1 00:00:14,490 --> 00:00:16,692 OUR SPEAKER TODAY IS DAVE WHO 2 00:00:16,692 --> 00:00:19,328 IS TRAINED IN THE PHILOSOPHY OF 3 00:00:19,328 --> 00:00:22,031 SCIENCE AND BEEN AT THE NIH FOR 4 00:00:22,031 --> 00:00:24,567 30 YEARS AS A FELLOW AND 5 00:00:24,567 --> 00:00:30,614 CURRENTLY SENIOR INVESTIGATOR AND. 6 00:00:30,614 --> 00:00:31,782 TOPICS ASSESSING RISK 7 00:00:31,782 --> 00:00:35,653 SYSTEMATICALLY AND AUTONOMY AND 8 00:00:35,653 --> 00:00:38,422 PEDIATRIC RESEARCH AND RESEARCH 9 00:00:38,422 --> 00:00:38,859 STORED BY LOGICAL SAMPLES. 10 00:00:38,859 --> 00:00:40,394 TODAY'S PRESENTATION WILL BE 11 00:00:40,394 --> 00:00:42,829 ARCHIVED IN THE NIH VIDEO SITE 12 00:00:42,829 --> 00:00:46,300 AND LINK TO THE VIDEO CAST AND 13 00:00:46,300 --> 00:00:50,304 SLIETDS FROM THE SESSION ON THE 14 00:00:50,304 --> 00:00:53,540 WEBSITE AND SESSION AND 15 00:00:53,540 --> 00:00:54,574 PRESENTATION ARCHIVE SESSION 16 00:00:54,574 --> 00:00:56,910 FOLLOWING EDUCATION TRAINING 17 00:00:56,910 --> 00:00:58,412 WEBPAGE AND ENCOURAGE YOU 18 00:00:58,412 --> 00:01:01,214 THROUGHOUT THE SESSION TO SUBMIT 19 00:01:01,214 --> 00:01:05,085 QUESTIONS CLICKING ON THE BOX 20 00:01:05,085 --> 00:01:06,486 ENTITLED LIVE FEEDBACK AND WILL 21 00:01:06,486 --> 00:01:08,488 ADDRESS THE QUESTIONS IN THE Q & 22 00:01:08,488 --> 00:01:09,623 A AFTER THE PRESENTATION AND 23 00:01:09,623 --> 00:01:12,025 THANKS FOR JOINING US AND LET'S 24 00:01:12,025 --> 00:01:12,359 GET STARTED. 25 00:01:12,359 --> 00:01:22,869 >> THANK YOU, PAT TY. 26 00:01:57,971 --> 00:01:59,072 >> INFORMED CONSENT IS IMPORTANT 27 00:01:59,072 --> 00:02:01,007 AND AS A RESULT OF THAT AND 28 00:02:01,007 --> 00:02:02,743 RELIANCE ON INFORMED CONSENT THE 29 00:02:02,743 --> 00:02:05,078 PARTICIPATION OF ADULTS WHO 30 00:02:05,078 --> 00:02:06,213 CAN'T CONSENT RAISES ETHICAL 31 00:02:06,213 --> 00:02:08,048 CONCERN AND THERE IS A WORRY 32 00:02:08,048 --> 00:02:09,983 BECAUSE THEY CAN'T CONSENT FOR 33 00:02:09,983 --> 00:02:11,752 THEMSELVES THAT THEY MIGHT BE 34 00:02:11,752 --> 00:02:13,019 ENROLLED OR PARTICIPATE IN 35 00:02:13,019 --> 00:02:14,454 RESEARCH INAPPROPRIATELY. 36 00:02:14,454 --> 00:02:16,857 SO TO ADDRESS THIS CONCERN, WHAT 37 00:02:16,857 --> 00:02:18,892 SOME PEOPLE DO IS FEWER THAN IN 38 00:02:18,892 --> 00:02:20,927 THE PAST AND STILL SOME 39 00:02:20,927 --> 00:02:22,629 GUIDELINES AND COMMENTATORS 40 00:02:22,629 --> 00:02:23,897 ARGUE THAT WE SHOULDN'T DO 41 00:02:23,897 --> 00:02:25,832 RESEARCH WITH ADULTS WHO CAN'T 42 00:02:25,832 --> 00:02:28,235 CONSENT AND FAMOUSLY A LOT OF 43 00:02:28,235 --> 00:02:32,539 PEOPLE PROBABLY KNOW THIS. THE 44 00:02:32,539 --> 00:02:33,540 NUREMBERG CODE SAYS SUBJECTS 45 00:02:33,540 --> 00:02:35,475 CONSENT AND NOT LA CONSENT AND 46 00:02:35,475 --> 00:02:36,777 SUBJECTS THEMSELVES CONSENT THAT 47 00:02:36,777 --> 00:02:39,079 IS ABSOLUTELY ESSENTIAL TO 48 00:02:39,079 --> 00:02:39,913 ETHICAL RESEARCH AND THAT 49 00:02:39,913 --> 00:02:42,149 APPROACH OBVIOUSLY IN TERMS OF 50 00:02:42,149 --> 00:02:43,950 PROTECTIONS HAS A LOT GOING FOR 51 00:02:43,950 --> 00:02:46,520 IT IF WE CAN'T ENROLL ADULTS WHO 52 00:02:46,520 --> 00:02:49,523 ARE NOT ABLE TO CONSENT INTO 53 00:02:49,523 --> 00:02:50,524 RESEARCH AND WE CAN'T EXPLOIT 54 00:02:50,524 --> 00:02:52,426 THEM IN THE RESEARCH PROCESS. 55 00:02:52,426 --> 00:02:54,060 IN TERMS OF PROTECTION, IT DOES 56 00:02:54,060 --> 00:02:56,530 A LOT. OBVIOUSLY, AT THE SAME 57 00:02:56,530 --> 00:02:58,532 TIME IT HAS SIGNIFICANT 58 00:02:58,532 --> 00:02:58,799 PROBLEMS. 59 00:02:58,799 --> 00:03:01,234 ONE, IT JUST BLOCKS VALUABLE 60 00:03:01,234 --> 00:03:01,668 RESOURCES. 61 00:03:01,668 --> 00:03:03,370 THERE IS AT LEAST SOME CASES IN 62 00:03:03,370 --> 00:03:06,139 WHICH ENROLLING ADULTS WHO CAN'T 63 00:03:06,139 --> 00:03:07,474 CONSENT IS IMPORTANT FOR 64 00:03:07,474 --> 00:03:09,075 SCIENTIFIC PURPOSES DEPENDING 65 00:03:09,075 --> 00:03:11,044 UPON THE CONDITION AND THE 66 00:03:11,044 --> 00:03:14,047 CIRCUMSTANCES THAT ARE BEING 67 00:03:14,047 --> 00:03:17,217 STUDIED AND ALSO WHILE IT 68 00:03:17,217 --> 00:03:18,685 PROTECTS INDIVIDUALS FROM BEING 69 00:03:18,685 --> 00:03:20,620 EXPLOITED IT PRECLUDES THEM FROM 70 00:03:20,620 --> 00:03:22,122 PARTICIPATING IN RESEARCH THAT 71 00:03:22,122 --> 00:03:24,090 MAY BENEFIT THEM CLINICALLY AND 72 00:03:24,090 --> 00:03:26,159 ARE SIGNIFICANT LIMITATIONS . 73 00:03:26,159 --> 00:03:28,595 SINCE NUREMBERG CODE PEOPLE HAVE 74 00:03:28,595 --> 00:03:30,397 BEEN STRUGGLING WITH WAYS TO TRY 75 00:03:30,397 --> 00:03:31,798 TO PROTECT ADULTS THAT CAN'T 76 00:03:31,798 --> 00:03:34,267 CONSENT AND ALLOWING VALUABLE 77 00:03:34,267 --> 00:03:35,869 RESEARCH ON CONDITIONS THAT 78 00:03:35,869 --> 00:03:36,937 EFFECT THEM AND SOME PEOPLE 79 00:03:36,937 --> 00:03:40,307 MIGHT KNOW THAT DECLARATION OF 80 00:03:40,307 --> 00:03:45,078 HELSINKI AND MOTIVATING IDEAS 81 00:03:45,078 --> 00:03:49,816 BEHIND DECLARATION OF HELSINKI 82 00:03:49,816 --> 00:03:52,219 AND GO AROUND THIS AND 83 00:03:52,219 --> 00:03:55,288 PARTICIPATE IN RESEARCH WHEN 84 00:03:55,288 --> 00:04:02,362 APPROPRIATE TO DO SO 85 00:04:02,362 --> 00:04:05,232 YOU HAVE TO GET CONSENT OF 86 00:04:05,232 --> 00:04:07,634 PARTICIPANT THEMSELVES OR 87 00:04:07,634 --> 00:04:08,502 LEGALLY AUTHORIZED 88 00:04:08,502 --> 00:04:10,570 REPRESENTATIVE AND COMING TO 89 00:04:10,570 --> 00:04:11,905 ADULTS INLIKE PEDIATRIC RESEARCH 90 00:04:11,905 --> 00:04:14,341 THAT IS IT AS FAR AS US 91 00:04:14,341 --> 00:04:16,109 REGULATIONS ARE CONCERNED AND IS 92 00:04:16,109 --> 00:04:18,178 NOT CONDITIONAL CONDITIONS WITH 93 00:04:18,178 --> 00:04:21,047 RESEARCH ADULTS AS THERE ARE IN 94 00:04:21,047 --> 00:04:22,516 PEDIATRIC RESEARCH AND IMPORTANT 95 00:04:22,516 --> 00:04:23,750 IMPLICATION FOR TODAY'S TALK OF 96 00:04:23,750 --> 00:04:25,886 THAT IS THERE IS NO REGULATORY 97 00:04:25,886 --> 00:04:30,790 MANDATE AT LEAST ACCORDING TO US 98 00:04:30,790 --> 00:04:33,059 FEDERAL REGS TO OBTAIN ASSETS 99 00:04:33,059 --> 00:04:35,695 FROM ADULTS THAT CAN'T CONSENT 100 00:04:35,695 --> 00:04:37,464 OR LATER TO RESPECT THEIR 101 00:04:37,464 --> 00:04:39,032 DISSENT AND SOME PEOPLE ACTUALLY 102 00:04:39,032 --> 00:04:40,800 SUPPORT THAT APPROACH AND 103 00:04:40,800 --> 00:04:42,302 BASICALLY ARE USING SOMETHING 104 00:04:42,302 --> 00:04:44,538 ALONG THE LINES OF IF AN ADULT 105 00:04:44,538 --> 00:04:46,239 CAN'T GIVE INFORMED CONSENT AND 106 00:04:46,239 --> 00:04:49,442 IF THEY CAN'T CONSENT FOR 107 00:04:49,442 --> 00:04:50,744 THEMSELVES, IT FOLLOWS THEY ARE 108 00:04:50,744 --> 00:04:52,379 NOT ABLE TO UNDERSTAND OR ABLE 109 00:04:52,379 --> 00:04:54,180 TO MAKE THEIR OWN DECISIONS AND 110 00:04:54,180 --> 00:04:55,148 IN THAT CASE IT DOESN'T MAKE 111 00:04:55,148 --> 00:04:57,717 SENSE TO TRY TO OBTAIN CONSENT 112 00:04:57,717 --> 00:04:58,785 AND DOESN'T MAKE SENSE TO 113 00:04:58,785 --> 00:05:01,121 EXPLAIN THE STUDY TO THEM AND 114 00:05:01,121 --> 00:05:04,257 SOLICIT THEIR AFFIRMATIVE 115 00:05:04,257 --> 00:05:05,625 AGREEMENT TO PARTICIPATE OR NOT. 116 00:05:05,625 --> 00:05:07,193 THAT IS AN ASSUMPTION THAT LOTS 117 00:05:07,193 --> 00:05:10,764 OF PEOPLE MAKE AND DON'T KNOW IF 118 00:05:10,764 --> 00:05:12,566 SOME PEOPLE ARE FAMILIAR WITH 119 00:05:12,566 --> 00:05:15,101 THIS AND THAT IS A PROMINENT 120 00:05:15,101 --> 00:05:18,405 LEGAL CASE AND DISTRICT COURT OF 121 00:05:18,405 --> 00:05:20,307 APPEALS IN TARL OE DC AND WON'T 122 00:05:20,307 --> 00:05:23,009 GO INTO DETAILS OF THIS AND 123 00:05:23,009 --> 00:05:25,211 MENTIONING PROMINENT SUPPORT OF 124 00:05:25,211 --> 00:05:27,080 THIS VIEW AND SUIT BY THREE DC 125 00:05:27,080 --> 00:05:29,049 RESIDENT DEPARTMENTS WITH 126 00:05:29,049 --> 00:05:30,183 INTELLECTUAL DISABILITIES THAT 127 00:05:30,183 --> 00:05:31,751 WERE SUBJECTED TO ELECTIVE 128 00:05:31,751 --> 00:05:33,219 SURGERY WITHOUT THEIR INPUT THAT 129 00:05:33,219 --> 00:05:36,256 WASN'T SOLICITED AND AGREEMENT 130 00:05:36,256 --> 00:05:36,923 WASN'T OBTAINED. 131 00:05:36,923 --> 00:05:39,092 THERE WAS A STRING OF SUITS AND 132 00:05:39,092 --> 00:05:45,198 APPEALS THAT ENDED UP AT COU CO 133 00:05:45,198 --> 00:05:47,634 OF APPEALS AND DOESN'T MAKE 134 00:05:47,634 --> 00:05:49,235 LOGICAL SENSE TO SOLICIT VIEWS 135 00:05:49,235 --> 00:05:51,738 OF PATIENTS WHO LACK DECISIONAL 136 00:05:51,738 --> 00:05:54,741 CAPACITY AND THOUGHT THERE WAS 137 00:05:54,741 --> 00:05:57,077 AT THE POINT THAT SOMEBODY LACKS 138 00:05:57,077 --> 00:05:58,445 DECISIONAL CAPACITY THERE IS NO 139 00:05:58,445 --> 00:06:00,180 POINT IN INVITING THEM AND 140 00:06:00,180 --> 00:06:01,214 INVOLVING THEM IN DECISION 141 00:06:01,214 --> 00:06:02,015 MAKING AT ALL. 142 00:06:02,015 --> 00:06:04,718 WHAT IS WRONG WITH THIS VIEW? 143 00:06:04,718 --> 00:06:06,586 IT IS WRONG AND WHAT IS WRONG 144 00:06:06,586 --> 00:06:09,189 WITH IT AND BASIC PROBLEM IS IT 145 00:06:09,189 --> 00:06:11,358 ASSUMES DECISIONAL CAPACITY IS 146 00:06:11,358 --> 00:06:13,093 ALL OR NOTHING AND ASSUMES THAT 147 00:06:13,093 --> 00:06:14,961 YOU HAVE GOT DECISIONAL CAPACITY 148 00:06:14,961 --> 00:06:16,329 OR DON'T HAVE DECISIONAL 149 00:06:16,329 --> 00:06:17,230 CAPACITY AT ALL. 150 00:06:17,230 --> 00:06:18,999 IF THAT WERE RIGHT, THEN I THINK 151 00:06:18,999 --> 00:06:20,233 THAT THE COURT WOULD HAVE BEEN 152 00:06:20,233 --> 00:06:22,202 RIGHT AND SEEKING INPUT OF 153 00:06:22,202 --> 00:06:24,070 PEOPLE WITH DECISIONAL CAPACITY 154 00:06:24,070 --> 00:06:25,739 DOESN'T MAKE SENSE FOR HOW THEY 155 00:06:25,739 --> 00:06:28,041 ARE TREATED AND INSTEAD WE 156 00:06:28,041 --> 00:06:29,609 SHOULD FOCUS ON MAKING TREATMENT 157 00:06:29,609 --> 00:06:31,511 DECISIONS BASED ON WHAT IS IN 158 00:06:31,511 --> 00:06:33,079 THE INDIVIDUAL'S BEST INTEREST 159 00:06:33,079 --> 00:06:35,281 AND THAT WOULD RAISE COMPLICATED 160 00:06:35,281 --> 00:06:36,716 INTERESTING QUESTIONS ABOUT WHAT 161 00:06:36,716 --> 00:06:38,418 THE IMPLICATIONS WOULD BE FOR 162 00:06:38,418 --> 00:06:40,086 RESEARCH ESPECIALLY AND RESEARCH 163 00:06:40,086 --> 00:06:43,089 THAT DOESN'T OFFER PROSPECT OF 164 00:06:43,089 --> 00:06:44,391 DIRECT BENEFIT. 165 00:06:44,391 --> 00:06:46,526 BUT IF IT IS NOT RIGHT IT IS NOT 166 00:06:46,526 --> 00:06:48,361 RIGHT BECAUSE IT IGNORES FACT 167 00:06:48,361 --> 00:06:50,030 THAT CAPACITY TO CONSENT IS A 168 00:06:50,030 --> 00:06:51,898 MATTER OF DEGREE AND WHY IS IT A 169 00:06:51,898 --> 00:06:53,600 MATTER OF DEGREE? 170 00:06:53,600 --> 00:06:55,502 A COUPLE REASONS I WILL GO 171 00:06:55,502 --> 00:06:56,536 THROUGH QUICKLY THAT ARE 172 00:06:56,536 --> 00:06:58,505 FAMILIAR TO MOST PEOPLE ON THE 173 00:06:58,505 --> 00:06:58,705 CALL. 174 00:06:58,705 --> 00:07:00,874 ONE IS JUST THAT THE CAPACITY TO 175 00:07:00,874 --> 00:07:03,043 CONCEPT IS NOT UNITARY AND 176 00:07:03,043 --> 00:07:05,111 DEPENDS UPON A NUMBER OF 177 00:07:05,111 --> 00:07:05,745 UNDERLYING CAPACITIES AND IS 178 00:07:05,745 --> 00:07:07,180 SOME DEBATE ABOUT THIS AND THIS 179 00:07:07,180 --> 00:07:09,783 IS A STANDARD VIEW AND TO HAVE 180 00:07:09,783 --> 00:07:12,152 CAPACITY CONSENT YOU NEED 181 00:07:12,152 --> 00:07:13,453 CAPACITIES TO UNDERSTAND, TO 182 00:07:13,453 --> 00:07:16,122 APPRECIATE THE INFORMATION, TO 183 00:07:16,122 --> 00:07:17,924 REASON ABOUT IT IN LIGHT OF 184 00:07:17,924 --> 00:07:19,793 PREFERENCES AND VALUES AND TO 185 00:07:19,793 --> 00:07:21,094 MAKE A VOLUNTARY DECISION 186 00:07:21,094 --> 00:07:22,762 WHETHER OR NOT TO PARTICIPATE IN 187 00:07:22,762 --> 00:07:25,865 RESEARCH IN OUR CASE. 188 00:07:25,865 --> 00:07:28,068 AND THEN COMMUNICATE THAT 189 00:07:28,068 --> 00:07:29,869 DECISION AFTER THINKING ABOUT IT 190 00:07:29,869 --> 00:07:33,073 AND POINT IS NOT ONLY IS THERE A 191 00:07:33,073 --> 00:07:34,941 NUMBER OF CAPACITIES HERE BUT 192 00:07:34,941 --> 00:07:36,142 CAPACITIES THEMSELVES ARE 193 00:07:36,142 --> 00:07:37,644 COMPLICATED AND ONE CHALLENGE 194 00:07:37,644 --> 00:07:39,079 FOR THIS TALK WAS TO SEE CAN I 195 00:07:39,079 --> 00:07:42,148 GET ALL OF THE ITEMS THAT THE US 196 00:07:42,148 --> 00:07:43,450 REGULATIONS LIST AS IMPORTANT IN 197 00:07:43,450 --> 00:07:46,319 TERMS OF UNDERSTANDING 198 00:07:46,319 --> 00:07:48,321 REQUIREMENT ON TO ONE'S SLIDE? 199 00:07:48,321 --> 00:07:48,955 I THINK I DID. 200 00:07:48,955 --> 00:07:51,591 AS YOU WILL SEE, IT IS A LOT. 201 00:07:51,591 --> 00:07:52,358 UNDERSTANDING ITSELF IS 202 00:07:52,358 --> 00:07:53,893 COMPLICATED AND THERE IS A LOT 203 00:07:53,893 --> 00:07:55,595 OF THINGS YOU NEED TO UNDERSTAND 204 00:07:55,595 --> 00:07:57,097 AND NOT ONLY DO YOU NEED FIVE 205 00:07:57,097 --> 00:08:00,967 DIFFERENT CAPACITIES AND EACH OF 206 00:08:00,967 --> 00:08:02,268 THE CAPACITIES HERE 207 00:08:02,268 --> 00:08:03,103 UNDERSTANDING ITSELF IS 208 00:08:03,103 --> 00:08:05,071 COMPLICATED THAT IS A NUMBER OF 209 00:08:05,071 --> 00:08:07,741 SUB ELEMENTS AND FINALLY, THOSE 210 00:08:07,741 --> 00:08:09,075 ELEMENTS THEMSELVES ARE 211 00:08:09,075 --> 00:08:09,743 COMPLICATED. 212 00:08:09,743 --> 00:08:11,311 SO ONE OF THE ELEMENTS 213 00:08:11,311 --> 00:08:11,978 PREVIOUSLY YOU NEED TO 214 00:08:11,978 --> 00:08:14,948 UNDERSTAND IS IN THE WORDS OF 215 00:08:14,948 --> 00:08:16,683 THE REGULATIONS AND REASONABLY 216 00:08:16,683 --> 00:08:17,217 FORESEEABLE RISKS. 217 00:08:17,217 --> 00:08:19,152 OF COURSE, IT IS RARE THAT 218 00:08:19,152 --> 00:08:22,188 THERE IS NEVER, I GUESS, A 219 00:08:22,188 --> 00:08:23,823 PROTOCOL WITH ONE FORESEEABLE 220 00:08:23,823 --> 00:08:25,191 RISKS AND LOTS OF THEM AND COULD 221 00:08:25,191 --> 00:08:27,260 BE 5 OR 10 OR 20 AND THEY COULD 222 00:08:27,260 --> 00:08:29,229 INCLUDE DIFFERENT KINDS OF SHORT 223 00:08:29,229 --> 00:08:31,498 TERM RISKS LONG TERM RISKS AND 224 00:08:31,498 --> 00:08:33,032 LIKELY AND UNLIKELY RISKS AND 225 00:08:33,032 --> 00:08:34,200 THE POINT HERE IS THAT THERE IS 226 00:08:34,200 --> 00:08:36,469 A LOT GOING ON AND LOTS THAT 227 00:08:36,469 --> 00:08:39,773 NEEDS TO BE IN PLACE FOR 228 00:08:39,773 --> 00:08:41,775 SOMEBODY TO HAVE DECISIONAL 229 00:08:41,775 --> 00:08:43,243 CAPACITY AND POINT IS THAT IF 230 00:08:43,243 --> 00:08:43,877 SOMEBODY DOESN'T HAVE ONE OF 231 00:08:43,877 --> 00:08:47,147 THOSE CAPACITIES OR ONE OF THOSE 232 00:08:47,147 --> 00:08:47,480 SUB-ELEMENTS. 233 00:08:47,480 --> 00:08:49,949 I WILL CALL THEM HERE ESSENTIAL 234 00:08:49,949 --> 00:08:51,117 ELEMENTS AND LET'S IMAGINE WE 235 00:08:51,117 --> 00:08:53,987 HAVE A PROTOCOL FOR LONG TERM 236 00:08:53,987 --> 00:08:55,622 RISKS THAT ARE ESSENTIAL 237 00:08:55,622 --> 00:08:56,890 ELEMENTS IN A SENSE THAT TO 238 00:08:56,890 --> 00:08:59,292 CONSENT TO THE STUDY YOU NEED TO 239 00:08:59,292 --> 00:09:01,127 LEARN OR KNOW AND UNDERSTAND OR 240 00:09:01,127 --> 00:09:02,829 APPRECIATE LONG TERM RISK AND 241 00:09:02,829 --> 00:09:03,930 IMAGINE LONG TERM RISK IS RISK 242 00:09:03,930 --> 00:09:05,165 OF DEATH AND PEOPLE HAVE TO 243 00:09:05,165 --> 00:09:06,299 UNDERSTAND THAT IF THEY ARE 244 00:09:06,299 --> 00:09:08,201 GOING TO HAVE CAPACITY TO ENROLL 245 00:09:08,201 --> 00:09:10,236 IN THIS STUDY AND WHETHER IT IS 246 00:09:10,236 --> 00:09:13,106 SOMEBODY THAT DOESN'T UNDERSTAND 247 00:09:13,106 --> 00:09:14,808 THAT SPECIFIC ELEMENT THEN WILL 248 00:09:14,808 --> 00:09:16,442 HAVE DECISIONAL INCAPACITY AND 249 00:09:16,442 --> 00:09:18,511 WON'T BE ABLE TO CONSENT FOR 250 00:09:18,511 --> 00:09:19,846 THEMSELVES WITH RESPECT TO THIS 251 00:09:19,846 --> 00:09:22,582 SPECIFIC PROTOCOL. OF COURSE, 252 00:09:22,582 --> 00:09:24,350 NOT UNDERSTANDING THE LONG-TERM 253 00:09:24,350 --> 00:09:25,218 RISKS IS COMPATIBLE WITH 254 00:09:25,218 --> 00:09:26,853 SOMEBODY THAT IS UNDERSTANDING A 255 00:09:26,853 --> 00:09:28,688 LOT OF OTHER THINGS THAT ARE 256 00:09:28,688 --> 00:09:31,291 RELEVANT TO THE PROTOCOL. FOR 257 00:09:31,291 --> 00:09:32,292 INSTANCE, THEY MIGHT UNDERSTAND 258 00:09:32,292 --> 00:09:34,160 ITS RESEARCH OR THAT THEY ARE IN 259 00:09:34,160 --> 00:09:35,662 THE CLINICAL CENTER AND THEY 260 00:09:35,662 --> 00:09:37,230 MIGHT HAVE VERY GOOD SENSE FOR 261 00:09:37,230 --> 00:09:38,998 THEIR OWN VALUES AND PREFERENCES 262 00:09:38,998 --> 00:09:40,767 WITH RESPECT TO RESEARCH AND 263 00:09:40,767 --> 00:09:41,835 MIGHT KNOW THAT THERE IS 264 00:09:41,835 --> 00:09:43,303 SOMEBODY THAT SUPPORTS RESEARCH 265 00:09:43,303 --> 00:09:45,271 AND IS INTERESTED IN 266 00:09:45,271 --> 00:09:47,207 CONTRIBUTING TO IT AND ON THE 267 00:09:47,207 --> 00:09:50,343 OTHER HAND SOMEBODY WHO DOESN'T 268 00:09:50,343 --> 00:09:54,013 AND IS NOT INTERESTED IN 269 00:09:54,013 --> 00:09:56,749 CONTRIBUTING TO IT AND THAT IS 270 00:09:56,749 --> 00:09:59,786 THE FIRST POINT THAT DECISION 271 00:09:59,786 --> 00:10:00,954 MAKING CAPACITIES IS COMPLICATED 272 00:10:00,954 --> 00:10:03,089 AND MULTI-FACETED AND DON'T HAVE 273 00:10:03,089 --> 00:10:04,424 ONE ELEMENT IN PLACE DOESN'T 274 00:10:04,424 --> 00:10:06,125 MEAN YOU HAVE NOTHING IN PLACE 275 00:10:06,125 --> 00:10:07,660 THAT IS THE ASSUMPTION THAT THE 276 00:10:07,660 --> 00:10:09,329 ALL OR NOTHING VIEW ASSUMED. 277 00:10:09,329 --> 00:10:11,364 THAT VIEW IS MISTAKEN. 278 00:10:11,364 --> 00:10:13,233 NOW SOME PEOPLE REALLY RUN WITH 279 00:10:13,233 --> 00:10:13,733 THIS CONCLUSION. 280 00:10:13,733 --> 00:10:15,802 THEY WILL SAY, YEAH. THAT IS 281 00:10:15,802 --> 00:10:17,503 RIGHT. NOT ONLY IS IT A MATTER 282 00:10:17,503 --> 00:10:20,173 OF DEGREE, BUT NOBODY'S 283 00:10:20,173 --> 00:10:22,375 DECISIONAL CAPACITY IS PERFECT 284 00:10:22,375 --> 00:10:24,010 AND NOBODY UNDERSTANDS 285 00:10:24,010 --> 00:10:26,145 EVERYTHING AND NOBODY IS ABLE TO 286 00:10:26,145 --> 00:10:26,579 REASON PERFECTLY. 287 00:10:26,579 --> 00:10:28,882 SO WHAT IS NOW HAS BEEN CALLED 288 00:10:28,882 --> 00:10:29,682 PEOPLE MIGHT BE FAMILIAR WITH 289 00:10:29,682 --> 00:10:32,252 THIS AND WE CAN TALK MORE IN THE 290 00:10:32,252 --> 00:10:34,988 Q & A PEOPLE INTERESTED AND WHAT 291 00:10:34,988 --> 00:10:36,189 IS SUPPORTIVE DECISION MAKING 292 00:10:36,189 --> 00:10:37,924 AND PEOPLE IN EFFECT GOT OTHER 293 00:10:37,924 --> 00:10:39,092 WAY FROM ALL OR NOTHING VIEW. 294 00:10:39,092 --> 00:10:40,994 WHAT THEY WILL SAY IS, LOOK. IT 295 00:10:40,994 --> 00:10:43,930 IS A MATTER OF DEGREE. 296 00:10:43,930 --> 00:10:45,832 DAVE JUST SAID THAT AND NOBODY 297 00:10:45,832 --> 00:10:47,967 IS PERFECT AND HAS ZERO AND 298 00:10:47,967 --> 00:10:49,135 PEOPLE UNDERSTAND SOME THINGS. 299 00:10:49,135 --> 00:10:50,670 THAT IS THE FIRST POINT. 300 00:10:50,670 --> 00:10:52,472 WHAT SOME PEOPLE ARGUE THEN IS 301 00:10:52,472 --> 00:10:54,674 DRAWING A THRESHOLD ANYWHERE ON 302 00:10:54,674 --> 00:10:56,042 THE CONTINUUM WILL BE ARBITRARY 303 00:10:56,042 --> 00:10:57,944 AND WHAT WE DO. WE HAVE TO SAY 304 00:10:57,944 --> 00:11:00,179 HOW MUCH UNDERSTANDING IS 305 00:11:00,179 --> 00:11:02,015 SUFFICIENT OR ENOUGH. 306 00:11:02,015 --> 00:11:03,116 SOME PEOPLE CONCLUDE THAT 307 00:11:03,116 --> 00:11:04,584 WHEREVER YOU PLACE THE THRESHOLD 308 00:11:04,584 --> 00:11:05,818 IT IS ARBITRARY. 309 00:11:05,818 --> 00:11:07,253 THEY CONCLUDE FROM THAT FACT 310 00:11:07,253 --> 00:11:09,088 THAT YOU SHOULDN'T DRAW THE 311 00:11:09,088 --> 00:11:10,657 THRESHOLD AT ALL. 312 00:11:10,657 --> 00:11:12,458 INSTEAD, YOU SHOULD TAKE THE 313 00:11:12,458 --> 00:11:12,892 VIEW. 314 00:11:12,892 --> 00:11:14,594 THIS IS THE EXTREME SUPPORTIVE 315 00:11:14,594 --> 00:11:16,696 DECISION MAKING VIEW THAT 316 00:11:16,696 --> 00:11:19,232 EVERYBODY, NO MATTER WHAT 317 00:11:19,232 --> 00:11:20,900 COGNITIVE CAPACITY RETAINS THE 318 00:11:20,900 --> 00:11:22,535 RIGHT OR CLAIM TO MAKE DECISIONS 319 00:11:22,535 --> 00:11:23,536 FOR THEMSELVES AND MY VIEW IS 320 00:11:23,536 --> 00:11:25,204 BOTH OF THE VIEWS ARE WRONG. 321 00:11:25,204 --> 00:11:27,073 WE HAVE TO FIGURE OUT HOW TO 322 00:11:27,073 --> 00:11:29,642 LIVE IN THE MIDDLE. 323 00:11:29,642 --> 00:11:31,411 SO WHY IS THAT VIEW WRONG? 324 00:11:31,411 --> 00:11:33,079 I THINK THAT VIEW IS WRONG. 325 00:11:33,079 --> 00:11:36,916 WHAT THAT VIEW DOES IS IT JUST 326 00:11:36,916 --> 00:11:39,519 ASSUMES THAT NOT ONLY IMPORTANT 327 00:11:39,519 --> 00:11:41,788 BUT THE OVERRIDING IMPORTANCE IS 328 00:11:41,788 --> 00:11:45,325 JUST LETTING PEOPLE MAKE THEIR 329 00:11:45,325 --> 00:11:48,027 OWN DECISIONS AND LETTING PEOPLE 330 00:11:48,027 --> 00:11:49,462 GUIDE DECISIONS FOR THEMSELVES. 331 00:11:49,462 --> 00:11:50,730 THAT IS IMPORTANT BUT NOT ONLY 332 00:11:50,730 --> 00:11:52,899 THING WE CARE ABOUT AND NOT ONLY 333 00:11:52,899 --> 00:11:55,201 THANG IS PART OF RESPECT FOR 334 00:11:55,201 --> 00:11:55,568 OTHERS. 335 00:11:55,568 --> 00:11:56,636 THERE IS ALSO AN IMPORTANT 336 00:11:56,636 --> 00:11:58,504 COMPONENT OF RESPECTING AND 337 00:11:58,504 --> 00:12:00,106 PROTECTING THE VALUES AND 338 00:12:00,106 --> 00:12:03,076 INTERESTS OF OTHERS. 339 00:12:03,076 --> 00:12:04,510 WHEN SOMEBODY HAS LESS 340 00:12:04,510 --> 00:12:05,678 DECISIONAL CAPACITY, THEY 341 00:12:05,678 --> 00:12:07,680 THEMSELVES ARE LESS IN A 342 00:12:07,680 --> 00:12:11,351 POSITION TO PROTECT AND PROMOTE 343 00:12:11,351 --> 00:12:12,118 VALUES AND INTEREST AND 344 00:12:12,118 --> 00:12:14,220 THEREFORE WE HAVE REASON WHY WE 345 00:12:14,220 --> 00:12:15,588 SHOULD CHANGE WHAT WE DO AND 346 00:12:15,588 --> 00:12:17,056 MAKE SURE THAT THEIR VALUES AND 347 00:12:17,056 --> 00:12:18,858 INTERESTS ARE PROTECTED IN THE 348 00:12:18,858 --> 00:12:20,960 PROCESS HERE OF ENROLLING THEM 349 00:12:20,960 --> 00:12:22,595 AND THEY ARE PARTICIPATING IN 350 00:12:22,595 --> 00:12:22,862 RESEARCH. 351 00:12:22,862 --> 00:12:24,864 SO THIS LEAVES US WITH A 352 00:12:24,864 --> 00:12:28,067 CHALLENGE OF TRYING TO FIGURE 353 00:12:28,067 --> 00:12:29,569 OUT A WAY TO RECOGNIZE BOTH THAT 354 00:12:29,569 --> 00:12:31,237 PEOPLE HAVE DECISIONAL 355 00:12:31,237 --> 00:12:32,905 CAPACITIES AND THEY HAVE 356 00:12:32,905 --> 00:12:33,773 DECISIONAL LIMITATIONS. 357 00:12:33,773 --> 00:12:36,275 SO THE QUESTION IS CAN WE 358 00:12:36,275 --> 00:12:37,143 INVOLVE INDIVIDUALS IN THE 359 00:12:37,143 --> 00:12:38,945 DECISION MAKING PROCESS, ADULTS 360 00:12:38,945 --> 00:12:40,913 WHO CAN'T GIVE INFORMED CONSENT 361 00:12:40,913 --> 00:12:42,582 AFRND CAN WE INVOLVE THEM IN 362 00:12:42,582 --> 00:12:43,449 DECISION MAKING PROCESS ABOUT 363 00:12:43,449 --> 00:12:47,687 YOU DO IT IN A WAY THAT ALSO 364 00:12:47,687 --> 00:12:49,555 ADEQUATELY PROTECTS VALUES AND 365 00:12:49,555 --> 00:12:49,856 INTERESTS. 366 00:12:49,856 --> 00:12:51,090 SO TO SHOW US HOW LONG I HAVE 367 00:12:51,090 --> 00:12:53,226 BEEN AT THIS, THIS IS A PAPER 368 00:12:53,226 --> 00:12:55,161 THAT IS ALMOST 25 YEARS OLD. 369 00:12:55,161 --> 00:12:58,531 NOW THAT I WROTE WITH A FELLOW 370 00:12:58,531 --> 00:13:02,402 AT THE TIME KIERAN PRES AD AND I 371 00:13:02,402 --> 00:13:04,137 WENT BACK AND LOOKED AT THIS 372 00:13:04,137 --> 00:13:06,873 LAST WEEK AND PAPER HOLDS UP 373 00:13:06,873 --> 00:13:08,207 WELL THANKFULLY AND THAT PAPER 374 00:13:08,207 --> 00:13:10,309 WHAT WE DID IS WE ARGUED WAY YOU 375 00:13:10,309 --> 00:13:12,011 DO THIS WHAT I WAS CALLING 376 00:13:12,011 --> 00:13:14,280 LIVING IN THE MIDDLE HERE AND 377 00:13:14,280 --> 00:13:15,782 WAY YOU CONTINUE TO INVOLVE 378 00:13:15,782 --> 00:13:17,216 INDIVIDUALS WITH DECISIONAL 379 00:13:17,216 --> 00:13:18,317 IMPAIRMENTS IN THE DECISION 380 00:13:18,317 --> 00:13:20,553 PROCESS ABOUT YOU STILL PROTECT 381 00:13:20,553 --> 00:13:22,555 THEM IS WITH FIVE SAFEGUARDS AND 382 00:13:22,555 --> 00:13:24,424 I THINK THAT THE SAFEGUARDS WE 383 00:13:24,424 --> 00:13:26,759 SHOULD BE THINKING ABOUT WHEN WE 384 00:13:26,759 --> 00:13:28,694 ARE THINKING ABOUT RESEARCH WITH 385 00:13:28,694 --> 00:13:30,797 ADULTS THAT CAN'T CONSENT AND 386 00:13:30,797 --> 00:13:31,764 WON'T GO THROUGH FIRST FOUR AND 387 00:13:31,764 --> 00:13:33,399 TODAY WILL TALK ABOUT THE LAST 388 00:13:33,399 --> 00:13:38,204 ONE. IMPORTANCE OF SOLICITEE 389 00:13:38,204 --> 00:13:40,873 ASSENT AND RESPECTING DESCENT 390 00:13:40,873 --> 00:13:43,142 AND GIVING PART ON THIS 391 00:13:43,142 --> 00:13:44,610 LITERATURE AND LOTS OF PEOPLE 392 00:13:44,610 --> 00:13:46,512 OPINED ON THIS. THIS IS A 393 00:13:46,512 --> 00:13:48,414 SAMPLING OF THEM AND PEG HAS A 394 00:13:48,414 --> 00:13:50,049 LOT MORE FOR PEOPLE THAT ARE 395 00:13:50,049 --> 00:13:50,416 INTERESTED. 396 00:13:50,416 --> 00:13:52,118 THE POINT OF THIS IS GOING TO BE 397 00:13:52,118 --> 00:13:54,087 IN THE END THAT THERE IS JUST 398 00:13:54,087 --> 00:13:56,789 ALMOST UNANIMOUS, EXTREMELY WIDE 399 00:13:56,789 --> 00:14:00,660 AGREEMENT ABOUT THIS, THAT 400 00:14:00,660 --> 00:14:04,130 RESPECTING DECENT AND SOLICITING 401 00:14:04,130 --> 00:14:06,899 ASSENT ARE IMPORTANT AND THIS IS 402 00:14:06,899 --> 00:14:09,502 ADVISORY COMMITTEE TO OHAP AND 403 00:14:09,502 --> 00:14:12,138 THEY THINK YOU NEED TO GET 404 00:14:12,138 --> 00:14:13,840 ASSENT AS WELL THROUGHOUT COURSE 405 00:14:13,840 --> 00:14:16,409 OF RESEARCH INVOLVEMENT THEY 406 00:14:16,409 --> 00:14:19,145 EMPHASIZE THAT YOU COME BACK AND 407 00:14:19,145 --> 00:14:20,480 DECLARATION OF HELSINKI SAYS 408 00:14:20,480 --> 00:14:24,884 SIMILAR THING AND NO ET IN HERE 409 00:14:24,884 --> 00:14:26,586 THAT SUBJECT'S DECENT SHOULD BE 410 00:14:26,586 --> 00:14:27,987 RESPECTED AS WELL AND PEOPLE ARE 411 00:14:27,987 --> 00:14:29,689 NOT FAMILIAR WITH THIS COUNCIL 412 00:14:29,689 --> 00:14:30,857 OF ORGANIZATIONAL MEDICAL 413 00:14:30,857 --> 00:14:32,658 SCIENCES THAT IS A VERY 414 00:14:32,658 --> 00:14:35,061 PROMINENT SET OF GUIDELINES FOR 415 00:14:35,061 --> 00:14:37,130 RESEARCH AND LOW AND MIDDLE 416 00:14:37,130 --> 00:14:38,331 INCOME COUNTRIES AND DON'T KNOW 417 00:14:38,331 --> 00:14:40,166 AS MUCH ABOUT IT AND IS NOT AS 418 00:14:40,166 --> 00:14:42,602 POPULAR OR FAMILIAR IN THE US. 419 00:14:42,602 --> 00:14:44,203 AGAIN, SAME THING CONSENT OF 420 00:14:44,203 --> 00:14:45,671 EACH SUBJECT SHOULD BE OBTAINED 421 00:14:45,671 --> 00:14:46,806 TO EXTENT OF PERSON'S 422 00:14:46,806 --> 00:14:48,541 CAPABILITIES AND REFUSE ALE TO 423 00:14:48,541 --> 00:14:49,475 PARTICIPATE IN RESEARCH AND 424 00:14:49,475 --> 00:14:51,611 ALWAYS BE RESPECTED AND THERE IS 425 00:14:51,611 --> 00:14:52,945 A CAVEAT THAT SOME PEOPLE PUT ON 426 00:14:52,945 --> 00:14:55,948 IT AND WE CAN COME BACK IN Q & A 427 00:14:55,948 --> 00:14:57,917 WHEN PEOPLE ARE INTERESTED AND 428 00:14:57,917 --> 00:15:00,052 WHAT ABOUT DECENT IN SETTING OF 429 00:15:00,052 --> 00:15:01,954 RESEARCH STUDY THAT OFFERS 430 00:15:01,954 --> 00:15:03,289 REALLY IMPORTANT POTENTIAL 431 00:15:03,289 --> 00:15:05,224 BENEFITS NOT AVAILABLE OUTSIDE 432 00:15:05,224 --> 00:15:07,360 OF THE RESEARCH SETTING AND 433 00:15:07,360 --> 00:15:08,127 REMAINING IMPORTANT QUESTION IN 434 00:15:08,127 --> 00:15:10,363 THIS CONTEXT AND OTHERS IN NEW 435 00:15:10,363 --> 00:15:11,831 YORK STATE ADVISORY GROUP ABOUT 436 00:15:11,831 --> 00:15:13,399 20 YEARS AGO AND WENT THROUGH 437 00:15:13,399 --> 00:15:16,169 THIS DECENT AS WELL AS MARYLAND 438 00:15:16,169 --> 00:15:18,037 ATTORNEYS AND GROUP DID THE SAME 439 00:15:18,037 --> 00:15:20,873 THING AND CANADIAN TRICOUNSEL 440 00:15:20,873 --> 00:15:22,542 STATEMENT AND POLICY THAT REGS 441 00:15:22,542 --> 00:15:24,043 MIGHT BE FAMILIAR WITH AND LOOKS 442 00:15:24,043 --> 00:15:26,679 LIKE WE MAY HAVE THIS IS PART OF 443 00:15:26,679 --> 00:15:30,283 POLICY 403 AND IRBS SHOULD BE 444 00:15:30,283 --> 00:15:34,053 HEARING MORE ABOUT THAT IN THE 445 00:15:34,053 --> 00:15:35,388 NEAR TERM THAT ASSENT AROUND 446 00:15:35,388 --> 00:15:37,223 DECENT WILL BE PART OF POLICY 447 00:15:37,223 --> 00:15:42,795 AND PROCESSES AS WELL. 448 00:15:42,795 --> 00:15:44,597 THAT WAS TO SAY EVERYBODY AGREES 449 00:15:44,597 --> 00:15:47,767 ON THIS AND SHOULD BE SOLICITING 450 00:15:47,767 --> 00:15:49,235 ASSENT AND WHERE CHALLENGE AND 451 00:15:49,235 --> 00:15:50,570 WORK NEEDS TO BE DONE IS 452 00:15:50,570 --> 00:15:52,438 FIGURING OUT WHO HAS CAPACITY TO 453 00:15:52,438 --> 00:15:54,407 ASSENT AND THINGS SAY THAT IF 454 00:15:54,407 --> 00:15:56,309 SOMEBODY HAS CAPACITY TO CONCEPT 455 00:15:56,309 --> 00:15:57,610 YOU SHOULD OBTAIN IT AND DON'T 456 00:15:57,610 --> 00:15:59,946 SAY WHO HAS THAT CAPACITY AND IS 457 00:15:59,946 --> 00:16:01,347 THE REAL CHALLENGE THEN AND HOW 458 00:16:01,347 --> 00:16:02,915 DO WE FIGURE THAT OUT? 459 00:16:02,915 --> 00:16:06,352 THIS IS WAY THAT PHILOSOPHER 460 00:16:06,352 --> 00:16:07,386 THINKS AND WE NEED TO FIGURE 461 00:16:07,386 --> 00:16:08,955 THIS OUT AND WHAT IS THE POINT 462 00:16:08,955 --> 00:16:12,625 AND WHY ARE WE SOLICITING ASSENT 463 00:16:12,625 --> 00:16:14,560 IN THE FIRST PLACE? 464 00:16:14,560 --> 00:16:15,895 PRESUMABLY THE GOAL IS TO ENSURE 465 00:16:15,895 --> 00:16:17,730 PROPER RESPECT AS I MENTIONED 466 00:16:17,730 --> 00:16:19,932 FOR INDIVIDUALS THAT HAVE 467 00:16:19,932 --> 00:16:21,000 INTELLECTUAL OR COGNITIVE 468 00:16:21,000 --> 00:16:21,334 DISABILITIES. 469 00:16:21,334 --> 00:16:23,236 IF THAT IS RIGHT, THE WAY TO 470 00:16:23,236 --> 00:16:24,971 POSE THE QUESTION IS AS FOLLOWS 471 00:16:24,971 --> 00:16:27,106 WHEN DOES OBTAINING AFFIRMATIVE 472 00:16:27,106 --> 00:16:29,242 AGREEMENT OR ASSET AND WHEN DOES 473 00:16:29,242 --> 00:16:30,476 OBTAINING AFFIRMATIVE AGREEMENT 474 00:16:30,476 --> 00:16:34,013 OF ADULTS THAT CAN'T CONCEPT FOR 475 00:16:34,013 --> 00:16:35,214 THEMSELVES AND WHEN DOES THAT 476 00:16:35,214 --> 00:16:38,351 PROMOTE THIS GOAL OF RESPECTING 477 00:16:38,351 --> 00:16:39,418 THESE INDIVIDUALS? 478 00:16:39,418 --> 00:16:42,255 WHAT IS CURRENT GUIDANCE SAY? 479 00:16:42,255 --> 00:16:45,224 LARGELY IT SAYS IT DEPENDS AND 480 00:16:45,224 --> 00:16:46,892 ALSO SAYS THAT LOTS OF PEOPLE 481 00:16:46,892 --> 00:16:48,294 TAKE THIS SIMILAR WORDING AND 482 00:16:48,294 --> 00:16:50,863 PEOPLE MIGHT BE FAMILIAR WITH IN 483 00:16:50,863 --> 00:16:53,065 PEDIATRIC REGS TALKING ABOUT 484 00:16:53,065 --> 00:16:55,968 WHICH CHILDREN ARE ABLE TO 485 00:16:55,968 --> 00:16:57,570 DECENT YOU LOOK AT INDIVIDUAL'S 486 00:16:57,570 --> 00:16:59,338 ABILITIES AND PSYCHOLOGICAL AND 487 00:16:59,338 --> 00:17:00,973 EMOTIONAL STATE AND CONDITIONS 488 00:17:00,973 --> 00:17:02,208 AND CIRCUMSTANCES AND ALL THAT 489 00:17:02,208 --> 00:17:03,542 OBVIOUSLY MAKES SENSE. 490 00:17:03,542 --> 00:17:05,211 WE NEED TO KNOW MORE 491 00:17:05,211 --> 00:17:06,345 SPECIFICALLY WHAT ABOUT THEIR 492 00:17:06,345 --> 00:17:08,214 DECISIONAL ABILITIES AND WHAT 493 00:17:08,214 --> 00:17:08,814 DECISIONAL ABILITIES DO THEY 494 00:17:08,814 --> 00:17:12,785 NEED TO HAVE IN M PARTICULAR TO 495 00:17:12,785 --> 00:17:15,888 HAVE CAPACITY TO ASSENT? MY 496 00:17:15,888 --> 00:17:17,223 THOUGHT ABOUT THIS AND I 497 00:17:17,223 --> 00:17:18,658 ACTUALLY THINK SOME PEOPLE 498 00:17:18,658 --> 00:17:20,026 DISAGREE WITH THIS AND THINK IT 499 00:17:20,026 --> 00:17:21,160 IS RIGHT AND WOULD BE INTERESTED 500 00:17:21,160 --> 00:17:24,230 IN PEOPLE DOING THE Q & A AND 501 00:17:24,230 --> 00:17:25,898 SEEMS WE ARE TALKING ABOUT 502 00:17:25,898 --> 00:17:27,099 RESPECT HERE AND DON'T THINK IT 503 00:17:27,099 --> 00:17:29,802 IS RESPECTFUL TO ASK SOMEBODY TO 504 00:17:29,802 --> 00:17:31,370 AGREE TO SOMETHING THEY DON'T OR 505 00:17:31,370 --> 00:17:32,004 CAN'T UNDERSTAND. 506 00:17:32,004 --> 00:17:34,974 I DON'T SEE HOW THAT IS A MATTER 507 00:17:34,974 --> 00:17:36,342 OF RESPECTING THE PERSON. 508 00:17:36,342 --> 00:17:39,545 IF THAT IS RIGHT, TO JUST 509 00:17:39,545 --> 00:17:41,681 SOMETHING THAT IS A FOLLOWING 510 00:17:41,681 --> 00:17:43,182 PRINCIPLE WHICH IS WHETHER AN 511 00:17:43,182 --> 00:17:45,251 ADULT THAT CAN'T CONSENT HAS THE 512 00:17:45,251 --> 00:17:47,453 CAPACITY TO ASSENT IT DEPENDS 513 00:17:47,453 --> 00:17:48,754 WHETHER THEY CAN UNDERSTAND AT 514 00:17:48,754 --> 00:17:50,756 LEAST WHAT I'M CALLING THE BASIC 515 00:17:50,756 --> 00:17:52,391 ELEMENTS OF THE STUDY AND CAN 516 00:17:52,391 --> 00:17:53,993 THEY UNDERSTAND THE STUDY AT 517 00:17:53,993 --> 00:17:55,428 LEAST AT SOME BASIC ELEMENTARY 518 00:17:55,428 --> 00:17:57,229 LEVEL AND IF THEY CAN, MY VIEW 519 00:17:57,229 --> 00:18:00,066 IS THAT THEY HAVE THE CAPACITY 520 00:18:00,066 --> 00:18:02,234 TO ASSENT. IF THEY CAN'T, I 521 00:18:02,234 --> 00:18:04,370 DON'T THINK THEY HAVE CAPACITY 522 00:18:04,370 --> 00:18:06,005 TO ASSET AND NOW THAT RAISES 523 00:18:06,005 --> 00:18:07,940 QUESTION OF WHICH ARE AND WHAT 524 00:18:07,940 --> 00:18:10,509 ARE BASIC ELEMENTS THAT ARE 525 00:18:10,509 --> 00:18:13,379 IMPORTANT TO ASSENT. I DON'T 526 00:18:13,379 --> 00:18:14,480 KNOW IF PEG FOUND MORE I 527 00:18:14,480 --> 00:18:15,681 COULDN'T FIND MORE ON THIS. 528 00:18:15,681 --> 00:18:17,583 MAYBE THIS IS A GAP IN THE 529 00:18:17,583 --> 00:18:17,950 LITERATURE. 530 00:18:17,950 --> 00:18:19,985 I FOUND A LITTLE BIT AND WHAT I 531 00:18:19,985 --> 00:18:21,220 FOUND. THIS IS FROM STANFORD 532 00:18:21,220 --> 00:18:23,689 WHO SAYS THAT IN ORDER TO BE 533 00:18:23,689 --> 00:18:25,825 ABLE TO ASSENT, AN INDIVIDUAL 534 00:18:25,825 --> 00:18:27,760 HAS TO UNDERSTAND THESE BULLETED 535 00:18:27,760 --> 00:18:30,429 ITEMS AND SHOULD SAY THIS IS 536 00:18:30,429 --> 00:18:31,497 PULLED OFF THE INTERNET AND 537 00:18:31,497 --> 00:18:33,399 WHETHER IT IS UP TO DATE I DON'T 538 00:18:33,399 --> 00:18:34,734 REALLY KNOW AND LATEST 539 00:18:34,734 --> 00:18:35,901 INFORMATION TO FIND BUT MIGHT 540 00:18:35,901 --> 00:18:37,903 NOT BE UP TO DATE FOR ALL I 541 00:18:37,903 --> 00:18:38,104 KNOW. 542 00:18:38,104 --> 00:18:40,072 THIS IS TAKEN FROM THE FEDERAL 543 00:18:40,072 --> 00:18:42,007 REGS AND IT IS PROBABLY TAKEN A 544 00:18:42,007 --> 00:18:44,310 LITTLE TOO STRICTLY FROM THE 545 00:18:44,310 --> 00:18:45,611 FEDERAL REGULATIONS AND 546 00:18:45,611 --> 00:18:46,879 INSTANCE, I'M NOT SURE TO BE 547 00:18:46,879 --> 00:18:49,448 ABLE TO ASSENT THAT YOU HAVE TO 548 00:18:49,448 --> 00:18:50,649 UNDERSTAND THE PLAN FOR 549 00:18:50,649 --> 00:18:51,784 COMPENSATION FOR RESEARCH 550 00:18:51,784 --> 00:18:52,651 INJURIES AND IS IMPORTANT THAT 551 00:18:52,651 --> 00:18:54,520 THERE IS A PLAN AND I'M NOT SURE 552 00:18:54,520 --> 00:18:56,355 IT HAS TO BE UNDERSTOOD BY AN 553 00:18:56,355 --> 00:18:58,657 ADULT WHO CAN'T GIVE INFORMED 554 00:18:58,657 --> 00:19:00,960 CONCEPT AND I'M ALSO NOT SURE OR 555 00:19:00,960 --> 00:19:02,328 NOT CONVINCED AT LEAST THAT 556 00:19:02,328 --> 00:19:03,863 SOMEBODY TO GET ASSENT THAT THEY 557 00:19:03,863 --> 00:19:05,164 HAVE TO UNDERSTAND THAT THERE IS 558 00:19:05,164 --> 00:19:06,232 CERTAIN INFORMATION YOU MIGHT 559 00:19:06,232 --> 00:19:07,633 HAVE TO GET TO THE SPONSOR OF 560 00:19:07,633 --> 00:19:09,935 THE TRIAL AND SEEMS TO ME IS ON 561 00:19:09,935 --> 00:19:11,904 THE RIGHT TRACK WITH SOME OF IT 562 00:19:11,904 --> 00:19:14,140 AND SEEMS A LITTLE BIT TOO MUCH 563 00:19:14,140 --> 00:19:15,875 OR A LITTLE BIT TOO BROAD OR 564 00:19:15,875 --> 00:19:19,111 DEMANDING AND THIS IS FROM CHOP 565 00:19:19,111 --> 00:19:24,116 AND THIS CHILDREN'S HOSPITAL IN 566 00:19:24,116 --> 00:19:24,650 PENNSYLVANIA MOSTLY DOES 567 00:19:24,650 --> 00:19:25,684 PEDIATRICS AND TEENAGERS THAT 568 00:19:25,684 --> 00:19:27,920 TURN INTO ADULTS AND THEY KEEP 569 00:19:27,920 --> 00:19:29,422 TREATING THEM AND THEY HAVE A 570 00:19:29,422 --> 00:19:31,357 POLICY IN THIS REGARD AND THEY 571 00:19:31,357 --> 00:19:32,792 SAY SOMETHING VERY TRIMMED DOWN 572 00:19:32,792 --> 00:19:34,960 FROM STANFORD. YOU MUST BE ABLE 573 00:19:34,960 --> 00:19:35,961 TO UNDERSTAND THE GENERAL 574 00:19:35,961 --> 00:19:37,129 PURPOSE OF ROOT HE SEARCH AND 575 00:19:37,129 --> 00:19:38,931 NATURE OF PROCEDURES AND MUST BE 576 00:19:38,931 --> 00:19:42,802 ABLE TO UNDERSTAND CONCEPT OF 577 00:19:42,802 --> 00:19:43,402 VOLUME UNTARINESS AND DON'T 578 00:19:43,402 --> 00:19:45,204 UNDERSTAND WHAT IT MEANS CONCEPT 579 00:19:45,204 --> 00:19:47,740 OF VOLUNTEERS AND SEEMS ON RIGHT 580 00:19:47,740 --> 00:19:49,675 TRACK TO ME AND MAYBE SEEMS A 581 00:19:49,675 --> 00:19:52,445 LITTLE TOO MINIMAL AND IS MY 582 00:19:52,445 --> 00:19:53,779 TENTATIVE PROPOSAL AND WOULD BE 583 00:19:53,779 --> 00:19:54,680 VERY INTERESTED IN WHAT PEOPLE 584 00:19:54,680 --> 00:19:55,681 THINK ABOUT THIS. 585 00:19:55,681 --> 00:19:56,982 YOU NEED TO UNDERSTAND SOMETHING 586 00:19:56,982 --> 00:19:57,950 ABOUT RESEARCH. 587 00:19:57,950 --> 00:19:58,951 WHAT IS THAT? 588 00:19:58,951 --> 00:20:01,153 FOR ME, IT IS BASICALLY 589 00:20:01,153 --> 00:20:02,588 UNDERSTANDING THAT PART OF THE 590 00:20:02,588 --> 00:20:04,356 RESEARCH PROCESS INVOLVES TRYING 591 00:20:04,356 --> 00:20:06,492 TO LEARN THINGS IN THE 592 00:20:06,492 --> 00:20:07,026 INTERACTIONS WITH THIS 593 00:20:07,026 --> 00:20:08,928 INDIVIDUAL TO GAIN INFORMATION 594 00:20:08,928 --> 00:20:10,229 THAT MIGHT HELP OTHERS. 595 00:20:10,229 --> 00:20:11,363 THEN YOU HAVE TO ASK WHAT THEY 596 00:20:11,363 --> 00:20:13,232 WILL BE ASKED TO DO AND STAY 597 00:20:13,232 --> 00:20:14,800 HERE FOR A DAY AND GO THROUGH 598 00:20:14,800 --> 00:20:17,603 SOME TESTS AND WE WILL ASK YOU 599 00:20:17,603 --> 00:20:18,737 QUESTIONS AND GIVE YOU A DRUG OR 600 00:20:18,737 --> 00:20:20,906 WHOEVER IT IS. IF THERE IS A 601 00:20:20,906 --> 00:20:22,575 CHANCE OR NOT OF PERSONAL 602 00:20:22,575 --> 00:20:23,709 BENEFIT THEY SHOULD UNDERSTAND 603 00:20:23,709 --> 00:20:23,909 THAT. 604 00:20:23,909 --> 00:20:25,077 I DON'T THINK YOU NEED TO 605 00:20:25,077 --> 00:20:27,580 UNDERSTAND THE SPECIFIC HARMS IT 606 00:20:27,580 --> 00:20:29,248 WILL HURT MY KIDNEY VERSUS MY 607 00:20:29,248 --> 00:20:30,583 LIVER BUT THEY NEED TO 608 00:20:30,583 --> 00:20:31,317 UNDERSTAND SOMETHING ABOUT THE 609 00:20:31,317 --> 00:20:33,018 MAGNITUDE OF THE POTENTIAL HARMS 610 00:20:33,018 --> 00:20:34,920 AND THERE ARE SMALL HARMS AND 611 00:20:34,920 --> 00:20:37,056 THERE ARE SIGNIFICANT ONES. 612 00:20:37,056 --> 00:20:39,158 AT LEAST SOMETHING IN THE 613 00:20:39,158 --> 00:20:39,859 BALLPARK OF THEIR PROBABILITY 614 00:20:39,859 --> 00:20:41,160 AND THEY ARE UNLIKELY AND 615 00:20:41,160 --> 00:20:42,962 POSSIBLE AND THEY ARE LIKELY AND 616 00:20:42,962 --> 00:20:44,663 OBVIOUSLY THE PERSON AND THEY 617 00:20:44,663 --> 00:20:47,166 DON'T NEED TO UNDERSTAND THE 618 00:20:47,166 --> 00:20:49,401 CONCEPT OF VOLTAIRINESS AS CHOPS 619 00:20:49,401 --> 00:20:50,970 IS BUT THEY CERTAINLY NEED TO BE 620 00:20:50,970 --> 00:20:53,205 ABLE TO AND BE WILLING TO SAY 621 00:20:53,205 --> 00:20:53,539 NO. 622 00:20:53,539 --> 00:20:54,940 ONE THING ABOUT THAT THAT IS 623 00:20:54,940 --> 00:20:56,141 INTERESTING IS THAT I THINK 624 00:20:56,141 --> 00:20:57,910 PEOPLE AND I HAVE TO DO THIS AND 625 00:20:57,910 --> 00:20:59,144 GET TRIPPED UP WHEN YOU TALK 626 00:20:59,144 --> 00:21:00,880 ABOUT THIS AND HAVE AN ADULT 627 00:21:00,880 --> 00:21:02,214 THAT CAN'T CONSENT AND YOU HAVE 628 00:21:02,214 --> 00:21:04,149 AN LAR AND SOME PEOPLE DESCRIBE 629 00:21:04,149 --> 00:21:06,519 THAT AS IT IS NOT UP TO THE 630 00:21:06,519 --> 00:21:07,486 PARTICIPANT ANYMORE BUT UP TO 631 00:21:07,486 --> 00:21:08,287 THE LAR. 632 00:21:08,287 --> 00:21:11,624 WELL, IF YOU ARE GETTING ASSENT, 633 00:21:11,624 --> 00:21:13,158 THAT IS NOT TRUE. 634 00:21:13,158 --> 00:21:14,627 INSTEAD TO HAVE A PARTICIPATION, 635 00:21:14,627 --> 00:21:15,628 YOU NEED TWO YESES. 636 00:21:15,628 --> 00:21:16,328 RIGHT? 637 00:21:16,328 --> 00:21:17,630 THIS IS A JOINT DECISION. 638 00:21:17,630 --> 00:21:19,632 YOU NEED TWO YESES. 639 00:21:19,632 --> 00:21:22,468 IN THAT CASE, EITHER NO, NO FROM 640 00:21:22,468 --> 00:21:24,003 EITHER PARTY IS A NO. 641 00:21:24,003 --> 00:21:24,303 RIGHT? 642 00:21:24,303 --> 00:21:26,505 IF LAR DOESN'T GET PERMISSION 643 00:21:26,505 --> 00:21:29,208 YOU CAN'T ENROLL THEM AND IF THE 644 00:21:29,208 --> 00:21:30,409 INDIVIDUAL THEMSELVES DESCENT, 645 00:21:30,409 --> 00:21:33,379 YOU ENROLL THEM. 646 00:21:33,379 --> 00:21:36,682 ALL RIGHT. THIS IS WHAT I 647 00:21:36,682 --> 00:21:37,783 MENTIONED IS -- THOSE WERE 648 00:21:37,783 --> 00:21:39,885 INTENDED PROPOSALS AND BASIC 649 00:21:39,885 --> 00:21:41,220 ELEMENTS ARE AND THOUGHT IS IF 650 00:21:41,220 --> 00:21:42,421 SOMEBODY CAN UNDERSTAND THEM, 651 00:21:42,421 --> 00:21:43,255 THEY CAN UNDERSTAND WHAT IS 652 00:21:43,255 --> 00:21:46,091 BEING ASKED OF THEM AT LEAST AT 653 00:21:46,091 --> 00:21:47,660 A VERY BASIC LEVEL. 654 00:21:47,660 --> 00:21:49,228 YOU SHOULD SOLICIT THAT 655 00:21:49,228 --> 00:21:50,296 INDIVIDUAL ASSET. 656 00:21:50,296 --> 00:21:51,564 IF THEY CAN'T UNDERSTAND ONE OR 657 00:21:51,564 --> 00:21:53,032 MORE OF THOSE THINGS, THEY DON'T 658 00:21:53,032 --> 00:21:55,568 HAVE THE CAPACITY TO ASSENT. 659 00:21:55,568 --> 00:21:57,536 YOU SHOULDN'T SOLICIT THEIR 660 00:21:57,536 --> 00:21:57,903 ASSENT. 661 00:21:57,903 --> 00:21:59,805 SO HOW DO YOU DO THAT? 662 00:21:59,805 --> 00:22:01,640 OBVIOUSLY EXPLAIN THE BASIC 663 00:22:01,640 --> 00:22:03,342 ELEMENTS TO THE EXTENT AND IN A 664 00:22:03,342 --> 00:22:04,443 WAY THAT THE INDIVIDUAL 665 00:22:04,443 --> 00:22:05,244 HOPEFULLY CAN UNDERSTAND THEM 666 00:22:05,244 --> 00:22:08,247 AND HERE IS SOMETHING FROM AHARP 667 00:22:08,247 --> 00:22:11,016 THE ACCREDITATION PROCESS ABOUT 668 00:22:11,016 --> 00:22:13,953 MAKING SURE THAT THE INFORMING 669 00:22:13,953 --> 00:22:18,090 PROCESS IS KEEPING IN MIND 670 00:22:18,090 --> 00:22:20,092 ABILITIES AND PROCLIVITIES OF 671 00:22:20,092 --> 00:22:20,926 THIS SPECIFIC INDIVIDUAL. 672 00:22:20,926 --> 00:22:22,861 I THINK WE DID THIS STUDY AND 673 00:22:22,861 --> 00:22:24,964 HAVEN'T SEEN EMPIRICAL DATA ON 674 00:22:24,964 --> 00:22:25,197 THIS. 675 00:22:25,197 --> 00:22:29,802 WE DID AN EMPIRICAL STUDY A 676 00:22:29,802 --> 00:22:35,474 COUPLE YEARS AGO AND ASKED 677 00:22:35,474 --> 00:22:36,208 TEENA 678 00:22:36,208 --> 00:22:37,509 TEENAGER WHAT THEY THOUGHT ABOUT 679 00:22:37,509 --> 00:22:38,711 ASSENT AND ASKED THEM WHETHER OR 680 00:22:38,711 --> 00:22:40,412 NOT THEY WANTED TO SIGN A FORM 681 00:22:40,412 --> 00:22:42,848 AND GOING INTO IT NO THAT IS 682 00:22:42,848 --> 00:22:44,049 POINTLESS OR JUST DOCUMENTATION 683 00:22:44,049 --> 00:22:45,117 AND I DON'T CARE. 684 00:22:45,117 --> 00:22:47,152 WE WERE SURPRISED TO FIND THAT A 685 00:22:47,152 --> 00:22:50,422 VAST MAJORITY OF THEM WANTED TO 686 00:22:50,422 --> 00:22:52,157 SIGN A FORM AND FELT IT 687 00:22:52,157 --> 00:22:53,459 MEANINGFUL AND FELT IT SHOWED 688 00:22:53,459 --> 00:22:55,294 THAT RESEARCHERS WERE REALLY 689 00:22:55,294 --> 00:22:57,129 TAKING VIEWS AND OPINIONS 690 00:22:57,129 --> 00:22:59,064 SERIOUSLY AND IF WE ASSUME THAT 691 00:22:59,064 --> 00:23:01,066 THOSE VIEWS EXTRAPOLATE OUT TO 692 00:23:01,066 --> 00:23:02,434 ADULTS AS WELL, IT SUGGESTS THAT 693 00:23:02,434 --> 00:23:04,770 AT LEAST IN A LOT OF CASES IF 694 00:23:04,770 --> 00:23:06,271 THE PROCESS IS MEANINGFUL TO THE 695 00:23:06,271 --> 00:23:07,539 PERSON IF THEY CAN UNDERSTAND 696 00:23:07,539 --> 00:23:10,643 WHAT IT INVOLVES THEN HAVING 697 00:23:10,643 --> 00:23:11,610 THIS AND INFORMING THE 698 00:23:11,610 --> 00:23:13,212 INDIVIDUAL TO SIGN IT MAKES 699 00:23:13,212 --> 00:23:16,081 SENSE AND ONE THING THAT IS MY 700 00:23:16,081 --> 00:23:18,317 ACCESS AND TRY TO GRIND ON THE 701 00:23:18,317 --> 00:23:21,053 IRB AND SAT ON NIGHT IRB FOR 20 702 00:23:21,053 --> 00:23:22,655 YEARS AND ALWAYS FOUGHT WITH 703 00:23:22,655 --> 00:23:24,423 INVESTIGATORS OVER CONSENT FORMS 704 00:23:24,423 --> 00:23:26,592 AND THOUGHT NO OTHER HUMAN BEING 705 00:23:26,592 --> 00:23:28,160 EXCEPT FOR THEM COULD POSSIBLY 706 00:23:28,160 --> 00:23:28,460 UNDERSTAND. 707 00:23:28,460 --> 00:23:30,496 AT ONE POINT ONE OF THE 708 00:23:30,496 --> 00:23:32,064 INVESTIGATORS STARTED TO DO 709 00:23:32,064 --> 00:23:35,768 RESEARCH WITH TEENS AND CREATED 710 00:23:35,768 --> 00:23:38,003 ASSET IN FORUMS AND THOUGHT 711 00:23:38,003 --> 00:23:39,938 THERE IT IS AND WHAT A CONSENT 712 00:23:39,938 --> 00:23:41,573 FORM SHOULD LOOK LIKE AND THINK 713 00:23:41,573 --> 00:23:43,208 NOT ONLY ASSENT FORMS ARE GOOD 714 00:23:43,208 --> 00:23:45,144 FOR ADULTS THAT CAN'T CONSENT 715 00:23:45,144 --> 00:23:47,613 AND FOR TEENAGERS BUT MIGHT BE 716 00:23:47,613 --> 00:23:50,516 RIGHT WAY TO START WITH CREATING 717 00:23:50,516 --> 00:23:52,284 CONSENT FORMS. THEY SEEM MUCH 718 00:23:52,284 --> 00:23:54,787 CLEARER AND TO THE POINT TO ME 719 00:23:54,787 --> 00:23:55,854 THAN CONSENT FORMS AND GOES BACK 720 00:23:55,854 --> 00:23:57,723 TO WHAT I HIGHLIGHTED BEFORE 721 00:23:57,723 --> 00:24:00,626 FROM DECLARATION OF HELSINKI AND 722 00:24:00,626 --> 00:24:03,128 FOR MOST PART I'M FOCUSED ON 723 00:24:03,128 --> 00:24:05,197 INITIAL ENROLLMENT INTO A STUDY 724 00:24:05,197 --> 00:24:07,166 AND OBVIOUSLY IF A LONGITUDINAL 725 00:24:07,166 --> 00:24:08,967 STUDY THAT GOES ON FOR A WHILE 726 00:24:08,967 --> 00:24:12,671 THEY SHOULD BE SOLICITING THE 727 00:24:12,671 --> 00:24:14,139 ONGOING ASSET AT RECENT 728 00:24:14,139 --> 00:24:15,874 INTERVALS THAT IS DEPENDENT UPON 729 00:24:15,874 --> 00:24:17,409 THE NATURE OF THE STUDY AND 730 00:24:17,409 --> 00:24:19,478 INDIVIDUAL AND LAR AS I 731 00:24:19,478 --> 00:24:22,047 MENTIONED IF THEY AGREE AND GIVE 732 00:24:22,047 --> 00:24:23,048 AFFIRMATIVE AGREEMENT INDIVIDUAL 733 00:24:23,048 --> 00:24:25,217 CAN PARTICIPATE AND IF 734 00:24:25,217 --> 00:24:26,819 INDIVIDUAL DECLINES OR DISSCENTS 735 00:24:26,819 --> 00:24:31,757 THEY ARE NOT ENROLLED OR IF IN 736 00:24:31,757 --> 00:24:32,891 THE PROTOCOL ALREADY THEY SHOULD 737 00:24:32,891 --> 00:24:35,427 BE WITHDRAWN. 738 00:24:35,427 --> 00:24:37,196 THAT IS ASSET. 739 00:24:37,196 --> 00:24:38,964 PEDIATRIC REGULATIONS DO THIS 740 00:24:38,964 --> 00:24:41,100 THEY HAVE THIS THOUGHT DISSENT 741 00:24:41,100 --> 00:24:43,469 IS LACK OF ASSENT AND IF THEY 742 00:24:43,469 --> 00:24:44,970 DISSENT THEY ARE NOT GIVING 743 00:24:44,970 --> 00:24:46,004 ASSENT AND ASSUME FROM THAT AND 744 00:24:46,004 --> 00:24:48,907 THIS IS A MISTAKE THAT NATIONAL 745 00:24:48,907 --> 00:24:51,376 COMMISSION MADE THAT 746 00:24:51,376 --> 00:24:53,212 RECOMMENDATIONS FORM BASIS OF 747 00:24:53,212 --> 00:24:55,180 PEDIATRIC REGULATIONS IF THAT IS 748 00:24:55,180 --> 00:24:57,983 TRUE YOU DON'T NEED SEPARATE 749 00:24:57,983 --> 00:24:59,318 DISSENT REQUIREMENT ANYBODY THAT 750 00:24:59,318 --> 00:25:00,986 DISSCENTS IS NOT BY FORCE 751 00:25:00,986 --> 00:25:02,554 ASSENTING SO YOU TAKE THEM OUT 752 00:25:02,554 --> 00:25:04,423 AND PROBLEM WITH THAT IS AS WE 753 00:25:04,423 --> 00:25:06,625 NOTED THERE WILL BE AT LEAST 754 00:25:06,625 --> 00:25:08,327 SOME PEOPLE THAT NOT ONLY CAN'T 755 00:25:08,327 --> 00:25:10,028 CONSENT BUT DON'T HAVE CAPACITY 756 00:25:10,028 --> 00:25:10,996 TO ASSENT. 757 00:25:10,996 --> 00:25:14,933 SO IF THERE IS NOT A SEPARATE 758 00:25:14,933 --> 00:25:16,468 DISSENT REQUIREMENT OR DEMAND 759 00:25:16,468 --> 00:25:18,537 THAT YOU RESPECT THE DISSENT OF 760 00:25:18,537 --> 00:25:19,805 INDIVIDUALS, THEN YOU ARE NOT 761 00:25:19,805 --> 00:25:21,907 GOING TO HAVE ANY REQUIREMENT 762 00:25:21,907 --> 00:25:24,343 FOR RESPECTING THE DISSENTIVE 763 00:25:24,343 --> 00:25:26,378 INDIVIDUALS THAT ARE NOT ABLE TO 764 00:25:26,378 --> 00:25:26,612 ASSENT. 765 00:25:26,612 --> 00:25:29,214 IT IS IMPORTANT TO HAVE SEPARATE 766 00:25:29,214 --> 00:25:30,883 CONSIDERATION OF DISSENT FOR 767 00:25:30,883 --> 00:25:32,718 THOSE INDIVIDUALS. 768 00:25:32,718 --> 00:25:34,286 SO IMPORTANT THING IS AS ASSENT, 769 00:25:34,286 --> 00:25:35,821 I KNOW IT IS -- YOU DON'T 770 00:25:35,821 --> 00:25:37,389 UNDERSTAND EVERYTHING BUT HAVE 771 00:25:37,389 --> 00:25:39,558 TO UNDERSTAND SOME THINGS TO BE 772 00:25:39,558 --> 00:25:41,326 MAKING A DECISION ABOUT WHETHER 773 00:25:41,326 --> 00:25:43,595 ENROLL IN THE STUDY AND WHAT IS 774 00:25:43,595 --> 00:25:45,230 IMPORTANT ABOUT ASSENT SORRY 775 00:25:45,230 --> 00:25:47,833 ABOUT DISSENT IS IT IS NOT LIKE 776 00:25:47,833 --> 00:25:49,201 THAT. 777 00:25:49,201 --> 00:25:50,836 DISSENT DOESN'T REQUIRE 778 00:25:50,836 --> 00:25:51,203 UNDERSTANDING. 779 00:25:51,203 --> 00:25:53,772 IN FACT, IN PRACTICE A LOT OF 780 00:25:53,772 --> 00:25:55,073 TIMES, DISSENT MAY BE GENERATED 781 00:25:55,073 --> 00:25:57,209 BY A FAILURE TO UNDERSTAND AND 782 00:25:57,209 --> 00:25:58,210 SOMEBODY DOESN'T UNDERSTAND AND 783 00:25:58,210 --> 00:26:00,212 WHEN WE DON'T UNDERSTAND THINGS, 784 00:26:00,212 --> 00:26:03,115 WE TEND NOT TO LIKE THEM. 785 00:26:03,115 --> 00:26:06,718 THEREFORE, DISSENT MAY JUST BE A 786 00:26:06,718 --> 00:26:07,586 FUNCTION OF NOT UNDERSTANDING 787 00:26:07,586 --> 00:26:09,855 ANYTHING ABOUT THE STUDY AND NOT 788 00:26:09,855 --> 00:26:10,923 LIKING IT. 789 00:26:10,923 --> 00:26:14,326 SO, WHY DO WE WANT TO RESPECT 790 00:26:14,326 --> 00:26:15,694 PEOPLES DISSENT IF THEY CAN'T 791 00:26:15,694 --> 00:26:16,662 ASSENT? 792 00:26:16,662 --> 00:26:19,198 TWO REASONS. ONE, IT GIVES 793 00:26:19,198 --> 00:26:20,399 INDIVIDUALS SOME CONTINUED 794 00:26:20,399 --> 00:26:21,834 CONTROL OVER THEIR LIVES. 795 00:26:21,834 --> 00:26:23,502 AND THE OTHER THING IS THAT EVEN 796 00:26:23,502 --> 00:26:24,803 IF THEY CAN'T CONSENT AND CAN'T 797 00:26:24,803 --> 00:26:26,905 ASSENT, WE WANT TO BE VERY SURE 798 00:26:26,905 --> 00:26:29,508 WE ARE NOT EXPOSING THEM TO 799 00:26:29,508 --> 00:26:32,778 EXCESSIVE RISKS AND BURDENS OR 800 00:26:32,778 --> 00:26:34,146 EXCESSIVE STRESSES AND DISSENT 801 00:26:34,146 --> 00:26:36,114 IS A GOOD SIGNAL THAT MIGHT BE 802 00:26:36,114 --> 00:26:37,850 OCCURRING AND THIS MIGHT BE TOO 803 00:26:37,850 --> 00:26:39,451 MUCH AND MIGHT BE OVERWHELMING 804 00:26:39,451 --> 00:26:40,285 FOR THIS INDIVIDUAL. 805 00:26:40,285 --> 00:26:42,454 IT IS NOT JUST A MATTER OF 806 00:26:42,454 --> 00:26:45,123 GIVING THEM SOME CONTROL OVER 807 00:26:45,123 --> 00:26:46,725 THEIR LIVES ABOUT YOU IS ALSO 808 00:26:46,725 --> 00:26:48,594 MAKING SURE WE HAVE APPROPRIATE 809 00:26:48,594 --> 00:26:51,129 PROTECTIONS IN PLACE FOR THEIR 810 00:26:51,129 --> 00:26:53,198 WELLBEING AND THEIR INTERESTS. 811 00:26:53,198 --> 00:26:55,100 HERE IS ONE OF THE WORRIES THAT 812 00:26:55,100 --> 00:26:57,169 I TALK ABOUT THIS WITH CONSENT 813 00:26:57,169 --> 00:27:01,206 TO THE WAY THAT WE THINK OFTEN 814 00:27:01,206 --> 00:27:03,141 ABOUT INFORMING PEOPLE ABOUT 815 00:27:03,141 --> 00:27:04,309 CLINICAL TRIALS IS THROUGH 816 00:27:04,309 --> 00:27:06,011 CONSENT FORMS AND SOMETIMES 817 00:27:06,011 --> 00:27:07,946 ASSENT FORMS AND DESCRIBE STUDY 818 00:27:07,946 --> 00:27:11,183 IN CONSENT FORM AND ASSENT FORM 819 00:27:11,183 --> 00:27:13,252 AND HOW PEOPLE GET INFORMATION 820 00:27:13,252 --> 00:27:15,687 ABOUT STUDIES AND MY WORRY WITH 821 00:27:15,687 --> 00:27:16,889 THAT PRACTICE AND MAKES SENSE IS 822 00:27:16,889 --> 00:27:18,590 WHEN YOU START TO TALK ABOUT 823 00:27:18,590 --> 00:27:19,892 ADULTS THAT CAN'T CONSENT OR 824 00:27:19,892 --> 00:27:21,960 ASSENT AND THERE IS A WORRY IF 825 00:27:21,960 --> 00:27:24,129 ONLY INFORMING PROCESS OCCURS 826 00:27:24,129 --> 00:27:27,165 THROUGH CONSENT OR ASSENT FORM 827 00:27:27,165 --> 00:27:29,201 THAN THESE INDIVIDUALS WON'T BE 828 00:27:29,201 --> 00:27:31,103 PROVIDED WITH ANY INFORMATION AT 829 00:27:31,103 --> 00:27:31,837 ALL REGARDING PARTICIPATION AND 830 00:27:31,837 --> 00:27:33,739 HOPE THAT EVERYBODY AGREES WITH 831 00:27:33,739 --> 00:27:36,608 ME THAT IS A MISTAKE PROVIDING 832 00:27:36,608 --> 00:27:37,943 INFORMATION IS IMPORTANT AS A 833 00:27:37,943 --> 00:27:39,111 MEANS TO PUT PEOPLE IN A 834 00:27:39,111 --> 00:27:40,846 POSITION TO MAKE DECISIONS FOR 835 00:27:40,846 --> 00:27:42,080 THEMSELVES AND NOT THE ONLY 836 00:27:42,080 --> 00:27:43,782 REASON WHY WE PROVIDE PEOPLE 837 00:27:43,782 --> 00:27:44,249 WITH INFORMATION. 838 00:27:44,249 --> 00:27:46,551 THERE ARE OTHER REASONS. FOR 839 00:27:46,551 --> 00:27:47,719 INSTANCE, TO GIVE THEM A SENSE 840 00:27:47,719 --> 00:27:49,221 FOR WHAT TO EXPECT AND WHAT IS 841 00:27:49,221 --> 00:27:50,756 COMING AND WHAT THEY WILL BE 842 00:27:50,756 --> 00:27:53,225 DOING AND ALSO AT LEAST IN SOME 843 00:27:53,225 --> 00:27:56,295 CASES DOING THAT CAN REDUCE OR 844 00:27:56,295 --> 00:27:57,029 MINIMIZE DISTRESS WHEN PEOPLE 845 00:27:57,029 --> 00:27:58,797 KNOW WHAT IS GOING ON AND HOW 846 00:27:58,797 --> 00:28:00,265 LONG THEY WILL BE HERE FOR 847 00:28:00,265 --> 00:28:03,902 INSTANCE AND THAT CAN REDUCE THE 848 00:28:03,902 --> 00:28:06,204 STRESS OF BEING HERE. 849 00:28:06,204 --> 00:28:07,806 EEFSH FOR SOMEBODY WHO CAN'T 850 00:28:07,806 --> 00:28:09,241 CONSENT OR ASSENT STILL I THINK 851 00:28:09,241 --> 00:28:11,209 IT IS IMPORTANT TO HAVE A 852 00:28:11,209 --> 00:28:12,844 MECHANISM THAT THE INVESTIGATORS 853 00:28:12,844 --> 00:28:16,448 DESCRIBE FOR PROVIDING AT LEAST 854 00:28:16,448 --> 00:28:17,482 BASIC INFORMATION THAT PEOPLE 855 00:28:17,482 --> 00:28:18,917 CAN UNDERSTAND AND ALSO 856 00:28:18,917 --> 00:28:20,319 ASSESSING WHETHER OR NOT THEY 857 00:28:20,319 --> 00:28:21,553 HAVE ANY QUESTIONS EVEN IF THEY 858 00:28:21,553 --> 00:28:23,355 ARE NOT BEING ASKED FOR ASSENT. 859 00:28:23,355 --> 00:28:26,425 WE WANT TO ADDRESS THEIR 860 00:28:26,425 --> 00:28:27,793 QUESTIONS TO THE EXTENT THAT WE 861 00:28:27,793 --> 00:28:29,194 ARE ABLE TO DO SO. 862 00:28:29,194 --> 00:28:32,230 THIS CAN OBVIOUSLY GET REALLY 863 00:28:32,230 --> 00:28:32,431 HARD. 864 00:28:32,431 --> 00:28:35,100 A LOT OF TIMES WHETHER OR NOT 865 00:28:35,100 --> 00:28:37,235 SOMEBODY IS DISSENTING IS JUST 866 00:28:37,235 --> 00:28:38,103 NOT CLEAR. 867 00:28:38,103 --> 00:28:38,937 RIGHT? 868 00:28:38,937 --> 00:28:40,305 SOMETIMES IT IS. SOMETIMES 869 00:28:40,305 --> 00:28:42,708 SOMEBODY SAYS, NO. I DON'T WANT 870 00:28:42,708 --> 00:28:43,942 TO DO THIS ANYMORE. 871 00:28:43,942 --> 00:28:46,845 GET ME OUT OF HERE. THAT CAN BE 872 00:28:46,845 --> 00:28:48,246 RELATIVELY CLEAR AND OTHER CASES 873 00:28:48,246 --> 00:28:50,615 PARTICULARLY FOR PEOPLE WHO HAVE 874 00:28:50,615 --> 00:28:52,084 PROBLEMS WITH COMMUNICATION, 875 00:28:52,084 --> 00:28:53,752 PEOPLE WHO HAVE EXPRESSIVE 876 00:28:53,752 --> 00:28:55,053 PROBLEMS, IT CAN BE HARD. 877 00:28:55,053 --> 00:28:58,790 SO IF THEY ARE NOT ABLE TO 878 00:28:58,790 --> 00:29:01,026 COMMUNICATE CLEARLY WITH YOU BY 879 00:29:01,026 --> 00:29:02,794 LANGUAGE, THEY MIGHT BE PULLING 880 00:29:02,794 --> 00:29:04,329 AWAY AND ARE FROWNING AND DON'T 881 00:29:04,329 --> 00:29:05,797 LOOK LIKE THEY LIKE WHAT IS 882 00:29:05,797 --> 00:29:08,867 GOING ON AND IT CAN BE HARD AT 883 00:29:08,867 --> 00:29:11,837 LEAST IN SOME CASES TO FIGURE 884 00:29:11,837 --> 00:29:14,740 OUT WHETHER OR NOT THOSE ACTIONS 885 00:29:14,740 --> 00:29:19,344 OR EXPRESSIONS CONSTITUTE 886 00:29:19,344 --> 00:29:19,611 DISSENT. 887 00:29:19,611 --> 00:29:20,679 THIS WAS A CONSULT WE HAD A LONG 888 00:29:20,679 --> 00:29:23,715 TIME AGO NOW WHEN THERE WAS 889 00:29:23,715 --> 00:29:24,783 INPATIENT ALZHEIMER'S STUDY AND 890 00:29:24,783 --> 00:29:27,119 WAS A WOMAN HERE FOR A 891 00:29:27,119 --> 00:29:29,788 THREE-WEEK INPATIENT STUDY. 892 00:29:29,788 --> 00:29:31,223 AFTER ABOUT DAY 10, SHE STARTED 893 00:29:31,223 --> 00:29:35,260 TO SAY TO THE NURSES I WANT TO 894 00:29:35,260 --> 00:29:36,995 GO HOME. 895 00:29:36,995 --> 00:29:38,663 AND WE DID A CONSULT AND DID A 896 00:29:38,663 --> 00:29:40,899 NUMBER OF ASSESSMENTS AND HER 897 00:29:40,899 --> 00:29:43,802 HUSBAND GOT INVOLVED. 898 00:29:43,802 --> 00:29:45,037 WE COULDN'T FIGURE OUT EXACTLY 899 00:29:45,037 --> 00:29:48,206 WHAT WAS GOING ON OR WHETHER OR 900 00:29:48,206 --> 00:29:51,143 NOT THIS WAS AN EXPRESSION OF 901 00:29:51,143 --> 00:29:51,510 DISSENT. 902 00:29:51,510 --> 00:29:53,078 HOW DO YOU FIGURE THAT OUT? 903 00:29:53,078 --> 00:29:56,214 THERE IS TWO QUESTIONS YOU CAN 904 00:29:56,214 --> 00:29:57,616 ASK, WHETHER OR NOT 905 00:29:57,616 --> 00:29:58,817 COMMUNICATION OR EXPRESSION OR 906 00:29:58,817 --> 00:30:01,019 ACTION, WHETHER OR NOT IT IS 907 00:30:01,019 --> 00:30:02,788 FOCUSED ON THE STUDY ITSELF. 908 00:30:02,788 --> 00:30:04,790 I CAN TELL NEW THIS WOMAN'S CASE 909 00:30:04,790 --> 00:30:06,758 IT TURNED OUT NO THE TO BE 910 00:30:06,758 --> 00:30:08,293 WHENEVER SHE WAS HOME SHE SAID 911 00:30:08,293 --> 00:30:10,228 SHE WANTED TO GO HOME AS WELL 912 00:30:10,228 --> 00:30:12,831 AND JUST THAT SHE WASN'T 913 00:30:12,831 --> 00:30:13,765 COMFORTABLE WHEREVER SHE WAS. 914 00:30:13,765 --> 00:30:16,802 FOR HER, THOSE STATEMENTS 915 00:30:16,802 --> 00:30:17,836 WEREN'T AN EXPRESSION OF 916 00:30:17,836 --> 00:30:19,571 OBJECTIONS OR CONCERNS ABOUT THE 917 00:30:19,571 --> 00:30:21,206 STUDY BUT WAS CONCERNS ABOUT HER 918 00:30:21,206 --> 00:30:22,874 VERY UNFORTUNATE SITUATION. 919 00:30:22,874 --> 00:30:26,144 BUT SO WHAT WE WANT TO ASK IS, 920 00:30:26,144 --> 00:30:28,246 IS THE COMMUNICATION OR 921 00:30:28,246 --> 00:30:29,347 EXPRESSION OR ACTION INDICATING 922 00:30:29,347 --> 00:30:30,916 SOMETHING ABOUT THEY DON'T WANT 923 00:30:30,916 --> 00:30:32,350 TO BE IN THE STUDY? 924 00:30:32,350 --> 00:30:36,054 IT IS ABOUT THE STUDY OR JUST 925 00:30:36,054 --> 00:30:36,688 THEY ARE EXPERIENCING DISTRESS 926 00:30:36,688 --> 00:30:38,857 OR ANXIETY OR SOME OTHER 927 00:30:38,857 --> 00:30:40,926 AVERSIVE EMOTIONS AS A RESULT OF 928 00:30:40,926 --> 00:30:43,161 BEING IN A STUDY AND THINK THOSE 929 00:30:43,161 --> 00:30:45,130 ARE THE QUESTIONS TO ASK IN 930 00:30:45,130 --> 00:30:49,201 TRYING TO DO THESE 931 00:30:49,201 --> 00:30:52,237 INTERPRETATIONS. 932 00:30:52,237 --> 00:30:54,473 HERE IS A SUMMARY OF THAT. 933 00:30:54,473 --> 00:30:55,807 OBVIOUSLY WHAT WE FOUND IS TRUE 934 00:30:55,807 --> 00:30:58,110 IN LOTS OF CASES AND WHAT WE DID 935 00:30:58,110 --> 00:31:00,312 IN THAT CASE AS I MENTIONED WE 936 00:31:00,312 --> 00:31:01,746 CALLED IN THE HUSBAND AND AT 937 00:31:01,746 --> 00:31:03,181 LEAST PEOPLE WHO HAVE EXPERIENCE 938 00:31:03,181 --> 00:31:05,817 WITH THESE INDIVIDUALS SOMETIMES 939 00:31:05,817 --> 00:31:07,352 CAN TELL YOU WHAT ARE THEY 940 00:31:07,352 --> 00:31:09,421 TRYING TO EXPRESS? IS THIS A 941 00:31:09,421 --> 00:31:11,156 BASELINE FROWN THEY HAVE OR IS 942 00:31:11,156 --> 00:31:12,190 IT SOMETHING THAT IS PARTICULAR 943 00:31:12,190 --> 00:31:17,195 TO WHAT IS GOING ON WITH THEM 944 00:31:17,195 --> 00:31:21,800 NOW? 945 00:31:21,800 --> 00:31:23,835 ONE THING THAT I THINK IS 946 00:31:23,835 --> 00:31:26,037 IMPORTANT IS THAT WE WANT TO 947 00:31:26,037 --> 00:31:29,207 SOLICIT ASSENT AND WE ALSO WANT 948 00:31:29,207 --> 00:31:31,510 TO RESPECT DISSENT. LIKE I 949 00:31:31,510 --> 00:31:33,879 SAID, IF SOMEBODY SAYS, YEAH, 950 00:31:33,879 --> 00:31:35,080 MAN. YOU DON'T TAKE THAT 951 00:31:35,080 --> 00:31:36,548 FOREVER AS A DECISION AND YOU 952 00:31:36,548 --> 00:31:38,550 DISCUSS IT WITH THEM AND IF THEY 953 00:31:38,550 --> 00:31:39,885 CHANGE THEIR MIND THEY GET TO 954 00:31:39,885 --> 00:31:41,586 CHANGE THEIR MIND. 955 00:31:41,586 --> 00:31:43,321 SIMILARLY WITH DISSENT, WHILE WE 956 00:31:43,321 --> 00:31:46,491 WANT TO RESPECT DISSENT AND 957 00:31:46,491 --> 00:31:47,726 OBVIOUSLY DON'T WANT TO BULLY 958 00:31:47,726 --> 00:31:49,494 PEOPLE OR TRY TO NUDGE THEM INTO 959 00:31:49,494 --> 00:31:51,863 STAYING IN A STUDY, IT IS ALSO 960 00:31:51,863 --> 00:31:53,832 TRUE THAT I DON'T THINK 961 00:31:53,832 --> 00:31:55,267 RESPECTING DISSENT REQUIRES THAT 962 00:31:55,267 --> 00:31:57,269 THE INSTANT THAT YOU GET A CLEAR 963 00:31:57,269 --> 00:31:58,970 EXPRESSION OF DISSENT YOU NEED 964 00:31:58,970 --> 00:32:00,705 TO REMOVE THE PERSON FROM THE 965 00:32:00,705 --> 00:32:02,908 STUDY OR NOT ENROLL THEM IF A 966 00:32:02,908 --> 00:32:04,843 QUESTION OF INITIAL ENROLLMENT 967 00:32:04,843 --> 00:32:06,278 AND INSTEAD I THINK YOU GO 968 00:32:06,278 --> 00:32:08,146 THROUGH A PROCESS OF STOPPING, 969 00:32:08,146 --> 00:32:09,447 ASSESSING OR TRYING TO ADDRESS 970 00:32:09,447 --> 00:32:10,949 IT AND STOP WHAT IS GOING ON AND 971 00:32:10,949 --> 00:32:12,484 SEE IF YOU CAN FIGURE OUT WHAT 972 00:32:12,484 --> 00:32:13,952 THE -- IF THERE IS A CONCERN AND 973 00:32:13,952 --> 00:32:16,221 IF THERE IS A CONCERN WHAT THE 974 00:32:16,221 --> 00:32:19,391 CONCERN IS WITH RESPECT TO. 975 00:32:19,391 --> 00:32:21,026 THEN IF IT CAN BE IDENTIFIED, 976 00:32:21,026 --> 00:32:23,061 FIGURE OUT IF THERE ARE WAYS TO 977 00:32:23,061 --> 00:32:25,463 ADDRESS IT AND PUT OFF THE MRI 978 00:32:25,463 --> 00:32:27,165 SCAN FOR AN HOUR OR GIVE THEM 979 00:32:27,165 --> 00:32:29,234 MORE TIME TO THINK ABOUT IT OR 980 00:32:29,234 --> 00:32:30,835 GIVE THEM MORE EXPLANATION OR 981 00:32:30,835 --> 00:32:31,703 WHATEVER IT MIGHT BE. 982 00:32:31,703 --> 00:32:33,838 AND I THINK THAT IF THAT CAN BE 983 00:32:33,838 --> 00:32:35,273 DONE SUCCESSFULLY WHERE IT IS NO 984 00:32:35,273 --> 00:32:37,175 THE JUST A MATTER OF PUSHING 985 00:32:37,175 --> 00:32:39,844 THEM OR FORCING THEM TO GO AHEAD 986 00:32:39,844 --> 00:32:42,647 AND INSTEAD ACTUALLY ADDRESSING 987 00:32:42,647 --> 00:32:44,216 AND REMOVING THE CONCERN THEN 988 00:32:44,216 --> 00:32:47,419 THE INDIVIDUAL CAN CONTINUE TO 989 00:32:47,419 --> 00:32:47,752 PARTICIPATE. 990 00:32:47,752 --> 00:32:49,955 NOW IF AN INDIVIDUAL OBVIOUSLY 991 00:32:49,955 --> 00:32:52,457 CONTINUES TO DISSENT THEY SHOULD 992 00:32:52,457 --> 00:32:53,725 BE WITHDRAWN AND ONE EXCEPTION 993 00:32:53,725 --> 00:32:56,328 IS AT LEAST IN SOME CASES NO THE 994 00:32:56,328 --> 00:32:58,630 EVERY ASPECT OF OUR PROTOCOL IS 995 00:32:58,630 --> 00:32:59,631 ABSOLUTELY NECESSARY AND MIGHT 996 00:32:59,631 --> 00:33:02,400 BE AN MRI FOR SOME SECONDARY 997 00:33:02,400 --> 00:33:04,269 OUTCOME THAT INVESTIGATORS ARE 998 00:33:04,269 --> 00:33:05,136 LOOKING AT BUT MAYBE DOESN'T 999 00:33:05,136 --> 00:33:08,840 HAVE TO BE DONE IN EVERY SINGLE 1000 00:33:08,840 --> 00:33:09,107 SUBJECT. 1001 00:33:09,107 --> 00:33:11,743 MAYBE IN SOME CASES YOU CAN ASK 1002 00:33:11,743 --> 00:33:12,744 OKAY. WE UNDERSTAND THEY DON'T 1003 00:33:12,744 --> 00:33:16,581 LIKE THE MRI AND DO WE NEED THE 1004 00:33:16,581 --> 00:33:18,550 MRI IN THIS PERSON AND CAN WE 1005 00:33:18,550 --> 00:33:21,052 SKIP IT OR DROP IT AND IF SO 1006 00:33:21,052 --> 00:33:21,953 CONTINUE IN PROTOCOL AND IF NOT 1007 00:33:21,953 --> 00:33:24,155 PERSON IS GOING TO NEED TO BE 1008 00:33:24,155 --> 00:33:24,456 WITHDRAWN. 1009 00:33:24,456 --> 00:33:26,391 ALL RIGHT. THAT IS ALL I HAVE 1010 00:33:26,391 --> 00:33:30,328 FOR TODAY. JUST IN SUMMARY 1011 00:33:30,328 --> 00:33:31,596 IMPORTANT POINTS I THINK 1012 00:33:31,596 --> 00:33:33,832 DECISIONAL CAPACITY IS A MATTER 1013 00:33:33,832 --> 00:33:36,201 OF DEGREE AND OBTAINING ASSENT 1014 00:33:36,201 --> 00:33:38,103 OF ADULTS THAT HAVE CAPACITY TO 1015 00:33:38,103 --> 00:33:40,405 ASSENT IN TERMS OF GIVING 1016 00:33:40,405 --> 00:33:41,706 AFFIRMATIVE AGREEMENT SHOWS 1017 00:33:41,706 --> 00:33:45,043 RESPECT FOR THEIR REMAINING 1018 00:33:45,043 --> 00:33:46,945 CAPACITIES AND WHAT I WAS 1019 00:33:46,945 --> 00:33:48,480 ARGUING IS THAT WHETHER OR NOT 1020 00:33:48,480 --> 00:33:51,950 SOMEBODY HAS THE CAPACITY TO 1021 00:33:51,950 --> 00:33:53,018 ASSENT DEPENDS UPON THE FACT 1022 00:33:53,018 --> 00:33:55,520 THAT EVEN THOUGH THEY CAN'T 1023 00:33:55,520 --> 00:33:57,155 CONSENT CAN THEY NONETHELESS 1024 00:33:57,155 --> 00:33:58,590 UNDERSTAND WHAT I'M CALLING 1025 00:33:58,590 --> 00:34:00,725 BASIC ELEMENTS OF THE STUDY IN 1026 00:34:00,725 --> 00:34:01,159 QUESTION. 1027 00:34:01,159 --> 00:34:02,827 THEY CAN UNDERSTAND THE STUDY AT 1028 00:34:02,827 --> 00:34:05,230 A BASIC LEVEL. IF THEY CAN, IN 1029 00:34:05,230 --> 00:34:07,532 MY VIEW, THEY ARE ABLE TO 1030 00:34:07,532 --> 00:34:07,966 ASSENT. 1031 00:34:07,966 --> 00:34:09,167 IF THEY CAN'T UNDERSTAND EVEN 1032 00:34:09,167 --> 00:34:11,903 THOSE THINGS, THEN THEY ARE NOT 1033 00:34:11,903 --> 00:34:14,172 CAPABLE OF ASSENT AND PROVIDING 1034 00:34:14,172 --> 00:34:16,141 INFORMATION NOT JUST TO PEOPLE 1035 00:34:16,141 --> 00:34:17,542 THAT ARE CAPABLE OF ASSENT TO 1036 00:34:17,542 --> 00:34:19,110 EVERYBODY IN A WAY THAT THEY CAN 1037 00:34:19,110 --> 00:34:21,379 UNDERSTAND AND ALSO RESPECTING 1038 00:34:21,379 --> 00:34:24,816 DISSENT OF ALL INDIVIDUALS HELPS 1039 00:34:24,816 --> 00:34:25,483 TO PROTECT THEM FROM SIGNIFICANT 1040 00:34:25,483 --> 00:34:27,185 DISTRESS AND HELPS TO ENSURE 1041 00:34:27,185 --> 00:34:29,921 THAT WE ARE NOT DOING RESEARCH 1042 00:34:29,921 --> 00:34:31,756 THAT GOES OVER ACCEPTABLE RISK 1043 00:34:31,756 --> 00:34:33,491 LEVELS WITH ADULTS THAT ARE 1044 00:34:33,491 --> 00:34:35,627 UNABLE TO CONSENT OR EVEN UNABLE 1045 00:34:35,627 --> 00:34:36,961 TO ASSENT. 1046 00:34:36,961 --> 00:34:39,264 ALL RIGHT. SO THANK YOU. I 1047 00:34:39,264 --> 00:34:41,099 LOOK FORWARD TO ANY QUESTIONS 1048 00:34:41,099 --> 00:34:43,568 YOU HAVE. I WILL -- I THINK I 1049 00:34:43,568 --> 00:34:46,738 WILL STOP SHARING HERE. 1050 00:34:46,738 --> 00:34:48,907 >> OKAY. 1051 00:34:48,907 --> 00:34:50,742 PLEASE IF YOU HAVE QUESTIONS GO 1052 00:34:50,742 --> 00:34:52,711 AHEAD AND SUBMIT THEM CLICKING 1053 00:34:52,711 --> 00:34:55,246 ON BOX IN VIDEO SAYING LIVE 1054 00:34:55,246 --> 00:34:56,848 FEEDBACK LINK AND WE WILL BRING 1055 00:34:56,848 --> 00:34:58,383 THEM UP AND I HAVE ONE GENERAL 1056 00:34:58,383 --> 00:35:00,218 QUESTION IN TERMS OF -- I KNOW 1057 00:35:00,218 --> 00:35:01,886 YOU SERVED ON A NUMBER OF IRBS 1058 00:35:01,886 --> 00:35:03,855 AND WHEN THINGS COME UP WITH 1059 00:35:03,855 --> 00:35:06,091 REGARD TO MENTAL HEALTH RESEARCH 1060 00:35:06,091 --> 00:35:07,826 WHERE THERE IS EVEN AN 1061 00:35:07,826 --> 00:35:09,160 ANTICIPATION OF WAXING AND 1062 00:35:09,160 --> 00:35:11,863 WANING CAPACITY DUE TO CHANGES 1063 00:35:11,863 --> 00:35:12,330 IN MEDICATIONS. 1064 00:35:12,330 --> 00:35:12,731 >> YEAH. 1065 00:35:12,731 --> 00:35:14,766 >> HOW SHOULD THAT BE APPROACHED 1066 00:35:14,766 --> 00:35:17,001 AND WOULD YOU ADVISE? 1067 00:35:17,001 --> 00:35:19,037 >> YEAH. I THINK THAT IS REALLY 1068 00:35:19,037 --> 00:35:19,504 HARD. 1069 00:35:19,504 --> 00:35:21,473 SO I DON'T KNOW IF PEOPLE ARE 1070 00:35:21,473 --> 00:35:21,840 FAMILIAR. 1071 00:35:21,840 --> 00:35:25,243 SO I THINK THERE MIGHT BE 1072 00:35:25,243 --> 00:35:30,382 CHANGES TO THIS PROGRAM 1073 00:35:30,382 --> 00:35:32,016 INTRAMURAL MENTAL HEALTH FOR A 1074 00:35:32,016 --> 00:35:34,586 LONG TIME GOING BACK TO DAYS OF 1075 00:35:34,586 --> 00:35:35,620 [INDISCERNIBLE] PEOPLE MIGHT 1076 00:35:35,620 --> 00:35:37,255 REMEMBER HAVE HUMAN SUBJECTS 1077 00:35:37,255 --> 00:35:38,423 PROTECTION UNIT AND ONE THING 1078 00:35:38,423 --> 00:35:40,692 THAT UNIT DOES IS IT IS ASSIGNED 1079 00:35:40,692 --> 00:35:41,693 TO INDIVIDUALS AND INDIVIDUALS 1080 00:35:41,693 --> 00:35:45,296 THAT WOULD BE IN THIS CATEGORY 1081 00:35:45,296 --> 00:35:46,998 AND THEY MONITOR THEM OVER TIME 1082 00:35:46,998 --> 00:35:48,433 AND ADVANTAGE IS THERE AND YOU 1083 00:35:48,433 --> 00:35:49,901 GET SOMEBODY WHO REALLY KNOWS 1084 00:35:49,901 --> 00:35:51,603 THE PERSON AND STAYS WITH THE 1085 00:35:51,603 --> 00:35:54,539 PERSON OVER TIME AND THEN ON A 1086 00:35:54,539 --> 00:35:56,374 REGULAR BASIS CAN ASSESS THEIR 1087 00:35:56,374 --> 00:35:57,275 CAPACITY AND HOW THEY ARE DOG 1088 00:35:57,275 --> 00:35:59,077 AND WHETHER THEY ARE OKAY NOW 1089 00:35:59,077 --> 00:36:01,246 AND WHETHER THEY ARE NOT OKAY 1090 00:36:01,246 --> 00:36:01,579 NOW. 1091 00:36:01,579 --> 00:36:04,749 AND SO THAT IS IN REAL-TIME. 1092 00:36:04,749 --> 00:36:06,217 IF YOU CAN ANTICIPATE THAT I 1093 00:36:06,217 --> 00:36:07,919 THINK IT IS REALLY IMPORTANT TO 1094 00:36:07,919 --> 00:36:10,855 TRY TO HAVE IN PLACE A 1095 00:36:10,855 --> 00:36:11,289 SURROGATE. 1096 00:36:11,289 --> 00:36:12,991 FOR INSTANCE, IDEALLY TALKING TO 1097 00:36:12,991 --> 00:36:14,659 THESE PEOPLE AHEAD OF TIME AND 1098 00:36:14,659 --> 00:36:16,861 IT IS EXPECTED AND YOU WILL GET 1099 00:36:16,861 --> 00:36:18,563 HIGH DOSE STEROIDS AND THERE IS 1100 00:36:18,563 --> 00:36:20,665 LIKELY A CHANCE THAT YOU WILL 1101 00:36:20,665 --> 00:36:21,733 HAVE COGNITIVE EFFECTS FOR A 1102 00:36:21,733 --> 00:36:23,334 COUPLE OF DAYS AND WE ARE 1103 00:36:23,334 --> 00:36:25,236 WORRIED YOU MIGHT NOT BE IN A 1104 00:36:25,236 --> 00:36:26,771 POSITION TO MAKE DECISIONS FOR 1105 00:36:26,771 --> 00:36:29,240 YOURSELF AND TALK TO THAT PERSON 1106 00:36:29,240 --> 00:36:31,643 THROUGH THE PROCESS OF FILLING 1107 00:36:31,643 --> 00:36:33,545 OUT AN ADVANCED DIRECTIVE NAMING 1108 00:36:33,545 --> 00:36:35,513 SOMEBODY THAT WOULD BE THEIR 1109 00:36:35,513 --> 00:36:36,147 SURROGATE FOR THE TIME WHERE 1110 00:36:36,147 --> 00:36:37,949 THEY ARE NOT ABLE TO CONSENT 1111 00:36:37,949 --> 00:36:41,820 UNTIL THAT CAPACITY COMES BACK. 1112 00:36:41,820 --> 00:36:43,922 HOPEFULLY PEOPLE KNOW THAT WE 1113 00:36:43,922 --> 00:36:45,256 RESPECT ADVANCED DIRECTIVES THAT 1114 00:36:45,256 --> 00:36:46,357 PEOPLE BRING WITH THEM FROM 1115 00:36:46,357 --> 00:36:47,559 OTHER STATES. 1116 00:36:47,559 --> 00:36:49,928 WE ALSO HAVE OUR OWN ADVANCED 1117 00:36:49,928 --> 00:36:51,930 DIRECTIVES AND YOU COULD ALSO 1118 00:36:51,930 --> 00:36:53,231 ALWAYS HAVE SOMEBODY FILL OUT 1119 00:36:53,231 --> 00:36:59,037 ONE OF OURS AND ONE ADVANTAGE OF 1120 00:36:59,037 --> 00:37:00,772 FORM UNLIKE MOST STATE FORMS IS 1121 00:37:00,772 --> 00:37:02,941 WE HAVE AN EXPLICIT SECTION 1122 00:37:02,941 --> 00:37:04,509 DEVOTED TO RESEARCH PREFERENCES 1123 00:37:04,509 --> 00:37:06,144 AND NOT ONLY CAN A PERSON 1124 00:37:06,144 --> 00:37:08,246 IDENTIFY A SURROGATE BUT THERE 1125 00:37:08,246 --> 00:37:11,049 IS A SECOND BOX THEY CAN DO AN 1126 00:37:11,049 --> 00:37:12,917 ALTERNATE OR SECOND SURRO GATE 1127 00:37:12,917 --> 00:37:14,486 AND IS A SECTION ALSO IF THEY 1128 00:37:14,486 --> 00:37:16,521 HAVE SPECIFIC VIEWS ABOUT 1129 00:37:16,521 --> 00:37:17,288 RESEARCH PARTICIPATION AND 1130 00:37:17,288 --> 00:37:18,523 THINGS THEY WOULD BE WILLING OR 1131 00:37:18,523 --> 00:37:20,925 NOT WILLING TO DO AND IF THEY 1132 00:37:20,925 --> 00:37:21,893 COULDN'T CONCEPT THEY COULD 1133 00:37:21,893 --> 00:37:22,760 DESCRIBE THOSE PREFERENCES AS 1134 00:37:22,760 --> 00:37:23,995 WELL AND THINK IT IS A 1135 00:37:23,995 --> 00:37:27,465 COMBINATION OF TRYING TO 1136 00:37:27,465 --> 00:37:29,901 ANTICIPATE AND GET A POTENTIAL 1137 00:37:29,901 --> 00:37:32,604 SURROGATE IN PLACE AHEAD OF TIME 1138 00:37:32,604 --> 00:37:35,206 AND REASONABLE REGULAR 1139 00:37:35,206 --> 00:37:35,940 MONITORING OF THE INDIVIDUAL 1140 00:37:35,940 --> 00:37:37,709 OVER THE COURSE OF THE STUDY TO 1141 00:37:37,709 --> 00:37:39,177 SEE WHETHER OR NOT THEY REALLY 1142 00:37:39,177 --> 00:37:40,578 DO LOSE CAPACITY. 1143 00:37:40,578 --> 00:37:42,380 IF THEY DO, HOPEFULLY THERE IS 1144 00:37:42,380 --> 00:37:45,183 SOME RELIABLE PROCESS IN PLACE 1145 00:37:45,183 --> 00:37:47,285 FOR GETTING THAT SURROGATE 1146 00:37:47,285 --> 00:37:49,254 INVOLVED EITHER VIRTUALLY OR 1147 00:37:49,254 --> 00:37:51,956 GETTING THEM HERE IN PERSON. 1148 00:37:51,956 --> 00:37:55,460 >> OKAY. WE HAVE A QUESTION 1149 00:37:55,460 --> 00:37:55,660 HERE. 1150 00:37:55,660 --> 00:37:56,261 IF A [INDISCERNIBLE] BOTH 1151 00:37:56,261 --> 00:37:57,962 CHILDREN AND ADULTS THAT CAN'T 1152 00:37:57,962 --> 00:38:00,164 CONSENT THEMSELVES, DO YOU THINK 1153 00:38:00,164 --> 00:38:02,600 IT IS APPROPRIATE TO USE THE 1154 00:38:02,600 --> 00:38:04,569 SAME ASSENT FORM FOR BOTH 1155 00:38:04,569 --> 00:38:05,937 COHORTS AND SHOULD THEY BE 1156 00:38:05,937 --> 00:38:06,738 WRITTEN FOR CHILDREN AND 1157 00:38:06,738 --> 00:38:08,806 SEPARATE ONE FOR ADULTS AND IF 1158 00:38:08,806 --> 00:38:16,781 THE LATTER, WHAT DO YOU THINK 1159 00:38:16,781 --> 00:38:17,415 SHOULD DIFFER BETWEEN THEM? 1160 00:38:17,415 --> 00:38:19,751 >> SO IT IS A GOOD QUESTION. 1161 00:38:19,751 --> 00:38:21,920 THE FIRST THING I WILL SAY IS I 1162 00:38:21,920 --> 00:38:23,755 WILL GIVE THE TYPICAL 1163 00:38:23,755 --> 00:38:24,422 PHILOSOPHICAL ANSWER WHICH IS 1164 00:38:24,422 --> 00:38:25,690 THAT IT DEPENDS. 1165 00:38:25,690 --> 00:38:28,293 I THINK IT DEPENDS ON -- SO WE 1166 00:38:28,293 --> 00:38:30,895 WERE JUST TALKING ABOUT WHICH 1167 00:38:30,895 --> 00:38:35,066 ADULTS ARE CAPABLE OF GIVING 1168 00:38:35,066 --> 00:38:36,334 ASSENT AND NOT SURPRISINGLY 1169 00:38:36,334 --> 00:38:38,369 PEOPLE MIGHT KNOW ABOUT THIS. 1170 00:38:38,369 --> 00:38:41,105 THERE IS A LOT OF DEBATE OVER 1171 00:38:41,105 --> 00:38:42,707 WHICH MINORS ARE CAPABLE OF 1172 00:38:42,707 --> 00:38:45,176 GIVING ASSENT. 1173 00:38:45,176 --> 00:38:47,512 HERE, THERE IS JUST 1174 00:38:47,512 --> 00:38:49,080 EXTRAORDINARILY BROAD RANGE. I 1175 00:38:49,080 --> 00:38:50,682 KNOW PEOPLE THAT WORK IN 1176 00:38:50,682 --> 00:38:52,350 PEDIATRIC RESEARCH ETHICS AND 1177 00:38:52,350 --> 00:38:54,519 PEOPLE I RESPECT AND WHO ARE 1178 00:38:54,519 --> 00:38:56,220 SMART AND HAVE DONE IT A LONG 1179 00:38:56,220 --> 00:38:58,323 TIME AND THINK 3 AND FOUR YEAR 1180 00:38:58,323 --> 00:39:00,491 OLDS ARE CAPABLE OF ASSENT TO 1181 00:39:00,491 --> 00:39:01,059 RESEARCH PARTICIPATION. 1182 00:39:01,059 --> 00:39:03,294 I ALSO KNOW PEOPLE WHO ARE 1183 00:39:03,294 --> 00:39:05,096 REALLY SMART AND DONE THIS A 1184 00:39:05,096 --> 00:39:06,965 LONG TIME AND DON'T THINK 17 1185 00:39:06,965 --> 00:39:09,467 YEAR OLDS CAN GIVE ASSENT TO 1186 00:39:09,467 --> 00:39:10,034 RESEARCH PARTICIPATION. 1187 00:39:10,034 --> 00:39:12,870 SO MY ANSWER TO THE QUESTION IS 1188 00:39:12,870 --> 00:39:14,305 IT DEPENDS WHERE YOU FALL WITHIN 1189 00:39:14,305 --> 00:39:16,541 THAT RANGE AND WILL GIVE YOU MY 1190 00:39:16,541 --> 00:39:18,409 PERSONAL VIEW THAT WE CAN TALK 1191 00:39:18,409 --> 00:39:19,477 ABOUT MAYBE SOME OTHER TIME IF 1192 00:39:19,477 --> 00:39:20,645 PEOPLE ARE INTERESTED. 1193 00:39:20,645 --> 00:39:24,015 I THINK THAT FOR THE MOST PART 1194 00:39:24,015 --> 00:39:26,417 THAT MOST PEOPLE BECOME CAPABLE 1195 00:39:26,417 --> 00:39:28,419 OF ASSENT SOMETIME AROUND 13 OR 1196 00:39:28,419 --> 00:39:29,387 SOMETHING LIKE THAT AND BETWEEN 1197 00:39:29,387 --> 00:39:32,023 12 AND 14 AND UP TO 14. 1198 00:39:32,023 --> 00:39:33,925 SO ON THAT VIEW, THEN I THINK 1199 00:39:33,925 --> 00:39:35,493 THAT YOU SHOULD BASICALLY USE 1200 00:39:35,493 --> 00:39:36,227 THE SAME FORM. 1201 00:39:36,227 --> 00:39:39,163 I THINK THAT YOU ARE AT THE 1202 00:39:39,163 --> 00:39:44,268 POINT WHERE FOR MOST KIDS THEY 1203 00:39:44,268 --> 00:39:45,203 WILL BE ABLE TO UNDERSTAND SAME 1204 00:39:45,203 --> 00:39:47,939 THING ADULTS CAN UNDERSTAND AND 1205 00:39:47,939 --> 00:39:49,674 LOTS OF CASES CAN YOU USE THE 1206 00:39:49,674 --> 00:39:50,408 SAME FORP. 1207 00:39:50,408 --> 00:39:52,610 I THINK IF YOU HAVE A VIEW THAT 1208 00:39:52,610 --> 00:39:54,379 FOUR YEAR OLDS CAN GIVE ASSENT, 1209 00:39:54,379 --> 00:39:56,481 I THINK YOU HAVE TO HAVE IT 1210 00:39:56,481 --> 00:39:57,515 POSSIBLY A DIFFERENT VIEW AND 1211 00:39:57,515 --> 00:39:59,417 DON'T KNOW WHAT AN ASSENT FORM 1212 00:39:59,417 --> 00:40:01,619 WOULD LOOK LIKE FOR A 3 OR 4 1213 00:40:01,619 --> 00:40:03,187 YEAR OLD AND NOT SURE EVEN AND 1214 00:40:03,187 --> 00:40:05,156 DON'T THINK THEY COULD GIVE 1215 00:40:05,156 --> 00:40:06,257 ASSENT. I WOULDN'T DO IT IF YOU 1216 00:40:06,257 --> 00:40:07,925 HAVE THAT VIEW YOU WOULD HAVE A 1217 00:40:07,925 --> 00:40:09,861 DIFFERENT ONE AND IF TAKING MY 1218 00:40:09,861 --> 00:40:11,896 VIEW THAT SOMETHING LIKE 13 OR 1219 00:40:11,896 --> 00:40:14,365 14 IS AGE AT WHICH MOST KIDS ARE 1220 00:40:14,365 --> 00:40:17,135 ABLE TO ASSENT IT IS REASONABLE 1221 00:40:17,135 --> 00:40:19,270 TO THINK THAT THAT FORM SHOULD 1222 00:40:19,270 --> 00:40:21,239 INCLUDE WHAT I'M DESCRIBING AS 1223 00:40:21,239 --> 00:40:23,174 BASIC ELEMENTS BOTH FOR 14 YEAR 1224 00:40:23,174 --> 00:40:25,777 OLD AND ADULTS AND DON'T SEE 1225 00:40:25,777 --> 00:40:26,978 REASON YOU COULDN'T USE SAME 1226 00:40:26,978 --> 00:40:28,746 FORM AND INTERESTED IF QUESTION 1227 00:40:28,746 --> 00:40:32,016 OR ANYBODY ELSE HAD A DIFFERENT 1228 00:40:32,016 --> 00:40:35,153 THOUGHT ON THAT. 1229 00:40:35,153 --> 00:40:36,754 >> OKAY. ANOTHER QUESTION HERE. 1230 00:40:36,754 --> 00:40:39,524 DO AGREE IN SITUATIONS WHERE 1231 00:40:39,524 --> 00:40:41,693 DISSENT OR WITHDRAWAL OF ASSENT 1232 00:40:41,693 --> 00:40:42,960 MAY EMERGE AND SHOULD BE MORE 1233 00:40:42,960 --> 00:40:44,896 THAN ONE INDIVIDUAL INVOLVED IN 1234 00:40:44,896 --> 00:40:46,831 NEGOTIATING TO UNDERSTAND AND 1235 00:40:46,831 --> 00:40:49,801 ASSESS AND ADDRESS AND PROTECT 1236 00:40:49,801 --> 00:40:53,137 PARTICIPANTS FROM UNDUE PRESSURE 1237 00:40:53,137 --> 00:40:54,372 TO STAY ON AND WITHDRAWAL FROM 1238 00:40:54,372 --> 00:40:56,708 CONSENT AS WELL AND EQUALLY 1239 00:40:56,708 --> 00:40:58,443 PARTICIPANT SHOULD BE ABLE TO 1240 00:40:58,443 --> 00:40:59,644 HAVE SOMEONE ELSE INDEPENDENT 1241 00:40:59,644 --> 00:41:02,680 THAT IS VOFRED FOR THE SAME 1242 00:41:02,680 --> 00:41:03,181 REASON. 1243 00:41:03,181 --> 00:41:04,282 >> YES. ABSOLUTELY. 1244 00:41:04,282 --> 00:41:05,917 PARTICULARLY. SO ONE WORD I 1245 00:41:05,917 --> 00:41:07,819 HAVE WHEN I GIVE TALKS LIKE THIS 1246 00:41:07,819 --> 00:41:09,554 AND RESPONSE I WILL GET IS WHAT 1247 00:41:09,554 --> 00:41:12,123 I SAY AS I SAID IS THAT YOU 1248 00:41:12,123 --> 00:41:13,758 DON'T NEED TO WITHDRAW SOMEBODY 1249 00:41:13,758 --> 00:41:16,227 AT THE FIRST SIGN OF DISSENT. 1250 00:41:16,227 --> 00:41:17,662 YOU SHOULD STOP AND SHOULD 1251 00:41:17,662 --> 00:41:19,831 ASSESS IT AND TRY TO ADDRESS IT. 1252 00:41:19,831 --> 00:41:22,500 WORRY I THINK IS THIS PERSON IS 1253 00:41:22,500 --> 00:41:24,402 RIGHTLY POINTING OUT IS IN 1254 00:41:24,402 --> 00:41:25,703 IMPLEMENTATION THAT MIGHT TURN 1255 00:41:25,703 --> 00:41:28,072 INTO A PROCESS OF TRYING TO 1256 00:41:28,072 --> 00:41:29,373 PRESSURE OR BULLY THE PERSON 1257 00:41:29,373 --> 00:41:32,343 INTO RATHER THAN ADDRESSING 1258 00:41:32,343 --> 00:41:33,745 THEIR CONCERNS JUST SIMPLY 1259 00:41:33,745 --> 00:41:35,413 BULLYING THEM INTO STAYING IN 1260 00:41:35,413 --> 00:41:37,648 THE STUDY AND WITHDRAWING THEIR 1261 00:41:37,648 --> 00:41:39,183 DISSENT AND THAT IS REALLY BAD 1262 00:41:39,183 --> 00:41:40,685 AND TO ADDRESS THAT WE NEED TO 1263 00:41:40,685 --> 00:41:43,421 MAKE SURE THAT WE HAVE IN PLACE 1264 00:41:43,421 --> 00:41:45,690 PROTECTIONS FOR THE INDIVIDUAL. 1265 00:41:45,690 --> 00:41:47,291 I THINK FOR THE MOST PART IT IS 1266 00:41:47,291 --> 00:41:50,228 HARD FOR ME TO SEE WHY THAT 1267 00:41:50,228 --> 00:41:51,429 ASSESSMENT IN ALL OF THOSE 1268 00:41:51,429 --> 00:41:52,997 DISCUSSIONS SHOULD BE CONDUCTED 1269 00:41:52,997 --> 00:41:55,233 AND MAYBE THEY ARE EXCEPTIONAL 1270 00:41:55,233 --> 00:41:55,600 CIRCUMSTANCES. 1271 00:41:55,600 --> 00:41:57,168 FOR THE MOST PART, IT IS REALLY 1272 00:41:57,168 --> 00:42:00,404 HARD TO SEE WHY IT WOULD MAKE 1273 00:42:00,404 --> 00:42:01,973 SENSE FOR JUST ONE PERSON TO BE 1274 00:42:01,973 --> 00:42:03,574 DOING THAT AND THINK YOU NEED TO 1275 00:42:03,574 --> 00:42:05,076 HAVE MORE THAN ONE PERSON 1276 00:42:05,076 --> 00:42:05,343 INVOLVED. 1277 00:42:05,343 --> 00:42:06,811 WHEN I HAVE DISCUSSIONS LIKE 1278 00:42:06,811 --> 00:42:08,679 THIS, WHAT I WILL OFTEN DO IS WE 1279 00:42:08,679 --> 00:42:10,815 -- WELL, I TYPICALLY TAKE A 1280 00:42:10,815 --> 00:42:12,150 FELLOW WITH ME AND I WILL ALSO 1281 00:42:12,150 --> 00:42:15,153 ASK ONE OF THE CARE TEAMS. 1282 00:42:15,153 --> 00:42:16,687 FOR INSTANCE A FLOOR NURSE OR 1283 00:42:16,687 --> 00:42:17,522 SOCIAL WORKER WHO IS NOT 1284 00:42:17,522 --> 00:42:20,158 INVOLVED IN THE PROTOCOL AND ARE 1285 00:42:20,158 --> 00:42:22,193 INDEPENDENT OF THE PROTOCOL AND 1286 00:42:22,193 --> 00:42:23,161 HOPEFULLY THEY HAVE A 1287 00:42:23,161 --> 00:42:24,295 RELATIONSHIP WITH THE PERSON TO 1288 00:42:24,295 --> 00:42:29,233 GO INTO THE ROOM WITH ME. 1289 00:42:29,233 --> 00:42:34,972 >> OKAY. SO THE PEDIATRIC 1290 00:42:34,972 --> 00:42:36,174 REGULATIONS GIVEN EXCEPTION FOR 1291 00:42:36,174 --> 00:42:38,442 REQUIREMENT FOR ASSENT WHEN 1292 00:42:38,442 --> 00:42:39,644 POTENTIAL DIRECT BENEFIT AND 1293 00:42:39,644 --> 00:42:40,778 INTERVENTION IS ONLY AVAILABLE 1294 00:42:40,778 --> 00:42:42,280 IN A RESEARCH SETTING. 1295 00:42:42,280 --> 00:42:42,847 >> RIGHT. 1296 00:42:42,847 --> 00:42:44,882 >> HOW DO YOU FEEL WITH ADULTS 1297 00:42:44,882 --> 00:42:50,721 AND LACK OF CAPACITY TO CONSENT? 1298 00:42:50,721 --> 00:42:55,293 >> SO I THINK THAT -- I THINK IN 1299 00:42:55,293 --> 00:42:55,960 EXTRAORDINARY CIRCUMSTANCES THAT 1300 00:42:55,960 --> 00:42:58,196 MAKES SENSE WHEN IT COMES TO 1301 00:42:58,196 --> 00:42:58,429 MINORS. 1302 00:42:58,429 --> 00:43:00,364 I THINK THAT IT COULD MAKE SENSE 1303 00:43:00,364 --> 00:43:02,767 WHEN IT COMES TO SOME ADULTS 1304 00:43:02,767 --> 00:43:05,736 THAT CAN'T CONSENT AND WHO 1305 00:43:05,736 --> 00:43:06,270 DISSENT. 1306 00:43:06,270 --> 00:43:08,072 I'M MORE AT LEAST I'M MORE 1307 00:43:08,072 --> 00:43:09,173 HESITANT ABOUT IT OR MORE 1308 00:43:09,173 --> 00:43:12,109 WORRIED ABOUT IT. 1309 00:43:12,109 --> 00:43:13,244 REASON IS BECAUSE IT IS -- WHEN 1310 00:43:13,244 --> 00:43:16,347 YOU TALK ABOUT A 6 OR 7 OR 8 OR 1311 00:43:16,347 --> 00:43:18,282 9 YEAR OLD AND SOMETIMES I THINK 1312 00:43:18,282 --> 00:43:20,351 THAT THEY JUST DON'T UNDERSTAND 1313 00:43:20,351 --> 00:43:21,953 OBVIOUSLY THEIR MEDICAL 1314 00:43:21,953 --> 00:43:23,554 INTERESTS AND SECTLY THEY MIGHT 1315 00:43:23,554 --> 00:43:25,223 NOT HAVE DEVELOPED STRONG VALUES 1316 00:43:25,223 --> 00:43:29,227 WITH RESPECT TO RESEARCH 1317 00:43:29,227 --> 00:43:31,662 PARTICIPATION OFTEN OTHER HANDS 1318 00:43:31,662 --> 00:43:33,831 ADULTS SAY SOMEBODY THAT IS 70 1319 00:43:33,831 --> 00:43:36,367 OR HAD A STROKE OR IS DEVELOPING 1320 00:43:36,367 --> 00:43:38,302 MODERATE DEMENTIA MAY STILL HAVE 1321 00:43:38,302 --> 00:43:39,604 A REALLY GOOD SENSE FOR THEIR 1322 00:43:39,604 --> 00:43:42,440 OWN PREFERENCES AND VALUES AND 1323 00:43:42,440 --> 00:43:43,975 JUST THEIR VIEW MAY BE THAT 1324 00:43:43,975 --> 00:43:45,176 PARTICIPATING IN RESEARCH IS 1325 00:43:45,176 --> 00:43:46,811 JUST INCONSISTENT WITH THEM. 1326 00:43:46,811 --> 00:43:49,447 IN A CASE LIKE THAT, I WOULD BE 1327 00:43:49,447 --> 00:43:51,482 REALLY RELUCTANT AND SAY WOULD 1328 00:43:51,482 --> 00:43:54,552 BE JUST TO NEVER OVERRIDE 1329 00:43:54,552 --> 00:43:56,654 DISSENT ON THAT BASIS EVEN IF IT 1330 00:43:56,654 --> 00:43:58,689 IS IN A STUDY THAT REALLY OFFERS 1331 00:43:58,689 --> 00:44:01,626 THEM POTENTIAL FOR SIGNIFICANT 1332 00:44:01,626 --> 00:44:01,893 BENEFIT. 1333 00:44:01,893 --> 00:44:03,327 ONLY EXCEPTIONS I COULD IMAGINE 1334 00:44:03,327 --> 00:44:05,663 WOULD BE ONES WHERE THERE REALLY 1335 00:44:05,663 --> 00:44:06,998 IS THAT CIRCUMSTANCE OR NOTHING 1336 00:44:06,998 --> 00:44:07,999 ELSE FOR THIS PERSON AND THERE 1337 00:44:07,999 --> 00:44:10,401 IS REALLY GOOD REASON TO THINK 1338 00:44:10,401 --> 00:44:11,869 THIS COULD HELP THEM IN 1339 00:44:11,869 --> 00:44:14,105 SIGNIFICANT WAYS AND THERE IS 1340 00:44:14,105 --> 00:44:15,940 ALSO A GOOD REASON TO BELIEVE 1341 00:44:15,940 --> 00:44:19,343 THAT THEIR DISSENT IS BASED ON 1342 00:44:19,343 --> 00:44:20,478 CONFUSION. IF THEY REALLY 1343 00:44:20,478 --> 00:44:21,779 UNDERSTOOD THEY THEMSELVES WOULD 1344 00:44:21,779 --> 00:44:24,649 WANT TO BE IN THE STUDY. 1345 00:44:24,649 --> 00:44:26,450 AND SO I MEAN I WOULD BE WILLING 1346 00:44:26,450 --> 00:44:28,052 TO -- I'M SURE THERE MUST BE 1347 00:44:28,052 --> 00:44:29,921 SOME CASES LIKE THAT AND THEY 1348 00:44:29,921 --> 00:44:31,355 ARE PROBABLY EXTRAORDINARILY 1349 00:44:31,355 --> 00:44:32,490 RARE AND MY SUGGESTION WOULD BE 1350 00:44:32,490 --> 00:44:34,659 THIS IS SORT OF LIKE I HAVE A 1351 00:44:34,659 --> 00:44:35,993 CONFLICT OF INTEREST HERE AND 1352 00:44:35,993 --> 00:44:37,595 WOULD SAY IF YOU GET A CASE LIKE 1353 00:44:37,595 --> 00:44:39,964 THAT CALL A BIOETHICS 1354 00:44:39,964 --> 00:44:41,232 CONSULTATION AND TALK WITH 1355 00:44:41,232 --> 00:44:42,667 PEOPLE BEFORE YOU DO ANYTHING. 1356 00:44:42,667 --> 00:44:44,201 >> OKAY. ALL RIGHT. IF ANYBODY 1357 00:44:44,201 --> 00:44:46,971 HAS ANY QUESTIONS, GO AHEAD AND 1358 00:44:46,971 --> 00:44:49,440 SUBMIT THOSE NOW SO WE CAN 1359 00:44:49,440 --> 00:44:52,910 ADDRESS THEM BEFOREHAND OR 1360 00:44:52,910 --> 00:44:56,714 BEFORE WE LEAVE. 1361 00:44:56,714 --> 00:44:58,416 OKAY. I DON'T SEE ANYTHING ELSE 1362 00:44:58,416 --> 00:44:59,684 AND THANKS VERY MUCH. 1363 00:44:59,684 --> 00:45:00,584 >> ALL RIGHT. 1364 00:45:00,584 --> 00:45:02,353 >> FOR THIS INTERESTING 1365 00:45:02,353 --> 00:45:03,921 DISCUSSION WE GREATLY APPRECIATE 1366 00:45:03,921 --> 00:45:06,190 ESPECIALLY WITH CHANGE COMING 1367 00:45:06,190 --> 00:45:06,757 DOWN THE PIKE. 1368 00:45:06,757 --> 00:45:08,492 SURE. EXCITING CHANGES AND 1369 00:45:08,492 --> 00:45:11,228 THANKS FOR INVITING ME. 1370 00:45:11,228 --> 00:45:12,196 OKAY. TAKE CARE. 1371 00:45:12,196 --> 00:45:22,340 BYE,