A COUPLE 2772 01:56:19,005 --> 01:56:22,008 YEARS AGO THAT TOUCHED UPON THE 2773 01:56:22,075 --> 01:56:25,078 ISSUE OF RISK TO NON-RESEARCH 2774 01:56:25,144 --> 01:56:28,681 PARTICIPANTS, AND SO THERE'S 2775 01:56:28,748 --> 01:56:30,116 SOME -- THERE'S PROBABLY SOME 2776 01:56:30,183 --> 01:56:30,750 RECOMMENDATIONS OR GUIDANCE 2777 01:56:30,817 --> 01:56:34,253 THERE WE CAN DRAW UPON AS WELL. 2778 01:56:34,320 --> 01:56:36,422 AND THEN OVERSIGHT SUPPORT AND 2779 01:56:36,489 --> 01:56:38,725 SECURITY, THIS GETS TO THE ISSUE 2780 01:56:38,791 --> 01:56:41,060 OF WHAT DO, YOU KNOW, 2781 01:56:41,127 --> 01:56:44,464 INVESTIGATORS, SPONSORS, IRBs 2782 01:56:44,530 --> 01:56:45,531 AND RESEARCH INSTITUTIONS NEED 2783 01:56:45,598 --> 01:56:48,501 TO DO TO ENSURE APPROPRIATE 2784 01:56:48,568 --> 01:56:49,068 OVERSIGHT, INFRASTRUCTURE, 2785 01:56:49,135 --> 01:56:51,337 SECURITY AND OTHER SUPPORT FOR 2786 01:56:51,404 --> 01:56:54,841 THIS TYPE OF RESEARCH. 2787 01:56:54,907 --> 01:56:57,477 AND THEN THE FINAL QUESTION 2788 01:56:57,543 --> 01:56:58,778 RELATES TO REPORTING AND 2789 01:56:58,845 --> 01:57:01,647 DISSEMINATION OF FINDINGS. 2790 01:57:01,714 --> 01:57:03,049 SO, AGAIN, HERE IS WHEN YOU ARE 2791 01:57:03,116 --> 01:57:03,649 REPORTING. 2792 01:57:03,716 --> 01:57:05,184 THIS IS A TOPIC IN THE RESEARCH 2793 01:57:05,251 --> 01:57:06,219 COMMUNITY WE'VE BEEN TALKING 2794 01:57:06,285 --> 01:57:08,955 ABOUT, WHEN IS IT APPROPRIATE. 2795 01:57:09,021 --> 01:57:11,591 THE IF, WHEN, AND HOW TO REPORT 2796 01:57:11,657 --> 01:57:14,093 AND DISSEMINATE FINDINGS. 2797 01:57:14,160 --> 01:57:16,095 SO THIS REALLY IS FOCUSED ON 2798 01:57:16,162 --> 01:57:19,365 THAT ISSUE SO WHEN YOU ARE 2799 01:57:19,432 --> 01:57:20,466 REPORTING AND DISSEMINATING 2800 01:57:20,533 --> 01:57:23,336 FINDINGS HOW SHOULD 2801 01:57:23,403 --> 01:57:24,404 INVESTIGATORS, SPONSORS, IRBs 2802 01:57:24,470 --> 01:57:25,304 AND RESEARCH INSTITUTIONS SEEK 2803 01:57:25,371 --> 01:57:28,241 TO ENSURE THAT THE FINDINGS FROM 2804 01:57:28,307 --> 01:57:29,575 RESEARCH ARE REPORTED AND 2805 01:57:29,642 --> 01:57:33,946 DISSEMINATED IN A WAY THAT 2806 01:57:34,013 --> 01:57:34,814 PROMOTES TRANSPARENCY BECAUSE 2807 01:57:34,881 --> 01:57:37,350 THAT CAN BUILD TRUST 2808 01:57:37,417 --> 01:57:37,884 POTENTIALLY. 2809 01:57:37,950 --> 01:57:40,853 THE ISSUE OF COMMUNITY BENEFIT. 2810 01:57:40,920 --> 01:57:42,922 ALSO PREVENT MISREPRESENTATION 2811 01:57:42,989 --> 01:57:44,791 OR MISINFORMATION AS WELL AS 2812 01:57:44,857 --> 01:57:45,758 INDIVIDUAL OR INDIVIDUAL AND 2813 01:57:45,825 --> 01:57:47,193 COMMUNITY GROUP HARM. 2814 01:57:47,260 --> 01:57:50,530 THAT IS THE CHARGE DOCUMENT. 2815 01:57:50,596 --> 01:57:56,936 AND SO WHAT I WANT TO DO NOW IS 2816 01:57:57,003 --> 01:57:59,238 GO BACK TO MAYBE PAST THE 2817 01:57:59,305 --> 01:58:01,607 INTRODUCTION AND SORT OF FOCUS 2818 01:58:01,674 --> 01:58:06,979 NOW ON THE FIRST SECTION. 2819 01:58:07,046 --> 01:58:08,548 AND GET YOUR COMMENTS. 2820 01:58:08,614 --> 01:58:10,049 I'M THINKING WHAT'S GOING TO 2821 01:58:10,116 --> 01:58:11,584 HAPPEN HERE, WE'LL TAKE YOUR 2822 01:58:11,651 --> 01:58:16,622 COMMENTS AND DO OUR FIRST DRAFT 2823 01:58:16,689 --> 01:58:17,356 OF THE RECOMMENDATIONS. 2824 01:58:17,423 --> 01:58:18,357 THE PURPOSE IS TO WALK THROUGH 2825 01:58:18,424 --> 01:58:22,295 EACH OF THE QUESTIONS AND TO GET 2826 01:58:22,361 --> 01:58:24,764 YOUR -- MAYBE YOU MIGHT WANT TO 2827 01:58:24,831 --> 01:58:26,132 CLARIFY A FEW POINTS. 2828 01:58:26,199 --> 01:58:28,000 IF THERE ARE QUESTIONS ABOUT 2829 01:58:28,067 --> 01:58:31,404 WHAT IS BEING ASKED, BUT ALSO TO 2830 01:58:31,471 --> 01:58:33,339 GET YOUR FEEDBACK, EXAMPLES YOU 2831 01:58:33,406 --> 01:58:34,340 MIGHT WANT INCLUDED. 2832 01:58:34,407 --> 01:58:36,442 THIS IS AN OPEN CONVERSATION TO 2833 01:58:36,509 --> 01:58:37,977 HELP SHAPE THE FIRST DRAFT AND 2834 01:58:38,044 --> 01:58:40,146 FUTURE DRAFTS OF THE 2835 01:58:40,213 --> 01:58:40,880 RECOMMENDATION DOCUMENT. 2836 01:58:40,947 --> 01:58:45,384 SO I'LL STOP THERE AND THEN I'LL 2837 01:58:45,451 --> 01:58:47,253 MOVE ON TO SEE IF SOMEBODY WANTS 2838 01:58:47,320 --> 01:58:54,494 TO START WITH A COMMENT. 2839 01:58:54,560 --> 01:58:57,897 TWO HANDS UP. 2840 01:58:57,964 --> 01:59:01,601 I'LL START WITH SANDRA. 2841 01:59:01,667 --> 01:59:02,802 >> NO, I'M PROBABLY PREEMPTING 2842 01:59:02,869 --> 01:59:05,104 YOUR MOVEMENT TO THE FIRST 2843 01:59:05,171 --> 01:59:05,438 SECTION. 2844 01:59:05,505 --> 01:59:07,273 BUT I WANTED TO -- I UNDERSTAND 2845 01:59:07,340 --> 01:59:10,009 STARTING OFF IN THIS WAY, WHERE 2846 01:59:10,076 --> 01:59:14,146 LEGAL, REGULATORY AND ETHICAL 2847 01:59:14,213 --> 01:59:14,947 CONSIDERATIONS ARE INTRODUCING 2848 01:59:15,014 --> 01:59:15,681 THE CHARGE. 2849 01:59:15,748 --> 01:59:17,550 I DO THINK THAT THE ETHICAL 2850 01:59:17,617 --> 01:59:18,718 CONSIDERATIONS OF COURSE ARE 2851 01:59:18,784 --> 01:59:24,123 GOING TO RUN THROUGH THE ENTIRE 2852 01:59:24,190 --> 01:59:24,957 DOCUMENT, PARTICULARLY WITH 2853 01:59:25,024 --> 01:59:27,627 RESPECT TO, YOU KNOW, 2854 01:59:27,693 --> 01:59:28,728 CONSIDERATIONS AROUND DESIGN, 2855 01:59:28,794 --> 01:59:33,232 REVIEW, YOU KNOW, THE INCLUSION 2856 01:59:33,299 --> 01:59:34,600 OF STAKEHOLDERS IN TERMS OF, YOU 2857 01:59:34,667 --> 01:59:36,202 KNOW, HOW THEY ARE INCLUDED, HOW 2858 01:59:36,269 --> 01:59:38,938 THE RESEARCH IS BEING REPORTED. 2859 01:59:39,005 --> 01:59:40,673 SO, THIS IS JUST TO SAY YOU'RE 2860 01:59:40,740 --> 01:59:42,742 PROBABLY PLANNING TO DO THAT 2861 01:59:42,808 --> 01:59:44,176 ALREADY, BUT I WOULD HIGHLY 2862 01:59:44,243 --> 01:59:50,416 RECOMMEND THAT WE CALL OUT THE 2863 01:59:50,483 --> 01:59:55,888 ETHICAL CONSIDERATIONS 2864 01:59:55,955 --> 01:59:56,188 THROUGHOUT. 2865 01:59:56,255 --> 01:59:57,757 >> THANK YOU. 2866 01:59:57,823 --> 01:59:59,292 DOES ANYBODY ELSE WANT TO START? 2867 01:59:59,358 --> 02:00:00,493 WE DON'T HAVE TO START AT THE 2868 02:00:00,560 --> 02:00:01,694 FIRST QUESTION. 2869 02:00:01,761 --> 02:00:02,795 WE CAN START ANYWHERE YOU WOULD 2870 02:00:02,862 --> 02:00:11,804 LIKE AND THAT WILL GET THE 2871 02:00:11,871 --> 02:00:14,807 CONVERSATION GOING. 2872 02:00:19,178 --> 02:00:19,312 LOIS? 2873 02:00:19,378 --> 02:00:21,981 >> I WAS LOOKING AT THE -- SO I 2874 02:00:22,048 --> 02:00:22,848 THINK I MISUNDERSTOOD WHAT WE 2875 02:00:22,915 --> 02:00:23,583 WERE DOING. 2876 02:00:23,649 --> 02:00:26,586 SO THE CHARGE HAS ALREADY BEEN 2877 02:00:26,652 --> 02:00:29,622 ADOPT, IS THAT RIGHT? 2878 02:00:29,689 --> 02:00:31,824 >> THE CHARGE HAS BEEN -- IT'S 2879 02:00:31,891 --> 02:00:33,693 CONSIDERED FINALIZED. 2880 02:00:33,759 --> 02:00:35,194 IT DOESN'T MEAN, HOWEVER, THAT 2881 02:00:35,261 --> 02:00:36,028 IF THERE'S ADDITIONAL THOUGHTS 2882 02:00:36,095 --> 02:00:37,296 WE CAN CERTAINLY TALK ABOUT IT. 2883 02:00:37,363 --> 02:00:39,131 I THINK THE IDEA NOW WE WANT TO 2884 02:00:39,198 --> 02:00:41,434 MOVE TO THE RECOMMENDATIONS SO I 2885 02:00:41,500 --> 02:00:43,502 THINK WE HAVE ENOUGH OF A 2886 02:00:43,569 --> 02:00:45,171 FRAMEWORK TO SORT OF MOVE 2887 02:00:45,237 --> 02:00:45,404 FORWARD. 2888 02:00:45,471 --> 02:00:46,806 SO AS YOU'RE LOOKING AT THESE 2889 02:00:46,872 --> 02:00:47,573 QUESTIONS IT DOESN'T MEAN THIS 2890 02:00:47,640 --> 02:00:49,542 IS THE ONLY THING YOU CAN TALK 2891 02:00:49,609 --> 02:00:51,844 ABOUT IN A PARTICULAR SECTION. 2892 02:00:51,911 --> 02:00:53,579 IT JUST MEANS THIS SORT OF 2893 02:00:53,646 --> 02:00:54,580 SHAPES THE CONTENT THAT YOU 2894 02:00:54,647 --> 02:00:57,116 MIGHT WANT TO CONSIDER IN A 2895 02:00:57,183 --> 02:00:58,084 PARTICULAR SECTION. 2896 02:00:58,150 --> 02:00:59,885 >> RIGHT. 2897 02:00:59,952 --> 02:01:00,252 THANK YOU. 2898 02:01:00,319 --> 02:01:02,555 YEAH, I HAD A COMMENT ON THE 2899 02:01:02,622 --> 02:01:05,191 THIRD PARAGRAPH OF THE CHARGE. 2900 02:01:05,257 --> 02:01:06,959 SO I'M NOT ASKING THE CHARGE BE 2901 02:01:07,026 --> 02:01:08,661 CHANGED OR ANYTHING LIKE THAT, 2902 02:01:08,728 --> 02:01:09,895 BUT THIS MIGHT BE SOMETHING 2903 02:01:09,962 --> 02:01:13,399 THAT'S USEFUL IF WE GO FORWARD. 2904 02:01:13,466 --> 02:01:17,436 I WAS A LITTLE BIT STRUCK BY 2905 02:01:17,503 --> 02:01:18,537 SOME PHRASING. 2906 02:01:18,604 --> 02:01:20,706 SO THIS ISN'T GETTING TO THE 2907 02:01:20,773 --> 02:01:21,707 SUBSTANCE RIGHT NOW. 2908 02:01:21,774 --> 02:01:25,378 KIND OF GETTING TO THE WAY WE 2909 02:01:25,444 --> 02:01:26,112 PHRASE THINGS. 2910 02:01:26,178 --> 02:01:29,615 I DON'T KNOW IF LGBTQ -- THIS IS 2911 02:01:29,682 --> 02:01:33,319 IN THE THIRD PARAGRAPH, LGBTQI+ 2912 02:01:33,386 --> 02:01:36,589 PARTICIPANTS, I'D SAY THEY ARE 2913 02:01:36,656 --> 02:01:37,456 MEMBERS OF DISTINCT COMMUNITIES 2914 02:01:37,523 --> 02:01:38,224 RATHER THAN REPRESENT. 2915 02:01:38,290 --> 02:01:40,192 I THINK WE'RE GOING TO WANT TO 2916 02:01:40,259 --> 02:01:44,897 BE CAREFUL ABOUT THAT KIND OF 2917 02:01:44,964 --> 02:01:46,432 LANGUAGE. 2918 02:01:46,499 --> 02:01:51,370 THEY ARE NOT REPRESENTING A 2919 02:01:51,437 --> 02:01:51,904 COMMUNITY. 2920 02:01:51,971 --> 02:01:54,640 IN THE WAY WE THINK ABOUT 2921 02:01:54,707 --> 02:01:55,141 REPRESENTATION. 2922 02:01:55,207 --> 02:01:59,145 I WAS STRUCK WITH ITS OWN SET OF 2923 02:01:59,211 --> 02:01:59,712 SENSITIVITIES, THAT SOUNDED 2924 02:01:59,779 --> 02:02:02,448 LIKE, YOU KNOW, I LOOKED UP THE 2925 02:02:02,515 --> 02:02:03,516 WORD SENSITIVITIES BECAUSE IT 2926 02:02:03,582 --> 02:02:05,351 STRUCK ME. 2927 02:02:05,418 --> 02:02:08,020 IT'S LIKE THIS IDEA OF LIKE 2928 02:02:08,087 --> 02:02:10,322 BEING EASY TO OFFEND, AND I 2929 02:02:10,389 --> 02:02:12,692 DON'T THINK WE WANT TO CONVEY 2930 02:02:12,758 --> 02:02:13,125 THAT. 2931 02:02:13,192 --> 02:02:15,561 LIKE IN OUR FINAL, YOU KNOW, IN 2932 02:02:15,628 --> 02:02:16,395 WHATEVER RECOMMENDATIONS. 2933 02:02:16,462 --> 02:02:17,730 YOU KNOW, THEY MIGHT HAVE THEIR 2934 02:02:17,797 --> 02:02:20,700 OWN SET OF INTERESTS OR 2935 02:02:20,766 --> 02:02:23,235 CONCERNS, BUT SENSITIVITIES 2936 02:02:23,302 --> 02:02:26,072 MIGHT JUST BE NOT THE -- YEAH, A 2937 02:02:26,138 --> 02:02:30,109 LITTLE LOADED, MIGHT NOT BE WHAT 2938 02:02:30,176 --> 02:02:32,445 WE WANT GOING FORWARD. 2939 02:02:32,511 --> 02:02:40,653 THAT'S ALL. 2940 02:02:40,720 --> 02:02:41,954 >> THAT MAKES SENSE. 2941 02:02:42,021 --> 02:02:43,656 I THINK THE TERM REPRESENTATION, 2942 02:02:43,723 --> 02:02:46,025 THE WORD YOU USED IS A BETTER 2943 02:02:46,092 --> 02:02:47,860 WORD, THAT'S THE INTENT OF THAT 2944 02:02:47,927 --> 02:02:48,194 WORD. 2945 02:02:48,260 --> 02:02:49,829 NOT REPRESENTATION IN THE SENSE 2946 02:02:49,895 --> 02:02:58,904 YOU WERE THINKING BUT I AGREE. 2947 02:02:58,971 --> 02:03:00,306 LET'S WALK THROUGH AND TALK 2948 02:03:00,372 --> 02:03:06,679 ABOUT THE FIRST SECTION IN TERMS 2949 02:03:06,746 --> 02:03:07,947 OF-- OKAY, RUQAIIJAH? 2950 02:03:08,013 --> 02:03:09,715 >> YOU CAN GO AHEAD WITH YOUR 2951 02:03:09,782 --> 02:03:10,616 OVERVIEW FIRST, I WAS GOING TO 2952 02:03:10,683 --> 02:03:12,651 THE FIRST SECTION. 2953 02:03:12,718 --> 02:03:14,653 >> I WAS GOING TO JUMP AHEAD. 2954 02:03:14,720 --> 02:03:16,655 I WANTED TO FOCUS ON THE 2955 02:03:16,722 --> 02:03:19,825 QUESTIONS AND GET FEEDBACK ON 2956 02:03:19,892 --> 02:03:20,793 THAT. 2957 02:03:20,860 --> 02:03:23,329 BUT, AGAIN, ANY FEEDBACK IS 2958 02:03:23,395 --> 02:03:24,497 WELCOME, SO I WAS GOING BACK TO 2959 02:03:24,563 --> 02:03:25,431 THE FIRST SECTION. 2960 02:03:25,498 --> 02:03:27,233 WOULD YOU PREFER I USE THE 2961 02:03:27,299 --> 02:03:28,701 POWERPOINT TO DO THIS SO WE CAN 2962 02:03:28,768 --> 02:03:29,902 FOCUS ON THE QUESTION OR DO YOU 2963 02:03:29,969 --> 02:03:31,904 WANT ME TO PUT THE CHART? 2964 02:03:31,971 --> 02:03:33,372 EITHER WAY WORKS FOR ME. 2965 02:03:33,439 --> 02:03:35,975 >> I WAS GOING TO THE LANGUAGE 2966 02:03:36,041 --> 02:03:37,777 IN THE CHARGE UNDER NUMBER ONE 2967 02:03:37,843 --> 02:03:38,511 SPECIFICALLY. 2968 02:03:38,577 --> 02:03:46,418 SO THIS IS HELPFUL FOR ME. 2969 02:03:46,485 --> 02:03:48,754 IN REVIEWING I WOULD SUGGEST 2970 02:03:48,821 --> 02:03:50,623 SEPARATING OUT THE LAWS, 2971 02:03:50,689 --> 02:03:51,724 REGULATIONS, GUIDELINES, 2972 02:03:51,791 --> 02:03:52,258 DIRECTIVES, AND STANDARDS 2973 02:03:52,324 --> 02:03:59,598 BECAUSE THEY ARE NOT ALL ON 2974 02:03:59,665 --> 02:04:02,168 EQUAL FOOTING. 2975 02:04:02,234 --> 02:04:02,635 PARTICULARLY RELIGIOUS 2976 02:04:02,701 --> 02:04:03,235 DIRECTIVES, I DON'T KNOW HOW 2977 02:04:03,302 --> 02:04:04,637 THEY COME INTO THE DISCUSSION OF 2978 02:04:04,703 --> 02:04:11,577 RESEARCH, SO FOR THAT I WOULD 2979 02:04:11,644 --> 02:04:16,582 TALK ABOUT LAWS AND REGULATIONS, 2980 02:04:16,649 --> 02:04:17,483 SEPARATE GUIDELINES AND 2981 02:04:17,550 --> 02:04:21,320 STANDARDS, AND CUT OUT RELIGIOUS 2982 02:04:21,387 --> 02:04:22,188 DIRECT I WAS. 2983 02:04:22,254 --> 02:04:26,225 AND/OR JUST SAY DIRECT I WAS. 2984 02:04:26,292 --> 02:04:28,861 JUST BECAUSE LAWS AND 2985 02:04:28,928 --> 02:04:30,830 REGULATIONS ARE BINDING, WHEREAS 2986 02:04:30,896 --> 02:04:35,868 GUIDELINES, DIRECTIVES AND 2987 02:04:35,935 --> 02:04:36,936 STANDARDS ARE NOT. 2988 02:04:37,002 --> 02:04:38,904 BUT THOSE COULD COME MORE UNDER 2989 02:04:38,971 --> 02:04:41,774 THE REGULATORY SECTION OF IT. 2990 02:04:41,841 --> 02:04:42,408 >> OKAY. 2991 02:04:42,474 --> 02:04:43,843 SO IN THE RECOMMENDATION 2992 02:04:43,909 --> 02:04:44,844 DOCUMENT WE SHOULD SEPARATE 2993 02:04:44,910 --> 02:04:46,712 THOSE OUT IS WHAT YOU'RE 2994 02:04:46,779 --> 02:04:47,046 RECOMMENDING? 2995 02:04:47,112 --> 02:04:48,113 >> YES. 2996 02:04:48,180 --> 02:04:48,547 >> OKAY. 2997 02:04:48,614 --> 02:04:51,884 >> AND I WOULD ALMOST SAY THAT 2998 02:04:51,951 --> 02:04:57,089 IN THE CHARGE TOO, JUST BECAUSE 2999 02:04:57,156 --> 02:04:58,557 AS THIS IS COMING FROM I THINK, 3000 02:04:58,624 --> 02:05:05,431 OH, I DON'T KNOW WHO IT'S COMING 3001 02:05:05,497 --> 02:05:07,032 FROM, FROM SACHRP OR -- BUT 3002 02:05:07,099 --> 02:05:07,900 RELIGIOUS DIRECTIVES SHOULD NOT 3003 02:05:07,967 --> 02:05:12,304 BE A PART OF IT. 3004 02:05:12,371 --> 02:05:13,205 >> OKAY. 3005 02:05:13,272 --> 02:05:18,811 I WILL MAKE A NOTE THERE. 3006 02:05:18,878 --> 02:05:21,313 >> MAYBE YOU CAN TELL US WHAT 3007 02:05:21,380 --> 02:05:23,716 THE THINKING WAS WITH RESPECT TO 3008 02:05:23,782 --> 02:05:23,849 -- 3009 02:05:23,916 --> 02:05:25,150 >> IT WAS THAT THERE ARE 3010 02:05:25,217 --> 02:05:26,785 DIRECTIVES, I SHOULD SAY, MORE 3011 02:05:26,852 --> 02:05:28,187 BROADLY, BUT THE CONVERSATION 3012 02:05:28,254 --> 02:05:30,289 DID COME UP BECAUSE WHEN WE'RE 3013 02:05:30,356 --> 02:05:32,992 TALKING ABOUT COMPLEXITY OF SOME 3014 02:05:33,058 --> 02:05:33,893 LAWS, DIFFERING VIEWPOINTS, 3015 02:05:33,959 --> 02:05:36,161 THOSE TYPE OF ETHICS, WHEN 3016 02:05:36,228 --> 02:05:38,397 YOU'RE DOING RESEARCH THERE ARE 3017 02:05:38,464 --> 02:05:41,100 RELIGIOUS DIRECTIVES THAT DO 3018 02:05:41,166 --> 02:05:43,002 IMPACT HOW WE ACTUALLY CONDUCT 3019 02:05:43,068 --> 02:05:47,373 OUR REVIEWS, HOW WE DO OUR 3020 02:05:47,439 --> 02:05:49,008 CONCEPTING,-- CONSENTING, THEY 3021 02:05:49,074 --> 02:05:49,875 COME INTO PLAY. 3022 02:05:49,942 --> 02:05:52,511 WE COULD LEAVE IT AS DIRECTIVES 3023 02:05:52,578 --> 02:06:03,088 MORE GENERALLY TO YOUR POINT, 3024 02:06:03,589 --> 02:06:06,825 RUQAIIJAH, WE DO HAVE A LOT OF 3025 02:06:06,892 --> 02:06:08,360 INSTITUTIONS THAT YOU HAVE TO 3026 02:06:08,427 --> 02:06:12,431 PAY ATTENTION TO THOSE TYPES OF 3027 02:06:12,498 --> 02:06:13,933 DIRECTIVES POTENTIALLY IN 3028 02:06:13,999 --> 02:06:17,369 CONSENTING, PROTOCOL WRITING, SO 3029 02:06:17,436 --> 02:06:18,537 IT WAS MORE PRACTICALLY WHAT 3030 02:06:18,604 --> 02:06:21,206 HAPPENS, WHAT SOME OF US HAVE TO 3031 02:06:21,273 --> 02:06:23,709 FACE BUT I AGREE WITH YOU, 3032 02:06:23,776 --> 02:06:25,811 RUQAIIJAH, WE SHOULD -- I DON'T 3033 02:06:25,878 --> 02:06:27,346 THINK -- FOR SURE WE CAN 3034 02:06:27,413 --> 02:06:29,315 SEPARATE OUT THIS BULLET TO MAKE 3035 02:06:29,381 --> 02:06:30,716 IT CLEAR. 3036 02:06:30,783 --> 02:06:32,318 WE CAN SAY DIRECTIVES. 3037 02:06:32,384 --> 02:06:34,153 MINDY, YOU HAD A COMMENT? 3038 02:06:34,219 --> 02:06:36,188 >> I WAS GOING TO SAY I'M FINE 3039 02:06:36,255 --> 02:06:39,124 WITH SEPARATING OUT RELIGIOUS 3040 02:06:39,191 --> 02:06:40,693 DIRECTIVES SOMEWHERE ELSE. 3041 02:06:40,759 --> 02:06:41,894 AS YOU MENTIONED, THIS IS NEAR 3042 02:06:41,961 --> 02:06:44,530 AND DEAR TO MY HEART BECAUSE WE 3043 02:06:44,596 --> 02:06:46,065 SERVE A CATHOLIC HOSPITAL WHERE 3044 02:06:46,131 --> 02:06:47,599 THEY WON'T EVEN ALLOW US AT THIS 3045 02:06:47,666 --> 02:06:50,235 TIME TO EVEN TALK ABOUT THIS 3046 02:06:50,302 --> 02:06:53,605 ISSUE BECAUSE OF THE RELIGIOUS 3047 02:06:53,672 --> 02:06:54,173 DIRECTIVES. 3048 02:06:54,239 --> 02:06:58,177 AND RELIGIOUS DIRECTIVES ARE 3049 02:06:58,243 --> 02:07:05,884 BINDING UNDER CANON, THEY ARE 3050 02:07:05,951 --> 02:07:06,118 BINDING. 3051 02:07:06,185 --> 02:07:07,286 THANK YOU. 3052 02:07:07,353 --> 02:07:09,688 >> THEY ARE BINDING, BUT ARE 3053 02:07:09,755 --> 02:07:10,990 THEY BINDING OF THE GOVERNMENT 3054 02:07:11,056 --> 02:07:11,890 OR MORE THE INSTITUTION? 3055 02:07:11,957 --> 02:07:14,293 AND THAT'S WHY I WOULD SAY MAYBE 3056 02:07:14,360 --> 02:07:20,866 WE SEPARATE ON -- OUT TO 3057 02:07:20,933 --> 02:07:22,167 INSTITUTIONAL THINGS VERSUS SORT 3058 02:07:22,234 --> 02:07:23,268 OF FEDERAL? 3059 02:07:23,335 --> 02:07:25,571 BUT, MINDY, I WOULD LOVE TO HEAR 3060 02:07:25,637 --> 02:07:29,074 MORE OF YOUR PERSPECTIVE ON 3061 02:07:29,141 --> 02:07:29,375 THAT. 3062 02:07:29,441 --> 02:07:34,213 OF HOW WE GEAR THIS TO THE 3063 02:07:34,279 --> 02:07:35,414 DIFFERENT STAKEHOLDERS WHILE 3064 02:07:35,481 --> 02:07:36,815 STRIKE TO MAKE IT'S CLEAR IT'S 3065 02:07:36,882 --> 02:07:41,653 NOT SOMETHING THE GOVERNMENT IS 3066 02:07:41,720 --> 02:07:42,755 DOING BUT INSTITUTIONS MAY DO. 3067 02:07:42,821 --> 02:07:46,158 >> SURE, I UNDERSTAND THAT TOO. 3068 02:07:46,225 --> 02:07:47,459 IT WOULD BE INSTITUTION. 3069 02:07:47,526 --> 02:07:50,195 I GET THAT. 3070 02:07:50,262 --> 02:07:54,133 THANK YOU. 3071 02:07:54,199 --> 02:07:57,770 >> GOOD. 3072 02:07:57,836 --> 02:07:58,537 ERIC, GO AHEAD. 3073 02:07:58,604 --> 02:07:59,605 >> I APPRECIATE THE DISCUSSION. 3074 02:07:59,671 --> 02:08:03,208 I CAN IMAGINE THE THINKING, 3075 02:08:03,275 --> 02:08:06,278 WANTING A BROAD APPROACH TO 3076 02:08:06,345 --> 02:08:10,983 THIS, BEING ALMOST TO A WIDE 3077 02:08:11,050 --> 02:08:12,751 AUDIENCE BUT THIS WILL BE A 3078 02:08:12,818 --> 02:08:17,222 GOVERNMENT DOCUMENT THAT WE 3079 02:08:17,289 --> 02:08:19,191 FOCUS AS RUQAIIJAH WAS SAYING ON 3080 02:08:19,258 --> 02:08:20,092 LAWS AND REGULATION, GUIDELINES 3081 02:08:20,159 --> 02:08:23,562 IN THE CONTEXT OF WHAT SACHRP IS 3082 02:08:23,629 --> 02:08:25,097 OFFERING AS GUIDELINES. 3083 02:08:25,164 --> 02:08:28,167 THIS CONCEPT OF DIRECTIVES AND 3084 02:08:28,233 --> 02:08:29,535 STANDARDS IS A LITTLE UNUSUAL 3085 02:08:29,601 --> 02:08:31,570 FROM POINT OF VIEW OF WHAT I'VE 3086 02:08:31,637 --> 02:08:33,305 SEEN IN OTHER REGULATORY 3087 02:08:33,372 --> 02:08:33,572 DOCUMENTS. 3088 02:08:33,639 --> 02:08:38,977 SO MAYBE WE FOCUS ONLY ON LAWS, 3089 02:08:39,044 --> 02:08:42,514 REGULATIONS, AND GUIDELINES, IN 3090 02:08:42,581 --> 02:08:46,652 THE CONTEXT OF SACHRP. 3091 02:08:46,718 --> 02:08:48,954 WE CAN FOOTNOTE IT BUT MAYBE 3092 02:08:49,021 --> 02:08:50,489 TAKE THAT APPROACH. 3093 02:08:50,556 --> 02:08:52,658 >> THERE MIGHT BE OTHER 3094 02:08:52,724 --> 02:08:54,760 INSTITUTIONAL OR OTHER LOCAL 3095 02:08:54,827 --> 02:08:55,994 CONSIDERATIONS THAT -- WE ALWAYS 3096 02:08:56,061 --> 02:08:57,629 TALK ABOUT LOCAL CONTEXT. 3097 02:08:57,696 --> 02:08:59,798 WE TALK ABOUT INSTITUTIONAL 3098 02:08:59,865 --> 02:09:03,302 POLICIES, SO WHAT YOU'RE 3099 02:09:03,368 --> 02:09:04,069 SUGGESTING IS EITHER NOT 3100 02:09:04,136 --> 02:09:06,238 INCLUDING IT AT ALL OR JUST 3101 02:09:06,305 --> 02:09:08,674 HAVING A DIFFERENT SECTION, I 3102 02:09:08,740 --> 02:09:11,276 WANT TO CLARIFY WHAT YOU'RE 3103 02:09:11,343 --> 02:09:11,610 RECOMMENDING. 3104 02:09:11,677 --> 02:09:13,912 >> YEAH, WONDERING IF YOU 3105 02:09:13,979 --> 02:09:15,013 LABELED THIS SECTION LAWS, 3106 02:09:15,080 --> 02:09:19,818 REGULATIONS, AND GUIDELINES. 3107 02:09:19,885 --> 02:09:21,019 >> OKAY. 3108 02:09:21,086 --> 02:09:23,755 >> DIRECTIVES AND STANDARDS, THE 3109 02:09:23,822 --> 02:09:25,190 GUIDELINE MIGHT BE EVENTUALLY 3110 02:09:25,257 --> 02:09:28,393 INDIVIDUAL INSTITUTIONS MAY NEED 3111 02:09:28,460 --> 02:09:29,361 TO APPLY LOCAL CONSIDERATION, 3112 02:09:29,428 --> 02:09:31,997 THAT MAY BE THE GUIDELINE BUT 3113 02:09:32,064 --> 02:09:36,168 THE IDEA OF DIRECTIVES AND 3114 02:09:36,235 --> 02:09:38,370 STANDARDS IS LESS COMMON 3115 02:09:38,437 --> 02:09:39,905 THINKING ABOUT REGULATORY TEXT 3116 02:09:39,972 --> 02:09:43,308 AND GUIDANCE OHRP PUT OUT FOR 3117 02:09:43,375 --> 02:09:43,542 EXAMPLE. 3118 02:09:43,609 --> 02:09:44,610 >> THAT MAKES SENSE. 3119 02:09:44,676 --> 02:09:47,112 I'M NOT SURE WHO WAS UP NEXT. 3120 02:09:47,179 --> 02:09:48,780 I'LL GO WITH ALLISON AND KEVIN. 3121 02:09:48,847 --> 02:09:50,516 >> I'M NOT ON THIS POINT. 3122 02:09:50,582 --> 02:09:54,353 KEVIN, ARE YOU ON THIS POINT? 3123 02:09:54,419 --> 02:09:55,320 >> YEAH. 3124 02:09:55,387 --> 02:09:58,056 I'LL BE FAST. 3125 02:09:58,123 --> 02:09:59,057 THANKS, ALLISON. 3126 02:09:59,124 --> 02:10:04,096 I THINK I AGREE WITH ERIC. 3127 02:10:04,163 --> 02:10:06,064 IT WOULD BE CLEANER AND 3128 02:10:06,131 --> 02:10:06,565 COMPLEMENT ETHICAL 3129 02:10:06,632 --> 02:10:07,266 CONSIDERATIONS ABOVE. 3130 02:10:07,332 --> 02:10:08,467 BUT I'M ALSO LOOKING AT THE 3131 02:10:08,534 --> 02:10:10,002 TEXT. THERE IT SEEMS LIKE 3132 02:10:10,068 --> 02:10:12,638 THERE'S SOMETHING IN THE SPIRIT 3133 02:10:12,704 --> 02:10:16,241 OF THAT THAT THE QUESTION ASKERS 3134 02:10:16,308 --> 02:10:17,676 ARE GETTING -- ACKNOWLEDGING 3135 02:10:17,743 --> 02:10:20,646 THESE DIVERSE VIEWPOINTS THAT 3136 02:10:20,712 --> 02:10:24,583 ARE OUT THERE, THIS SORT OF MESS 3137 02:10:24,650 --> 02:10:26,652 OF FACTORS THAT COULD CREATE 3138 02:10:26,718 --> 02:10:29,488 BARRIERS TO DOING THE SORTS OF 3139 02:10:29,555 --> 02:10:30,489 THINGS THAT WE'RE RECOMMENDING, 3140 02:10:30,556 --> 02:10:33,992 SO I'M WONDERING IF WE DROP THAT 3141 02:10:34,059 --> 02:10:35,527 PART OUT OF THIS, CAN WE JUST 3142 02:10:35,594 --> 02:10:39,164 TAKE THAT AS SORT OF IMPLICIT 3143 02:10:39,231 --> 02:10:41,200 THROUGHOUT ALL OF THESE THAT 3144 02:10:41,266 --> 02:10:43,635 WE'RE TRYING TO MAKE 3145 02:10:43,702 --> 02:10:44,836 RECOMMENDATIONS IN THE CONTEXT 3146 02:10:44,903 --> 02:10:47,372 OF THESE VERY DIVERSE VIEWPOINTS 3147 02:10:47,439 --> 02:10:51,543 AND IMPACT OF POLITICAL AND 3148 02:10:51,610 --> 02:10:52,211 SOCIAL DETERMINANTS. 3149 02:10:52,277 --> 02:10:57,683 >> OKAY. 3150 02:10:57,749 --> 02:10:59,851 SO, I WANTED TO -- THIS IS ALL 3151 02:10:59,918 --> 02:11:04,156 CLEAR, SO MY QUESTION IS I JUST 3152 02:11:04,223 --> 02:11:05,791 WANTED TO CONFIRM. 3153 02:11:05,857 --> 02:11:07,859 SO LAWS, REGULATIONS, 3154 02:11:07,926 --> 02:11:09,394 GUIDELINES, THAT MAKES SENSE TO 3155 02:11:09,461 --> 02:11:09,628 ME. 3156 02:11:09,695 --> 02:11:11,129 ORIGINALLY I THINK WE HAD 3157 02:11:11,196 --> 02:11:13,131 SOMETHING MORE SPECIFIC TO THAT, 3158 02:11:13,198 --> 02:11:14,299 AS IT EVOLVED WE INCLUDED SOME 3159 02:11:14,366 --> 02:11:14,700 OTHER THINGS. 3160 02:11:14,766 --> 02:11:17,236 IN TERMS OF THE ISSUES OF 3161 02:11:17,302 --> 02:11:18,604 POLITICAL AND SOCIAL 3162 02:11:18,670 --> 02:11:20,172 DETERMINANTS OF HEALTH, WHAT YOU 3163 02:11:20,239 --> 02:11:21,440 JUST SAID, KEVIN, ARE YOU 3164 02:11:21,506 --> 02:11:23,408 SUGGESTING THAT WE DON'T NEED 3165 02:11:23,475 --> 02:11:25,944 ANOTHER BULLET FOR THE CHARGE? 3166 02:11:26,011 --> 02:11:27,779 AND/OR IT'S JUST SORT OF IMPLIED 3167 02:11:27,846 --> 02:11:29,448 WE'LL BE TOUCHING UPON THOSE 3168 02:11:29,514 --> 02:11:30,549 ISSUES THROUGHOUT THE DOCUMENTS? 3169 02:11:30,616 --> 02:11:32,484 I THINK THAT'S WHAT YOU HEARD, 3170 02:11:32,551 --> 02:11:33,719 THE LATTER IS WHAT I HEARD. 3171 02:11:33,785 --> 02:11:38,724 >> YEAH, I DON'T KNOW WHAT THE 3172 02:11:38,790 --> 02:11:40,158 INTENTION WAS WITH THAT 3173 02:11:40,225 --> 02:11:41,226 LANGUAGE. 3174 02:11:41,293 --> 02:11:42,761 ONE READING THESE ARE CONTEXTUAL 3175 02:11:42,828 --> 02:11:44,529 ISSUES THAT ARE GOING TO BE 3176 02:11:44,596 --> 02:11:46,832 RELEVANT PRETTY MUCH TO 3177 02:11:46,898 --> 02:11:48,133 EVERYTHING THERE, AND SO IF 3178 02:11:48,200 --> 02:11:49,468 THAT'S CORRECT WE COULD REMOVE 3179 02:11:49,534 --> 02:11:55,374 IT AND JUST KNOW IT'S IMPLICIT, 3180 02:11:55,440 --> 02:11:59,544 MAYBE REFLECTED, BUT IF IT 3181 02:11:59,611 --> 02:12:00,979 MEANT SOMETHING ELSE MAYBE 3182 02:12:01,046 --> 02:12:01,947 THERE'S ANOTHER BULLET THAT'S 3183 02:12:02,014 --> 02:12:03,382 REQUIRED THEN BECAUSE THERE'S A 3184 02:12:03,448 --> 02:12:05,784 SPECIFIC ISSUE THAT NEEDS TO BE 3185 02:12:05,851 --> 02:12:06,051 ADDRESSED. 3186 02:12:06,118 --> 02:12:08,186 >> I THINK THE ISSUE, THE REASON 3187 02:12:08,253 --> 02:12:10,389 WHY IT'S ADDED, BECAUSE IT WOULD 3188 02:12:10,455 --> 02:12:12,691 APPEAR IN THE RECOMMENDATIONS AS 3189 02:12:12,758 --> 02:12:14,526 YOU'RE DOING FRAMING, THE 3190 02:12:14,593 --> 02:12:15,927 RECOMMENDATIONS. 3191 02:12:15,994 --> 02:12:16,962 YOU WOULD PROBABLY TOUCH UPON, 3192 02:12:17,029 --> 02:12:20,932 ACKNOWLEDGE WHAT YOU JUST SAID, 3193 02:12:20,999 --> 02:12:21,900 CONTEXTUAL FEATURES OR ISSUES. 3194 02:12:21,967 --> 02:12:23,869 AND THAT'S WHY IT WAS ADDED. 3195 02:12:23,935 --> 02:12:29,408 BUT I THINK THAT WE CAN 3196 02:12:29,474 --> 02:12:31,843 CERTAINLY MAKE A CHANGE TO THE 3197 02:12:31,910 --> 02:12:35,781 CHARGE, AND ALSO REFLECT THAT IN 3198 02:12:35,847 --> 02:12:37,082 THE RECOMMENDATION DOCUMENT. 3199 02:12:37,149 --> 02:12:38,817 >> BUT IT SEEMS LIKE THOSE 3200 02:12:38,884 --> 02:12:43,322 CONSIDERATIONS WILL BE RELEVANT 3201 02:12:43,388 --> 02:12:44,790 TO A LOT OF QUESTIONS, KEEP IT 3202 02:12:44,856 --> 02:12:46,491 BUT PUT IT IN THE BIGGER 3203 02:12:46,558 --> 02:12:47,559 INTRODUCTION, NOT THIS SECTION. 3204 02:12:47,626 --> 02:12:49,328 >> I DO KNOW WHEN THIS 3205 02:12:49,394 --> 02:12:51,196 CONVERSATION, WHEN WE WERE 3206 02:12:51,263 --> 02:12:53,131 TALKING ABOUT THIS CONVERSATION 3207 02:12:53,198 --> 02:12:56,668 THERE WERE COMMENTS ALSO FROM 3208 02:12:56,735 --> 02:12:59,271 SOME EXPERTS THAT SPENT TIME 3209 02:12:59,338 --> 02:13:00,372 TALKING ABOUT NOT ONLY THE 3210 02:13:00,439 --> 02:13:02,441 COMPLEXITIES OF THE LAWS AND 3211 02:13:02,507 --> 02:13:03,542 REGULATIONS AND GUIDELINES AND 3212 02:13:03,608 --> 02:13:06,178 THOSE KINDS OF THINGS, HOW YOU 3213 02:13:06,244 --> 02:13:07,879 ACTUALLY CONDUCT RESEARCH IN 3214 02:13:07,946 --> 02:13:09,247 THIS AREA, BUT THEY FOCUSED A 3215 02:13:09,314 --> 02:13:11,116 LOT OF THEIR ATTENTION ON THE 3216 02:13:11,183 --> 02:13:12,417 IMPACT OF POLITICAL AND SOCIAL 3217 02:13:12,484 --> 02:13:13,819 DETERMINANTS OF HEALTH AS WELL. 3218 02:13:13,885 --> 02:13:15,487 AGAIN, I WANTED TO PUT THAT OUT 3219 02:13:15,554 --> 02:13:16,221 THERE. 3220 02:13:16,288 --> 02:13:17,556 THAT'S WHERE THAT LANGUAGE CAME 3221 02:13:17,622 --> 02:13:22,160 FROM, WHY IT WAS ADDED. 3222 02:13:22,227 --> 02:13:22,394 OKAY. 3223 02:13:22,461 --> 02:13:24,663 ALLISON, I'LL GO TO YOU NEXT. 3224 02:13:24,730 --> 02:13:28,734 >> I JUST WANTED TO POINT OUT, 3225 02:13:28,800 --> 02:13:31,603 AS MAYBE A REFERENCE OR 3226 02:13:31,670 --> 02:13:34,439 WHATEVER, FOR THE DOCUMENTS THAT 3227 02:13:34,506 --> 02:13:36,074 THE WHITE HOUSE RELEASED AN 3228 02:13:36,141 --> 02:13:37,175 EXECUTIVE ORDER ON ADVANCING 3229 02:13:37,242 --> 02:13:38,043 WOMEN'S HEALTH. 3230 02:13:38,110 --> 02:13:42,114 I'M A HUGE FAN OF HAVING, YOU 3231 02:13:42,180 --> 02:13:44,516 KNOW, SIMILAR LANGUAGE BETWEEN 3232 02:13:44,583 --> 02:13:47,786 VARIOUS THINGS, UNLESS THERE IS 3233 02:13:47,853 --> 02:13:50,856 A REASON TO HAVE DISSENTING 3234 02:13:50,922 --> 02:13:51,923 LANGUAGE OR FRAME THINGS 3235 02:13:51,990 --> 02:13:52,224 DIFFERENTLY. 3236 02:13:52,290 --> 02:13:54,459 I THOUGHT THAT WOULD BE A GOOD 3237 02:13:54,526 --> 02:13:56,528 RESOURCE TO LOOK AT HOW THEY 3238 02:13:56,595 --> 02:13:59,798 ADDRESS SOME OF THESE ISSUES IN 3239 02:13:59,865 --> 02:14:03,201 THE CONTEXT OF WOMEN AND WHERE 3240 02:14:03,268 --> 02:14:05,170 NECESSARY MAKE CHANGES BUT WHERE 3241 02:14:05,237 --> 02:14:08,006 THE LANGUAGE WORKS JUST GO AHEAD 3242 02:14:08,073 --> 02:14:12,277 AND USE IT. 3243 02:14:12,344 --> 02:14:13,712 >> OKAY. 3244 02:14:13,779 --> 02:14:15,113 I'M MAKING A NOTE. 3245 02:14:15,180 --> 02:14:16,081 EXCUSE ME, I'M TAKING NOTES 3246 02:14:16,148 --> 02:14:16,515 HERE. 3247 02:14:16,581 --> 02:14:18,817 >> I PUT THE LINK IN THE CHAT. 3248 02:14:18,884 --> 02:14:21,019 >> OKAY. 3249 02:14:21,086 --> 02:14:24,189 THANK YOU. 3250 02:14:24,256 --> 02:14:25,590 >> UH-HUH. 3251 02:14:25,657 --> 02:14:25,957 >> RUQAIIJAH? 3252 02:14:26,024 --> 02:14:28,460 >> A MINOR POINT, WHEN YOU WERE 3253 02:14:28,527 --> 02:14:29,428 DELETING PART, YOU DELETED 3254 02:14:29,494 --> 02:14:29,728 GUIDELINES. 3255 02:14:29,795 --> 02:14:34,833 YOU CAN KEEP THOSE THERE. 3256 02:14:34,900 --> 02:14:41,706 >> THANK YOU. 3257 02:14:41,773 --> 02:14:42,908 IN TERMS OF THIS SECTION THEN 3258 02:14:42,974 --> 02:14:44,242 ARE THERE ANY OTHER POINTS YOU 3259 02:14:44,309 --> 02:14:47,312 WANT TO MAKE BEFORE WE MOVE ON 3260 02:14:47,379 --> 02:14:54,686 TO THE NEXT? 3261 02:14:54,820 --> 02:14:58,790 I THINK -- I'M GOING TO MOVE 3262 02:14:58,857 --> 02:15:00,091 DOWN TO THE NEXT SECTION. 3263 02:15:00,158 --> 02:15:01,860 WE CAN ALWAYS COME BACK UP IF WE 3264 02:15:01,927 --> 02:15:03,028 NEED TO. 3265 02:15:03,094 --> 02:15:06,898 THE NEXT SECTION IS ON 3266 02:15:06,965 --> 02:15:08,400 ESTABLISHING INCLUSIVE AND 3267 02:15:08,467 --> 02:15:11,403 CULTURALLY SENSITIVITY RESEARCH 3268 02:15:11,470 --> 02:15:12,103 ENVIRONMENT. 3269 02:15:12,170 --> 02:15:12,804 COMMUNITY ENGAGEMENT, 3270 02:15:12,871 --> 02:15:15,974 COMPOSITION OF STUDY TEAM, 3271 02:15:16,041 --> 02:15:18,510 CULTURAL COMPETENCE, 3272 02:15:18,577 --> 02:15:19,110 INTERSECTIONALITY. 3273 02:15:19,177 --> 02:15:24,216 SO, HERE AGAIN THIS IS SORT OF 3274 02:15:24,282 --> 02:15:25,550 THE -- THESE ARE THE QUESTIONS 3275 02:15:25,617 --> 02:15:26,918 THAT WE'RE LOOKING AT. 3276 02:15:26,985 --> 02:15:30,121 I THOUGHT WE COULD MAYBE DELVE 3277 02:15:30,188 --> 02:15:31,756 MORE INTO EACH OF THESE. 3278 02:15:31,823 --> 02:15:35,160 I'LL START WITH COMMUNITY 3279 02:15:35,227 --> 02:15:35,594 ENGAGEMENT. 3280 02:15:35,660 --> 02:15:40,198 AND GETTING INTO MORE SPECIFICS 3281 02:15:40,265 --> 02:15:41,399 REGARDING WHAT KINDS OF THINGS 3282 02:15:41,466 --> 02:15:46,505 YOU WOULD LIKE TO SEE IN THIS 3283 02:15:46,571 --> 02:15:47,072 SECTION. 3284 02:15:47,138 --> 02:15:47,305 LOIS? 3285 02:15:47,372 --> 02:15:50,275 >> I GUESS TWO THINGS. 3286 02:15:50,342 --> 02:15:52,911 I FEEL LIKE WE'RE GOING TO NEED 3287 02:15:52,978 --> 02:15:57,048 TO DRAW ON EXPERTISE. 3288 02:15:57,115 --> 02:16:00,318 SO, TO SOME EXTENT THIS DOCUMENT 3289 02:16:00,385 --> 02:16:03,288 ESPECIALLY IS GOING TO NOT, YOU 3290 02:16:03,355 --> 02:16:05,690 KNOW, WHY THEY SHOULD, RIGHT? 3291 02:16:05,757 --> 02:16:06,791 BUT HOW CAN, RIGHT? 3292 02:16:06,858 --> 02:16:12,364 A LOT OF THESE QUESTIONS ARE HOW 3293 02:16:12,430 --> 02:16:15,767 CAN RATHER THAN A QUESTION OF 3294 02:16:15,834 --> 02:16:18,503 WHAT SHOULD BE DONE THAT, YOU 3295 02:16:18,570 --> 02:16:22,774 KNOW, MAYBE IN SOME WAYS -- I'M 3296 02:16:22,841 --> 02:16:24,075 ASKING QUESTIONS WHETHER IN SOME 3297 02:16:24,142 --> 02:16:25,710 WAYS THIS DOCUMENT IS GOING TO 3298 02:16:25,777 --> 02:16:34,152 BE TRYING TO HIGHLIGHT GOOD 3299 02:16:34,219 --> 02:16:34,686 RESOURCES. 3300 02:16:34,753 --> 02:16:36,855 OR IS THIS PROJECT NOT JUST 3301 02:16:36,922 --> 02:16:38,056 DOCUMENT, THE ONE WE EVENTUALLY 3302 02:16:38,123 --> 02:16:39,824 COME UP WITH, IS IT GOING TO BE 3303 02:16:39,891 --> 02:16:41,359 THE RESOURCE ITSELF? 3304 02:16:41,426 --> 02:16:44,663 SO THAT'S ONE QUESTION I HAVE 3305 02:16:44,729 --> 02:16:46,731 BECAUSE IT COULD BE A HUGE, HUGE 3306 02:16:46,798 --> 02:16:49,367 PROJECT OR IS IT MORE OF A WE'VE 3307 02:16:49,434 --> 02:16:53,305 GATHERED THESE KINDS OF THINGS 3308 02:16:53,371 --> 02:16:56,575 TOGETHER IN A HELPFUL WAY FOR 3309 02:16:56,641 --> 02:16:58,076 ALL THESE STAKEHOLDERS TO ACCESS 3310 02:16:58,143 --> 02:17:00,078 THINGS THAT WE THINK ARE GOOD. 3311 02:17:00,145 --> 02:17:01,046 SO THAT'S ONE QUESTION. 3312 02:17:01,112 --> 02:17:03,014 AND THEN THE OTHER QUESTION IS 3313 02:17:03,081 --> 02:17:04,649 JUST GOING FORWARD THINKING 3314 02:17:04,716 --> 02:17:06,184 ABOUT ULTIMATE THING WE PRODUCE, 3315 02:17:06,251 --> 02:17:11,890 THAT IT MIGHT BE HELPFUL TO HAVE 3316 02:17:11,957 --> 02:17:13,425 SOME CASE STUDIES. 3317 02:17:13,491 --> 02:17:14,726 ESPECIALLY I WAS THINKING BACK 3318 02:17:14,793 --> 02:17:16,795 ON THE ONE WE'VE ALREADY LEFT 3319 02:17:16,861 --> 02:17:21,933 ABOUT THE LAWS BUT ALL OF THESE 3320 02:17:22,000 --> 02:17:23,234 THINGS INTERACT, INTERRELATE. 3321 02:17:23,301 --> 02:17:26,037 BUT WITH SOME EXAMPLES OF HOW 3322 02:17:26,104 --> 02:17:29,274 WITH THESE, YOU KNOW, COMPLEX 3323 02:17:29,341 --> 02:17:32,210 REGULATIONS AND LAWS THAT MAY BE 3324 02:17:32,277 --> 02:17:36,815 AT SOME POINTS, YOU KNOW, AT 3325 02:17:36,881 --> 02:17:40,685 LOGGERHEADS, HOW DOES ONE 3326 02:17:40,752 --> 02:17:41,553 NAVIGATE THAT? 3327 02:17:41,620 --> 02:17:43,655 OR WHAT ARE WE TRYING TO GIVE 3328 02:17:43,722 --> 02:17:46,725 TOOLS OR TRYING -- I GUESS 3329 02:17:46,791 --> 02:17:50,128 THAT'S THE -- I'M WONDERING WHAT 3330 02:17:50,195 --> 02:17:53,198 THIS ULTIMATE DOCUMENT MIGHT BE 3331 02:17:53,264 --> 02:17:55,066 LOOKING LIKE, WHAT PEOPLE'S 3332 02:17:55,133 --> 02:17:58,236 THOUGHTS ARE ON THAT. 3333 02:17:58,303 --> 02:17:59,871 >> ANY OTHERS ON THAT? 3334 02:17:59,938 --> 02:18:02,040 LET'S SEE HERE. 3335 02:18:02,107 --> 02:18:02,741 SANDRA? 3336 02:18:02,807 --> 02:18:03,808 >> NO, NO, I HAVE A SIMILAR 3337 02:18:03,875 --> 02:18:04,075 QUESTION. 3338 02:18:04,142 --> 02:18:06,044 I GUESS I WAS THINKING IT WAS 3339 02:18:06,111 --> 02:18:08,279 NOT ONLY GOING TO BE HOW DO YOU 3340 02:18:08,346 --> 02:18:11,116 DO IT BUT ALSO WHY SHOULD YOU DO 3341 02:18:11,182 --> 02:18:12,651 IT. 3342 02:18:12,717 --> 02:18:15,286 AND SO THIS IS WHERE, YOU KNOW, 3343 02:18:15,353 --> 02:18:19,257 IN TERMS OF COMMUNITY 3344 02:18:19,324 --> 02:18:20,892 ENGAGEMENT, ETHICAL FRAMING OF 3345 02:18:20,959 --> 02:18:23,628 THIS IN TERMS OF RESPECT MIGHT 3346 02:18:23,695 --> 02:18:24,929 BE GOOD TO MENTION IN TERMS OF 3347 02:18:24,996 --> 02:18:27,699 WHY YOU MIGHT WANT TO DO IT. 3348 02:18:27,766 --> 02:18:29,868 THE OTHER IS THAT IT SEEMS SOME 3349 02:18:29,934 --> 02:18:31,403 OF THESE SUBPOINTS MIGHT BE 3350 02:18:31,469 --> 02:18:32,937 SYNERGISTIC WITH EACH OTHER. 3351 02:18:33,004 --> 02:18:35,106 THE IDEA THAT YOU SHOULD DO 3352 02:18:35,173 --> 02:18:36,641 COMMUNITY ENGAGEMENT AND HOW YOU 3353 02:18:36,708 --> 02:18:40,045 MIGHT DO IT IS RELATED TO THE 3354 02:18:40,111 --> 02:18:43,415 COMPOSITION OF THE STUDY TEAM IN 3355 02:18:43,481 --> 02:18:45,950 TERMS OF EXPERTISE IN COMMUNITY 3356 02:18:46,017 --> 02:18:46,284 ENGAGEMENT. 3357 02:18:46,351 --> 02:18:50,188 I COULD SEE THOSE BEING 3358 02:18:50,255 --> 02:18:50,488 SYNERGISTIC. 3359 02:18:50,555 --> 02:18:52,724 SO, JUST TO THINK ABOUT THESE 3360 02:18:52,791 --> 02:18:55,894 LESSONS KIND OF SEPARATE BULLET 3361 02:18:55,960 --> 02:18:57,562 POINTS I GUESS BUT IN 3362 02:18:57,629 --> 02:19:02,133 COMMUNICATION WITH EACH OTHER. 3363 02:19:02,200 --> 02:19:04,669 >> OKAY. 3364 02:19:04,736 --> 02:19:05,870 KEVIN? 3365 02:19:05,937 --> 02:19:07,505 >> TO LOIS' QUESTION, I HAD THE 3366 02:19:07,572 --> 02:19:09,574 REACTION GOING THROUGH THIS THAT 3367 02:19:09,641 --> 02:19:14,946 FOR SOME OF THESE I MEAN THE 3368 02:19:15,013 --> 02:19:16,481 ANSWERS TO THESE QUESTIONS, YOU 3369 02:19:16,548 --> 02:19:18,683 KNOW, ARE FAIRLY MASSIVE 3370 02:19:18,750 --> 02:19:23,054 TOOLKITS AND REPORTS BY OTHER 3371 02:19:23,121 --> 02:19:23,288 GROUPS. 3372 02:19:23,354 --> 02:19:28,259 AND SO I WAS GUESSING WE'RE NOT 3373 02:19:28,326 --> 02:19:30,595 PRODUCING THAT, AND SO WE WOULD 3374 02:19:30,662 --> 02:19:33,031 NEED TO TRY TO IDENTIFY THOSE 3375 02:19:33,098 --> 02:19:35,900 RESOURCES THAT ARE OUT THERE, OR 3376 02:19:35,967 --> 02:19:38,436 RESOURCES THAT COULD BE ADAPTED, 3377 02:19:38,503 --> 02:19:45,477 FOR EXAMPLE, THERE'S A LOT OF 3378 02:19:45,543 --> 02:19:46,211 GREAT STUFF ON INCORPORATING 3379 02:19:46,277 --> 02:19:47,479 PERSPECTIVES INTO THE DESIGN OF 3380 02:19:47,545 --> 02:19:49,247 STUDIES AND THINGS LIKE THAT, 3381 02:19:49,314 --> 02:19:51,649 BEST PRACTICES FOR THAT. 3382 02:19:51,716 --> 02:19:53,384 THE SAME QUESTIONS WERE COMING 3383 02:19:53,451 --> 02:19:57,355 TO MY MIND AS LOIS ASKED. 3384 02:19:57,422 --> 02:19:59,758 s I WOULD SAY IT'S PRACTICALLY 3385 02:19:59,824 --> 02:20:02,727 IMPOSSIBLE FOR US TO GIVE A 3386 02:20:02,794 --> 02:20:04,929 REALLY THOROUGH ANSWER TO SOME 3387 02:20:04,996 --> 02:20:07,198 OF THESE BUT WE COULD UNDERSCORE 3388 02:20:07,265 --> 02:20:10,602 WHY THEY ARE IMPORTANT AS SANDRA 3389 02:20:10,668 --> 02:20:14,439 SAID, AND POINT TO SOME 3390 02:20:14,506 --> 02:20:16,174 RESOURCES THAT COULD BE 3391 02:20:16,241 --> 02:20:18,176 AVAILABLE TO FOLKS. 3392 02:20:18,243 --> 02:20:24,716 >> OKAY. 3393 02:20:24,783 --> 02:20:28,219 MY UNDERSTANDING IT'S A 3394 02:20:28,286 --> 02:20:30,522 COMBINATION OF THE WHY HIGHER 3395 02:20:30,588 --> 02:20:32,157 LEVEL BUT ALSO HOW, BUT NOT IN 3396 02:20:32,223 --> 02:20:35,326 LOOKING AT SOME OTHER SACHRP 3397 02:20:35,393 --> 02:20:36,194 RECOMMENDATIONS THEY TEND TO 3398 02:20:36,261 --> 02:20:38,396 BE -- THERE'S A LITTLE BIT OF 3399 02:20:38,463 --> 02:20:39,397 SPECIFICITY BUT TYPICALLY NOT 3400 02:20:39,464 --> 02:20:41,900 GOING TO BE LIKE A TOOLKIT SO I 3401 02:20:41,966 --> 02:20:43,401 AGREE WITH YOU ON THAT. 3402 02:20:43,468 --> 02:20:46,337 WE WANT IT TO BE HELPFUL, I 3403 02:20:46,404 --> 02:20:47,605 WOULD IMAGINE. 3404 02:20:47,672 --> 02:20:51,676 SO THAT IT'S NOT JUST THE WHY. 3405 02:20:51,743 --> 02:20:55,046 BUT OF COURSE EACH OF THESE 3406 02:20:55,113 --> 02:20:56,047 TOPICS, COMMUNITY ENGAGEMENT 3407 02:20:56,114 --> 02:20:58,983 JUST BY ITSELF, JUST THE FIRST 3408 02:20:59,050 --> 02:21:01,186 QUESTION, TOOL KIT WOULD BE 3409 02:21:01,252 --> 02:21:02,720 QUITE A MASSIVE UNDERTAKING. 3410 02:21:02,787 --> 02:21:04,255 BUT THERE'S STILL A LOT OF 3411 02:21:04,322 --> 02:21:06,191 LESSONS LEARNED FROM OTHER 3412 02:21:06,257 --> 02:21:07,725 ORGANIZATIONS THAT DO THIS, AND 3413 02:21:07,792 --> 02:21:08,960 MAYBE DOING THIS WELL THAT WE 3414 02:21:09,027 --> 02:21:10,261 MIGHT WANT TO INCORPORATE. 3415 02:21:10,328 --> 02:21:12,130 SO, AGAIN, THAT'S GOING TO BE 3416 02:21:12,197 --> 02:21:15,333 PART OF THE EXERCISE PUTTING 3417 02:21:15,400 --> 02:21:18,303 TOGETHER THESE RECOMMENDATIONS. 3418 02:21:24,342 --> 02:21:26,678 ALL RIGHT. 3419 02:21:26,744 --> 02:21:28,546 LET'S TALK ABOUT -- I'M GOING 3420 02:21:28,613 --> 02:21:31,049 THROUGH EACH OF THE BULLETS. 3421 02:21:31,115 --> 02:21:32,350 ANYBODY HAVE ANYTHING MORE 3422 02:21:32,417 --> 02:21:34,552 SPECIFIC ON COMPOSITION OF THE 3423 02:21:34,619 --> 02:21:36,087 TEAM? 3424 02:21:36,154 --> 02:21:39,123 SOME EXAMPLES TO SHARE? 3425 02:21:39,190 --> 02:21:41,125 HOW YOU SEE YOUR ORGANIZATION, 3426 02:21:41,192 --> 02:21:42,126 OTHER ORGANIZATIONS DO THIS, 3427 02:21:42,193 --> 02:21:43,962 MAYBE WE CAN INCORPORATE SOME OF 3428 02:21:44,028 --> 02:21:45,597 THAT, WE COULD DO THAT AS WELL. 3429 02:21:45,663 --> 02:21:47,799 THAT MIGHT BE HELPFUL FOR THIS 3430 02:21:47,866 --> 02:21:48,900 CONVERSATION AS WELL, NOT JUST 3431 02:21:48,967 --> 02:21:53,705 SORT OF LIKE A HIGH LEVEL. 3432 02:21:53,771 --> 02:21:55,573 I KNOW ONE OF THE COMMENTS THAT 3433 02:21:55,640 --> 02:22:00,912 CAME UP HERE WAS THE FACT THAT 3434 02:22:00,979 --> 02:22:03,214 IN TERMS OF ENSURING YOUR 3435 02:22:03,281 --> 02:22:05,416 COMPOSITION, YOU KNOW, REFLECTS 3436 02:22:05,483 --> 02:22:08,152 THE COMMUNITY'S PERSPECTIVE ONE 3437 02:22:08,219 --> 02:22:11,422 OF THE COMMENTS WAS THAT EVEN IF 3438 02:22:11,489 --> 02:22:14,726 YOU HAVE CERTAIN MEMBERS OF THE 3439 02:22:14,792 --> 02:22:15,994 COMMUNITY, THESE COMMUNITIES ON 3440 02:22:16,060 --> 02:22:18,563 SAY YOUR IRB FOR EXAMPLE THAT 3441 02:22:18,630 --> 02:22:19,964 EVEN THAT INDIVIDUAL MAY NOT BE 3442 02:22:20,031 --> 02:22:21,399 ABLE TO FIX THE ENTIRE 3443 02:22:21,466 --> 02:22:21,900 COMMUNITY. 3444 02:22:21,966 --> 02:22:23,368 THINGS LIKE THAT THAT WE NEED TO 3445 02:22:23,434 --> 02:22:23,902 FLESH OUT. 3446 02:22:23,968 --> 02:22:28,072 SO IT WOULD BE HELPFUL TO HEAR 3447 02:22:28,139 --> 02:22:31,776 DO YOU HAVE ANY EXPERIENCE WITH 3448 02:22:31,843 --> 02:22:33,444 THIS, EXAMPLES YOU WANT TO 3449 02:22:33,511 --> 02:22:39,784 SHARE, THAT WE CAN MAYBE ADD TO 3450 02:22:39,851 --> 02:22:40,285 RECOMMENDATIONS ON THIS. 3451 02:22:40,351 --> 02:22:42,620 >> NOT FOR THIS POPULATION BUT, 3452 02:22:42,687 --> 02:22:44,622 YOU KNOW, WE'VE HAD THE SAME 3453 02:22:44,689 --> 02:22:45,390 PROBLEMS IN PEDIATRICS, YOU 3454 02:22:45,456 --> 02:22:45,657 KNOW. 3455 02:22:45,723 --> 02:22:49,994 LIKE WE HAVE TO HAVE A PEDIATRIC 3456 02:22:50,061 --> 02:22:51,529 SPECIALIST REVIEWING PROTOCOLS 3457 02:22:51,596 --> 02:22:52,297 DEALING WITH KIDS. 3458 02:22:52,363 --> 02:22:55,033 I MEAN, YOU KNOW, WHAT KIND OF 3459 02:22:55,099 --> 02:22:56,000 PEDIATRIC SPECIALIST? 3460 02:22:56,067 --> 02:22:58,536 YOU COULD HAVE SOMEONE WHO KNOWS 3461 02:22:58,603 --> 02:23:01,940 ABSOLUTELY NOTHING ABOUT THE 3462 02:23:02,006 --> 02:23:03,474 PROCEDURES INVOLVED, THE RISKS, 3463 02:23:03,541 --> 02:23:06,277 YOU KNOW, WHATEVER, WHATEVER. 3464 02:23:06,344 --> 02:23:09,047 SO, YEAH, I THINK JUST BECAUSE 3465 02:23:09,113 --> 02:23:12,750 SOMEONE HAS A PARTICULAR NAME OR 3466 02:23:12,817 --> 02:23:14,118 PARTICULAR IDENTITY DOES NOT 3467 02:23:14,185 --> 02:23:16,354 NECESSARILY MEAN THAT THEY ARE 3468 02:23:16,421 --> 02:23:17,989 COMPETENT TO BRING THE LIVED 3469 02:23:18,056 --> 02:23:19,824 EXPERIENCE OR THE, YOU KNOW, 3470 02:23:19,891 --> 02:23:24,329 KNOWLEDGE THAT WE WOULD BE 3471 02:23:24,395 --> 02:23:24,595 WANTING. 3472 02:23:24,662 --> 02:23:26,364 >> ANOTHER EXAMPLE WOULD BE 3473 02:23:26,431 --> 02:23:27,498 TYPICALLY A LOT OF IRBs, WHAT 3474 02:23:27,565 --> 02:23:30,435 THEY WILL DO IS IF THEY DON'T 3475 02:23:30,501 --> 02:23:32,337 HAVE EXPERTISE ON THE IRB THEY 3476 02:23:32,403 --> 02:23:34,305 MIGHT CONSULT WITH SOMEONE THAT 3477 02:23:34,372 --> 02:23:35,606 MIGHT HAVE SPECIFIC EXPERTISE IN 3478 02:23:35,673 --> 02:23:36,040 A PARTICULAR AREA. 3479 02:23:36,107 --> 02:23:38,042 THOSE ARE THE KIND OF THINGS YOU 3480 02:23:38,109 --> 02:23:39,277 COULD CONSIDER ADDING TO 3481 02:23:39,344 --> 02:23:40,445 RECOMMENDATION DOCUMENT LIKE IN 3482 02:23:40,511 --> 02:23:42,280 TERMS OF BEST PRACTICE. 3483 02:23:42,347 --> 02:23:44,816 SIMILARLY FOR YOUR STUDY TEAM OR 3484 02:23:44,882 --> 02:23:46,017 YOUR ORGANIZATIONAL LEADERSHIP, 3485 02:23:46,084 --> 02:23:46,884 MAYBE THERE'S SOME EXAMPLES OUT 3486 02:23:46,951 --> 02:23:48,987 THERE IN TERMS OF BEST PRACTICES 3487 02:23:49,053 --> 02:23:52,357 ON HOW YOU MIGHT GO ABOUT DOING 3488 02:23:52,423 --> 02:23:52,590 THAT. 3489 02:23:52,657 --> 02:24:00,431 SO THAT'S JUST AN EXAMPLE. 3490 02:24:00,498 --> 02:24:01,666 OKAY. 3491 02:24:01,733 --> 02:24:04,102 LET'S MOVE ON TO CULTURAL 3492 02:24:04,168 --> 02:24:04,502 COMPETENCE. 3493 02:24:04,569 --> 02:24:08,773 IN THIS ONE, THIS SPEAKS TO THE 3494 02:24:08,840 --> 02:24:12,610 ISSUE OF FOSTERING CULTURING 3495 02:24:12,677 --> 02:24:16,447 AWARENESS, HUMILITY, I GAVE 3496 02:24:16,514 --> 02:24:18,750 EXAMPLES ABOUT WHETHER IT'S 3497 02:24:18,816 --> 02:24:20,385 EDUCATION IN TRAINING, CREATING 3498 02:24:20,451 --> 02:24:22,253 AN ENVIRONMENT THAT IS OPEN, 3499 02:24:22,320 --> 02:24:23,154 THOSE KINDS OF THINGS. 3500 02:24:23,221 --> 02:24:24,555 BUT I THINK THIS ONE YOU MIGHT 3501 02:24:24,622 --> 02:24:27,725 WANT TO TALK ABOUT A BIT. 3502 02:24:27,792 --> 02:24:29,027 RUQAIIJAH, YOU MADE SOME 3503 02:24:29,093 --> 02:24:29,827 COMMENTS EARLIER. 3504 02:24:29,894 --> 02:24:31,329 DID YOU WANT TO MAYBE SURE, I 3505 02:24:31,396 --> 02:24:33,197 DON'T WANT TO PUT YOU ON THE 3506 02:24:33,264 --> 02:24:34,399 SPOT, YOUR THOUGHTS ON THIS 3507 02:24:34,465 --> 02:24:37,602 BECAUSE THIS MIGHT BE ONE WHERE 3508 02:24:37,668 --> 02:24:39,003 I MIGHT BE SIMPLIFYING THE 3509 02:24:39,070 --> 02:24:40,104 EDUCATION AND TRAINING WE ALWAYS 3510 02:24:40,171 --> 02:24:41,773 SAY BUT THERE'S MORE TO IT. 3511 02:24:41,839 --> 02:24:44,275 THAT MIGHT BE HELPFUL FOR YOU TO 3512 02:24:44,342 --> 02:24:45,476 SHARE YOUR THOUGHTS. 3513 02:24:45,543 --> 02:24:48,980 >> YES, THANK YOU FOR THAT, 3514 02:24:49,047 --> 02:24:49,247 LINDA. 3515 02:24:49,313 --> 02:24:52,483 I WOULD SAY THE DISCUSSION THAT 3516 02:24:52,550 --> 02:24:54,118 WE HAD DURING THE SUBCOMMITTEE 3517 02:24:54,185 --> 02:24:57,422 WAS THAT WE DIDN'T WANT TO JUST 3518 02:24:57,488 --> 02:24:58,523 STOP THAT CULTURAL COMPETENCY 3519 02:24:58,589 --> 02:25:00,591 BUT THAT PRESUMES YOU COULD TAKE 3520 02:25:00,658 --> 02:25:03,661 A CLASS AND LEARN EVERYTHING YOU 3521 02:25:03,728 --> 02:25:08,900 NEED TO KNOW, WHEREAS HUMILITY 3522 02:25:08,966 --> 02:25:10,668 SIGNALS CONTINUATION OF 3523 02:25:10,735 --> 02:25:14,038 LEARNING, AND ALSO ALLOWS YOU TO 3524 02:25:14,105 --> 02:25:17,542 FULLY UNDERSTAND THAT IT'S 3525 02:25:17,608 --> 02:25:18,409 NOT -- ONE PERSON IS NOT GOING 3526 02:25:18,476 --> 02:25:21,245 TO BE REPRESENTATIVE OF ALL 3527 02:25:21,312 --> 02:25:22,547 VIEWPOINTS, DIVERSE VIEWPOINTS. 3528 02:25:22,613 --> 02:25:24,882 I LIKE THE LANGUAGE HERE IN 3529 02:25:24,949 --> 02:25:29,153 TERMS OF CULTURAL AWARENESS, 3530 02:25:29,220 --> 02:25:29,887 EVEN UNDERSTANDING THAT PEOPLE 3531 02:25:29,954 --> 02:25:33,091 MAY VIEW THINGS OR TAKE THINGS 3532 02:25:33,157 --> 02:25:34,058 DIFFERENTLY, COMPETENCY IS STILL 3533 02:25:34,125 --> 02:25:36,160 THERE BECAUSE IT IS A WORD THAT 3534 02:25:36,227 --> 02:25:43,501 PEOPLE TEND TO USE MORE OFTEN 3535 02:25:43,568 --> 02:25:44,368 THEN HUMILITY, UNDERSTANDING 3536 02:25:44,435 --> 02:25:47,872 IT'S IMPORTANT TO ASK QUESTIONS 3537 02:25:47,939 --> 02:25:50,942 OF INDIVIDUALS, OF PEOPLE FROM 3538 02:25:51,008 --> 02:25:54,445 DIFFERENT AND DIVERSE 3539 02:25:54,512 --> 02:25:55,980 COMMUNITIES. 3540 02:25:56,047 --> 02:25:58,216 AND CONTINUE THAT LEARNING. 3541 02:25:58,282 --> 02:26:04,288 >> THANK YOU. 3542 02:26:04,355 --> 02:26:05,590 DOES ANYBODY HAVE COMMENTS ON 3543 02:26:05,656 --> 02:26:07,658 THIS SECTION, THIS QUESTION AT 3544 02:26:07,725 --> 02:26:07,925 ALL? 3545 02:26:07,992 --> 02:26:10,094 ANYTHING YOU WANT TO ADD? 3546 02:26:10,161 --> 02:26:14,499 ANY CLARIFICATIONS? 3547 02:26:18,436 --> 02:26:18,569 KEVIN? 3548 02:26:18,636 --> 02:26:23,641 >> I WANT TO SAY I LOVE WHAT 3549 02:26:23,708 --> 02:26:24,408 RUQAIIJAH SAID. 3550 02:26:24,475 --> 02:26:27,445 WE COULD MAKE THAT A LOUD 3551 02:26:27,512 --> 02:26:28,079 STATEMENT. 3552 02:26:28,146 --> 02:26:32,250 BECAUSE THERE ARE SO MANY TIMES 3553 02:26:32,316 --> 02:26:34,785 WHEN WE'RE JUST OFFERING 3554 02:26:34,852 --> 02:26:37,288 WORKSHOPS OR WATCH SOMETHING AND 3555 02:26:37,355 --> 02:26:41,993 CHECK A BOX, BUT UNDERSCORING 3556 02:26:42,059 --> 02:26:48,466 THAT IT REQUIRES HUMILITY AND 3557 02:26:48,533 --> 02:26:50,334 CONSTANT LISTENING AND 3558 02:26:50,401 --> 02:26:50,835 QUESTIONING. 3559 02:26:50,902 --> 02:26:51,869 THINGS ARE ALWAYS CHANGING TOO. 3560 02:26:51,936 --> 02:27:00,211 THAT SEEMS LIKE A REALLY 3561 02:27:00,278 --> 02:27:01,612 IMPORTANT MESSAGE. 3562 02:27:01,679 --> 02:27:02,480 >> OKAY. 3563 02:27:02,547 --> 02:27:02,680 LOIS? 3564 02:27:02,747 --> 02:27:03,014 >> YES. 3565 02:27:03,080 --> 02:27:09,487 GOING BACK TO THE KIND OF THE 3566 02:27:09,554 --> 02:27:10,688 WHY AND HOW QUESTION, I'M 3567 02:27:10,755 --> 02:27:11,989 THINKING FOR EXAMPLE OF THE 3568 02:27:12,056 --> 02:27:14,425 QUESTION HOW CAN INVESTIGATORS, 3569 02:27:14,492 --> 02:27:16,727 SPONSORS, IRBs, RESEARCH 3570 02:27:16,794 --> 02:27:19,130 INSTITUTIONS ACTIVELY PROMOTE, 3571 02:27:19,197 --> 02:27:19,497 RIGHT? 3572 02:27:19,564 --> 02:27:24,936 AND, AGAIN, I MEAN I'M NOT 3573 02:27:25,002 --> 02:27:27,872 AGAINST US COMING UP WITH A LIST 3574 02:27:27,939 --> 02:27:29,740 OF RESOURCES AND DOING SOMETHING 3575 02:27:29,807 --> 02:27:31,475 LIKE THAT BUT MAYBE PART OF WHAT 3576 02:27:31,542 --> 02:27:38,950 WE SHOULD BE THINKING ABOUT IS 3577 02:27:39,016 --> 02:27:41,819 MORE WHY SHOULD THEY, HOW MUCH 3578 02:27:41,886 --> 02:27:42,787 SHOULD THEY, HOW MUCH ATTENTION 3579 02:27:42,853 --> 02:27:44,222 SHOULD BE PLACED ON THIS. 3580 02:27:44,288 --> 02:27:45,856 WHEN DO YOU KNOW IF YOU HAVE 3581 02:27:45,923 --> 02:27:46,190 ENOUGH? 3582 02:27:46,257 --> 02:27:52,997 WHEN DO YOU KNOW IF YOU'VE DONE 3583 02:27:53,064 --> 02:27:54,165 A GOOD ENOUGH JOB? 3584 02:27:54,232 --> 02:27:56,267 NOT SO MUCH THE PRACTICAL, 3585 02:27:56,334 --> 02:27:58,102 ALTHOUGH THAT'S IMPORTANT IF WE 3586 02:27:58,169 --> 02:27:59,637 CAN FIND GREAT RESOURCES, BUT 3587 02:27:59,704 --> 02:28:01,405 WHY IT'S IMPORTANT AND HOW 3588 02:28:01,472 --> 02:28:02,940 IMPORTANT IT IS COMPARED TO 3589 02:28:03,007 --> 02:28:12,984 OTHER THINGS. 3590 02:28:13,050 --> 02:28:15,620 THAT ETHICAL WAY, HOW MANY 3591 02:28:15,686 --> 02:28:16,721 COMMUNITY PERSPECTIVES DOES ONE 3592 02:28:16,787 --> 02:28:17,722 NEED? 3593 02:28:17,788 --> 02:28:23,494 THOSE TO ME ARE MORE THE ETHICAL 3594 02:28:23,561 --> 02:28:25,696 QUESTIONS RATHER THAN PRACTICAL 3595 02:28:25,763 --> 02:28:27,331 HOW TO GO ABOUT DOING THIS. 3596 02:28:27,398 --> 02:28:29,100 THAT'S -- YOU KNOW, JUST AS WE 3597 02:28:29,166 --> 02:28:30,534 MOVE FORWARD SEEMS TO ME WE WANT 3598 02:28:30,601 --> 02:28:40,811 TO TRY TO FIGURE OUT WHAT THOSE 3599 02:28:40,878 --> 02:28:43,247 KIND OF TOUGH QUESTIONS ARE, IF 3600 02:28:43,314 --> 02:28:44,849 SOMEONE IS READING THIS, WE 3601 02:28:44,915 --> 02:28:47,251 DON'T DO ANY OF THIS, WE DO 3602 02:28:47,318 --> 02:28:52,189 SOME, BUT NOT AS FAR AS OUR 3603 02:28:52,256 --> 02:28:54,058 MECHANISMS, BUT HAVE WE MET THE 3604 02:28:54,125 --> 02:28:55,293 BAR? 3605 02:28:55,359 --> 02:29:00,631 IS THERE A BAR HERE TO MEET? 3606 02:29:00,698 --> 02:29:02,400 TO ME THOSE ARE THE QUESTIONS 3607 02:29:02,466 --> 02:29:07,905 THAT ARE MORE ETHICAL QUESTIONS. 3608 02:29:07,972 --> 02:29:09,206 >> LINDA, THIS IS JULIA. 3609 02:29:09,273 --> 02:29:12,376 I DON'T MEAN TO JUMP THE LINE 3610 02:29:12,443 --> 02:29:13,277 PER SE. 3611 02:29:13,344 --> 02:29:21,986 BUT I DID WANT TO JUST TAKE A 3612 02:29:22,053 --> 02:29:24,388 MOMENT TO COMMENT THAT AT THIS 3613 02:29:24,455 --> 02:29:29,226 POINT IT WAS OHRP'S GENERAL 3614 02:29:29,293 --> 02:29:30,995 EXPECTATION THAT THE CHARGE PER 3615 02:29:31,062 --> 02:29:35,466 SE WAS ESSENTIALLY COMPLETE. 3616 02:29:35,533 --> 02:29:37,768 AND FINAL. 3617 02:29:37,835 --> 02:29:41,906 AND THAT ASIDE FROM, YOU KNOW, 3618 02:29:41,972 --> 02:29:42,773 EXPLAINING THE CONCEPTS AND 3619 02:29:42,840 --> 02:29:44,442 DISCUSSION THAT WE'VE HAD OVER 3620 02:29:44,508 --> 02:29:47,178 THE PAST FEW MONTHS WE WERE 3621 02:29:47,244 --> 02:29:49,914 HOPING THAT MOST OF THE FOCUS IN 3622 02:29:49,980 --> 02:29:52,550 TODAY'S MEETING WAS GOING TO 3623 02:29:52,616 --> 02:29:55,853 MOVE BEYOND JUST THE CHARGE 3624 02:29:55,920 --> 02:29:58,289 INTO, YOU KNOW, THE ACTUAL TEXT, 3625 02:29:58,356 --> 02:29:59,857 STARTING OF THE RECOMMENDATIONS 3626 02:29:59,924 --> 02:30:00,157 THEMSELVES. 3627 02:30:00,224 --> 02:30:07,932 I WANT TO PUT THAT OUT THERE AS 3628 02:30:07,998 --> 02:30:08,199 PREDICATE. 3629 02:30:08,265 --> 02:30:15,473 ALSO, I THINK LINES 27 AND 28, 3630 02:30:15,539 --> 02:30:18,642 GIVEN SOME EDITING AND SOME OF 3631 02:30:18,709 --> 02:30:20,311 WHAT WE'VE HEARD, MAYBE THIS 3632 02:30:20,378 --> 02:30:25,316 LINE NEEDS A LITTLE BIT OF AN 3633 02:30:25,383 --> 02:30:28,586 EDIT RATHER THAN SAYING SIMPLY 3634 02:30:28,652 --> 02:30:30,354 OHRP SEEKS INPUT FROM SACHRP 3635 02:30:30,421 --> 02:30:33,991 REGARDING, YOU KNOW, THE 3636 02:30:34,058 --> 02:30:34,625 FOLLOWING QUESTIONS, THAT, YOU 3637 02:30:34,692 --> 02:30:38,362 KNOW, SOMETHING TO THE EFFECT 3638 02:30:38,429 --> 02:30:41,632 OF, YOU KNOW, SACHRP IS -- HOPES 3639 02:30:41,699 --> 02:30:44,735 TO ADDRESS THE FOLLOWING 3640 02:30:44,802 --> 02:30:45,503 QUESTIONS. 3641 02:30:45,569 --> 02:30:45,903 >> OKAY. 3642 02:30:45,970 --> 02:30:46,670 >> OKAY. 3643 02:30:46,737 --> 02:30:48,406 >> I'LL MAKE A NOTE. 3644 02:30:48,472 --> 02:30:52,476 >> JULIA, POINT OF 3645 02:30:52,543 --> 02:30:52,810 CLARIFICATION. 3646 02:30:52,877 --> 02:30:54,645 I KNOW RUQAIIJAH'S HAND WAS UP. 3647 02:30:54,712 --> 02:30:56,080 SOME CONFUSION ON MY PART, I 3648 02:30:56,147 --> 02:30:58,716 DON'T WANT TO SPEAK ON BEHALF OF 3649 02:30:58,783 --> 02:31:00,017 THE OTHER MEMBERS, WHAT WAS SENT 3650 02:31:00,084 --> 02:31:03,421 TO US WAS THIS WORD DOCUMENT 3651 02:31:03,487 --> 02:31:04,989 WHICH MAKES IT FEEL LIKE WE WERE 3652 02:31:05,055 --> 02:31:06,390 SUPPOSED TO EDIT IT. 3653 02:31:06,457 --> 02:31:09,994 >> YEAH, NO, I UNDERSTAND THAT. 3654 02:31:10,060 --> 02:31:12,296 YOU KNOW, I TOTALLY TAKE THE 3655 02:31:12,363 --> 02:31:16,000 BLAME HERE IF THERE'S ANY 3656 02:31:16,066 --> 02:31:16,901 CONFUSION REGARDING THIS. 3657 02:31:16,967 --> 02:31:19,737 I THINK THAT THE INTENT HAD BEEN 3658 02:31:19,804 --> 02:31:22,773 TO GO OVER THIS DOCUMENT, 3659 02:31:22,840 --> 02:31:25,509 EXPLAIN THIS DOCUMENT, WHERE THE 3660 02:31:25,576 --> 02:31:27,778 DOCUMENT WAS HOPING TO GO. 3661 02:31:27,845 --> 02:31:29,480 YOU KNOW, PRINCIPLES, ET CETERA. 3662 02:31:29,547 --> 02:31:31,749 BUT AT SOME POINT HERE WE'RE 3663 02:31:31,816 --> 02:31:38,222 HOPING TO MOVE BEYOND EDITING 3664 02:31:38,289 --> 02:31:39,223 THE CHARGE. 3665 02:31:39,290 --> 02:31:40,191 I'M SORRY, LINDA. 3666 02:31:40,257 --> 02:31:41,826 I HOPE THAT WAS YOUR 3667 02:31:41,892 --> 02:31:42,159 UNDERSTANDING. 3668 02:31:42,226 --> 02:31:42,860 >> IT WAS MY UNDERSTANDING. 3669 02:31:42,927 --> 02:31:44,895 I DID SAY IT BUT I DIDN'T WANT 3670 02:31:44,962 --> 02:31:47,865 TO OBVIOUSLY SINCE THERE WAS 3671 02:31:47,932 --> 02:31:48,299 COMMENTARY. 3672 02:31:48,365 --> 02:31:48,699 >> RIGHT. 3673 02:31:48,766 --> 02:31:53,103 I JUST DON'T WANT THIS ENTIRE 3674 02:31:53,170 --> 02:31:54,672 SESSION HERE TO FOCUS ON THE 3675 02:31:54,738 --> 02:31:55,139 CHARGE. 3676 02:31:55,206 --> 02:31:56,941 WE REALLY ARE CONSIDERING THE 3677 02:31:57,007 --> 02:31:59,143 CHARGE MORE OR LESS COMPLETE. 3678 02:31:59,210 --> 02:32:01,111 AND ARE HOPING TO GO BEYOND THAT 3679 02:32:01,178 --> 02:32:04,381 AT THIS POINT. 3680 02:32:04,448 --> 02:32:04,682 >> GREAT. 3681 02:32:04,748 --> 02:32:06,917 I'LL TURN IT BACK TO RUQAIIJAH 3682 02:32:06,984 --> 02:32:07,551 OR LINDA. 3683 02:32:07,618 --> 02:32:10,855 I DIDN'T SEE A SECOND DOCUMENT, 3684 02:32:10,921 --> 02:32:11,822 THE LARGE DOCUMENT. 3685 02:32:11,889 --> 02:32:15,993 WE WEREN'T SUPPOSED TO REVIEW 3686 02:32:16,060 --> 02:32:16,193 THAT. 3687 02:32:16,260 --> 02:32:16,760 >> THAT'S TRUE. 3688 02:32:16,827 --> 02:32:17,328 >> THANK YOU. 3689 02:32:17,394 --> 02:32:19,063 >> SORRY FOR THE INTERRUPTION. 3690 02:32:19,129 --> 02:32:21,098 >> NO, THANK YOU, JULIA. 3691 02:32:21,165 --> 02:32:24,401 I'M GLAD YOU REITERATED THAT 3692 02:32:24,468 --> 02:32:24,635 POINT. 3693 02:32:24,702 --> 02:32:25,936 THE DOCUMENT IS JUST A CHARGE. 3694 02:32:26,003 --> 02:32:27,705 THE IDEA WAS TO ACTUALLY TALK 3695 02:32:27,771 --> 02:32:30,241 ABOUT THE CONTENT OF THE 3696 02:32:30,307 --> 02:32:35,412 FIRST -- SO WE CAN START 3697 02:32:35,479 --> 02:32:36,447 DRAFTING THE RECOMMENDATIONS. 3698 02:32:36,514 --> 02:32:39,783 LET ME -- NOT SURE WHO WAS NEXT. 3699 02:32:39,850 --> 02:32:41,085 I THINK IT WAS RUQAIIJAH. 3700 02:32:41,151 --> 02:32:43,287 >> YEAH, COULD I ASK A QUESTION 3701 02:32:43,354 --> 02:32:45,022 ABOUT THAT, JULIA? 3702 02:32:45,089 --> 02:32:48,325 SO, I CAN BE GETTING THIS 3703 02:32:48,392 --> 02:32:48,659 CONFUSED. 3704 02:32:48,726 --> 02:32:51,395 FROM MY REFERENCE POINT WE'VE 3705 02:32:51,462 --> 02:32:52,162 GONE OVER THIS DOCUMENT A FEW 3706 02:32:52,229 --> 02:32:53,230 TIMES IN THE SUBCOMMITTEE BUT I 3707 02:32:53,297 --> 02:32:56,634 FEEL LIKE THIS IS THE FIRST TIME 3708 02:32:56,700 --> 02:32:59,770 THAT SACHRP AS A GROUP HAS 3709 02:32:59,837 --> 02:33:01,472 REVIEWED THE DOCUMENT TO TALK 3710 02:33:01,539 --> 02:33:04,341 ABOUT WHAT WE'VE DONE IN THE 3711 02:33:04,408 --> 02:33:05,376 SUBCOMMITTEE. 3712 02:33:05,442 --> 02:33:06,143 IS THAT INCORRECT? 3713 02:33:06,210 --> 02:33:09,013 OR -- AND THEN HOW DO WE PROCEED 3714 02:33:09,079 --> 02:33:10,848 WHEN THINGS ARE LIKE FINALIZED 3715 02:33:10,915 --> 02:33:12,716 IN THE SUBCOMMITTEE AND THEN WE 3716 02:33:12,783 --> 02:33:17,221 SEE IT AND WE STILL SEE POINTS? 3717 02:33:17,288 --> 02:33:18,856 >> THE CHARGE I BELIEVE HAD BEEN 3718 02:33:18,923 --> 02:33:20,824 PRESENTED BACK IN OCTOBER AT THE 3719 02:33:20,891 --> 02:33:21,792 OCTOBER MEETING. 3720 02:33:21,859 --> 02:33:25,863 AND THE INTENT HAD BEEN TO BE 3721 02:33:25,930 --> 02:33:26,931 DISCUSSING IT, YOU KNOW, 3722 02:33:26,997 --> 02:33:31,869 CONSIDERING THE CONTENT FOR THE 3723 02:33:31,936 --> 02:33:33,304 RECOMMENDATIONS THEMSELVES AT 3724 02:33:33,370 --> 02:33:35,706 THE SUBCOMMITTEE LEVEL. 3725 02:33:35,773 --> 02:33:38,642 AND IN THE PAST, CHARGES FOR 3726 02:33:38,709 --> 02:33:40,210 PARTICULAR TOPICS HAVE BEEN 3727 02:33:40,277 --> 02:33:42,580 HANDLED A VARIETY OF WAYS. 3728 02:33:42,646 --> 02:33:47,084 SOMETIMES THEY COME PURELY FROM 3729 02:33:47,151 --> 02:33:47,985 OHRP. 3730 02:33:48,052 --> 02:33:51,121 SOMETIMES IT'S A CROSS-EFFORT 3731 02:33:51,188 --> 02:33:55,259 REALLY WITH OHRP, AND SACHRP, OR 3732 02:33:55,326 --> 02:33:56,493 THE SUBCOMMITTEES, AND WILL 3733 02:33:56,560 --> 02:33:58,796 BECOME PART OF THE 3734 02:33:58,862 --> 02:33:59,830 RECOMMENDATIONS THEMSELVES. 3735 02:33:59,897 --> 02:34:02,066 I WOULD EXPECT THAT WITH THIS 3736 02:34:02,132 --> 02:34:04,401 DOCUMENT IT WOULD PROBABLY BE 3737 02:34:04,468 --> 02:34:07,104 THE LATTER WHERE IT WOULD BE 3738 02:34:07,171 --> 02:34:08,872 HELPFUL TO SEE THE CHARGE AS 3739 02:34:08,939 --> 02:34:11,942 PART OF THE DOCUMENT THAT HAS 3740 02:34:12,009 --> 02:34:12,576 THE RESPONSIVE RECOMMENDATIONS. 3741 02:34:12,643 --> 02:34:15,245 AT THE END SACHRP IS VOTING ON 3742 02:34:15,312 --> 02:34:16,413 THE DOCUMENT AS A WHOLE. 3743 02:34:16,480 --> 02:34:17,047 >> THANKS. 3744 02:34:17,114 --> 02:34:18,482 THAT'S HELPFUL. 3745 02:34:18,549 --> 02:34:20,117 I WOULD SAY, YES, FOR ME, AND I 3746 02:34:20,184 --> 02:34:21,852 DON'T KNOW ABOUT OTHER PEOPLE, I 3747 02:34:21,919 --> 02:34:23,420 KNOW WE TALKED ABOUT IT IN 3748 02:34:23,487 --> 02:34:23,721 OCTOBER. 3749 02:34:23,787 --> 02:34:27,057 BUT WE DIDN'T HAVE THIS DOCUMENT 3750 02:34:27,124 --> 02:34:27,558 UNTIL NOW. 3751 02:34:27,625 --> 02:34:30,294 AND SO I THINK IT'S HELPFUL FOR 3752 02:34:30,361 --> 02:34:33,130 US AT LEAST WHAT I'M HEARING 3753 02:34:33,197 --> 02:34:36,000 PARTICULARLY FROM LOIS AND KEVIN 3754 02:34:36,066 --> 02:34:38,068 AND OTHERS IS THAT LOOKING AT 3755 02:34:38,135 --> 02:34:40,604 THIS DOCUMENT AND THEN 3756 02:34:40,671 --> 02:34:41,672 TRANSLATING IT INTO 3757 02:34:41,739 --> 02:34:42,573 RECOMMENDATIONS THAT THESE 3758 02:34:42,640 --> 02:34:45,409 CHANGES ARE TO TRY TO HELP US 3759 02:34:45,476 --> 02:34:47,578 GET TO THE RECOMMENDATIONS, AND 3760 02:34:47,645 --> 02:34:49,113 ONE OF MY SUGGESTIONS WHY I 3761 02:34:49,179 --> 02:34:52,416 RAISED MY HAND IS THAT IT WAS 3762 02:34:52,483 --> 02:34:54,284 GOING BACK TO THE INITIAL 3763 02:34:54,351 --> 02:34:56,253 DISCUSSION ABOUT HOW THERE SEEMS 3764 02:34:56,320 --> 02:35:01,492 TO BE SOME OVERLAP, PARTICULARLY 3765 02:35:01,558 --> 02:35:03,260 UNDER 2, GETTING TO HOW DO WE 3766 02:35:03,327 --> 02:35:04,328 RECOMMEND THE THINGS THAT PEOPLE 3767 02:35:04,395 --> 02:35:05,129 ARE DOING. 3768 02:35:05,195 --> 02:35:09,733 I FEEL LIKE ALMOST IF WE COULD 3769 02:35:09,800 --> 02:35:12,102 TIE COMMUNITY ENGAGEMENT TO YOUR 3770 02:35:12,169 --> 02:35:15,205 SECOND BULLET, AND TO THE THIRD 3771 02:35:15,272 --> 02:35:17,174 BULLET UNDER HERE WHEN WE TALK 3772 02:35:17,241 --> 02:35:19,443 ABOUT COMPOSITION AND CULTURAL 3773 02:35:19,510 --> 02:35:21,979 COMPETENCE, IT ALMOST IS REALLY 3774 02:35:22,046 --> 02:35:25,883 TALKING ABOUT THE FACT THAT 3775 02:35:25,949 --> 02:35:27,451 COMMUNITY ENGAGEMENT IS ONE OF 3776 02:35:27,518 --> 02:35:29,887 THE WAYS THAT WE CAN FIGURE OUT 3777 02:35:29,953 --> 02:35:33,023 IF THE COMPOSITION OF THE STUDY 3778 02:35:33,090 --> 02:35:35,292 TEAM IS APPROPRIATE, IF THERE IS 3779 02:35:35,359 --> 02:35:36,393 ACTUAL CULTURAL COMPETENCE. 3780 02:35:36,460 --> 02:35:38,595 AND I THINK THAT WILL TIE IT TO 3781 02:35:38,662 --> 02:35:40,464 SOME OF OUR RECOMMENDATIONS THAT 3782 02:35:40,531 --> 02:35:41,565 WE DO. 3783 02:35:41,632 --> 02:35:44,401 AND CAN TALK ABOUT LATER IS THAT 3784 02:35:44,468 --> 02:35:46,070 REALLY THE COMMUNITY ENGAGEMENT 3785 02:35:46,136 --> 02:35:48,305 IS THROUGHOUT THE WHOLE PROCESS, 3786 02:35:48,372 --> 02:35:51,642 AND SO IT SHOULDN'T JUST BE LIKE 3787 02:35:51,709 --> 02:35:53,077 ONE INDIVIDUAL ON THE STUDY TEAM 3788 02:35:53,143 --> 02:35:56,146 BUT GOING BACK TO WHAT YOU 3789 02:35:56,213 --> 02:35:57,114 TALKED ABOUT, LINDA, LIKE 3790 02:35:57,181 --> 02:35:58,015 CONSULTATION, RIGHT? 3791 02:35:58,082 --> 02:36:00,751 NOT JUST WITH THE INDIVIDUAL BUT 3792 02:36:00,818 --> 02:36:03,353 MAYBE ALSO WITH COMMUNITY. 3793 02:36:03,420 --> 02:36:04,555 AND THE SAME THING AROUND 3794 02:36:04,621 --> 02:36:05,556 CULTURAL COMPETENCY. 3795 02:36:05,622 --> 02:36:07,424 IT'S NOT LIKE YOU'RE GOING TO 3796 02:36:07,491 --> 02:36:08,625 GET A CERTIFICATE IN THESE 3797 02:36:08,692 --> 02:36:12,129 THINGS BUT IF YOU CONTINUE TO 3798 02:36:12,196 --> 02:36:14,298 ENGAGE WITH THE COMMUNITY THEN I 3799 02:36:14,364 --> 02:36:16,500 THINK YOU COULD ACTUALLY GET TO 3800 02:36:16,567 --> 02:36:19,903 THE POINT THAT YOU WANT TO, SO I 3801 02:36:19,970 --> 02:36:23,841 WOULD EVEN SUGGEST THE EVEN JUST 3802 02:36:23,907 --> 02:36:25,476 PUTTING A COMMA AFTER, TO 3803 02:36:25,542 --> 02:36:31,815 REFLECT COMMUNITY PER 3804 02:36:31,882 --> 02:36:32,416 PERSPECTIVES OBTAINED THROUGH 3805 02:36:32,483 --> 02:36:33,350 COMMUNITY ENGAGEMENT, SAME FOR 3806 02:36:33,417 --> 02:36:33,984 CULTURAL COMPETENCY. 3807 02:36:34,051 --> 02:36:36,086 AND WHEN WE GET TO 3808 02:36:36,153 --> 02:36:38,155 RECOMMENDATIONS REALLY THINK 3809 02:36:38,222 --> 02:36:39,022 ABOUT WHAT WE'RE RECOMMENDING 3810 02:36:39,089 --> 02:36:39,456 FOR PEOPLE. 3811 02:36:39,523 --> 02:36:45,729 I THINK IT'S GOING TO BE AN 3812 02:36:45,796 --> 02:36:47,731 EASIER THING TO TRANSITION. 3813 02:36:47,798 --> 02:36:49,099 >> NO, THANK YOU, RUQAIIJAH. 3814 02:36:49,166 --> 02:36:50,300 THAT DOES MAKE SENSE. 3815 02:36:50,367 --> 02:36:51,935 WHEN I LOOKED AT SOME OF THESE 3816 02:36:52,002 --> 02:36:56,140 HEADINGS, I THINK FROM COMMUNITY 3817 02:36:56,206 --> 02:36:57,307 ENGAGEMENT DOES OBVIOUSLY PLAY A 3818 02:36:57,374 --> 02:36:58,609 ROLE IN EVERYTHING WE DO HERE, 3819 02:36:58,675 --> 02:37:00,410 BUT I THINK THERE'S SPECIFIC 3820 02:37:00,477 --> 02:37:01,779 RECOMMENDATIONS YOU MIGHT WANT 3821 02:37:01,845 --> 02:37:04,414 TO CONSIDER AS A COMMITTEE, THAT 3822 02:37:04,481 --> 02:37:06,083 ARE JUST FOCUSED ON COMMUNITY 3823 02:37:06,150 --> 02:37:06,784 ENGAGEMENT, THAT WOULD BE 3824 02:37:06,850 --> 02:37:07,951 SEPARATE FROM SOME OF THESE 3825 02:37:08,018 --> 02:37:08,585 AREAS AS WELL. 3826 02:37:08,652 --> 02:37:10,687 I THINK IT'S BOTH. 3827 02:37:10,754 --> 02:37:12,523 IT'S BOTH INTEGRATED, WOVEN 3828 02:37:12,589 --> 02:37:16,393 THROUGHOUT WHAT WE'RE TALKING 3829 02:37:16,460 --> 02:37:18,095 ABOUT TODAY, ALSO THERE'S 3830 02:37:18,162 --> 02:37:20,330 SEPARATE CONSIDERATIONS, LOTS OF 3831 02:37:20,397 --> 02:37:22,166 MOVED ALSO THAT VIEW, LOOK FROM 3832 02:37:22,232 --> 02:37:22,933 THAT PERSPECTIVE. 3833 02:37:23,000 --> 02:37:24,134 FOR PURPOSES OF THE 3834 02:37:24,201 --> 02:37:25,235 RECOMMENDATION DOCUMENT WE CAN 3835 02:37:25,302 --> 02:37:26,103 CERTAINLY DO THAT. 3836 02:37:26,170 --> 02:37:29,173 I THINK, AGAIN, THE PURPOSE OF 3837 02:37:29,239 --> 02:37:29,940 CALLING OUT SPECIFIC QUESTIONS 3838 02:37:30,007 --> 02:37:33,310 WAS JUST TO MAKE SURE WE'RE NOT 3839 02:37:33,377 --> 02:37:34,411 MISSING ANYTHING, AS WE'RE 3840 02:37:34,478 --> 02:37:35,846 WRITING THE DOCUMENT YOU CAN DO 3841 02:37:35,913 --> 02:37:37,181 ALL THE THINGS YOU'RE TALKING 3842 02:37:37,247 --> 02:37:38,015 ABOUT, RUQAIIJAH. 3843 02:37:38,081 --> 02:37:39,116 I THINK THAT'S WHAT WE WERE 3844 02:37:39,183 --> 02:37:46,723 THINKING AT THE TIME ANYWAY. 3845 02:37:46,790 --> 02:37:49,326 SOME OTHER PEOPLE HAVE HANDS UP, 3846 02:37:49,393 --> 02:37:54,464 BUT I CAN'T -- DON'T SEE THEM 3847 02:37:54,531 --> 02:37:57,334 ANYMORE. 3848 02:37:57,401 --> 02:37:57,968 DOES ANYBODY HAVE THOUGHTS ON 3849 02:37:58,035 --> 02:38:01,505 ANY OF THE OTHER TOPICS, 3850 02:38:01,572 --> 02:38:02,472 INTERSECTIONALITY, NOT IN TERMS 3851 02:38:02,539 --> 02:38:04,541 OF THE QUESTION ITSELF BUT JUST 3852 02:38:04,608 --> 02:38:07,911 IN TERMS OF CERTAIN INFORMATION 3853 02:38:07,978 --> 02:38:09,446 OR EXAMPLES OF THINGS WE MIGHT 3854 02:38:09,513 --> 02:38:13,684 WANT TO ADD TO RECOMMENDATION 3855 02:38:13,750 --> 02:38:15,719 DOCUMENT ON INTERSECTIONALITY? 3856 02:38:15,786 --> 02:38:18,422 ANY THOUGHTS THERE? 3857 02:38:24,561 --> 02:38:24,728 NO? 3858 02:38:24,795 --> 02:38:27,197 OKAY. 3859 02:38:34,104 --> 02:38:36,773 LET'S MOVE ON TO THE NEXT 3860 02:38:36,840 --> 02:38:37,107 SECTION. 3861 02:38:37,174 --> 02:38:46,583 SO THIS GETS TO -- THIS IS ABOUT 3862 02:38:46,650 --> 02:38:47,651 THE DESIGN, REVIEW, CONDUCT, 3863 02:38:47,718 --> 02:38:50,554 DISSEMINATION OF RESULTS. 3864 02:38:50,621 --> 02:38:51,054 SANDRA? 3865 02:38:51,121 --> 02:38:52,522 >> ANOTHER RESOURCE THAT WE 3866 02:38:52,589 --> 02:38:59,096 COULD POINT TO, I'M SURE YOU'RE 3867 02:38:59,162 --> 02:39:00,297 AWARE NASEM, NATIONAL ACADEMIES 3868 02:39:00,364 --> 02:39:04,234 REPORT ON HOW YOU MEASURE SEX, 3869 02:39:04,301 --> 02:39:05,135 GENDER, ORIENTATION, THEY GO 3870 02:39:05,202 --> 02:39:06,803 THROUGH A LOT OF THINGS THAT ONE 3871 02:39:06,870 --> 02:39:08,939 MIGHT CONSIDER IN TERMS OF 3872 02:39:09,006 --> 02:39:11,775 RESEARCH DESIGN AND ANALYSIS 3873 02:39:11,842 --> 02:39:14,011 MAKING SURE THAT DIFFERENT 3874 02:39:14,077 --> 02:39:16,413 VARIABLES ARE NOT KIND OF BEING 3875 02:39:16,480 --> 02:39:20,784 USED IN PRECISELY FOR PROXIES 3876 02:39:20,851 --> 02:39:22,519 FOR BIOLOGICAL DIFFERENCES AND 3877 02:39:22,586 --> 02:39:23,921 THINGS LIKE THIS. 3878 02:39:23,987 --> 02:39:30,193 THIS IS A GOOD RESOURCE I THINK 3879 02:39:30,260 --> 02:39:34,464 TO PERHAPS REFER TO. 3880 02:39:34,531 --> 02:39:37,734 >> THANK YOU. 3881 02:39:37,801 --> 02:39:38,869 KEVIN? 3882 02:39:38,936 --> 02:39:40,337 >> YEAH, INTERSECTIONALITY IS 3883 02:39:40,404 --> 02:39:43,874 MAKING ME THINK ABOUT THE GREAT 3884 02:39:43,941 --> 02:39:45,275 DISCUSSION THAT I READ. 3885 02:39:45,342 --> 02:39:47,577 I WASN'T AT THE LAST MEETING BUT 3886 02:39:47,644 --> 02:39:51,415 I READ, AND THE PRESENTATION 3887 02:39:51,481 --> 02:39:53,583 THAT FOCUSED ON ESPECIALLY 3888 02:39:53,650 --> 02:39:54,584 TEENS, IT SEEMS LIKE THERE WERE 3889 02:39:54,651 --> 02:39:58,422 A LOT OF THESE ISSUES THAT MIGHT 3890 02:39:58,488 --> 02:40:02,159 BE SOME SPECIFIC CONSIDERATIONS 3891 02:40:02,225 --> 02:40:04,661 FOR YOUNGER FOLKS, AND IS THAT 3892 02:40:04,728 --> 02:40:10,167 SOMETHING WE ADDRESS UNDER 3893 02:40:10,233 --> 02:40:15,973 INTERSECTIONALITY HERE, IS THAT 3894 02:40:16,039 --> 02:40:17,607 A SPECIAL -- ADDRESSING -- I WAS 3895 02:40:17,674 --> 02:40:18,809 REMEMBERING ALL THE REALLY GOOD 3896 02:40:18,875 --> 02:40:20,177 MATERIAL THAT WAS THERE AND 3897 02:40:20,243 --> 02:40:21,778 WANTED TO KNOW, YOU KNOW, WHAT'S 3898 02:40:21,845 --> 02:40:26,249 THE BEST WAY TO REFLECT THAT AND 3899 02:40:26,316 --> 02:40:27,617 OUR ANSWERS TO THIS DOCUMENT. 3900 02:40:27,684 --> 02:40:30,387 >> SO THE ANSWER IS YES, WE 3901 02:40:30,454 --> 02:40:34,891 WOULD BE FOCUSING ON BOTH MINORS 3902 02:40:34,958 --> 02:40:35,659 AND ADULTS. 3903 02:40:35,726 --> 02:40:37,060 FOR EACH -- FOR ALL THESE 3904 02:40:37,127 --> 02:40:40,497 QUESTIONS, TO THE EXTENT THEY 3905 02:40:40,564 --> 02:40:48,905 ARE APPLICABLE. 3906 02:40:48,972 --> 02:40:52,509 I'M GOING TO MOVE ON TO THE 3907 02:40:52,576 --> 02:40:53,810 CONSIDERATIONS FOR DESIGN, 3908 02:40:53,877 --> 02:41:01,118 REVIEW, AND CONDUCT OF RESEARCH. 3909 02:41:01,184 --> 02:41:05,622 THERE ARE, LET'S SEE, SIX 3910 02:41:05,689 --> 02:41:09,893 QUESTIONS. 3911 02:41:09,960 --> 02:41:20,170 WE CAN START WITH RESEARCH, 3912 02:41:20,237 --> 02:41:28,879 DESIGN, AND ANALYSIS. 3913 02:41:30,947 --> 02:41:33,784 >> I DON'T KNOW IF THIS IS 3914 02:41:33,850 --> 02:41:35,952 REALLY THE PLACE TO PUT THIS IN 3915 02:41:36,019 --> 02:41:44,161 BUT I WANT TO MAKE SURE THAT WE 3916 02:41:44,227 --> 02:41:46,096 ADDRESS, AND THIS GETS INTO YOUR 3917 02:41:46,163 --> 02:41:52,335 CATEGORIES OF RESEARCH AT THE 3918 02:41:52,402 --> 02:41:55,639 VERY BEGINNING, BUT THAT THE 3919 02:41:55,705 --> 02:41:59,142 DESIGN AND ANALYSIS INTERSECT 3920 02:41:59,209 --> 02:42:01,878 APPROPRIATELY WITH INCLUSION 3921 02:42:01,945 --> 02:42:04,748 APPROACHES THAT REFLECT THE 3922 02:42:04,815 --> 02:42:07,884 PURPOSE OF INCLUSION AND 3923 02:42:07,951 --> 02:42:08,585 REPRESENTATION OF THESE 3924 02:42:08,652 --> 02:42:08,885 COMMUNITIES. 3925 02:42:08,952 --> 02:42:10,420 WHAT I MEAN BY THAT IS THERE 3926 02:42:10,487 --> 02:42:12,289 WILL BE TIMES WHERE IT'S REALLY 3927 02:42:12,355 --> 02:42:14,357 IMPORTANT TO HAVE ADEQUATE 3928 02:42:14,424 --> 02:42:14,991 REPRESENTATION TO MAKE 3929 02:42:15,058 --> 02:42:15,792 SCIENTIFIC INFERENCES. 3930 02:42:15,859 --> 02:42:16,860 THERE ARE OTHER TIMES WHERE 3931 02:42:16,927 --> 02:42:21,665 YOU'RE DOING IT AS A RESULT OF A 3932 02:42:21,731 --> 02:42:22,599 MORAL IMPERATIVE TO BE BROADLY 3933 02:42:22,666 --> 02:42:25,836 INCLUSIVE OF RESEARCH. 3934 02:42:25,902 --> 02:42:27,704 THOSE HAVE IMPORTANT SCIENTIFIC 3935 02:42:27,771 --> 02:42:28,472 CONNECTIONS. 3936 02:42:28,538 --> 02:42:31,174 >> OKAY. 3937 02:42:36,980 --> 02:42:38,748 THANK YOU. 3938 02:42:38,815 --> 02:42:40,417 >> I THINK THOSE DISTINCTIONS 3939 02:42:40,484 --> 02:42:41,651 OFTEN GET LOST, IF WE CAN 3940 02:42:41,718 --> 02:42:45,122 HIGHLIGHT THEM IT WOULD BE 3941 02:42:45,188 --> 02:42:47,524 HELPFUL. 3942 02:42:47,591 --> 02:42:50,827 >> OKAY. 3943 02:42:50,894 --> 02:42:51,728 LET'S SEE. 3944 02:42:51,795 --> 02:42:51,962 SANDRA? 3945 02:42:52,028 --> 02:42:54,097 >> NEIL, I DON'T KNOW IF THIS IS 3946 02:42:54,164 --> 02:42:58,468 WHAT YOU'RE GETTING AT, BUT 3947 02:42:58,535 --> 02:42:59,336 MAYBE SIMILARLY, TRYING TO 3948 02:42:59,402 --> 02:43:02,739 ATTEND TO THE GOAL OF 3949 02:43:02,806 --> 02:43:03,473 INCLUSIVENESS. 3950 02:43:03,540 --> 02:43:05,041 BUT BEING MINDFUL THAT DATA IS 3951 02:43:05,108 --> 02:43:07,277 BEING COLLECTED TO ANSWER THE 3952 02:43:07,344 --> 02:43:09,980 QUESTIONS, THE RESEARCH QUESTION 3953 02:43:10,046 --> 02:43:11,848 AND APPROPRIATE WAY, HAVING DATA 3954 02:43:11,915 --> 02:43:14,017 PARSIMONY, IF YOU WILL, LIKE THE 3955 02:43:14,084 --> 02:43:16,786 IDEA THAT YOU COLLECT DATA FOR 3956 02:43:16,853 --> 02:43:18,622 ANSWERING THE QUESTION. 3957 02:43:18,688 --> 02:43:20,590 AND THEN CONSIDERATIONS ABOUT 3958 02:43:20,657 --> 02:43:21,958 REPRESENTATION SHOULD ALSO BE 3959 02:43:22,025 --> 02:43:28,598 CONSIDERED BUT YOU DON'T WANT TO 3960 02:43:28,665 --> 02:43:30,033 NECESSARILY INCLUDE INFORMATION 3961 02:43:30,100 --> 02:43:32,536 ABOUT SEXUAL IDENTITY THAT ISN'T 3962 02:43:32,602 --> 02:43:34,404 TIED NECESSARILY TO THE RESEARCH 3963 02:43:34,471 --> 02:43:37,574 QUESTION, OR TRYING TO BALANCE 3964 02:43:37,641 --> 02:43:40,744 KIND OF THE RISKS AROUND 3965 02:43:40,810 --> 02:43:42,612 COLLECTING INFORMATION AND IT 3966 02:43:42,679 --> 02:43:47,584 NOT BEING NECESSARILY TIED TO 3967 02:43:47,651 --> 02:43:48,552 RESEARCH QUESTIONS. 3968 02:43:48,618 --> 02:43:52,122 BUT NEIL YOU'VE UNMUTED SO MAYBE 3969 02:43:52,189 --> 02:43:58,728 YOU HAVE YOU HAVE SOMETHING TO 3970 02:43:58,795 --> 02:43:58,929 SAY. 3971 02:43:58,995 --> 02:44:00,797 >> I WOULD SECOND WHAT YOU JUST 3972 02:44:00,864 --> 02:44:01,665 SAID. 3973 02:44:01,731 --> 02:44:02,332 I AGREE 100%. 3974 02:44:02,399 --> 02:44:05,068 I THINK THERE IS A SEPARATE 3975 02:44:05,135 --> 02:44:07,504 ISSUE WHEN I'M THINKING LESS 3976 02:44:07,571 --> 02:44:08,672 ABOUT TYPES OF DATA COLLECTION 3977 02:44:08,738 --> 02:44:11,107 AND WHAT NOT, AND MORE INCLUSION 3978 02:44:11,174 --> 02:44:15,111 IN STUDIES WHERE LINES CAN GET 3979 02:44:15,178 --> 02:44:17,447 BLURRED BETWEEN WHEN YOU ARE 3980 02:44:17,514 --> 02:44:19,549 INCLUDING PEOPLE BECAUSE YOU'RE 3981 02:44:19,616 --> 02:44:21,017 INTENDING TO DRAW SPECIFIC 3982 02:44:21,084 --> 02:44:22,385 INFERENCES ABOUT THAT POPULATION 3983 02:44:22,452 --> 02:44:23,687 VERSUS WHEN YOU'RE INCLUDING 3984 02:44:23,753 --> 02:44:24,888 PEOPLE BECAUSE YOU WANT RESEARCH 3985 02:44:24,955 --> 02:44:30,760 IN GENERAL TO BE AN INCLUSIVE 3986 02:44:30,827 --> 02:44:32,929 ACTIVITY THAT, YOU KNOW, FOR 3987 02:44:32,996 --> 02:44:35,765 DIFFERENT -- FOR REASONS, MAYBE 3988 02:44:35,832 --> 02:44:36,233 THERE'S SCIENTIFIC 3989 02:44:36,299 --> 02:44:37,200 CONSIDERATIONS SOMETIMES TOO BUT 3990 02:44:37,267 --> 02:44:39,402 FOR REASONS OTHER THAN JUST 3991 02:44:39,469 --> 02:44:39,636 SCIENCE. 3992 02:44:39,703 --> 02:44:43,006 SO I'M THINKING TO PUT A SHARP 3993 02:44:43,073 --> 02:44:45,642 POINT OUT SOMETIMES YOU NEED TO 3994 02:44:45,709 --> 02:44:47,177 DO SUBGROUP ANALYSIS, OTHER 3995 02:44:47,244 --> 02:44:49,446 TIMES YOU HAVE NO INTEREST, BUT 3996 02:44:49,512 --> 02:44:52,282 YOU WOULDN'T WANT TO EXCLUDE 3997 02:44:52,349 --> 02:44:55,485 THEM BECAUSE THIS IS SUPPOSED TO 3998 02:44:55,552 --> 02:44:56,720 BE FOR JUSTICE-RELATED REASONS, 3999 02:44:56,786 --> 02:44:57,988 PROMOTION OF TRUST, ALL SORTS OF 4000 02:44:58,054 --> 02:44:59,856 REASONS, IT'S REALLY IMPORTANT 4001 02:44:59,923 --> 02:45:02,158 TO BE INCLUSIVE AND 4002 02:45:02,225 --> 02:45:03,293 REPRESENTATIVE. 4003 02:45:03,360 --> 02:45:04,894 SO I THINK TEASING THOSE ISSUES 4004 02:45:04,961 --> 02:45:07,564 APART IS REALLY IMPORTANT AND 4005 02:45:07,631 --> 02:45:09,065 OFTEN GET BLURRED, A LOT OF 4006 02:45:09,132 --> 02:45:10,367 EFFORT TO INCREASE DIVERSITY IN 4007 02:45:10,433 --> 02:45:12,769 RESEARCH RIGHT NOW IT'S REALLY 4008 02:45:12,836 --> 02:45:13,770 IMPORTANT TO BE ATTENTIVE TO 4009 02:45:13,837 --> 02:45:15,705 YOUR GOALS IN THE CONTEXT OF 4010 02:45:15,772 --> 02:45:17,574 SPECIFIC STUDIES. 4011 02:45:17,641 --> 02:45:22,178 >> YEAH, I WOULD AGREE 4012 02:45:22,245 --> 02:45:23,280 WHOLEHEARTEDLY, THINKING ABOUT 4013 02:45:23,346 --> 02:45:24,714 PERHAPS THE ANALOGOUS SITUATION 4014 02:45:24,781 --> 02:45:27,450 WITH SOME OF THE DISCUSSION 4015 02:45:27,517 --> 02:45:29,085 WE'VE HAD AROUND POPULATION 4016 02:45:29,152 --> 02:45:30,086 DESCRIPTORS OF RACE AND 4017 02:45:30,153 --> 02:45:31,821 ETHNICITY AND HOW THAT 4018 02:45:31,888 --> 02:45:32,589 CONFLATION CAN EASILY HAPPEN 4019 02:45:32,656 --> 02:45:33,890 WHEN PEOPLE ARE NOT BEING 4020 02:45:33,957 --> 02:45:37,227 PRECISE ABOUT WHY THEY WERE 4021 02:45:37,294 --> 02:45:44,234 USING CERTAIN IDENTIFIERS. 4022 02:45:44,301 --> 02:45:44,534 >> KEVIN? 4023 02:45:44,601 --> 02:45:47,771 ADD TO THAT, I COMPLETELY AGREE. 4024 02:45:47,837 --> 02:45:50,073 IT'S REALLY IMPORTANT AND AN 4025 02:45:50,140 --> 02:45:56,112 EXAMPLE OF A SITUATION WHERE THE 4026 02:45:56,179 --> 02:45:57,347 RESEARCH QUESTIONS MIGHT NOT 4027 02:45:57,414 --> 02:45:59,582 REQUIRE THAT WE NEED TO COLLECT 4028 02:45:59,649 --> 02:46:01,217 SUFFICIENT SAMPLES TO DO 4029 02:46:01,284 --> 02:46:03,653 SUBGROUP ANALYSES BECAUSE WE'VE 4030 02:46:03,720 --> 02:46:05,622 GOT SCIENTIFIC QUESTIONS ABOUT 4031 02:46:05,689 --> 02:46:09,893 RELATIONSHIPS AMONG VARIABLES IN 4032 02:46:09,959 --> 02:46:12,162 THOSE GROUPS, BUT WE'RE 4033 02:46:12,228 --> 02:46:12,996 DEVELOPING A SURVEY MEASURE, FOR 4034 02:46:13,063 --> 02:46:15,131 EXAMPLE, AND WANT TO MAKE SURE 4035 02:46:15,198 --> 02:46:19,703 THAT EVERYONE -- FIRST, THAT 4036 02:46:19,769 --> 02:46:20,804 WE'RE RECRUITING REPRESENTATIVE 4037 02:46:20,870 --> 02:46:22,572 SAMPLES, AND THAT EVERYONE WHO 4038 02:46:22,639 --> 02:46:25,408 SEES THOSE SURVEY QUESTIONS 4039 02:46:25,475 --> 02:46:26,710 FEELS LIKE THOSE QUESTIONS MAKE 4040 02:46:26,776 --> 02:46:27,811 SENSE TO THEM. 4041 02:46:27,877 --> 02:46:29,012 AND FOR THEM. 4042 02:46:29,079 --> 02:46:32,749 AND IT'S NOT PUTTING THEM OFF 4043 02:46:32,816 --> 02:46:33,416 WITH SOME LANGUAGE. 4044 02:46:33,483 --> 02:46:36,686 WE RUN INTO THAT ALL THE TIME 4045 02:46:36,753 --> 02:46:40,390 WHERE THE STUDY MAY NOT HAVE A 4046 02:46:40,457 --> 02:46:42,459 SPECIFIC FOCUS ON LGBTQ+ 4047 02:46:42,525 --> 02:46:45,862 POPULATIONS BUT THERE ARE LGBTQ+ 4048 02:46:45,929 --> 02:46:47,163 PARTICIPANTS IN THE STUDY AND WE 4049 02:46:47,230 --> 02:46:49,132 DIDN'T REALLY THINK AHEAD BUT 4050 02:46:49,199 --> 02:46:53,169 ACTUALLY THIS QUESTION READS A 4051 02:46:53,236 --> 02:46:54,070 LITTLE BIT HETERONORMATIVE WEIRD 4052 02:46:54,137 --> 02:46:56,139 FOR SOME PEOPLE. 4053 02:46:56,206 --> 02:46:58,241 IT'S A REALLY IMPORTANT POINT TO 4054 02:46:58,308 --> 02:46:59,542 MAKE THAT DISTINCTION THAT 4055 02:46:59,609 --> 02:47:01,111 NEIL'S CALLING OUT WHEN WE'RE 4056 02:47:01,177 --> 02:47:07,050 ANSWERING THIS QUESTION. 4057 02:47:15,125 --> 02:47:18,495 >> OKAY, THANK YOU. 4058 02:47:18,561 --> 02:47:21,131 ANYONE ELSE ON THIS RESEARCH, 4059 02:47:21,197 --> 02:47:22,632 DESIGN, AND ANALYSIS PIECE? 4060 02:47:22,699 --> 02:47:23,066 OKAY. 4061 02:47:23,133 --> 02:47:26,136 WE CAN TURN TO ACCESS AND 4062 02:47:26,202 --> 02:47:27,337 INCLUSION. 4063 02:47:27,404 --> 02:47:29,305 THIS IS FOCUSED ON RECRUITMENT 4064 02:47:29,372 --> 02:47:32,609 PRIMARILY BUT OF COURSE WE 4065 02:47:32,675 --> 02:47:33,910 ALREADY TALKED ABOUT INCLUSION 4066 02:47:33,977 --> 02:47:36,546 OR DIVERSITY IN THE CONTEXT OF 4067 02:47:36,613 --> 02:47:37,847 OTHER QUESTIONS IN THIS 4068 02:47:37,914 --> 02:47:39,149 DOCUMENT. 4069 02:47:39,215 --> 02:47:41,050 SO ANYTHING HERE WE MIGHT WANT 4070 02:47:41,117 --> 02:47:43,420 TO TALK ABOUT? 4071 02:47:43,486 --> 02:47:46,222 OR ADD TO RECOMMENDATIONS? 4072 02:47:51,261 --> 02:47:51,394 NEIL? 4073 02:47:51,461 --> 02:47:53,363 >> YES, I GUESS I WOULD JUST PUT 4074 02:47:53,430 --> 02:47:58,601 A PLUG IN FOR I THOUGHT IN OUR 4075 02:47:58,668 --> 02:48:05,175 MEETING IN THE FALL THERE NICE 4076 02:48:05,241 --> 02:48:07,410 EXAMPLES ABOUT RECRUITMENT 4077 02:48:07,477 --> 02:48:08,244 STRATEGIES DEVELOPED BY PEOPLE 4078 02:48:08,311 --> 02:48:14,184 EMBEDDED IN, KNEW THE COMMUNITY 4079 02:48:14,250 --> 02:48:18,455 WELL, AND OVERSIGHT BODIES, 4080 02:48:18,521 --> 02:48:20,023 IRBs AND OTHERS WERE APPLYING 4081 02:48:20,089 --> 02:48:21,291 LANGUAGE THAT WAS OUT OF STEP 4082 02:48:21,357 --> 02:48:25,228 WITH WHAT THAT COMMUNITY MIGHT 4083 02:48:25,295 --> 02:48:27,764 WANT, EXAMPLES OF THE 4084 02:48:27,831 --> 02:48:29,065 INVESTIGATORS THAT DESCRIBED 4085 02:48:29,132 --> 02:48:31,167 USING THE WORD QUEER ON FLYERS, 4086 02:48:31,234 --> 02:48:34,103 THE IRB WANTED HIM NOT TO DO 4087 02:48:34,170 --> 02:48:34,537 THAT. 4088 02:48:34,604 --> 02:48:39,042 HE'S LIKE THIS IS LANGUAGE THAT 4089 02:48:39,108 --> 02:48:43,947 IS WHAT PEOPLE KNOW AND USE TO 4090 02:48:44,013 --> 02:48:44,747 REFER TO THEMSELVES. 4091 02:48:44,814 --> 02:48:47,584 TO NOT USE THAT LANGUAGE WOULD 4092 02:48:47,650 --> 02:48:48,685 NOT BE APPROPRIATELY ENGAGING 4093 02:48:48,751 --> 02:48:49,419 WITH THE COMMUNITY. 4094 02:48:49,486 --> 02:48:51,521 I THINK IF WE CAN HIGHLIGHT THE 4095 02:48:51,588 --> 02:48:54,891 IMPORTANCE OF HAVING RECRUITMENT 4096 02:48:54,958 --> 02:48:56,426 STRATEGIES THAT ARE CONSISTENT 4097 02:48:56,493 --> 02:48:58,294 WITH NORMS AND EXPECTATIONS FOR 4098 02:48:58,361 --> 02:48:59,395 THE COMMUNITIES YOU'RE HOPING TO 4099 02:48:59,462 --> 02:49:03,233 ENGAGE AND THAT ARE INFORMED BY 4100 02:49:03,299 --> 02:49:04,968 WHAT THEY CARE ABOUT WILL BE AN 4101 02:49:05,034 --> 02:49:07,270 IMPORTANT MESSAGE THAT CAN COME 4102 02:49:07,337 --> 02:49:12,308 OUT OF THIS. 4103 02:49:12,375 --> 02:49:12,742 >> OKAY. 4104 02:49:12,809 --> 02:49:13,510 THANK YOU. 4105 02:49:13,576 --> 02:49:16,012 AGAIN, THAT TIES INTO THE 4106 02:49:16,079 --> 02:49:17,480 FIRST -- THE SECOND SECTION, 4107 02:49:17,547 --> 02:49:18,515 CULTURAL COMPETENCE, ALL THOSE 4108 02:49:18,581 --> 02:49:20,617 THINGS WE TALKED ABOUT, SORT OF 4109 02:49:20,683 --> 02:49:24,320 LIKE -- WE THINK ABOUT THE THREE 4110 02:49:24,387 --> 02:49:25,088 CATEGORIES, THE OVERARCHING HIGH 4111 02:49:25,154 --> 02:49:27,190 LEVEL AND IT GETS MORE NARROW, 4112 02:49:27,257 --> 02:49:28,258 NOW YOU'RE APPLYING THAT TO 4113 02:49:28,324 --> 02:49:31,661 THESE AREAS IN TERMS OF CONDUCT 4114 02:49:31,728 --> 02:49:32,362 OF RESEARCH. 4115 02:49:32,428 --> 02:49:34,497 THIS IS GOING TO BE DIFFICULT, 4116 02:49:34,564 --> 02:49:35,865 CHALLENGING TO PULL THIS 4117 02:49:35,932 --> 02:49:37,100 TOGETHER BUT A LOT OF THIS IS 4118 02:49:37,166 --> 02:49:39,636 NOT GOING TO BE -- IT'S REALLY 4119 02:49:39,702 --> 02:49:41,738 GOING TO FLOW INTO OTHER 4120 02:49:41,804 --> 02:49:44,908 QUESTIONS AND SOME WILL BE 4121 02:49:44,974 --> 02:49:46,309 DISTINCT AND SOME WILL BE -- 4122 02:49:46,376 --> 02:49:47,610 WILL HAVE TO TIE TOGETHER AND 4123 02:49:47,677 --> 02:49:52,215 SOME OF YOU HAVE ALREADY SAID. 4124 02:49:52,282 --> 02:49:53,449 ANYTHING ON INFORMED CONSENT 4125 02:49:53,516 --> 02:50:01,591 SPECIFICALLY? 4126 02:50:15,738 --> 02:50:17,607 SOME OF THE SAME COMMENTS THAT 4127 02:50:17,674 --> 02:50:21,210 YOU MADE, NEIL, IN REGARD TO 4128 02:50:21,277 --> 02:50:21,878 RECRUITMENT STRATEGY APPLY HERE 4129 02:50:21,945 --> 02:50:22,512 AS WELL. 4130 02:50:22,579 --> 02:50:25,415 IS THERE ANYTHING ELSE YOU CAN 4131 02:50:25,481 --> 02:50:26,449 THINK OF RIGHT NOW? 4132 02:50:26,516 --> 02:50:28,418 THAT MIGHT BE SPECIFIC TO 4133 02:50:28,484 --> 02:50:29,218 INFORMED CONSENT? 4134 02:50:29,285 --> 02:50:32,388 THAT MAY NOT APPLY IN THE 4135 02:50:32,455 --> 02:50:35,391 RECRUITMENT PIECE? 4136 02:50:38,995 --> 02:50:42,432 >> GO AHEAD, ALLISON OR NEIL. 4137 02:50:42,498 --> 02:50:43,333 ALLISON, THEN NEIL. 4138 02:50:43,399 --> 02:50:46,269 >> I DON'T HAVE AN ARTICULATED 4139 02:50:46,336 --> 02:50:47,136 THOUGHT HERE. 4140 02:50:47,203 --> 02:50:52,809 EONS AGO I WROTE WITH A STUDENT 4141 02:50:52,875 --> 02:50:54,544 A LITTLE ESSAY ABOUT -- I CAN'T 4142 02:50:54,611 --> 02:50:58,615 REMEMBER THE NAME OF THE APP, 4143 02:50:58,681 --> 02:50:59,949 GRINDER OR SOMETHING, THE FACT 4144 02:51:00,016 --> 02:51:01,384 THAT PEOPLE HAD NO IDEA WHEN 4145 02:51:01,451 --> 02:51:03,720 THEY SIGNED UP TO USE THIS APP 4146 02:51:03,786 --> 02:51:09,892 THAT SOMEWHERE IN THE FINE PRINT 4147 02:51:09,959 --> 02:51:11,661 THEY WERE AGREEING TO LET THEIR 4148 02:51:11,728 --> 02:51:16,699 PROFILES BE USED FOR RESEARCH. 4149 02:51:16,766 --> 02:51:20,603 SOMETHING ABOUT THE FACT THAT 4150 02:51:20,670 --> 02:51:22,171 JUST REMINDING PEOPLE THAT THEY 4151 02:51:22,238 --> 02:51:25,041 MAY HAVE CONSENTED TO RESEARCH 4152 02:51:25,108 --> 02:51:31,381 WITHOUT EVEN REALIZING THEY WERE 4153 02:51:31,447 --> 02:51:34,784 ENGAGING IN CONSENT. 4154 02:51:34,851 --> 02:51:35,752 >> OKAY. 4155 02:51:35,818 --> 02:51:40,490 >> NOT ALL RESEARCH IS THE SAME. 4156 02:51:40,556 --> 02:51:42,425 >> RIGHT. 4157 02:51:42,492 --> 02:51:44,961 OKAY. 4158 02:51:45,028 --> 02:51:45,161 NEIL? 4159 02:51:45,228 --> 02:51:47,163 >> YEAH, AGAIN, WHAT I HAVE TO 4160 02:51:47,230 --> 02:51:49,365 SAY IS ENTIRELY UNEARTH 4161 02:51:49,432 --> 02:51:50,767 SHATTERING BUT IF WE'RE TRYING 4162 02:51:50,833 --> 02:51:53,169 TO AIR THOUGHTS WHAT WE THINK 4163 02:51:53,236 --> 02:51:55,038 STRUCTURE OUGHT TO LOOK LIKE AS 4164 02:51:55,104 --> 02:51:58,307 THINGS TAKE SHAPE THE TWO KEY 4165 02:51:58,374 --> 02:51:59,509 STRUCTURAL COMPONENTS OF 4166 02:51:59,575 --> 02:52:01,144 SOMETHING FOCUSED ON CONSENT 4167 02:52:01,210 --> 02:52:11,721 WOULD BE, ONE, I GUESS NOT TO 4168 02:52:12,155 --> 02:52:13,656 PLAY INTO MAYBE 4169 02:52:13,723 --> 02:52:14,357 OVERVULNERABLIZING POPULATIONS 4170 02:52:14,424 --> 02:52:16,759 AND RESPECTING THEM AS DECISION 4171 02:52:16,826 --> 02:52:19,996 MAKERS, AND SOMETIMES WE CAN BE 4172 02:52:20,063 --> 02:52:21,631 OVERPROTECTIVE OF COMMUNITIES 4173 02:52:21,698 --> 02:52:24,067 THAT WE THINK HAVE 4174 02:52:24,133 --> 02:52:24,434 VULNERABILITIES. 4175 02:52:24,500 --> 02:52:27,670 SECOND WOULD BE KIND OF IN THE 4176 02:52:27,737 --> 02:52:30,273 CONVERSE OF THAT, BEING WE 4177 02:52:30,339 --> 02:52:33,776 SHOULD BE, YOU KNOW, AWARE OF 4178 02:52:33,843 --> 02:52:35,411 UNIQUE RISKS OR POTENTIAL 4179 02:52:35,478 --> 02:52:38,047 BENEFITS THAT WOULD BE 4180 02:52:38,114 --> 02:52:40,550 APPLICABLE TO A PARTICULAR 4181 02:52:40,616 --> 02:52:43,419 POPULATION, AND JUST, YOU KNOW, 4182 02:52:43,486 --> 02:52:45,054 MAKE AN EFFORT TO BE SUBJECT 4183 02:52:45,121 --> 02:52:46,522 CENTRIC IN THE WAY WE THINK 4184 02:52:46,589 --> 02:52:47,924 ABOUT WHAT RISKS AND WHAT 4185 02:52:47,990 --> 02:52:50,793 BENEFITS ARE LIKELY TO BE 4186 02:52:50,860 --> 02:52:52,528 MEANINGFUL AND MIGHT NEED TO BE, 4187 02:52:52,595 --> 02:52:53,596 YOU KNOW, HAVE INCREASED 4188 02:52:53,663 --> 02:52:56,599 ATTENTION IN THE CONTEXT OF 4189 02:52:56,666 --> 02:52:58,000 CONSENT DISCUSSION. 4190 02:52:58,067 --> 02:52:59,736 SO BOTH OF THOSE BALANCED 4191 02:52:59,802 --> 02:53:01,370 APPROACHES WILL BE REALLY 4192 02:53:01,437 --> 02:53:06,342 IMPORTANT AND THINKING ABOUT 4193 02:53:06,409 --> 02:53:07,977 COMMUNITIES THAT -- YOU KNOW, 4194 02:53:08,044 --> 02:53:08,511 LIKE THIS. 4195 02:53:08,578 --> 02:53:11,681 >> OKAY. 4196 02:53:11,748 --> 02:53:15,785 I'M GOING TO MOVE ON TO THE 4197 02:53:15,852 --> 02:53:24,360 PRIVACY AND CONFIDENTIALITY. 4198 02:53:26,763 --> 02:53:29,632 AS WE THINK ABOUT RESEARCH, HOW 4199 02:53:29,699 --> 02:53:33,803 IT'S CONDUCTED, WHERE THE DATA 4200 02:53:33,870 --> 02:53:35,972 GOES, CONFIDENTIALITY, THOSE 4201 02:53:36,038 --> 02:53:37,106 TYPE OF THINGS PROBABLY WOULD BE 4202 02:53:37,173 --> 02:53:40,376 IN THIS TYPE OF SECTION IN TERMS 4203 02:53:40,443 --> 02:53:41,711 OF MEASURES THAT MIGHT BE TAKEN 4204 02:53:41,778 --> 02:53:43,446 BUT THERE MIGHT BE SOME OTHERS 4205 02:53:43,513 --> 02:53:52,588 WE MIGHT WANT TO INCLUDE HERE. 4206 02:54:09,205 --> 02:54:10,706 I'LL JUST WAIT FOR A MINUTE SO 4207 02:54:10,773 --> 02:54:13,209 WE CAN TAKE TIME TO LOOK AT IT. 4208 02:54:13,276 --> 02:54:23,820 I KNOW IT'S -- WE COULD INCLUDE 4209 02:54:38,868 --> 02:54:40,503 THINGS RELATED TO LIKE 4210 02:54:40,570 --> 02:54:43,372 CERTIFICATES OF CONFIDENTIALITY, 4211 02:54:43,439 --> 02:54:46,809 AGAIN A QUESTION WOULD BE 4212 02:54:46,876 --> 02:54:48,578 WHETHER OR NOT THAT IS THE ONLY 4213 02:54:48,644 --> 02:54:51,981 MEASURE YOU WOULD TAKE, RIGHT? 4214 02:54:52,048 --> 02:54:52,849 THERE'S PROBABLY OTHER THINGS, 4215 02:54:52,915 --> 02:54:53,950 PROBABLY GAPS. 4216 02:54:54,016 --> 02:54:55,384 IN TERMS OF EXPERIENCE, 4217 02:54:55,451 --> 02:54:56,919 CONDUCTING RESEARCH, IS THERE 4218 02:54:56,986 --> 02:54:59,889 ANYTHING ELSE HERE THAT YOU 4219 02:54:59,956 --> 02:55:01,090 MIGHT WANT TO CONSIDER? 4220 02:55:01,157 --> 02:55:03,059 THAT'S WHAT I'M GETTING AT. 4221 02:55:03,125 --> 02:55:07,163 BESIDES THAT ONE EXAMPLE. 4222 02:55:07,230 --> 02:55:08,865 THAT WE MIGHT WANT TO INCLUDE IN 4223 02:55:08,931 --> 02:55:15,304 RECOMMENDATIONS HERE. 4224 02:55:15,371 --> 02:55:17,607 IF NOT, I CAN MOVE ON. 4225 02:55:17,673 --> 02:55:18,341 MAYBE I'LL MOVE ON. 4226 02:55:18,407 --> 02:55:20,309 IF YOU THINK OF SOMETHING LET ME 4227 02:55:20,376 --> 02:55:20,509 KNOW. 4228 02:55:20,576 --> 02:55:23,846 A LOT OF QUIET. 4229 02:55:23,913 --> 02:55:25,047 NO ONE SAYING ANYTHING. 4230 02:55:25,114 --> 02:55:26,883 I CAN THINK OF A FEW THINGS, IN 4231 02:55:26,949 --> 02:55:28,618 TERMS OF A DRAFT OUR GROUP WILL 4232 02:55:28,684 --> 02:55:29,852 PUT SOMETHING TOGETHER AND YOU 4233 02:55:29,919 --> 02:55:32,722 CAN MAYBE THINK ABOUT IT. 4234 02:55:32,788 --> 02:55:34,790 LET'S MOVE TO OVERSIGHT, 4235 02:55:34,857 --> 02:55:35,758 SUPPORT, AND SECURITY. 4236 02:55:35,825 --> 02:55:38,828 THIS GETS INTO WHAT SORT OF -- 4237 02:55:38,895 --> 02:55:40,463 WHAT CAN THESE VARIOUS 4238 02:55:40,529 --> 02:55:44,100 STAKEHOLDERS TO DO PROCEED 4239 02:55:44,166 --> 02:55:44,967 APPROPRIATE OVERSIGHT, THINK 4240 02:55:45,034 --> 02:55:46,002 WHAT YOU WOULD LIKE TO SEE 4241 02:55:46,068 --> 02:55:48,804 HAPPEN OR IF THERE ARE GAPS AT 4242 02:55:48,871 --> 02:55:49,672 YOUR INSTITUTION, SO, AGAIN, 4243 02:55:49,739 --> 02:55:54,510 SIMILAR TO THE PRIVACY AND 4244 02:55:54,577 --> 02:55:58,414 CONFIDENTIALITY QUESTION AS 4245 02:55:58,481 --> 02:55:58,948 WELL. 4246 02:55:59,015 --> 02:55:59,181 LOIS? 4247 02:55:59,248 --> 02:56:01,784 >> WELL, I FINALLY HAD A 4248 02:56:01,851 --> 02:56:02,018 THOUGHT. 4249 02:56:02,084 --> 02:56:03,452 >> OKAY, GREAT. 4250 02:56:03,519 --> 02:56:03,853 THANK YOU! 4251 02:56:03,920 --> 02:56:09,992 >> WITH RESPECT TO PRIVACY AND 4252 02:56:10,059 --> 02:56:11,327 CONFIDENTIALITY, IS THERE 4253 02:56:11,394 --> 02:56:12,862 INTENTION IN ASKING, YOU KNOW, 4254 02:56:12,929 --> 02:56:16,799 IN TRYING TO BE INCLUSIVE AND 4255 02:56:16,866 --> 02:56:19,535 TO, YOU KNOW, GET PEOPLE TO 4256 02:56:19,602 --> 02:56:21,304 SELF-IDENTIFY AS A MEMBER OF ONE 4257 02:56:21,370 --> 02:56:26,876 OF THESE COMMUNITIES? 4258 02:56:26,943 --> 02:56:28,277 INTENTION BETWEEN THAT AND BEING 4259 02:56:28,344 --> 02:56:30,246 ABLE TO PROTECT, IF THEY HAD AN 4260 02:56:30,313 --> 02:56:33,215 INTEREST IN BEING -- IN HAVING 4261 02:56:33,282 --> 02:56:34,317 THAT INFORMATION BE PRIVATE? 4262 02:56:34,383 --> 02:56:36,385 IN OTHER WORDS, IT SEEMS TO ME 4263 02:56:36,452 --> 02:56:38,554 PART OF THE -- I'M ASKING THIS 4264 02:56:38,621 --> 02:56:38,821 QUESTION. 4265 02:56:38,888 --> 02:56:44,927 SEEMS TO ME PART OF WHAT THE 4266 02:56:44,994 --> 02:56:48,197 PROJECT IS, WE WANT MORE 4267 02:56:48,264 --> 02:56:49,098 INCLUSIVITY, RIGHT? 4268 02:56:49,165 --> 02:56:53,069 AND SO TO GET THAT INCLUSIVITY, 4269 02:56:53,135 --> 02:56:55,338 THEN IN ALL KINDS OF RESEARCH, 4270 02:56:55,404 --> 02:56:57,640 YOU KNOW, NEIL WAS TALKING ABOUT 4271 02:56:57,707 --> 02:56:59,508 THE ONES WHERE MEMBERSHIP IN ONE 4272 02:56:59,575 --> 02:57:02,011 OF THESE COMMUNITIES MAY BE 4273 02:57:02,078 --> 02:57:04,113 SOMETHING THAT'S STUDIED, YOU 4274 02:57:04,180 --> 02:57:05,848 KNOW, AS FAR AS ANALYSIS GOES. 4275 02:57:05,915 --> 02:57:08,818 OTHER TIMES JUST FOR INCLUSION. 4276 02:57:08,884 --> 02:57:12,188 SO IF WE'RE -- IF WE'RE 4277 02:57:12,254 --> 02:57:13,155 ENCOURAGING RESEARCHERS, ARE WE 4278 02:57:13,222 --> 02:57:14,857 I GUESS IS THE QUESTION, IN 4279 02:57:14,924 --> 02:57:16,292 ORDER TO MEET THAT INCLUSIVITY 4280 02:57:16,359 --> 02:57:17,360 YOU'RE GOING TO COLLECT THIS 4281 02:57:17,426 --> 02:57:20,763 DATA BUT THEN YOU HAVE MORE DATA 4282 02:57:20,830 --> 02:57:26,002 COLLECTED THAT YOU HAVE TO 4283 02:57:26,068 --> 02:57:26,369 PROTECT. 4284 02:57:26,435 --> 02:57:31,073 IS THERE INTENTION THERE? 4285 02:57:31,140 --> 02:57:36,746 THAT'S MY QUESTION. 4286 02:57:36,812 --> 02:57:37,947 >> MAYBE LOIS, I'LL BUILD ON 4287 02:57:38,014 --> 02:57:43,652 WHAT I'M HEARING YOU SAY. 4288 02:57:43,719 --> 02:57:44,653 MAYBE BECAUSE THERE'S THIS 4289 02:57:44,720 --> 02:57:47,723 PATCHWORK OF APPROACHES TO THIS 4290 02:57:47,790 --> 02:57:55,131 RESEARCH AND HOW THE COMMUNITY 4291 02:57:55,197 --> 02:57:57,867 IS -- EACH STATE HAS DIFFERENT 4292 02:57:57,933 --> 02:58:00,169 APPROACHES, PATCHWORK OF LAWS 4293 02:58:00,236 --> 02:58:02,371 THAT CONSIDERATIONS MAY BE MADE 4294 02:58:02,438 --> 02:58:03,806 IN THIS, LIKE SUBPOENAING 4295 02:58:03,873 --> 02:58:06,976 RECORDS, FOR EXAMPLE, THAT MIGHT 4296 02:58:07,043 --> 02:58:08,277 SOMEHOW PUT THE LGBTQ COMMUNITY 4297 02:58:08,344 --> 02:58:11,814 AT RISK IN CERTAIN STATES WHERE 4298 02:58:11,881 --> 02:58:14,316 THAT WOULDN'T BE ALLOWED IN 4299 02:58:14,383 --> 02:58:15,851 OTHER STATES, IS THAT SOMETHING 4300 02:58:15,918 --> 02:58:16,952 THAT TOUCHES ON WHAT YOU'RE 4301 02:58:17,019 --> 02:58:18,154 SAYING, AM I FOLLOWING? 4302 02:58:18,220 --> 02:58:19,355 >> WHATEVER THE RISKS ARE. 4303 02:58:19,422 --> 02:58:20,756 MAYBE THAT WOULD BE HELPFUL TO 4304 02:58:20,823 --> 02:58:23,526 IDENTIFY WHAT THE RISKS ARE TO 4305 02:58:23,592 --> 02:58:26,495 BREACHES OF CONFIDENTIALITY AND 4306 02:58:26,562 --> 02:58:29,198 PRIVACY, OTHER THAN LEGAL BUT 4307 02:58:29,265 --> 02:58:30,966 OTHER KINDS OF -- WHAT ARE THE 4308 02:58:31,033 --> 02:58:32,735 RISKS ASSOCIATED WITH THAT? 4309 02:58:32,802 --> 02:58:35,671 AND DOES IT EVEN MATTER IF THERE 4310 02:58:35,738 --> 02:58:37,540 ARE RISKS OF HARM IF SOMEONE 4311 02:58:37,606 --> 02:58:40,276 DOESN'T WANT CERTAIN INFORMATION 4312 02:58:40,342 --> 02:58:43,779 TO BE, YOU KNOW, AVAILABLE TO 4313 02:58:43,846 --> 02:58:44,046 OTHERS. 4314 02:58:44,113 --> 02:58:45,614 AND THEN I'M JUST WONDERING IF 4315 02:58:45,681 --> 02:58:49,151 PART OF THIS PROJECT IS GOING TO 4316 02:58:49,218 --> 02:58:52,655 ENCOURAGE THE COLLECTION OF 4317 02:58:52,721 --> 02:58:54,623 DATA, SELF-IDENTIFIED, RIGHT? 4318 02:58:54,690 --> 02:58:56,025 BUT FOR PEOPLE IN RESEARCH GOING 4319 02:58:56,092 --> 02:58:59,762 TO ASK FOR CERTAIN KINDS OF 4320 02:58:59,829 --> 02:59:01,664 INFORMATION THAT MAYBE FOR 4321 02:59:01,730 --> 02:59:08,003 WHATEVER REASON THEY, YOU KNOW, 4322 02:59:08,070 --> 02:59:10,940 WANT TO KEEP CONFIDENTIAL, THEN 4323 02:59:11,006 --> 02:59:13,042 DOES THAT GO AGAINST -- SHOULD 4324 02:59:13,109 --> 02:59:16,011 THAT BE CONSIDERED IN WHAT KINDS 4325 02:59:16,078 --> 02:59:16,979 OF INFORMATION IS ORIGINALLY 4326 02:59:17,046 --> 02:59:19,348 SOUGHT? 4327 02:59:19,415 --> 02:59:23,319 DOES THAT MAKE SENSE? 4328 02:59:23,385 --> 02:59:24,420 ARE CONCERNS ABOUT 4329 02:59:24,487 --> 02:59:25,521 CONFIDENTIALITY AND PRIVACY ANY 4330 02:59:25,588 --> 02:59:27,289 DIFFERENT THAN THEY ARE ABOUT 4331 02:59:27,356 --> 02:59:31,427 ANY OTHER PIECE OF INFORMATION 4332 02:59:31,494 --> 02:59:36,732 THAT IS GIVEN BY PARTICIPANTS? 4333 02:59:36,799 --> 02:59:37,600 >> SIMILAR QUESTION, RIGHT? 4334 02:59:37,666 --> 02:59:43,839 I MEAN IF SOMEONE THOUGHT THE 4335 02:59:43,906 --> 02:59:44,607 INFORMATION WOULD BE 4336 02:59:44,673 --> 02:59:45,374 CONFIDENTIAL, AND THERE AREN'T 4337 02:59:45,441 --> 02:59:46,742 MEASURES IN PLACE TO PROTECT IT 4338 02:59:46,809 --> 02:59:49,011 I THINK IT'S THE SAME ISSUES FOR 4339 02:59:49,078 --> 02:59:55,551 OTHER -- FOR ALL TYPES OF 4340 02:59:55,618 --> 02:59:56,118 RESEARCH, THINGS WE STRUGGLE 4341 02:59:56,185 --> 02:59:56,986 WITH ALL THE TIME. 4342 02:59:57,052 --> 03:00:00,789 THERE ARE MEASURES IN PLACE. 4343 03:00:00,856 --> 03:00:02,224 ALREADY THINGS LIKE HIPAA, 4344 03:00:02,291 --> 03:00:04,193 THERE'S COC, OTHER THINGS THAT 4345 03:00:04,260 --> 03:00:07,696 HELP TO ADDRESS SOME OF THAT BUT 4346 03:00:07,763 --> 03:00:09,231 IT'S NOT FOOLPROOF, RIGHT? 4347 03:00:09,298 --> 03:00:10,866 THERE ARE GAPS POTENTIALLY. 4348 03:00:10,933 --> 03:00:11,200 POTENTIALLY. 4349 03:00:11,267 --> 03:00:12,401 THAT'S THE KIND OF THING THAT 4350 03:00:12,468 --> 03:00:13,936 WOULD PROBABLY GO IN A SECTION 4351 03:00:14,003 --> 03:00:16,305 LIKE THIS, TALK ABOUT WHAT IS 4352 03:00:16,372 --> 03:00:17,540 AVAILABLE NOW TO HELP 4353 03:00:17,606 --> 03:00:19,842 POTENTIALLY PROTECT SOME OF THIS 4354 03:00:19,909 --> 03:00:21,911 INFORMATION, BUT WHAT ARE SOME 4355 03:00:21,977 --> 03:00:23,445 OF POTENTIAL GAPS, HOW DOES THIS 4356 03:00:23,512 --> 03:00:25,314 SORT OF INTERSECT WITH STATE LAW 4357 03:00:25,381 --> 03:00:26,182 QUESTION, RIGHT? 4358 03:00:26,248 --> 03:00:28,484 IF YOU'RE IN A JURISDICTION 4359 03:00:28,551 --> 03:00:31,854 WHERE CERTAIN THINGS ARE 4360 03:00:31,921 --> 03:00:37,159 CRIMINALIZED, HOW CAN THAT BE 4361 03:00:37,226 --> 03:00:39,261 ADDRESSED, POTENTIALLY. 4362 03:00:39,328 --> 03:00:40,095 SORRY, LOIS. 4363 03:00:40,162 --> 03:00:42,498 >> JUST TO FOLLOW UP, I AGREE 4364 03:00:42,565 --> 03:00:44,567 WITH ALL THAT. 4365 03:00:44,633 --> 03:00:45,701 ADDITIONAL THING I'M WONDERING 4366 03:00:45,768 --> 03:00:50,506 ABOUT IS IS THE DRIVE TOWARDS 4367 03:00:50,573 --> 03:00:54,643 INCLUSION GOING TO ADD, IS THERE 4368 03:00:54,710 --> 03:00:55,878 A SUGGESTION HERE EXPECTATION 4369 03:00:55,945 --> 03:01:00,583 WOULD BE FOR RESEARCHERS TO ADD 4370 03:01:00,649 --> 03:01:01,784 MORE QUESTIONS ABOUT THESE 4371 03:01:01,850 --> 03:01:09,658 MEMBERSHIP IN ANY OF THESE 4372 03:01:09,725 --> 03:01:09,959 COMMUNITIES. 4373 03:01:10,025 --> 03:01:12,861 AND IS THAT -- YOU KNOW, IN ALL 4374 03:01:12,928 --> 03:01:15,497 RESEARCH, IS THAT KIND OF WHAT'S 4375 03:01:15,564 --> 03:01:19,501 ON THE TABLE, IN ALL RESEARCH? 4376 03:01:19,568 --> 03:01:21,403 OR IN ANY RESEARCH OR CERTAIN 4377 03:01:21,470 --> 03:01:22,571 KINDS OF RESEARCH? 4378 03:01:22,638 --> 03:01:28,177 AND THEN WHAT ARE THE BENEFITS 4379 03:01:28,244 --> 03:01:29,545 FOR ASKING THAT INFORMATION, IT 4380 03:01:29,612 --> 03:01:31,580 TELLS US WHETHER OR NOT TO 4381 03:01:31,647 --> 03:01:34,750 PEOPLE WHO ARE MEMBERS OF THESE 4382 03:01:34,817 --> 03:01:36,151 COMMUNITIES ARE INCLUDED, RIGHT? 4383 03:01:36,218 --> 03:01:37,486 IF YOU'RE CALLING FOR INCLUSION 4384 03:01:37,553 --> 03:01:40,122 WHAT'S YOUR MEASURE OF 4385 03:01:40,189 --> 03:01:40,856 INCLUSION? 4386 03:01:40,923 --> 03:01:43,525 AND IT SEEMS LIKE IT'S -- YOU 4387 03:01:43,592 --> 03:01:45,494 KNOW, DATA ABOUT PARTICIPATION 4388 03:01:45,561 --> 03:01:46,795 BY MEMBERS OF THESE COMMUNITIES 4389 03:01:46,862 --> 03:01:48,664 BUT THEN YOU'RE ASKING FOR 4390 03:01:48,731 --> 03:01:49,531 INFORMATION THAT THERE'S A 4391 03:01:49,598 --> 03:01:51,634 SUGGESTION IN HERE WITH RESPECT 4392 03:01:51,700 --> 03:01:54,903 TO PRIVACY AND CONFIDENTIALITY 4393 03:01:54,970 --> 03:01:57,406 THAT THEY HAVE HIGHER CONCERNS, 4394 03:01:57,473 --> 03:01:59,808 YOU KNOW, ABOUT THOSE ISSUES, 4395 03:01:59,875 --> 03:02:02,645 AND IT SEEMS LIKE IT'S AROUND 4396 03:02:02,711 --> 03:02:06,382 THOSE ISSUES, THE SUGGESTION IS, 4397 03:02:06,448 --> 03:02:07,816 AND SO, RIGHT, COLLECTING DATA 4398 03:02:07,883 --> 03:02:11,520 WHICH MAY NOT BE USED TO ADVANCE 4399 03:02:11,587 --> 03:02:14,590 SCIENCE, MAY, BUT MAY NOT, AND 4400 03:02:14,657 --> 03:02:16,659 THEN IS THAT INTENTION THEN AND 4401 03:02:16,725 --> 03:02:20,296 THEN YOU'RE GOING TO HAVE MORE 4402 03:02:20,362 --> 03:02:20,963 PRIVACY AND CONFIDENTIALITY 4403 03:02:21,030 --> 03:02:21,363 CONCERNS. 4404 03:02:21,430 --> 03:02:27,036 THAT'S THE QUESTION I'M RAISING. 4405 03:02:27,102 --> 03:02:27,703 >> THANK YOU. 4406 03:02:27,770 --> 03:02:29,672 ANOTHER QUESTION THAT CAN COME 4407 03:02:29,738 --> 03:02:31,874 UP ALSO IS IF CERTAIN 4408 03:02:31,940 --> 03:02:34,810 INFORMATION IS SHARED ABOUT 4409 03:02:34,877 --> 03:02:36,445 IDENTITY, HOW DOES THE RESEARCH 4410 03:02:36,512 --> 03:02:37,880 TEAM USE THAT DATA? 4411 03:02:37,946 --> 03:02:41,583 DO THEY ACCEPT THAT INFORMATION, 4412 03:02:41,650 --> 03:02:41,784 RIGHT? 4413 03:02:41,850 --> 03:02:43,452 OR DO THEY NOT? 4414 03:02:43,519 --> 03:02:46,955 I THINK THAT CAME UP IN THE LAST 4415 03:02:47,022 --> 03:02:48,157 SACHRP MEETING AGAIN, HOW DO YOU 4416 03:02:48,223 --> 03:02:49,792 ADDRESS THAT ISSUE AS WELL IN 4417 03:02:49,858 --> 03:02:52,428 TERMS OF THE -- THAT GETS BACK 4418 03:02:52,494 --> 03:02:54,029 TO THE RESEARCH CONDUCT AND 4419 03:02:54,096 --> 03:02:55,397 COLLECTION OF INFORMATION. 4420 03:02:55,464 --> 03:02:57,466 WHAT IS BEING COMMUNICATED IN 4421 03:02:57,533 --> 03:02:58,467 TERMS OF SELF-IDENTIFICATION 4422 03:02:58,534 --> 03:03:00,836 VERSUS HOW THAT INFORMATION IS 4423 03:03:00,903 --> 03:03:04,807 USED AND MIGHT BE CHANGED 4424 03:03:04,873 --> 03:03:11,814 POTENTIALLY, DEPENDING ON THE 4425 03:03:11,880 --> 03:03:13,015 RESEARCHER CONDUCTING THE 4426 03:03:13,082 --> 03:03:15,117 RESEARCH. 4427 03:03:15,184 --> 03:03:17,052 KEVIN AND THEN NEIL. 4428 03:03:17,119 --> 03:03:17,920 >> I THINK LOIS TOUCHED ON SOME 4429 03:03:17,986 --> 03:03:20,456 OF THE THINGS I WAS GOING TO 4430 03:03:20,522 --> 03:03:20,656 SAY. 4431 03:03:20,723 --> 03:03:26,829 I'M LOOKING AT THE PRIVACY, 4432 03:03:26,895 --> 03:03:27,696 CONFIDENTIALITY, OVERSIGHT, 4433 03:03:27,763 --> 03:03:29,231 SUPPORT AND SECURITY, SIMILAR 4434 03:03:29,298 --> 03:03:30,999 QUESTIONS AS LOIS. 4435 03:03:31,066 --> 03:03:34,503 YOU KNOW, WHAT ARE THE -- WHERE 4436 03:03:34,570 --> 03:03:36,472 ARE THE LEAKS, WHAT'S THE NATURE 4437 03:03:36,538 --> 03:03:41,610 OF THE LEAKS THAT WE'RE 4438 03:03:41,677 --> 03:03:43,879 CONSIDERING EXTRA MEASURES TO 4439 03:03:43,946 --> 03:03:46,548 ADDRESS BEYOND WHAT'S ALREADY 4440 03:03:46,615 --> 03:03:48,417 DONE, AND SO I'M HAVING A LITTLE 4441 03:03:48,484 --> 03:03:50,819 BIT OF TROUBLE TRYING TO GET 4442 03:03:50,886 --> 03:03:52,354 CONCRETE ANSWERS TO THOSE THINGS 4443 03:03:52,421 --> 03:03:54,223 BECAUSE I DON'T HAVE AS GOOD A 4444 03:03:54,289 --> 03:03:56,158 SENSE OF WHERE THINGS ARE 4445 03:03:56,225 --> 03:03:58,794 FALLING DOWN SO THAT ADDITIONAL 4446 03:03:58,861 --> 03:04:02,498 MEASURES ARE NEEDED. 4447 03:04:02,564 --> 03:04:04,833 I KNOW THE OVERSIGHT AND SUPPORT 4448 03:04:04,900 --> 03:04:06,335 DOESN'T SAY ADDITIONAL BUT 4449 03:04:06,402 --> 03:04:07,970 PRESUMABLY THAT'S IMPLIED 4450 03:04:08,036 --> 03:04:18,180 BECAUSE WE ALREADY HAVE 4451 03:04:18,247 --> 03:04:24,486 OVERSIGHT, SECURITY, ET CETERA. 4452 03:04:24,553 --> 03:04:24,920 >> OKAY. 4453 03:04:24,987 --> 03:04:25,120 NEIL? 4454 03:04:25,187 --> 03:04:26,688 >> SO I THINK A COUPLE THOUGHTS 4455 03:04:26,755 --> 03:04:28,424 THAT I THINK ARE IMPORTANT TO AT 4456 03:04:28,490 --> 03:04:30,426 LEAST HAVE A PLACE IN THIS 4457 03:04:30,492 --> 03:04:35,898 SECTION, ONE OF WHICH IS THAT 4458 03:04:35,964 --> 03:04:37,299 WHAT WE HEARD FROM, YOU KNOW, AT 4459 03:04:37,366 --> 03:04:40,469 LEAST IN THE PRIOR MEETING WAS A 4460 03:04:40,536 --> 03:04:45,841 DESIRE TO BE ASKED QUESTIONS, 4461 03:04:45,908 --> 03:04:49,912 RIGHT, ABOUT IDENTITY IN VARIOUS 4462 03:04:49,978 --> 03:04:55,684 FORMS, AND SO I THINK THAT 4463 03:04:55,751 --> 03:04:58,387 NOTION OF BOTH THE DEFAULT 4464 03:04:58,454 --> 03:05:01,423 NOTION THAT THESE ARE QUESTIONS 4465 03:05:01,490 --> 03:05:02,558 THAT INDIVIDUALS GENERALLY WANT 4466 03:05:02,624 --> 03:05:03,992 TO BE ASKED ABOUT BECAUSE THEY 4467 03:05:04,059 --> 03:05:05,727 ARE IMPORTANT PARTS OF WHO THEY 4468 03:05:05,794 --> 03:05:07,463 ARE AND THEY WANT THAT 4469 03:05:07,529 --> 03:05:08,897 REPRESENTED WITHIN STUDIES THEY 4470 03:05:08,964 --> 03:05:10,432 ARE PARTICIPATING AND THEY ARE 4471 03:05:10,499 --> 03:05:11,266 USED TO ANSWERING THESE 4472 03:05:11,333 --> 03:05:16,038 QUESTIONS ON A REGULAR BASIS IS 4473 03:05:16,104 --> 03:05:16,705 IMPORTANT DEFAULT BASELINE THAT 4474 03:05:16,772 --> 03:05:18,207 I THINK CAN PUSH IT A LITTLE BIT 4475 03:05:18,273 --> 03:05:21,276 AGAINST THE NOTION OF KIND OF 4476 03:05:21,343 --> 03:05:22,010 OVEREXTENSION OF PROTECTIONISM 4477 03:05:22,077 --> 03:05:22,945 IN THIS SPACE. 4478 03:05:23,011 --> 03:05:25,914 THE SECOND PIECE I THINK THAT'S 4479 03:05:25,981 --> 03:05:27,149 REALLY IMPORTANT THAT UNDERLIES 4480 03:05:27,216 --> 03:05:30,285 A LOT OF WHAT ALL OF US HAVE 4481 03:05:30,352 --> 03:05:32,254 BEEN SAYING IS JUST IN SOME 4482 03:05:32,321 --> 03:05:37,960 SENSE WE SHOULD REFLECT A BIT OF 4483 03:05:38,026 --> 03:05:42,431 A COMMITMENT TO TAILORING 4484 03:05:42,498 --> 03:05:43,499 OVERSIGHT AND PROTECTIVE 4485 03:05:43,565 --> 03:05:46,935 MEASURES TO ACTUAL DATA ON WHAT 4486 03:05:47,002 --> 03:05:53,809 RISKS AND VULNERABILITIES EXIST, 4487 03:05:53,876 --> 03:05:55,344 ANYTHING DONE SHOULD BE 4488 03:05:55,410 --> 03:06:01,783 APPROPRIATE FOR ACTUAL RISK THAT 4489 03:06:01,850 --> 03:06:03,652 MIGHT BE IMPORTANT RATHER THAN 4490 03:06:03,719 --> 03:06:07,055 SOMETIMES HAVING A REACTIONARY 4491 03:06:07,122 --> 03:06:08,824 OVEREXTENSION OF PROTECTION 4492 03:06:08,891 --> 03:06:09,892 BECAUSE OF PERCEIVED 4493 03:06:09,958 --> 03:06:11,894 VULNERABILITY. 4494 03:06:11,960 --> 03:06:18,433 WE HEARD A CLEAR MESSAGE THAT WE 4495 03:06:18,500 --> 03:06:20,936 SHOULD ASK PEOPLE QUESTIONS 4496 03:06:21,003 --> 03:06:22,804 ABOUT SEX AND GENDER IDENTITY, 4497 03:06:22,871 --> 03:06:24,706 THAT I THINK THERE'S A WAY IN 4498 03:06:24,773 --> 03:06:27,142 WHICH THAT NEEDS TO BE A BIT OF 4499 03:06:27,209 --> 03:06:32,648 AN ANCHOR IN SOME OF OUR 4500 03:06:32,714 --> 03:06:33,949 RECOMMENDATIONS. 4501 03:06:34,016 --> 03:06:35,984 >> OKAY. 4502 03:06:36,051 --> 03:06:39,555 THANK YOU, NEIL. 4503 03:06:39,621 --> 03:06:39,821 RUQAIIJAH? 4504 03:06:39,888 --> 03:06:43,258 >> YES, SO I WANT TO SAY YES, I 4505 03:06:43,325 --> 03:06:45,127 AGREE ABOUT WHAT WE HEARD IN 4506 03:06:45,193 --> 03:06:48,196 OCTOBER WHICH WAS THAT PEOPLE DO 4507 03:06:48,263 --> 03:06:51,266 WANT THIS INFORMATION COLLECTED, 4508 03:06:51,333 --> 03:06:54,236 AND THAT THE ACTUAL 4509 03:06:54,303 --> 03:06:57,372 VULNERABILITIES ARE LEGAL, 4510 03:06:57,439 --> 03:06:58,574 RIGHT? 4511 03:06:58,640 --> 03:06:59,575 THAT SOME JURISDICTIONS ARE 4512 03:06:59,641 --> 03:07:01,443 COLLECTING THAT INFORMATION, AND 4513 03:07:01,510 --> 03:07:03,645 THEN IT'S BEING USED IN WAYS 4514 03:07:03,712 --> 03:07:05,180 THAT HARM INDIVIDUALS. 4515 03:07:05,247 --> 03:07:09,084 SO, YES, I DO THINK THAT THERE 4516 03:07:09,151 --> 03:07:11,386 ARE ADDITIONAL PRIVACY AND 4517 03:07:11,453 --> 03:07:13,589 CONFIDENTIALITY MEASURES THAT 4518 03:07:13,655 --> 03:07:14,823 ARE REQUIRED HERE BUT I 4519 03:07:14,890 --> 03:07:16,325 DEFINITELY THINK THAT IT IS 4520 03:07:16,391 --> 03:07:17,960 BALANCED WITH THE FACT THAT 4521 03:07:18,026 --> 03:07:19,161 PEOPLE DO WANT THAT INFORMATION 4522 03:07:19,227 --> 03:07:23,332 OUT THERE TO BE USED. 4523 03:07:23,398 --> 03:07:26,268 AND SO I DO LIKE THIS. 4524 03:07:26,335 --> 03:07:29,137 I THINK IT GOES BACK TO THE 4525 03:07:29,204 --> 03:07:30,772 POINTS THAT ERIC MADE, THAT MAY 4526 03:07:30,839 --> 03:07:34,176 BE PUTTING IT TOGETHER IN OUR 4527 03:07:34,242 --> 03:07:38,013 RECOMMENDATIONS IS, AS NEIL 4528 03:07:38,080 --> 03:07:39,214 MENTIONED, GIVING SOME ACTUAL 4529 03:07:39,281 --> 03:07:40,983 INFORMATION WHICH COULD PICK UP 4530 03:07:41,049 --> 03:07:44,219 ON WHAT MINDY SAID EARLIER ABOUT 4531 03:07:44,286 --> 03:07:45,554 PARTICULAR INSTITUTIONS HAVING 4532 03:07:45,621 --> 03:07:47,856 SOME OF THESE ISSUES, RIGHT? 4533 03:07:47,923 --> 03:07:50,392 BUT STILL WANTING PEOPLE TO BE 4534 03:07:50,459 --> 03:07:52,461 ABLE TO SHARE THE INFORMATION 4535 03:07:52,527 --> 03:07:56,498 BECAUSE IT CAN HELP IN TERMS OF 4536 03:07:56,565 --> 03:07:59,034 A SCIENTIFIC DISCUSSION, RIGHT? 4537 03:07:59,101 --> 03:08:05,807 WE DON'T KNOW HOW ONE SEXUAL 4538 03:08:05,874 --> 03:08:07,242 ORIENTATION OR ACTIVITY IMPACTS 4539 03:08:07,309 --> 03:08:09,111 OUTCOMES BUT ALSO I THINK THE 4540 03:08:09,177 --> 03:08:12,814 BEST RESEARCH PRACTICES IS TO 4541 03:08:12,881 --> 03:08:15,917 HAVE AS MANY DIVERSE PEOPLE IN 4542 03:08:15,984 --> 03:08:19,121 RESEARCH, AND SO I THINK WE CAN 4543 03:08:19,187 --> 03:08:22,324 GET AT THAT IN THE 4544 03:08:22,391 --> 03:08:23,392 RECOMMENDATIONS. 4545 03:08:23,458 --> 03:08:26,061 >> THANK YOU. 4546 03:08:26,128 --> 03:08:29,798 ALLISON? 4547 03:08:29,865 --> 03:08:30,432 AND THEN NEIL. 4548 03:08:30,499 --> 03:08:32,300 >> I WANTED TO TAKE A MOMENT TO 4549 03:08:32,367 --> 03:08:33,301 GO BACK TO INFORMED CONSENT 4550 03:08:33,368 --> 03:08:35,470 BECAUSE I CAN'T BELIEVE I PASSED 4551 03:08:35,537 --> 03:08:37,005 UP THE OPPORTUNITY TO RANT ABOUT 4552 03:08:37,072 --> 03:08:40,275 MY FAVORITE THING TO RANT ABOUT. 4553 03:08:40,342 --> 03:08:44,613 WHICH IS WHEN YOU HAVE AN 4554 03:08:44,680 --> 03:08:46,314 INFORMED CONSENT FORM FOR A 4555 03:08:46,381 --> 03:08:52,988 STUDY THAT IS NOT FOCUSED ON, 4556 03:08:53,055 --> 03:08:55,824 YOU KNOW, THESE SEXUAL 4557 03:08:55,891 --> 03:08:56,925 MINORITY-FOCUSED ISSUES, WE 4558 03:08:56,992 --> 03:08:59,428 ALWAYS COME BACK TO THIS 4559 03:08:59,494 --> 03:09:01,730 BIOLOGICAL BINARY OF MALE OR 4560 03:09:01,797 --> 03:09:03,699 FEMALE, AND QUESTIONS OF CAN THE 4561 03:09:03,765 --> 03:09:06,301 PERSON GET PREGNANT, CAN THEY 4562 03:09:06,368 --> 03:09:07,536 NOT GET PREGNANT, IF YOU'RE A 4563 03:09:07,602 --> 03:09:09,705 MALE YOU HAVE TO DO THIS, IF 4564 03:09:09,771 --> 03:09:11,239 YOU'RE FEMALE YOU HAVE TO TAKE 4565 03:09:11,306 --> 03:09:13,642 THE PREGNANCY TEST, ET CETERA. 4566 03:09:13,709 --> 03:09:15,277 EVERY TIME I REVIEW ONE OF THESE 4567 03:09:15,343 --> 03:09:18,346 FORMS I'M ALWAYS CROSSING IT OUT 4568 03:09:18,413 --> 03:09:20,982 AND BEING LIKE, YOU KNOW, PERSON 4569 03:09:21,049 --> 03:09:22,918 CAPABLE OF PREGNANCY, ET CETERA. 4570 03:09:22,984 --> 03:09:26,321 SO I WOULD REALLY WANT TO 4571 03:09:26,388 --> 03:09:27,956 UNDERSCORE IN THIS SECTION THAT 4572 03:09:28,023 --> 03:09:29,391 WHEN WE'RE TALKING ABOUT 4573 03:09:29,458 --> 03:09:31,359 CONCERNS ABOUT PREGNANCY WE JUST 4574 03:09:31,426 --> 03:09:33,562 NEED TO GET RID OF COMMENTS 4575 03:09:33,628 --> 03:09:35,197 ABOUT MALE, FEMALE, OR ANY OF 4576 03:09:35,263 --> 03:09:37,365 THOSE THINGS AND JUST FOCUS ON 4577 03:09:37,432 --> 03:09:38,934 IT'S THE PREGNANCY WE'RE WORRIED 4578 03:09:39,000 --> 03:09:42,337 ABOUT, NOT WHAT YOUR GENDER 4579 03:09:42,404 --> 03:09:44,072 IDENTITY IS. 4580 03:09:44,139 --> 03:09:47,142 >> THAT TIES INTO THE CULTURAL 4581 03:09:47,209 --> 03:09:51,179 COMPETENCE PIECE, THE IDEA IN 4582 03:09:51,246 --> 03:09:53,782 TERMS OF EDUCATING ALL 4583 03:09:53,849 --> 03:09:56,218 STAKEHOLDERS, PEOPLE THAT WRITE 4584 03:09:56,284 --> 03:09:57,119 CONSENT FORM, REVIEWERS, WE NEED 4585 03:09:57,185 --> 03:09:58,286 TO PAY ATTENTION. 4586 03:09:58,353 --> 03:09:59,054 >> RANT OVER. 4587 03:09:59,121 --> 03:10:00,822 THANK YOU. 4588 03:10:00,889 --> 03:10:07,295 >> THANK YOU. 4589 03:10:07,362 --> 03:10:12,634 THAT'S AN IMPORTANT POINT. 4590 03:10:12,701 --> 03:10:13,969 >> KEVIN, DID YOU HAVE A 4591 03:10:14,035 --> 03:10:14,202 COMMENT? 4592 03:10:14,269 --> 03:10:18,673 >> I DIDN'T HAVE MY HAND UP. 4593 03:10:18,740 --> 03:10:18,974 >> OKAY. 4594 03:10:19,040 --> 03:10:22,377 >> I FAILED TO PUT MINE DOWN. 4595 03:10:22,444 --> 03:10:24,246 IT WASN'T UP. 4596 03:10:24,312 --> 03:10:26,248 >> ALL RIGHT, PERFECT. 4597 03:10:26,314 --> 03:10:31,153 ANYTHING ELSE ON - LAST QUESTION 4598 03:10:31,219 --> 03:10:33,221 IS ON REPORTING AND 4599 03:10:33,288 --> 03:10:36,491 DISSEMINATION OF FINDINGS. 4600 03:10:36,558 --> 03:10:38,794 ON THIS ONE IT'S FRAMED AS WHEN 4601 03:10:38,860 --> 03:10:41,196 WE'RE DOING IT, WHEN REPORTING 4602 03:10:41,263 --> 03:10:42,497 AND DISSEMINATING FINDINGS. 4603 03:10:42,564 --> 03:10:50,605 THIS ONE OF COURSE AS I THINK I 4604 03:10:50,672 --> 03:10:51,473 MENTIONED IF, WHEN, AND HOW, 4605 03:10:51,540 --> 03:10:54,910 UNDER WHAT CIRCUMSTANCES. 4606 03:10:54,976 --> 03:10:57,379 THERE'S A LOT ABOUT THIS IN 4607 03:10:57,445 --> 03:11:02,217 TERMS OF RETURNING INDIVIDUAL 4608 03:11:02,284 --> 03:11:04,052 RESULTS, AGGREGATE RESULTS, 4609 03:11:04,119 --> 03:11:06,254 TIMING, PROBABLY WE COULD 4610 03:11:06,321 --> 03:11:07,355 PROBABLY GET INTO IT A LITTLE 4611 03:11:07,422 --> 03:11:10,192 BIT HERE. 4612 03:11:10,258 --> 03:11:12,694 THIS QUESTION FOCUSES ON ALSO 4613 03:11:12,761 --> 03:11:15,897 SEEKING TO ENSURE THAT THE 4614 03:11:15,964 --> 03:11:20,569 REPORTING AND DISSEMINATION IS 4615 03:11:20,635 --> 03:11:23,305 TRANSPARENT AND IT ALSO -- TWO 4616 03:11:23,371 --> 03:11:24,406 SIDES, MISREPRESENTATION OF 4617 03:11:24,472 --> 03:11:26,842 INFORMATION AND THE ISSUE OF 4618 03:11:26,908 --> 03:11:28,243 INDIVIDUAL ANT COMMUNITY HARM. 4619 03:11:28,310 --> 03:11:30,979 ANYTHING HERE THAT YOU WANTED TO 4620 03:11:31,046 --> 03:11:32,514 DISCUSS OR TOUCH ON FOR 4621 03:11:32,581 --> 03:11:40,822 RECOMMENDATIONS? 4622 03:11:40,889 --> 03:11:46,628 TALKING ABOUT THE WHY AS WELL, A 4623 03:11:46,695 --> 03:11:48,263 LITTLE ABOUT THE HOW. 4624 03:11:48,330 --> 03:11:58,540 BUT AGAIN -- 4625 03:12:06,147 --> 03:12:10,185 >> LINDA, WAS THERE A PARTICULAR 4626 03:12:10,252 --> 03:12:14,990 EXAMPLE YOU GUYS WORKING ON THIS 4627 03:12:15,056 --> 03:12:17,359 VERY CAREFULLY HAD IN MIND HERE? 4628 03:12:17,425 --> 03:12:17,826 LIKE A MISSTEP? 4629 03:12:17,893 --> 03:12:19,127 >> I THINK, YOU KNOW, WE LOOKED 4630 03:12:19,194 --> 03:12:21,897 AT SOME OF THE LITERATURE, SOME 4631 03:12:21,963 --> 03:12:22,731 OF THE STUDY EXAMPLES. 4632 03:12:22,797 --> 03:12:26,034 THERE ARE LOTS OF EXAMPLES OUT 4633 03:12:26,101 --> 03:12:28,536 THERE THAT REALLY GET INTO WHEN 4634 03:12:28,603 --> 03:12:35,877 YOU DISSEMINATE RESULTS HOW IT'S 4635 03:12:35,944 --> 03:12:36,645 BEING COMMUNICATED, LOOKING AT 4636 03:12:36,711 --> 03:12:37,846 COMMUNITY HARM FOR EXAMPLE. 4637 03:12:37,913 --> 03:12:39,915 LIKE YOU PUBLISH SOMETHING, HOW 4638 03:12:39,981 --> 03:12:40,916 IT'S PUBLISHED, HAVE YOU 4639 03:12:40,982 --> 03:12:42,651 CONSULTED WITH THE COMMUNITY ON 4640 03:12:42,717 --> 03:12:43,518 IT? 4641 03:12:43,585 --> 03:12:45,053 ARE THEY AWARE? 4642 03:12:45,120 --> 03:12:46,321 I THINK THAT'S WHAT I WAS 4643 03:12:46,388 --> 03:12:50,125 THINKING ABOUT. 4644 03:12:50,191 --> 03:12:51,493 IF YOU THINK ABOUT, YOU KNOW, 4645 03:12:51,559 --> 03:12:53,895 STUDIES OUT THERE WHERE THERE'S 4646 03:12:53,962 --> 03:12:55,764 BEEN SOME MISSTEPS, THOSE ARE 4647 03:12:55,830 --> 03:12:57,198 DIFFERENT AND REASONS FOR 4648 03:12:57,265 --> 03:12:58,500 MISSTEPS ARE DIFFERENT. 4649 03:12:58,566 --> 03:13:01,903 YOU MIGHT IMAGINE THAT THERE'S 4650 03:13:01,970 --> 03:13:04,306 RESEARCH THAT'S BEING DONE BY 4651 03:13:04,372 --> 03:13:05,941 LOTS OF DIFFERENT INVESTIGATORS 4652 03:13:06,007 --> 03:13:06,741 WITH MAYBE DIFFERENT VIEWPOINTS 4653 03:13:06,808 --> 03:13:08,677 ABOUT SOME OF THE THINGS WE'RE 4654 03:13:08,743 --> 03:13:12,080 TALKING ABOUT, AND THEN HOW THAT 4655 03:13:12,147 --> 03:13:13,281 INFORMATION IS BEING 4656 03:13:13,348 --> 03:13:14,049 DISSEMINATED, WAS THERE A 4657 03:13:14,115 --> 03:13:14,816 CONSULTATION WITH THE COMMUNITY 4658 03:13:14,883 --> 03:13:17,986 ON IT OR NOT AND HOW WE ADDRESS 4659 03:13:18,053 --> 03:13:18,186 THAT. 4660 03:13:18,253 --> 03:13:20,255 SO WE PROBABLY CAN FIND A NUMBER 4661 03:13:20,322 --> 03:13:22,123 OF CASE STUDY EXAMPLES TO ADD TO 4662 03:13:22,190 --> 03:13:23,758 THIS SECTION ABOUT HOW THERE 4663 03:13:23,825 --> 03:13:25,527 COULD BE INDIVIDUAL OR COMMUNITY 4664 03:13:25,593 --> 03:13:29,898 HARM, WHAT YOU MIGHT WANT TO DO 4665 03:13:29,965 --> 03:13:31,766 TO POTENTIALLY ENGAGE OR PARTNER 4666 03:13:31,833 --> 03:13:32,734 WITH THE COMMUNITY SO THAT 4667 03:13:32,801 --> 03:13:35,136 DOESN'T HAPPEN OR SOME OF THOSE 4668 03:13:35,203 --> 03:13:36,805 ISSUES MIGHT BE MITIGATED. 4669 03:13:36,871 --> 03:13:41,176 THAT'S I THINK WHAT THE GROUP 4670 03:13:41,242 --> 03:13:41,743 WAS INTENDING WITH THIS 4671 03:13:41,810 --> 03:13:44,012 QUESTION. 4672 03:13:44,079 --> 03:13:47,415 >> YEAH, AND HERE THERE ARE SOME 4673 03:13:47,482 --> 03:13:48,516 ANALOGOUS HELPFUL GUIDES THAT 4674 03:13:48,583 --> 03:13:49,951 HAVE JUST RECENTLY COME OUT 4675 03:13:50,018 --> 03:13:53,221 ABOUT THE USE OF POPULATION 4676 03:13:53,288 --> 03:13:54,756 DESCRIPTORS, IN PUBLICATIONS, 4677 03:13:54,823 --> 03:13:57,826 AND I KNOW THERE ARE SEVERAL 4678 03:13:57,892 --> 03:13:59,027 JOURNALS THAT ARE DEVELOPING 4679 03:13:59,094 --> 03:14:02,097 BEST PRACTICES WHEN TO USE 4680 03:14:02,163 --> 03:14:05,133 POPULATION DESCRIPTORS AND 4681 03:14:05,200 --> 03:14:08,436 TITLES AND TRYING TO MITIGATE 4682 03:14:08,503 --> 03:14:09,838 THE RISKS AROUND CONFLATION. 4683 03:14:09,904 --> 03:14:15,810 SO WE COULD PROBABLY POINT TO 4684 03:14:15,877 --> 03:14:16,978 SOME OF THOSE. 4685 03:14:17,045 --> 03:14:21,216 THE OTHER POINT GOES BAG UP TO 4686 03:14:21,282 --> 03:14:21,750 RESEARCH DESIGN, SOMEBODY 4687 03:14:21,816 --> 03:14:30,759 TOUCHED ON THIS BUT IN ITEMS OF 4688 03:14:30,825 --> 03:14:31,993 HARMONIZATION OF DATASETS AND 4689 03:14:32,060 --> 03:14:33,428 PROBLEMS THAT COME UP WHEN 4690 03:14:33,495 --> 03:14:34,229 RESEARCHERS MAKE DECISIONS HOW 4691 03:14:34,295 --> 03:14:39,768 TO SCALE UP IN TERMS OF OR TO 4692 03:14:39,834 --> 03:14:41,503 COMBINE DATASETS THAT HAVE BEEN 4693 03:14:41,569 --> 03:14:42,303 DESCRIBED DIFFERENTLY, THAT'S A 4694 03:14:42,370 --> 03:14:44,706 PLACE YOU CAN SEE THE ORIGINAL 4695 03:14:44,773 --> 03:14:46,441 INTENTIONS OF COMMUNITIES AND 4696 03:14:46,508 --> 03:14:47,409 INDIVIDUALS TO IDENTIFY 4697 03:14:47,475 --> 03:14:49,444 THEMSELVES GET LOST. 4698 03:14:49,511 --> 03:14:52,213 SO JUST BEING MINDFUL ABOUT THAT 4699 03:14:52,280 --> 03:14:52,881 HARMONIZATION PROCESS. 4700 03:14:52,947 --> 03:14:58,953 >> OKAY. 4701 03:14:59,020 --> 03:15:00,622 IN TERMS OF -- WE TALKED ABOUT 4702 03:15:00,688 --> 03:15:01,723 THE HARM PART. 4703 03:15:01,790 --> 03:15:10,665 THERE'S ALSO THE PIECE ABOUT 4704 03:15:10,732 --> 03:15:11,433 PROMOTING TRANSPARENCY, THAT 4705 03:15:11,499 --> 03:15:12,867 BUILDS TRUST IF YOU'RE 4706 03:15:12,934 --> 03:15:13,635 TRANSPARENT, YOU MIGHT WANT TO 4707 03:15:13,701 --> 03:15:15,270 THINK ABOUT THE FLIP SIDE AS 4708 03:15:15,336 --> 03:15:18,673 WELL IN THE RECOMMENDATIONS AS 4709 03:15:18,740 --> 03:15:20,508 WELL IN TERMS OF HOW THAT MIGHT 4710 03:15:20,575 --> 03:15:21,309 BE ACCOMPLISHED. 4711 03:15:21,376 --> 03:15:26,114 AGAIN, IF YOU'RE A COMMUNITY 4712 03:15:26,181 --> 03:15:27,615 ENGAGEMENT -- IF YOUR COMMUNITY 4713 03:15:27,682 --> 03:15:29,050 ENGAGEMENT HAS BEEN DONE IN A 4714 03:15:29,117 --> 03:15:30,819 WAY THAT YOU'VE ACTUALLY DONE 4715 03:15:30,885 --> 03:15:34,622 THAT, THAT WILL CERTAINLY HELP 4716 03:15:34,689 --> 03:15:36,591 WITH THIS PIECE AS WELL, GETTING 4717 03:15:36,658 --> 03:15:37,926 INPUT POTENTIALLY DEPENDING ON 4718 03:15:37,992 --> 03:15:38,793 THE STUDY. 4719 03:15:38,860 --> 03:15:40,595 IT MAY NOT BE APPROPRIATE FOR 4720 03:15:40,662 --> 03:15:43,598 EVERY STUDY BUT IN TERMS OF 4721 03:15:43,665 --> 03:15:44,899 DESIGN AND THE CONSENT PROCESS 4722 03:15:44,966 --> 03:15:48,636 AND ALSO IN TERMS OF REPORTING 4723 03:15:48,703 --> 03:15:49,871 DISSEMINATION OF FINDINGS, 4724 03:15:49,938 --> 03:15:51,473 THROUGHOUT THE LIFE CYCLE OF A 4725 03:15:51,539 --> 03:15:58,513 STUDY IS THE INTENT THERE. 4726 03:15:58,580 --> 03:15:58,813 OKAY. 4727 03:15:58,880 --> 03:16:01,549 SO, LET ME JUST ASK THIS 4728 03:16:01,616 --> 03:16:02,150 QUESTION. 4729 03:16:02,217 --> 03:16:03,651 DOES ANYBODY HAVE ANY GENERAL -- 4730 03:16:03,718 --> 03:16:05,854 NOT LOOKING AT THE CHARGE 4731 03:16:05,920 --> 03:16:08,690 DOCUMENT OR JUST ANY SPECIFIC 4732 03:16:08,756 --> 03:16:10,125 QUESTION, ANYTHING, JUST IN 4733 03:16:10,191 --> 03:16:11,659 GENERAL, YOU AS A GROUP WOULD 4734 03:16:11,726 --> 03:16:13,428 LIKE TO SEE IN THE 4735 03:16:13,495 --> 03:16:13,962 RECOMMENDATIONS? 4736 03:16:14,028 --> 03:16:15,463 WE TALKED A LITTLE ABOUT 4737 03:16:15,530 --> 03:16:17,332 INCORPORATING SOME OF THE WHY, 4738 03:16:17,398 --> 03:16:19,000 WHICH MAKES SENSE. 4739 03:16:19,067 --> 03:16:22,370 AND THAT THE HOW CANNOT BE TOO 4740 03:16:22,437 --> 03:16:23,238 DETAILED BECAUSE THAT WOULD BE 4741 03:16:23,304 --> 03:16:24,205 DIFFICULT TO ACCOMPLISH. 4742 03:16:24,272 --> 03:16:25,673 IS THERE ANYTHING ELSE YOU WOULD 4743 03:16:25,740 --> 03:16:29,511 LIKE TO SEE? 4744 03:16:29,577 --> 03:16:35,917 AS WE TAKE THIS BACK AND START 4745 03:16:35,984 --> 03:16:46,161 DRAFTING. 4746 03:16:46,928 --> 03:16:47,128 KEVIN? 4747 03:16:47,195 --> 03:16:48,530 >> MAYBE WE GOT THIS DOWN IN THE 4748 03:16:48,596 --> 03:16:51,166 NOTES, BUT THE INTRODUCTION 4749 03:16:51,232 --> 03:16:52,901 MIGHT BE HELPFUL TO MAKE SURE 4750 03:16:52,967 --> 03:16:55,870 THAT WE'RE REALLY CLEAR ABOUT 4751 03:16:55,937 --> 03:16:57,071 THOSE DIFFERENT FUNCTIONS OF 4752 03:16:57,138 --> 03:17:00,141 INCLUSION THAT NEIL HAD SKETCHED 4753 03:17:00,208 --> 03:17:05,280 OUT AND CASES WHERE WE'RE 4754 03:17:05,346 --> 03:17:06,915 INVESTIGATING THE SCIENTIFIC 4755 03:17:06,981 --> 03:17:10,418 QUESTIONS, THE FOCUS ON LGBTQ+ 4756 03:17:10,485 --> 03:17:12,820 COMMUNITY OR SCIENTIFIC 4757 03:17:12,887 --> 03:17:13,688 QUESTION, SUBANALYSES REGARDING 4758 03:17:13,755 --> 03:17:17,892 THAT, OR THERE'S A SPECIFIC 4759 03:17:17,959 --> 03:17:20,828 SCIENTIFIC QUESTION BUT THERE'S 4760 03:17:20,895 --> 03:17:23,698 MORAL JUSTIFICATION FOR SOME 4761 03:17:23,765 --> 03:17:25,867 LEVEL OF APPROPRIATE INCLUSION. 4762 03:17:25,934 --> 03:17:26,534 >> OKAY. 4763 03:17:26,601 --> 03:17:27,735 >> THINGS LIKE THAT, KEEPING 4764 03:17:27,802 --> 03:17:30,138 THOSE DISTINCTIONS IN MIND WILL 4765 03:17:30,205 --> 03:17:33,441 BE IMPORTANT FOR SOME OF THESE. 4766 03:17:33,508 --> 03:17:38,446 >> OKAY. 4767 03:17:38,513 --> 03:17:38,880 RUQAIIJAH? 4768 03:17:38,947 --> 03:17:43,284 >> YEAH, I WANT US TO THINK 4769 03:17:43,351 --> 03:17:44,419 ABOUT ARE THOSE DISTINCTIONS -- 4770 03:17:44,485 --> 03:17:47,088 THEY ARE GREAT FOR US IN SORT OF 4771 03:17:47,155 --> 03:17:49,757 THE RECOMMENDATIONS, BUT CAN WE 4772 03:17:49,824 --> 03:17:51,926 EVEN MAKE THOSE DISTINCTIONS 4773 03:17:51,993 --> 03:17:52,193 HONESTLY? 4774 03:17:52,260 --> 03:17:54,896 RIGHT? 4775 03:17:54,963 --> 03:17:57,065 AND I THINK THE ISSUE BECOMES 4776 03:17:57,131 --> 03:17:59,400 THAT IT'S NOT JUST ABOUT SEXUAL 4777 03:17:59,467 --> 03:18:01,236 ORIENTATION BUT WHEN YOU HAVE 4778 03:18:01,302 --> 03:18:05,840 THE OTHER GROUPS THAT INTERSECTS 4779 03:18:05,907 --> 03:18:09,110 AND ASEXUAL THAT IT'S NOT JUST 4780 03:18:09,177 --> 03:18:11,846 ABOUT SEXUAL ORIENTATION, THAT 4781 03:18:11,913 --> 03:18:16,217 IT MIGHT BE ACTUALLY PART OF 4782 03:18:16,284 --> 03:18:19,921 BIOLOGY WITH THE INTERSECTS AND 4783 03:18:19,988 --> 03:18:22,257 HORMONES AND SO I THINK THAT 4784 03:18:22,323 --> 03:18:24,125 WHAT SANDRA WAS SAYING ABOUT 4785 03:18:24,192 --> 03:18:26,094 LOOKING AT THE NASEM REPORT MAY 4786 03:18:26,160 --> 03:18:30,798 BE VERY HELPFUL FOR US, AND 4787 03:18:30,865 --> 03:18:32,767 BEING ABLE TO CREATE SOME 4788 03:18:32,834 --> 03:18:35,970 LANGUAGE THAT ALLOWS FOR US TO 4789 03:18:36,037 --> 03:18:37,572 TALK ABOUT THE OVERLAP BETWEEN 4790 03:18:37,639 --> 03:18:39,440 WHEN IT IS A SCIENTIFIC 4791 03:18:39,507 --> 03:18:41,175 QUESTION, WHEN IT'S NOT A 4792 03:18:41,242 --> 03:18:44,112 SCIENTIFIC QUESTION, AND WHEN WE 4793 03:18:44,178 --> 03:18:45,813 DON'T KNOW BECAUSE I THINK THAT 4794 03:18:45,880 --> 03:18:47,882 WE DON'T KNOW WHEN IT IS A 4795 03:18:47,949 --> 03:18:50,285 SCIENTIFIC QUESTION AND WHEN 4796 03:18:50,351 --> 03:18:51,352 IT'S NOT. 4797 03:18:51,419 --> 03:18:56,424 AND WHAT WE'RE TRYING TO DO IS 4798 03:18:56,491 --> 03:18:57,959 PERHAPS INCREASE THE DIVERSITY 4799 03:18:58,026 --> 03:19:01,763 OF PARTICIPATION SO THAT WE 4800 03:19:01,829 --> 03:19:05,366 COULD FIGURE OUT THOSE ISSUES. 4801 03:19:05,433 --> 03:19:08,670 AND HOW THOSE ISSUES COULD BE 4802 03:19:08,736 --> 03:19:10,204 SOCIAL, THEY COULD BE 4803 03:19:10,271 --> 03:19:11,406 BIOLOGICAL, THEY COULD BE 4804 03:19:11,472 --> 03:19:12,940 POLITICAL, RIGHT? 4805 03:19:13,007 --> 03:19:15,910 IT COULD BE AN OVERLAP OF ALL OF 4806 03:19:15,977 --> 03:19:22,016 THOSE THINGS. 4807 03:19:22,083 --> 03:19:25,953 >> THANK YOU, RUQAIIJAH. 4808 03:19:26,020 --> 03:19:30,224 ANYTHING ELSE FROM ANYONE? 4809 03:19:30,291 --> 03:19:32,193 DAVID, YOU PROBABLY WANT TO GET 4810 03:19:32,260 --> 03:19:34,295 BACK TO YOUR TOPIC TOO. 4811 03:19:34,362 --> 03:19:38,533 SO ANY OTHER COMMENTS ON THIS 4812 03:19:38,599 --> 03:19:43,271 AND WE CAN -- I THINK WE HAVE A 4813 03:19:43,338 --> 03:19:44,806 LOT OF GOOD FEEDBACK. 4814 03:19:44,872 --> 03:19:47,608 JULIA, I DID HAVE A QUESTION FOR 4815 03:19:47,675 --> 03:19:49,277 YOU IN TERMS OF THAT EDIT, 4816 03:19:49,344 --> 03:19:52,013 WHETHER I SHOULD DO THAT NOW OR 4817 03:19:52,080 --> 03:19:53,448 WHETHER WE CAN -- OR WHETHER WE 4818 03:19:53,514 --> 03:19:55,616 CAN JUST DO THAT AFTER THE FACT. 4819 03:19:55,683 --> 03:19:57,051 IF YOU COULD CLARIFY THAT, THAT 4820 03:19:57,118 --> 03:19:59,354 WOULD BE HELPFUL BEFORE I END. 4821 03:19:59,420 --> 03:20:01,356 >> WELL, WHY DON'T WE DO IT NOW 4822 03:20:01,422 --> 03:20:08,229 SINCE WE HAVE THE TIME AND -- 4823 03:20:08,296 --> 03:20:10,732 >> OKAY. 4824 03:20:10,798 --> 03:20:12,700 THIS IS WHAT THE SECTION WAS 4825 03:20:12,767 --> 03:20:23,277 THAT YOU HAD QUESTIONS ABOUT. 4826 03:20:31,252 --> 03:20:32,754 I'M TRYING TO LOOK AT MY NOTES 4827 03:20:32,820 --> 03:20:35,590 AS TO WHAT YOU HAD SAID. 4828 03:20:35,656 --> 03:20:37,792 >> YEAH, I THINK IT'S SOMETHING 4829 03:20:37,859 --> 03:20:43,364 MORE ALONG THE LINES CONSISTENT 4830 03:20:43,431 --> 03:20:46,367 WITH THESE PRINCIPLES, SACHRP -- 4831 03:20:46,434 --> 03:20:47,869 SACHRP MAKES RECOMMENDATIONS ON 4832 03:20:47,935 --> 03:20:49,070 THE FOLLOWING, OR SOMETHING -- 4833 03:20:49,137 --> 03:20:51,873 YOU KNOW, THERE'S BEEN 4834 03:20:51,939 --> 03:20:54,976 CONSIDERABLE INPUT ON THE CHARGE 4835 03:20:55,042 --> 03:20:56,778 SINCE IT WAS ORIGINALLY PROVIDED 4836 03:20:56,844 --> 03:21:00,348 BY OHRP SO I THINK THAT NEEDS TO 4837 03:21:00,415 --> 03:21:04,051 BE REFLECTED HERE, POINT BEING 4838 03:21:04,118 --> 03:21:06,254 IT'S NOT NECESSARILY NOW PURELY 4839 03:21:06,320 --> 03:21:08,222 DIRECTED FROM OHRP BUT HAS HAD 4840 03:21:08,289 --> 03:21:12,393 INPUT FROM THE SUBCOMMITTEES AND 4841 03:21:12,460 --> 03:21:14,462 FROM SACHRP, IT'S MORE ACCURATE 4842 03:21:14,529 --> 03:21:16,864 TO REFLECT THAT. 4843 03:21:16,931 --> 03:21:17,432 >> OKAY. 4844 03:21:17,498 --> 03:21:19,066 LET ME JUST -- GIVE ME JUST A 4845 03:21:19,133 --> 03:21:29,343 SECOND HERE. 4846 03:21:30,077 --> 03:21:31,145 >> SACHRP MAKES RECOMMENDATIONS 4847 03:21:31,212 --> 03:21:32,413 ADDRESSING THE FOLLOWING, OR WE 4848 03:21:32,480 --> 03:21:34,248 CAN REFINE THIS LATER BUT I WANT 4849 03:21:34,315 --> 03:21:35,950 TO MAKE SURE THAT EVERYONE 4850 03:21:36,017 --> 03:21:42,156 UNDERSTANDS THE POINT. 4851 03:21:42,223 --> 03:21:45,860 >> I HAVE A QUESTION, JULIA. 4852 03:21:45,927 --> 03:21:48,296 SO, DOES SACHRP JUST MAKE 4853 03:21:48,362 --> 03:21:51,032 RECOMMENDATIONS ON ITS OWN? 4854 03:21:51,098 --> 03:21:51,532 OR -- 4855 03:21:51,599 --> 03:21:53,868 >> TYPICALLY NOT. 4856 03:21:53,935 --> 03:21:56,838 THE AGENDA FOR SACHRP IS SET BY 4857 03:21:56,904 --> 03:21:59,140 OHRP. 4858 03:21:59,207 --> 03:22:01,309 >> CAN WE SAY BUILDING ON THE 4859 03:22:01,375 --> 03:22:02,743 CHARGE FROM OHRP? 4860 03:22:02,810 --> 03:22:09,851 >> UH-HUH, YEAH, SOMETHING LIKE 4861 03:22:09,917 --> 03:22:20,361 THAT WOULD BE APPROPRIATE. 4862 03:22:23,164 --> 03:22:25,366 >> OKAY. 4863 03:22:27,101 --> 03:22:29,871 >> WE CAN REFINE IT BUT THAT'S 4864 03:22:29,937 --> 03:22:31,739 THE BASIC IDEA. 4865 03:22:31,806 --> 03:22:33,074 >> MY NEXT QUESTION GIVEN WHAT 4866 03:22:33,140 --> 03:22:38,312 WE JUST SAID EARLIER ABOUT THIS 4867 03:22:38,379 --> 03:22:39,347 CHARGE BEING ESSENTIALLY FINAL, 4868 03:22:39,413 --> 03:22:42,283 JULIA, IN TERMS OF THE 4869 03:22:42,350 --> 03:22:43,150 RECOMMENDATIONS TODAY, WOULD YOU 4870 03:22:43,217 --> 03:22:45,119 LIKE ME TO MAKE SOME EDITS HERE 4871 03:22:45,186 --> 03:22:49,924 OR SHOULD WE MAKE EDITS HERE? 4872 03:22:49,991 --> 03:22:54,428 >> WELL, I THINK GIVEN THE 4873 03:22:54,495 --> 03:22:55,830 DISCUSSION TODAY, I WOULD SAY 4874 03:22:55,897 --> 03:22:55,997 YES. 4875 03:22:56,063 --> 03:22:58,432 I MEAN, THIS WAS DISCUSSED AT 4876 03:22:58,499 --> 03:23:00,434 THE SUBCOMMITTEE LEVEL. 4877 03:23:00,501 --> 03:23:00,701 >> OKAY. 4878 03:23:00,768 --> 03:23:02,069 >> THEREFORE I THINK IT HAS TO 4879 03:23:02,136 --> 03:23:04,272 BE GIVEN THE OPPORTUNITY TO BE 4880 03:23:04,338 --> 03:23:10,811 DISCUSSED AT THE PARENT LEVEL. 4881 03:23:10,878 --> 03:23:12,013 >> OKAY. 4882 03:23:12,079 --> 03:23:12,446 >> THAT SAID -- 4883 03:23:12,513 --> 03:23:14,649 >> SORRY. 4884 03:23:14,715 --> 03:23:18,386 >> WE'RE REACHING THE END, 4885 03:23:18,452 --> 03:23:19,253 FOCUS ON THE CHARGE. 4886 03:23:19,320 --> 03:23:20,021 >> I AGREE. 4887 03:23:20,087 --> 03:23:24,292 LET ME JUST GO AHEAD AND -- 4888 03:23:24,358 --> 03:23:27,261 >> NOW, WERE YOU HOPING IN THE 4889 03:23:27,328 --> 03:23:31,432 TIME REMAINING TODAY, LINDA, TO 4890 03:23:31,499 --> 03:23:33,067 MOVE ON INTO DISCUSSION OF 4891 03:23:33,134 --> 03:23:34,602 THE -- BEGINNING DISCUSSION OF 4892 03:23:34,669 --> 03:23:35,870 THE RECOMMENDATIONS? 4893 03:23:35,937 --> 03:23:38,539 HOW WERE YOU -- WHAT WAS YOUR 4894 03:23:38,606 --> 03:23:39,507 VISION CONCLUDING TODAY? 4895 03:23:39,574 --> 03:23:41,609 >> I THINK BASED UPON WHAT I'VE 4896 03:23:41,676 --> 03:23:43,244 HEARD I'M NOT SURE -- IT'S UP TO 4897 03:23:43,311 --> 03:23:44,045 THE GROUP. 4898 03:23:44,111 --> 03:23:45,546 I'VE HEARD A LOT OF COMMENTS. 4899 03:23:45,613 --> 03:23:47,281 I THINK THERE'S A PATH FORWARD 4900 03:23:47,348 --> 03:23:50,918 FOR STARTING TO DRAFT THE 4901 03:23:50,985 --> 03:23:51,485 RECOMMENDATIONS. 4902 03:23:51,552 --> 03:23:54,088 SO UNLESS INDIVIDUALS ON THE 4903 03:23:54,155 --> 03:23:56,157 PARENT COMMITTEE HAVE -- WANT TO 4904 03:23:56,223 --> 03:23:56,824 ACTUALLY PROVIDE MORE SPECIFICS, 4905 03:23:56,891 --> 03:23:59,360 I THINK I WAS FINISHED FOR 4906 03:23:59,427 --> 03:23:59,660 TODAY. 4907 03:23:59,727 --> 03:23:59,927 >> OKAY. 4908 03:23:59,994 --> 03:24:01,862 >> I'M HAPPY BECAUSE I DO THINK 4909 03:24:01,929 --> 03:24:06,033 I HAVE ENOUGH TO START DRAFTING 4910 03:24:06,100 --> 03:24:07,668 BUT, AGAIN, I THINK THEY HAVE 4911 03:24:07,735 --> 03:24:10,171 PROVIDED SOME FEEDBACK FOR THE 4912 03:24:10,237 --> 03:24:11,205 RECOMMENDATIONS THEMSELVES. 4913 03:24:11,272 --> 03:24:14,342 WE HAVE MOVED BEYOND THE CHARGE. 4914 03:24:14,408 --> 03:24:16,811 JUST I THINK WE -- IN THE 4915 03:24:16,877 --> 03:24:17,745 BEGINNING I THINK IT WAS A 4916 03:24:17,812 --> 03:24:21,048 LITTLE BIT OF DISCUSSION ABOUT A 4917 03:24:21,115 --> 03:24:25,953 COUPLE THINGS GOING FORWARD. 4918 03:24:26,020 --> 03:24:27,388 >> YEAH, I UNDERSTAND. 4919 03:24:27,455 --> 03:24:30,458 TYPICALLY THE MODEL IS REACTING 4920 03:24:30,524 --> 03:24:31,058 TO A DRAFTED -- 4921 03:24:31,125 --> 03:24:35,262 >> RIGHT. 4922 03:24:35,329 --> 03:24:36,197 >> A DRAFTED RECOMMENDATION AS 4923 03:24:36,263 --> 03:24:41,702 OPPOSED TO DRAFTING AT THE 4924 03:24:41,769 --> 03:24:44,538 MEETING LEVEL. 4925 03:24:44,605 --> 03:24:46,641 >> I WILL JUST -- WHAT I DID DO, 4926 03:24:46,707 --> 03:24:51,245 JULIA, I DID SEPARATE OUT THE 4927 03:24:51,312 --> 03:24:53,080 LAWS, REGULATIONS, GUIDELINES 4928 03:24:53,147 --> 03:24:55,483 FROM STANDARDS, I NEED WORD 4929 03:24:55,549 --> 03:24:59,086 SMITH THIS BULLET, I CAN DO THAT 4930 03:24:59,153 --> 03:25:02,490 AND THERE WAS ONE WORD CHANGE, 4931 03:25:02,556 --> 03:25:04,792 REPRESENT, A WORD THAT LOIS HAD, 4932 03:25:04,859 --> 03:25:08,629 I CAN CHANGE AS WELL. 4933 03:25:08,696 --> 03:25:10,731 BEYOND THAT, YOUR COMMENTS, I 4934 03:25:10,798 --> 03:25:18,906 THINK THE CHARGE WOULD BE FINAL. 4935 03:25:18,973 --> 03:25:19,774 WE'LL START DRAFTING. 4936 03:25:19,840 --> 03:25:22,543 I DON'T WANT TO CUT ANYONE OFF. 4937 03:25:22,610 --> 03:25:23,944 UNLESS YOU HAVE ANY OTHER 4938 03:25:24,011 --> 03:25:25,246 SUGGESTIONS OR COMMENTS FOR 4939 03:25:25,312 --> 03:25:27,548 TODAY I WAS GOING TO STOP WITH 4940 03:25:27,615 --> 03:25:33,154 WHAT I HAVE RIGHT NOW. 4941 03:25:33,220 --> 03:25:34,255 IS THAT OKAY WITH EVERYONE? 4942 03:25:34,321 --> 03:25:35,690 ALL RIGHT. 4943 03:25:35,756 --> 03:25:35,923 OKAY. 4944 03:25:35,990 --> 03:25:37,658 THANK YOU, JULIA. 4945 03:25:37,725 --> 03:25:38,059 >> SURE. 4946 03:25:38,125 --> 03:25:40,494 >> THANK YOU, LINDA. 4947 03:25:40,561 --> 03:25:41,495 >> THANK YOU, LINDA. 4948 03:25:41,562 --> 03:25:43,864 >> THANK YOU, LINDA. 4949 03:25:43,931 --> 03:25:44,865 THIS LOOKS GREAT. 4950 03:25:44,932 --> 03:25:46,734 >> YOU GOT PROBABLY WHAT YOU 4951 03:25:46,801 --> 03:25:49,336 NEED FOR THE SUBCOMMITTEE TO 4952 03:25:49,403 --> 03:25:50,571 DRAFT SOMETHING WHICH WE CAN 4953 03:25:50,638 --> 03:25:53,074 THEN REACT TO AT OUR NEXT 4954 03:25:53,140 --> 03:25:54,575 MEETING. 4955 03:25:54,642 --> 03:25:57,778 SO, AT THIS POINT WE WILL HEAD 4956 03:25:57,845 --> 03:26:02,883 BACK TO OUR BEST INTEREST 4957 03:26:02,950 --> 03:26:04,452 STANDARD PROJECT AND TURN IT 4958 03:26:04,518 --> 03:26:12,460 BACK OVER TO DAVID BORASKY WITH 4959 03:26:12,526 --> 03:26:13,027 REVISIONS. 4960 03:26:13,094 --> 03:26:16,297 OUR GOAL IF WE CAN GET THERE IS 4961 03:26:16,363 --> 03:26:18,365 VOTE ON A FINAL DOCUMENT TODAY 4962 03:26:18,432 --> 03:26:22,103 AND WE'LL SEE WHERE WE END UP. 4963 03:26:22,169 --> 03:26:25,372 >> WE'LL SEE. 4964 03:26:25,439 --> 03:26:27,007 WE'LL SEE. 4965 03:26:27,074 --> 03:26:28,042 IS MY SCREEN VISIBLE? 4966 03:26:28,109 --> 03:26:29,210 >> YES. 4967 03:26:29,276 --> 03:26:32,646 >> OKAY, GREAT. 4968 03:26:32,713 --> 03:26:33,914 SO, I'VE GONE THROUGH AND I'LL 4969 03:26:33,981 --> 03:26:35,649 START BY GOING BACK THROUGH ALL 4970 03:26:35,716 --> 03:26:39,820 THE PLACES THAT I'VE GOT SOME 4971 03:26:39,887 --> 03:26:40,688 EDITS. 4972 03:26:40,755 --> 03:26:42,990 THINGS THAT WERE CONSENSUS ON 4973 03:26:43,057 --> 03:26:44,959 STRIKING I'VE JUST ACCEPTED SO 4974 03:26:45,025 --> 03:26:48,229 THEY ARE NOT CLUTTERING UP THE 4975 03:26:48,295 --> 03:26:49,663 SCREEN ANYMORE. 4976 03:26:49,730 --> 03:26:51,065 SO, WHAT'S SHOWING ON MY SCREEN 4977 03:26:51,132 --> 03:26:52,266 IN BLUE ARE THINGS I EITHER 4978 03:26:52,333 --> 03:26:54,602 ADDED DURING THE BREAK OR THAT 4979 03:26:54,668 --> 03:27:00,441 WE ADDED WHILE TALKING. 4980 03:27:00,508 --> 03:27:04,545 SO I'LL JUST STOP AND SORT OF 4981 03:27:04,612 --> 03:27:07,047 LET PEOPLE SEE THIS. 4982 03:27:07,114 --> 03:27:10,084 A NUMBER OF MINOR CHANGES IN 4983 03:27:10,151 --> 03:27:20,394 PARAGRAPH 57. 4984 03:27:34,875 --> 03:27:37,812 AND THEN WHAT'S VISIBLE ON THE 4985 03:27:37,878 --> 03:27:39,780 SCREEN RIGHT NOW THESE ARE 4986 03:27:39,847 --> 03:27:42,082 CHANGES WE MADE WHEN WE WERE 4987 03:27:42,149 --> 03:27:43,517 DISCUSSING THIS BEFORE. 4988 03:27:43,584 --> 03:27:48,322 NOTHING BIG THERE. 4989 03:27:48,389 --> 03:27:49,857 I'VE ADDED THE BULLET WE AGREED 4990 03:27:49,924 --> 03:27:51,358 ON IN THE LAST DISCUSSION. 4991 03:27:51,425 --> 03:27:53,494 BUT LET'S JUMP TO THIS 4992 03:27:53,561 --> 03:27:54,528 PARAGRAPH. 4993 03:27:54,595 --> 03:27:57,431 THE OLD FIDUCIARY DUTY PARAGRAPH 4994 03:27:57,498 --> 03:27:58,098 AT 106. 4995 03:27:58,165 --> 03:28:00,835 SO, WHAT I'VE CUT OUT IN THIS 4996 03:28:00,901 --> 03:28:08,542 CASE I'VE LEFT THERE AND TRIED 4997 03:28:08,609 --> 03:28:10,177 TO WHITTLE IT DOWN SO IF WE'RE 4998 03:28:10,244 --> 03:28:11,679 NOT HAPPY WITH IT, IT'S FINE BUT 4999 03:28:11,745 --> 03:28:13,447 THIS IS SORT OF MY STAB AT 5000 03:28:13,514 --> 03:28:19,887 TRYING TO CLEAR THIS UP A LITTLE 5001 03:28:19,954 --> 03:28:30,064 BIT. 5002 03:28:38,806 --> 03:28:41,775 >> DAVE, CAN'T REMEMBER DO YOU 5003 03:28:41,842 --> 03:28:44,111 USE PATIENT SUBJECT ELSEWHERE IN 5004 03:28:44,178 --> 03:28:44,879 THIS DOCUMENT? 5005 03:28:44,945 --> 03:28:46,080 >> NO, DON'T BELIEVE SO. 5006 03:28:46,146 --> 03:28:49,383 >> I'D BE IN FAVOR OF JUST USING 5007 03:28:49,450 --> 03:28:51,619 SUBJECTS. 5008 03:28:52,486 --> 03:28:53,187 >> LOIS? 5009 03:28:53,254 --> 03:28:56,457 >> I MEAN, I THINK I WOULD JUST 5010 03:28:56,523 --> 03:28:58,525 GET RID OF THAT, STARTING OFF 5011 03:28:58,592 --> 03:29:01,262 THAT WAY, BECAUSE WHO IS GOING 5012 03:29:01,328 --> 03:29:02,596 TO DETERMINE -- IT'S SUGGESTING 5013 03:29:02,663 --> 03:29:07,201 SOMEONE IS GOING TO MAKE SOME 5014 03:29:07,268 --> 03:29:08,736 DETERMINATION. 5015 03:29:08,802 --> 03:29:09,703 MAYBE RESEARCHERS MAY SOMETIMES 5016 03:29:09,770 --> 03:29:16,977 HAVE THE DUTY OR IN SOME 5017 03:29:17,044 --> 03:29:17,645 CIRCUMSTANCES -- 5018 03:29:17,711 --> 03:29:18,245 >> LET'S START -- 5019 03:29:18,312 --> 03:29:21,682 >> SUCH AS IN CONTEXT OF 5020 03:29:21,749 --> 03:29:22,650 THERAPEUTIC RELATIONSHIP, COMMA, 5021 03:29:22,716 --> 03:29:28,355 RESEARCHERS MAY HAVE A DUTY TO 5022 03:29:28,422 --> 03:29:31,859 ENSURE -- MAY HAVE DUTY TO 5023 03:29:31,926 --> 03:29:39,867 FACILITATE TRANSITION. 5024 03:29:39,934 --> 03:29:42,069 I WOULD GET RID OF IF IT IS 5025 03:29:42,136 --> 03:29:42,803 DETERMINED. 5026 03:29:42,870 --> 03:29:43,203 >> YEAH, RIGHT. 5027 03:29:43,270 --> 03:29:46,540 >> I SEE WHAT YOU'RE DOING, 5028 03:29:46,607 --> 03:29:46,874 SORRY. 5029 03:29:46,941 --> 03:29:49,076 >> SO IMAGINE IT STARTS THERE. 5030 03:29:49,143 --> 03:29:51,946 >> RESEARCHERS MAY HAVE A DUTY, 5031 03:29:52,012 --> 03:30:00,988 MAY HAVE A DUTY TO TRANSITION 5032 03:30:01,055 --> 03:30:02,890 SUBJECT INTO OTHER, AND THEN 5033 03:30:02,957 --> 03:30:07,761 JUST -- AND PICK UP WHERE YOU 5034 03:30:07,828 --> 03:30:07,995 HAVE. 5035 03:30:08,062 --> 03:30:09,430 THAT MIGHT FIX IT. 5036 03:30:09,496 --> 03:30:14,635 I'LL SEE WHAT OTHER PEOPLE 5037 03:30:14,702 --> 03:30:15,669 THINK. 5038 03:30:15,736 --> 03:30:18,072 >> THERE IS REFERENCE TO 5039 03:30:18,138 --> 03:30:20,808 THERAPEUTIC RELATIONSHIP. 5040 03:30:20,874 --> 03:30:23,877 I WANT TO MAKE SURE EVERYBODY IS 5041 03:30:23,944 --> 03:30:26,246 COMFORTABLE MOVING THE WORD 5042 03:30:26,313 --> 03:30:27,848 "PATIENT," AND LIMITING TO 5043 03:30:27,915 --> 03:30:30,050 "SUBJECTS." 5044 03:30:37,524 --> 03:30:38,759 >> GOING BACK TO A PREVIOUS 5045 03:30:38,826 --> 03:30:41,595 COMMENT, CAN'T REMEMBER WHO, I 5046 03:30:41,662 --> 03:30:46,100 THOUGHT THE IMPORTANCE WAS THAT 5047 03:30:46,166 --> 03:30:48,035 THERE WAS THIS -- THE 5048 03:30:48,102 --> 03:30:49,803 RELATIONSHIP BETWEEN THE 5049 03:30:49,870 --> 03:30:50,838 INVESTIGATOR AND PARTICIPANT 5050 03:30:50,904 --> 03:30:56,577 SUBJECT, THAT WAS THE FOCUS, 5051 03:30:56,643 --> 03:30:58,579 LIKE THAT ACKNOWLEDGMENT, SO I 5052 03:30:58,645 --> 03:31:03,817 GUESS FOR ME, I STILL FEEL LIKE 5053 03:31:03,884 --> 03:31:08,389 IT'S REPETITIVE TO SEE 101, LINE 5054 03:31:08,455 --> 03:31:10,024 101, BUT THIS IS -- AGAIN, IF WE 5055 03:31:10,090 --> 03:31:12,259 FEEL LIKE WE WANT THIS, THAT'S 5056 03:31:12,326 --> 03:31:12,459 NINE. 5057 03:31:12,526 --> 03:31:17,398 BUT I HAVE A CONCERN ABOUT THE 5058 03:31:17,464 --> 03:31:18,932 WORD "DUTY," THAT PUTS A LOT OF 5059 03:31:18,999 --> 03:31:21,235 REQUIREMENT ON IT AND I WOULD 5060 03:31:21,301 --> 03:31:25,706 RATHER IT SAY MAY WANT TO 5061 03:31:25,773 --> 03:31:26,140 TRANSITION SUBJECTS. 5062 03:31:26,206 --> 03:31:28,342 A LOT OF DUTY TO PROTECT AND 5063 03:31:28,409 --> 03:31:30,844 DUTY TO DELIVER, DUTY TO -- YOU 5064 03:31:30,911 --> 03:31:33,714 KNOW, IT'S THE HIGHER, VERY HIGH 5065 03:31:33,781 --> 03:31:35,883 EXPECTATION TO ME. 5066 03:31:35,949 --> 03:31:37,651 I DON'T KNOW THAT THAT'S WHAT WE 5067 03:31:37,718 --> 03:31:47,928 WANT TO SAY. 5068 03:31:48,395 --> 03:31:49,663 >> I'LL THINK ABOUT WHAT ERIC IS 5069 03:31:49,730 --> 03:31:50,330 TALKING ABOUT. 5070 03:31:50,397 --> 03:31:52,299 TO MAKE SURE WHAT I WAS 5071 03:31:52,366 --> 03:31:54,802 SUGGESTING, DAVE, YOU WOULD 5072 03:31:54,868 --> 03:31:56,003 DELETE EVERYTHING FROM SUBJECTS 5073 03:31:56,070 --> 03:31:59,673 TO SUBJECTS. 5074 03:31:59,740 --> 03:32:00,374 >> YEAH, YEAH. 5075 03:32:00,441 --> 03:32:03,343 >> IN THE CONTEXT OF A 5076 03:32:03,410 --> 03:32:03,877 THERAPEUTIC RELATIONSHIP, 5077 03:32:03,944 --> 03:32:06,747 RESEARCHERS MAY HAVE A DUTY TO 5078 03:32:06,814 --> 03:32:07,648 TRANSITION SUBJECTS. 5079 03:32:07,714 --> 03:32:11,885 YOU THINK THAT'S TOO STRONG, 5080 03:32:11,952 --> 03:32:12,219 ERIC? 5081 03:32:12,286 --> 03:32:16,223 CONTEXT OF -- MAYBE OBLIGATED? 5082 03:32:16,290 --> 03:32:17,791 >> OR MAY WANT TO. 5083 03:32:17,858 --> 03:32:22,262 I DON'T KNOW THAT THEY WOULD -- 5084 03:32:22,329 --> 03:32:24,932 AGAIN, I DON'T SEE HOW THAT'S 5085 03:32:24,998 --> 03:32:26,667 DIFFERENT THAN LINE 101C. 5086 03:32:26,733 --> 03:32:28,635 >> IT'S DIFFERENT IF IT'S 5087 03:32:28,702 --> 03:32:33,006 OBLIGATED, MAY WANT TO, IT'S THE 5088 03:32:33,073 --> 03:32:33,207 SAME. 5089 03:32:33,273 --> 03:32:36,844 >> I THINK REFERENCE TO THE 5090 03:32:36,910 --> 03:32:37,711 THERAPEUTIC RELATIONSHIP MAKES 5091 03:32:37,778 --> 03:32:47,688 IT MORE OF A DUTY. 5092 03:32:47,754 --> 03:32:50,224 >> IT'S NOT -- WE'RE NOT SAYING 5093 03:32:50,290 --> 03:32:52,192 THAT -- WE'RE NOT IMPOSING A 5094 03:32:52,259 --> 03:32:52,392 DUTY. 5095 03:32:52,459 --> 03:32:54,361 WE'RE SAYING IN SOME 5096 03:32:54,428 --> 03:32:55,462 CIRCUMSTANCES RESEARCHERS MAY 5097 03:32:55,529 --> 03:32:57,331 HAVE A DUTY. 5098 03:32:57,397 --> 03:33:00,701 KIND OF THE POINT IS KIND OF -- 5099 03:33:00,767 --> 03:33:01,835 DON'T FORGET THAT AS YOU'RE 5100 03:33:01,902 --> 03:33:04,638 DOING THIS, IT'S IN THE BEST 5101 03:33:04,705 --> 03:33:09,176 INTEREST THAT ESPECIALLY I THINK 5102 03:33:09,243 --> 03:33:11,445 INSTITUTIONS NEED TO RESPECT 5103 03:33:11,512 --> 03:33:14,314 THAT INVESTIGATORS IN A 5104 03:33:14,381 --> 03:33:15,716 THERAPEUTIC RELATIONSHIP WITH 5105 03:33:15,782 --> 03:33:16,316 PATIENT SUBJECTS OR SUBJECTS, 5106 03:33:16,383 --> 03:33:21,622 WHATEVER WE WANT TO SAY, MAY 5107 03:33:21,688 --> 03:33:22,723 HAVE THIS DUTY. 5108 03:33:22,789 --> 03:33:25,893 NOT THAT -- IT'S APPROPRIATE TO 5109 03:33:25,959 --> 03:33:28,295 DO THIS, THAT'S DIFFERENT. 5110 03:33:28,362 --> 03:33:30,697 OR MAY WANT TO, IT'S VERY 5111 03:33:30,764 --> 03:33:31,098 DIFFERENT. 5112 03:33:31,165 --> 03:33:32,032 >> I'M TRYING TO PLAY THIS OUT 5113 03:33:32,099 --> 03:33:36,203 IN A PRACTICAL SITUATION. 5114 03:33:36,270 --> 03:33:38,138 LET'S SAY THE STUDY ENDS, RIGHT? 5115 03:33:38,205 --> 03:33:41,308 AND THIS PERSON DOESN'T HAVE ANY 5116 03:33:41,375 --> 03:33:43,844 OPTIONS FOR CARE. 5117 03:33:43,911 --> 03:33:45,379 THEY ARE INDIGENT. 5118 03:33:45,445 --> 03:33:49,416 WHAT'S THE DUTY HERE FOR 5119 03:33:49,483 --> 03:33:50,284 TRANSITION TO CARE? 5120 03:33:50,350 --> 03:33:52,486 I DON'T KNOW THE ANSWER TO THAT. 5121 03:33:52,553 --> 03:33:53,687 EVEN IF IT'S A THERAPEUTIC 5122 03:33:53,754 --> 03:33:55,322 RELATIONSHIP I DON'T KNOW THE 5123 03:33:55,389 --> 03:33:58,926 ANSWER TO THAT. 5124 03:33:58,992 --> 03:34:01,562 >> WELL, IF IT'S A THERAPEUTIC 5125 03:34:01,628 --> 03:34:02,429 RELATIONSHIP THEY CAN'T ABANDON 5126 03:34:02,496 --> 03:34:02,763 THEM. 5127 03:34:02,829 --> 03:34:04,965 THEY HAVE TO GIVE NOTICE AND 5128 03:34:05,032 --> 03:34:05,499 REFERRAL. 5129 03:34:05,566 --> 03:34:05,933 >> YEAH. 5130 03:34:05,999 --> 03:34:07,901 >> AND OPPORTUNITY TO SEEK CARE 5131 03:34:07,968 --> 03:34:08,202 ELSEWHERE. 5132 03:34:08,268 --> 03:34:09,503 THAT'S JUST A LEGAL DUTY, NOT 5133 03:34:09,570 --> 03:34:14,708 THAT WE NEED TO GET INTO THE 5134 03:34:14,775 --> 03:34:15,475 WEEDS ON THAT. 5135 03:34:15,542 --> 03:34:16,677 >> IT'S FINE. 5136 03:34:16,743 --> 03:34:19,012 IF THE COMMITTEE FEELS DUTY IS 5137 03:34:19,079 --> 03:34:20,314 THE RIGHT WORD, I'M IN THE 5138 03:34:20,380 --> 03:34:24,051 MINORITY HERE AND I'M OKAY WITH 5139 03:34:24,117 --> 03:34:25,452 THAT. 5140 03:34:25,519 --> 03:34:28,522 >> YEAH, I WOULD AGREE WITH 5141 03:34:28,589 --> 03:34:32,459 THAT. 5142 03:34:32,526 --> 03:34:34,962 >> IF WE GET TO THE BOTTOM AND 5143 03:34:35,028 --> 03:34:36,730 PEOPLE WANT TO SEE IT AGAIN I 5144 03:34:36,797 --> 03:34:42,970 CAN COME BACK UP TO IT. 5145 03:34:43,036 --> 03:34:43,737 OKAY. 5146 03:34:43,804 --> 03:34:47,341 SO, THIS RUQAIIJAH ON LINE 140, 5147 03:34:47,407 --> 03:34:49,643 THESE ARE NOT LIKE THE GREATEST 5148 03:34:49,710 --> 03:34:51,845 EXAMPLES ON EARTH BUT THEY WERE 5149 03:34:51,912 --> 03:34:55,048 SOME EXAMPLES OF WHAT MIGHT BE 5150 03:34:55,115 --> 03:35:03,156 DONE WITH SAMPLES OR DATA THAT'S 5151 03:35:03,223 --> 03:35:06,426 RETURNED TO -- FROM SPONSOR BACK 5152 03:35:06,493 --> 03:35:16,870 TO THE INVESTIGATOR. 5153 03:35:24,511 --> 03:35:25,912 AND THEN I LEFT THAT SCRATCHED 5154 03:35:25,979 --> 03:35:35,922 OUT BUT WE HAD AGREED TO DELETE 5155 03:35:35,989 --> 03:35:39,293 THAT. 5156 03:35:40,761 --> 03:35:42,062 ULTIMATELY HERE WE HAD THE 5157 03:35:42,129 --> 03:35:51,872 USUALLY KNOW -- OH, A LOT OF 5158 03:35:51,938 --> 03:35:55,475 THIS IS PRETTY MINOR. 5159 03:35:55,542 --> 03:35:58,545 THIS AGAIN I THINK WE AGREED ON 5160 03:35:58,612 --> 03:36:01,381 THIS, THIS LANGUAGE, FOR PART OF 5161 03:36:01,448 --> 03:36:04,418 6 ABOUT THE PLACEBO ASPECT. 5162 03:36:09,790 --> 03:36:12,326 NUMBER 8, ANOTHER ONE WHERE WE 5163 03:36:12,392 --> 03:36:13,327 HAD THERAPEUTIC RELATIONSHIP. 5164 03:36:13,393 --> 03:36:16,730 SO I'LL LEAVE THAT ONE UP FOR A 5165 03:36:16,797 --> 03:36:17,030 SECOND. 5166 03:36:17,097 --> 03:36:21,101 I TRIED TO COMBINE BOTH WHAT WE 5167 03:36:21,168 --> 03:36:23,603 WERE THINKING ABOUT AND ADDRESS 5168 03:36:23,670 --> 03:36:25,105 OHRP'S CLARIFICATION ABOUT WHAT 5169 03:36:25,172 --> 03:36:35,615 IT WAS THEY WERE ASKING. 5170 03:36:48,295 --> 03:36:49,429 >> I THINK THIS IS A GOOD 5171 03:36:49,496 --> 03:36:49,796 CHANGE. 5172 03:36:49,863 --> 03:36:51,965 I THINK YOU DID A NICE JOB SORT 5173 03:36:52,032 --> 03:36:54,468 OF MAKING THE POINT THAT 5174 03:36:54,534 --> 03:36:57,104 PRESERVATION OF THAT 5175 03:36:57,170 --> 03:36:59,940 RELATIONSHIP SHOULD NOT BE 5176 03:37:00,006 --> 03:37:02,342 (INDISCERNIBLE) FOR RESEARCH 5177 03:37:02,409 --> 03:37:03,043 PARTICIPATION, THE KEY POINT 5178 03:37:03,110 --> 03:37:04,444 THAT NEEDS TO BE THERE SO IT'S 5179 03:37:04,511 --> 03:37:10,550 GOOD. 5180 03:37:10,617 --> 03:37:12,085 >> OKAY. 5181 03:37:12,152 --> 03:37:13,954 AND THEN SO ALLISON, HERE I 5182 03:37:14,020 --> 03:37:17,791 DON'T KNOW IF THIS LITTLE 5183 03:37:17,858 --> 03:37:18,425 INSERTION SORT OF RESOLVES, YOU 5184 03:37:18,492 --> 03:37:20,761 KNOW, WHAT I THOUGHT WAS A FAIR 5185 03:37:20,827 --> 03:37:25,465 POINT YOU MADE ABOUT THE NATURE 5186 03:37:25,532 --> 03:37:34,574 OF CONTINUING TO COLLECT DATA. 5187 03:37:34,641 --> 03:37:36,410 >> YEAH, I'M OKAY WITH THIS. 5188 03:37:36,476 --> 03:37:38,078 >> YEAH, I STARTED TO WRITE MORE 5189 03:37:38,145 --> 03:37:38,879 ABOUT THE WHOLE LONG-TERM 5190 03:37:38,945 --> 03:37:40,680 MONITORING AND I WAS GOING TO 5191 03:37:40,747 --> 03:37:42,549 HAVE A REFERENCE TO, YOU KNOW, 5192 03:37:42,616 --> 03:37:44,618 THE CAR T GUIDANCE. 5193 03:37:44,684 --> 03:37:45,919 IT WAS GETTING TO BE A BIT TOO 5194 03:37:45,986 --> 03:37:47,354 MUCH SO I THOUGHT IF YOU DIDN'T 5195 03:37:47,421 --> 03:37:50,190 LIKE THIS I COULD SLAP THAT 5196 03:37:50,257 --> 03:37:56,229 STUFF BACK IN, BUT -- 5197 03:37:56,296 --> 03:37:59,933 AND THEN, YEAH, THAT WAS SORT OF 5198 03:38:00,000 --> 03:38:00,600 IT, DOUG. 5199 03:38:00,667 --> 03:38:03,470 ERIC, IF YOU WANT TO SEE THAT 5200 03:38:03,537 --> 03:38:04,805 LANGUAGE HIGHER UP AGAIN. 5201 03:38:04,871 --> 03:38:05,572 >> NO, I'M GOOD. 5202 03:38:05,639 --> 03:38:09,376 >> OKAY. 5203 03:38:09,443 --> 03:38:11,144 >> SO THOSE ARE THE CHANGES THAT 5204 03:38:11,211 --> 03:38:15,882 HAVE BEEN MADE. 5205 03:38:15,949 --> 03:38:18,018 ARE THERE ANY OTHER ISSUES 5206 03:38:18,084 --> 03:38:19,019 COMMITTEE MEMBERS WANT TO RAISE 5207 03:38:19,085 --> 03:38:22,322 AT THIS POINT? 5208 03:38:22,389 --> 03:38:25,992 ARE WE HAPPY WITH THE DOCUMENT? 5209 03:38:31,364 --> 03:38:32,966 >> DAVE, I THINK YOU AND THE 5210 03:38:33,033 --> 03:38:35,035 COMMITTEE HAVE DONE A NICE JOB 5211 03:38:35,101 --> 03:38:35,902 WITH THE DOCUMENTS. 5212 03:38:35,969 --> 03:38:36,937 >> I APPRECIATE THAT ON BEHALF 5213 03:38:37,003 --> 03:38:38,772 OF THE COMMITTEE OF COURSE, YOU 5214 03:38:38,839 --> 03:38:41,007 AND RUQAIIJAH AND OTHERS AND 5215 03:38:41,074 --> 03:38:43,143 NEAL WITH PART OF THE 5216 03:38:43,210 --> 03:38:44,678 SUBCOMMITTEE DISCUSSIONS, WHICH 5217 03:38:44,744 --> 03:38:47,881 WERE HELPFUL, WORKING THROUGH 5218 03:38:47,948 --> 03:38:51,151 HERE IN THIS VENUE SO ... 5219 03:38:51,218 --> 03:38:51,885 >> ALL RIGHT. 5220 03:38:51,952 --> 03:38:54,421 THIS IS YOUR LAST CHANCE BEFORE 5221 03:38:54,488 --> 03:38:58,458 WE MOVE TO A VOTE. 5222 03:38:58,525 --> 03:38:59,526 ANY LAST CHANGES OR COMMENTS 5223 03:38:59,593 --> 03:39:04,030 PEOPLE HAVE? 5224 03:39:04,097 --> 03:39:05,465 OTHERWISE, I'M HAPPY TO 5225 03:39:05,532 --> 03:39:06,366 ENTERTAIN A MOTION TO APPROVE 5226 03:39:06,433 --> 03:39:09,302 THIS. 5227 03:39:09,369 --> 03:39:10,804 >> MOVE TO APPROVE. 5228 03:39:10,871 --> 03:39:12,472 >> I SECOND. 5229 03:39:12,539 --> 03:39:14,541 >> WE HAVE A MOTION AND SECOND. 5230 03:39:14,608 --> 03:39:16,510 WE'LL GO WITH A SHOW OF HANDS 5231 03:39:16,576 --> 03:39:16,943 AGAIN. 5232 03:39:17,010 --> 03:39:18,712 ALL IN FAVOR OF APPROVING THE 5233 03:39:18,778 --> 03:39:23,517 DOCUMENT? 5234 03:39:23,583 --> 03:39:24,317 I SEE NINE. 5235 03:39:24,384 --> 03:39:28,889 OPPOSED? 5236 03:39:28,955 --> 03:39:29,122 ZERO. 5237 03:39:29,189 --> 03:39:32,926 AND ANY ABSTENTIONS? 5238 03:39:32,993 --> 03:39:36,997 ALSO ZERO. 5239 03:39:37,063 --> 03:39:37,330 OKAY. 5240 03:39:37,397 --> 03:39:38,231 WELL, THAT WAS QUICKER THAN I 5241 03:39:38,298 --> 03:39:39,599 THOUGHT IT WOULD BE. 5242 03:39:39,666 --> 03:39:42,369 VERY NICE WORK ON THAT ONE, 5243 03:39:42,435 --> 03:39:42,903 DAVID. 5244 03:39:42,969 --> 03:39:43,436 >> THANKS, DOUG. 5245 03:39:43,503 --> 03:39:44,871 THANKS, EVERYBODY. 5246 03:39:44,938 --> 03:39:47,173 I APPRECIATE IT. 5247 03:39:47,240 --> 03:39:50,043 >> SO WE -- THE LAST ITEM IS 5248 03:39:50,110 --> 03:39:51,244 PUBLIC COMMENT. 5249 03:39:51,311 --> 03:39:56,616 WE HAVE NO PUBLIC COMMENTS. 5250 03:39:56,683 --> 03:39:59,886 SO WE ARE APPROACHING 5251 03:39:59,953 --> 03:40:00,220 ADJOURNMENT. 5252 03:40:00,287 --> 03:40:02,188 AND I WOULD JUST SAY IN CLOSING 5253 03:40:02,255 --> 03:40:04,958 OUR MEETING I DO WANT TO REMIND 5254 03:40:05,025 --> 03:40:06,826 EVERYONE THAT OUR NEXT MEETING 5255 03:40:06,893 --> 03:40:10,363 WHICH WILL ALSO BE VIRTUAL IS 5256 03:40:10,430 --> 03:40:13,266 SCHEDULED FOR JULY 23 AND 24. 5257 03:40:13,333 --> 03:40:15,569 I THINK I GOT THOSE RIGHT, JULIA 5258 03:40:15,635 --> 03:40:19,739 WILL LET ME KNOW IF I DIDN'T. 5259 03:40:19,806 --> 03:40:21,374 GOOD WORK TOGETHER. 5260 03:40:21,441 --> 03:40:23,343 WE APPROVED THE BEST INTEREST 5261 03:40:23,410 --> 03:40:25,445 STANDARD DOCUMENT. 5262 03:40:25,512 --> 03:40:30,784 AND I THINK WE PROVIDED LINDA 5263 03:40:30,850 --> 03:40:31,551 AND SUBCOMMITTEE WITH SOME 5264 03:40:31,618 --> 03:40:33,653 MATERIAL THAT THEY CAN MOVE 5265 03:40:33,720 --> 03:40:35,689 FORWARD WITH AND HAVE A DOCUMENT 5266 03:40:35,755 --> 03:40:40,327 FOR US TO TAKE A LOOK AT AT THE 5267 03:40:40,393 --> 03:40:41,294 JULY MEETING, IN ADDITION WE 5268 03:40:41,361 --> 03:40:42,963 WILL HAVE ONE OR TWO MORE TOPICS 5269 03:40:43,029 --> 03:40:47,968 TO TAKE UP AT THAT MEETING AS 5270 03:40:48,034 --> 03:40:48,668 WELL. 5271 03:40:48,735 --> 03:40:50,270 THANKS, EVERYBODY, FOR YOUR 5272 03:40:50,337 --> 03:40:50,470 WORK. 5273 03:40:50,537 --> 03:40:52,339 AS ALWAYS, MANY THANKS TO 5274 03:40:52,405 --> 03:40:55,742 MEMBERS OF THE SUBCOMMITTEE FOR 5275 03:40:55,809 --> 03:40:58,478 THE HUGE AMOUNT OF WORK THEY DO 5276 03:40:58,545 --> 03:41:01,781 BETWEEN OUR MEETINGS IN ORDER TO 5277 03:41:01,848 --> 03:41:04,517 ENABLE US TO DO THE WORK WE DO. 5278 03:41:04,584 --> 03:41:08,555 AND OF COURSE THE ENTIRE OHRP 5279 03:41:08,622 --> 03:41:10,390 STAFF AND JULIE IN PARTICULAR. 5280 03:41:10,457 --> 03:41:11,725 JULIE KANESHIRO, I DON'T KNOW IF 5281 03:41:11,791 --> 03:41:13,593 YOU WANT TO SAY ANYTHING IN 5282 03:41:13,660 --> 03:41:17,764 CLOSING? 5283 03:41:17,831 --> 03:41:19,833 >> NOT IN PARTICULAR, DOUG, BUT 5284 03:41:19,899 --> 03:41:22,502 JUST ECHOING THANKS TO ALL OF 5285 03:41:22,569 --> 03:41:24,337 YOU AND THE SUBCOMMITTEE'S 5286 03:41:24,404 --> 03:41:25,772 EXCELLENT WORK, AND GREAT 5287 03:41:25,839 --> 03:41:26,172 DISCUSSION TODAY. 5288 03:41:26,239 --> 03:41:32,045 SO THANKS SO MUCH. 5289 03:41:32,112 --> 03:41:35,649 >> AND JULIA, ANYTHING YOU WANT 5290 03:41:35,715 --> 03:41:37,617 US TO KNOW? 5291 03:41:37,684 --> 03:41:39,486 >> YOU KNOW, AGAIN, I WOULD NOT 5292 03:41:39,552 --> 03:41:41,655 EXPECT THAT JULY IS GOING TO BE 5293 03:41:41,721 --> 03:41:44,424 A ONE-DAY MEETING SO DO EXPECT 5294 03:41:44,491 --> 03:41:47,260 THE JULY 23 AND 24 IS GOING TO 5295 03:41:47,327 --> 03:41:50,964 BE A FULL ROBUST TWO-DAY VIRTUAL 5296 03:41:51,031 --> 03:41:51,297 MEETING. 5297 03:41:51,364 --> 03:41:52,832 BUT EVERYONE, PLEASE BEAR IN 5298 03:41:52,899 --> 03:41:55,435 MIND AND MAKE SURE YOUR 5299 03:41:55,502 --> 03:41:59,372 CALENDARS ARE MARKED FOR OCTOBER 5300 03:41:59,439 --> 03:42:03,009 22 AND 23, WHICH WILL BE AN 5301 03:42:03,076 --> 03:42:04,310 IN-PERSON MEETING. 5302 03:42:04,377 --> 03:42:06,513 OKAY, OCTOBER IS IN PERSON, SO 5303 03:42:06,579 --> 03:42:08,281 JUST BE CERTAIN YOU'VE GOT THAT 5304 03:42:08,348 --> 03:42:09,649 ON YOUR CALENDAR NOW. 5305 03:42:09,716 --> 03:42:11,985 OTHER THAN THAT, THANK YOU VERY 5306 03:42:12,052 --> 03:42:12,385 MUCH. 5307 03:42:12,452 --> 03:42:13,620 THAT'S IT. 5308 03:42:13,687 --> 03:42:16,056 >> HOPEFULLY WE'LL HAVE A COUPLE 5309 03:42:16,122 --> 03:42:18,124 NEW MEMBERS COME JULY. 5310 03:42:18,191 --> 03:42:18,491 >> HOPEFULLY. 5311 03:42:18,558 --> 03:42:20,226 >> THANKS AGAIN, EVERYBODY. 5312 03:42:20,293 WE'RE OFFICIALLY ADJOURNED.