1 00:00:05,440 --> 00:00:08,840 WELCOME TO SESSION 5. 2 00:00:08,840 --> 00:00:10,280 TODAY IS INFORMED CONSENT DAY. 3 00:00:10,280 --> 00:00:13,320 WE'RE GOING TO START OFF WITH 4 00:00:13,320 --> 00:00:15,720 DR. CHRISTINE GRADY, TWO QUICK 5 00:00:15,720 --> 00:00:17,120 ANNOUNCEMENTS TODAY, THE WORD OF 6 00:00:17,120 --> 00:00:23,160 THE DAY IS ASSENT, AND KATIE 7 00:00:23,160 --> 00:00:25,400 TODDMAN, WHO WILL JOIN US FOR 8 00:00:25,400 --> 00:00:26,480 THE CAPACITY ASSESSMENT AND 9 00:00:26,480 --> 00:00:28,880 PRACTICE, CAN'T JOIN US. 10 00:00:28,880 --> 00:00:30,560 HER COLLEAGUE CAROL SQUIRES IS 11 00:00:30,560 --> 00:00:35,320 GOING TO JOIN US INSTEAD. 12 00:00:35,320 --> 00:00:38,360 IT'S MY PLEASURE TO ONCE AGAIN 13 00:00:38,360 --> 00:00:39,840 INTRODUCE DR. CHRISTINE GRADY, 14 00:00:39,840 --> 00:00:41,480 CHAIR OF OUR DEPARTMENT OF 15 00:00:41,480 --> 00:00:43,880 BIOETHICS AT THE CLINICAL CENTER 16 00:00:43,880 --> 00:00:46,280 AT THE NIH. 17 00:00:46,280 --> 00:00:49,640 HER FULL BIO I COULD NEVER COVER 18 00:00:49,640 --> 00:00:51,040 TODAY IS LINKED IN THE FIRST 19 00:00:51,040 --> 00:00:52,920 MODULE OF THE COURSE IF YOU'D 20 00:00:52,920 --> 00:00:54,080 LIKE TO HEAR MORE. 21 00:00:54,080 --> 00:01:00,240 I'M GOING TO HAND IT OVER TO 22 00:01:00,240 --> 00:01:00,680 CHRISTINE. 23 00:01:00,680 --> 00:01:04,200 THANK YOU. 24 00:01:04,200 --> 00:01:07,080 >>GOOD MORNING. 25 00:01:07,080 --> 00:01:08,280 BIG CROWDED AUDITORIUM. 26 00:01:08,280 --> 00:01:10,960 I'M GOING TO TAKE MY MASK OFF SO 27 00:01:10,960 --> 00:01:16,120 AT LEAST YOU GUYS CAN HEAR ME. 28 00:01:16,120 --> 00:01:18,040 NICE TO BE BACK IN THE COURSE 29 00:01:18,040 --> 00:01:18,280 AGAIN. 30 00:01:18,280 --> 00:01:20,600 TODAY AS HOLLY SAID I'M GOING TO 31 00:01:20,600 --> 00:01:22,080 TALK ABOUT INFORMED CONSENT. 32 00:01:22,080 --> 00:01:22,960 SOMETHING THAT PEOPLE THINK 33 00:01:22,960 --> 00:01:24,520 ABOUT ALL THE TIME WHEN THEY 34 00:01:24,520 --> 00:01:32,800 THINK ABOUT ETHICS OF RESEARCH. 35 00:01:32,800 --> 00:01:33,520 THE USUAL DISCLAIMER. 36 00:01:33,520 --> 00:01:35,000 SO WHAT I THOUGHT I'D DO IN THE 37 00:01:35,000 --> 00:01:37,120 TIME I HAVE IS A LITTLE BIT OF 38 00:01:37,120 --> 00:01:38,960 SORT OF BASICS OF INFORMED 39 00:01:38,960 --> 00:01:40,320 CONSENT, INCLUDING SOME OF THE 40 00:01:40,320 --> 00:01:42,920 DATA ON HOW WE'RE DOING, SOME OF 41 00:01:42,920 --> 00:01:44,840 THE CHALLENGES WITH RESPECT TO 42 00:01:44,840 --> 00:01:46,880 INFORMED CONSENT IN THE RESEARCH 43 00:01:46,880 --> 00:01:49,240 CONTEXT, AND THEN SOME OF THE 44 00:01:49,240 --> 00:01:51,560 CHANGES IN RESEARCH AND IN THE 45 00:01:51,560 --> 00:01:53,520 PROCESSES OF INFORMED CONSENT 46 00:01:53,520 --> 00:01:59,800 THAT CREATED SORT OF NEW 47 00:01:59,800 --> 00:02:03,160 CHALLENGES I GUESS, OR NEW 48 00:02:03,160 --> 00:02:08,840 OPPORTUNITIES FOR CREATIVITY AND 49 00:02:08,840 --> 00:02:09,600 LEARNING. 50 00:02:09,600 --> 00:02:11,760 CONSENT IS A PRETTY COMMON THING 51 00:02:11,760 --> 00:02:13,800 IN OUR LIVES, A POWERFUL THING. 52 00:02:13,800 --> 00:02:16,600 AS PEOPLE SAY, MORAL AND LEGAL 53 00:02:16,600 --> 00:02:17,520 PROTECTION FROM UNAUTHORIZED 54 00:02:17,520 --> 00:02:20,200 INVASION OF ONE'S BODY AND 55 00:02:20,200 --> 00:02:20,480 PROPERTY. 56 00:02:20,480 --> 00:02:23,120 HAS A VERY STRONG TRANSFORMATIVE 57 00:02:23,120 --> 00:02:25,240 OR FACILITATIVE MORAL POWER, 58 00:02:25,240 --> 00:02:26,520 MAKING CERTAIN THINGS OKAY THAT 59 00:02:26,520 --> 00:02:29,840 WITHOUT CONSENT WOULD NOT BE 60 00:02:29,840 --> 00:02:30,280 OKAY. 61 00:02:30,280 --> 00:02:31,520 ONE EXAMPLE, SOMEBODY ASKED TO 62 00:02:31,520 --> 00:02:33,760 BORROW MY CAR, I GAVE MY 63 00:02:33,760 --> 00:02:39,400 CONSENT, PERFECTLY FINE. 64 00:02:39,400 --> 00:02:41,000 IF THEY TOOK MY CAR WITHOUT 65 00:02:41,000 --> 00:02:42,080 ASKING, THAT WOULD NOT BE FINE, 66 00:02:42,080 --> 00:02:44,040 THAT WOULD BE STEALING. 67 00:02:44,040 --> 00:02:45,240 CONSENT IS WELL ENTRENCHED IN 68 00:02:45,240 --> 00:02:47,960 THINGS WE DO IN LIFE, IN OUR 69 00:02:47,960 --> 00:02:55,400 VALUES, JURISPRUDENCE, AND IN 70 00:02:55,400 --> 00:02:55,840 OUR HEALTH CARE. 71 00:02:55,840 --> 00:02:57,920 IN HEALTH CARE WE TAKE ABOUT 72 00:02:57,920 --> 00:02:58,920 INFORMED CONSENT. 73 00:02:58,920 --> 00:03:00,640 INFORMED CONSENT REQUIRES SOME 74 00:03:00,640 --> 00:03:02,000 UNDERSTANDING OF WHAT THE 75 00:03:02,000 --> 00:03:02,880 REQUEST IS. 76 00:03:02,880 --> 00:03:04,160 SO THERE ARE A LOT OF 77 00:03:04,160 --> 00:03:06,840 DEFINITIONS OF INFORMED CONSENT. 78 00:03:06,840 --> 00:03:08,560 ONE IS AUTHORIZATION OF AN 79 00:03:08,560 --> 00:03:11,400 ACTIVITY BASED ON UNDERSTANDING 80 00:03:11,400 --> 00:03:12,000 WHAT THAT ACTIVITY ENTAILS. 81 00:03:12,000 --> 00:03:15,920 IT IS A LEGAL AND REGULATORY AND 82 00:03:15,920 --> 00:03:19,040 ETHICAL REQUIREMENT NOT ONLY IN 83 00:03:19,040 --> 00:03:20,040 RESEARCH BUT IN MOST HEALTH 84 00:03:20,040 --> 00:03:20,440 CARE. 85 00:03:20,440 --> 00:03:22,040 INFORMED CONSENT IS REQUIRED IN 86 00:03:22,040 --> 00:03:23,880 HEALTH CARE, AND MOST RESEARCH 87 00:03:23,880 --> 00:03:26,000 WITH HUMAN SUBJECTS. 88 00:03:26,000 --> 00:03:27,680 IT'S ALSO AND I'M SURE YOU'VE 89 00:03:27,680 --> 00:03:29,600 HEARD THIS BEFORE, IT'S A 90 00:03:29,600 --> 00:03:30,040 PROCESS. 91 00:03:30,040 --> 00:03:31,840 IT'S A PROCESS OF REASONED 92 00:03:31,840 --> 00:03:32,560 DECISION MAKING. 93 00:03:32,560 --> 00:03:34,520 IT'S NOT A FORM. 94 00:03:34,520 --> 00:03:36,400 IT'S NOT AN EPISODE ONE-TIME 95 00:03:36,400 --> 00:03:36,680 THING. 96 00:03:36,680 --> 00:03:40,240 IT'S A PROCESS OF LEARNING ABOUT 97 00:03:40,240 --> 00:03:42,200 AND DECIDING ABOUT SOMETHING IN 98 00:03:42,200 --> 00:03:44,920 HEALTH CARE OR RESEARCH. 99 00:03:44,920 --> 00:03:47,200 AND RUTH FADEN AND TOM BEACHAM 100 00:03:47,200 --> 00:03:52,600 WHO WROTE ONE OF THE MOST 101 00:03:52,600 --> 00:03:53,240 IMPORTANT TREATISES, 102 00:03:53,240 --> 00:03:55,440 UNFORTUNATELY NOW MORE THAN 30 103 00:03:55,440 --> 00:03:57,240 YEARS OLD, CALLED IT AUTONOMOUS 104 00:03:57,240 --> 00:03:58,560 AUTHORIZATION, THE IDEA THE 105 00:03:58,560 --> 00:04:01,600 PERSON WHO HAS THE CAPACITY TO 106 00:04:01,600 --> 00:04:02,400 BE AUTONOMOUS UNDERSTANDS WHAT 107 00:04:02,400 --> 00:04:04,080 THEY ARE BEING ASKED TO DO AND 108 00:04:04,080 --> 00:04:09,120 AUTHORIZES IT ON THAT BASIS. 109 00:04:09,120 --> 00:04:12,240 SO,ETICALLY WE THINK ABOUT 110 00:04:12,240 --> 00:04:12,960 INFORMED CONSENT AS BEING BASED 111 00:04:12,960 --> 00:04:18,720 ON A PRINCIPLE OF RESPECT FOR 112 00:04:18,720 --> 00:04:23,800 AUTONOMY OR PERSONS, RESPECT FOR 113 00:04:23,800 --> 00:04:25,200 INDIVIDUAL'S CAPACITY AND RIGHT 114 00:04:25,200 --> 00:04:27,040 TO DEFINE THEIR OWN GOALS AND 115 00:04:27,040 --> 00:04:28,600 MAKE CHOICES CONSISTENT WITH 116 00:04:28,600 --> 00:04:28,920 THOSE GOALS. 117 00:04:28,920 --> 00:04:30,800 IN THE BELMONT REPORT WHICH 118 00:04:30,800 --> 00:04:34,720 YOU'VE HEARD ABOUT ALREADY SAYS 119 00:04:34,720 --> 00:04:36,000 THEY SUCCINCTLY, RESPECT FOR 120 00:04:36,000 --> 00:04:37,320 PERSONS REQUIRES SUBJECTS TO THE 121 00:04:37,320 --> 00:04:39,760 DEGREE THEY ARE CAPABLE BE GIVEN 122 00:04:39,760 --> 00:04:41,600 THE OPPORTUNITY TO CHOOSE WHAT 123 00:04:41,600 --> 00:04:43,040 SHALL OR SHALL NOT HAPPEN TO 124 00:04:43,040 --> 00:04:43,520 THEM. 125 00:04:43,520 --> 00:04:46,320 AND THAT OPPORTUNITY IS PROVIDED 126 00:04:46,320 --> 00:04:49,760 WHEN INFORMED CONSENT IS 127 00:04:49,760 --> 00:04:50,080 SATISFIED. 128 00:04:50,080 --> 00:05:00,600 SO, HOLLY SAID THE WORD OF THE 129 00:05:01,760 --> 00:05:03,520 DAY IS ASSENT. 130 00:05:03,520 --> 00:05:05,640 THEY ARE BOTH BASED UPON AN IDEA 131 00:05:05,640 --> 00:05:07,560 OF RESPECT FOR PERSONS. 132 00:05:07,560 --> 00:05:09,760 A WAY WE RESPECT PERSONS WHEN WE 133 00:05:09,760 --> 00:05:11,960 ASK FOR THEIR ASSENT. 134 00:05:11,960 --> 00:05:13,320 A DISTINCTION BETWEEN THE TWO, 135 00:05:13,320 --> 00:05:16,520 PEOPLE WHO DO NOT HAVE THE 136 00:05:16,520 --> 00:05:19,560 CAPACITY OR AUTHORITY TO GIVE 137 00:05:19,560 --> 00:05:20,880 CONSENT ARE ASKED FOR THEIR 138 00:05:20,880 --> 00:05:22,960 ASSENT IN THE PROCESS OF 139 00:05:22,960 --> 00:05:23,320 RESEARCH. 140 00:05:23,320 --> 00:05:24,160 THERE'S STILL SOME ASKING THEM 141 00:05:24,160 --> 00:05:24,960 FOR SOME AGREEMENT. 142 00:05:24,960 --> 00:05:26,600 THERE'S GOT TO BE SOME 143 00:05:26,600 --> 00:05:27,360 UNDERSTANDING, A LITTLE BIT, 144 00:05:27,360 --> 00:05:29,240 ABOUT WHAT THEY ARE DOING, BUT 145 00:05:29,240 --> 00:05:31,520 NOT NECESSARILY THE CAPACITY TO 146 00:05:31,520 --> 00:05:34,520 UNDERSTAND WHAT THE SORT OF 147 00:05:34,520 --> 00:05:36,080 TOTAL ASK IS, IN OTHER WORDS 148 00:05:36,080 --> 00:05:37,640 WHAT THE STUDY IS THEY ARE BEING 149 00:05:37,640 --> 00:05:41,240 ASKED TO THINK ABOUT AND DECIDE 150 00:05:41,240 --> 00:05:43,520 ABOUT. 151 00:05:43,520 --> 00:05:45,960 WE THINK ABOUT ASSENT PRIMARILY 152 00:05:45,960 --> 00:05:47,680 WITH CHILDREN, CHILDREN WHO DO 153 00:05:47,680 --> 00:05:49,400 NOT BY LAW REALLY OR REGULATION 154 00:05:49,400 --> 00:05:51,560 AS WELL, BUT BY LAW, HAVE THE 155 00:05:51,560 --> 00:05:54,520 AUTHORITY TO CONSENT FOR 156 00:05:54,520 --> 00:05:55,440 THEMSELVES. 157 00:05:55,440 --> 00:05:59,800 AND SO WHEN WE ENROLL CHILDREN 158 00:05:59,800 --> 00:06:00,680 IN RESEARCH, WHENEVER POSSIBLE 159 00:06:00,680 --> 00:06:03,840 WE ASK FOR THEIR ASSENT AND 160 00:06:03,840 --> 00:06:05,840 THEIR PARENTS' PERMISSION OR 161 00:06:05,840 --> 00:06:07,720 GUARDIAN'S PERMISSION TO ENROLL 162 00:06:07,720 --> 00:06:08,240 THEM. 163 00:06:08,240 --> 00:06:09,840 ASSENT IS AN IMPORTANT CONCEPT 164 00:06:09,840 --> 00:06:11,120 WHEN THINKING ABOUT ADULTS WHO 165 00:06:11,120 --> 00:06:13,120 DON'T HAVE THE CAPACITY TO 166 00:06:13,120 --> 00:06:14,080 CONSENT FOR THEMSELVES BECAUSE, 167 00:06:14,080 --> 00:06:16,880 AGAIN, IT'S A SIGN OF RESPECT 168 00:06:16,880 --> 00:06:19,280 FOR WHAT CAPACITIES THEY DO 169 00:06:19,280 --> 00:06:19,520 HAVE. 170 00:06:19,520 --> 00:06:21,560 I UNDERSTAND SCOTT IS COMING IN 171 00:06:21,560 --> 00:06:27,480 THE NEXT HOUR TO TALK ABOUT 172 00:06:27,480 --> 00:06:28,120 CAPACITY. 173 00:06:28,120 --> 00:06:31,640 SO, IN RESEARCH AND CLINICAL 174 00:06:31,640 --> 00:06:33,240 RESEARCH, INFORMED CONSENT MAYBE 175 00:06:33,240 --> 00:06:34,200 HAS A LITTLE BIT MORE WEIGHT I 176 00:06:34,200 --> 00:06:36,520 GUESS IS THE WAY I WOULD SAY IT 177 00:06:36,520 --> 00:06:37,680 THAN IN HEALTH CARE FOR THE 178 00:06:37,680 --> 00:06:38,200 FOLLOWING REASON. 179 00:06:38,200 --> 00:06:41,160 THAT THE GOAL OF RESEARCH IS TO 180 00:06:41,160 --> 00:06:42,440 PRODUCE KNOWLEDGE THAT WILL 181 00:06:42,440 --> 00:06:45,600 BENEFIT OTHERS, AND NOT 182 00:06:45,600 --> 00:06:46,400 NECESSARILY BENEFIT THE 183 00:06:46,400 --> 00:06:49,680 PARTICIPANT THEMSELVES. 184 00:06:49,680 --> 00:06:52,880 THERE IS A SPECIAL ETHICAL 185 00:06:52,880 --> 00:06:54,800 IMPORTANCE TO -- AGAINST USING 186 00:06:54,800 --> 00:06:57,520 PEOPLE FOR THE BENEFIT OF OTHERS 187 00:06:57,520 --> 00:07:00,160 WITHOUT THEIR VALID CONSENT. 188 00:07:00,160 --> 00:07:01,720 AND THEREFORE, CONSENT, THE 189 00:07:01,720 --> 00:07:04,360 CONTEXT OF RESEARCH, GIVES US 190 00:07:04,360 --> 00:07:05,960 THE PERMISSION TO USE PEOPLE FOR 191 00:07:05,960 --> 00:07:07,200 THE BENEFIT OF OTHERS BASICALLY 192 00:07:07,200 --> 00:07:12,000 IS WHAT WE'RE ASKING PEOPLE TO 193 00:07:12,000 --> 00:07:12,640 DO. 194 00:07:12,640 --> 00:07:14,840 THE CONNOTATION OF GUINEA PIG IS 195 00:07:14,840 --> 00:07:17,840 OFTEN USED IN RESEARCH, BUT ONCE 196 00:07:17,840 --> 00:07:20,040 A PERSON GIVES CONSENT, THEY ARE 197 00:07:20,040 --> 00:07:21,160 NO LONGER A GUINEA PIG. 198 00:07:21,160 --> 00:07:24,720 THEY ARE MORE A PARTNER IN THE 199 00:07:24,720 --> 00:07:25,880 PROCESS. 200 00:07:25,880 --> 00:07:27,360 I THINK ALSO INFORMED CONSENT 201 00:07:27,360 --> 00:07:30,560 ALTHOUGH MANY PEOPLE THINK ABOUT 202 00:07:30,560 --> 00:07:32,960 IT AS A VERY ESSENTIAL PART OF 203 00:07:32,960 --> 00:07:35,040 ETHICAL RESEARCH, I HOPE THAT AT 204 00:07:35,040 --> 00:07:36,440 THIS POINT IN SESSION 5 YOU KNOW 205 00:07:36,440 --> 00:07:39,880 IT'S ONLY ONE ASPECT OF 206 00:07:39,880 --> 00:07:41,360 CONDUCTING ETHICAL CLINICAL 207 00:07:41,360 --> 00:07:41,920 RESEARCH. 208 00:07:41,920 --> 00:07:44,800 IN FACT, THE FRAMEWORK THAT WE 209 00:07:44,800 --> 00:07:49,080 USE AND THIS COURSE IS BASED ON 210 00:07:49,080 --> 00:07:50,400 IS LIKE THE SEVENTH OUT OF EIGHT 211 00:07:50,400 --> 00:07:51,240 IN SEQUENTIAL ORDER. 212 00:07:51,240 --> 00:07:53,320 SO YOU DON'T EVEN GO TO ASK 213 00:07:53,320 --> 00:07:55,120 PEOPLE FOR THEIR INFORMED 214 00:07:55,120 --> 00:08:00,520 CONSENT UNTIL ALL OF THE OTHER 215 00:08:00,520 --> 00:08:02,000 THINGS ARE SATISFIED. 216 00:08:02,000 --> 00:08:02,920 INFORMED CONSENT IN CLINICAL 217 00:08:02,920 --> 00:08:04,360 RESEARCH IS REQUIRED BY 218 00:08:04,360 --> 00:08:06,840 VIRTUALLY EVERY CODE OF RESEARCH 219 00:08:06,840 --> 00:08:08,400 ETHICS, BY THE REGULATIONS, BY 220 00:08:08,400 --> 00:08:09,720 THE LAWS. 221 00:08:09,720 --> 00:08:11,520 THERE ARE SOME EXCEPTIONS, SOME 222 00:08:11,520 --> 00:08:14,000 EXCEPTIONS IN THE COMMON RULE 223 00:08:14,000 --> 00:08:16,560 AND FDA REGULATIONS, THAT ALLOW 224 00:08:16,560 --> 00:08:23,440 FOR WAIVING INFORMED CONSENT OR 225 00:08:23,440 --> 00:08:24,040 ALTERING INFORMED CONSENT, 226 00:08:24,040 --> 00:08:25,560 IMPORTANT THOSE OF YOU IN THE 227 00:08:25,560 --> 00:08:29,800 WORLD NEED TO KNOW ABOUT. 228 00:08:29,800 --> 00:08:31,720 IN FDA THERE'S EXCEPTION FOR 229 00:08:31,720 --> 00:08:33,720 EMERGENCY RESEARCH BUT A NUMBER 230 00:08:33,720 --> 00:08:34,840 OF OTHER CONTINGENCIES THAT NEED 231 00:08:34,840 --> 00:08:36,880 TO BE SATISFIED WHEN EMERGENCY 232 00:08:36,880 --> 00:08:45,000 RESEARCH IS BEING CONDUCTED. 233 00:08:45,000 --> 00:08:45,960 ICH-GCP PROMINENTLY REQUIRES 234 00:08:45,960 --> 00:08:48,200 INFORMED CONSENT FOR ALL 235 00:08:48,200 --> 00:08:55,440 RESEARCH, SO DOES DECLARATION OF 236 00:08:55,440 --> 00:08:58,440 HELSINKI, CIOMS, AND A LOT OF 237 00:08:58,440 --> 00:08:59,520 NATIONAL, STATE, INSTITUTIONAL 238 00:08:59,520 --> 00:09:05,080 EMPHASIZE THE REQUIREMENT FOR 239 00:09:05,080 --> 00:09:06,280 INFORMED CONSENT. 240 00:09:06,280 --> 00:09:08,160 IN 45 CFR 46 COMMON RULE, NO 241 00:09:08,160 --> 00:09:09,560 INVESTIGATOR MAY INVOLVE A HUMAN 242 00:09:09,560 --> 00:09:12,160 BEING AS A SUBJECT IN RESEARCH 243 00:09:12,160 --> 00:09:14,480 UNLESS THE INVESTIGATOR HAS 244 00:09:14,480 --> 00:09:15,720 OBTAINED THE LEGALLY EFFECTIVE 245 00:09:15,720 --> 00:09:17,760 INFORMED CONSENT OF THE SUBJECT 246 00:09:17,760 --> 00:09:20,320 OR THE SUBJECT'S LEGALLY 247 00:09:20,320 --> 00:09:21,720 AUTHORIZED REPRESENTATIVE. 248 00:09:21,720 --> 00:09:22,360 REALLY IMPORTANT. 249 00:09:22,360 --> 00:09:24,360 THERE ARE LIMITED EXCEPTIONS IN 250 00:09:24,360 --> 00:09:26,040 THE REGULATIONS THAT GO ON TO 251 00:09:26,040 --> 00:09:28,000 TALK ABOUT THOSE BUT I'M NOT 252 00:09:28,000 --> 00:09:30,440 GOING TO TALK ABOUT THAT NOW. 253 00:09:30,440 --> 00:09:32,560 REGS SAY INFORMED CONSENT HAS TO 254 00:09:32,560 --> 00:09:38,200 BE SOUGHT PROSPECTIVELY AND THEN 255 00:09:38,200 --> 00:09:38,640 DOCUMENTED. 256 00:09:38,640 --> 00:09:41,520 THE FDA PUT OUT A GUIDANCE IN 257 00:09:41,520 --> 00:09:47,240 2014 WHICH IS VERY COMPREHENSIVE 258 00:09:47,240 --> 00:09:48,640 ABOUT INFORMED CONSENT, AND THIS 259 00:09:48,640 --> 00:09:50,000 EXPLAINS AS MANY OF THE 260 00:09:50,000 --> 00:09:52,280 LITERATURE AND MANY OF THE OTHER 261 00:09:52,280 --> 00:09:53,600 REGULATIONS AND GUIDANCES DO 262 00:09:53,600 --> 00:09:55,520 THAT INFORMED CONSENT HAS A 263 00:09:55,520 --> 00:09:57,240 NUMBER OF PARTS TO IT. 264 00:09:57,240 --> 00:10:00,280 SO IT INVOLVED PROVIDING A 265 00:10:00,280 --> 00:10:01,280 POTENTIAL SUBJECT WITH 266 00:10:01,280 --> 00:10:02,640 INFORMATION, ADEQUATE 267 00:10:02,640 --> 00:10:05,880 INFORMATION, TO ALLOW FOR A 268 00:10:05,880 --> 00:10:08,080 DECISION, FACILITATING THEIR 269 00:10:08,080 --> 00:10:09,920 COMPREHENSION OF THAT 270 00:10:09,920 --> 00:10:10,720 INFORMATION, PROVIDING 271 00:10:10,720 --> 00:10:13,200 OPPORTUNITY FOR QUESTIONS AND 272 00:10:13,200 --> 00:10:15,960 COMMENTS OR DISCUSSION, AND THEN 273 00:10:15,960 --> 00:10:16,720 OBTAINING THEIR VOLUNTARY 274 00:10:16,720 --> 00:10:17,400 AGREEMENT. 275 00:10:17,400 --> 00:10:19,040 SO THESE ARE THE THREE PARTS OF 276 00:10:19,040 --> 00:10:21,560 CONSENT THAT I'M GOING TO FOCUS 277 00:10:21,560 --> 00:10:22,560 ON. 278 00:10:22,560 --> 00:10:23,760 PROVIDING INFORMATION OR 279 00:10:23,760 --> 00:10:25,160 DISCLOSURE, COMPREHENSION OR 280 00:10:25,160 --> 00:10:28,440 UNDERSTANDING OF THAT 281 00:10:28,440 --> 00:10:29,240 INFORMATION, AND VOLUNTARY 282 00:10:29,240 --> 00:10:29,800 AGREEMENT. 283 00:10:29,800 --> 00:10:31,800 IN ADDITION TO THOSE THREE, 284 00:10:31,800 --> 00:10:33,480 THERE ARE -- THERE'S A THRESHOLD 285 00:10:33,480 --> 00:10:35,920 THAT PEOPLE HAVE TO HAVE THE 286 00:10:35,920 --> 00:10:37,280 CAPACITY TO CONSENT. 287 00:10:37,280 --> 00:10:40,920 THERE HAS TO BE AN EVALUATION OF 288 00:10:40,920 --> 00:10:42,800 WHETHER OR NOT THEY HAVE THE 289 00:10:42,800 --> 00:10:44,200 CAPACITY TO UNDERSTAND AND MAKE 290 00:10:44,200 --> 00:10:44,560 DECISIONS. 291 00:10:44,560 --> 00:10:45,520 SCOTT WILL TALK ABOUT THAT IN 292 00:10:45,520 --> 00:10:47,200 THE NEXT HOUR. 293 00:10:47,200 --> 00:10:49,920 I WILL SAY THAT FOR THE MOST 294 00:10:49,920 --> 00:10:52,120 PART, FOR ADULTS, WE JUST ASSUME 295 00:10:52,120 --> 00:10:54,280 THEY HAVE THE CAPACITY UNLESS WE 296 00:10:54,280 --> 00:10:55,720 HAVE SOME INDICATION THERE'S -- 297 00:10:55,720 --> 00:10:57,520 THAT THEY MIGHT, AND THEN 298 00:10:57,520 --> 00:10:58,520 THERE'S A CAPACITY ASSESSMENT. 299 00:10:58,520 --> 00:11:00,600 THE OTHER PART OF CONSENT, WHICH 300 00:11:00,600 --> 00:11:02,400 IS IMPORTANT, BUT I'M NOT 301 00:11:02,400 --> 00:11:04,080 GROWING TO TALK ABOUT, IS 302 00:11:04,080 --> 00:11:04,480 AUTHORIZATION. 303 00:11:04,480 --> 00:11:06,440 SO I MENTIONED ALREADY FROM THE 304 00:11:06,440 --> 00:11:10,160 REGULATIONS THAT THEY REQUIRE 305 00:11:10,160 --> 00:11:11,240 DOCUMENTATION OF A PROSPECTIVELY 306 00:11:11,240 --> 00:11:13,240 SOUGHT CONSENT. 307 00:11:13,240 --> 00:11:16,360 THAT'S USUALLY IN THE FORM OF A 308 00:11:16,360 --> 00:11:19,880 SIGNATURE ON A CONSENT DOCUMENT 309 00:11:19,880 --> 00:11:21,680 OR IN A CONSENT APPLICATION, 310 00:11:21,680 --> 00:11:24,320 ONLINE THESE DAYS, BUT IT'S AN 311 00:11:24,320 --> 00:11:25,960 INDICATION OF THE AUTHORIZATION. 312 00:11:25,960 --> 00:11:28,880 SHORT OF A WRITTEN INDICATION OF 313 00:11:28,880 --> 00:11:30,160 AUTHORIZATION, THERE ARE TIMES 314 00:11:30,160 --> 00:11:33,920 WHEN IT'S A VERBAL OR AN ORAL 315 00:11:33,920 --> 00:11:35,400 CONSENT AUTHORIZATION THAT ALSO 316 00:11:35,400 --> 00:11:37,080 NEEDS TO BE DOCUMENTED. 317 00:11:37,080 --> 00:11:41,200 BUT I'M NOT GOING TO TALK MORE 318 00:11:41,200 --> 00:11:42,440 ABOUT THAT. 319 00:11:42,440 --> 00:11:45,360 WHAT ABOUT DISCLOSURES? 320 00:11:45,360 --> 00:11:46,360 THERE'S AN INTERESTING QUESTION, 321 00:11:46,360 --> 00:11:48,480 WHAT INFORMATION SHOULD BE 322 00:11:48,480 --> 00:11:48,800 DISCLOSED? 323 00:11:48,800 --> 00:11:49,640 WHAT IS ADEQUATE INFORMATION FOR 324 00:11:49,640 --> 00:11:50,680 SOMEBODY TO BE ABLE TO 325 00:11:50,680 --> 00:11:51,480 UNDERSTAND WHAT YOU'RE ASKING 326 00:11:51,480 --> 00:11:54,360 THEM TO DO IN THE SETTING OF A 327 00:11:54,360 --> 00:11:56,680 RESEARCH STUDY, AND USE THAT 328 00:11:56,680 --> 00:11:58,240 INFORMATION TO MAKE DECISIONS. 329 00:11:58,240 --> 00:12:04,600 WHAT'S RELEVANT TO THEM? 330 00:12:04,600 --> 00:12:05,280 IT'S A CHALLENGING QUESTION 331 00:12:05,280 --> 00:12:07,400 BECAUSE ANY OF YOU INVOLVED IN 332 00:12:07,400 --> 00:12:09,000 RESEARCH KNOW THERE'S A LOT OF 333 00:12:09,000 --> 00:12:11,400 COMPLEXITY TO CERTAIN KINDS OF 334 00:12:11,400 --> 00:12:11,800 RESEARCH STUDIES. 335 00:12:11,800 --> 00:12:15,680 THE QUESTION I'LL TELL YOU ONE 336 00:12:15,680 --> 00:12:17,400 STORY YEARS AGO, CALLED FOR 337 00:12:17,400 --> 00:12:20,400 CONSULT ABOUT A PATIENT WHO THE 338 00:12:20,400 --> 00:12:22,040 FELLOW THOUGHT DID NOT HAVE THE 339 00:12:22,040 --> 00:12:23,280 CAPACITY TO CONSENT. 340 00:12:23,280 --> 00:12:27,360 AND WHEN WE WENT UP TO SPEAK TO 341 00:12:27,360 --> 00:12:28,560 THIS PATIENT, SHE BASICALLY 342 00:12:28,560 --> 00:12:30,920 UNDERSTOOD WHAT THE STUDY WAS 343 00:12:30,920 --> 00:12:32,480 ABOUT, WHAT SHE HAD TO DO, AND 344 00:12:32,480 --> 00:12:33,600 WHAT THE RISKS WERE. 345 00:12:33,600 --> 00:12:36,160 WHAT SHE DIDN'T KNOW WAS THE 346 00:12:36,160 --> 00:12:38,760 NAME OF THE DRUG, THE MECHANISM 347 00:12:38,760 --> 00:12:40,720 OF THE DRUG, SORT OF THE DETAILS 348 00:12:40,720 --> 00:12:41,680 OF WHAT WAS HAPPENING. 349 00:12:41,680 --> 00:12:43,600 HE THOUGHT THAT THAT WAS 350 00:12:43,600 --> 00:12:46,240 INADEQUATE IN TERMS OF HER 351 00:12:46,240 --> 00:12:47,520 UNDERSTANDING OR HER DISCLOSURE 352 00:12:47,520 --> 00:12:48,200 AND UNDERSTANDING. 353 00:12:48,200 --> 00:12:51,080 BUT THEY TOLD HER THE NAME. 354 00:12:51,080 --> 00:12:52,760 THEY TOLD HER THE MECHANISM, 355 00:12:52,760 --> 00:12:56,040 THAT WASN'T RELEVANT TO HER. 356 00:12:56,040 --> 00:12:58,360 THERE'S ALSO A QUESTION ABOUT 357 00:12:58,360 --> 00:13:00,400 HOW THE INFORMATION ONCE ONE 358 00:13:00,400 --> 00:13:01,680 DETERMINES WHAT'S ADEQUATE 359 00:13:01,680 --> 00:13:03,000 INFORMATION TO DISCLOSE, HOW IT 360 00:13:03,000 --> 00:13:04,160 SHOULD BE PRESENTED. 361 00:13:04,160 --> 00:13:06,600 SO THAT IT IS THE MOST 362 00:13:06,600 --> 00:13:07,920 UNDERSTANDABLE TO THE PEOPLE 363 00:13:07,920 --> 00:13:10,200 THAT YOU ARE PRESENTING IT TO, 364 00:13:10,200 --> 00:13:11,680 CONSIDERING THEIR CIRCUMSTANCES, 365 00:13:11,680 --> 00:13:13,280 THEIR SETTING, AND THE 366 00:13:13,280 --> 00:13:14,640 POPULATION THAT YOU'RE TALKING 367 00:13:14,640 --> 00:13:14,840 TO. 368 00:13:14,840 --> 00:13:16,120 AND THERE ARE LOTS OF 369 00:13:16,120 --> 00:13:17,560 INTERESTING QUESTIONS HERE. 370 00:13:17,560 --> 00:13:19,280 YOU KNOW, WE WORK IN RESEARCH 371 00:13:19,280 --> 00:13:22,960 OFTEN WITH PEOPLE WHO ARE QUITE 372 00:13:22,960 --> 00:13:23,160 ILL. 373 00:13:23,160 --> 00:13:26,440 WE WORK IN RESEARCH WITH PEOPLE 374 00:13:26,440 --> 00:13:27,280 WHO ARE IN UNUSUAL 375 00:13:27,280 --> 00:13:27,760 CIRCUMSTANCES. 376 00:13:27,760 --> 00:13:30,480 WHO ARE UNDER A FAIR AMOUNT OF 377 00:13:30,480 --> 00:13:31,080 DISTRESS. 378 00:13:31,080 --> 00:13:32,000 CONSIDERING THOSE KINDS OF 379 00:13:32,000 --> 00:13:33,120 THINGS ACTUALLY IS IMPORTANT 380 00:13:33,120 --> 00:13:34,120 WHEN WE'RE THINKING ABOUT WHAT 381 00:13:34,120 --> 00:13:35,200 KIND OF INFORMATION, HOW MUCH 382 00:13:35,200 --> 00:13:41,560 INFORMATION, AND HOW TO PRESENT 383 00:13:41,560 --> 00:13:42,760 INFORMATION. 384 00:13:42,760 --> 00:13:44,440 THE REGULATIONS GO ON TO SAY 385 00:13:44,440 --> 00:13:45,480 THAT THE INFORMATION GIVEN TO 386 00:13:45,480 --> 00:13:47,520 THE SUBJECT SHOULD BE IN 387 00:13:47,520 --> 00:13:49,280 LANGUAGE THAT'S UNDERSTANDABLE 388 00:13:49,280 --> 00:13:51,920 TO THE SUBJECT, BUT IN THE MORE 389 00:13:51,920 --> 00:13:53,880 RECENT REVISIONS TO THE COMMON 390 00:13:53,880 --> 00:13:56,200 RULE QUALIFY THAT BY SAYING 391 00:13:56,200 --> 00:13:59,600 UNDERSTANDABLE IN THE WAY THAT A 392 00:13:59,600 --> 00:14:01,360 REASONABLE PERSON WOULD WANT TO 393 00:14:01,360 --> 00:14:01,720 HAVE. 394 00:14:01,720 --> 00:14:04,120 SO, THERE'S A SORT OF REASONABLE 395 00:14:04,120 --> 00:14:07,200 PERSON STANDARD IN TERMS OF 396 00:14:07,200 --> 00:14:08,400 UNDERSTANDING WHAT A PARTICULAR 397 00:14:08,400 --> 00:14:11,840 INDIVIDUAL MIGHT NEED TO KNOW. 398 00:14:11,840 --> 00:14:13,720 THAT REASONABLE PERSON STANDARD 399 00:14:13,720 --> 00:14:16,280 GUIDES THE SORT OF SCRIPT THAT 400 00:14:16,280 --> 00:14:17,040 INVESTIGATORS USE, THE CONSENT 401 00:14:17,040 --> 00:14:20,920 AS IT IS WRITTEN OUT OR PROVIDED 402 00:14:20,920 --> 00:14:21,680 ELECTRONICALLY. 403 00:14:21,680 --> 00:14:24,200 BUT THERE MAY BE THINGS THAT A 404 00:14:24,200 --> 00:14:25,720 PARTICULAR PERSON NEEDS TO KNOW 405 00:14:25,720 --> 00:14:27,560 THAT ARE ABOVE AND BEYOND WHAT 406 00:14:27,560 --> 00:14:31,240 THE REASONABLE PERSON WANTS TO 407 00:14:31,240 --> 00:14:31,600 KNOW. 408 00:14:31,600 --> 00:14:35,280 THE REGULATIONS ALSO GO ON TO 409 00:14:35,280 --> 00:14:36,560 SAY THAT THE CONSENT, SINCE 410 00:14:36,560 --> 00:14:38,880 AGAIN THE REVISIONS TO THE 411 00:14:38,880 --> 00:14:40,400 COMMON RULE IN 2018 HAVE TO 412 00:14:40,400 --> 00:14:43,680 BEGIN WITH A CONCISE AND FOCUSED 413 00:14:43,680 --> 00:14:45,200 PRESENTATION OF THE KEY 414 00:14:45,200 --> 00:14:47,520 INFORMATION THAT'S LIKELY TO 415 00:14:47,520 --> 00:14:49,080 GIVE A PERSON REASONS WHY THEY 416 00:14:49,080 --> 00:14:52,480 MIGHT OR MIGHT NOT WANT TO 417 00:14:52,480 --> 00:14:53,720 PARTICIPATE. 418 00:14:53,720 --> 00:14:54,480 SO, CONCISE AND FOCUSED 419 00:14:54,480 --> 00:14:58,920 ORGANIZED IN A WAY THAT 420 00:14:58,920 --> 00:15:00,840 FACILITATES COMPREHENSION BUT IN 421 00:15:00,840 --> 00:15:02,640 SUFFICIENT DETAIL THAT THEY CAN 422 00:15:02,640 --> 00:15:04,240 UNDERSTAND WHAT THE DETAILS ARE. 423 00:15:04,240 --> 00:15:06,360 AND SO THIS IS A CHALLENGE, AND 424 00:15:06,360 --> 00:15:08,320 I THINK WE'RE STILL WORKING ON 425 00:15:08,320 --> 00:15:10,920 HOW WE DO THIS IN EACH CASE, 426 00:15:10,920 --> 00:15:16,880 WITH CONSENT FORMS, FOR EXAMPLE. 427 00:15:16,880 --> 00:15:19,600 ALSO THERE'S LOTS OF GUIDANCE 428 00:15:19,600 --> 00:15:21,080 THAT SUGGESTS CONSENT FORMS, 429 00:15:21,080 --> 00:15:22,960 WRITTEN FORMS OR, AGAIN, ONLINE 430 00:15:22,960 --> 00:15:27,160 FORMS, SHOULD BE READABLE AND 431 00:15:27,160 --> 00:15:28,200 UNDERSTANDABLE. 432 00:15:28,200 --> 00:15:30,200 THAT INCLUDES ANYTHING THAT THE 433 00:15:30,200 --> 00:15:31,360 PARTICIPANTS OR POTENTIAL 434 00:15:31,360 --> 00:15:32,840 PARTICIPANTS ARE PROVIDED LIKE 435 00:15:32,840 --> 00:15:37,720 ADS OR PAMPHLETS OR FLYERS THAT 436 00:15:37,720 --> 00:15:38,880 MIGHT BE ACCOMPANYING OR 437 00:15:38,880 --> 00:15:40,680 PRECEDING THE PROCESS OF MAKING 438 00:15:40,680 --> 00:15:41,800 A DECISION. 439 00:15:41,800 --> 00:15:44,160 THOSE ARE ALL IMPORTANT PARTS OF 440 00:15:44,160 --> 00:15:45,200 GIVING PEOPLE INFORMATION. 441 00:15:45,200 --> 00:15:47,720 AND THOSE ALL NEED TO BE 442 00:15:47,720 --> 00:15:53,160 APPROVED BY THE REVIEWING IRB OR 443 00:15:53,160 --> 00:15:53,520 IRBs. 444 00:15:53,520 --> 00:15:55,320 REASON TO BELIEVE AND EVIDENCE 445 00:15:55,320 --> 00:15:58,400 TO SHOW THAT THE LENGTH OF 446 00:15:58,400 --> 00:16:01,040 CONSENT FORMS, THE FORMAT, THE 447 00:16:01,040 --> 00:16:02,160 READING LEVEL AND COMPLEXITY ARE 448 00:16:02,160 --> 00:16:05,000 ALL IMPORTANT IN TERMS OF 449 00:16:05,000 --> 00:16:06,000 DISCLOSING INFORMATION. 450 00:16:06,000 --> 00:16:07,880 SO IMAGINE JUST FOR A SECOND A 451 00:16:07,880 --> 00:16:09,680 PAGE OF INFORMATION WITH NO 452 00:16:09,680 --> 00:16:12,480 HEADINGS AND NO SORT OF MARGINS 453 00:16:12,480 --> 00:16:13,640 OR VERY MINIMAL MARGINS, HOW 454 00:16:13,640 --> 00:16:16,080 HARD THAT IS TO READ, AS OPPOSED 455 00:16:16,080 --> 00:16:19,280 TO A PAGE OF INFORMATION THAT 456 00:16:19,280 --> 00:16:21,360 HAS HEADINGS AND MARGINS AND 457 00:16:21,360 --> 00:16:23,280 MAYBE GRAPHICS, THAT'S THE KIND 458 00:16:23,280 --> 00:16:27,200 OF DISTINCTION THAT I THINK IS 459 00:16:27,200 --> 00:16:30,320 IMPORTANT TO THINK ABOUT BECAUSE 460 00:16:30,320 --> 00:16:32,200 IT DOES MAKE A DIFFERENCE IN HOW 461 00:16:32,200 --> 00:16:33,920 PEOPLE READ IT AND UNDERSTAND 462 00:16:33,920 --> 00:16:34,200 IT. 463 00:16:34,200 --> 00:16:37,320 THERE'S ALSO QUESTIONS ABOUT FOR 464 00:16:37,320 --> 00:16:39,320 THE CONSENT FORM ITSELF HOW 465 00:16:39,320 --> 00:16:41,640 OFTEN IS IT USED IN THE 466 00:16:41,640 --> 00:16:42,800 DISCUSSION? 467 00:16:42,800 --> 00:16:43,920 SO CONSENT DISCUSSIONS ALWAYS 468 00:16:43,920 --> 00:16:45,640 ACCOMPANY WRITTEN INFORMATION OF 469 00:16:45,640 --> 00:16:47,480 ANY KIND. 470 00:16:47,480 --> 00:16:49,640 AND SO DOES THE DISCUSSION 471 00:16:49,640 --> 00:16:52,400 FOLLOW THE SORT OF WRITTEN 472 00:16:52,400 --> 00:16:53,320 INFORMATION WORD FOR WORD? 473 00:16:53,320 --> 00:16:55,920 IS IT MORE SYNTHESIS OF THAT 474 00:16:55,920 --> 00:16:56,360 INFORMATION? 475 00:16:56,360 --> 00:16:59,760 IS IT USING THAT INFORMATION AND 476 00:16:59,760 --> 00:17:01,560 PROVIDING GRAPHICS OF SOME SORT, 477 00:17:01,560 --> 00:17:03,640 VISUAL MATERIAL OF SOME SORT? 478 00:17:03,640 --> 00:17:04,560 OR SOME COMBINATION. 479 00:17:04,560 --> 00:17:05,720 AND THOSE ARE ALL DECISIONS THAT 480 00:17:05,720 --> 00:17:08,000 NEED TO BE MADE ABOUT DISCLOSING 481 00:17:08,000 --> 00:17:11,360 INFORMATION IN THE PROCESS OF 482 00:17:11,360 --> 00:17:13,320 INFORMED CONSENT. 483 00:17:13,320 --> 00:17:16,720 IT'S IMPORTANT TO REMEMBER THAT 484 00:17:16,720 --> 00:17:17,640 UNFORTUNATELY HEALTH LITERACY IS 485 00:17:17,640 --> 00:17:19,240 NOT GREAT. 486 00:17:19,240 --> 00:17:21,320 THIS CAME FROM THE FDA CONSENT 487 00:17:21,320 --> 00:17:25,360 GUIDANCE SHEET THAT I MENTIONED 488 00:17:25,360 --> 00:17:25,840 ALREADY. 489 00:17:25,840 --> 00:17:28,560 BASICALLY SAYING THAT IN THE 490 00:17:28,560 --> 00:17:31,200 UNITED STATES ANYWAY, ONE-THIRD 491 00:17:31,200 --> 00:17:33,160 OF ADULTS OR 77 MILLION PEOPLE 492 00:17:33,160 --> 00:17:36,480 HAVE BASIC OR BELOW BASIC HEALTH 493 00:17:36,480 --> 00:17:37,000 LITERACY. 494 00:17:37,000 --> 00:17:39,360 AND THIS GOES ACROSS ALL RACIAL 495 00:17:39,360 --> 00:17:40,200 AND ETHNIC GROUPS. 496 00:17:40,200 --> 00:17:42,360 I DON'T KNOW THE DATA FROM OTHER 497 00:17:42,360 --> 00:17:52,840 COUNTRIES BUT I SUSPECT IT'S 498 00:17:58,840 --> 00:18:00,320 PROBABLY SIMILAR. 499 00:18:00,320 --> 00:18:04,280 WORSE IS QUANTITATIVE, HALF OR 500 00:18:04,280 --> 00:18:05,440 BELOW HALF HAVE QUANTITATIVE 501 00:18:05,440 --> 00:18:06,120 LITERACY. 502 00:18:06,120 --> 00:18:07,840 WHEN THINKING ABOUT PRESENTING 503 00:18:07,840 --> 00:18:10,360 INFORMATION IN THE PROCESS OF 504 00:18:10,360 --> 00:18:13,440 INFORMED CONSENT, SOME IS 505 00:18:13,440 --> 00:18:14,120 PROBABILITY OR NUMERICAL DATA, 506 00:18:14,120 --> 00:18:15,800 THINK ABOUT THE WAY IN WHICH 507 00:18:15,800 --> 00:18:17,520 PEOPLE WHO DON'T HAVE 508 00:18:17,520 --> 00:18:19,480 QUANTITATIVE LITERACY CAN 509 00:18:19,480 --> 00:18:22,440 UNDERSTAND THAT. 510 00:18:22,440 --> 00:18:24,520 OR CAN'T UNDERSTAND THAT. 511 00:18:24,520 --> 00:18:26,040 THERE ARE SOME GUIDANCES ABOUT 512 00:18:26,040 --> 00:18:27,680 HOW TO WRITE CONSENT FORMS. 513 00:18:27,680 --> 00:18:29,280 THIS IS ALL PRETTY 514 00:18:29,280 --> 00:18:30,840 STRAIGHTFORWARD AND ANYBODY WHO 515 00:18:30,840 --> 00:18:32,400 HAS WRITTEN OR HAS LEARNED 516 00:18:32,400 --> 00:18:39,760 ABOUT, YOU KNOW, HOW TO WRITE 517 00:18:39,760 --> 00:18:41,040 FOR LAY AUDIENCES SHOULD THINK 518 00:18:41,040 --> 00:18:43,560 ABOUT THESE KINDS OF RULES, 519 00:18:43,560 --> 00:18:45,000 USING FAMILIAR AND CONSISTENT 520 00:18:45,000 --> 00:18:47,000 VOICE, ACTIVE VOICE, PERSONAL 521 00:18:47,000 --> 00:18:51,640 PRONOUNCE, SHORT SIMPLE 522 00:18:51,640 --> 00:18:55,360 SENTENCES, SHORT PARAGRAPHS. 523 00:18:55,360 --> 00:18:56,560 LOGICALLY SEQUENCED IDEAS, 524 00:18:56,560 --> 00:18:58,240 AVOIDING ACRONYMS, AND FORMAT 525 00:18:58,240 --> 00:18:59,560 WHICH I ALREADY MENTIONED. 526 00:18:59,560 --> 00:19:01,680 SO HOW ARE WE DOING ON THIS? 527 00:19:01,680 --> 00:19:03,680 WHEN WE LOOK AT CONSENT FORMS, 528 00:19:03,680 --> 00:19:06,320 THESE ARE DATA THAT CAME FROM A 529 00:19:06,320 --> 00:19:07,960 NUMBER OF DIFFERENT STUDIES 530 00:19:07,960 --> 00:19:14,960 ACROSS TIME, I EASTBOUND -- 531 00:19:14,960 --> 00:19:17,480 EVEN WAS LOOKING FOR SOMETHING 532 00:19:17,480 --> 00:19:17,800 RECENT. 533 00:19:17,800 --> 00:19:19,480 READING LEVEL IN CONSENT FORMS 534 00:19:19,480 --> 00:19:21,000 IS USUALLY HIGH EVEN THOUGH WE 535 00:19:21,000 --> 00:19:24,240 KNOW THERE'S A HEALTH LITERACY 536 00:19:24,240 --> 00:19:25,800 ISSUE AND THAT MANY OF THE 537 00:19:25,800 --> 00:19:28,240 GUIDANCES THAT DO EXIST ABOUT 538 00:19:28,240 --> 00:19:31,040 CONSENT SAY WE SHOULD BE WRITING 539 00:19:31,040 --> 00:19:32,800 FORMS AT EIGHTH GRADE LEVEL. 540 00:19:32,800 --> 00:19:34,480 WHEN STUDIES LOOKED AT CONSENT 541 00:19:34,480 --> 00:19:36,960 FORMS OR TEMPLATES, THEY ARE 542 00:19:36,960 --> 00:19:38,480 OFTEN WRITTEN MORE AT AN 543 00:19:38,480 --> 00:19:40,240 ELEVENTH GRADE LEVEL OR HIGHER. 544 00:19:40,240 --> 00:19:41,320 THEY ARE ALSO LONG. 545 00:19:41,320 --> 00:19:42,480 THEY HAVE BEEN GETTING LONGER 546 00:19:42,480 --> 00:19:43,640 OVER TIME. 547 00:19:43,640 --> 00:19:46,240 IF YOU LOOK AT CONSENT FORMS 548 00:19:46,240 --> 00:19:47,800 FROM 30 YEARS AGO YOU CAN FIND 549 00:19:47,800 --> 00:19:49,640 SOME THAT ARE FIVE PAGES LONG. 550 00:19:49,640 --> 00:19:54,120 NOW THEY ARE 25 PAGES LONG OR 551 00:19:54,120 --> 00:19:55,400 SOMETIMES LONGER. 552 00:19:55,400 --> 00:19:58,200 AND SOME STUDIES HAVE LOOKED AT 553 00:19:58,200 --> 00:20:00,560 EVEN LONG AND COMPLEX DO THEY 554 00:20:00,560 --> 00:20:05,440 INCLUDE ALL THE KINDS OF 555 00:20:05,440 --> 00:20:06,320 INFORMATION THAT THE REGULATIONS 556 00:20:06,320 --> 00:20:09,080 REQUIRE OR THAT MIGHT BE 557 00:20:09,080 --> 00:20:09,880 RELEVANT TO PEOPLE PARTICIPATING 558 00:20:09,880 --> 00:20:11,480 IN A PARTICULAR STUDY. 559 00:20:11,480 --> 00:20:13,360 STUDIES ON THAT ANGLE FOUND 560 00:20:13,360 --> 00:20:16,200 THERE ARE THINGS MISSING DESPITE 561 00:20:16,200 --> 00:20:20,800 THE LENGTH AND COMPLEXITY; THEY 562 00:20:20,800 --> 00:20:22,120 ARE MISSING IMPORTANT THINGS. 563 00:20:22,120 --> 00:20:25,400 I'VE MENTIONED PRESENTATION AND 564 00:20:25,400 --> 00:20:25,640 SETTING. 565 00:20:25,640 --> 00:20:26,880 ONE INTERESTING CHALLENGE FOR 566 00:20:26,880 --> 00:20:29,400 PEOPLE DOING RESEARCH IS NOT 567 00:20:29,400 --> 00:20:30,600 ONLY PRESENTING INFORMATION AT 568 00:20:30,600 --> 00:20:32,600 THE TIME TO THE PERSONS THEY ARE 569 00:20:32,600 --> 00:20:35,120 SPEAKING TO BUT IS THAT IN 570 00:20:35,120 --> 00:20:36,040 PERSON -- SORRY, IS THAT 571 00:20:36,040 --> 00:20:37,640 INDIVIDUAL, IS THAT IN A GROUP, 572 00:20:37,640 --> 00:20:39,560 IS IT BOTH, SHOULD THERE BE 573 00:20:39,560 --> 00:20:40,600 WRITTEN INFORMATION FIRST, 574 00:20:40,600 --> 00:20:44,320 SHOULD THERE BE VISUAL 575 00:20:44,320 --> 00:20:46,080 INFORMATION FIRST? 576 00:20:46,080 --> 00:20:50,120 MAYBE TIMES RESEARCH TEAMS SEND 577 00:20:50,120 --> 00:20:52,080 OUT INFORMATION TO PROSPECTIVE 578 00:20:52,080 --> 00:20:54,760 PARTICIPANTS BEFORE THEY COME TO 579 00:20:54,760 --> 00:20:56,320 A CLINIC GIVING PEOPLE A HEADS 580 00:20:56,320 --> 00:20:58,960 UP AND ALLOWED THEM TO TALK TO 581 00:20:58,960 --> 00:21:07,360 PEOPLE THEY TRUST TO HELP THEM 582 00:21:07,360 --> 00:21:15,680 EXPLAINING EXPLAIN THINGS. 583 00:21:15,680 --> 00:21:18,200 I MENTIONED PEOPLE WHO ARE SICK, 584 00:21:18,200 --> 00:21:19,080 CONFUSED, IN DISTRESSED. 585 00:21:19,080 --> 00:21:20,720 I MENTIONED CHALLENGES TO 586 00:21:20,720 --> 00:21:23,720 WRITING AND PRESENTING CONSENT 587 00:21:23,720 --> 00:21:25,320 INFORMATION IN ACCESSIBLE 588 00:21:25,320 --> 00:21:29,280 UNDERSTANDABLE WAYS THAT'S 589 00:21:29,280 --> 00:21:32,600 RELEVANT TO PEOPLE WHO YOU'RE 590 00:21:32,600 --> 00:21:33,680 SPEAKING TO. 591 00:21:33,680 --> 00:21:35,240 NATHANIEL HAWTHORNE SAID A LONG 592 00:21:35,240 --> 00:21:37,320 TIME AGO, EASYING READING IS 593 00:21:37,320 --> 00:21:38,600 DAMN HARD WRITING. 594 00:21:38,600 --> 00:21:40,720 IT'S EASIER TO WRITE A LONGER 595 00:21:40,720 --> 00:21:42,040 PIECE THAN SHORTER PIECE, TO 596 00:21:42,040 --> 00:21:47,480 REALLY FOCUS AND GET IT RIGHT IS 597 00:21:47,480 --> 00:21:49,880 NOT EASY. 598 00:21:49,880 --> 00:21:50,920 THE WRITTEN INFORMED CONSENT 599 00:21:50,920 --> 00:21:53,200 INFORMATION NOT ONLY PROVIDES 600 00:21:53,200 --> 00:22:01,360 INFORMATION TO THE PROSPECTIVE 601 00:22:01,360 --> 00:22:03,720 PARTICIPANTS BUT PROTECTS THE 602 00:22:03,720 --> 00:22:04,760 SPONSOR, MORE INFORMATION TO 603 00:22:04,760 --> 00:22:06,640 PROTECT AGAINST LIABILITY AND 604 00:22:06,640 --> 00:22:07,600 RECOGNIZING MORE INFORMATION 605 00:22:07,600 --> 00:22:10,800 OFTEN MAKES THINGS HARDER TO 606 00:22:10,800 --> 00:22:12,480 UNDERSTAND. 607 00:22:12,480 --> 00:22:13,760 IT'S ALSO INTERESTING, IRBs 608 00:22:13,760 --> 00:22:20,480 HAVE HAVE WANTED CONSENT FORMS 609 00:22:20,480 --> 00:22:24,440 FOR UNDERSTANDABLE BUT THEY ARE 610 00:22:24,440 --> 00:22:25,960 OFTEN REQUIRING MORE INFORMATION 611 00:22:25,960 --> 00:22:30,160 MAKING FORMS LONGER AND MORE 612 00:22:30,160 --> 00:22:30,640 COMPLEX. 613 00:22:30,640 --> 00:22:32,800 SO, DISCLOSING INFORMATION IS 614 00:22:32,800 --> 00:22:33,560 IMPORTANT PART. 615 00:22:33,560 --> 00:22:35,360 NOW THE QUESTION AND THE PURPOSE 616 00:22:35,360 --> 00:22:37,560 AS WE DESCRIBED IS SO PEOPLE CAN 617 00:22:37,560 --> 00:22:38,480 UNDERSTAND AND MAKE A DECISION 618 00:22:38,480 --> 00:22:40,600 BASED ON IT. 619 00:22:40,600 --> 00:22:42,000 SO, THERE HAVE BEEN A NUMBER OF 620 00:22:42,000 --> 00:22:43,400 STUDIES OTHER THE YEARS THAT 621 00:22:43,400 --> 00:22:46,320 LOOKED AT HOW WELL DO PEOPLE WHO 622 00:22:46,320 --> 00:22:48,040 ARE PARTICIPANTS IN RESEARCH 623 00:22:48,040 --> 00:22:49,680 UNDERSTAND WHAT THEY HAVE 624 00:22:49,680 --> 00:22:52,480 DON'TED TO BASICALLY, WHAT THEY 625 00:22:52,480 --> 00:22:54,440 HAVE SIGNED THEIR CONSENT FOR. 626 00:22:54,440 --> 00:23:02,160 AND THE STUDIES, THE ONES AT THE 627 00:23:02,160 --> 00:23:05,880 TOP ALL ARE SORT OF 628 00:23:05,880 --> 00:23:06,760 META-ANALYSES OR SYSTEMATIC 629 00:23:06,760 --> 00:23:09,360 REVIEWS THAT LOOKED AT CONSENT 630 00:23:09,360 --> 00:23:11,400 STUDIES ACROSS A WIDE SPECTRUM 631 00:23:11,400 --> 00:23:15,920 AND COME UP WITH THIS PRETTY 632 00:23:15,920 --> 00:23:17,080 UNSATISFACTORY CONCLUSION THAT 633 00:23:17,080 --> 00:23:19,520 PEOPLE HAVE A VARIABLE 634 00:23:19,520 --> 00:23:19,840 UNDERSTANDING. 635 00:23:19,840 --> 00:23:21,640 BUT VARIABLE MEANING NOT AS GOOD 636 00:23:21,640 --> 00:23:23,040 AS WE WOULD HOPE IN TERMS OF 637 00:23:23,040 --> 00:23:24,400 WHAT WE'RE TRYING TO ACHIEVE IN 638 00:23:24,400 --> 00:23:28,040 THE PROCESS OF INFORMED CONSENT. 639 00:23:28,040 --> 00:23:30,320 IF YOU LOOK AT THE PARTICULAR 640 00:23:30,320 --> 00:23:33,000 STUDIES YOU CAN SEE IN TERMS OF 641 00:23:33,000 --> 00:23:34,560 SPECIFIC THINGS LIKE 642 00:23:34,560 --> 00:23:35,160 UNDERSTANDING RESEARCH PURPOSE 643 00:23:35,160 --> 00:23:38,200 AND NATURE, SOME STUDIES FIND AS 644 00:23:38,200 --> 00:23:40,760 LOW AS 20% OF PEOPLE IN THE 645 00:23:40,760 --> 00:23:41,720 STUDIES UNDERSTAND THE PURPOSE 646 00:23:41,720 --> 00:23:43,640 AND NATURE OF THE RESEARCH THAT 647 00:23:43,640 --> 00:23:44,960 THEY ARE IN. 648 00:23:44,960 --> 00:23:47,080 IN OTHER STUDIES IT'S UP TO 649 00:23:47,080 --> 00:23:47,360 100%. 650 00:23:47,360 --> 00:23:49,560 SAME WITH RESEARCH RISK. 651 00:23:49,560 --> 00:23:52,360 SOME STUDIES IN THE 20s. 652 00:23:52,360 --> 00:23:55,520 AND I HAVE TO SAY THERE ARE SOME 653 00:23:55,520 --> 00:23:57,520 REASONS THAT THESE DATA ARE 654 00:23:57,520 --> 00:23:59,840 DIFFICULT TO PUT TOGETHER IN THE 655 00:23:59,840 --> 00:24:01,840 FOLLOWING SENSE, SOME STUDIES 656 00:24:01,840 --> 00:24:04,080 ASK CAN YOU RECALL RISKS THAT 657 00:24:04,080 --> 00:24:05,080 THEY DISCLOSE TO YOU? 658 00:24:05,080 --> 00:24:08,720 AND ASK FOR PEOPLE TO RECALL. 659 00:24:08,720 --> 00:24:09,720 OTHERS, YOU KNOW, GIVE 660 00:24:09,720 --> 00:24:10,960 PARTICIPANTS A LIST AND SAY 661 00:24:10,960 --> 00:24:12,920 CHOOSE THE ONES YOU HEARD ABOUT. 662 00:24:12,920 --> 00:24:15,040 AND OF COURSE PEOPLE DO BETTER 663 00:24:15,040 --> 00:24:22,160 ON THE SECOND STYLE THAN THE 664 00:24:22,160 --> 00:24:23,600 FIRST STYLE. 665 00:24:23,600 --> 00:24:25,320 IT ALSO MATTERS WHEN QUESTIONS 666 00:24:25,320 --> 00:24:26,560 ARE ASKED BUT THE GENERAL IDEA 667 00:24:26,560 --> 00:24:28,040 IS THERE'S A REAL CHANGE IN 668 00:24:28,040 --> 00:24:32,240 TERMS OF WHAT PEOPLE UNDERSTAND. 669 00:24:32,240 --> 00:24:33,640 CONSISTENTLY IN EVERY STUDY 670 00:24:33,640 --> 00:24:34,600 THAT'S ASKED ABOUT IT, THE KINDS 671 00:24:34,600 --> 00:24:38,000 OF THINGS THAT PEOPLE HAVE THE 672 00:24:38,000 --> 00:24:42,120 HARDEST TIME UNDERSTANDING ARE 673 00:24:42,120 --> 00:24:42,920 THINGS LIKE RANDOMIZATION, 674 00:24:42,920 --> 00:24:44,320 COMMON USED IN RESEARCH, PEOPLE 675 00:24:44,320 --> 00:24:45,240 HAVE A HARD TIME UNDERSTANDING 676 00:24:45,240 --> 00:24:47,560 WHAT IT MEANS AND HOW IT APPLIES 677 00:24:47,560 --> 00:24:48,920 TO THEM. 678 00:24:48,920 --> 00:24:50,840 THE OTHER THING THAT COMES IN 679 00:24:50,840 --> 00:24:51,840 SOME STUDIES IS PLACEBO USE. 680 00:24:51,840 --> 00:24:53,640 A LOT OF PEOPLE DON'T UNDERSTAND 681 00:24:53,640 --> 00:24:54,440 THAT EITHER. 682 00:24:54,440 --> 00:25:00,800 SO THE PERCENTAGE OF PEOPLE THAT 683 00:25:00,800 --> 00:25:01,600 UNDERSTAND RANDOMIZATION AND 684 00:25:01,600 --> 00:25:03,600 PLACEBO IS MUCH LOWER ACROSS THE 685 00:25:03,600 --> 00:25:04,200 BOARD. 686 00:25:04,200 --> 00:25:08,480 THIS IS FROM THE META-ANALYSIS 687 00:25:08,480 --> 00:25:09,080 TAM AND COLLEAGUES PUBLISHED A 688 00:25:09,080 --> 00:25:10,680 FEW YEARS AGO. 689 00:25:10,680 --> 00:25:12,400 WHAT'S INTERESTING IS TWO 690 00:25:12,400 --> 00:25:12,640 THINGS. 691 00:25:12,640 --> 00:25:17,320 ONE IS THAT NOTHING IS MORE THAN 692 00:25:17,320 --> 00:25:20,240 75%. 693 00:25:20,240 --> 00:25:21,800 SO NO -- UNDERSTANDING OF 694 00:25:21,800 --> 00:25:24,520 NOTHING, 1 OUT OF 4 PEOPLE IN 695 00:25:24,520 --> 00:25:28,680 RESEARCH DON'T UNDERSTAND ANY OF 696 00:25:28,680 --> 00:25:29,280 THIS. 697 00:25:29,280 --> 00:25:30,120 THE OTHER THING IS TO LOOK AT 698 00:25:30,120 --> 00:25:31,760 THE LIST ON THE LEFT. 699 00:25:31,760 --> 00:25:33,800 I THINK THERE ARE THINGS ON THIS 700 00:25:33,800 --> 00:25:35,240 LIST THAT ARE PROBABLY MORE 701 00:25:35,240 --> 00:25:37,240 IMPORTANT TO UNDERSTAND THAN 702 00:25:37,240 --> 00:25:37,800 OTHERS. 703 00:25:37,800 --> 00:25:38,840 SO CERTAINLY YOU WANT PEOPLE TO 704 00:25:38,840 --> 00:25:40,280 UNDERSTAND THE RISKS OF WHAT 705 00:25:40,280 --> 00:25:41,960 THEY ARE BEING ASKED TO DO. 706 00:25:41,960 --> 00:25:44,280 YOU WANT PEOPLE TO UNDERSTAND 707 00:25:44,280 --> 00:25:45,600 THAT THEY CAN WITHDRAW IF THEY 708 00:25:45,600 --> 00:25:47,560 DON'T WANT TO DO IT OR SAY NO IF 709 00:25:47,560 --> 00:25:49,680 THEY DON'T WANT TO DO IT. 710 00:25:49,680 --> 00:25:56,200 AND NONE OF THOSE THINGS 711 00:25:56,200 --> 00:25:57,360 APPROACH 100%. 712 00:25:57,360 --> 00:25:59,160 SO, IT'S ALSO INTERESTING TO 713 00:25:59,160 --> 00:26:00,280 THINK ABOUT WHAT AFFECTS 714 00:26:00,280 --> 00:26:00,840 UNDERSTANDING. 715 00:26:00,840 --> 00:26:02,640 WHY DO PEOPLE HAVE A HARD TIME 716 00:26:02,640 --> 00:26:03,880 UNDERSTANDING SOME DETAILS OF 717 00:26:03,880 --> 00:26:05,520 THE RESEARCH THEY ARE IN? 718 00:26:05,520 --> 00:26:06,760 CERTAINLY THERE ARE HOST 719 00:26:06,760 --> 00:26:07,320 FACTORS. 720 00:26:07,320 --> 00:26:11,040 THERE'S BEEN DATA TO SHOW, FOR 721 00:26:11,040 --> 00:26:12,360 EXAMPLE, AGE MATTERS. 722 00:26:12,360 --> 00:26:13,080 EDUCATION MATTERS. 723 00:26:13,080 --> 00:26:16,480 PEOPLE IN PAIN OR HAVE COGNITIVE 724 00:26:16,480 --> 00:26:17,080 IMPAIRMENT CAPACITY, LITERACY, 725 00:26:17,080 --> 00:26:20,000 ALL OF THOSE THINGS CAN AFFECT 726 00:26:20,000 --> 00:26:21,400 WHAT A PERSON ABSORBS FROM 727 00:26:21,400 --> 00:26:22,720 INFORMATION, HOW WELL THEY 728 00:26:22,720 --> 00:26:24,000 UNDERSTAND IT. 729 00:26:24,000 --> 00:26:27,040 I THINK IMPORTANTLY AND PROBABLY 730 00:26:27,040 --> 00:26:28,960 LESS WELL DOCUMENTED BUT SEEMS 731 00:26:28,960 --> 00:26:31,160 TO ME ACTUALLY PROBABLY MORE 732 00:26:31,160 --> 00:26:32,040 INFLUENTIAL IS THIS WHOLE 733 00:26:32,040 --> 00:26:34,480 CATEGORY OF WHAT I'M CALLING 734 00:26:34,480 --> 00:26:35,480 EXPECTATIONS AND FAMILIARITY. 735 00:26:35,480 --> 00:26:38,680 THE PEOPLE HAVE A VARIETY OF 736 00:26:38,680 --> 00:26:40,040 DIFFERENT MOTIVATIONS FOR 737 00:26:40,040 --> 00:26:40,760 PARTICIPATING, IN A RESEARCH 738 00:26:40,760 --> 00:26:41,400 STUDY. 739 00:26:41,400 --> 00:26:42,840 IF THEY ARE DRIVEN TO 740 00:26:42,840 --> 00:26:44,200 PARTICIPATE IN A RESEARCH 741 00:26:44,200 --> 00:26:47,280 STUDIES BECAUSE THEY THINK THAT 742 00:26:47,280 --> 00:26:49,360 THE INTERVENTION BEING TESTED IN 743 00:26:49,360 --> 00:26:52,040 THIS STUDY IS GIVING THEM THE 744 00:26:52,040 --> 00:26:53,440 BEST OPTION FOR TREATMENT, AND 745 00:26:53,440 --> 00:26:56,080 THEY DON'T HAVE VERY MANY OTHER 746 00:26:56,080 --> 00:26:58,160 OPTIONS, THEN THEY ARE LESS 747 00:26:58,160 --> 00:27:00,720 INTERESTED IN UNDERSTANDING THE 748 00:27:00,720 --> 00:27:01,760 DETAILS OF THE PARTICULAR STUDY 749 00:27:01,760 --> 00:27:04,000 BECAUSE THEY HAVE ALREADY MADE 750 00:27:04,000 --> 00:27:05,920 THAT SORT OF EXPECTATION OF 751 00:27:05,920 --> 00:27:08,560 THEIR MOTIVATIONS TO BE 752 00:27:08,560 --> 00:27:08,800 BENEFITED. 753 00:27:08,800 --> 00:27:12,680 THERE'S BEEN -- WE DID A STUDY 754 00:27:12,680 --> 00:27:15,200 WITH PARTICIPANTS IN CANCER 755 00:27:15,200 --> 00:27:16,960 CLINICAL TRIALS, AND ALMOST 50% 756 00:27:16,960 --> 00:27:19,880 OF THE PEOPLE IN THE TRIAL, IN 757 00:27:19,880 --> 00:27:21,840 OUR STUDY, EXCUSE ME, SAID THEY 758 00:27:21,840 --> 00:27:22,880 DIDN'T PAY ATTENTION TO THE 759 00:27:22,880 --> 00:27:25,080 RISKS AND BENEFITS OF THE STUDY 760 00:27:25,080 --> 00:27:26,680 BECAUSE THEY WANTED THE BENEFIT 761 00:27:26,680 --> 00:27:28,480 AND TRUSTED IN THEIR PROVIDER 762 00:27:28,480 --> 00:27:30,320 WHO TOLD THEM THIS IS YOUR BEST 763 00:27:30,320 --> 00:27:31,040 OPTION. 764 00:27:31,040 --> 00:27:36,880 SO THEY DIDN'T BOTHER TO READ 765 00:27:36,880 --> 00:27:37,360 THE DETAILS. 766 00:27:37,360 --> 00:27:39,520 THERE ARE ALSO CHALLENGES 767 00:27:39,520 --> 00:27:41,680 RELATED TO CULTURAL VIEWS, HOW 768 00:27:41,680 --> 00:27:42,800 PEOPLE UNDERSTAND WHAT RESEARCH 769 00:27:42,800 --> 00:27:46,160 IS AND WHY RESEARCH IS BEING 770 00:27:46,160 --> 00:27:51,160 DONE, OR THAT RESEARCH IS, AND 771 00:27:51,160 --> 00:27:54,720 THOSE CREATE CHALLENGES TO 772 00:27:54,720 --> 00:27:55,480 UNDERSTANDING. 773 00:27:55,480 --> 00:27:58,200 ANOTHER EXAMPLE OF A CONSULT WE 774 00:27:58,200 --> 00:28:00,080 HAD WHERE THE INTERVENTION 775 00:28:00,080 --> 00:28:03,320 ITSELF WAS BASICALLY STANDARD 776 00:28:03,320 --> 00:28:05,320 CARE, AND THEY WERE -- THE 777 00:28:05,320 --> 00:28:07,080 RESEARCH PART OF THE STUDY WAS 778 00:28:07,080 --> 00:28:07,920 TAKING PART OF THE TUMOR THAT 779 00:28:07,920 --> 00:28:10,040 WAS GOING TO BE SURGICALLY 780 00:28:10,040 --> 00:28:11,320 REMOVED AND STUDYING THE TISSUE 781 00:28:11,320 --> 00:28:14,000 IN THE LABORATORY. 782 00:28:14,000 --> 00:28:15,600 AND THE FAMILY OF THE PERSON WHO 783 00:28:15,600 --> 00:28:19,600 WAS GOING TO HAVE THE SURGERY 784 00:28:19,600 --> 00:28:21,600 WAS JUST LIKE, RESEARCH, NO, WE 785 00:28:21,600 --> 00:28:24,040 DON'T DO RESEARCH. 786 00:28:24,040 --> 00:28:25,480 AND SORT OF PARSING OUT THAT 787 00:28:25,480 --> 00:28:27,640 THIS WAS THE KIND OF CARE THAT 788 00:28:27,640 --> 00:28:29,000 SHE WOULD GET ANYWHERE, BUT THAT 789 00:28:29,000 --> 00:28:30,120 THEY WERE JUST GOING TO LOOK AT 790 00:28:30,120 --> 00:28:33,480 HER TISSUE IN THE LABORATORY 791 00:28:33,480 --> 00:28:35,920 AFTERWARDS WAS VERY DIFFICULT 792 00:28:35,920 --> 00:28:38,000 BECAUSE ALL THEY HEARD WAS 793 00:28:38,000 --> 00:28:39,200 RESEARCH AND DIDN'T WANT HER TO 794 00:28:39,200 --> 00:28:40,840 BE EXPERIMENTED ON. 795 00:28:40,840 --> 00:28:45,360 PEOPLE ALSO HAVE WHAT HAS BEEN 796 00:28:45,360 --> 00:28:45,920 TERMED THERAPEUTIC 797 00:28:45,920 --> 00:28:47,320 MISCONCEPTION, BASICALLY JUST 798 00:28:47,320 --> 00:28:49,400 MISUNDERSTANDING THAT RESEARCH 799 00:28:49,400 --> 00:28:55,320 IS DONE FOR THEM. 800 00:28:55,320 --> 00:28:59,280 IT CAME FROM A -- PAUL APPLEBAUM 801 00:28:59,280 --> 00:29:07,520 AND COLLEAGUES STUDYING 802 00:29:07,520 --> 00:29:08,480 PARTICIPANTS WITH SCHIZOPHRENIA 803 00:29:08,480 --> 00:29:09,240 AND INTERVIEWED THEM AFTER 804 00:29:09,240 --> 00:29:10,920 CONSENT FOR THE TRIAL. 805 00:29:10,920 --> 00:29:12,920 A LARGE PERCENTAGE SAID, YES, I 806 00:29:12,920 --> 00:29:14,600 UNDERSTAND THIS IS A RESEARCH. 807 00:29:14,600 --> 00:29:16,440 YES, I UNDERSTAND THEY ARE 808 00:29:16,440 --> 00:29:16,960 RANDOMIZING. 809 00:29:16,960 --> 00:29:17,880 YES, I UNDERSTAND THERE'S 810 00:29:17,880 --> 00:29:18,760 PLACEBO INVOLVED. 811 00:29:18,760 --> 00:29:20,600 OH, NO, MY DOCTOR WOULD NOT LET 812 00:29:20,600 --> 00:29:21,600 ME HAVE PLACEBO. 813 00:29:21,600 --> 00:29:24,600 THEY ARE GOING TO GIVE ME THE 814 00:29:24,600 --> 00:29:25,680 INTERVENTION. 815 00:29:25,680 --> 00:29:28,520 SO, IT WAS A MISUNDERSTANDING OF 816 00:29:28,520 --> 00:29:31,160 THE INTENT OF RESEARCH AS 817 00:29:31,160 --> 00:29:32,440 APPLIED TO THE PERSON. 818 00:29:32,440 --> 00:29:34,520 THERE ARE ALSO OF COURSE A LOT 819 00:29:34,520 --> 00:29:37,040 OF PROCESS-RELATED FACTORS. 820 00:29:37,040 --> 00:29:38,840 YOU CAN IMAGINE UNDERSTANDING IS 821 00:29:38,840 --> 00:29:40,200 INFLUENCED BY WHAT IS DISCLOSED 822 00:29:40,200 --> 00:29:42,720 AND HOW THINGS ARE DISCLOSED AND 823 00:29:42,720 --> 00:29:44,800 WHO DISCLOSES IT. 824 00:29:44,800 --> 00:29:46,680 AND HOW WELL THE PARTICIPANT 825 00:29:46,680 --> 00:29:47,320 LISTENS. 826 00:29:47,320 --> 00:29:48,560 ANOTHER EXAMPLE OF A CONSULT 827 00:29:48,560 --> 00:29:51,280 MANY YEARS AGO, A YOUNG MAN WHO 828 00:29:51,280 --> 00:29:57,800 WAS VERY ILL, VERY SCARED, AND 829 00:29:57,800 --> 00:30:00,360 CAME FOR A PRETTY INTENSE 830 00:30:00,360 --> 00:30:03,640 PROTOCOL WHICH INVOLVED LOTS OF 831 00:30:03,640 --> 00:30:04,440 REALLY RISKY STUFF. 832 00:30:04,440 --> 00:30:06,480 AND I'M NOT GOING TO GIVE YOU 833 00:30:06,480 --> 00:30:08,120 MORE DETAILS THAN THAT. 834 00:30:08,120 --> 00:30:10,720 HERE IS THE SCENARIO. 835 00:30:10,720 --> 00:30:12,280 THIS IS HOW CONSENT SHOULD NOT 836 00:30:12,280 --> 00:30:12,560 HAPPEN. 837 00:30:12,560 --> 00:30:13,560 WE WERE IN THE CLINIC. 838 00:30:13,560 --> 00:30:14,320 I WAS THERE WITH HIM. 839 00:30:14,320 --> 00:30:16,880 WE WERE IN THE CLINIC, HE WAS 840 00:30:16,880 --> 00:30:20,720 SITTING IN A CHAIR. THERE WERE 841 00:30:20,720 --> 00:30:22,120 THREE INVESTIGATORS STANDING 842 00:30:22,120 --> 00:30:24,320 OVER HIM GIVING HIM INFORMATION. 843 00:30:24,320 --> 00:30:29,080 THEY GAVE HIM TONS OF 844 00:30:29,080 --> 00:30:29,680 INFORMATION, REALLY CAREFULLY 845 00:30:29,680 --> 00:30:33,320 DETAILED ALL OF THE PARTS OF THE 846 00:30:33,320 --> 00:30:34,440 PROTOCOL AND WHAT WOULD HAPPEN 847 00:30:34,440 --> 00:30:37,440 TO HIM . 848 00:30:37,440 --> 00:30:42,400 IN THE MIDST OF GIVING HIM 849 00:30:42,400 --> 00:30:44,080 INFORMATION, A PAGER WENT OFF, 850 00:30:44,080 --> 00:30:46,080 IT WAS A CHAOTIC PRESENTATION OF 851 00:30:46,080 --> 00:30:47,800 INFORMATION AS WELL BUT IT FELT 852 00:30:47,800 --> 00:30:49,200 LIKE SORT OF A DUMP OF 853 00:30:49,200 --> 00:30:51,840 INFORMATION ON THIS PERSON WHO 854 00:30:51,840 --> 00:30:54,440 WAS SITTING DOWN UNDERNEATH 855 00:30:54,440 --> 00:30:55,800 THESE THREE BIG -- NOT THAT BIG 856 00:30:55,800 --> 00:31:02,120 BUT YOU KNOW WHAT I MEAN, 857 00:31:02,120 --> 00:31:02,720 INVESTIGATORS. 858 00:31:02,720 --> 00:31:03,040 INTIMIDATING. 859 00:31:03,040 --> 00:31:04,320 AND IT JUST HAS ALWAYS STUCK IN 860 00:31:04,320 --> 00:31:07,560 MY MIND AS THE WAY NOT TO GIVE 861 00:31:07,560 --> 00:31:10,280 PEOPLE INFORMATION AND CERTAINLY 862 00:31:10,280 --> 00:31:15,920 IT IMPACTED, AND SHOULD HAVE, 863 00:31:15,920 --> 00:31:18,000 WHAT HE WAS ABLE TO ABSORB AND 864 00:31:18,000 --> 00:31:18,360 UNDERSTOOD. 865 00:31:18,360 --> 00:31:19,080 THERE ARE INTERESTING CHALLENGES 866 00:31:19,080 --> 00:31:22,120 THAT HAVE NOT BEEN RESOLVED IN 867 00:31:22,120 --> 00:31:23,480 THE RESEARCH ETHICS WORLD THAT 868 00:31:23,480 --> 00:31:25,080 RELATE TO UNDERSTANDING IN THE 869 00:31:25,080 --> 00:31:26,720 PROCESS OF INFORMED CONSENT. 870 00:31:26,720 --> 00:31:30,280 ONE IS HOW IS OR HOW SHOULD 871 00:31:30,280 --> 00:31:31,240 UNDERSTANDING BE ASSESSED. 872 00:31:31,240 --> 00:31:32,760 SOMETIMES IN THE PROCESS OF 873 00:31:32,760 --> 00:31:34,440 INFORMED CONSENT THE TEAM WILL 874 00:31:34,440 --> 00:31:35,840 GIVE PEOPLE INFORMATION. 875 00:31:35,840 --> 00:31:37,720 THEY WILL HAVE SENT INFORMATION. 876 00:31:37,720 --> 00:31:39,000 THEY WILL HAVE TALKED TO FIVE 877 00:31:39,000 --> 00:31:41,600 MEMBERS OF THE TEAM, HAVE READ 878 00:31:41,600 --> 00:31:42,960 THE CONSENT FORM, AND THEN 879 00:31:42,960 --> 00:31:44,240 SOMEBODY SAYS TO THE 880 00:31:44,240 --> 00:31:46,720 PARTICIPANT, DO YOU HAVE ANY 881 00:31:46,720 --> 00:31:47,280 QUESTIONS? 882 00:31:47,280 --> 00:31:50,360 AND THE PERSON WHO SAYS NO, THE 883 00:31:50,360 --> 00:31:52,760 ASSUMPTION IS THEY UNDERSTAND. 884 00:31:52,760 --> 00:31:55,280 THAT RANGES FROM THAT MINIMAL 885 00:31:55,280 --> 00:31:58,960 KIND OF ASSESSMENT TO THERE ARE 886 00:31:58,960 --> 00:32:02,160 SOME STUDIES THAT HAVE, 887 00:32:02,160 --> 00:32:03,760 ESPECIALLY RISKY STUDIES, THAT 888 00:32:03,760 --> 00:32:04,760 HAVE BUILT-IN QUIZZES. 889 00:32:04,760 --> 00:32:06,840 AFTER THE PERSON GETS 890 00:32:06,840 --> 00:32:07,680 INFORMATION AND THEY HAVE TO 891 00:32:07,680 --> 00:32:11,040 TAKE A QUIZ AND PASS BY 80% OR 892 00:32:11,040 --> 00:32:12,560 MORE TO ENROLL IN THE STUDY. 893 00:32:12,560 --> 00:32:13,800 THERE'S NO AGREEMENT ON WHAT'S 894 00:32:13,800 --> 00:32:16,640 THE RIGHT WAY TO ASSESS 895 00:32:16,640 --> 00:32:17,680 UNDERSTANDING. 896 00:32:17,680 --> 00:32:18,560 THERE'S ALSO DISAGREEMENT ABOUT 897 00:32:18,560 --> 00:32:19,600 HOW MUCH PARTICIPANTS SHOULD 898 00:32:19,600 --> 00:32:19,880 UNDERSTAND. 899 00:32:19,880 --> 00:32:22,280 I ALREADY TOLD YOU ABOUT THE 900 00:32:22,280 --> 00:32:23,520 WOMAN WHO DIDN'T KNOW THE NAME 901 00:32:23,520 --> 00:32:26,360 OF THE DRUG BUT THERE'S A LOT OF 902 00:32:26,360 --> 00:32:29,720 INTERESTING LITERATURE ON IF WE 903 00:32:29,720 --> 00:32:32,520 REALLY THINK PEOPLE NEED TO 904 00:32:32,520 --> 00:32:33,280 UNDERSTAND XYZ WE SHOULDN'T 905 00:32:33,280 --> 00:32:35,000 REALLY BE LETTING THEM IN THE 906 00:32:35,000 --> 00:32:36,960 STUDY BECAUSE SO MANY PEOPLE 907 00:32:36,960 --> 00:32:38,520 DON'T UNDERSTAND XYZ SO THERE'S 908 00:32:38,520 --> 00:32:43,280 INTERESTING QUESTIONS ABOUT WHAT 909 00:32:43,280 --> 00:32:44,080 SHOULD PEOPLE UNDERSTAND THAT 910 00:32:44,080 --> 00:32:45,280 THERE'S SOME DISAGREEMENT ABOUT. 911 00:32:45,280 --> 00:32:47,480 AND THEN WHAT HAPPENS OR WHAT 912 00:32:47,480 --> 00:32:48,800 SHOULD HAPPEN WHEN A PARTICIPANT 913 00:32:48,800 --> 00:32:50,600 DOESN'T UNDERSTAND, WHEN YOU'RE 914 00:32:50,600 --> 00:32:53,960 ABLE TO SUSS OUT THAT 915 00:32:53,960 --> 00:32:54,400 PARTICIPANTS DON'T. 916 00:32:54,400 --> 00:32:59,880 A LOT OF PEOPLE WOULD SAY JUST 917 00:32:59,880 --> 00:33:01,720 CATEGORICALLY IF THEY DON'T 918 00:33:01,720 --> 00:33:02,520 UNDERSTAND ESSENTIAL ELEMENTS, 919 00:33:02,520 --> 00:33:04,800 THEY SHOULDN'T BE ALLOWED TO 920 00:33:04,800 --> 00:33:05,200 PARTICIPATE. 921 00:33:05,200 --> 00:33:08,640 BUT, AGAIN, THAT'S A JUDGMENT 922 00:33:08,640 --> 00:33:10,160 AND THAT'S CONTINGENT ON MAKING 923 00:33:10,160 --> 00:33:11,360 A DECISION WHAT ARE ESSENTIAL 924 00:33:11,360 --> 00:33:17,800 ELEMENTS THEY DO NEED TO 925 00:33:17,800 --> 00:33:19,560 UNDERSTAND. 926 00:33:19,560 --> 00:33:22,720 THERE'S BEEN WORK, A PAPER DAVE 927 00:33:22,720 --> 00:33:26,040 WINDL ERICR WROTE TEN YEARS AGO, 928 00:33:26,040 --> 00:33:29,320 THAT ARGUES, AND I AGREE, THE 929 00:33:29,320 --> 00:33:31,080 THRESHOLD FOR WHAT SOMEBODY 930 00:33:31,080 --> 00:33:32,680 UNDERSTANDS AS RISK OR NOVELTY 931 00:33:32,680 --> 00:33:34,200 OF THE STUDY INCREASES. 932 00:33:34,200 --> 00:33:35,800 SO THE RISKIER THE STUDY, THE 933 00:33:35,800 --> 00:33:36,600 MORE WE WANT PEOPLE TO 934 00:33:36,600 --> 00:33:38,000 UNDERSTAND ABOUT WHAT THEY ARE 935 00:33:38,000 --> 00:33:39,320 BEING ASKED TO DO. 936 00:33:39,320 --> 00:33:43,200 WHICH MAKES PERFECT SENSE. 937 00:33:43,200 --> 00:33:51,960 AND HIS -- TO ME. 938 00:33:51,960 --> 00:33:54,840 HIS PROPOSAL YOU ASSUME CAPACITY 939 00:33:54,840 --> 00:33:57,360 FOR LOW OR MODERATE RISK BUT 940 00:33:57,360 --> 00:33:59,160 NEED TO MEASURE FOR HIGH RISK, 941 00:33:59,160 --> 00:34:00,640 ASSUME UNDERSTANDING FOR LOW 942 00:34:00,640 --> 00:34:03,040 RISK MAYBE HAVE INFORMAL 943 00:34:03,040 --> 00:34:04,240 ASSESSMENT FOR MEDIUM RISK, BUT 944 00:34:04,240 --> 00:34:06,120 DO SOME KIND OF FORMAL 945 00:34:06,120 --> 00:34:10,120 ASSESSMENT FOR HIGHER RISK OF 946 00:34:10,120 --> 00:34:10,320 STUDIES. 947 00:34:10,320 --> 00:34:12,040 AND, AGAIN, THE ASSESSMENT OF 948 00:34:12,040 --> 00:34:14,360 VOLUNTARINESS WHICH I'LL GET TO 949 00:34:14,360 --> 00:34:15,000 IN A MINUTE ANYWAY. 950 00:34:15,000 --> 00:34:18,160 THERE ARE, I ALREADY MENTIONED, 951 00:34:18,160 --> 00:34:19,160 THERAPEUTIC MISCONCEPTION, A 952 00:34:19,160 --> 00:34:22,400 REALLY IMPORTANT CONCEPT IN 953 00:34:22,400 --> 00:34:23,400 RESEARCH. 954 00:34:23,400 --> 00:34:25,640 THERE ARE OTHER TYPES OF 955 00:34:25,640 --> 00:34:27,240 MISUNDERSTANDING, IF YOU WILL, 956 00:34:27,240 --> 00:34:29,840 IN TERMS OF RESEARCH. 957 00:34:29,840 --> 00:34:33,640 A FELLOW AND I SORT OF DEFINED 958 00:34:33,640 --> 00:34:34,800 THREE KINDS OF MISUNDERSTANDING, 959 00:34:34,800 --> 00:34:36,760 ABOUT 20 YEARS AGO, WHICH HAS 960 00:34:36,760 --> 00:34:38,600 GOTTEN A LOT OF ATTENTION. 961 00:34:38,600 --> 00:34:39,400 MISCONCEPTION IS CERTAINLY ONE 962 00:34:39,400 --> 00:34:42,360 OF THEM BUT NOT THE ONLY ONE. 963 00:34:42,360 --> 00:34:44,000 SOMETIMES PEOPLE ACTUALLY DO 964 00:34:44,000 --> 00:34:45,000 UNDERSTAND THEIR OWN RESEARCH 965 00:34:45,000 --> 00:34:49,480 BUT HAVE A REALLY HIGH 966 00:34:49,480 --> 00:34:51,640 EXPECTATION OF BENEFIT OR REALLY 967 00:34:51,640 --> 00:34:53,160 UNDERESTIMATE OF RISK. 968 00:34:53,160 --> 00:34:54,200 WE CALLED THAT MISESTIMATION. 969 00:34:54,200 --> 00:34:57,640 AND THEN THERE ARE PEOPLE WHO 970 00:34:57,640 --> 00:34:59,200 SEEM TO UNDERSTAND EVERYTHING 971 00:34:59,200 --> 00:35:00,960 BUT SAY, I CAN REMEMBER A 972 00:35:00,960 --> 00:35:02,040 PATIENT I TOOK CARE OF YEARS 973 00:35:02,040 --> 00:35:03,400 AGO, I KNOW THIS IS RESEARCH, 974 00:35:03,400 --> 00:35:05,120 YOU DON'T KNOW IF IT'S GOING TO 975 00:35:05,120 --> 00:35:06,200 WORK, IT'S GOT A LOT OF RISKS 976 00:35:06,200 --> 00:35:07,880 BUT I'M GOING TO BE THE ONE. 977 00:35:07,880 --> 00:35:09,560 IT'S GOING TO HELP ME! 978 00:35:09,560 --> 00:35:13,680 SO THAT KIND OF OPTIMISM IS 979 00:35:13,680 --> 00:35:15,560 CERTAINLY UNDERSTANDABLE AND 980 00:35:15,560 --> 00:35:17,720 SOME PEOPLE HAVE IT. 981 00:35:17,720 --> 00:35:20,760 THERE'S A REALLY IMPORTANT 982 00:35:20,760 --> 00:35:21,760 DISTINCTION AND UNDERSTANDING 983 00:35:21,760 --> 00:35:22,680 BETWEEN KNOWLEDGE, PEOPLE BEING 984 00:35:22,680 --> 00:35:23,960 ABLE TO SPIT BACK THE 985 00:35:23,960 --> 00:35:25,360 INFORMATION THAT YOU'VE GIVEN 986 00:35:25,360 --> 00:35:27,400 THEM BASICALLY, THEY UNDERSTAND 987 00:35:27,400 --> 00:35:28,800 WHAT YOU'VE TOLD THEM, AND 988 00:35:28,800 --> 00:35:30,200 APPRECIATING HOW IT APPLIES TO 989 00:35:30,200 --> 00:35:31,200 THEM. 990 00:35:31,200 --> 00:35:33,600 AND THAT'S THE SORT OF 991 00:35:33,600 --> 00:35:37,000 MISUNDERSTANDING EXAMPLE I GAVE 992 00:35:37,000 --> 00:35:38,320 YOU A LITTLE BIT AGO. 993 00:35:38,320 --> 00:35:40,640 I'M GOING TO SKIP THIS SINCE I 994 00:35:40,640 --> 00:35:42,600 ALREADY MENTIONED IT. 995 00:35:42,600 --> 00:35:44,480 THERE'S BEEN A FAIR AMOUNT OF 996 00:35:44,480 --> 00:35:48,320 STUDIES THAT HAVE BEEN DONE TO 997 00:35:48,320 --> 00:35:50,280 TRY TO FIGURE OUT WAYS WE MIGHT 998 00:35:50,280 --> 00:35:51,360 BE ABLE TO IMPROVE UNDERSTANDING 999 00:35:51,360 --> 00:35:53,120 IN THE CONTEXT OF RESEARCH AND 1000 00:35:53,120 --> 00:35:55,440 INFORMED CONSENT. 1001 00:35:55,440 --> 00:35:57,680 THERE HAVE BEEN TWO, AGAIN, 1002 00:35:57,680 --> 00:35:59,560 SYSTEMATIC REVIEWS OF THESE 1003 00:35:59,560 --> 00:35:59,960 STUDIES. 1004 00:35:59,960 --> 00:36:01,880 ONE PUBLISHED IN 2004, ONE IN 1005 00:36:01,880 --> 00:36:04,040 2013, I WAS LOOKING FOR ONE MORE 1006 00:36:04,040 --> 00:36:04,280 RECENT. 1007 00:36:04,280 --> 00:36:06,240 I FOUND ONE THAT SORT OF 1008 00:36:06,240 --> 00:36:08,320 PARTIALLY DOES THIS, THAT WAS 1009 00:36:08,320 --> 00:36:10,480 PUBLISHED IN 2018, BUT IT'S NOT 1010 00:36:10,480 --> 00:36:13,680 QUITE AS COMPREHENSIVE AS THESE 1011 00:36:13,680 --> 00:36:15,120 TWO WERE. 1012 00:36:15,120 --> 00:36:17,360 BASICALLY THEY DIVIDED STUDIES 1013 00:36:17,360 --> 00:36:19,120 DONE INTO THESE CATEGORIES, 1014 00:36:19,120 --> 00:36:21,560 MULTIMEDIA, MEANING VIDEOTAPES 1015 00:36:21,560 --> 00:36:22,320 AND INTERACTIVE COMPUTERS, 1016 00:36:22,320 --> 00:36:23,720 ENHANCED CONSENT FORMS WHICH 1017 00:36:23,720 --> 00:36:27,120 MODIFIED THE LENGTH OF THE 1018 00:36:27,120 --> 00:36:28,360 FORMAT, EXTENDED DISCUSSION OF 1019 00:36:28,360 --> 00:36:31,960 THE TEAM WITH THE PARTICIPANT, 1020 00:36:31,960 --> 00:36:33,320 TEST FEEDBACK WHICH IS YOU GIVE 1021 00:36:33,320 --> 00:36:38,600 SOMEBODY A QUIZ AND IF THEY 1022 00:36:38,600 --> 00:36:41,640 DIDN'T GET 80% OR THE THRESHOLD 1023 00:36:41,640 --> 00:36:43,440 YOU EXPLAIN IT AGAIN AND SEE IF 1024 00:36:43,440 --> 00:36:45,360 THEY DO BETTER, AND THERE WAS 1025 00:36:45,360 --> 00:36:46,280 MIXED AND MISCELLANEOUS. 1026 00:36:46,280 --> 00:36:55,320 WHO WANTS TO GUESS WHICH WORKED 1027 00:36:55,320 --> 00:36:56,840 THE BEST? 1028 00:36:56,840 --> 00:36:59,040 ANY GUESSES? 1029 00:36:59,040 --> 00:37:00,960 RICH? 1030 00:37:00,960 --> 00:37:03,080 MIXED? 1031 00:37:03,080 --> 00:37:05,680 NO. 1032 00:37:05,680 --> 00:37:07,160 MULTIMEDIA? 1033 00:37:07,160 --> 00:37:08,320 NO. 1034 00:37:08,320 --> 00:37:08,520 HOLLY? 1035 00:37:08,520 --> 00:37:09,560 >>EXTENDED DISCUSSION. 1036 00:37:09,560 --> 00:37:10,080 >>EXTENDED DISCUSSION. 1037 00:37:10,080 --> 00:37:11,600 IN THE STUDIES, IT WAS THE ONE 1038 00:37:11,600 --> 00:37:13,680 THAT WORKED THE BEST WHICH MEANT 1039 00:37:13,680 --> 00:37:15,920 THE MORE YOU TELL PEOPLE, THE 1040 00:37:15,920 --> 00:37:18,520 MORE YOU EXPLAIN, THE BETTER 1041 00:37:18,520 --> 00:37:19,080 THEY UNDERSTAND IT. 1042 00:37:19,080 --> 00:37:21,040 I THINK THERE NEEDS TO BE AN 1043 00:37:21,040 --> 00:37:24,080 UPDATE OF SYSTEMATIC REVIEW FOR 1044 00:37:24,080 --> 00:37:25,560 THE FOLLOWING REASON. 1045 00:37:25,560 --> 00:37:26,680 ANDREW JUST MENTIONED IT. 1046 00:37:26,680 --> 00:37:28,680 THERE HAVE BEEN MANY STUDIES IN 1047 00:37:28,680 --> 00:37:32,280 RECENT YEARS OF USING VISUALS, 1048 00:37:32,280 --> 00:37:34,840 COMPUTERS, APPS, VIDEOTAPES, 1049 00:37:34,840 --> 00:37:37,200 THINGS LIKE THAT, VIDEO, WE 1050 00:37:37,200 --> 00:37:40,720 DON'T USE VIDEOTAPES ANYMORE BUT 1051 00:37:40,720 --> 00:37:42,080 VIDEO PRESENTATIONS, AND EARLY 1052 00:37:42,080 --> 00:37:43,280 DATA SUGGESTED ONLY IN CERTAIN 1053 00:37:43,280 --> 00:37:45,360 KINDS OF POPULATIONS DID IT MAKE 1054 00:37:45,360 --> 00:37:45,680 A DIFFERENCE. 1055 00:37:45,680 --> 00:37:48,480 BUT I THINK WE SHOULD LOOK AGAIN 1056 00:37:48,480 --> 00:37:50,160 AT WHAT KINDS OF DIFFERENCE 1057 00:37:50,160 --> 00:37:54,880 THOSE KINDS OF PRESENTATIONS 1058 00:37:54,880 --> 00:37:55,320 MIGHT MAKE. 1059 00:37:55,320 --> 00:37:57,760 WE DID A SERIES OF STUDIES WHERE 1060 00:37:57,760 --> 00:38:01,120 WE COMPARED CONSENT FORMS, WHERE 1061 00:38:01,120 --> 00:38:02,320 WE RANDOMIZED PEOPLE WITHIN 1062 00:38:02,320 --> 00:38:03,960 OTHER CLINICAL STUDIES BOTH 1063 00:38:03,960 --> 00:38:05,720 HEALTHY VOLUNTEERS AND PATIENT 1064 00:38:05,720 --> 00:38:06,880 VOLUNTEERS TO RECEIVE THIS 1065 00:38:06,880 --> 00:38:08,360 STANDARD CONSENT FORM THAT OF 1066 00:38:08,360 --> 00:38:12,000 THE TEAM PUT TOGETHER IN A MUCH 1067 00:38:12,000 --> 00:38:14,200 SHORTER SIMPLER VERSION OF THE 1068 00:38:14,200 --> 00:38:17,720 SAME AND PEOPLE RANDOMIZED AND 1069 00:38:17,720 --> 00:38:21,560 WE ASSESSED THEIR UNDERSTANDING 1070 00:38:21,560 --> 00:38:23,440 AFTER THEY SIGNED CONSENT, AND 1071 00:38:23,440 --> 00:38:24,840 INTERESTINGLY, AND IN THE 1072 00:38:24,840 --> 00:38:27,040 PATIENT STUDY WE HAD MORE THAN 1073 00:38:27,040 --> 00:38:28,120 4,000 PARTICIPANTS FROM AROUND 1074 00:38:28,120 --> 00:38:30,360 THE WORLD, WHAT WE FOUND ACROSS 1075 00:38:30,360 --> 00:38:32,920 ALL OF THESE STUDIES THERE WAS 1076 00:38:32,920 --> 00:38:33,760 NO DIFFERENCE. 1077 00:38:33,760 --> 00:38:34,640 PEOPLE EITHER DID OR DIDN'T 1078 00:38:34,640 --> 00:38:37,480 UNDERSTAND WHAT THEY WERE DOING. 1079 00:38:37,480 --> 00:38:40,440 IT DIDN'T MATTER IF THEY HAD A 1080 00:38:40,440 --> 00:38:42,320 22-PAGE CONSENT FORM OR 10-PAGE 1081 00:38:42,320 --> 00:38:43,040 CONSENT FORM. 1082 00:38:43,040 --> 00:38:44,560 THEY DIDN'T ALWAYS READ THE 1083 00:38:44,560 --> 00:38:46,960 CONSENT FORMS BUT RELIED ON WHAT 1084 00:38:46,960 --> 00:38:48,200 THEY EXPECTED AND WHAT PEOPLE 1085 00:38:48,200 --> 00:38:49,800 TOLD THEM AND THEY DIDN'T RELY 1086 00:38:49,800 --> 00:38:55,640 THAT MUCH ON WHAT WAS WRITTEN ON 1087 00:38:55,640 --> 00:38:56,800 THE PAPERS. 1088 00:38:56,800 --> 00:39:00,640 SO, THE LAST PART OF CONSENT, SO 1089 00:39:00,640 --> 00:39:01,160 DISCLOSING INFORMATION, 1090 00:39:01,160 --> 00:39:02,200 UNDERSTANDING INFORMATION, AND 1091 00:39:02,200 --> 00:39:04,520 THEN MAKING A VOLUNTARY 1092 00:39:04,520 --> 00:39:09,800 DECISION, IS THIS VOLUNTARINESS. 1093 00:39:09,800 --> 00:39:15,000 AND IT BASICALLY MAKES SENSE 1094 00:39:15,000 --> 00:39:16,360 YOU WANT INFORMED CONSENT TO BE 1095 00:39:16,360 --> 00:39:17,800 REAL, YOU WANT PEOPLE TO ABSORB 1096 00:39:17,800 --> 00:39:22,240 WHAT IT IS YOU'RE ASKING THEM TO 1097 00:39:22,240 --> 00:39:23,360 DO AND DECIDE, VOLUNTARILY 1098 00:39:23,360 --> 00:39:24,600 DECIDE, YES, THIS IS SOMETHING I 1099 00:39:24,600 --> 00:39:26,760 WANT TO DO OR, NO, THIS IS 1100 00:39:26,760 --> 00:39:30,520 SOMETHING I DON'T WANT TO DO. 1101 00:39:30,520 --> 00:39:32,440 VOLUNTARINESS IS A VERY 1102 00:39:32,440 --> 00:39:33,880 UNDERSTUDIED CONCEPT. 1103 00:39:33,880 --> 00:39:36,040 IN OTHER WORDS, WHAT DOES IT 1104 00:39:36,040 --> 00:39:36,800 EXACTLY MEAN? 1105 00:39:36,800 --> 00:39:40,080 ALL OF US, ALL THE TIME, MAKE 1106 00:39:40,080 --> 00:39:43,800 CHOICES THAT ARE CLEARLY 1107 00:39:43,800 --> 00:39:45,040 INFLUENCED BY OUR EXPERIENCES, 1108 00:39:45,040 --> 00:39:46,840 OUR TRAINING, THE PEOPLE WE 1109 00:39:46,840 --> 00:39:49,360 KNOW, PEOPLE WE LOVE, ET CETERA. 1110 00:39:49,360 --> 00:39:52,960 SO, HOW DO WE MAKE VOLUNTARY 1111 00:39:52,960 --> 00:39:53,720 CHOICES? 1112 00:39:53,720 --> 00:39:58,680 THE REGULATIONS SUGGEST NO 1113 00:39:58,680 --> 00:40:01,040 DECEPTION, COERCION OR UNDUE 1114 00:40:01,040 --> 00:40:02,040 INFLUENCE. 1115 00:40:02,040 --> 00:40:03,000 DECEPTION IS CONCEALING OR 1116 00:40:03,000 --> 00:40:05,640 DISTORTING THE TRUTH TO MISLEAD. 1117 00:40:05,640 --> 00:40:06,920 COERCION IS COMPELLING BY FORCE 1118 00:40:06,920 --> 00:40:08,560 OR THREATENING TO MAKE THEM 1119 00:40:08,560 --> 00:40:09,200 WORSE OFF. 1120 00:40:09,200 --> 00:40:11,400 UNDUE INFLUENCE WHICH HAS THE 1121 00:40:11,400 --> 00:40:14,120 LEAST CLEAR DEFINITION IS AN 1122 00:40:14,120 --> 00:40:16,000 OFFER THAT DISTORTS JUDGMENT OR 1123 00:40:16,000 --> 00:40:17,160 MAKES PEOPLE MAKE DECISIONS THAT 1124 00:40:17,160 --> 00:40:20,000 ARE CONTRARY TO THEIR INTERESTS. 1125 00:40:20,000 --> 00:40:22,880 AND WE WORRY MORE ABOUT THESE 1126 00:40:22,880 --> 00:40:26,280 THINGS THAN WE PROBABLY SHOULD, 1127 00:40:26,280 --> 00:40:27,080 ESPECIALLY UNDUE INFLUENCES. 1128 00:40:27,080 --> 00:40:30,240 THERE ARE LOTS OF POTENTIAL 1129 00:40:30,240 --> 00:40:32,000 INFLUENCES INCLUDING DEPENDENT 1130 00:40:32,000 --> 00:40:32,800 POSITION AND POWER RELATIONSHIP 1131 00:40:32,800 --> 00:40:34,000 AND PRESSURE FROM OTHERS. 1132 00:40:34,000 --> 00:40:36,320 IF YOU ARE BEING ASKED TO 1133 00:40:36,320 --> 00:40:39,440 PARTICIPATE IN A STUDY BY YOUR 1134 00:40:39,440 --> 00:40:43,720 SUPERVISOR, YOU MAY BE LESS ABLE 1135 00:40:43,720 --> 00:40:44,720 TO SAY NO. 1136 00:40:44,720 --> 00:40:46,680 QUESTION, IS IT TRUE IF YOU'RE 1137 00:40:46,680 --> 00:40:48,720 BEING ASKED BY YOUR HEALTH CARE 1138 00:40:48,720 --> 00:40:49,280 PROVIDER. 1139 00:40:49,280 --> 00:40:50,880 LOTS OF QUESTIONS ABOUT THE 1140 00:40:50,880 --> 00:40:53,080 EXTENT TO WHICH HAVING 1141 00:40:53,080 --> 00:40:56,480 RESTRICTED CHOICES, BEING ILL, 1142 00:40:56,480 --> 00:41:01,000 OR BEING OFFERED INCENTIVES 1143 00:41:01,000 --> 00:41:02,400 INFLUENCES VOLUNTARINESS. 1144 00:41:02,400 --> 00:41:03,840 THERE'S BEEN SOME LITERATURE, 1145 00:41:03,840 --> 00:41:05,600 SOME STUDIES THAT HAVE LOOKED AT 1146 00:41:05,600 --> 00:41:05,800 THIS. 1147 00:41:05,800 --> 00:41:08,880 TWO THINGS ARE REALLY IMPORTANT. 1148 00:41:08,880 --> 00:41:11,960 ONE IS SOME STUDIES HAVE 1149 00:41:11,960 --> 00:41:12,720 DISTINGUISHED PRESSURE FROM 1150 00:41:12,720 --> 00:41:13,960 OTHERS, FROM PRESSURE FROM 1151 00:41:13,960 --> 00:41:15,320 HAVING A DISEASE. 1152 00:41:15,320 --> 00:41:16,680 AND I THINK THAT MAKES SOME 1153 00:41:16,680 --> 00:41:18,480 SENSE THAT THE PRESSURE FROM 1154 00:41:18,480 --> 00:41:20,640 OTHERS MOST PEOPLE SAY VERY 1155 00:41:20,640 --> 00:41:22,000 SMALL PERCENTAGE FEEL PRESSURE 1156 00:41:22,000 --> 00:41:22,920 FROM OTHERS. 1157 00:41:22,920 --> 00:41:25,520 OTHERS INCLUDED NOT ONLY 1158 00:41:25,520 --> 00:41:26,120 RESEARCH TEAMS BUT FAMILY. 1159 00:41:26,120 --> 00:41:27,760 ON THE OTHER HAND, WHEN PEOPLE 1160 00:41:27,760 --> 00:41:30,440 HAVE DISEASES OR IN THIS 1161 00:41:30,440 --> 00:41:31,760 PARTICULAR STUDY THEIR CHILD HAD 1162 00:41:31,760 --> 00:41:33,440 A DISEASE THEY FEEL PRESSURE TO 1163 00:41:33,440 --> 00:41:34,760 ENROLL BECAUSE THEY DON'T FEEL 1164 00:41:34,760 --> 00:41:36,600 LIKE THEY HAVE OTHER OPTIONS. 1165 00:41:36,600 --> 00:41:39,760 HOW MANY PEOPLE KNOW THEY WOULD 1166 00:41:39,760 --> 00:41:40,800 QUIT? 1167 00:41:40,800 --> 00:41:42,160 THERE'S A WIDE RANGE, AND A WIDE 1168 00:41:42,160 --> 00:41:43,880 RANGE IN TERMS OF ACTUAL 1169 00:41:43,880 --> 00:41:44,640 DECLINERS. 1170 00:41:44,640 --> 00:41:47,840 I THINK, AGAIN, POINTING OUT 1171 00:41:47,840 --> 00:41:50,480 THIS META-ANALYSIS FROM TAM ET 1172 00:41:50,480 --> 00:41:51,320 AL., THREE-QUARTERS OF PEOPLE 1173 00:41:51,320 --> 00:41:53,120 KNEW THEY HAD THE CHOICE TO 1174 00:41:53,120 --> 00:41:55,920 PARTICIPATE AND FREEDOM TO 1175 00:41:55,920 --> 00:42:00,040 WITHDRAW WITH MEANS AT LEAST 25% 1176 00:42:00,040 --> 00:42:00,880 DON'T KNOW THAT. 1177 00:42:00,880 --> 00:42:01,440 ALL RIGHT. 1178 00:42:01,440 --> 00:42:03,560 I THINK I'M GOING TO JUST END 1179 00:42:03,560 --> 00:42:09,600 WITH THESE NEXT TWO SLIDES. 1180 00:42:09,600 --> 00:42:11,320 INFORMED CONSENT IS COMPLEX, 1181 00:42:11,320 --> 00:42:13,440 IMPERFECT, THERE ARE ENDURING 1182 00:42:13,440 --> 00:42:14,200 CHALLENGES HOW WE DISCLOSE 1183 00:42:14,200 --> 00:42:15,240 INFORMATION, HOW PEOPLE 1184 00:42:15,240 --> 00:42:17,880 UNDERSTAND INFORMATION, HOW 1185 00:42:17,880 --> 00:42:19,440 CHOICES ARE MADE. 1186 00:42:19,440 --> 00:42:22,000 IT IS AFFECTED BY MOTIVATIONS 1187 00:42:22,000 --> 00:42:23,280 AND EXPECTATIONS. 1188 00:42:23,280 --> 00:42:26,440 IT'S AFFECTED BY CAPACITY. 1189 00:42:26,440 --> 00:42:29,640 IT'S AFFECTED BY EXPERIENCE OF 1190 00:42:29,640 --> 00:42:30,320 INTOLERANCE, INCONVENIENCE, 1191 00:42:30,320 --> 00:42:33,680 BURDEN, DIFFERENTIAL RESPONSES 1192 00:42:33,680 --> 00:42:34,040 TO INCENTIVES. 1193 00:42:34,040 --> 00:42:35,440 AND THERE ARE LOTS OF CHANGES 1194 00:42:35,440 --> 00:42:36,960 WHICH I THINK I'M NOT GOING TO 1195 00:42:36,960 --> 00:42:38,840 GET A CHANCE TO TALK ABOUT. 1196 00:42:38,840 --> 00:42:40,440 IS THAT RIGHT, HOLLY? 1197 00:42:40,440 --> 00:42:40,760 TWO MINUTES. 1198 00:42:40,760 --> 00:42:43,600 >>WELL, AT THE MOMENT I DON'T 1199 00:42:43,600 --> 00:42:48,920 HAVE ANY QUESTIONS FROM OUR 1200 00:42:48,920 --> 00:42:50,000 VIRTUAL AUDIENCE, AND NO 1201 00:42:50,000 --> 00:42:50,880 QUESTIONS HERE. 1202 00:42:50,880 --> 00:42:51,920 WHY DON'T YOU CONTINUE FOR 1203 00:42:51,920 --> 00:42:53,600 ANOTHER FIVE MINUTES? 1204 00:42:53,600 --> 00:42:55,600 >>OKAY, I'LL GO THROUGH SOME 1205 00:42:55,600 --> 00:42:56,280 CHANGES. 1206 00:42:56,280 --> 00:42:58,480 >>I'LL LET YOU KNOW IF SOMEONE 1207 00:42:58,480 --> 00:42:59,320 CHIMES IN. 1208 00:42:59,320 --> 00:43:00,880 >>THERE ARE TIMES OF RESEARCH 1209 00:43:00,880 --> 00:43:02,880 THAT ARE VERY PREVALENT RIGHT 1210 00:43:02,880 --> 00:43:04,000 NOW THAT CREATE CHALLENGES FOR 1211 00:43:04,000 --> 00:43:07,560 HOW WE THINK ABOUT AND HOW WE 1212 00:43:07,560 --> 00:43:09,680 IMPLEMENT A PROCESS OF INFORMED 1213 00:43:09,680 --> 00:43:12,440 CONSENT INCLUDING THESE THINGS 1214 00:43:12,440 --> 00:43:13,560 ON HERE BIOBANKS, DATA 1215 00:43:13,560 --> 00:43:14,640 REPOSITORIES, BIG DATA, 1216 00:43:14,640 --> 00:43:15,280 PRAGMATIC TRIALS, LEARNING 1217 00:43:15,280 --> 00:43:16,280 HEALTH CARE SYSTEMS I SHOULD 1218 00:43:16,280 --> 00:43:18,600 HAVE PUT. THERE THERE'S BEEN A 1219 00:43:18,600 --> 00:43:23,640 HUGE CHANGE IN HOW WE GET AND 1220 00:43:23,640 --> 00:43:25,000 EXCHANGE INFORMATION IN THE LAST 1221 00:43:25,000 --> 00:43:26,400 FEW YEARS. 1222 00:43:26,400 --> 00:43:27,720 THE IDEA OF 25-PAGE PAPER 1223 00:43:27,720 --> 00:43:29,680 CONSENTS WHICH WE STILL USE, BY 1224 00:43:29,680 --> 00:43:33,200 THE WAY, IS BECOMING OUTMODED 1225 00:43:33,200 --> 00:43:36,200 BECAUSE ELECTRONIC CONSENT IS 1226 00:43:36,200 --> 00:43:38,480 AVAILABLE, THROUGH DEVICES, 1227 00:43:38,480 --> 00:43:39,520 APPS, WEB INTERFACES AND 1228 00:43:39,520 --> 00:43:40,000 TELEHEALTH. 1229 00:43:40,000 --> 00:43:43,120 JUST TO GIVE YOU THE FRAME HERE, 1230 00:43:43,120 --> 00:43:45,760 TYPICALLY IN A TYPICAL CLINICAL 1231 00:43:45,760 --> 00:43:47,800 RESEARCH, SORT OF OLD-FASHIONED 1232 00:43:47,800 --> 00:43:48,400 CLINICAL RESEARCH, THE 1233 00:43:48,400 --> 00:43:50,280 RESEARCHER OR TEAM WOULD MEET 1234 00:43:50,280 --> 00:43:53,720 WITH THE PARTICIPANTS, HAVE A 1235 00:43:53,720 --> 00:43:55,280 FORM SIGNED, TO CONSENT, APPLY 1236 00:43:55,280 --> 00:43:57,320 THE INTERVENTION, THERE WOULD BE 1237 00:43:57,320 --> 00:44:00,880 DATA AND PUBLICATIONS FROM THAT 1238 00:44:00,880 --> 00:44:01,160 RESEARCH. 1239 00:44:01,160 --> 00:44:02,240 THAT'S THE CONSENT PART. 1240 00:44:02,240 --> 00:44:05,920 BUT WHEN WE HAVE RESEARCH WITH 1241 00:44:05,920 --> 00:44:07,040 DATA AND BIOSPECIMENS IT STARTS 1242 00:44:07,040 --> 00:44:10,600 WITH A REPOSITORY OF DATA OR 1243 00:44:10,600 --> 00:44:11,160 BIOSPECIMENS. 1244 00:44:11,160 --> 00:44:13,760 THERE'S NO INTERACTION WITH THE 1245 00:44:13,760 --> 00:44:14,920 RESEARCHER AND PARTICIPANT FROM 1246 00:44:14,920 --> 00:44:17,680 WHOM THOSE DATA OR BIOSPECIMENS 1247 00:44:17,680 --> 00:44:20,120 CAME, BEFORE THE RESEARCH IS 1248 00:44:20,120 --> 00:44:21,520 DONE AND RESEARCH IS PUBLISHED. 1249 00:44:21,520 --> 00:44:25,000 YET THERE IS A PERSON OR THERE 1250 00:44:25,000 --> 00:44:26,640 ARE PEOPLE FROM WHOM THOSE 1251 00:44:26,640 --> 00:44:28,560 SPECIMENS AND DATA CAME. 1252 00:44:28,560 --> 00:44:30,040 SO, THE QUESTION HAS BEEN HOW DO 1253 00:44:30,040 --> 00:44:33,680 WE DEAL WITH THIS KIND OF 1254 00:44:33,680 --> 00:44:34,240 CONSENT? 1255 00:44:34,240 --> 00:44:35,720 AND THERE'S NOT CONSENSUS AT THE 1256 00:44:35,720 --> 00:44:38,000 MOMENT BUT THIS WAS A STUDY WE 1257 00:44:38,000 --> 00:44:40,200 DID, A PAPER WE DID SOME YEARS 1258 00:44:40,200 --> 00:44:47,240 BACK, WHERE WE TALKED ABOUT THE 1259 00:44:47,240 --> 00:44:49,040 SPECTRUM FROM NO CONSENT WHICH 1260 00:44:49,040 --> 00:44:49,920 REGULATIONS ALLOW WHEN THERE'S 1261 00:44:49,920 --> 00:44:51,280 NO IDENTIFIERS, WE CAN DO 1262 00:44:51,280 --> 00:44:52,760 RESEARCH WITH SPECIMENS AND DATA 1263 00:44:52,760 --> 00:44:57,440 WITH NO CONSENT AT ALL, AND THEN 1264 00:44:57,440 --> 00:45:00,040 THERE'S A SPECTRUM OF INCREASING 1265 00:45:00,040 --> 00:45:01,280 CONTROL FROM THE PARTICIPANT 1266 00:45:01,280 --> 00:45:03,400 SIDE, BUT ALSO INCREASING BURDEN 1267 00:45:03,400 --> 00:45:05,640 FROM OF THE RESEARCH TEAM SIDE, 1268 00:45:05,640 --> 00:45:07,520 IN TERMS OF HOW CONSENT MIGHT BE 1269 00:45:07,520 --> 00:45:09,400 OBTAINED FOR THOSE KINDS OF 1270 00:45:09,400 --> 00:45:09,840 RESEARCH. 1271 00:45:09,840 --> 00:45:13,120 AND WE CAME DOWN IN THIS PAPER 1272 00:45:13,120 --> 00:45:15,800 ON WHAT IS CALLED BROAD CONSENT, 1273 00:45:15,800 --> 00:45:17,480 BASICALLY THIS IDEA THAT PEOPLE 1274 00:45:17,480 --> 00:45:19,920 CAN SAY, YOU CAN TAKE MY DATA, 1275 00:45:19,920 --> 00:45:22,360 YOU CAN TAKE MY SPECIMENS AND 1276 00:45:22,360 --> 00:45:26,960 USE THEM FOR FUTURE RESEARCH, 1277 00:45:26,960 --> 00:45:29,880 HERE ARE LIMITATIONS I PUT ON 1278 00:45:29,880 --> 00:45:30,920 THEM, DIFFERENT THAN BLANKET 1279 00:45:30,920 --> 00:45:32,360 CONSENT WHICH IS DO ANYTHING YOU 1280 00:45:32,360 --> 00:45:32,800 WANT. 1281 00:45:32,800 --> 00:45:34,880 SINCE THIS TIME BROAD CONSENT 1282 00:45:34,880 --> 00:45:36,840 HAS BECOME A PART OF THE 1283 00:45:36,840 --> 00:45:41,360 REGULATORY FRAMEWORK THAT WE 1284 00:45:41,360 --> 00:45:45,040 LIVE WITH, AND THERE'S A LOT 1285 00:45:45,040 --> 00:45:46,560 OF -- DEBATE I GUESS IS THE 1286 00:45:46,560 --> 00:45:47,680 RIGHT WORD WHETHER THAT'S BROAD 1287 00:45:47,680 --> 00:45:49,280 CONSENT OR WHETHER THERE'S 1288 00:45:49,280 --> 00:45:50,920 SOMETHING ELSE THAT'S BROAD 1289 00:45:50,920 --> 00:45:54,720 CONSENT, HOW YOU IMPLEMENT, BUT 1290 00:45:54,720 --> 00:45:56,320 THERE ARE REGULATORY GUIDANCE OR 1291 00:45:56,320 --> 00:45:58,120 RULES HOW BROAD CONSENT CAN BE 1292 00:45:58,120 --> 00:46:00,400 OBTAINED AND WHAT IT CAN BE USED 1293 00:46:00,400 --> 00:46:00,960 FOR. 1294 00:46:00,960 --> 00:46:03,560 SO THEN THERE'S PRAGMATIC 1295 00:46:03,560 --> 00:46:05,160 TRIALS, LEARNING HEALTH CARE 1296 00:46:05,160 --> 00:46:07,080 SYSTEMS TRIALS. 1297 00:46:07,080 --> 00:46:12,520 AGAIN, DIFFERENT FROM THE 1298 00:46:12,520 --> 00:46:13,600 PARADIGMATIC CLINICAL RESEARCH, 1299 00:46:13,600 --> 00:46:16,080 RESEARCH TAKES PLACE IN A HEALTH 1300 00:46:16,080 --> 00:46:17,360 CARE SETTING AND FACILITY WITH 1301 00:46:17,360 --> 00:46:19,560 PEOPLE THERE FOR HEALTH CARE 1302 00:46:19,560 --> 00:46:21,680 REASONS, AND SO SOMETIMES THE 1303 00:46:21,680 --> 00:46:23,120 INTERVENTION IS APPLIED TO THE 1304 00:46:23,120 --> 00:46:27,520 HEALTH CARE SYSTEM OR TO THE 1305 00:46:27,520 --> 00:46:28,960 PROVIDERS, AND SO NOT CONSENT 1306 00:46:28,960 --> 00:46:30,400 FROM THE INDIVIDUAL PARTICIPANTS 1307 00:46:30,400 --> 00:46:32,840 OR THE PEOPLE WHO MIGHT BE BEING 1308 00:46:32,840 --> 00:46:36,360 MEASURED IN SOME RESPECTS IS NOT 1309 00:46:36,360 --> 00:46:39,560 ALWAYS PART OF THE EQUATION. 1310 00:46:39,560 --> 00:46:43,320 BUT AGAIN THERE ARE PEOPLE IN 1311 00:46:43,320 --> 00:46:44,200 THESE SITUATIONS. 1312 00:46:44,200 --> 00:46:46,480 I'M NOT GOING TO BOTHER WITH 1313 00:46:46,480 --> 00:46:47,040 THAT. 1314 00:46:47,040 --> 00:46:48,960 AND THERE'S ALSO RESEARCH WITH 1315 00:46:48,960 --> 00:46:51,640 BIG DATA. 1316 00:46:51,640 --> 00:46:53,120 AND THIS IS SOMETHING THAT I 1317 00:46:53,120 --> 00:46:55,720 HAVE TO ADMIT I DON'T FULLY 1318 00:46:55,720 --> 00:46:57,040 UNDERSTAND BUT I WILL TELL YOU 1319 00:46:57,040 --> 00:46:58,680 THAT THERE ARE DATA OUT THERE 1320 00:46:58,680 --> 00:47:00,400 ABOUT ALL OF US AND THEY ARE 1321 00:47:00,400 --> 00:47:04,360 BEING USED FOR RESEARCH ALL THE 1322 00:47:04,360 --> 00:47:04,760 TIME. 1323 00:47:04,760 --> 00:47:07,960 AND THAT WE BY SOME PEOPLE'S 1324 00:47:07,960 --> 00:47:09,520 LIGHTS HAVE GIVEN CONSENT. 1325 00:47:09,520 --> 00:47:11,160 I WOULD SAY NOT INFORMED CONSENT 1326 00:47:11,160 --> 00:47:14,520 BECAUSE MANY OF US SIGNED THOSE 1327 00:47:14,520 --> 00:47:16,200 THINGS ON THE COMPUTER WITHOUT 1328 00:47:16,200 --> 00:47:18,000 READING THEM OR WITHOUT EVEN 1329 00:47:18,000 --> 00:47:19,160 UNDERSTANDING WHAT THEY ARE 1330 00:47:19,160 --> 00:47:20,200 ACTUALLY GOING TO DO WITH OUR 1331 00:47:20,200 --> 00:47:22,120 DATA BUT THEY ARE USING IT. 1332 00:47:22,120 --> 00:47:23,080 THEY ARE SELLING IT. 1333 00:47:23,080 --> 00:47:26,360 THEY ARE USING IT FOR RESEARCH. 1334 00:47:26,360 --> 00:47:31,240 AND SO THIS IS SOMETHING THAT 1335 00:47:31,240 --> 00:47:32,360 SOMETIMES BUBBLES TO THE SURFACE 1336 00:47:32,360 --> 00:47:33,840 WHEN THERE'S A SCANDAL THAT 1337 00:47:33,840 --> 00:47:34,560 PEOPLE DON'T LIKE. 1338 00:47:34,560 --> 00:47:39,200 I THINK WE'LL SEE MORE OF IT. 1339 00:47:39,200 --> 00:47:42,600 ELECTRONIC CONSENT, THIS WAS 1340 00:47:42,600 --> 00:47:45,600 GUIDANCE THAT WAS PUBLISHED IN 1341 00:47:45,600 --> 00:47:46,240 2016 FROM DEPARTMENT OF HEALTH 1342 00:47:46,240 --> 00:47:49,080 AND HUMAN SERVICES THAT COVERS 1343 00:47:49,080 --> 00:47:52,160 FDA AND COMMON RULE WHICH 1344 00:47:52,160 --> 00:47:53,280 BASICALLY SAID ELECTRONIC 1345 00:47:53,280 --> 00:47:55,360 PROCESSES ARE OKAY, WE CAN USE 1346 00:47:55,360 --> 00:47:56,080 ELECTRONIC PROCESSES. 1347 00:47:56,080 --> 00:47:57,600 WE DON'T HAVE TO USE PAPER 1348 00:47:57,600 --> 00:47:57,880 ANYMORE. 1349 00:47:57,880 --> 00:48:01,400 YOU CAN SEE FROM THIS QUOTE I 1350 00:48:01,400 --> 00:48:03,040 PULLED OUT, IT INCLUDES A BUNCH 1351 00:48:03,040 --> 00:48:03,320 OF STUFF. 1352 00:48:03,320 --> 00:48:08,560 THERE'S A LOT OF MODES OF 1353 00:48:08,560 --> 00:48:09,200 ELECTRONIC SYSTEMS AND PROCESSES 1354 00:48:09,200 --> 00:48:09,800 THAT COULD BE USED. 1355 00:48:09,800 --> 00:48:12,320 THIS IS WHY I SAY WE NEED MORE 1356 00:48:12,320 --> 00:48:16,520 DATA HOW WELL THEY ARE WORKING. 1357 00:48:16,520 --> 00:48:22,040 THERE'S ALSO -- THIS REALLY 1358 00:48:22,040 --> 00:48:23,680 BURGEONED DURING COVID, THIS 1359 00:48:23,680 --> 00:48:24,720 NOTION OF DECENTRALIZED TRIALS 1360 00:48:24,720 --> 00:48:28,080 WHICH A LOT OF PEOPLE ARE USING. 1361 00:48:28,080 --> 00:48:29,760 THIS IS WHERE YOU HAVE ONE 1362 00:48:29,760 --> 00:48:31,960 LOCATION WHERE THE STUDY TEAM OR 1363 00:48:31,960 --> 00:48:33,920 THE INFORMATION IS BEING 1364 00:48:33,920 --> 00:48:35,000 COLLECTED, BUT PEOPLE ARE 1365 00:48:35,000 --> 00:48:36,360 PARTICIPATING FROM ALL OVER THE 1366 00:48:36,360 --> 00:48:37,280 PLACE. 1367 00:48:37,280 --> 00:48:39,160 SO THIS IS ELECTRONIC CONSENT IS 1368 00:48:39,160 --> 00:48:41,680 DEFINITELY USED IN THESE TRIALS, 1369 00:48:41,680 --> 00:48:43,600 AND THERE'S NO REASON FOR 1370 00:48:43,600 --> 00:48:46,200 ANYBODY TO EVEN COME OR EVER 1371 00:48:46,200 --> 00:48:50,200 SOMETIMES EVER MEET THE RESEARCH 1372 00:48:50,200 --> 00:48:50,520 TEAM. 1373 00:48:50,520 --> 00:48:51,600 SO, AGAIN, ANOTHER SORT OF 1374 00:48:51,600 --> 00:48:54,120 DIFFERENCE IN TERMS OF HOW WE 1375 00:48:54,120 --> 00:48:56,280 THINK ABOUT CONSENT IN 1376 00:48:56,280 --> 00:48:57,040 DECENTRALIZED TRIALS. 1377 00:48:57,040 --> 00:48:59,440 I WOULD SAY THAT ALL OF THESE 1378 00:48:59,440 --> 00:49:00,400 ELECTRONIC METHODS STILL HAVE 1379 00:49:00,400 --> 00:49:02,160 SOME OF THESE CHALLENGES ABOUT 1380 00:49:02,160 --> 00:49:04,040 WHAT DO WE DISCLOSE, HOW DO WE 1381 00:49:04,040 --> 00:49:05,240 KNOW IF PEOPLE UNDERSTAND, WHAT 1382 00:49:05,240 --> 00:49:06,760 DO THEY NEED TO UNDERSTAND, HOW 1383 00:49:06,760 --> 00:49:09,400 DO WE KNOW IF THEY ARE MAKING A 1384 00:49:09,400 --> 00:49:10,120 CHOICE. 1385 00:49:10,120 --> 00:49:13,400 SO I'M GOING TO STOP BY THIS 1386 00:49:13,400 --> 00:49:14,760 SLIDE, INFORMED CONSENT IS A 1387 00:49:14,760 --> 00:49:19,840 PROCESS BASED ON RESPECT FOR 1388 00:49:19,840 --> 00:49:21,800 PERSONS, ALSO PROMOTES 1389 00:49:21,800 --> 00:49:23,160 PARTICIPANT WELFARE, PROMOTES 1390 00:49:23,160 --> 00:49:26,480 VALUES, OFFERS TRUST, HELPS 1391 00:49:26,480 --> 00:49:28,320 ENSURE INTEGRITY BUT CHANGES 1392 00:49:28,320 --> 00:49:30,040 CREATE OPPORTUNITIES FOR 1393 00:49:30,040 --> 00:49:31,920 INNOVATIVE EVIDENCE-BASED 1394 00:49:31,920 --> 00:49:32,800 STRATEGIES FOR INFORMED CONSENT. 1395 00:49:32,800 --> 00:49:35,560 >>BIG ROUND OF APPLAUSE FROM 1396 00:49:35,560 --> 00:49:39,880 THE GIANT CROWD HERE IN LIPSETT. 1397 00:49:39,880 --> 00:49:40,400 [APPLAUSE] 1398 00:49:40,400 --> 00:49:41,160 WE HAVE A QUESTION. 1399 00:49:41,160 --> 00:49:42,640 >>OKAY, GOOD. 1400 00:49:42,640 --> 00:49:44,320 >>I'M GOING TO SLIGHTLY REFRAME 1401 00:49:44,320 --> 00:49:48,160 THE QUESTION. 1402 00:49:48,160 --> 00:49:49,440 SO, YOU MENTIONED THAT A LOT OF 1403 00:49:49,440 --> 00:49:52,600 RESEARCH IS BEING DONE WITH 1404 00:49:52,600 --> 00:49:52,880 BIOBANKS. 1405 00:49:52,880 --> 00:49:54,760 AND DO YOU THINK IT'S ENOUGH FOR 1406 00:49:54,760 --> 00:49:59,800 US TO KNOW THAT WHEN WE SURVEY 1407 00:49:59,800 --> 00:50:01,480 PEOPLE THEY SAY, SURE, THAT 1408 00:50:01,480 --> 00:50:07,280 SEEMS OKAY TO ME, THAT IF YOU 1409 00:50:07,280 --> 00:50:10,440 USE DE-IDENTIFIED SAMPLES FOR 1410 00:50:10,440 --> 00:50:12,960 RESEARCH VERSUS GETTING DIRECT 1411 00:50:12,960 --> 00:50:14,800 CONSENT FROM AN INDIVIDUAL, 1412 00:50:14,800 --> 00:50:16,800 ABOUT USING THEIR BIOSPECIMEN 1413 00:50:16,800 --> 00:50:17,520 FOR RESEARCH. 1414 00:50:17,520 --> 00:50:19,840 >>SO, DO I THINK IT'S OKAY IS 1415 00:50:19,840 --> 00:50:20,880 THE QUESTION? 1416 00:50:20,880 --> 00:50:24,840 >>YEAH, IS THAT ENOUGH FOR US 1417 00:50:24,840 --> 00:50:28,280 TO SAY, YOU KNOW, SEEMS LIKE 1418 00:50:28,280 --> 00:50:29,440 PEOPLE SUPPORT THIS ENDEAVOR, IS 1419 00:50:29,440 --> 00:50:32,360 IT OKAY FOR US TO THEN, YOU 1420 00:50:32,360 --> 00:50:36,240 KNOW, PUT IT INTO REGULATIONS? 1421 00:50:36,240 --> 00:50:37,800 OKAY TO USE DE-IDENTIFIED 1422 00:50:37,800 --> 00:50:38,760 SAMPLES FOR RESEARCH? 1423 00:50:38,760 --> 00:50:40,200 >>IT'S A GREAT QUESTION. 1424 00:50:40,200 --> 00:50:42,880 AND I THINK FOR PEOPLE WHO 1425 00:50:42,880 --> 00:50:46,400 FOLLOWED THIS IN THE, YOU KNOW, 1426 00:50:46,400 --> 00:50:47,080 YEARS PRECEDING REVISIONS TO THE 1427 00:50:47,080 --> 00:50:49,240 COMMON RULE THIS WAS THE MAJOR 1428 00:50:49,240 --> 00:50:51,520 QUESTION THAT WAS DEBATED AND 1429 00:50:51,520 --> 00:50:55,520 FOR WHICH PUBLIC COMMENT WAS 1430 00:50:55,520 --> 00:51:00,320 SUBMITTED ON THE PROPOSED CHANGE 1431 00:51:00,320 --> 00:51:01,720 TO REGULATIONS. 1432 00:51:01,720 --> 00:51:04,800 AN EARLIER CHANGE WAS USE OF 1433 00:51:04,800 --> 00:51:06,000 DE-IDENTIFIED SPECIMENS AND DATA 1434 00:51:06,000 --> 00:51:08,520 WITHOUT CONSENT WOULD NOT BE 1435 00:51:08,520 --> 00:51:13,600 ALLOWED BECAUSE, AND WE KNOW 1436 00:51:13,600 --> 00:51:14,440 THIS, DE-IDENTIFICATION CANNOT 1437 00:51:14,440 --> 00:51:14,800 BE ABSOLUTE. 1438 00:51:14,800 --> 00:51:18,880 THERE'S NO WAY TO COMPLETELY 1439 00:51:18,880 --> 00:51:20,120 DE-IDENTIFY ANYTHING ANYMORE. 1440 00:51:20,120 --> 00:51:21,920 ESPECIALLY CERTAIN KINDS OF 1441 00:51:21,920 --> 00:51:22,200 DATA. 1442 00:51:22,200 --> 00:51:26,840 THERE WAS DEBATE ABOUT CAN WE DO 1443 00:51:26,840 --> 00:51:27,240 THIS. 1444 00:51:27,240 --> 00:51:30,280 VOICES THAT WERE LOUD WERE 1445 00:51:30,280 --> 00:51:33,320 PEOPLE THAT ARGUED THAT RESEARCH 1446 00:51:33,320 --> 00:51:35,080 WITH HUGE AMOUNTS OF DATA IS 1447 00:51:35,080 --> 00:51:39,600 VERY VALUABLE AND WE CAN LEARN 1448 00:51:39,600 --> 00:51:41,480 THINGS WE COULDN'T LEARN IN 1449 00:51:41,480 --> 00:51:42,600 OTHER WAYS. 1450 00:51:42,600 --> 00:51:44,600 CONSENT MAKES THAT IMPOSSIBLE TO 1451 00:51:44,600 --> 00:51:47,000 DO OR COULD SKEW IT BECAUSE 1452 00:51:47,000 --> 00:51:48,600 PEOPLE WHO SAID NO MIGHT BE 1453 00:51:48,600 --> 00:51:53,200 DIFFERENT THAN PEOPLE WHO SAID 1454 00:51:53,200 --> 00:51:56,000 YES. 1455 00:51:56,000 --> 00:51:57,560 THOSE ARE VOICES THAT WON THE 1456 00:51:57,560 --> 00:52:00,000 DAY IN TERMS OF REGULATIONS. 1457 00:52:00,000 --> 00:52:03,320 IN THE REGULATIONS THERE IS 1458 00:52:03,320 --> 00:52:04,920 INTERESTINGLY A -- I DON'T KNOW 1459 00:52:04,920 --> 00:52:07,920 WHAT IT IS, A PROMISE THAT THE 1460 00:52:07,920 --> 00:52:09,800 QUESTION OF DE-IDENTIFICATION 1461 00:52:09,800 --> 00:52:11,040 WILL BE REVISITED EVERY COUPLE 1462 00:52:11,040 --> 00:52:11,440 YEARS. 1463 00:52:11,440 --> 00:52:13,200 I DON'T THINK THAT THAT -- I 1464 00:52:13,200 --> 00:52:15,840 THINK THAT MEANS THIS COULD 1465 00:52:15,840 --> 00:52:18,240 CHANGE IN THE FUTURE. 1466 00:52:18,240 --> 00:52:20,240 I THINK THE BALANCE BETWEEN 1467 00:52:20,240 --> 00:52:21,120 WHAT'S GOOD FOR RESEARCH, IN 1468 00:52:21,120 --> 00:52:23,080 OTHER WORDS WHAT CAN WE LEARN 1469 00:52:23,080 --> 00:52:26,280 FROM LARGE AMOUNTS OF 1470 00:52:26,280 --> 00:52:27,840 DEIDENTIFIED DATA AND HOW PEOPLE 1471 00:52:27,840 --> 00:52:31,760 FEEL ABOUT WHETHER OR NOT THEIR 1472 00:52:31,760 --> 00:52:35,560 DATA CAN BE USED IS A TRICKY 1473 00:52:35,560 --> 00:52:36,200 ONE. 1474 00:52:36,200 --> 00:52:39,040 MANY PEOPLE SAY SURE, GO AHEAD. 1475 00:52:39,040 --> 00:52:40,560 THERE ARE PEOPLE WHO SAY NO. 1476 00:52:40,560 --> 00:52:46,200 >>AND RESPECTING BOTH IS THE 1477 00:52:46,200 --> 00:52:46,600 CHALLENGE. 1478 00:52:46,600 --> 00:52:55,480 ANDREW HAS A QUESTION. 1479 00:52:55,480 --> 00:52:56,040 >>ABOUT BIOSAMPLES AND 1480 00:52:56,040 --> 00:53:00,320 EQUITABLE -- AND FINANCES THAT 1481 00:53:00,320 --> 00:53:04,960 COME OUT OF THOSE. 1482 00:53:04,960 --> 00:53:05,600 SURVEILLANCE SAMPLING, PROTOCOL 1483 00:53:05,600 --> 00:53:11,560 FROM THE U.N. HOW DATA AND 1484 00:53:11,560 --> 00:53:12,480 SAMPLES ARE COLLECTED FROM 1485 00:53:12,480 --> 00:53:16,000 MIDDLE INCOME OR POOR INCOME 1486 00:53:16,000 --> 00:53:17,160 COUNTRIES AND HOW BENEFITS ARE 1487 00:53:17,160 --> 00:53:20,400 DISTRIBUTED BACK TO THE THOSE 1488 00:53:20,400 --> 00:53:22,520 COUNTRIES, SIMILAR DISCUSSIONS 1489 00:53:22,520 --> 00:53:23,720 OR THOUGHTS ABOUT THOSE IN 1490 00:53:23,720 --> 00:53:24,600 CLINICAL RESEARCH SPECIFIC LIVE 1491 00:53:24,600 --> 00:53:26,520 WHERE YOU COULD BE COLLECTING 1492 00:53:26,520 --> 00:53:29,080 SAMPLES FROM PEOPLE AND PERHAPS 1493 00:53:29,080 --> 00:53:30,520 MAKE DISCOVERIES FROM THOSE THAT 1494 00:53:30,520 --> 00:53:33,120 ARE THEN USED IN INTERVENTIONS 1495 00:53:33,120 --> 00:53:35,720 OR THINGS GOING ON, IS THERE 1496 00:53:35,720 --> 00:53:37,360 WAYS TO CONSIDER ABOUT BRINGING 1497 00:53:37,360 --> 00:53:39,120 THE BENEFITS OF THOSE 1498 00:53:39,120 --> 00:53:42,040 FINANCIALLY BACK TO THOSE 1499 00:53:42,040 --> 00:53:42,640 PARTICIPANTS WHO DONATED 1500 00:53:42,640 --> 00:53:43,360 SAMPLES? 1501 00:53:43,360 --> 00:53:48,400 >>THAT'S A WHOLE OTHER DAY OF 1502 00:53:48,400 --> 00:53:49,200 DISCUSSION. 1503 00:53:49,200 --> 00:53:52,840 >>AND WE WILL BE TALKING ABOUT 1504 00:53:52,840 --> 00:53:56,040 SPECIMENS NEXT WEEK, GENETIC IN 1505 00:53:56,040 --> 00:53:56,320 PARTICULAR. 1506 00:53:56,320 --> 00:53:57,440 >>A SHORT ANSWER I WAS TALKING 1507 00:53:57,440 --> 00:53:59,240 ABOUT HOW DO WE ASK PEOPLE TO 1508 00:53:59,240 --> 00:54:01,040 USE THEIR SPECIMENS. 1509 00:54:01,040 --> 00:54:02,440 THERE ARE HUGE DEBATES, 1510 00:54:02,440 --> 00:54:04,000 DIFFERENCES IN LAWS AND 1511 00:54:04,000 --> 00:54:05,400 REGULATIONS ACROSS THE WORLD IN 1512 00:54:05,400 --> 00:54:06,600 TERMS OF WHAT SPECIMENS CAN BE 1513 00:54:06,600 --> 00:54:07,800 USED AND HOW THEY CAN BE USED 1514 00:54:07,800 --> 00:54:10,960 AND WHO THEY CAN BE SENT TO AND 1515 00:54:10,960 --> 00:54:12,760 ALL THAT STUFF. 1516 00:54:12,760 --> 00:54:13,600 THAT'S CREATING CONSTERNATION ON 1517 00:54:13,600 --> 00:54:19,520 THE PART OF SOME RESEARCH TEAMS. 1518 00:54:19,520 --> 00:54:21,160 BUT THERE'S ALSO BEEN A 1519 00:54:21,160 --> 00:54:22,600 LONGSTANDING REALIZATION THAT IF 1520 00:54:22,600 --> 00:54:24,080 WE GET SPECIMENS FROM A CERTAIN 1521 00:54:24,080 --> 00:54:26,200 REGION OF THE WORLD THAT HELP 1522 00:54:26,200 --> 00:54:27,800 THE WHOLE WORLD THAT THE PLACE 1523 00:54:27,800 --> 00:54:31,040 FROM WHICH THEY COME SHOULD GET 1524 00:54:31,040 --> 00:54:32,640 BENEFIT FROM THAT, WHATEVER WE 1525 00:54:32,640 --> 00:54:33,920 DISCOVER, WHATEVER WE MAKE, A 1526 00:54:33,920 --> 00:54:36,720 VACCINE OR WHATEVER IT IS, 1527 00:54:36,720 --> 00:54:39,120 STARTED WITH INFLUENZA IN THE 1528 00:54:39,120 --> 00:54:40,320 EARLY 2000s AND SO, YEAH, 1529 00:54:40,320 --> 00:54:43,600 THERE'S A LOT OF DISCUSSION 1530 00:54:43,600 --> 00:54:45,040 ABOUT THAT. 1531 00:54:45,040 --> 00:54:46,520 >>WE'LL SHALL TALKING ABOUT 1532 00:54:46,520 --> 00:54:48,160 INTERNATIONAL ISSUES ON DAY 7. 1533 00:54:48,160 --> 00:54:50,400 ANOTHER PLACE TO REVISIT THESE 1534 00:54:50,400 --> 00:54:50,800 QUESTIONS. 1535 00:54:50,800 --> 00:55:01,280 THANK YOU AGAIN, DR. GRADY. 1536 00:55:09,320 --> 00:55:09,520 [APPLAUSE] 1537 00:55:09,520 --> 00:55:13,720 IT'S MY PLEASURE TO INTRODUCE 1538 00:55:13,720 --> 00:55:17,840 DR. SCOTT KIM, HE'S TRAINED AS A 1539 00:55:17,840 --> 00:55:19,320 PSYCHIATRIST AND PHILOSOPHER, 1540 00:55:19,320 --> 00:55:24,840 AND DOES EMPIRICAL WORK SO HE'S 1541 00:55:24,840 --> 00:55:28,880 A TRIPLE THREAT. 1542 00:55:28,880 --> 00:55:29,600 AREAS OF INTEREST INCLUDE 1543 00:55:29,600 --> 00:55:31,240 DECISION MAKING WITH ADULTS THAT 1544 00:55:31,240 --> 00:55:32,400 DON'T HAVE CAPACITY AND HE WILL 1545 00:55:32,400 --> 00:55:34,920 TALK ABOUT THAT AS WELL AS 1546 00:55:34,920 --> 00:55:40,280 ISSUES AROUND ASSISTED DYING. 1547 00:55:40,280 --> 00:55:41,200 WITHOUT FURTHER ADO. 1548 00:55:41,200 --> 00:55:43,240 YOU'RE NOT TALKING ABOUT THAT, I 1549 00:55:43,240 --> 00:55:44,960 WAS JUST SHARING THE RANGE OF 1550 00:55:44,960 --> 00:55:45,880 YOUR INTEREST. 1551 00:55:45,880 --> 00:55:47,480 HE WILL NOT TALK ABOUT ASSISTED 1552 00:55:47,480 --> 00:55:57,720 DYING TODAY. 1553 00:56:04,560 --> 00:56:05,680 TAKE IT AWAY. 1554 00:56:05,680 --> 00:56:07,040 >>YOU'VE SEEN THIS BEFORE. 1555 00:56:07,040 --> 00:56:11,440 JUST TO START WITH A LITTLE 1556 00:56:11,440 --> 00:56:13,400 HISTORY, BECAUSE THIS TOPIC 1557 00:56:13,400 --> 00:56:15,000 SEEMS RATHER ESOTERIC BECAUSE IT 1558 00:56:15,000 --> 00:56:18,040 ONLY APPLIES TO A SMALL 1559 00:56:18,040 --> 00:56:23,120 SUBSECTION OF RESEARCH WITH THE 1560 00:56:23,120 --> 00:56:25,840 VERY SMALL SUBGROUP OF RESEARCH 1561 00:56:25,840 --> 00:56:27,360 PARTICIPANTS BUT HISTORICALLY 1562 00:56:27,360 --> 00:56:29,680 YOU COULD ARGUE CONCERNS ABOUT 1563 00:56:29,680 --> 00:56:34,360 POPULATIONS OF PEOPLE WHO ARE 1564 00:56:34,360 --> 00:56:35,400 PARTICULARLY VULNERABLE BECAUSE 1565 00:56:35,400 --> 00:56:36,840 OF IMPAIRMENTS IN TERMS OF 1566 00:56:36,840 --> 00:56:38,840 GIVING CONSENT AND SO FORTH WAS 1567 00:56:38,840 --> 00:56:41,480 VERY MUCH AT THE CENTER OF WHAT 1568 00:56:41,480 --> 00:56:46,320 WE NOW HAVE COME TO KNOW AS THE 1569 00:56:46,320 --> 00:56:47,440 RESEARCH ETHICS ENTERPRISE. 1570 00:56:47,440 --> 00:56:51,120 SO I WANT TO QUICKLY GO THROUGH 1571 00:56:51,120 --> 00:56:53,280 THAT BY USING ONE OF THE PRIME 1572 00:56:53,280 --> 00:56:55,680 EXAMPLES OR SOURCE IN WHICH WE 1573 00:56:55,680 --> 00:57:00,480 TALK ABOUT THIS HISTORY AS HENRY 1574 00:57:00,480 --> 00:57:02,720 BEECHER'S 1966 ARTICLE WHERE HE 1575 00:57:02,720 --> 00:57:04,680 DESCRIBES, YOU COULD ARGUE BRIEF 1576 00:57:04,680 --> 00:57:08,520 BUT GORY DETAIL OF HOW SOME 1577 00:57:08,520 --> 00:57:12,160 VIOLATIONS TOOK PLACE. 1578 00:57:12,160 --> 00:57:14,400 FOR EXAMPLE, NINE OF THE 22 1579 00:57:14,400 --> 00:57:15,840 EXAMPLES HE USED INVOLVED AT 1580 00:57:15,840 --> 00:57:18,280 LEAST SOME PEOPLE WHO PROBABLY 1581 00:57:18,280 --> 00:57:20,600 HAD DIFFICULTY PROVIDING 1582 00:57:20,600 --> 00:57:23,120 INFORMED CONSENT. 1583 00:57:23,120 --> 00:57:25,040 FOR INSTANCE, EXAMPLE 4, THIS IS 1584 00:57:25,040 --> 00:57:29,760 SOMEWHAT DATED LANGUAGE SO 1585 00:57:29,760 --> 00:57:33,120 YOU'LL HAVE TO EXCUSE. 1586 00:57:33,120 --> 00:57:37,160 IT DESCRIBES MENTAL DEFECTIVE 1587 00:57:37,160 --> 00:57:42,760 AND DELINQUENT JUVENILES GIVEN 1588 00:57:42,760 --> 00:57:44,280 DRUG, BIOPSIES TAKEN, 1589 00:57:44,280 --> 00:57:45,680 RECHALLENGE WITH SAME DRUG, NOT 1590 00:57:45,680 --> 00:57:48,440 BENIGN TYPE OF RESEARCH. 1591 00:57:48,440 --> 00:57:50,280 ANOTHER EXPERIMENT OF 44 1592 00:57:50,280 --> 00:57:52,960 PATIENTS WHO HAD COGNITIVE 1593 00:57:52,960 --> 00:57:58,240 ABILITIES, ESTIMATED TO BE 1594 00:57:58,240 --> 00:57:59,440 SECOND TO TENTH GRADE. 1595 00:57:59,440 --> 00:58:02,240 OH, I'M SORRY, THIS IS ACTUALLY 1596 00:58:02,240 --> 00:58:05,080 THE -- THIS ONE IS THE CHILDREN 1597 00:58:05,080 --> 00:58:08,800 WHERE THEY DID ALL SORTS OF 1598 00:58:08,800 --> 00:58:11,400 MANEUVERS, THEY DID EXPERIMENTS 1599 00:58:11,400 --> 00:58:12,280 ON UNCONSCIOUS PATIENTS, 1600 00:58:12,280 --> 00:58:15,680 PATIENTS ABOUT TO BE IN A COMA 1601 00:58:15,680 --> 00:58:17,320 BECAUSE OF LIVER FAILURE AND DID 1602 00:58:17,320 --> 00:58:22,640 ALL SORTS OF EXPERIMENTS WITH 1603 00:58:22,640 --> 00:58:23,560 THEM, QUITE INVASIVE. 1604 00:58:23,560 --> 00:58:25,880 THERE WERE SEVERAL EXAMPLES 1605 00:58:25,880 --> 00:58:27,440 INVOLVING CHILDREN. 1606 00:58:27,440 --> 00:58:32,080 YOU CAN IMAGINE HOW MUCH 1607 00:58:32,080 --> 00:58:35,160 CONTROVERSY THESE KIND OF 1608 00:58:35,160 --> 00:58:36,720 STUDIES RAISED IN TERMS OF ALL 1609 00:58:36,720 --> 00:58:38,280 THE DISCUSSION THAT TOOK PLACE, 1610 00:58:38,280 --> 00:58:41,560 AND YOU COULD ARGUE THIS IS THE 1611 00:58:41,560 --> 00:58:42,480 BEGINNING OF THE SOUL SEARCHING 1612 00:58:42,480 --> 00:58:45,560 THAT WENT ON THAT LED TO ALL 1613 00:58:45,560 --> 00:58:46,440 THESE COMMISSIONS, DEVELOPMENT 1614 00:58:46,440 --> 00:58:48,960 OF LAWS AND SO FORTH, JUST TO 1615 00:58:48,960 --> 00:58:52,800 GIVE A LITTLE FLAVOR I'M GOING 1616 00:58:52,800 --> 00:58:54,440 TO LIST THEM. 1617 00:58:54,440 --> 00:58:58,640 1978 IS MOST FAMOUS, BELMONT 1618 00:58:58,640 --> 00:59:00,360 COMMISSION PUBLISHING RESEARCH 1619 00:59:00,360 --> 00:59:01,680 INVOLVING THOSE 1620 00:59:01,680 --> 00:59:03,240 INSTITUTIONALIZED AS MENTALLY 1621 00:59:03,240 --> 00:59:03,760 INFIRM. 1622 00:59:03,760 --> 00:59:09,880 BACK THEN, MANY, MANY PATIENTS 1623 00:59:09,880 --> 00:59:10,480 WERE INSTITUTIONALIZED. 1624 00:59:10,480 --> 00:59:14,160 THIS WAS MORE IN A CLINICAL 1625 00:59:14,160 --> 00:59:16,640 SETTING, A QUESTION HOW DO YOU 1626 00:59:16,640 --> 00:59:17,720 TREAT AND DEAL WITH THE QUESTION 1627 00:59:17,720 --> 00:59:20,800 OF PEOPLE WHO CAN'T GIVE THEIR 1628 00:59:20,800 --> 00:59:22,960 OWN CONSENT FOR TREATMENT. 1629 00:59:22,960 --> 00:59:25,720 AND THEN IN 1990s WE REVISITED 1630 00:59:25,720 --> 00:59:27,000 THAT BECAUSE OF SOME 1631 00:59:27,000 --> 00:59:28,960 CONTROVERSIES THAT OCCURRED. 1632 00:59:28,960 --> 00:59:32,200 THERE WAS A SPECIFIC MARYLAND 1633 00:59:32,200 --> 00:59:35,000 ATTORNEY'S WORKING GROUP MAINLY 1634 00:59:35,000 --> 00:59:38,400 BECAUSE NIH SITS WITHIN 1635 00:59:38,400 --> 00:59:44,960 MARYLAND, AND THEN THERE WAS A 1636 00:59:44,960 --> 00:59:45,880 NATIONAL BIOETHICS COMMISSION IN 1637 00:59:45,880 --> 00:59:48,280 1998 THAT ADDRESSED THE ISSUE. 1638 00:59:48,280 --> 00:59:50,120 THERE'S ANOTHER STATE WORKING 1639 00:59:50,120 --> 00:59:52,560 GROUP IN NEW YORK MAINLY BECAUSE 1640 00:59:52,560 --> 00:59:54,760 THERE WAS LOTS OF DISCREPANCY 1641 00:59:54,760 --> 00:59:57,640 WITHIN THE STATE AS TO HOW TO 1642 00:59:57,640 --> 01:00:01,080 CONDUCT RESEARCH WITH PEOPLE WHO 1643 01:00:01,080 --> 01:00:03,440 COULDN'T CONSENT. 1644 01:00:03,440 --> 01:00:04,080 FINALLY THE AGENCY, DEPARTMENT 1645 01:00:04,080 --> 01:00:07,040 OF HEALTH AND HUMAN SERVICES, 1646 01:00:07,040 --> 01:00:10,400 APPOINTED AN ADVISORY COMMITTEE. 1647 01:00:10,400 --> 01:00:12,080 THEY ISSUED TWO REPORTS IN 2009 1648 01:00:12,080 --> 01:00:19,360 ON THE SAME TOPIC. 1649 01:00:19,360 --> 01:00:26,080 AGAIN, IN 2015, WHEN PRESIDENT 1650 01:00:26,080 --> 01:00:28,680 OBAMA HAD A COMMISSION ON THESE 1651 01:00:28,680 --> 01:00:30,880 ISSUES, IT WAS, AGAIN, 1652 01:00:30,880 --> 01:00:31,200 REVISITED. 1653 01:00:31,200 --> 01:00:33,560 SO IT'S BEEN AN ONGOING ISSUE. 1654 01:00:33,560 --> 01:00:36,560 AND FINALLY ONE CHANGE THAT DID 1655 01:00:36,560 --> 01:00:39,200 TAKE PLACE IN 2018 THERE WAS -- 1656 01:00:39,200 --> 01:00:40,880 IT DID ADDRESS ONE SPECIFIC 1657 01:00:40,880 --> 01:00:45,720 ISSUE AS I'LL TRY. 1658 01:00:45,720 --> 01:00:46,560 OKAY. 1659 01:00:46,560 --> 01:00:47,720 THAT'S THE HISTORY. 1660 01:00:47,720 --> 01:00:50,560 IF YOU ONLY TAKE AWAY ONE LESSON 1661 01:00:50,560 --> 01:00:56,560 FROM MY TALK, IT'S THIS. 1662 01:00:56,560 --> 01:00:59,360 INVOLVING THOSE LACKING 1663 01:00:59,360 --> 01:01:00,400 DECISION-MAKING CAPACITY OR 1664 01:01:00,400 --> 01:01:04,720 PEOPLE AT RISK OF LOSING THEIR 1665 01:01:04,720 --> 01:01:06,800 CAPACITY MUST BE SPECIFICALLY 1666 01:01:06,800 --> 01:01:07,080 JUSTIFIED. 1667 01:01:07,080 --> 01:01:10,080 THAT SEEMS LIKE AN OBVIOUS 1668 01:01:10,080 --> 01:01:14,120 NO-BRAINER COMMON SENSE 1669 01:01:14,120 --> 01:01:15,760 STATEMENT, BUT YOU'LL NOTICE 1670 01:01:15,760 --> 01:01:17,880 WITH THE HISTORICAL EXAMPLES I 1671 01:01:17,880 --> 01:01:22,160 GAVE YOU THESE FOLKS WERE TAKEN 1672 01:01:22,160 --> 01:01:24,520 ADVANTAGE OF, EXPLOITED, BECAUSE 1673 01:01:24,520 --> 01:01:25,960 THEY WERE AVAILABLE, CONVENIENT 1674 01:01:25,960 --> 01:01:26,680 TO EXPLOIT. 1675 01:01:26,680 --> 01:01:31,520 AND BECAUSE THEY WERE 1676 01:01:31,520 --> 01:01:32,120 VULNERABLE. 1677 01:01:32,120 --> 01:01:36,360 SO NOW WE HAVE CREATED A 1678 01:01:36,360 --> 01:01:37,720 SPECIFIC NEED FOR JUSTIFICATION, 1679 01:01:37,720 --> 01:01:39,760 RESEARCH, YOU HAVE TO SAY WHY 1680 01:01:39,760 --> 01:01:42,160 THEY CAN'T DO THIS IMPORTANT 1681 01:01:42,160 --> 01:01:44,200 RESEARCH WITHOUT INVOLVING THESE 1682 01:01:44,200 --> 01:01:48,040 FOLKS, AND IT HAS TO BE FOCUSED 1683 01:01:48,040 --> 01:01:54,160 ON THE DISORDER OR THE 1684 01:01:54,160 --> 01:01:55,280 CONSEQUENCES OF THAT DISOFFERED 1685 01:01:55,280 --> 01:01:57,520 SO YOU HAVE TO JUSTIFY THE 1686 01:01:57,520 --> 01:01:59,280 INVOLVEMENT OF THIS POPULATION. 1687 01:01:59,280 --> 01:02:01,320 RARELY THERE CAN BE QUESTIONS OF 1688 01:02:01,320 --> 01:02:04,120 EQUITY AND DISCRIMINATION THAT 1689 01:02:04,120 --> 01:02:05,320 ARISE IF YOU SYSTEMATICALLY 1690 01:02:05,320 --> 01:02:06,560 EXCLUDE THESE FOLKS FROM CERTAIN 1691 01:02:06,560 --> 01:02:08,800 TYPES OF RESEARCH BUT THAT'S 1692 01:02:08,800 --> 01:02:12,200 RARE AND WE DEAL WITH THOSE ON A 1693 01:02:12,200 --> 01:02:14,280 CASE-BY-CASE BASIS. 1694 01:02:14,280 --> 01:02:14,600 OKAY. 1695 01:02:14,600 --> 01:02:16,840 WHAT I'M GOING TO DO IS GIVE YOU 1696 01:02:16,840 --> 01:02:18,680 BACKGROUND AND DECISION MAKING 1697 01:02:18,680 --> 01:02:24,040 CAPACITY AND IMPAIRMENT. 1698 01:02:24,040 --> 01:02:25,280 GIVE YOU SOME EMPIRICAL 1699 01:02:25,280 --> 01:02:26,440 INFORMATION THROUGHOUT THE TALK 1700 01:02:26,440 --> 01:02:33,440 AS WELL ON THIS TOPIC. 1701 01:02:33,440 --> 01:02:35,840 ASK THE QUESTION OF IS IT 1702 01:02:35,840 --> 01:02:38,000 PERMISSIBLE TO DO RESEARCH WITH 1703 01:02:38,000 --> 01:02:39,720 THESE FOLKS? 1704 01:02:39,720 --> 01:02:42,720 IF SO, WHO SHOULD GIVE CONSENT 1705 01:02:42,720 --> 01:02:44,600 BECAUSE THE WHOLE POINT IS THEY 1706 01:02:44,600 --> 01:02:48,400 CAN'T GIVE CONSENT FOR 1707 01:02:48,400 --> 01:02:49,920 THEMSELVES, WHO SHOULD? 1708 01:02:49,920 --> 01:02:52,080 AND THE OTHER MOST IMPORTANT 1709 01:02:52,080 --> 01:02:54,760 ISSUE OF COURSE IS THAT DO WE 1710 01:02:54,760 --> 01:02:56,720 TREAT THIS LIKE AN INDIVIDUAL 1711 01:02:56,720 --> 01:03:00,120 GIVING CONSENT FOR HIM OR 1712 01:03:00,120 --> 01:03:02,320 HERSELF, OR GIVEN THAT SOMEBODY 1713 01:03:02,320 --> 01:03:05,840 ELSE IS GIVING CONSENT FOR 1714 01:03:05,840 --> 01:03:08,360 ANOTHER PERSON, SHOULD THERE BE 1715 01:03:08,360 --> 01:03:16,440 MORE RESTRICTIONS ON THE 1716 01:03:16,440 --> 01:03:17,760 RISK/BENEFIT CALCULUS? 1717 01:03:17,760 --> 01:03:19,400 I'M GOING TO GIVE EMPIRICAL 1718 01:03:19,400 --> 01:03:21,480 DATA, OR DATA IS ALWAYS 1719 01:03:21,480 --> 01:03:26,040 EMPIRICAL OF COURSE, SOME DATA 1720 01:03:26,040 --> 01:03:29,080 ON -- THAT'S RELEVANT TO THIS 1721 01:03:29,080 --> 01:03:29,360 QUESTION. 1722 01:03:29,360 --> 01:03:31,520 PARTLY BECAUSE A LOT OF THESE 1723 01:03:31,520 --> 01:03:35,720 ETHICAL ISSUES WE OFTEN TALK AS 1724 01:03:35,720 --> 01:03:38,320 THOUGH THERE'S SOME A PRIORI 1725 01:03:38,320 --> 01:03:43,880 RIGHT ANSWER BUT OFTEN IT'S A 1726 01:03:43,880 --> 01:03:44,920 QUESTION OF PROCEDURAL 1727 01:03:44,920 --> 01:03:46,200 COLLECTIVE AGREEMENT AS A 1728 01:03:46,200 --> 01:03:49,200 SOCIETY AS TO WHAT'S ACCEPTABLE, 1729 01:03:49,200 --> 01:03:53,200 EACH OF US PUTTING INTO THE POOL 1730 01:03:53,200 --> 01:03:55,480 OR MORAL INTUITIONS. 1731 01:03:55,480 --> 01:03:57,200 AND THIS IS WHY THE PUBLIC'S 1732 01:03:57,200 --> 01:04:00,800 VIEW CAN BE QUITE HELPFUL. 1733 01:04:00,800 --> 01:04:01,480 OKAY. 1734 01:04:01,480 --> 01:04:04,160 THEN I END WITH SOME ADDITIONAL 1735 01:04:04,160 --> 01:04:04,920 PROTECTIONS AND CONSIDERATIONS 1736 01:04:04,920 --> 01:04:06,320 THAT WE SHOULD THINK ABOUT. 1737 01:04:06,320 --> 01:04:08,920 I'M GOING TO TRY TO COMPLICATE 1738 01:04:08,920 --> 01:04:13,000 THE MATTER A LITTLE BIT BECAUSE 1739 01:04:13,000 --> 01:04:15,520 I JUST WANT TO REITERATE WHAT'S 1740 01:04:15,520 --> 01:04:16,720 REALLY IMPORTANT IS TO 1741 01:04:16,720 --> 01:04:20,560 UNDERSTAND AT THE CONCRETE LEVEL 1742 01:04:20,560 --> 01:04:22,160 WHAT KIND OF VULNERABILITIES 1743 01:04:22,160 --> 01:04:23,640 PEOPLE ARE FACING, NOT JUST 1744 01:04:23,640 --> 01:04:26,040 THEORY DID THEY HAVE OR NOT HAVE 1745 01:04:26,040 --> 01:04:27,160 DECISION MAKING CAPACITY. 1746 01:04:27,160 --> 01:04:28,480 THAT SHOULD BECOME CLEAR AS WE 1747 01:04:28,480 --> 01:04:29,200 GO. 1748 01:04:29,200 --> 01:04:29,840 ALL RIGHT. 1749 01:04:29,840 --> 01:04:33,880 SO WHAT TIME AM I ENDING, HOLLY? 1750 01:04:33,880 --> 01:04:38,040 >>YOU ARE ENDING AT 11:00 1751 01:04:38,040 --> 01:04:40,480 WITH -- SORRY, SORRY, SORRY. 1752 01:04:40,480 --> 01:04:42,560 10:10 WITH 10 MINUTES OF 1753 01:04:42,560 --> 01:04:43,200 DISCUSSION. 1754 01:04:43,200 --> 01:04:44,600 >>OKAY, 10:10. 1755 01:04:44,600 --> 01:04:45,200 THANK YOU. 1756 01:04:45,200 --> 01:04:48,800 A LITTLE BACKGROUND. 1757 01:04:48,800 --> 01:04:50,440 NOT EVERYBODY HAS A BACKGROUND 1758 01:04:50,440 --> 01:04:54,960 IN THIS. 1759 01:04:54,960 --> 01:04:55,560 THERE'S TERMS AND DEFINITIONS, 1760 01:04:55,560 --> 01:04:57,880 YOU HAVE TO TRUST ME, EVEN 1761 01:04:57,880 --> 01:05:00,680 THOUGH I CONSIDER MYSELF PRETTY 1762 01:05:00,680 --> 01:05:01,600 KNOWLEDGEABLE ABOUT THIS TOPIC, 1763 01:05:01,600 --> 01:05:04,160 YOU'D BE SURPRISED THAT I GIVE 1764 01:05:04,160 --> 01:05:06,800 TALKS AND PEOPLE CORRECT ME THAT 1765 01:05:06,800 --> 01:05:07,640 I DON'T UNDERSTAND THESE TERMS 1766 01:05:07,640 --> 01:05:09,600 AT THE TALKS I GIVE. 1767 01:05:09,600 --> 01:05:11,040 THAT'S PROBABLY BECAUSE WE ALL 1768 01:05:11,040 --> 01:05:12,720 HAVE OUR OWN FAVORITE WAYS OF 1769 01:05:12,720 --> 01:05:14,280 TALKING ABOUT THIS AND THINK 1770 01:05:14,280 --> 01:05:15,400 THAT'S THE RIGHT WAY. 1771 01:05:15,400 --> 01:05:17,520 BUT WHAT'S IMPORTANT FOR US IS 1772 01:05:17,520 --> 01:05:19,560 TO UNDERSTAND HOW I'M USING IT 1773 01:05:19,560 --> 01:05:22,240 TODAY AND YOU CAN TRANSLATE IT 1774 01:05:22,240 --> 01:05:26,320 OUTSIDE OF THIS ROOM LATER. 1775 01:05:26,320 --> 01:05:27,760 ALL RIGHT. 1776 01:05:27,760 --> 01:05:35,280 I'M GOING TO STREET THE TERMS 1777 01:05:35,280 --> 01:05:35,600 EQUIVALENTLY. 1778 01:05:35,600 --> 01:05:39,200 AND IT REFERS TO THE DICHOTOMOUS 1779 01:05:39,200 --> 01:05:42,800 YES/NO, HAVE IT OR DON'T HAVE IT 1780 01:05:42,800 --> 01:05:44,640 CONCEPT. 1781 01:05:44,640 --> 01:05:47,840 AND ONE OFTEN HEARS COMPETENCE A 1782 01:05:47,840 --> 01:05:48,920 LEGAL TERM, CAPACITY ISN'T. 1783 01:05:48,920 --> 01:05:50,520 IT'S NOT TRUE. 1784 01:05:50,520 --> 01:05:52,320 MOST MODERN LAWS ON DECISION 1785 01:05:52,320 --> 01:05:54,480 MAKING CAPACITY USE THE TERM 1786 01:05:54,480 --> 01:05:55,720 DECISION MAKING CAPACITY AND 1787 01:05:55,720 --> 01:06:00,000 RARELY USE THE TERM COMPETENCE. 1788 01:06:00,000 --> 01:06:01,040 IN THE COURTS SOMETIMES, REALLY 1789 01:06:01,040 --> 01:06:04,000 PREFERRED LEGAL TERM IS ACTUALLY 1790 01:06:04,000 --> 01:06:04,640 CAPACITY NOW. 1791 01:06:04,640 --> 01:06:07,840 SO, THIS IS WHAT I JUST SAID. 1792 01:06:07,840 --> 01:06:10,320 SO LET'S GO THROUGH SOME 1793 01:06:10,320 --> 01:06:10,640 DEFINITIONS. 1794 01:06:10,640 --> 01:06:14,040 IF WHAT YOU MEAN IS THIS 1795 01:06:14,040 --> 01:06:15,480 PERSON'S STATUS, THEIR DECISION 1796 01:06:15,480 --> 01:06:16,480 MAKING CAPACITY STATUS HAS BEEN 1797 01:06:16,480 --> 01:06:18,280 DETERMINED BY A JUDGE WE SHOULD 1798 01:06:18,280 --> 01:06:21,040 SAY THAT'S WHAT'S HAPPENED. 1799 01:06:21,040 --> 01:06:23,440 IT'S BEEN ADJUDICATED. 1800 01:06:23,440 --> 01:06:26,280 OF COURSE, MOST CASES DON'T GO 1801 01:06:26,280 --> 01:06:27,920 TO COURT. 1802 01:06:27,920 --> 01:06:29,840 IT'S DETERMINED USUALLY IN A 1803 01:06:29,840 --> 01:06:35,040 CLINICAL SETTING FOR TREATMENT 1804 01:06:35,040 --> 01:06:38,200 OR RESEARCH CONSENT, THE 1805 01:06:38,200 --> 01:06:39,400 CLINICIANS AAPPROXIMATION OF 1806 01:06:39,400 --> 01:06:40,840 WHAT A JUDGE WOULD DECIDE FIT 1807 01:06:40,840 --> 01:06:41,880 WENT TO COURT. 1808 01:06:41,880 --> 01:06:46,960 THIS HAS LEGAL BACKING IN THE 1809 01:06:46,960 --> 01:06:50,000 CLINICAL ARENA BECAUSE THE LAW 1810 01:06:50,000 --> 01:06:54,080 SPECIFICALLY SAYS THE ATTENDING 1811 01:06:54,080 --> 01:06:55,320 PHYSICIAN SHALL DETERMINE 1812 01:06:55,320 --> 01:06:56,200 DECISION-MAKING CAPACITY, ALSO 1813 01:06:56,200 --> 01:06:59,880 IN THE RESEARCH SETTING AS WELL, 1814 01:06:59,880 --> 01:07:02,280 IN THE POLICIES. 1815 01:07:02,280 --> 01:07:04,440 WE HAVE TO DISTINGUISH THAT 1816 01:07:04,440 --> 01:07:06,760 STATUS OF HAVING DECISIONAL 1817 01:07:06,760 --> 01:07:09,000 AUTHORITY BY VIRTUE OF HAVING 1818 01:07:09,000 --> 01:07:11,160 DECISION MAKING CAPACITY FROM 1819 01:07:11,160 --> 01:07:12,160 THE SPECIFIC ABILITIES RELEVANT 1820 01:07:12,160 --> 01:07:14,000 TO CAPACITY. 1821 01:07:14,000 --> 01:07:15,000 THESE ARE FUNCTIONAL, THAT WE 1822 01:07:15,000 --> 01:07:16,480 CAN MEASURE. 1823 01:07:16,480 --> 01:07:20,640 WE HAVE ACTUALLY INSTRUMENTS TO 1824 01:07:20,640 --> 01:07:21,320 DO THAT. 1825 01:07:21,320 --> 01:07:23,280 I'M GIVING YOU THE FOUR 1826 01:07:23,280 --> 01:07:24,200 ABILITIES MODEL BECAUSE THAT'S 1827 01:07:24,200 --> 01:07:27,560 THE MOST POPULAR IN THE U.S., IN 1828 01:07:27,560 --> 01:07:29,240 MANY JURISDICTIONS, BUT IN OTHER 1829 01:07:29,240 --> 01:07:31,280 PLACES THEY MIGHT HAVE OTHERS, 1830 01:07:31,280 --> 01:07:33,640 OTHER CRITERIA, THAT ARE 1831 01:07:33,640 --> 01:07:35,120 SLIGHTLY DIFFERENT BUT THE POINT 1832 01:07:35,120 --> 01:07:40,200 IS THAT YOU CAN SORT OF BREAK IT 1833 01:07:40,200 --> 01:07:42,040 DOWN INTO FUNCTIONAL COMPONENTS. 1834 01:07:42,040 --> 01:07:45,280 SO THESE ABILITIES CAN BE 1835 01:07:45,280 --> 01:07:46,280 MEASURED WITH INSTRUMENTS. 1836 01:07:46,280 --> 01:07:49,640 DID YOU THE DETERMINATION OF 1837 01:07:49,640 --> 01:07:54,320 YES,/NO IS A NORMATIVE AND 1838 01:07:54,320 --> 01:07:55,080 CLINICAL JUDGMENT. 1839 01:07:55,080 --> 01:07:58,640 IT IS PART OF THE INFORMED 1840 01:07:58,640 --> 01:07:59,600 CONSENT DOCTRINE. 1841 01:07:59,600 --> 01:08:01,280 INFORMED CONSENT HAS THREE 1842 01:08:01,280 --> 01:08:01,600 COMPONENTS. 1843 01:08:01,600 --> 01:08:05,640 THE PERSON HAS TO BE COMPETENT 1844 01:08:05,640 --> 01:08:06,920 TO GIVE INFORMED CONSENT BASED 1845 01:08:06,920 --> 01:08:08,120 ON ADEQUATE INFORMATION THAT'S 1846 01:08:08,120 --> 01:08:10,960 BEEN PROVIDED TO HIM OR HER. 1847 01:08:10,960 --> 01:08:14,720 AND THEY SHOULDN'T BE COERCED OR 1848 01:08:14,720 --> 01:08:16,640 UNDULY INFLUENCED IN MAKING THAT 1849 01:08:16,640 --> 01:08:17,240 DECISION. 1850 01:08:17,240 --> 01:08:22,240 AND CAPACITY IS JUST ONE OF 1851 01:08:22,240 --> 01:08:29,080 THOSE THREE ELEMENTS. 1852 01:08:29,080 --> 01:08:34,440 IT USED TO BE WE USED SENILEITY, 1853 01:08:34,440 --> 01:08:36,760 UNSOUND MIND, YOU CAN GO TO 1854 01:08:36,760 --> 01:08:38,000 COURT DOCUMENTS OR EARLY 1855 01:08:38,000 --> 01:08:39,520 LEGISLATION THAT WOULD SAY YOU 1856 01:08:39,520 --> 01:08:46,040 CAN COMMIT A PERSON TO AN INSANE 1857 01:08:46,040 --> 01:08:49,640 ASYLUM BASED ON TWO PHYSICIANS 1858 01:08:49,640 --> 01:08:51,480 CERTIFYING THE PERSON IS OF 1859 01:08:51,480 --> 01:08:52,480 UNSOUND MIND. 1860 01:08:52,480 --> 01:08:55,000 YOU CAN IMAGINE WHAT KIND OF 1861 01:08:55,000 --> 01:08:56,400 ABUSES THINGS LIKE THAT COULD 1862 01:08:56,400 --> 01:08:57,360 AND DID LEAD TO. 1863 01:08:57,360 --> 01:08:59,240 SO NOW WE DON'T DO THAT. 1864 01:08:59,240 --> 01:09:03,400 WE FOCUS ON THE FUNCTIONAL 1865 01:09:03,400 --> 01:09:03,680 ABILITIES. 1866 01:09:03,680 --> 01:09:05,560 THE THRESHOLD OF WHETHER A 1867 01:09:05,560 --> 01:09:07,320 PERSON HAS CAPACITY IS AFFECTED 1868 01:09:07,320 --> 01:09:09,480 BY THE CONTEXT. 1869 01:09:09,480 --> 01:09:12,680 MOST IMPORTANT, RISK/BENEFITS OF 1870 01:09:12,680 --> 01:09:14,280 THE DECISION, MOMENTOUS 1871 01:09:14,280 --> 01:09:18,160 SERIOUSNESS OF THE DECISION. 1872 01:09:18,160 --> 01:09:20,360 AND IT IS TASK OR DECISION 1873 01:09:20,360 --> 01:09:22,320 SPECIFIC. 1874 01:09:22,320 --> 01:09:24,960 I MIGHT BE INCOMPETENT TO DECIDE 1875 01:09:24,960 --> 01:09:31,280 ON DECISION A, BUT COMPETENT TO 1876 01:09:31,280 --> 01:09:33,280 DECIDE ON DECISION B. 1877 01:09:33,280 --> 01:09:36,160 I'M GOING TO GIVE YOU AN ASIDE. 1878 01:09:36,160 --> 01:09:38,920 IF YOU'RE INTERESTED TO HEAR 1879 01:09:38,920 --> 01:09:40,160 ABOUT THIS, I NEED TO INTRODUCE 1880 01:09:40,160 --> 01:09:44,400 IT AND PUT IT ASIDE. 1881 01:09:44,400 --> 01:09:46,560 THE U.N. COMMITTEE ON THE RIGHTS 1882 01:09:46,560 --> 01:09:48,080 OF PERSONS WITH DISABILITIES, 1883 01:09:48,080 --> 01:09:49,720 ALSO RESPONSIBLE FOR WRITING THE 1884 01:09:49,720 --> 01:09:53,680 CONVENTION ON THE RIGHTS OF 1885 01:09:53,680 --> 01:09:56,720 PERSONS WITH DISABILITIES, IN 1886 01:09:56,720 --> 01:09:58,200 2008, VERY IMPORTANT DOCUMENT 1887 01:09:58,200 --> 01:10:01,600 BECAUSE IT SETS OUT A KIND OF 1888 01:10:01,600 --> 01:10:04,440 GLOBAL STANDARD FOR THE KIND OF 1889 01:10:04,440 --> 01:10:08,600 EQUITABLE TREATMENT OF PERSONS 1890 01:10:08,600 --> 01:10:09,240 WITH DISABILITIES. 1891 01:10:09,240 --> 01:10:10,920 NOW, GENERALLY I WOULD SAY THE 1892 01:10:10,920 --> 01:10:13,320 FOLLOWING. 1893 01:10:13,320 --> 01:10:16,640 SADLY U.S. IS NOT IS A SIGNATORY 1894 01:10:16,640 --> 01:10:17,840 TO THIS CONVENTION, EVEN THOUGH 1895 01:10:17,840 --> 01:10:22,760 IT SHOULD BE SAID THAT WE WERE 1896 01:10:22,760 --> 01:10:24,480 AHEAD OF THE CURVE WITH 1897 01:10:24,480 --> 01:10:26,160 AMERICANS WITH DISABILITIES ACT, 1898 01:10:26,160 --> 01:10:30,600 THAT TOOK PLACE ACTUALLY DECADES 1899 01:10:30,600 --> 01:10:31,000 BEFORE. 1900 01:10:31,000 --> 01:10:35,240 WHY DO I MENTION THIS? 1901 01:10:35,240 --> 01:10:38,440 BECAUSE THERE'S AN ARTICLE THAT 1902 01:10:38,440 --> 01:10:43,240 HAS BEEN INTERPRETED BY THE 1903 01:10:43,240 --> 01:10:44,880 COMMITTEE ITSELF IN A SEPARATE 1904 01:10:44,880 --> 01:10:49,560 COMMENTARY ON THE ARTICLES THAT 1905 01:10:49,560 --> 01:10:53,440 WHAT THEY MEAN BY THAT ARTICLE 1906 01:10:53,440 --> 01:10:58,000 IS THAT LEGAL REGIMES WHICH 1907 01:10:58,000 --> 01:10:59,440 ALLOW SUBSTITUTE DECISION MAKING 1908 01:10:59,440 --> 01:11:02,880 SHOULD BE REPLACED BY SUPPORTED 1909 01:11:02,880 --> 01:11:05,480 DECISION MAKING BECAUSE 1910 01:11:05,480 --> 01:11:06,520 REGARDLESS OF FUNCTIONAL 1911 01:11:06,520 --> 01:11:07,400 ABILITIES EVERYBODY STILL 1912 01:11:07,400 --> 01:11:09,640 RETAINS LEGAL CAPACITY. 1913 01:11:09,640 --> 01:11:11,400 NOW, THERE ARE MOUNTAINS OF 1914 01:11:11,400 --> 01:11:12,320 ARTICLES WRITTEN ON THIS. 1915 01:11:12,320 --> 01:11:15,080 AND IF YOU'RE INTERESTED YOU CAN 1916 01:11:15,080 --> 01:11:18,680 LOOK AT IT. 1917 01:11:18,680 --> 01:11:21,120 BUT I'M GOING TO PUT THIS ASIDE 1918 01:11:21,120 --> 01:11:24,120 FOR MANY REASONS BECAUSE NO 1919 01:11:24,120 --> 01:11:25,160 SIGNIFICANT JURISDICTION HAS 1920 01:11:25,160 --> 01:11:27,480 REALLY TAKEN THAT UP AND IT'S 1921 01:11:27,480 --> 01:11:29,040 HIGHLY UNLIKELY THAT WILL EVER 1922 01:11:29,040 --> 01:11:29,320 HAPPEN. 1923 01:11:29,320 --> 01:11:32,280 AND EVEN THE COMMITTEE ITSELF 1924 01:11:32,280 --> 01:11:35,280 WITH CHANGES IN MEMBERSHIP HAVE 1925 01:11:35,280 --> 01:11:36,920 SOFTENED ITS VIEWS ON THIS. 1926 01:11:36,920 --> 01:11:37,920 I MENTION THAT BECAUSE YOU'LL 1927 01:11:37,920 --> 01:11:40,480 HEAR ABOUT IT. 1928 01:11:40,480 --> 01:11:40,840 OKAY. 1929 01:11:40,840 --> 01:11:43,920 SO LET'S JUST STEP BACK AND LOOK 1930 01:11:43,920 --> 01:11:46,080 AT SORT OF THE CLINICAL SIDE, 1931 01:11:46,080 --> 01:11:48,640 WHO ARE THE PEOPLE THAT WE'RE 1932 01:11:48,640 --> 01:11:49,720 TALKING ABOUT? 1933 01:11:49,720 --> 01:11:51,880 OBVIOUSLY IT'S PEOPLE WITH 1934 01:11:51,880 --> 01:11:54,280 COGNITIVE DISORDERS, THAT'S MOST 1935 01:11:54,280 --> 01:11:57,120 AFFECTED BY THIS ISSUE. 1936 01:11:57,120 --> 01:11:59,240 PEOPLE WITH NEURODEGENERATIVE 1937 01:11:59,240 --> 01:11:59,520 DISORDERS. 1938 01:11:59,520 --> 01:12:01,840 AS YOU KNOW, ALZHEIMER'S IS 1939 01:12:01,840 --> 01:12:03,200 VERY, VERY COMMON. 1940 01:12:03,200 --> 01:12:06,880 YOU HAVE A SIGNIFICANT RISK AS 1941 01:12:06,880 --> 01:12:08,920 YOU AGE. 1942 01:12:08,920 --> 01:12:13,000 THERE ARE OTHER DEMENTIAS. 1943 01:12:13,000 --> 01:12:15,880 ALZHEIMER'S TAKES OUT 70 TO 80% 1944 01:12:15,880 --> 01:12:20,720 OF ALL BUT IT'S COMMON, 1945 01:12:20,720 --> 01:12:22,720 NEURODEVELOPMENTAL DISORDERS, 1946 01:12:22,720 --> 01:12:24,000 PEOPLE WITH SIGNIFICANT 1947 01:12:24,000 --> 01:12:26,880 INJURIES, AS WELL AS PEOPLE WITH 1948 01:12:26,880 --> 01:12:30,760 MEDICAL PROBLEMS WHO ARE IN 1949 01:12:30,760 --> 01:12:33,720 TEMPORARY STATES OF CONFUSION IN 1950 01:12:33,720 --> 01:12:34,920 THE HOSPITAL. 1951 01:12:34,920 --> 01:12:37,120 ALSO PEOPLE WITH PSYCHOTIC 1952 01:12:37,120 --> 01:12:37,520 DISORDERS. 1953 01:12:37,520 --> 01:12:40,160 I WOULD INCLUDE IN THIS PEOPLE 1954 01:12:40,160 --> 01:12:42,480 WITH MOOD DISORDERS IN PSYCHOTIC 1955 01:12:42,480 --> 01:12:46,000 STATES LIKE, SAY, MANIA, PEOPLE 1956 01:12:46,000 --> 01:12:47,720 WITH BIPOLAR DISORDER. 1957 01:12:47,720 --> 01:12:49,800 MOOD DISORDER IS WHEN THEY ARE 1958 01:12:49,800 --> 01:12:50,240 SEVERE. 1959 01:12:50,240 --> 01:12:52,800 DEPRESSION IS WHAT I MEAN HERE 1960 01:12:52,800 --> 01:12:54,640 BECAUSE YOU HAVE SIGNIFICANT 1961 01:12:54,640 --> 01:12:56,160 COGNITIVE AND REALITY TESTING 1962 01:12:56,160 --> 01:12:59,880 DIFFICULTIES IF YOU'RE SEVERELY 1963 01:12:59,880 --> 01:13:00,160 DEPRESSED. 1964 01:13:00,160 --> 01:13:01,400 EATING DISORDERS WHEN SEVERE. 1965 01:13:01,400 --> 01:13:03,320 THERE'S SOME WRITINGS ABOUT WHAT 1966 01:13:03,320 --> 01:13:05,920 ABOUT EXTREME FORMS OF 1967 01:13:05,920 --> 01:13:07,200 PERSONALITY DISORDERS OR 1968 01:13:07,200 --> 01:13:08,920 SUBSTANCE ABUSE DISORDERS, SO 1969 01:13:08,920 --> 01:13:11,040 THERE'S A SMALL LITERATURE IN 1970 01:13:11,040 --> 01:13:11,920 EACH OF THOSE. 1971 01:13:11,920 --> 01:13:13,440 IMPORTANT THING TO TAKE AWAY 1972 01:13:13,440 --> 01:13:16,840 FROM THIS SLIDE IS THAT I'M NOT 1973 01:13:16,840 --> 01:13:17,920 SAYING THAT THESE CONSTITUTE 1974 01:13:17,920 --> 01:13:20,840 REASONS TO BELIEVE THE PERSON 1975 01:13:20,840 --> 01:13:24,040 LACKS CAPACITY BUT RATHER THEY 1976 01:13:24,040 --> 01:13:25,200 ARE RISK FACTORS. 1977 01:13:25,200 --> 01:13:26,720 IF A PERSON HAS, FOR EXAMPLE, 1978 01:13:26,720 --> 01:13:27,840 ALZHEIMER'S DISEASE THAT'S WELL 1979 01:13:27,840 --> 01:13:29,760 DIAGNOSED AND YOU'RE ASKING HIM 1980 01:13:29,760 --> 01:13:34,280 OR HER TO CONSENT TO A 1981 01:13:34,280 --> 01:13:35,520 SIGNIFICANT RISK PROCEDURE, THEN 1982 01:13:35,520 --> 01:13:38,560 YOU NEED TO REALLY THINK ABOUT 1983 01:13:38,560 --> 01:13:42,040 THE CAPACITY ISSUE, NOT ASSUME 1984 01:13:42,040 --> 01:13:43,000 THEY CAN'T BUT SUSPEND 1985 01:13:43,000 --> 01:13:46,480 PRESUMPTION PERHAPS THAT THEY 1986 01:13:46,480 --> 01:13:47,760 ARE CAPABLE. 1987 01:13:47,760 --> 01:13:47,960 OKAY. 1988 01:13:47,960 --> 01:13:51,000 SO WHAT IS THE PREVALENCE OF 1989 01:13:51,000 --> 01:13:52,080 DECISIONAL CAPACITY? 1990 01:13:52,080 --> 01:13:54,160 THIS IS VERY ROUGH ESTIMATES. 1991 01:13:54,160 --> 01:13:56,720 I'VE SORT OF SUMMARIZED LOTS OF 1992 01:13:56,720 --> 01:14:00,600 LITERATURE TO GIVE YOU A FEEL. 1993 01:14:00,600 --> 01:14:02,960 I GIVE YOU THAT CAVEAT BECAUSE 1994 01:14:02,960 --> 01:14:05,600 THE ACTUAL, AS YOU REMEMBER, 1995 01:14:05,600 --> 01:14:07,680 DECISION MAKING CAPACITY IS 1996 01:14:07,680 --> 01:14:08,640 DECISION SPECIFIC, CONTEXT 1997 01:14:08,640 --> 01:14:09,080 SPECIFIC. 1998 01:14:09,080 --> 01:14:10,440 THIS IS CUTTING ACROSS ALL 1999 01:14:10,440 --> 01:14:14,360 DIFFERENT TYPES OF DECISIONS AND 2000 01:14:14,360 --> 01:14:15,120 CONTEXTS. 2001 01:14:15,120 --> 01:14:15,320 OKAY. 2002 01:14:15,320 --> 01:14:19,760 SO, YOU KNOW, IF YOU WALK INTO A 2003 01:14:19,760 --> 01:14:20,400 GENERAL HOSPITAL, SIBLEY 2004 01:14:20,400 --> 01:14:23,760 HOSPITAL OR JOHNS HOPKINS 2005 01:14:23,760 --> 01:14:25,800 HOSPITAL, YOU WILL IMMEDIATELY 2006 01:14:25,800 --> 01:14:27,240 FIND SIGNIFICANT MINORITY OF 2007 01:14:27,240 --> 01:14:28,200 PERSONS PROBABLY CAN'T GIVE 2008 01:14:28,200 --> 01:14:29,120 THEIR OWN CONSENT. 2009 01:14:29,120 --> 01:14:34,800 IT HAS TO DO WITH HOW AGED THE 2010 01:14:34,800 --> 01:14:37,040 HOSPITAL POPULATION IS AND HOW 2011 01:14:37,040 --> 01:14:38,080 SERIOUSLY ILL MOST PEOPLE ARE 2012 01:14:38,080 --> 01:14:40,600 WHO ARE IN THE HOSPITAL THESE 2013 01:14:40,600 --> 01:14:41,120 DAYS. 2014 01:14:41,120 --> 01:14:43,320 NURSING HOMES, IT'S EVEN HIGHER. 2015 01:14:43,320 --> 01:14:45,160 IN PSYCHIATRIC HOSPITAL UNITS 2016 01:14:45,160 --> 01:14:46,920 THE STUDIES SHOW IT VARIES QUITE 2017 01:14:46,920 --> 01:14:53,600 A BIT DEPENDING ON TYPE OF UNIT. 2018 01:14:53,600 --> 01:14:57,760 PEOPLE WITH DIAGNOSIS OF 2019 01:14:57,760 --> 01:15:03,360 SCHIZOPHRENIA OR CHRONIC 2020 01:15:03,360 --> 01:15:04,880 SCHIZO-EFFECTIVE DISORDERS, 2021 01:15:04,880 --> 01:15:06,680 ACTUALLY MAJORITY HAVE CAPACITY 2022 01:15:06,680 --> 01:15:08,240 TO MAKE MOST DECISIONS. 2023 01:15:08,240 --> 01:15:12,120 THE LARGE MINORITY MIGHT HAVE 2024 01:15:12,120 --> 01:15:15,760 DIFFICULTY BUT YOU CAN'T ASSUME 2025 01:15:15,760 --> 01:15:17,640 DIAGNOSES MEANS YOU'RE 2026 01:15:17,640 --> 01:15:17,920 INCOMPETENT. 2027 01:15:17,920 --> 01:15:19,040 EVEN MODERATE DEPRESSION MAKES 2028 01:15:19,040 --> 01:15:20,600 VERY LITTLE IMPACT BECAUSE OF 2029 01:15:20,600 --> 01:15:24,560 THE WAY WE MEASURE CAPACITY 2030 01:15:24,560 --> 01:15:25,160 BECAUSE CAPACITY, REMEMBER, HAS 2031 01:15:25,160 --> 01:15:27,560 TO DO WITH WHETHER OR NOT THE 2032 01:15:27,560 --> 01:15:28,760 PERSON RETAINS DECISIONAL 2033 01:15:28,760 --> 01:15:29,040 AUTHORITY. 2034 01:15:29,040 --> 01:15:31,440 WE'RE NOT EAGER TO TAKE THAT 2035 01:15:31,440 --> 01:15:33,960 AWAY UNLESS WE'RE REALLY 2036 01:15:33,960 --> 01:15:35,360 CONVINCED IT'S SIGNIFICANTLY 2037 01:15:35,360 --> 01:15:35,800 IMPAIRED. 2038 01:15:35,800 --> 01:15:38,640 USING THAT STANDARD, IT DOESN'T 2039 01:15:38,640 --> 01:15:41,080 REALLY AFFECT THAT THAT MUCH. 2040 01:15:41,080 --> 01:15:43,280 INPATIENT DEPRESSION WHEN MORE 2041 01:15:43,280 --> 01:15:44,880 SEVERELY DEPRESSED IT DOES MAKE 2042 01:15:44,880 --> 01:15:46,880 A DIFFERENCE. 2043 01:15:46,880 --> 01:15:48,280 SOME STUDIES SHOW, MAYBE A 2044 01:15:48,280 --> 01:15:58,720 QUARTER OR MORE, CAN BE 2045 01:15:58,720 --> 01:15:58,960 AFFECTED. 2046 01:15:58,960 --> 01:16:05,920 I WANT TO EMPHASIZE PEOPLE WITH 2047 01:16:05,920 --> 01:16:08,200 ALZHEIMER'S DEMENTIA AND PEOPLE 2048 01:16:08,200 --> 01:16:09,640 WITH SCHIZOPHRENIA, A FLAVOR FOR 2049 01:16:09,640 --> 01:16:13,120 HOW MUCH PEOPLE ARE AFFECTED. 2050 01:16:13,120 --> 01:16:17,640 EVEN WITH MILD COGNITIVE 2051 01:16:17,640 --> 01:16:20,040 IMPAIRMENT, CONSIDERED A PRE--- 2052 01:16:20,040 --> 01:16:22,480 NOT A CATEGORIZATION, YOU COULD 2053 01:16:22,480 --> 01:16:28,400 CALL IT PRESYMPTOMATIC 2054 01:16:28,400 --> 01:16:35,240 ALZHEIMER'S OH PRESYMPTOMATIC OR 2055 01:16:35,240 --> 01:16:35,680 PRE-ALZHEIMER'S. 2056 01:16:35,680 --> 01:16:37,400 A PERFECT SCORE IS 30. 2057 01:16:37,400 --> 01:16:41,160 THESE FOLKS ARE DOING WHAT WOULD 2058 01:16:41,160 --> 01:16:42,640 BE CONSIDERED NORMAL MINI 2059 01:16:42,640 --> 01:16:46,240 MENTAL, UP TO 40% WOULD HAVE SO 2060 01:16:46,240 --> 01:16:47,440 MUCH TROUBLE BASED ON EVALUATION 2061 01:16:47,440 --> 01:16:50,920 THEY WOULD NOT BE ABLE TO 2062 01:16:50,920 --> 01:16:52,080 CONSENT TO RCT. 2063 01:16:52,080 --> 01:16:55,200 IN OTHER STUDIES IT'S A MAJORITY 2064 01:16:55,200 --> 01:16:57,720 OF PEOPLE WITH MODERATE DEMENTIA 2065 01:16:57,720 --> 01:16:59,440 WOULD NOT BE ABLE. 2066 01:16:59,440 --> 01:17:04,720 ON THE OTHER HAND, PEOPLE WITH 2067 01:17:04,720 --> 01:17:06,120 SCHIZOPHRENIA, THE LARGEST STUDY 2068 01:17:06,120 --> 01:17:09,200 IN TERMS OF DECISION-MAKING 2069 01:17:09,200 --> 01:17:10,160 CAPACITY FOR CLINICAL TRIAL 2070 01:17:10,160 --> 01:17:12,000 PARTICIPATION, THIS IS ONE OF 2071 01:17:12,000 --> 01:17:13,720 THE MEASURES, THE UNDERSTANDING 2072 01:17:13,720 --> 01:17:13,920 SCORE. 2073 01:17:13,920 --> 01:17:18,240 YOU CAN SEE IF YOU USE A CUTOFF, 2074 01:17:18,240 --> 01:17:20,200 THE RED ARROW THAT A PANEL 2075 01:17:20,200 --> 01:17:22,040 THINKS IF THEY SCORE HIGHER THEY 2076 01:17:22,040 --> 01:17:23,680 SHOULD BE CONSIDERED CAPABLE, 2077 01:17:23,680 --> 01:17:25,280 YOU CAN SEE OVERWHELM MAG JOTTER 2078 01:17:25,280 --> 01:17:34,720 ARE ABLE TO UNDERSTAND THE 2079 01:17:34,720 --> 01:17:35,720 INFORMATION. 2080 01:17:35,720 --> 01:17:39,560 STILL OVERWHELMING MAJORITY FOR 2081 01:17:39,560 --> 01:17:40,760 APPRECIATION STANDARD TO APPLY 2082 01:17:40,760 --> 01:17:42,320 TO YOUR OWN SITUATION. 2083 01:17:42,320 --> 01:17:47,360 THAT GIVES YOU SOME FEEL FOR 2084 01:17:47,360 --> 01:17:50,160 CONTEXT AND POPULATIONS. 2085 01:17:50,160 --> 01:17:50,360 OKAY. 2086 01:17:50,360 --> 01:17:52,240 HERE'S THE QUESTION. 2087 01:17:52,240 --> 01:17:54,360 IF STUDIES WITH PEOPLE LACKING 2088 01:17:54,360 --> 01:18:03,880 OR AT RISK OF LACKING DMC ARE 2089 01:18:03,880 --> 01:18:05,600 PERMISSIBLE WHO GIVES CONSENT? 2090 01:18:05,600 --> 01:18:10,160 NOW, THE WAY I PUT THAT, I SAID 2091 01:18:10,160 --> 01:18:14,720 IF. 2092 01:18:14,720 --> 01:18:16,240 BUT IN THEORY FEDERAL 2093 01:18:16,240 --> 01:18:16,680 REGULATIONS ALLOWED. 2094 01:18:16,680 --> 01:18:23,280 BEFORE THE COMMON RULE REVISION, 2095 01:18:23,280 --> 01:18:25,840 THE TERM LEGALLY AUTHORIZED 2096 01:18:25,840 --> 01:18:26,920 REPRESENTATIVE, LAR, YOU'LL HEAR 2097 01:18:26,920 --> 01:18:30,960 THAT TERM, THOSE WHO MIGHT GO ON 2098 01:18:30,960 --> 01:18:32,960 CONSULTS TO DO ASSESSMENTS WE 2099 01:18:32,960 --> 01:18:38,160 TALK ABOUT LAR, THAT IS THE 2100 01:18:38,160 --> 01:18:38,920 FEDERAL RESEARCH ETHICS 2101 01:18:38,920 --> 01:18:40,320 REGULATIONS, THE COMMON RULE'S 2102 01:18:40,320 --> 01:18:45,120 TERM FOR PERSON WHO SERVE AS 2103 01:18:45,120 --> 01:18:46,760 SURROGATES FOR RESEARCH CONSENT. 2104 01:18:46,760 --> 01:18:50,080 NOW, IT WAS DEFINED AS PERSONS 2105 01:18:50,080 --> 01:18:53,120 AUTHORIZED UNDER APPLICABLE LAW 2106 01:18:53,120 --> 01:18:55,320 TO CONSENT ON BEHALF OF A 2107 01:18:55,320 --> 01:18:56,840 SUBJECT TO THE SUBJECT'S 2108 01:18:56,840 --> 01:18:57,880 PARTICIPATION AND PROCEDURES 2109 01:18:57,880 --> 01:19:00,800 INVOLVED IN RESEARCH. 2110 01:19:00,800 --> 01:19:02,440 NOW, THAT APPLICABLE LAW WAS 2111 01:19:02,440 --> 01:19:04,480 REFERRING TO LOCAL AND STATE 2112 01:19:04,480 --> 01:19:05,280 LAWS. 2113 01:19:05,280 --> 01:19:09,680 AND AT THE TIME, VERY FEW 2114 01:19:09,680 --> 01:19:10,480 JURISDICTIONS HAD CLEAR LAWS 2115 01:19:10,480 --> 01:19:12,120 ABOUT THIS. 2116 01:19:12,120 --> 01:19:14,640 IN FACT, WHEN I WROTE THIS SLIDE 2117 01:19:14,640 --> 01:19:21,160 WHICH IS A FEW YEARS AGO, THE 2118 01:19:21,160 --> 01:19:23,840 FUTURE RESTRICTIONS HAVE CLEAR 2119 01:19:23,840 --> 01:19:24,280 POLICIES. 2120 01:19:24,280 --> 01:19:25,480 NOW, WHAT'S HAPPENED, AND THEN 2121 01:19:25,480 --> 01:19:27,920 THERE WAS A LOT OF DISCUSSION AS 2122 01:19:27,920 --> 01:19:32,640 I MENTIONED, A SECRETARY'S 2123 01:19:32,640 --> 01:19:34,200 ADVISORY COMMITTEE TO THE 2124 01:19:34,200 --> 01:19:36,680 AGENCY, AND WHAT THEY NOTICED IN 2125 01:19:36,680 --> 01:19:39,320 THEIR REVIEW IS AT BEST THE 2126 01:19:39,320 --> 01:19:40,320 FIELD IS CHARACTERIZED BY A 2127 01:19:40,320 --> 01:19:45,080 PATCHWORK OF IRB POLICIES AN 2128 01:19:45,080 --> 01:19:47,520 RESEARCH PRACTICES. 2129 01:19:47,520 --> 01:19:49,640 SO, AFTER MUCH, MUCH DEBATE AND 2130 01:19:49,640 --> 01:19:51,520 MANY, MANY COMMISSIONS AND 2131 01:19:51,520 --> 01:19:53,680 WORKING GROUPS AND DISCUSSIONS 2132 01:19:53,680 --> 01:19:57,160 AND SO FORTH, THE LAW, 2133 01:19:57,160 --> 01:19:59,400 REGULATORY LAW, WAS CHANGED. 2134 01:19:59,400 --> 01:20:01,640 THE COMMON RULE WAS REVISED. 2135 01:20:01,640 --> 01:20:04,640 YOU SEE THE GRAY PART WHAT WE 2136 01:20:04,640 --> 01:20:07,120 READ EARLIER, NOW THE BLACK PART 2137 01:20:07,120 --> 01:20:10,840 HAS BEEN ADDED. 2138 01:20:10,840 --> 01:20:12,120 IF THERE IS NO APPLICABLE LAW, 2139 01:20:12,120 --> 01:20:16,040 SO IF YOU LIVE IN A STATE WHERE 2140 01:20:16,040 --> 01:20:17,160 THE LAW DOESN'T SPECIFY AND 2141 01:20:17,160 --> 01:20:21,680 CAN'T GUIDE YOU, WHAT YOU CAN DO 2142 01:20:21,680 --> 01:20:25,520 IS ASK, DOES THE INSTITUTION IN 2143 01:20:25,520 --> 01:20:28,560 WHICH THE RESEARCH TAKES PLACE 2144 01:20:28,560 --> 01:20:30,400 DEFINE WHAT IT IS? 2145 01:20:30,400 --> 01:20:32,360 SO, BASICALLY IT REALLY WIDENS 2146 01:20:32,360 --> 01:20:35,800 THE SCOPE BECAUSE THE 2147 01:20:35,800 --> 01:20:37,360 INSTITUTIONS, IF THEY CAN CREATE 2148 01:20:37,360 --> 01:20:39,600 A POLICY, THEN THAT CAN BE 2149 01:20:39,600 --> 01:20:43,480 RELIED UPON TO SAY THAT PERSON 2150 01:20:43,480 --> 01:20:45,080 CAN SERVE AS LAR. 2151 01:20:45,080 --> 01:20:48,200 NOW, THERE ARE VARIOUS TYPES OF 2152 01:20:48,200 --> 01:20:52,640 LARs, PROS AND CONS. 2153 01:20:52,640 --> 01:20:56,360 LAR IS JUST A PLACEHOLDER FOR A 2154 01:20:56,360 --> 01:20:57,960 PERSON WHO SERVES THAT FUNCTION, 2155 01:20:57,960 --> 01:21:01,760 THEY CAN QUALIFY THROUGH VARIOUS 2156 01:21:01,760 --> 01:21:05,600 WAYS DEPENNING ON POLICY OR LAW. 2157 01:21:05,600 --> 01:21:06,760 LEGAL GUARDIANS, LAWYERS LIKE 2158 01:21:06,760 --> 01:21:09,400 THIS BECAUSE IT'S CLEAR, LEGALLY 2159 01:21:09,400 --> 01:21:13,200 VERY CLEAR, THE JUDGE SAYS YOU, 2160 01:21:13,200 --> 01:21:14,440 I'M THE JUDGE, I'M TELLING YOU 2161 01:21:14,440 --> 01:21:15,840 TO MAKE DECISIONS ON THIS FOR 2162 01:21:15,840 --> 01:21:16,800 THAT PERSON. 2163 01:21:16,800 --> 01:21:19,040 THAT'S LEGAL GUARDIAN. 2164 01:21:19,040 --> 01:21:21,880 THAT LEGAL GUARDIAN AS I'LL 2165 01:21:21,880 --> 01:21:23,640 EXPLAIN DOESN'T HAVE TO BE THE 2166 01:21:23,640 --> 01:21:27,480 PERSON WHO KNOWS THE PERSON THE 2167 01:21:27,480 --> 01:21:27,800 PEST. 2168 01:21:27,800 --> 01:21:34,720 IT'S LEGAL CLARITY, DOESN'T 2169 01:21:34,720 --> 01:21:36,760 ALWAYS FOLLOW, SORT OF THE 2170 01:21:36,760 --> 01:21:38,280 COMMON SENSE ISSUES. 2171 01:21:38,280 --> 01:21:41,400 HEALTH CARE PROXIES ARE SECOND 2172 01:21:41,400 --> 01:21:47,040 MOST KIND OF LEGALLY CLEAR TYPE 2173 01:21:47,040 --> 01:21:48,360 OF QUALIFICATION. 2174 01:21:48,360 --> 01:21:49,640 THE SUBJECT GETS TO CHOOSE. 2175 01:21:49,640 --> 01:21:51,600 I ASK THIS PERSON TO BE MY 2176 01:21:51,600 --> 01:21:54,080 DECISION MAKER IF I CAN'T MAKE 2177 01:21:54,080 --> 01:21:54,880 THESE DECISIONS. 2178 01:21:54,880 --> 01:21:59,480 IN THIS CASE IT WAS FOR 2179 01:21:59,480 --> 01:22:00,120 HEALTHCARE DECISIONS. 2180 01:22:00,120 --> 01:22:02,960 HOWEVER, IT CAN BE USED 2181 01:22:02,960 --> 01:22:08,360 ACCORDING TO LAW FOR RESEARCH 2182 01:22:08,360 --> 01:22:08,600 CONSENT. 2183 01:22:08,600 --> 01:22:11,680 AND SINCE MANY PEOPLE DON'T HAVE 2184 01:22:11,680 --> 01:22:16,240 EITHER OF THE ABOVE, WE OFTEN 2185 01:22:16,240 --> 01:22:19,040 FALL TO THE DE FACTO FAMILY, 2186 01:22:19,040 --> 01:22:20,120 HEALTH CARE SURROGATE, VIRTUALLY 2187 01:22:20,120 --> 01:22:21,720 EVERY STATE HAS A LAW THAT SAYS 2188 01:22:21,720 --> 01:22:23,880 WHEN THE PERSON CAN'T GIVE 2189 01:22:23,880 --> 01:22:25,080 CONSENT TO TREATMENT, THESE ARE 2190 01:22:25,080 --> 01:22:30,480 THE ORDER IN WHICH YOU GO TO 2191 01:22:30,480 --> 01:22:30,840 SEEK PERMISSION. 2192 01:22:30,840 --> 01:22:32,560 OF COURSE, THIS IS NOT THE 2193 01:22:32,560 --> 01:22:33,760 PERSON THAT THE PERSON 2194 01:22:33,760 --> 01:22:34,680 SPECIFICALLY CHOSE. 2195 01:22:34,680 --> 01:22:36,360 SO IT DOESN'T HAVE THAT. 2196 01:22:36,360 --> 01:22:40,680 BUT IT IS DEFINED IN LAW. 2197 01:22:40,680 --> 01:22:43,600 WHAT WOULD BE NICE IF EVERYBODY 2198 01:22:43,600 --> 01:22:45,200 SAID, WELL, I MIGHT BE ASKED TO 2199 01:22:45,200 --> 01:22:47,280 BE IN RESEARCH WHEN I CAN'T 2200 01:22:47,280 --> 01:22:49,440 CONSENT SO I'LL FILL OUT A FORM 2201 01:22:49,440 --> 01:22:51,240 TO DESIGNATE WHO WILL DO THAT. 2202 01:22:51,240 --> 01:22:53,640 THAT'S NICE BUT NO ONE DOES IT. 2203 01:22:53,640 --> 01:22:56,040 WE HAVE STUDIES THAT SHOW EVEN 2204 01:22:56,040 --> 01:22:58,120 WHEN PEOPLE SAY I'M GOING TO DO 2205 01:22:58,120 --> 01:23:00,840 IT THEY DON'T DO IT. 2206 01:23:00,840 --> 01:23:10,760 IT JUST ISN'T HIGH ON PEOPLE'S 2207 01:23:10,760 --> 01:23:11,120 PRIORITY. 2208 01:23:11,120 --> 01:23:11,560 OKAY. 2209 01:23:11,560 --> 01:23:12,560 FOUR THROUGH EIGHT I PUT IN TO 2210 01:23:12,560 --> 01:23:15,080 GIVE A SENSE OF THE MOST COMMON 2211 01:23:15,080 --> 01:23:18,600 LEGAL HIERARCHY WHEN YOU DON'T 2212 01:23:18,600 --> 01:23:23,040 HAVE A PRE-SPECIFIED LEGAL 2213 01:23:23,040 --> 01:23:23,520 APPOINTEE. 2214 01:23:23,520 --> 01:23:25,360 I LEAVE THIS SLIDE IN TO LET YOU 2215 01:23:25,360 --> 01:23:31,000 KNOW, BECAUSE IT'S A GREAT 2216 01:23:31,000 --> 01:23:33,120 ARTICLE, YOU'LL BE SHOCKED BUT 2217 01:23:33,120 --> 01:23:34,680 ENTERTAINED BECAUSE IT'S SO WELL 2218 01:23:34,680 --> 01:23:36,480 WRITTEN. 2219 01:23:36,480 --> 01:23:40,600 I GIVE THIS EXAMPLE MAINLY TO 2220 01:23:40,600 --> 01:23:43,680 SHOW THAT EVEN THOUGH 2221 01:23:43,680 --> 01:23:44,680 GUARDIANSHIP IS LEGALLY CLEAR, 2222 01:23:44,680 --> 01:23:48,120 IT HAS -- IT CAN HAVE A LOT OF 2223 01:23:48,120 --> 01:23:48,760 PROBLEMS. 2224 01:23:48,760 --> 01:23:50,520 IT'S A REMINDER WE SHOULDN'T 2225 01:23:50,520 --> 01:23:54,800 EQUATE LEGAL CLARITY WITH 2226 01:23:54,800 --> 01:23:55,520 ETHICALLY OPTIMAL. 2227 01:23:55,520 --> 01:24:02,640 I REFER THIS ARTICLE TO YOU TO 2228 01:24:02,640 --> 01:24:03,520 READ. 2229 01:24:03,520 --> 01:24:06,480 WHAT PROPORTION OF ADULTS 2230 01:24:06,480 --> 01:24:07,640 PREPARE AN ADVANCE DIRECTIVE? 2231 01:24:07,640 --> 01:24:11,400 THIS IS IMPORTANT TO THIS TOPIC. 2232 01:24:11,400 --> 01:24:13,800 THERE WAS A MASSIVE AGGREGATE 2233 01:24:13,800 --> 01:24:16,960 REVIEW LOOKING AT DATA OVER 15 2234 01:24:16,960 --> 01:24:18,560 YEARS, AND IT SHOWED ONLY ABOUT 2235 01:24:18,560 --> 01:24:21,840 A THIRD OF THE PEOPLE HAD 2236 01:24:21,840 --> 01:24:25,000 COMPLETED ADVANCE DIRECTIVE, AND 2237 01:24:25,000 --> 01:24:25,840 PROXY DIRECTIVES, MEANING 2238 01:24:25,840 --> 01:24:29,160 APPOINTING SOMEBODY, WAS A 2239 01:24:29,160 --> 01:24:31,520 SUBSET, SIMILAR ACROSS YEARS 2240 01:24:31,520 --> 01:24:37,600 REVIEWED AND PATIENTS WITH 2241 01:24:37,600 --> 01:24:39,560 CHRONIC ILLNESS ANT HEALTHY 2242 01:24:39,560 --> 01:24:40,080 ADULTS. 2243 01:24:40,080 --> 01:24:42,080 BOTTOM LINE ONLY A SMALL 2244 01:24:42,080 --> 01:24:44,480 MINORITY HAVE DURABLE POWER OF 2245 01:24:44,480 --> 01:24:45,920 ATTORNEY OR HEALTH CARE PROXY. 2246 01:24:45,920 --> 01:24:48,960 ESSENTIALLY WE'RE GOING TO HAVE 2247 01:24:48,960 --> 01:24:53,160 TO RELY ON DE FACTO FAMILY 2248 01:24:53,160 --> 01:24:55,840 SURROGATES TO SERVE AS LARs. 2249 01:24:55,840 --> 01:25:00,040 AND SO IS THIS ACCEPTABLE? 2250 01:25:00,040 --> 01:25:02,120 FAMILIES DO PLAY KEY ROLE IN 2251 01:25:02,120 --> 01:25:03,240 CLINICAL SETTINGS REGARDING LIFE 2252 01:25:03,240 --> 01:25:05,240 AND DEATH DECISIONS SEE THIS 2253 01:25:05,240 --> 01:25:06,000 SEEMS VERY NATURAL. 2254 01:25:06,000 --> 01:25:08,600 SO BUT WHAT KIND OF RISK/BENEFIT 2255 01:25:08,600 --> 01:25:10,400 LIMIT SHOULD SUCH PERSONS HAVE 2256 01:25:10,400 --> 01:25:12,560 IN TERMS OF MAKING DECISIONS FOR 2257 01:25:12,560 --> 01:25:19,560 OTHER PEOPLE? 2258 01:25:19,560 --> 01:25:22,080 WE'VE STUDIED THIS TOPIC. 2259 01:25:22,080 --> 01:25:25,160 LET ME GIVE THE MOST COMMON 2260 01:25:25,160 --> 01:25:26,920 APPROACH MOST IRBs USE. 2261 01:25:26,920 --> 01:25:28,640 I SHOULD SAY THIS QUESTION OF 2262 01:25:28,640 --> 01:25:32,160 SHOULD THERE BE FURTHER 2263 01:25:32,160 --> 01:25:34,320 RESTRICTIONS ON RISK IS NOT PART 2264 01:25:34,320 --> 01:25:35,200 OF THE COMMON RULE. 2265 01:25:35,200 --> 01:25:38,120 IT'S NOT PART OF THE 2266 01:25:38,120 --> 01:25:39,440 REGULATIONS. 2267 01:25:39,440 --> 01:25:41,280 IT ONLY NOW CLARIFIES AND THAT 2268 01:25:41,280 --> 01:25:44,200 ONLY FROM A FEDERAL PERSPECTIVE 2269 01:25:44,200 --> 01:25:47,440 WHO CAN SERVE AS SURROGATE LAR, 2270 01:25:47,440 --> 01:25:53,800 IT DOESN'T SPECIFY HOW THEY DO 2271 01:25:53,800 --> 01:25:58,280 IT. 2272 01:25:58,280 --> 01:25:59,720 UNLIKE PEDIATRIC REGULATIONS 2273 01:25:59,720 --> 01:26:01,760 WHICH YOU'LL HEAR ABOUT, HOLLY, 2274 01:26:01,760 --> 01:26:02,880 THERE'S HIERARCHY OF DIFFERENT 2275 01:26:02,880 --> 01:26:04,240 RISK GROUPS ABOUT WHAT YOU CAN 2276 01:26:04,240 --> 01:26:06,360 AND CAN'T DO AND SO FORTH. 2277 01:26:06,360 --> 01:26:08,720 WHAT PEOPLE HAVE DONE IN IRBs 2278 01:26:08,720 --> 01:26:10,840 IN INSTITUTIONAL POLICIES TO 2279 01:26:10,840 --> 01:26:14,120 HAVE KIND OF ADOPTED THAT 2280 01:26:14,120 --> 01:26:17,200 PEDIATRIC FRAMEWORK, SO THERE'S 2281 01:26:17,200 --> 01:26:19,520 A CATEGORY CALLED PROSPECT FOR 2282 01:26:19,520 --> 01:26:21,680 DIRECT BENEFIT, THEY DISTINGUISH 2283 01:26:21,680 --> 01:26:24,360 FROM NO PROSPECT, LET'S SAY 2284 01:26:24,360 --> 01:26:24,960 PURELY PHYSIOLOGICAL STUDIES, 2285 01:26:24,960 --> 01:26:26,280 FOR EXAMPLE. 2286 01:26:26,280 --> 01:26:29,400 AND YOU CAN CATEGORIZE THAT AS 2287 01:26:29,400 --> 01:26:32,400 MINIMAL RISK OR MINOR INCREASE 2288 01:26:32,400 --> 01:26:33,560 OVER MINIMAL RISK WHICH I'M SURE 2289 01:26:33,560 --> 01:26:36,360 ALL OF OF YOU KNOW EXACTLY WHAT 2290 01:26:36,360 --> 01:26:38,280 IT MEANS, AND GREATER THAN MINOR 2291 01:26:38,280 --> 01:26:40,000 INCREASE WHICH IRBs ARE NOT 2292 01:26:40,000 --> 01:26:41,680 ALLOWED TO APPROVE. 2293 01:26:41,680 --> 01:26:45,240 AT THIS INSTITUTION, IN MANY 2294 01:26:45,240 --> 01:26:46,440 PLACES, AT THIS INSTITUTION YOU 2295 01:26:46,440 --> 01:26:50,640 CAN DO IT BUT ONLY IF THE HEAD 2296 01:26:50,640 --> 01:26:52,240 OF THE INTRAMURAL RESEARCH 2297 01:26:52,240 --> 01:26:53,800 PROGRAM APPROVES IT. 2298 01:26:53,800 --> 01:26:55,160 SO, IT'S A VERY -- AS FAR AS I 2299 01:26:55,160 --> 01:26:57,080 KNOW THERE'S ONLY BEEN ONE 2300 01:26:57,080 --> 01:27:01,600 INSTANCE IN OVER HOW MANY YEARS 2301 01:27:01,600 --> 01:27:02,280 THAT'S OCCURRED. 2302 01:27:02,280 --> 01:27:04,960 AND THE REASON FOR THAT IS THAT 2303 01:27:04,960 --> 01:27:07,560 SACHRP, THE ADVISORY COMMITTEE 2304 01:27:07,560 --> 01:27:09,920 ON OF I MENTIONED, POINTED OUT 2305 01:27:09,920 --> 01:27:13,960 IF YOU REALLY LIMIT THE RESEARCH 2306 01:27:13,960 --> 01:27:17,000 ONLY TO MINOR INCREASE OVER 2307 01:27:17,000 --> 01:27:19,280 MINIMAL RISK YOU COULD REALLY 2308 01:27:19,280 --> 01:27:21,200 RULE OUT IN THE FUTURE THE RARE 2309 01:27:21,200 --> 01:27:23,280 BUT VERY IMPORTANT RESEARCH THAT 2310 01:27:23,280 --> 01:27:25,280 COULD BE HIGHER RISK. 2311 01:27:25,280 --> 01:27:27,280 AND THIS IS BASICALLY WHAT IT'S 2312 01:27:27,280 --> 01:27:27,840 SAYING. 2313 01:27:27,840 --> 01:27:29,800 IT GIVES THE CRITERIA BY WHICH 2314 01:27:29,800 --> 01:27:32,920 YOU COULD TRY TO JUSTIFY DOING 2315 01:27:32,920 --> 01:27:36,600 THAT RESEARCH, THAT THE SPECIAL 2316 01:27:36,600 --> 01:27:38,720 GROUP THAT THE INSTITUTIONAL 2317 01:27:38,720 --> 01:27:40,240 OFFICIAL WOULD CONSTITUTE TO 2318 01:27:40,240 --> 01:27:43,040 REVIEW SUCH STUDIES. 2319 01:27:43,040 --> 01:27:43,520 OKAY. 2320 01:27:43,520 --> 01:27:46,560 SO LET ME JUST GO THROUGH SOME 2321 01:27:46,560 --> 01:27:47,200 DATA. 2322 01:27:47,200 --> 01:27:50,640 WHAT WE DID HERE WAS WE SURVEYED 2323 01:27:50,640 --> 01:27:53,440 NATIONAL REPRESENTATIVE SAMPLE 2324 01:27:53,440 --> 01:27:57,160 OF U.S. PUBLIC AGES 50 AND 2325 01:27:57,160 --> 01:27:57,680 OLDER. 2326 01:27:57,680 --> 01:27:59,800 AND WE ASKED THIS QUESTION. 2327 01:27:59,800 --> 01:28:01,960 IF PATIENTS CAN'T MAKE THEIR OWN 2328 01:28:01,960 --> 01:28:04,920 DECISIONS ABOUT BEING IN AND YOU 2329 01:28:04,920 --> 01:28:06,760 SEE THE FOUR COLUMNS, AND THESE 2330 01:28:06,760 --> 01:28:09,560 WERE TYPES OF PROCEDURES CLOSED 2331 01:28:09,560 --> 01:28:14,360 IN THE STUDY, THE VACCINE RCT IS 2332 01:28:14,360 --> 01:28:24,920 A LITTLE -- GENE TRANSFER WOULD 2333 01:28:26,680 --> 01:28:33,680 INVOLVE BRAIN SURGERY SO IT'S 2334 01:28:33,680 --> 01:28:34,400 HIGHLY INVASIVE. 2335 01:28:34,400 --> 01:28:35,560 SHOULD SOCIETY ALLOW FAMILIES TO 2336 01:28:35,560 --> 01:28:37,520 MAKE THE DECISION? 2337 01:28:37,520 --> 01:28:39,840 WE NOW THE MOST COMMENT 2338 01:28:39,840 --> 01:28:43,960 ONSCENARIO IS NOT HEALTH CARE 2339 01:28:43,960 --> 01:28:45,320 GUARDIAN, JUST FAMILIES, IS THAT 2340 01:28:45,320 --> 01:28:48,160 OKAY FOR PEOPLE WHO ARE AGED 50 2341 01:28:48,160 --> 01:28:48,760 AND OLDER? 2342 01:28:48,760 --> 01:28:53,400 ANDS THIS IS WHAT WE FOUND. 2343 01:28:53,400 --> 01:28:55,600 LUMBAR PUNCTURE, 72%. 2344 01:28:55,600 --> 01:28:58,120 DRUG RCT. 2345 01:28:58,120 --> 01:29:00,840 DRUG RCT WAS WHERE THEY WERE 2346 01:29:00,840 --> 01:29:03,480 TESTING ANTI-INFLAMMATORY DRUG, 2347 01:29:03,480 --> 01:29:05,680 FAIRLY LOW RISK. 2348 01:29:05,680 --> 01:29:11,080 VACCINE AND GENE TRANSFER, THIS 2349 01:29:11,080 --> 01:29:12,400 IS SIGNIFICANTLY PRO RESEARCH 2350 01:29:12,400 --> 01:29:18,560 KIND OF RESULT EVEN THOUGH THIS 2351 01:29:18,560 --> 01:29:21,160 IS QUITE INVASIVE. 2352 01:29:21,160 --> 01:29:24,720 NOW, AFTER WE DID THAT 2353 01:29:24,720 --> 01:29:25,280 NATIONALLY REPRESENTATIVE 2354 01:29:25,280 --> 01:29:30,840 SAMPLE, WHAT WE DID WAS BRING IN 2355 01:29:30,840 --> 01:29:38,360 173 SUCH FOLKS FROM THE PUBLIC, 2356 01:29:38,360 --> 01:29:40,240 THREE SEGMENTS, LARGE BANQUET 2357 01:29:40,240 --> 01:29:42,520 ROOM, SIX TO EIGHT PEOPLE EACH. 2358 01:29:42,520 --> 01:29:44,200 WE SPENT AN ENTIRE DAY 2359 01:29:44,200 --> 01:29:45,800 DISCUSSING THIS TOPIC. 2360 01:29:45,800 --> 01:29:47,120 SO THEY HEARD MUCH OF WHAT YOU 2361 01:29:47,120 --> 01:29:50,400 HEARD THE PROS AND CONS OF THIS 2362 01:29:50,400 --> 01:29:52,080 RESEARCH AND SO FORTH. 2363 01:29:52,080 --> 01:29:56,680 WE SURVEYED THEM BEFORE THEY 2364 01:29:56,680 --> 01:29:58,440 CAME IN AFTER GOING THROUGH THE 2365 01:29:58,440 --> 01:30:02,600 EXERCISE, YOU CAN SEE WHAT'S 2366 01:30:02,600 --> 01:30:05,080 STRIKING IS THAT AFTER PEOPLE 2367 01:30:05,080 --> 01:30:07,800 DISCUSSED A TOPIC, THEY ARE MUCH 2368 01:30:07,800 --> 01:30:11,360 MORE LIKELY TO SAY DEFINITELY 2369 01:30:11,360 --> 01:30:12,600 ALLOW FAMILY SURROGATES TO 2370 01:30:12,600 --> 01:30:16,520 PERMIT THIS KIND OF RESEARCH. 2371 01:30:16,520 --> 01:30:20,080 EVEN AT A PRETTY HIGH RISK 2372 01:30:20,080 --> 01:30:20,680 RESEARCH. 2373 01:30:20,680 --> 01:30:31,200 EVEN THOUGH THE NUMBERS MIGHT BE 2374 01:30:34,120 --> 01:30:35,280 SIMILAR, TRANSITION IS NOTABLE. 2375 01:30:35,280 --> 01:30:36,760 WHAT ACCOUNTS FOR IT? 2376 01:30:36,760 --> 01:30:39,080 ONCE PEOPLE TALK ABOUT THIS, 2377 01:30:39,080 --> 01:30:42,120 THIS IS THE KIND OF CONCLUSIONS 2378 01:30:42,120 --> 01:30:43,840 THEY REACH. 2379 01:30:43,840 --> 01:30:46,360 PARTICIPANT A, REMEMBER THESE 2380 01:30:46,360 --> 01:30:47,320 ARE LAYPEOPLE, PUBLIC FOLKS 2381 01:30:47,320 --> 01:30:49,840 BROUGHT IN AND THEY SPENT ALL 2382 01:30:49,840 --> 01:30:51,200 DAY TALKING ABOUT THIS WITH 2383 01:30:51,200 --> 01:30:52,200 EXPERTS AND PEERS. 2384 01:30:52,200 --> 01:30:54,840 IF THE ANSWER IS NO, YOU CAN'T 2385 01:30:54,840 --> 01:30:56,920 LET SURROGATES MAKE DECISIONS 2386 01:30:56,920 --> 01:30:58,640 FOR GENE TRANSFER STUDY, LET'S 2387 01:30:58,640 --> 01:31:05,760 SAY, THEN THERE'S NO HOPE FOR 2388 01:31:05,760 --> 01:31:07,840 EVER GETTING ANYWHERE. 2389 01:31:07,840 --> 01:31:09,960 PARTICIPANT B, BY VOTING NO WHAT 2390 01:31:09,960 --> 01:31:12,400 YOU'RE SAYING IS YOU'RE 2391 01:31:12,400 --> 01:31:12,920 ESSENTIALLY MAKING POLICY, 2392 01:31:12,920 --> 01:31:13,200 RIGHT? 2393 01:31:13,200 --> 01:31:14,600 THAT'S WHAT THIS PERSON IS 2394 01:31:14,600 --> 01:31:14,840 SAYING. 2395 01:31:14,840 --> 01:31:16,840 YOU'RE PUTTING YOURSELF IN A 2396 01:31:16,840 --> 01:31:18,640 POSITION OF IMPACTING EVERY 2397 01:31:18,640 --> 01:31:22,320 FAMILY WHO HAS ALZHEIMER'S. 2398 01:31:22,320 --> 01:31:24,080 SO, ONE OF THE THINGS THEY SEE 2399 01:31:24,080 --> 01:31:25,000 AND DISCUSS WHEN YOU'RE SITTING 2400 01:31:25,000 --> 01:31:26,920 IN THE ROOM IS THAT NOT JUST 2401 01:31:26,920 --> 01:31:29,520 WHAT WOULD YOU DO FOR YOUR OWN 2402 01:31:29,520 --> 01:31:32,400 LOVED ONE BUT AS A MEMBER OF 2403 01:31:32,400 --> 01:31:36,760 SOCIETY WHAT PERSPECTIVE WOULD 2404 01:31:36,760 --> 01:31:37,680 YOU TAKE? 2405 01:31:37,680 --> 01:31:39,400 THIS WAS A VERY INSIGHTFUL 2406 01:31:39,400 --> 01:31:39,920 COMMENT. 2407 01:31:39,920 --> 01:31:41,400 IT SEEMS AS THOUGH WE ALMOST 2408 01:31:41,400 --> 01:31:45,040 HAVE NO CHOICE BUT TO HAVE SOME 2409 01:31:45,040 --> 01:31:46,200 FORM OF SURROGATE SENT, THE 2410 01:31:46,200 --> 01:31:48,120 CHALLENGES BECOMES HOW DO WE 2411 01:31:48,120 --> 01:31:55,120 MAKE IT WORK AND BUILD 2412 01:31:55,120 --> 01:31:56,640 PROTECTIONs FOR THE 2413 01:31:56,640 --> 01:31:58,080 ALZHEIMER'S VICTIM, THE 2414 01:31:58,080 --> 01:31:58,360 PATIENTS. 2415 01:31:58,360 --> 01:32:01,720 ONE OF THE THINGS WE LOOKED AT 2416 01:32:01,720 --> 01:32:04,160 IN THIS WAS TO ASK THE LEEWAY 2417 01:32:04,160 --> 01:32:07,320 QUESTION, WE MEAN THE FOLLOWING. 2418 01:32:07,320 --> 01:32:09,120 THIS IS DIFFERENT FROM THE 2419 01:32:09,120 --> 01:32:10,200 POLICY QUESTION, SHOULD OUR 2420 01:32:10,200 --> 01:32:15,000 SOCIETY ALLOW IT. 2421 01:32:15,000 --> 01:32:18,120 BUT THIS QUESTION IS, DO YOU, IF 2422 01:32:18,120 --> 01:32:19,080 YOU BECAME INCAPACITATED, HOW 2423 01:32:19,080 --> 01:32:21,080 WOULD YOU WANT YOUR FAMILY TO, 2424 01:32:21,080 --> 01:32:21,440 WHATEVER. 2425 01:32:21,440 --> 01:32:23,960 THEY ANSWERED YES OR NO, ENROLL 2426 01:32:23,960 --> 01:32:25,120 ME, DON'T ENROLL ME. 2427 01:32:25,120 --> 01:32:28,440 THEN WE ALSO ASKED THEM, OKAY, 2428 01:32:28,440 --> 01:32:32,920 YOU SAID YOU WOULD WANT OR YOU 2429 01:32:32,920 --> 01:32:34,600 WOULDN'T WANT. 2430 01:32:34,600 --> 01:32:36,320 WHAT IF -- HOW MUCH FREEDOM OR 2431 01:32:36,320 --> 01:32:37,680 LEEWAY WOULD YOU GIVE YOUR 2432 01:32:37,680 --> 01:32:39,080 FAMILY MEMBER WHO WOULD HAVE TO 2433 01:32:39,080 --> 01:32:40,840 MAKE A DECISION FOR YOU WHEN YOU 2434 01:32:40,840 --> 01:32:44,040 CAN'T TO GO AGAINST WHAT YOU 2435 01:32:44,040 --> 01:32:44,760 JUST SAID? 2436 01:32:44,760 --> 01:32:47,280 SO YOU GAVE US A PREFERENCE. 2437 01:32:47,280 --> 01:32:48,760 WOULD YOU GIVE THEM THE FREEDOM 2438 01:32:48,760 --> 01:32:53,640 TO GO AGAINST WHAT YOU SAID? 2439 01:32:53,640 --> 01:32:54,640 ESSENTIALLY DOING OPPOSITE. 2440 01:32:54,640 --> 01:32:58,160 THIS IS WHAT WE FOUND. 2441 01:32:58,160 --> 01:33:04,080 ONLY A QUARTER OF PEOPLE SAY NO 2442 01:33:04,080 --> 01:33:05,520 LEEWAY WHATSOEVER. 2443 01:33:05,520 --> 01:33:07,760 OVERWHELMING MAJORITY OF PEOPLE 2444 01:33:07,760 --> 01:33:11,160 WOULD GIVE SOME LEEWAY OR 2445 01:33:11,160 --> 01:33:11,560 COMPLETE LEEWAY. 2446 01:33:11,560 --> 01:33:14,200 MINORITY, ONE IN SIX OR SO, 2447 01:33:14,200 --> 01:33:16,160 WOULD GIVE COMPLETE LEEWAY. 2448 01:33:16,160 --> 01:33:18,280 AND THE REST FELL IN THE MIDDLE. 2449 01:33:18,280 --> 01:33:22,080 NOW, AS YOU MIGHT EXPECT, PEOPLE 2450 01:33:22,080 --> 01:33:26,120 WHO SAID THEY DO WANT TO BE IN 2451 01:33:26,120 --> 01:33:28,080 IT AND YES MY FAMILY CAN 2452 01:33:28,080 --> 01:33:30,480 OVERTURN THAT WERE MORE LIKELY 2453 01:33:30,480 --> 01:33:31,600 TO GIVE LEEWAY BECAUSE THAT 2454 01:33:31,600 --> 01:33:34,120 SEEMS LIKE A SAFER OPTION THAT 2455 01:33:34,120 --> 01:33:34,800 THEY WOULD TAKE. 2456 01:33:34,800 --> 01:33:36,840 BUT THERE WAS A SIGNIFICANT 2457 01:33:36,840 --> 01:33:38,960 PROPORTION OF PEOPLE WHO SAID 2458 01:33:38,960 --> 01:33:41,680 I'M SAYING NO BUT I'LL LEAVE IT 2459 01:33:41,680 --> 01:33:42,880 TO MY FUTURE SURROGATE. 2460 01:33:42,880 --> 01:33:45,960 I THINK THIS IS IMPORTANT TO 2461 01:33:45,960 --> 01:33:48,280 THINK ABOUT BECAUSE BY THEORY WE 2462 01:33:48,280 --> 01:33:51,000 THINK, WELL, IF THE PERSON SAYS 2463 01:33:51,000 --> 01:33:54,520 A TODAY, THIS SHOULD LOCK IN THE 2464 01:33:54,520 --> 01:33:56,320 FUTURE FOREVER, AND THAT'S WHAT 2465 01:33:56,320 --> 01:33:57,360 PEOPLE INTEND. 2466 01:33:57,360 --> 01:33:59,200 WELL, THIS SHOWS, YOU KNOW, IT'S 2467 01:33:59,200 --> 01:34:00,200 MORE COMPLICATED. 2468 01:34:00,200 --> 01:34:02,120 AND THIS APPLIES TO NOT ONLY 2469 01:34:02,120 --> 01:34:06,120 RESEARCH ETHICS BUT ALSO IN 2470 01:34:06,120 --> 01:34:07,320 CLINICAL SITUATIONS TOO. 2471 01:34:07,320 --> 01:34:08,680 THERE'S INTERESTING STUDIES IN 2472 01:34:08,680 --> 01:34:15,440 THE CLINICAL SETTING OF THE SAME 2473 01:34:15,440 --> 01:34:16,400 METHODOLOGY. 2474 01:34:16,400 --> 01:34:17,120 OKAY. 2475 01:34:17,120 --> 01:34:19,280 DON'T BE ALARMED, FALL 2476 01:34:19,280 --> 01:34:21,480 ALLERGIES. 2477 01:34:21,480 --> 01:34:21,800 OKAY. 2478 01:34:21,800 --> 01:34:23,200 OTHER PROTECTIONS, AND I'M GOING 2479 01:34:23,200 --> 01:34:27,200 TO CLOSE WITH TWO EXAMPLES TO 2480 01:34:27,200 --> 01:34:29,560 COMPLICATE MATTERS A BIT. 2481 01:34:29,560 --> 01:34:31,080 TO REALLY PAY ATTENTION TO THE 2482 01:34:31,080 --> 01:34:32,840 FACTS ON THE GROUND AS PART OF 2483 01:34:32,840 --> 01:34:35,720 YOUR THINKING ABOUT THE ETHICS. 2484 01:34:35,720 --> 01:34:38,240 SO, THIS IS MR. A WITH 2485 01:34:38,240 --> 01:34:38,560 ALZHEIMER'S. 2486 01:34:38,560 --> 01:34:40,200 HE'S NOT ABLE TO GIVE 2487 01:34:40,200 --> 01:34:42,000 INDEPENDENT CONSENT. 2488 01:34:42,000 --> 01:34:44,280 HE'S A RETIRED PROFESSOR, 2489 01:34:44,280 --> 01:34:45,400 FINANCIALLY WELL OFF, 2490 01:34:45,400 --> 01:34:46,440 PSYCHOSOCIAL RESOURCES ARE AS 2491 01:34:46,440 --> 01:34:50,440 GOOD AS IT GETS FOR A PERSON IN 2492 01:34:50,440 --> 01:34:52,480 OUR SOCIETY. 2493 01:34:52,480 --> 01:34:53,680 SPOUSE, CHILDREN, SUPPORTIVE, 2494 01:34:53,680 --> 01:34:56,600 SAVVY AT USING THE INTERNET, 2495 01:34:56,600 --> 01:34:58,600 FINDING THE RIGHT KIND OF -- THE 2496 01:34:58,600 --> 01:35:00,400 KIND OF PEOPLE WE'RE SURROUNDED 2497 01:35:00,400 --> 01:35:03,320 BY IN THIS BUILDING ESSENTIALLY. 2498 01:35:03,320 --> 01:35:09,640 NOW, HE ENROLLS IN MINOR 2499 01:35:09,640 --> 01:35:11,360 INTERVENTION, MINOR EFFECT IN 2500 01:35:11,360 --> 01:35:12,480 THE EARLIER STUDY. 2501 01:35:12,480 --> 01:35:14,800 UP TO 1,000 PEOPLE RECEIVED THIS 2502 01:35:14,800 --> 01:35:16,360 DRUG, LET'S SAY. 2503 01:35:16,360 --> 01:35:20,120 THE GOAL IS TO SLOW DOWN THE 2504 01:35:20,120 --> 01:35:20,320 DISEASE. 2505 01:35:20,320 --> 01:35:23,560 HE STRONGLY WANTS TO BE IN THE 2506 01:35:23,560 --> 01:35:25,160 STUDY, ALTRUISTIC MOTIVE, ALSO 2507 01:35:25,160 --> 01:35:29,440 WANTS TO BENEFIT, IF IT 2508 01:35:29,440 --> 01:35:29,960 BENEFITS. 2509 01:35:29,960 --> 01:35:31,120 ALL RIGHT. 2510 01:35:31,120 --> 01:35:32,960 SO, HOW ALARMED WOULD WE BE 2511 01:35:32,960 --> 01:35:34,480 ABOUT THIS PERSON BEING ENROLLED 2512 01:35:34,480 --> 01:35:36,920 UNTIL A STUDY LIKE THIS? 2513 01:35:36,920 --> 01:35:38,120 HOLD THAT THOUGHT. 2514 01:35:38,120 --> 01:35:40,560 THE PERSON, REMEMBER, HE CAN'T 2515 01:35:40,560 --> 01:35:40,800 CONSENT. 2516 01:35:40,800 --> 01:35:44,880 IN CONTRAST THINK ABOUT MR. S, 2517 01:35:44,880 --> 01:35:46,760 HE MASS SCHIZOPHRENIA, MEETS 2518 01:35:46,760 --> 01:35:48,880 THRESHOLD FOR CAPACITY, ABLE TO 2519 01:35:48,880 --> 01:35:50,000 UNDERSTAND, CARRY ON A 2520 01:35:50,000 --> 01:35:52,000 CONVERSATION, GIVE ALL THE RIGHT 2521 01:35:52,000 --> 01:35:55,240 ANSWERS TO OUR QUESTIONNAIRE AND 2522 01:35:55,240 --> 01:35:56,320 INTERVIEW QUESTIONS. 2523 01:35:56,320 --> 01:35:58,320 HE CAN GIVE CONSENT FOR HIMSELF 2524 01:35:58,320 --> 01:36:04,160 IN . 2525 01:36:04,160 --> 01:36:06,800 HE'S SINGLE, SOCIAL UNEMPLOYED 2526 01:36:06,800 --> 01:36:08,000 AND ISOLATED, RACIAL AND ETHNIC 2527 01:36:08,000 --> 01:36:15,040 MINORITY, OFTEN THE CASE HERE. 2528 01:36:15,040 --> 01:36:18,800 RCT IS ALREADY MARKETED, NOT A 2529 01:36:18,800 --> 01:36:22,480 NEW PARADIGM, IN THEORY 2530 01:36:22,480 --> 01:36:23,520 DIFFERENT FORMULATION, COULD 2531 01:36:23,520 --> 01:36:26,080 OPTIMIZE BUT YOU MIGHT WONDER 2532 01:36:26,080 --> 01:36:27,320 THERE'S MARKETING CONSIDERATIONS 2533 01:36:27,320 --> 01:36:29,200 HERE, THAT DRUG COMPANY WANTS TO 2534 01:36:29,200 --> 01:36:31,160 EXTEND A PATENT. 2535 01:36:31,160 --> 01:36:32,320 OKAY. 2536 01:36:32,320 --> 01:36:34,400 SO THERE'S NO STRONG INCENTIVE 2537 01:36:34,400 --> 01:36:36,160 TO ENROLL IN THIS CASE. 2538 01:36:36,160 --> 01:36:38,320 HOW WOULD YOU FEEL ABOUT THIS 2539 01:36:38,320 --> 01:36:39,720 PERSON WHO IS COMPETENT BEING 2540 01:36:39,720 --> 01:36:40,840 ENROLLED IN THIS STUDY? 2541 01:36:40,840 --> 01:36:44,760 I WANT YOU TO THINK ABOUT 2542 01:36:44,760 --> 01:36:45,560 CONTRAST BETWEEN THE STUDIES 2543 01:36:45,560 --> 01:36:50,120 THAT CUTS ACROSS THE ISSUE OF 2544 01:36:50,120 --> 01:36:51,080 DECISION-MAKING CAPACITY. 2545 01:36:51,080 --> 01:36:52,880 SO I'M GOING TO END WITH THIS 2546 01:36:52,880 --> 01:36:54,040 LIST OF POTENTIAL OTHER 2547 01:36:54,040 --> 01:37:00,160 PROTECTIONS THAT WE SHOULD THINK 2548 01:37:00,160 --> 01:37:00,520 ABOUT. 2549 01:37:00,520 --> 01:37:01,920 IF IT'S REALLY IMPORTANT WE NEED 2550 01:37:01,920 --> 01:37:06,360 TO MAKE SURE THE WAY WE MEASURE 2551 01:37:06,360 --> 01:37:10,360 CAPACITY IS REALLY GROUNDED IN 2552 01:37:10,360 --> 01:37:11,440 VALID INSTRUMENTS AND CONCEPTS. 2553 01:37:11,440 --> 01:37:14,760 WE SHOULD TRY TO RESPECT THE 2554 01:37:14,760 --> 01:37:16,040 PRESERVED ABILITIES EVEN THOUGH 2555 01:37:16,040 --> 01:37:19,280 WE DRAW THIS LINE IN SOME SENSE 2556 01:37:19,280 --> 01:37:20,480 BETWEEN COMPETENT AND 2557 01:37:20,480 --> 01:37:21,080 INCOMPETENT. 2558 01:37:21,080 --> 01:37:24,880 AMONG THE PEOPLE DECLARED 2559 01:37:24,880 --> 01:37:27,480 INCOMPETENT THEY MIGHT HAVE WIDE 2560 01:37:27,480 --> 01:37:28,880 RANGE OF REMAINING ABILITIES. 2561 01:37:28,880 --> 01:37:34,960 THIS IS WHY WE TALK ABOUT ASSENT 2562 01:37:34,960 --> 01:37:36,000 DISSENT, COLLABORATIVE 2563 01:37:36,000 --> 01:37:36,280 DECISIONS. 2564 01:37:36,280 --> 01:37:37,400 THERE ARE DIFFERENT CATEGORIES 2565 01:37:37,400 --> 01:37:41,000 OF PEOPLE PROPOSED AND USED IN 2566 01:37:41,000 --> 01:37:43,160 RESEARCH SETTINGS TO PROTECT 2567 01:37:43,160 --> 01:37:48,560 PEOPLE WHO MAY BE VULNERABLE IN 2568 01:37:48,560 --> 01:37:49,520 THIS REGARD. 2569 01:37:49,520 --> 01:37:52,240 WE DO AT LEAST AN INFORMAL AND 2570 01:37:52,240 --> 01:37:53,840 SOMETIMES MORE FORMAL ASSESSMENT 2571 01:37:53,840 --> 01:37:56,680 OF THE SURROGATES TO SEE IF THEY 2572 01:37:56,680 --> 01:38:01,880 ARE IN THE RIGHT POSITION TO 2573 01:38:01,880 --> 01:38:04,640 PROVIDE KIND OF NOT ONLY 2574 01:38:04,640 --> 01:38:06,720 ACCURATE REPRESENTATION OF THE 2575 01:38:06,720 --> 01:38:08,640 PERSON, THE PRINCIPLE, BUT ALSO 2576 01:38:08,640 --> 01:38:10,880 HAVE THEIR BEST INTEREST AT 2577 01:38:10,880 --> 01:38:11,240 HEART. 2578 01:38:11,240 --> 01:38:12,840 AND THERE MAY BE OTHERS. 2579 01:38:12,840 --> 01:38:15,480 BUT I WANT YOU TO THINK ABOUT 2580 01:38:15,480 --> 01:38:17,560 THESE OTHER PROTECTIONS THAT ARE 2581 01:38:17,560 --> 01:38:19,160 AVAILABLE FOR IRBs TO USE IN 2582 01:38:19,160 --> 01:38:25,840 THE RIGHT KIND OF SETTINGS. 2583 01:38:25,840 --> 01:38:27,920 AND THESE SHOULD BE TAILORED TO 2584 01:38:27,920 --> 01:38:28,600 CONTEXT. 2585 01:38:28,600 --> 01:38:30,480 THE CONTEXT REALLY MATTERS, AS I 2586 01:38:30,480 --> 01:38:32,200 ILLUSTRATED TO YOU. 2587 01:38:32,200 --> 01:38:32,800 OKAY. 2588 01:38:32,800 --> 01:38:35,080 I'M A MINUTE AND 30 SECONDS 2589 01:38:35,080 --> 01:38:35,480 EARLY. 2590 01:38:35,480 --> 01:38:36,680 >>THANK YOU, SCOTT. 2591 01:38:36,680 --> 01:38:42,840 BIG ROUND OF APPLAUSE. 2592 01:38:42,840 --> 01:38:43,200 [APPLAUSE] 2593 01:38:43,200 --> 01:38:44,560 THANK YOU SO MUCH. 2594 01:38:44,560 --> 01:38:47,760 AND JUST AS A REMINDER WE'LL 2595 01:38:47,760 --> 01:38:49,600 HAVE CAROL SQUIRES JOIN US AFTER 2596 01:38:49,600 --> 01:38:50,720 THE BREAK. 2597 01:38:50,720 --> 01:38:53,240 AND TALK ABOUT AN EXAMPLE OF 2598 01:38:53,240 --> 01:38:56,520 THAT FIRST TYPE OF SORT OF 2599 01:38:56,520 --> 01:38:58,240 FORMAL CAPACITY ASSESSMENT, SO A 2600 01:38:58,240 --> 01:38:59,320 COUPLE QUESTIONS. 2601 01:38:59,320 --> 01:39:00,840 I'M NOT EXACTLY SURE ABOUT THIS 2602 01:39:00,840 --> 01:39:03,200 QUESTION BUT I'M GOING TO ASK IT 2603 01:39:03,200 --> 01:39:06,440 AND MAYBE WE CAN FIGURE IT OUT. 2604 01:39:06,440 --> 01:39:08,880 ON THE HEALTH CARE PROXY IS 2605 01:39:08,880 --> 01:39:10,800 THERE A SPECIFICATION THAT IT 2606 01:39:10,800 --> 01:39:12,240 CAN BE USED FOR RESEARCH 2607 01:39:12,240 --> 01:39:13,440 CONSENTING PURPOSES? 2608 01:39:13,440 --> 01:39:16,440 AND THEN THE FOLLOW-UP IS, DOES 2609 01:39:16,440 --> 01:39:18,080 THE PERSON IN QUESTION KNOW OR 2610 01:39:18,080 --> 01:39:21,640 HAVE TO OPT OUT FROM RESEARCH IF 2611 01:39:21,640 --> 01:39:23,960 HE OR SHE PREFERS? 2612 01:39:23,960 --> 01:39:26,080 I THINK WHAT THEY ARE ASKING 2613 01:39:26,080 --> 01:39:27,560 DOES A HEALTH CARE 2614 01:39:27,560 --> 01:39:32,800 PROSPECTIVELIY -- PROXY HAVE TO 2615 01:39:32,800 --> 01:39:33,480 HAVE THAT? 2616 01:39:33,480 --> 01:39:35,240 >>THERE ARE A LOT OF DETAILS IS 2617 01:39:35,240 --> 01:39:37,560 THE RIGHT WAY TO PUT IT. 2618 01:39:37,560 --> 01:39:40,880 HEALTH CARE PROXY JUST MEANS 2619 01:39:40,880 --> 01:39:42,240 THAT THERE'S SOME LEGAL 2620 01:39:42,240 --> 01:39:45,360 MECHANISM THE PERSON USED TO 2621 01:39:45,360 --> 01:39:45,880 APPOINT SOMEBODY FOR 2622 01:39:45,880 --> 01:39:48,280 HEALTH-RELATED DECISION MAKING. 2623 01:39:48,280 --> 01:39:50,960 THAT CAN -- DEPENDING ON THE 2624 01:39:50,960 --> 01:39:52,760 INSTITUTION OR THE STATE, THAT 2625 01:39:52,760 --> 01:39:56,480 FORM WILL VARY. 2626 01:39:56,480 --> 01:39:58,080 SO OUR CLINICAL CENTER FORM 2627 01:39:58,080 --> 01:40:00,200 ACTUALLY HAS PARTS WHERE YOU CAN 2628 01:40:00,200 --> 01:40:02,320 ACTUALLY APPOINT PEOPLE TO SERVE 2629 01:40:02,320 --> 01:40:03,440 AS RESEARCH PROXY. 2630 01:40:03,440 --> 01:40:07,880 SO, I DIDN'T GO INTO IT, BUT 2631 01:40:07,880 --> 01:40:12,080 THERE'S THIS CONCEPT OF 2632 01:40:12,080 --> 01:40:12,840 CONCURRENT PROXY, MEANING 2633 01:40:12,840 --> 01:40:15,080 REMEMBER I SAID DECISION MAKING 2634 01:40:15,080 --> 01:40:17,520 CAPACITY CAN BE -- YOU CAN DO A 2635 01:40:17,520 --> 01:40:18,640 BUT NOT B. 2636 01:40:18,640 --> 01:40:21,720 SUPPOSE YOU CAN'T CONSENT FOR 2637 01:40:21,720 --> 01:40:23,600 THE STUDY, BUT YOU'VE BEEN 2638 01:40:23,600 --> 01:40:25,840 DETERMINED ABLE TO APPOINT A 2639 01:40:25,840 --> 01:40:28,000 PROXY, THAT'S POSSIBLE, SO FOR 2640 01:40:28,000 --> 01:40:30,320 THOSE FOLKS YOU MIGHT ACTUALLY 2641 01:40:30,320 --> 01:40:33,840 HAVE THEM FILL OUT A PROXY, 2642 01:40:33,840 --> 01:40:35,480 APPOINT SOMEBODY AND SAY -- THEN 2643 01:40:35,480 --> 01:40:36,800 SAY, YES, I WANT TO BE IN 2644 01:40:36,800 --> 01:40:39,400 RESEARCH IN THE FUTURE OR NOT 2645 01:40:39,400 --> 01:40:40,800 AND SO FORTH. 2646 01:40:40,800 --> 01:40:42,520 THAT WILL VARY BY INSTITUTION. 2647 01:40:42,520 --> 01:40:44,720 THE QUESTION OF ACTUALLY 2648 01:40:44,720 --> 01:40:52,920 SPECIFYING I WANT TO BE IN A 2649 01:40:52,920 --> 01:40:53,560 NOT, THAT CONSTITUTES 2650 01:40:53,560 --> 01:40:54,840 INSTRUCTIONAL DIRECTIVE, OR 2651 01:40:54,840 --> 01:40:57,480 LIVING WILLS, THAT WILL VARY AS 2652 01:40:57,480 --> 01:40:57,720 WELL. 2653 01:40:57,720 --> 01:40:59,800 IT'S AN INTERESTING -- I COULD 2654 01:40:59,800 --> 01:41:00,560 GO ON. 2655 01:41:00,560 --> 01:41:02,520 IT DEPENDS WHAT IS THE 2656 01:41:02,520 --> 01:41:04,480 SIGNIFICANCE OF THAT? 2657 01:41:04,480 --> 01:41:07,480 WELL, THAT WOULD DEPEND ON HOW 2658 01:41:07,480 --> 01:41:08,800 LAWS REGULATING HEALTH CARE 2659 01:41:08,800 --> 01:41:10,680 PROXIES IN THAT JURISDICTION. 2660 01:41:10,680 --> 01:41:11,920 >>RIGHT. 2661 01:41:11,920 --> 01:41:13,040 IN CASE THIS IS EMBEDDED, THAT 2662 01:41:13,040 --> 01:41:15,240 PERSON WOULD ALWAYS HAVE THE 2663 01:41:15,240 --> 01:41:18,080 OPTION TO SAY NO, RIGHT? 2664 01:41:18,080 --> 01:41:20,280 IF YOU'RE MY PROXY, AND, YOU 2665 01:41:20,280 --> 01:41:22,320 KNOW, ETHAN TELLS YOU ABOUT THE 2666 01:41:22,320 --> 01:41:22,720 STUDY. 2667 01:41:22,720 --> 01:41:23,880 >>THAT'S RIGHT. 2668 01:41:23,880 --> 01:41:27,400 A PERSON WHO IS CAPABLE OF 2669 01:41:27,400 --> 01:41:29,720 DISSENTING WILL SAY NO. 2670 01:41:29,720 --> 01:41:33,240 AND THAT CARRIES THE DAY. 2671 01:41:33,240 --> 01:41:41,160 SO IN THE RESEARCH SETTING, THE 2672 01:41:41,160 --> 01:41:42,800 PERSON'S NO CARRIES A LOT OF 2673 01:41:42,800 --> 01:41:44,600 WEIGHT. 2674 01:41:44,600 --> 01:41:44,880 >>ANDREW? 2675 01:41:44,880 --> 01:41:46,200 >>A QUESTION ABOUT ASSENT. 2676 01:41:46,200 --> 01:41:47,960 ASSENT MAKES AT LEAST IN MY 2677 01:41:47,960 --> 01:41:50,440 MIND, IT'S CLEAR WHEN WE'RE 2678 01:41:50,440 --> 01:41:52,120 THINKING ABOUT CHILDREN. 2679 01:41:52,120 --> 01:41:53,280 PARENTS OR GUARDIANS CAN GIVE 2680 01:41:53,280 --> 01:41:55,560 CONSENT BUT YOU TALK TO CHILDREN 2681 01:41:55,560 --> 01:41:58,200 AND THEY CAN GIVE ASSENT. 2682 01:41:58,200 --> 01:42:00,120 WHAT ABOUT IN CASES YOU'RE 2683 01:42:00,120 --> 01:42:03,160 TALKING ABOUT, SAY, FOR 2684 01:42:03,160 --> 01:42:05,160 ALZHEIMER'S WHEN THE LEGAL 2685 01:42:05,160 --> 01:42:08,280 GUARDIANS WOULD GIVE CONSENT BUT 2686 01:42:08,280 --> 01:42:09,520 DEPENDING WHEN YOU'RE TALKING TO 2687 01:42:09,520 --> 01:42:12,000 THE SUBJECT THE ANSWER MAY 2688 01:42:12,000 --> 01:42:12,200 CHANGE? 2689 01:42:12,200 --> 01:42:15,600 IF THEY ARE IN A LUCID OR 2690 01:42:15,600 --> 01:42:16,680 NON-LUCID STATE. 2691 01:42:16,680 --> 01:42:18,280 >>WHAT WAS THE LAST SENTENCE? 2692 01:42:18,280 --> 01:42:22,520 WHAT DO YOU DO IN ALZHEIMER'S 2693 01:42:22,520 --> 01:42:24,040 PATIENTS FOR EXAMPLE WHEN THEY 2694 01:42:24,040 --> 01:42:26,120 MAY OR MAY NOT GIVE YOU THE SAME 2695 01:42:26,120 --> 01:42:28,400 ANSWER DEPENDING WHEN YOU TALK 2696 01:42:28,400 --> 01:42:28,920 TO THEM. 2697 01:42:28,920 --> 01:42:32,400 >>OH, RIGHT, OKAY. 2698 01:42:32,400 --> 01:42:33,840 THERE'S A COUPLE QUESTIONS IN 2699 01:42:33,840 --> 01:42:34,440 THERE. 2700 01:42:34,440 --> 01:42:39,280 ONE IS THE QUESTION OF WHEN IS 2701 01:42:39,280 --> 01:42:40,960 IT A TRUE DISSENT YOU HAVE TO 2702 01:42:40,960 --> 01:42:43,720 RESPECT, HOW SUSTAINED SHOULD IT 2703 01:42:43,720 --> 01:42:44,120 BE? 2704 01:42:44,120 --> 01:42:45,960 THE OTHER IS SORT OF 2705 01:42:45,960 --> 01:42:48,400 COORDINATING BETWEEN THE PERSON 2706 01:42:48,400 --> 01:42:50,120 WHO GIVES CONSENT AND THE 2707 01:42:50,120 --> 01:42:53,760 PATIENT OR THE RESEARCH 2708 01:42:53,760 --> 01:42:56,160 PARTICIPANT OR SUBJECT HIMSELF. 2709 01:42:56,160 --> 01:42:59,280 WE'LL START WITH THE SECOND ONE. 2710 01:42:59,280 --> 01:43:02,000 THERE'S NO ABSOLUTE GUIDANCE ON 2711 01:43:02,000 --> 01:43:06,360 THIS. 2712 01:43:06,360 --> 01:43:08,280 YOU HAVE TO USE JUDGMENT BECAUSE 2713 01:43:08,280 --> 01:43:10,920 A PERSON MAY SAY NO, YOU DON'T 2714 01:43:10,920 --> 01:43:14,160 KNOW IF THEY ARE SAYING NO TO 2715 01:43:14,160 --> 01:43:17,320 RESEARCH WITH THAT IN MIND OR 2716 01:43:17,320 --> 01:43:18,920 THEY ARE JUST EXPRESSING 2717 01:43:18,920 --> 01:43:20,520 SOMETHING NEGATIVE IN THE 2718 01:43:20,520 --> 01:43:23,400 CURRENT PRESENT CONTEXT, RIGHT? 2719 01:43:23,400 --> 01:43:25,680 SO, YOU CAN'T WRITE RULES TO 2720 01:43:25,680 --> 01:43:26,680 REGULATE THOSE KIND OF THINGS 2721 01:43:26,680 --> 01:43:27,640 AHEAD OF TIME. 2722 01:43:27,640 --> 01:43:29,960 THAT'S WHY YOU HAVE EXPERIENCED 2723 01:43:29,960 --> 01:43:31,120 CLINICIANS WHERE HAVE TO 2724 01:43:31,120 --> 01:43:32,080 EXERCISE THEIR JUDGMENT. 2725 01:43:32,080 --> 01:43:34,280 YOU CAN PROVIDE SOME GUIDANCE. 2726 01:43:34,280 --> 01:43:36,920 BUT IF IT'S A CONSISTENT NO, 2727 01:43:36,920 --> 01:43:38,040 OBVIOUSLY PEOPLE WOULD SAY, 2728 01:43:38,040 --> 01:43:39,720 YEAH, YOU CAN'T DO THAT. 2729 01:43:39,720 --> 01:43:41,280 SO AN EXAMPLE WOULD BE THE 2730 01:43:41,280 --> 01:43:41,520 FOLLOWING. 2731 01:43:41,520 --> 01:43:43,520 THE PERSON WHO REALLY IS 2732 01:43:43,520 --> 01:43:44,760 UNCOMFORTABLE DOING A CERTAIN 2733 01:43:44,760 --> 01:43:46,040 PROCEDURE AND EVERY TIME YOU TRY 2734 01:43:46,040 --> 01:43:51,280 TO DO IT THEY MOVE AND THEY SAY 2735 01:43:51,280 --> 01:43:53,120 NO, WELL, YOU KNOW, THAT BECOMES 2736 01:43:53,120 --> 01:43:53,800 PRETTY CLEAR. 2737 01:43:53,800 --> 01:43:58,960 ON THE OTHER HAND, THE PERSON 2738 01:43:58,960 --> 01:44:00,720 SAYS NO, YOU THINK, OKAY, LET'S 2739 01:44:00,720 --> 01:44:02,560 SEE, YOU WAIT, COME BACK NEXT 2740 01:44:02,560 --> 01:44:04,680 DAY, THEY ARE HAPPIER, THEY 2741 01:44:04,680 --> 01:44:06,640 COOPERATE, THEY DO THE THING. 2742 01:44:06,640 --> 01:44:08,240 THEN YOU HAVE SOME INDICATION 2743 01:44:08,240 --> 01:44:10,840 THAT IT'S MORE OF A TEMPORARY 2744 01:44:10,840 --> 01:44:11,240 THING. 2745 01:44:11,240 --> 01:44:12,080 DOES THAT HELP? 2746 01:44:12,080 --> 01:44:14,480 AND IN TERMS OF THE COORDINATION 2747 01:44:14,480 --> 01:44:16,560 WITH THE PATIENTS AND THEIR 2748 01:44:16,560 --> 01:44:19,760 SURROGATE, I THINK THE PARADIGM 2749 01:44:19,760 --> 01:44:21,560 REALLY IN ALZHEIMER'S RESEARCH 2750 01:44:21,560 --> 01:44:25,600 WHEN THE FOCUS WAS INDEED, 2751 01:44:25,600 --> 01:44:26,720 PEOPLE WITH SIGNIFICANT 2752 01:44:26,720 --> 01:44:29,560 IMPAIRMENTS, WAS REALLY TRYING 2753 01:44:29,560 --> 01:44:33,240 TO WORK TOGETHER WITH THE 2754 01:44:33,240 --> 01:44:37,640 SUBJECT AND THE PERSON WHO 2755 01:44:37,640 --> 01:44:38,280 PROVIDES CONSENT. 2756 01:44:38,280 --> 01:44:41,080 PEOPLE USE THE TERM STUDY 2757 01:44:41,080 --> 01:44:42,600 PARTNER, A TEAM APPROACH, BUT 2758 01:44:42,600 --> 01:44:43,520 LEGAL AUTHORITY ULTIMATELY OF 2759 01:44:43,520 --> 01:44:46,960 COURSE HAS TO FALL ON A SINGLE 2760 01:44:46,960 --> 01:44:47,280 PERSON. 2761 01:44:47,280 --> 01:44:48,840 >>WE'LL TAKE ISABELLE, IF WE 2762 01:44:48,840 --> 01:44:50,920 HAVE TIME ONE MORE OR WE'LL 2763 01:44:50,920 --> 01:44:52,720 FINISH WITH ISABELLE. 2764 01:44:52,720 --> 01:44:54,960 >>I JUST HAD TWO QUESTIONS 2765 01:44:54,960 --> 01:44:57,760 RELATED TO THE LEEWAY STUDY. 2766 01:44:57,760 --> 01:44:59,840 ONE, I WAS CURIOUS ABOUT REASONS 2767 01:44:59,840 --> 01:45:02,080 PEOPLE GAVE FOR WANTING SOME 2768 01:45:02,080 --> 01:45:02,360 LEEWAY. 2769 01:45:02,360 --> 01:45:04,400 I WANTED TO HEAR MORE AND THE 2770 01:45:04,400 --> 01:45:06,400 SECOND QUESTION WAS I WAS 2771 01:45:06,400 --> 01:45:08,920 CURIOUS WHAT WAS THE NATURE OF 2772 01:45:08,920 --> 01:45:10,440 THE INCAPACITY THAT YOU GAVE IN 2773 01:45:10,440 --> 01:45:12,480 THE EXAMPLE TO THESE 2774 01:45:12,480 --> 01:45:13,080 PARTICIPANTS? 2775 01:45:13,080 --> 01:45:17,320 WAS IT SOMETHING WHERE WE'RE 2776 01:45:17,320 --> 01:45:19,400 TALKING ABOUT LIKE A CONDITION 2777 01:45:19,400 --> 01:45:21,800 THAT'S WORSENING WHERE THEY ARE 2778 01:45:21,800 --> 01:45:23,520 UNLIKELY TO REGAIN CAPACITY AND 2779 01:45:23,520 --> 01:45:25,960 THAT'S THE SITUATION OR IT'S A 2780 01:45:25,960 --> 01:45:28,040 VERY TEMPORARY INCAPACITY, 2781 01:45:28,040 --> 01:45:29,720 BECAUSE I WOULD IMAGINE YOU 2782 01:45:29,720 --> 01:45:31,600 WOULD RECEIVE DIFFERENT ANSWERS. 2783 01:45:31,600 --> 01:45:37,840 >>IN THE SETTING OF 2784 01:45:37,840 --> 01:45:38,840 ALZHEIMER'S, PROGRESSIVE 2785 01:45:38,840 --> 01:45:39,760 IRREVERSIBLE DECLINE, AND WHAT 2786 01:45:39,760 --> 01:45:41,640 REASONS THEY HAD, IT WAS A 2787 01:45:41,640 --> 01:45:43,600 SURVEY QUESTION. 2788 01:45:43,600 --> 01:45:46,880 WE DIDN'T ELICIT THE QUALITATIVE 2789 01:45:46,880 --> 01:45:47,680 ANSWERS FOR THAT. 2790 01:45:47,680 --> 01:45:50,200 YOU CAN LOOK UP STUDIES AND 2791 01:45:50,200 --> 01:45:52,000 RELATED FIELDS IN WHICH PEOPLE 2792 01:45:52,000 --> 01:45:53,440 MIGHT GIVE ALL SORTS OF 2793 01:45:53,440 --> 01:45:55,960 DIFFERENT REASONS FOR IT. 2794 01:45:55,960 --> 01:45:57,720 IT'S LIKE, FOR EXAMPLE, IN THE 2795 01:45:57,720 --> 01:46:00,760 DISCUSSIONS PEOPLE MIGHT SAY, 2796 01:46:00,760 --> 01:46:02,320 WELL, LOOK, I DON'T WANT TO BE 2797 01:46:02,320 --> 01:46:05,600 IN IT NOW BUT, HEY, IF THEY 2798 01:46:05,600 --> 01:46:07,680 THINK IT'S REALLY PROMISING WHY 2799 01:46:07,680 --> 01:46:07,840 NOT? 2800 01:46:07,840 --> 01:46:10,120 BUT RIGHT NOW THIS IS HOW I 2801 01:46:10,120 --> 01:46:10,400 FEEL. 2802 01:46:10,400 --> 01:46:12,920 THINGS LIKE THAT. 2803 01:46:12,920 --> 01:46:13,840 >>BRIEF FOLLOW-UP, HOW DOES 2804 01:46:13,840 --> 01:46:15,480 THAT MAKE YOU THINK ABOUT THE 2805 01:46:15,480 --> 01:46:18,680 ROLE OF ADVANCE DIRECTIVES WHERE 2806 01:46:18,680 --> 01:46:19,720 PEOPLE ARE SPECIFYING TREATMENTS 2807 01:46:19,720 --> 01:46:21,400 THEY WANT IN THE FUTURE IF WE 2808 01:46:21,400 --> 01:46:22,640 TAKE INTO ACCOUNT PEOPLE ARE 2809 01:46:22,640 --> 01:46:25,680 CHANGING THEIR MINDS A LOT OR 2810 01:46:25,680 --> 01:46:26,960 ALSO WANT, SAY I'M 2811 01:46:26,960 --> 01:46:28,520 INCAPACITATED, IT MIGHT MATTER 2812 01:46:28,520 --> 01:46:29,800 MORE HOW MY FAMILY FEELS ABOUT 2813 01:46:29,800 --> 01:46:33,560 THE SITUATION OR MY LOVED ONES 2814 01:46:33,560 --> 01:46:34,880 FEEL THAN SOME PARTICULAR 2815 01:46:34,880 --> 01:46:36,040 SPECIFICATION ABOUT TREATMENT IN 2816 01:46:36,040 --> 01:46:40,760 ADVANCE, FOR EXAMPLE. 2817 01:46:40,760 --> 01:46:43,160 >>THAT'S A HUGE TOPIC. 2818 01:46:43,160 --> 01:46:47,240 NOT ABOUT RESEARCH ETHICS 2819 01:46:47,240 --> 01:46:47,640 SPECIFICALLY. 2820 01:46:47,640 --> 01:46:50,240 I WOULD SAY IT'S PROBABLY A FAIR 2821 01:46:50,240 --> 01:46:54,640 STATEMENT -- HOW CAN I SAY THIS 2822 01:46:54,640 --> 01:46:55,640 WITHOUT SOUNDING TOO 2823 01:46:55,640 --> 01:46:56,200 CONTROVERSIAL? 2824 01:46:56,200 --> 01:46:57,360 IT'S POSSIBLE WE COULD BE IN THE 2825 01:46:57,360 --> 01:47:01,640 GRIP OF A THEORY TO THINK WE CAN 2826 01:47:01,640 --> 01:47:05,360 PIN DOWN THE FUTURE THROUGH 2827 01:47:05,360 --> 01:47:06,560 PRESENT AUTONOMY FRAMEWORK, BUT 2828 01:47:06,560 --> 01:47:08,960 PEOPLE IN THE REAL WORLD WHEN 2829 01:47:08,960 --> 01:47:12,240 THEY MAKE DECISIONS HAVE MUCH 2830 01:47:12,240 --> 01:47:13,280 BROADER SET OF CONSIDERATIONS, 2831 01:47:13,280 --> 01:47:15,840 LET'S LEAVE IT AT THAT. 2832 01:47:15,840 --> 01:47:21,840 >>WE CAN REFER YOU TO SOME 2833 01:47:21,840 --> 01:47:22,240 LITERATURE. 2834 01:47:22,240 --> 01:47:24,640 THIS IS SLIGHTLY OFF TOPIC BUT 2835 01:47:24,640 --> 01:47:26,160 SOMEONE ASKED, THEY HAVE HEARD 2836 01:47:26,160 --> 01:47:27,960 HERE IN THE UNITED STATES THERE 2837 01:47:27,960 --> 01:47:29,880 ARE SOME CIRCUMSTANCES WHERE YOU 2838 01:47:29,880 --> 01:47:33,400 CAN DO RESEARCH ON AN INDIVIDUAL 2839 01:47:33,400 --> 01:47:35,040 WITHOUT CONSENT. 2840 01:47:35,040 --> 01:47:36,000 IN AN EMERGENCY CONTEXT. 2841 01:47:36,000 --> 01:47:38,080 I DON'T KNOW IF YOU WANT TO SAY 2842 01:47:38,080 --> 01:47:40,360 SOMETHING ABOUT THAT OR WE CAN 2843 01:47:40,360 --> 01:47:40,480 -- 2844 01:47:40,480 --> 01:47:46,760 >>YEAH, IS THERE A TALK ON 2845 01:47:46,760 --> 01:47:47,880 THAT? 2846 01:47:47,880 --> 01:47:48,760 >>NO. 2847 01:47:48,760 --> 01:47:50,080 >>THE MOST TALKED ABOUT AND 2848 01:47:50,080 --> 01:47:51,160 DISCUSSED SITUATION WHERE A 2849 01:47:51,160 --> 01:47:53,280 PERSON WHO CAN'T GIVE CONSENT, 2850 01:47:53,280 --> 01:47:58,120 WOULD YOU DO THAT, WOULD BE THE 2851 01:47:58,120 --> 01:47:59,040 EXCEPTION FROM CONSENT -- 2852 01:47:59,040 --> 01:48:02,760 >>I ARRIVE AT THE HOSPITAL -- 2853 01:48:02,760 --> 01:48:04,160 >>FDA REGULATIONS, FOR EXAMPLE, 2854 01:48:04,160 --> 01:48:06,680 STUDIES THAT TEST OUT BLOOD 2855 01:48:06,680 --> 01:48:07,360 SUBSTITUTES IN THE EMERGENCY, 2856 01:48:07,360 --> 01:48:10,120 OUT IN THE FIELD WHEN SOMEBODY'S 2857 01:48:10,120 --> 01:48:11,800 BLEEDING, OBVIOUSLY YOU CAN'T 2858 01:48:11,800 --> 01:48:13,640 GET CONSENT, THEIR SURROGATE IS 2859 01:48:13,640 --> 01:48:14,800 NOT AVAILABLE, YOU HAVE TO MAKE 2860 01:48:14,800 --> 01:48:17,640 A DECISION RIGHT THERE. 2861 01:48:17,640 --> 01:48:19,640 THERE'S A SET OF GUIDELINES HOW 2862 01:48:19,640 --> 01:48:21,880 THIS HAS TO BE, YOU KNOW, ALL 2863 01:48:21,880 --> 01:48:22,920 SORTS OF CONDITIONS HAVE TO BE 2864 01:48:22,920 --> 01:48:25,120 MET BEFORE THEY CAN DO THAT. 2865 01:48:25,120 --> 01:48:30,440 YES, THAT'S TRUE, BUT THAT'S 2866 01:48:30,440 --> 01:48:32,480 DIFFERENT FROM THE QUESTION 2867 01:48:32,480 --> 01:48:33,520 OF -- SOMEWHAT DIFFERENT. 2868 01:48:33,520 --> 01:48:34,720 RELATED OBVIOUSLY. 2869 01:48:34,720 --> 01:48:37,880 >>I CAN POST THOSE FDA 2870 01:48:37,880 --> 01:48:38,840 GUIDELINES ONLINE. 2871 01:48:38,840 --> 01:48:41,160 THANK YOU AGAIN, DR. KIM. 2872 01:48:41,160 --> 01:48:41,440 >>OKAY. 2873 01:48:41,440 --> 01:48:41,720 [APPLAUSE] 2874 01:48:41,720 --> 01:48:44,080 JUST TO GIVE YOU ALL A SENSE OF 2875 01:48:44,080 --> 01:48:45,640 THE PLAN FOR THE REST OF THE 2876 01:48:45,640 --> 01:48:48,800 DAY, WE'RE GOING TO TAKE OUR 2877 01:48:48,800 --> 01:48:50,960 BREAK AT 10:20 AND THEN WE'RE 2878 01:48:50,960 --> 01:48:52,240 GOING TO BE JOINED BY CAROL 2879 01:48:52,240 --> 01:48:59,880 SQUIRES WHO IS GOING TO TALK TO 2880 01:48:59,880 --> 01:49:02,800 US ABOUT HOW THIS PROCESS OF 2881 01:49:02,800 --> 01:49:05,680 ASSESSMENT OF CAPACITY WORKS IN 2882 01:49:05,680 --> 01:49:06,280 THE CLINICAL CENTER. 2883 01:49:06,280 --> 01:49:07,800 IT'S KIND OF THE WORLD. 2884 01:49:07,800 --> 01:49:11,400 AND WE'RE GOING TO INCLUDE SOME 2885 01:49:11,400 --> 01:49:12,760 SLIDO QUESTIONS, AND SO I EAR 2886 01:49:12,760 --> 01:49:17,480 MAILED YOU ALL TO BE ON ALERT. 2887 01:49:17,480 --> 01:49:19,400 I E-MAILED YOU TO BE ON ALERT. 2888 01:49:19,400 --> 01:49:22,000 I'LL SAY THE NUMBER NOW AND 2889 01:49:22,000 --> 01:49:23,600 BEFORE CAROL'S TALK, I WILL ALSO 2890 01:49:23,600 --> 01:49:26,200 SEND IT OUT AS AN E-MAIL WHILE 2891 01:49:26,200 --> 01:49:31,520 YOU'RE ON BREAK. 2892 01:49:31,520 --> 01:49:32,520 IT'S 232-1871. 2893 01:49:32,520 --> 01:49:35,520 AND PLEASE JUST USE IT FOR THE 2894 01:49:35,520 --> 01:49:38,480 QUESTIONS I'M GOING TO ASK YOU. 2895 01:49:38,480 --> 01:49:40,320 YOU CAN USE IT TO CHITCHAT BUT 2896 01:49:40,320 --> 01:49:41,840 I'M NOT GOING TO PAY ATTENTION 2897 01:49:41,840 --> 01:49:43,920 TO THOSE QUESTIONS. 2898 01:49:43,920 --> 01:49:45,920 IF YOU HAVE QUESTIONS POST THEM 2899 01:49:45,920 --> 01:49:47,960 IN THE DISCUSSION BOARD. 2900 01:49:47,960 --> 01:49:52,040 WITH THAT, WE'LL TAKE OUR BREAK. 2901 01:49:52,040 --> 01:49:53,880 IT'S ABOUT 10:20 HERE. 2902 01:49:53,880 --> 01:49:57,440 LET'S COME BACK TOGETHER AT 2903 01:49:57,440 --> 01:49:59,160 10:35. 2904 01:49:59,160 --> 01:50:04,240 THANK YOU ALL. 2905 01:50:04,240 --> 01:50:05,960 >>WELCOME BACK, EVERYBODY. 2906 01:50:05,960 --> 01:50:07,600 TWO QUICK ANNOUNCEMENTS. 2907 01:50:07,600 --> 01:50:09,680 THE WORD OF THE DAY IS ASSENT. 2908 01:50:09,680 --> 01:50:11,960 WE'VE TALKED ABOUT THAT A COUPLE 2909 01:50:11,960 --> 01:50:12,640 TIMES. 2910 01:50:12,640 --> 01:50:16,200 AND THE CODE FOR SLIDO WHICH I 2911 01:50:16,200 --> 01:50:22,480 SENT OUT BY E-MAIL AND 2912 01:50:22,480 --> 01:50:24,480 ANNOUNCEMENT IS 232 1871, WE'LL 2913 01:50:24,480 --> 01:50:27,320 BE USING THAT ONCE CAROL JOINS 2914 01:50:27,320 --> 01:50:33,640 US TO GET YOUR INPUT ON TWO 2915 01:50:33,640 --> 01:50:34,240 CASES. 2916 01:50:34,240 --> 01:50:36,240 IT'S MY GREAT PLEASURE TO 2917 01:50:36,240 --> 01:50:36,920 INTRODUCE CAROL SQUIRES, 2918 01:50:36,920 --> 01:50:41,000 GRACIOUS ENOUGH TO STEP IN FOR 2919 01:50:41,000 --> 01:50:42,080 KATIE TODDMAN WHO CAN'T JOIN US 2920 01:50:42,080 --> 01:50:42,520 TODAY. 2921 01:50:42,520 --> 01:50:47,240 SHE AND KATIE AND OTHERS ARE 2922 01:50:47,240 --> 01:50:50,960 PART OF THE HUMAN SUBJECTS 2923 01:50:50,960 --> 01:50:51,520 PROTECTION UNIT IN NATIONAL 2924 01:50:51,520 --> 01:50:53,120 INSTITUTE OF MENTAL HEALTH. 2925 01:50:53,120 --> 01:50:53,880 YOU KNOW THAT THERE ARE 2926 01:50:53,880 --> 01:50:55,520 PARTICULAR ISSUES THAT COME UP 2927 01:50:55,520 --> 01:50:57,680 IN THAT SETTING, GIVEN WHAT YOU 2928 01:50:57,680 --> 01:50:58,760 HEARD FROM SCOTT, SO THEY ARE 2929 01:50:58,760 --> 01:51:01,120 THERE TO SERVE THE INTRAMURAL 2930 01:51:01,120 --> 01:51:01,720 PROGRAM. 2931 01:51:01,720 --> 01:51:02,840 WITH THAT, I'M GOING TO STAND IT 2932 01:51:02,840 --> 01:51:03,920 OVER TO CAROL. 2933 01:51:03,920 --> 01:51:05,480 SHE'S GOING TO TALK FOR A BIT 2934 01:51:05,480 --> 01:51:09,560 AND WE'RE GOING TO LAUNCH INTO 2935 01:51:09,560 --> 01:51:16,200 TWO CASES.. 2936 01:51:16,200 --> 01:51:16,920 >>THANK YOU VERY MUCH, HOLLY. 2937 01:51:16,920 --> 01:51:20,240 THANK YOU ALL FOR BEING HERE 2938 01:51:20,240 --> 01:51:22,640 TODAY. 2939 01:51:22,640 --> 01:51:27,280 NEXT SLIDE PLEASE. 2940 01:51:27,280 --> 01:51:32,800 HERE IS MY DISCLAIMER. 2941 01:51:32,800 --> 01:51:35,600 HSPU IS COMPRISED OF CLINICAL 2942 01:51:35,600 --> 01:51:37,120 RESEARCH ADVOCATES, CLINICIANS 2943 01:51:37,120 --> 01:51:38,480 TRAINED IN BIOETHICS AND 2944 01:51:38,480 --> 01:51:41,000 INDEPENDENT OF THE RESEARCH 2945 01:51:41,000 --> 01:51:41,760 TEAM. 2946 01:51:41,760 --> 01:51:43,640 HSPU STAFF ARE CLINICIANS, 2947 01:51:43,640 --> 01:51:46,000 EXPERIENCED AS ADVOCATES FOR 2948 01:51:46,000 --> 01:51:46,800 RESEARCH PARTICIPANTS. 2949 01:51:46,800 --> 01:51:48,960 ADDITIONALLY WE ARE MEMBERS OF 2950 01:51:48,960 --> 01:51:49,800 THE ABILITY TO CONSENT 2951 01:51:49,800 --> 01:51:51,240 ASSESSMENT TEAM. 2952 01:51:51,240 --> 01:51:54,600 WHICH IS A COMBINATION OF THE 2953 01:51:54,600 --> 01:51:56,080 HSPU AND CLINICAL CENTER 2954 01:51:56,080 --> 01:51:58,200 BIOETHICS DEPARTMENT WHO PERFORM 2955 01:51:58,200 --> 01:52:00,040 CAPACITY ASSESSMENTS THROUGHOUT 2956 01:52:00,040 --> 01:52:03,960 THE CLINICAL CENTER. 2957 01:52:03,960 --> 01:52:06,600 NEXT SLIDE PLEASE. 2958 01:52:06,600 --> 01:52:08,920 OUR HSPU FUNCTIONS INCLUDE WE 2959 01:52:08,920 --> 01:52:10,920 PROVIDE PROTECTION AND ADVOCACY 2960 01:52:10,920 --> 01:52:13,680 FOR HUMAN SUBJECTS, WITH FOCUS 2961 01:52:13,680 --> 01:52:15,160 ON POTENTIALLY VULNERABLE 2962 01:52:15,160 --> 01:52:18,200 PARTICIPANTS AND POPULATIONS. 2963 01:52:18,200 --> 01:52:21,960 WE ASSESS, DEVELOP, IMPLEMENT 2964 01:52:21,960 --> 01:52:23,280 LEVELS OF PROTECTION IN ALL 2965 01:52:23,280 --> 01:52:24,760 PHASES OF RESEARCH. 2966 01:52:24,760 --> 01:52:29,360 WE ASSIST IN THE APPLICATION OF 2967 01:52:29,360 --> 01:52:31,480 FEDERAL NIH AND NIMH HUMAN 2968 01:52:31,480 --> 01:52:33,480 SUBJECTS RESEARCH REGULATIONS 2969 01:52:33,480 --> 01:52:34,520 AND POLICIES. 2970 01:52:34,520 --> 01:52:36,640 WE ALSO PROVIDE EDUCATION SUCH 2971 01:52:36,640 --> 01:52:38,160 AS THIS CLASS. 2972 01:52:38,160 --> 01:52:42,320 THE NIMH OFFICE OF THE CLINICAL 2973 01:52:42,320 --> 01:52:43,480 DIRECTOR REQUIRES CONSENT 2974 01:52:43,480 --> 01:52:45,040 TRAINING FOR ALL INVESTIGATORS 2975 01:52:45,040 --> 01:52:48,160 WHO WILL BE OBTAINING INFORMED 2976 01:52:48,160 --> 01:52:49,160 CONSENT FROM PARTICIPANTS IN 2977 01:52:49,160 --> 01:52:53,080 NIMH STUDIES AT THE CLINICAL 2978 01:52:53,080 --> 01:52:53,600 CENTER. 2979 01:52:53,600 --> 01:52:55,520 NEXT SLIDE PLEASE. 2980 01:52:55,520 --> 01:52:57,880 TO ADDRESS NEED FOR A SYSTEMATIC 2981 01:52:57,880 --> 01:52:59,840 APPROACH TO ASSESS POTENTIAL 2982 01:52:59,840 --> 01:53:00,760 RESEARCH PARTICIPANTS, WHOSE 2983 01:53:00,760 --> 01:53:03,600 ABILITY TO CONSENT MAY BE 2984 01:53:03,600 --> 01:53:04,080 UNCERTAIN, THE NATIONAL 2985 01:53:04,080 --> 01:53:06,560 INSTITUTE OF MENTAL HEALTH HAS 2986 01:53:06,560 --> 01:53:08,760 CREATED THE HUMAN SUBJECTS 2987 01:53:08,760 --> 01:53:09,800 PROTECTION UNIT, THAT EVALUATES 2988 01:53:09,800 --> 01:53:13,120 WHETHER PERSONS HAVE THE 2989 01:53:13,120 --> 01:53:23,160 CAPACITY TO CONSENT AND IF NOT, 2990 01:53:23,160 --> 01:53:25,600 WHETHER RETAIN ABILITIES TO 2991 01:53:25,600 --> 01:53:27,640 ASSIGN DECISION MAKER, WHETHER 2992 01:53:27,640 --> 01:53:29,120 ALSO THEY ARE APPROPRIATE TO 2993 01:53:29,120 --> 01:53:32,440 MAKE DECISIONS ON BEHALF OF 2994 01:53:32,440 --> 01:53:33,960 INCAPACITATED PARTICIPANT. 2995 01:53:33,960 --> 01:53:35,160 HAVING SUCH A CONSULTATION 2996 01:53:35,160 --> 01:53:37,640 SERVICE THAT IS INDEPENDENT OF 2997 01:53:37,640 --> 01:53:38,720 RESEARCH PERSONNEL CAN BE USEFUL 2998 01:53:38,720 --> 01:53:41,440 BECAUSE IT IS LIKELY TO BE FREER 2999 01:53:41,440 --> 01:53:43,320 OF CONFLICTS OF INTEREST THAN 3000 01:53:43,320 --> 01:53:45,600 RESEARCH TEAM AND MAY THEREFORE 3001 01:53:45,600 --> 01:53:47,520 BE ABLE TO PROVIDE A MORE 3002 01:53:47,520 --> 01:53:49,280 OBJECTIVE ASSESSMENT BY VIRTUE 3003 01:53:49,280 --> 01:53:52,440 OF THEIR DISTANCE FROM THE 3004 01:53:52,440 --> 01:53:52,720 RESEARCH. 3005 01:53:52,720 --> 01:53:54,240 FURTHERMORE, SUCH CONSULTANTS 3006 01:53:54,240 --> 01:53:56,200 HAVE SPECIAL TRAINING AND 3007 01:53:56,200 --> 01:53:57,480 EXPERIENCE IN PERFORMING 3008 01:53:57,480 --> 01:53:58,400 CAPACITY ASSESSMENTS THAT 3009 01:53:58,400 --> 01:54:01,080 RESEARCH TEAMS ARE UNLIKELY TO 3010 01:54:01,080 --> 01:54:03,400 HAVE, SUCH A CONSULTATION 3011 01:54:03,400 --> 01:54:05,440 SERVICE CAN PLAY A CRUCIAL ROLE 3012 01:54:05,440 --> 01:54:07,120 IN CONDUCT OF ETHICALLY 3013 01:54:07,120 --> 01:54:08,360 RESPONSIBLE CLINICAL RESEARCH 3014 01:54:08,360 --> 01:54:13,320 AND SERVE AS AN IMPORTANT 3015 01:54:13,320 --> 01:54:14,320 PROTECTIVE FUNCTION BY KEEPING 3016 01:54:14,320 --> 01:54:22,680 INCAPACITATED ADULTS FROM BEING 3017 01:54:22,680 --> 01:54:24,400 INAPPROPRIATELY ENROLLED OR 3018 01:54:24,400 --> 01:54:24,800 EXCLUDED. 3019 01:54:24,800 --> 01:54:26,360 CAPACITY AND COMPETENCE ARE 3020 01:54:26,360 --> 01:54:29,120 TERMS THAT ARE OFTEN USED 3021 01:54:29,120 --> 01:54:29,920 INTERCHANGEABLY. 3022 01:54:29,920 --> 01:54:31,480 FOR OUR PURPOSES, CAPACITY 3023 01:54:31,480 --> 01:54:33,360 REFERS TO THE ONE-TIME CLINICAL 3024 01:54:33,360 --> 01:54:34,560 JUDGMENT OF A POTENTIAL 3025 01:54:34,560 --> 01:54:37,400 SUBJECT'S ABILITY TO GIVE 3026 01:54:37,400 --> 01:54:37,800 INFORMED CONSENT. 3027 01:54:37,800 --> 01:54:43,400 IN OTHER WORDS, IT'S A SNAPSHOT 3028 01:54:43,400 --> 01:54:44,640 ABOUT AN INDIVIDUAL'S ABILITY TO 3029 01:54:44,640 --> 01:54:46,920 MAKE A DECISION ABOUT A 3030 01:54:46,920 --> 01:54:47,600 PARTICULAR PROTOCOL. 3031 01:54:47,600 --> 01:54:49,480 IT IS POSSIBLE SOMEONE COULD 3032 01:54:49,480 --> 01:54:52,240 HAVE CAPACITY FOR ONE PROTOCOL 3033 01:54:52,240 --> 01:54:53,680 AND NOT ANOTHER. 3034 01:54:53,680 --> 01:54:55,480 FOR EXAMPLE, ONE COULD 3035 01:54:55,480 --> 01:54:57,920 ADEQUATELY UNDERSTAND AND MAKE A 3036 01:54:57,920 --> 01:55:00,200 DECISION ABOUT AN MRI STUDY 3037 01:55:00,200 --> 01:55:03,000 INVOLVING ONE VISIT FOR AN MRI 3038 01:55:03,000 --> 01:55:05,160 VERSUS A MORE COMPLICATED 3039 01:55:05,160 --> 01:55:07,480 LENGTHY DOUBLE BLIND PLACEBO 3040 01:55:07,480 --> 01:55:09,040 CONTROLLED STUDY WITH AN 3041 01:55:09,040 --> 01:55:09,840 INVESTIGATIONAL MEDICATION. 3042 01:55:09,840 --> 01:55:11,400 THE OUTCOMES OF THESE 3043 01:55:11,400 --> 01:55:13,400 ASSESSMENTS HAVE NO BEARING ON 3044 01:55:13,400 --> 01:55:15,080 AN INDIVIDUAL'S ABILITY TO MAKE 3045 01:55:15,080 --> 01:55:17,120 OTHER DECISIONS OR THEIR LEGAL 3046 01:55:17,120 --> 01:55:18,480 AUTHORITY TO MAKE DECISIONS. 3047 01:55:18,480 --> 01:55:20,280 FOR EXAMPLE, WHEN WE'RE 3048 01:55:20,280 --> 01:55:21,120 ASSESSING SOMEONE, WE'RE NOT 3049 01:55:21,120 --> 01:55:22,880 LOOKING AT WHETHER THEY CAN LIVE 3050 01:55:22,880 --> 01:55:25,920 INDEPENDENTLY OUTSIDE OF THE 3051 01:55:25,920 --> 01:55:26,720 CLINICAL CENTER. 3052 01:55:26,720 --> 01:55:27,720 WE'RE JUST LOOKING AT THE IDEA 3053 01:55:27,720 --> 01:55:28,720 OF THEIR UNDERSTANDING ABOUT THE 3054 01:55:28,720 --> 01:55:31,400 STUDY THEY ARE ABOUT TO 3055 01:55:31,400 --> 01:55:33,480 PARTICIPATE IN. 3056 01:55:33,480 --> 01:55:35,720 NEXT SLIDE PLEASE. 3057 01:55:35,720 --> 01:55:39,200 CAPACITY ASSESSMENTS MAY BE 3058 01:55:39,200 --> 01:55:41,920 INITIATED BY RESEARCHER REQUEST, 3059 01:55:41,920 --> 01:55:46,480 ORGANIZATIONAL POLICY, OR AN IRB 3060 01:55:46,480 --> 01:55:47,240 REQUIREMENT. 3061 01:55:47,240 --> 01:55:48,840 NEXT SLIDE PLEASE. 3062 01:55:48,840 --> 01:55:51,520 THE HSPU CREATES AND ADMINISTERS 3063 01:55:51,520 --> 01:55:54,920 TWO TYPES OF CAPACITY 3064 01:55:54,920 --> 01:55:56,880 ASSESSMENT. 3065 01:55:56,880 --> 01:55:58,080 FIRST, THE PROTOCOL-SPECIFIC 3066 01:55:58,080 --> 01:55:59,680 CAPACITY ASSESSMENT USED WHEN A 3067 01:55:59,680 --> 01:56:01,200 PROTOCOL ROUTINELY REQUIRES SOME 3068 01:56:01,200 --> 01:56:03,440 OR ALL POTENTIAL PARTICIPANTS TO 3069 01:56:03,440 --> 01:56:07,840 BE FORMALLY ASSESSED PRIOR TO 3070 01:56:07,840 --> 01:56:09,160 CONSENTING BECAUSE RESEARCH TEAM 3071 01:56:09,160 --> 01:56:12,800 AND IRB ANTICIPATE A HIGH 3072 01:56:12,800 --> 01:56:14,200 PROBABILITY OF CAPACITY TO 3073 01:56:14,200 --> 01:56:15,400 CONSENT AMONG THE STUDY 3074 01:56:15,400 --> 01:56:15,680 POPULATION. 3075 01:56:15,680 --> 01:56:18,600 IT'S CREATED IN ADVANCE OF 3076 01:56:18,600 --> 01:56:21,840 PARTICIPANTS AND EXPECTED 3077 01:56:21,840 --> 01:56:23,480 RESPONSES TO QUESTIONS HAVE BEEN 3078 01:56:23,480 --> 01:56:23,880 DEVELOPED. 3079 01:56:23,880 --> 01:56:24,800 GENERIC CAPACITY ASSESSMENT IS 3080 01:56:24,800 --> 01:56:27,280 USED AS GUIDE FOR ASSESSMENT OF 3081 01:56:27,280 --> 01:56:28,880 INDIVIDUALS WHO ARE BEING 3082 01:56:28,880 --> 01:56:30,800 CONSIDERED FOR ENROLLMENT IN A 3083 01:56:30,800 --> 01:56:34,320 PROTOCOL THAT NORMALLY DOES NOT 3084 01:56:34,320 --> 01:56:36,200 ENROLL COGNITIVELY IMPAIRED 3085 01:56:36,200 --> 01:56:36,760 INDIVIDUALS. 3086 01:56:36,760 --> 01:56:38,800 IT CONSISTS OF GENERIC QUESTIONS 3087 01:56:38,800 --> 01:56:40,800 AND RESPONDENT ANSWERS ARE 3088 01:56:40,800 --> 01:56:42,000 EXPECTED TO BE APPROPRIATE TO 3089 01:56:42,000 --> 01:56:43,840 PROTOCOL IN QUESTION. 3090 01:56:43,840 --> 01:56:45,880 EXAMPLES CAN BE FOUND AT THE 3091 01:56:45,880 --> 01:56:48,240 WEBSITE BELOW ON THIS SLIDE IN 3092 01:56:48,240 --> 01:56:50,200 THE NIMH TOOLKIT FOR HUMAN 3093 01:56:50,200 --> 01:56:51,000 SUBJECTS PROTECTIONS. 3094 01:56:51,000 --> 01:56:54,440 I WILL PUT A PLUG IN FOR THE 3095 01:56:54,440 --> 01:56:55,080 TOOLKIT. 3096 01:56:55,080 --> 01:56:55,960 IT IS EXTRAORDINARILY THOROUGH 3097 01:56:55,960 --> 01:56:58,680 AND IT WAS A COMBINED EFFORT 3098 01:56:58,680 --> 01:57:00,680 WITH MY COLLEAGUE KATIE TODDMAN 3099 01:57:00,680 --> 01:57:05,360 REALLY TAKING A LEAD ON THIS BUT 3100 01:57:05,360 --> 01:57:06,720 WORTH TAKING A LOOK. 3101 01:57:06,720 --> 01:57:10,320 >>WE ACTUALLY POSTED IT IN THE 3102 01:57:10,320 --> 01:57:11,480 COURSE. 3103 01:57:11,480 --> 01:57:11,760 >>GREAT. 3104 01:57:11,760 --> 01:57:11,960 GREAT. 3105 01:57:11,960 --> 01:57:14,120 NEXT SLIDE PLEASE. 3106 01:57:14,120 --> 01:57:15,720 CAPACITY ASSESSMENT TOOLS ARE 3107 01:57:15,720 --> 01:57:17,080 CLINICALLY DERIVED AND HAVEN'T 3108 01:57:17,080 --> 01:57:18,840 BEEN VALIDATED. 3109 01:57:18,840 --> 01:57:20,920 BOTH PROTOCOL SPECIFIC AND 3110 01:57:20,920 --> 01:57:22,320 GENERIC ASSESSMENT TOOLS ASSESS 3111 01:57:22,320 --> 01:57:24,480 THE FOUR DOMAINS THROUGH A 3112 01:57:24,480 --> 01:57:26,440 SERIES OF NINE TO ELEVEN 3113 01:57:26,440 --> 01:57:28,240 OPEN-ENDED QUESTIONS WHICH MAY 3114 01:57:28,240 --> 01:57:30,240 LEAD TO FURTHER FOLLOW-UP 3115 01:57:30,240 --> 01:57:34,840 QUESTIONS. 3116 01:57:34,840 --> 01:57:36,200 THE FIRST DOMAIN IS 3117 01:57:36,200 --> 01:57:36,520 UNDERSTANDING. 3118 01:57:36,520 --> 01:57:37,800 WHEN WE'RE LOOKING AT THAT, 3119 01:57:37,800 --> 01:57:39,120 WE'RE TRYING TO GET A BETTER 3120 01:57:39,120 --> 01:57:42,920 IDEA OF THE UNDERSTANDING OF THE 3121 01:57:42,920 --> 01:57:44,840 POTENTIAL PARTICIPANT'S PERSONAL 3122 01:57:44,840 --> 01:57:45,560 SITUATION. 3123 01:57:45,560 --> 01:57:47,120 SOME EXAMPLES OF QUESTIONS IN 3124 01:57:47,120 --> 01:57:49,520 THAT REGARD WOULD BE WHAT IS THE 3125 01:57:49,520 --> 01:57:50,560 ILLNESS OR MEDICAL CONCERN THAT 3126 01:57:50,560 --> 01:57:52,200 BRINGS YOU HERE TODAY? 3127 01:57:52,200 --> 01:57:54,720 WHAT DO YOU HAVE THAT THE 3128 01:57:54,720 --> 01:57:55,880 INVESTIGATORS ARE INTERESTED IN 3129 01:57:55,880 --> 01:57:56,640 UNDERSTANDING BETTER? 3130 01:57:56,640 --> 01:58:00,240 WE ALSO WANT TO KNOW THEIR 3131 01:58:00,240 --> 01:58:00,640 UNDERSTANDING ABOUT 3132 01:58:00,640 --> 01:58:01,760 STUDY-SPECIFIC PROCEDURES OR 3133 01:58:01,760 --> 01:58:02,040 TASKS. 3134 01:58:02,040 --> 01:58:03,840 A QUESTION WOULD BE WHAT WILL 3135 01:58:03,840 --> 01:58:06,720 YOU BE ASKED TO DO AS PART OF 3136 01:58:06,720 --> 01:58:07,200 THE STUDY? 3137 01:58:07,200 --> 01:58:10,280 WHAT ARE THE POTENTIAL RISKS AND 3138 01:58:10,280 --> 01:58:12,240 POTENTIAL BENEFITS OF EITHER THE 3139 01:58:12,240 --> 01:58:14,120 TASKS THEMSELVES OR THE OVERALL 3140 01:58:14,120 --> 01:58:14,360 STUDY. 3141 01:58:14,360 --> 01:58:16,360 A QUESTION FOR THAT WOULD BE 3142 01:58:16,360 --> 01:58:17,720 WHAT ARE THE MOST IMPORTANT 3143 01:58:17,720 --> 01:58:18,560 RISKS TO YOU? 3144 01:58:18,560 --> 01:58:20,360 HOW DO YOU FEEL ABOUT 3145 01:58:20,360 --> 01:58:21,120 PARTICIPATING IN RESEARCH THAT 3146 01:58:21,120 --> 01:58:22,680 IS DESIGNED TO HELP OTHERS IN 3147 01:58:22,680 --> 01:58:23,200 THE FUTURE? 3148 01:58:23,200 --> 01:58:25,680 WE HAVE SEVERAL OF THOSE STUDIES 3149 01:58:25,680 --> 01:58:26,960 IN MENTAL HEALTH WITH NO DIRECT 3150 01:58:26,960 --> 01:58:30,640 BENEFIT BUT IT REALLY IS ABOUT 3151 01:58:30,640 --> 01:58:31,560 ANSWERING THE LARGER QUESTION 3152 01:58:31,560 --> 01:58:33,080 AND HELPING THE FUTURE. 3153 01:58:33,080 --> 01:58:35,000 ALTERNATIVES, WHAT ARE THE 3154 01:58:35,000 --> 01:58:36,040 DIFFERENCES BETWEEN BEING IN 3155 01:58:36,040 --> 01:58:37,760 THIS RESEARCH AND OTHER 3156 01:58:37,760 --> 01:58:39,520 TREATMENT OPTIONS? 3157 01:58:39,520 --> 01:58:40,720 THE SECOND DOMAIN THEN IS 3158 01:58:40,720 --> 01:58:42,200 APPRECIATION, AND I SHOULD 3159 01:58:42,200 --> 01:58:43,480 MENTION THESE DOMAINS BUILD ONE 3160 01:58:43,480 --> 01:58:45,920 ON THE OTHER AS YOU'RE TALKING 3161 01:58:45,920 --> 01:58:46,800 AN INDIVIDUAL. 3162 01:58:46,800 --> 01:58:48,800 SO WE WANT TO KNOW THAT THE 3163 01:58:48,800 --> 01:58:50,800 PERSON CAN APPRECIATE THE 3164 01:58:50,800 --> 01:58:52,400 EFFECTS OF STUDY PARTICIPATION, 3165 01:58:52,400 --> 01:58:53,760 ON THEMSELVES. 3166 01:58:53,760 --> 01:58:56,600 FOR EXAMPLE, WE HAVE TO STOP ANY 3167 01:58:56,600 --> 01:58:58,760 CURRENT TREATMENT -- WILL YOU 3168 01:58:58,760 --> 01:58:59,760 HAVE TO STOP CURRENT TREATMENT 3169 01:58:59,760 --> 01:59:01,800 OR MEDICATION TO COME INTO THE 3170 01:59:01,800 --> 01:59:02,000 STUDY? 3171 01:59:02,000 --> 01:59:03,200 ONE THING WE ASK BECAUSE WE'VE 3172 01:59:03,200 --> 01:59:08,800 GOT A LENGTH ANY STUDY THAT 3173 01:59:08,800 --> 01:59:10,680 COULD LAST SEVERAL MONTHS, ARE 3174 01:59:10,680 --> 01:59:11,520 YOU GOING TO HAVE TO TAKE TIME 3175 01:59:11,520 --> 01:59:13,080 OFF FROM SCHOOL OR JOB IF YOU'RE 3176 01:59:13,080 --> 01:59:14,240 WORKING, DO YOU HAVE A PET, 3177 01:59:14,240 --> 01:59:16,840 SOMEBODY TO WATCH THEM, ARE YOU 3178 01:59:16,840 --> 01:59:17,480 TRAVELING FROM ANOTHER PART OF 3179 01:59:17,480 --> 01:59:19,680 THE COUNTRY IN ORDER TO GET 3180 01:59:19,680 --> 01:59:19,880 HERE? 3181 01:59:19,880 --> 01:59:22,200 SO, HOW IS THIS GOING TO AFFECT 3182 01:59:22,200 --> 01:59:25,720 YOU DIRECTLY BY BEING HERE? 3183 01:59:25,720 --> 01:59:28,160 ALSO WE WANT TO KNOW WHY THEY 3184 01:59:28,160 --> 01:59:35,200 WOULD WANT TO BE -- PART OF THE 3185 01:59:35,200 --> 01:59:36,200 NEXT DOMAIN IS REASONING. 3186 01:59:36,200 --> 01:59:40,240 WHAT WOULD BE THE REASON OR 3187 01:59:40,240 --> 01:59:41,400 RATIONALE WHY SOMEBODY WANTS TO 3188 01:59:41,400 --> 01:59:42,280 PARTICIPATE IN RESEARCH? 3189 01:59:42,280 --> 01:59:45,080 WE SAY WE'RE NOT THE MOTIVATION 3190 01:59:45,080 --> 01:59:46,080 POLICE. 3191 01:59:46,080 --> 01:59:47,120 POLICE HAVE DIFFERENT REASONS 3192 01:59:47,120 --> 01:59:51,080 AND RATIONALES FOR WHY THEY WANT 3193 01:59:51,080 --> 01:59:54,200 TO PARTICIPATE BUT WE WANT TO 3194 01:59:54,200 --> 01:59:57,360 KNOW WHAT THEY ARE THINKING. 3195 01:59:57,360 --> 01:59:58,800 ONE QUESTION WE MIGHT ASK WHY DO 3196 01:59:58,800 --> 02:00:02,240 YOU THINK PARTICIPATING IS THE 3197 02:00:02,240 --> 02:00:03,840 BETTER OPTION FOR YOU? 3198 02:00:03,840 --> 02:00:05,640 AGAIN, WHAT WE'RE LOOKING AT IS 3199 02:00:05,640 --> 02:00:07,120 WHETHER SOMEBODY IS THINKING, 3200 02:00:07,120 --> 02:00:08,400 FOR EXAMPLE, BASED ON 3201 02:00:08,400 --> 02:00:09,400 RISK/BENEFIT LEVEL IF THEY ARE 3202 02:00:09,400 --> 02:00:11,000 SAYING IF I COME INTO THIS STUDY 3203 02:00:11,000 --> 02:00:12,640 YOU'LL BE ABLE TO CURE ME. 3204 02:00:12,640 --> 02:00:16,440 WELL, IT MAY NOT BE A TREATMENT 3205 02:00:16,440 --> 02:00:16,680 STUDY. 3206 02:00:16,680 --> 02:00:18,480 IT MAY BE WILL HELPING THE 3207 02:00:18,480 --> 02:00:19,880 FUTURE, GATHERING INFORMATION. 3208 02:00:19,880 --> 02:00:21,600 SOMEONE'S RATIONALE FOR DOING 3209 02:00:21,600 --> 02:00:23,080 THAT MIGHT BE I KNOW IT'S NOT 3210 02:00:23,080 --> 02:00:24,720 GOING TO HELP ME DIRECTLY BUT I 3211 02:00:24,720 --> 02:00:26,440 WANT TO HELP THE FUTURE. 3212 02:00:26,440 --> 02:00:29,520 OR I MIGHT GET MORE INFORMATION 3213 02:00:29,520 --> 02:00:30,120 ABOUT MY OWN INDIVIDUAL 3214 02:00:30,120 --> 02:00:31,560 SITUATION THAT MIGHT HELP ME 3215 02:00:31,560 --> 02:00:33,320 MAKE BETTER CHOICES OR 3216 02:00:33,320 --> 02:00:33,840 DECISIONS. 3217 02:00:33,840 --> 02:00:34,960 I MIGHT BE EDUCATED AND LEARN 3218 02:00:34,960 --> 02:00:36,600 SOME THINGS THAT WILL HELP ME AS 3219 02:00:36,600 --> 02:00:37,560 I GO HE FORWARD. 3220 02:00:37,560 --> 02:00:40,240 THOSE ARE THE KINDS OF QUESTIONS 3221 02:00:40,240 --> 02:00:41,200 AND CONVERSATIONS THAT WE'RE 3222 02:00:41,200 --> 02:00:43,000 HAVING WITH FOLKS AT THAT POINT. 3223 02:00:43,000 --> 02:00:44,880 THE LAST DOMAIN IS CHOICE. 3224 02:00:44,880 --> 02:00:46,480 WHOSE DECISION IS IT TO ENROLL 3225 02:00:46,480 --> 02:00:47,600 IN THIS STUDY? 3226 02:00:47,600 --> 02:00:48,840 WHAT WOULD HAPPEN IF YOU DIDN'T? 3227 02:00:48,840 --> 02:00:50,840 ONE OF THE QUESTIONS WE ALWAYS 3228 02:00:50,840 --> 02:00:51,960 ASK INDIVIDUALS AT THIS POINT IS 3229 02:00:51,960 --> 02:00:56,240 LOU -- HOW WOULD YOU LET THE 3230 02:00:56,240 --> 02:00:57,800 RESEARCHERS KNOW IF YOU DECIDED 3231 02:00:57,800 --> 02:00:59,720 YOU DIDN'T WANT TO PARTICIPATE? 3232 02:00:59,720 --> 02:01:02,600 SOMETIMES WE'LL FIND FOLKS ARE 3233 02:01:02,600 --> 02:01:03,640 CONCERNED ABOUT NOT 3234 02:01:03,640 --> 02:01:05,680 PARTICIPATING, THEY ARE LETTING 3235 02:01:05,680 --> 02:01:07,480 SOMEBODY DOWN, WHETHER IT'S 3236 02:01:07,480 --> 02:01:08,360 PERHAPS A FAMILY MEMBER OR 3237 02:01:08,360 --> 02:01:09,280 RESEARCHERS THEMSELVES. 3238 02:01:09,280 --> 02:01:11,240 WE WANT PEOPLE TO THINK FROM THE 3239 02:01:11,240 --> 02:01:12,200 BEGINNING, YOU KNOW, RESEARCH 3240 02:01:12,200 --> 02:01:13,800 DOESN'T WORK FOR EVERYBODY. 3241 02:01:13,800 --> 02:01:15,720 THERE CAN BE A LOT OF DIFFERENT 3242 02:01:15,720 --> 02:01:16,880 REASONS SOMEBODY CAN'T 3243 02:01:16,880 --> 02:01:17,200 PARTICIPATE. 3244 02:01:17,200 --> 02:01:19,040 SO WE WANT THEM TO BE THINKING 3245 02:01:19,040 --> 02:01:20,200 HOW WOULD THEY TALK TO THE TEAM 3246 02:01:20,200 --> 02:01:21,760 ABOUT THIS. 3247 02:01:21,760 --> 02:01:23,400 WE WANT THEM TO FEEL COMFORTABLE 3248 02:01:23,400 --> 02:01:25,600 ENOUGH TO HAVE THAT 3249 02:01:25,600 --> 02:01:26,280 CONVERSATION. 3250 02:01:26,280 --> 02:01:28,280 THE THRESHOLDS ON SUFFICIENCY 3251 02:01:28,280 --> 02:01:30,440 FOR EACH OF THESE DOMAINS ARE 3252 02:01:30,440 --> 02:01:32,600 WITH RARE EXCEPTION BASED ON THE 3253 02:01:32,600 --> 02:01:35,240 JUDGMENTS BY TWO EVALUATORS WHO 3254 02:01:35,240 --> 02:01:37,760 MUST REACH AND AGREEMENT 3255 02:01:37,760 --> 02:01:39,080 REGARDING THEIR RECOMMENDATIONS, 3256 02:01:39,080 --> 02:01:41,280 EACH EVALUATOR RATES POTENTIAL 3257 02:01:41,280 --> 02:01:42,280 PARTICIPANT'S ANSWER TO 3258 02:01:42,280 --> 02:01:44,680 QUESTIONS PERTAINING TO THE FOUR 3259 02:01:44,680 --> 02:01:45,040 DOMAINS. 3260 02:01:45,040 --> 02:01:47,000 WE WANT TO SEE DO THEY 3261 02:01:47,000 --> 02:01:48,920 UNDERSTAND, DO THEY HAVE PARTIAL 3262 02:01:48,920 --> 02:01:51,520 UNDERSTANDING, ARE THEY NOT 3263 02:01:51,520 --> 02:01:53,120 UNDERSTANDING AT ALL WHAT THE 3264 02:01:53,120 --> 02:01:54,880 STUDY IS ABOUT? 3265 02:01:54,880 --> 02:02:01,800 AND TWO EVALUATORS MAKE OVERALL 3266 02:02:01,800 --> 02:02:02,960 ASSESSMENT MUCH INDIVIDUAL'S 3267 02:02:02,960 --> 02:02:03,440 CAPACITY FOR CONSENT. 3268 02:02:03,440 --> 02:02:04,200 NEXT SLIDE PLEASE. 3269 02:02:04,200 --> 02:02:07,360 THIS IS A PAGE FROM ONE OF OUR 3270 02:02:07,360 --> 02:02:09,880 CAPACITY ASSESSMENT TOOLS. 3271 02:02:09,880 --> 02:02:11,800 SO, THE NUMBERS FOLLOWING THE 3272 02:02:11,800 --> 02:02:13,000 QUESTIONS LIKE THE NUMBER 1 THAT 3273 02:02:13,000 --> 02:02:16,160 REFERS TO THE IDEA THAT SOMEONE 3274 02:02:16,160 --> 02:02:17,560 IS ABLE, THAT THEY ARE 3275 02:02:17,560 --> 02:02:18,240 UNDERSTANDING WHAT YOU'RE ASKING 3276 02:02:18,240 --> 02:02:22,000 AND ABLE TO UNDERSTAND THAT 3277 02:02:22,000 --> 02:02:23,400 QUESTION. 3278 02:02:23,400 --> 02:02:24,200 2, IT'S QUESTIONABLE ABILITY, 3279 02:02:24,200 --> 02:02:25,960 MAYBE THEY ARE GETTING PART BUT 3280 02:02:25,960 --> 02:02:27,240 NOT THE FULL UNDERSTANDING OF 3281 02:02:27,240 --> 02:02:28,520 WHAT YOU'RE ASKING THEM TO TALK 3282 02:02:28,520 --> 02:02:30,080 TO YOU ABOUT IN TERMS OF WHAT'S 3283 02:02:30,080 --> 02:02:31,480 INVOLVED IN THE STUDY. 3284 02:02:31,480 --> 02:02:34,760 OR 3, THEY ARE UNABLE TO 3285 02:02:34,760 --> 02:02:36,440 UNDERSTAND THAT PARTICULAR 3286 02:02:36,440 --> 02:02:36,760 QUESTION. 3287 02:02:36,760 --> 02:02:38,000 THEY ARE RATINGS, BUT THEY ARE 3288 02:02:38,000 --> 02:02:38,720 NOT A SCORE. 3289 02:02:38,720 --> 02:02:40,120 THEY ARE USED AS INDICATORS OF 3290 02:02:40,120 --> 02:02:42,560 AREAS OF CONCERN FOR RATERS TO 3291 02:02:42,560 --> 02:02:44,200 DISCUSS AFTER THE INTERVIEW IS 3292 02:02:44,200 --> 02:02:44,760 COMPLETE. 3293 02:02:44,760 --> 02:02:46,720 THE INTERVIEW MAY BE STOPPED IF 3294 02:02:46,720 --> 02:02:48,280 IT'S CLEAR THAT AN INDIVIDUAL 3295 02:02:48,280 --> 02:02:49,600 DOESN'T HAVE CAPACITY PRIOR TO 3296 02:02:49,600 --> 02:02:50,800 ALL THE QUESTIONS BEING 3297 02:02:50,800 --> 02:02:51,600 ADMINISTERED. 3298 02:02:51,600 --> 02:02:52,800 WE DON'T FEEL LIKE YOU HAVE TO 3299 02:02:52,800 --> 02:02:54,600 FORCE SOMEONE TO CONTINUE TO NOT 3300 02:02:54,600 --> 02:02:55,560 BE ABLE TO ANSWER QUESTIONS IF 3301 02:02:55,560 --> 02:02:59,600 IT'S CLEAR THAT THEY ARE NOT 3302 02:02:59,600 --> 02:02:59,960 UNDERSTANDING. 3303 02:02:59,960 --> 02:03:01,200 ONE IMPORTANT PIECE IS A 3304 02:03:01,200 --> 02:03:02,680 PARTICIPANT MUST BE EDUCATED 3305 02:03:02,680 --> 02:03:04,080 ABOUT THE STUDY BEFORE HAVING 3306 02:03:04,080 --> 02:03:07,920 THEIR CAPACITY TO CONSENT 3307 02:03:07,920 --> 02:03:08,920 ASSESSED. 3308 02:03:08,920 --> 02:03:11,680 US ASKING INDIVIDUALS QUESTIONS 3309 02:03:11,680 --> 02:03:13,720 ABOUT THE TASKS THEY WILL BE 3310 02:03:13,720 --> 02:03:14,920 ASKED TO DO IF SOMEONE HAS NOT 3311 02:03:14,920 --> 02:03:16,120 DISCUSSED AHEAD OF TIME IT'S NOT 3312 02:03:16,120 --> 02:03:19,480 FAIR TO ASK THAT QUESTION. 3313 02:03:19,480 --> 02:03:21,200 WE ENSURE THAT INVESTIGATORS HAD 3314 02:03:21,200 --> 02:03:25,080 AN OPPORTUNITY TO EDUCATE THE 3315 02:03:25,080 --> 02:03:26,120 INDIVIDUAL BEFORE THE ASSESSMENT 3316 02:03:26,120 --> 02:03:27,680 TAKES PLACE. 3317 02:03:27,680 --> 02:03:30,400 NEXT SLIDE PLEASE. 3318 02:03:30,400 --> 02:03:35,480 AGAIN, I GIVE ALL THANKS TO MY 3319 02:03:35,480 --> 02:03:37,920 CO-WORKERS KATHERINE TODDMAN WHO 3320 02:03:37,920 --> 02:03:40,280 DEVELOPED THIS ASSESSMENT 3321 02:03:40,280 --> 02:03:41,840 ALGORITHM TRYING TO DISTILL IT 3322 02:03:41,840 --> 02:03:43,840 DOWN SO IF AN INVESTIGATOR IS 3323 02:03:43,840 --> 02:03:45,320 TAKING IT LOOK IT WALKS THEM 3324 02:03:45,320 --> 02:03:47,600 THROUGH THE BEGINNINGS OF 3325 02:03:47,600 --> 02:03:50,320 EDUCATING A PARTICIPANT ABOUT 3326 02:03:50,320 --> 02:03:52,000 THE STUDY THEIR CAPACITY IS 3327 02:03:52,000 --> 02:03:53,360 BEING ASSESSED FOR THROUGH 3328 02:03:53,360 --> 02:03:55,800 ASSESSING THEIR CAPACITY AND 3329 02:03:55,800 --> 02:03:57,320 THEN ULTIMATELY AN OUTCOME. 3330 02:03:57,320 --> 02:04:01,600 THIS IS TO HELP WALK THEM 3331 02:04:01,600 --> 02:04:03,800 THROUGH THE PROCESS AHEAD OF 3332 02:04:03,800 --> 02:04:04,000 TIME. 3333 02:04:04,000 --> 02:04:10,480 NOW WE GO TO VIGNETTE 1. 3334 02:04:10,480 --> 02:04:12,280 THANK YOU. 3335 02:04:12,280 --> 02:04:13,480 INVESTIGATORS SUBMIT A PROTOCOL 3336 02:04:13,480 --> 02:04:18,360 TO THE IRB TO STUDY ADULTING 3337 02:04:18,360 --> 02:04:20,240 DIAGNOSED WITH SCHIZOPHRENIA 3338 02:04:20,240 --> 02:04:22,040 THROUGH IMAGING, PET AND MRI 3339 02:04:22,040 --> 02:04:27,080 SCANS, ON AND OFF ANTIPSYCHOTIC 3340 02:04:27,080 --> 02:04:27,720 MEDICATIONS. 3341 02:04:27,720 --> 02:04:31,080 THE PROTOCOL IS A DOUBLE BLIND 3342 02:04:31,080 --> 02:04:32,480 PLACEBO CONTROLLED CROSS-OVER 3343 02:04:32,480 --> 02:04:35,600 DESIGN, LASTS FOR 10 WEEKS, 3344 02:04:35,600 --> 02:04:37,560 REQUIRES AN INPATIENT STAY, IT 3345 02:04:37,560 --> 02:04:40,680 DOES NOT ALLOW PRN OR ADDITIONAL 3346 02:04:40,680 --> 02:04:41,840 MEDICATIONS, FOR EXAMPLE 3347 02:04:41,840 --> 02:04:42,600 ANTIDEPRESSANTS. 3348 02:04:42,600 --> 02:04:44,680 IT DOES NOT ALLOW FOR INDIVIDUAL 3349 02:04:44,680 --> 02:04:46,200 THERAPY DURING THIS STUDY. 3350 02:04:46,200 --> 02:04:48,280 THERE CAN BE GROUPS AND OTHER 3351 02:04:48,280 --> 02:04:50,640 ACTIVITIES OFFERED BUT NO 3352 02:04:50,640 --> 02:04:52,320 STRUCTURED INDIVIDUAL THERAPY. 3353 02:04:52,320 --> 02:04:55,000 IT PROVIDES STANDARD TREATMENT 3354 02:04:55,000 --> 02:04:56,840 AFTER STUDY PROCEDURES AND/OR 3355 02:04:56,840 --> 02:04:59,160 WHEN A PARTICIPANT HAPPENS TO 3356 02:04:59,160 --> 02:04:59,400 WITHDRAW. 3357 02:04:59,400 --> 02:05:01,480 THE IRB HAS DETERMINED THAT THE 3358 02:05:01,480 --> 02:05:03,960 PROTOCOL IS MORE THAN MINIMAL 3359 02:05:03,960 --> 02:05:06,320 RISK, HAS NO PROSPECT OF DIRECT 3360 02:05:06,320 --> 02:05:08,680 BENEFIT, DOES NOT ALLOW FOR 3361 02:05:08,680 --> 02:05:10,800 SURROGATE CONSENT, AND REQUIRES 3362 02:05:10,800 --> 02:05:18,360 AN INDEPENDENT CAPACITY 3363 02:05:18,360 --> 02:05:24,760 ASSESSMENT FOR ALL PARTICIPANTS. 3364 02:05:24,760 --> 02:05:29,640 >>SO, HERE IS THE PERSON WHO 3365 02:05:29,640 --> 02:05:31,480 WE'RE TALKING ABOUT. 3366 02:05:31,480 --> 02:05:36,120 THEY ARE 21 AND DIAGNOSED WITH 3367 02:05:36,120 --> 02:05:36,440 SCHIZOPHRENIA. 3368 02:05:36,440 --> 02:05:39,880 THEY ARE TREATMENT NAIVE, 3369 02:05:39,880 --> 02:05:41,200 CURRENTLY EXPERIENCING AUDITORY 3370 02:05:41,200 --> 02:05:43,600 HALLUCINATIONS AND ANXIETY. 3371 02:05:43,600 --> 02:05:44,440 DURING CAPACITY ASSESSMENT, 3372 02:05:44,440 --> 02:05:48,360 IMAGINE CAROL IS THERE DOING THE 3373 02:05:48,360 --> 02:05:50,000 CAPACITY ASSESSMENT. 3374 02:05:50,000 --> 02:05:51,960 M STATES SHE'S AT THE NIMH 3375 02:05:51,960 --> 02:05:53,520 BECAUSE SHE'S HEARING VOICES AND 3376 02:05:53,520 --> 02:05:55,760 THE DOCTORS WOULD LIKE TO TAKE 3377 02:05:55,760 --> 02:05:58,880 PICTURES OF HER BRAIN OFF AND ON 3378 02:05:58,880 --> 02:05:59,520 MEDICATIONS. 3379 02:05:59,520 --> 02:06:01,200 SHE'S WILLING TO STAY ON THE 3380 02:06:01,200 --> 02:06:03,040 INPATIENT UNIT BUT IS NOT ABLE 3381 02:06:03,040 --> 02:06:06,440 TO DISTINGUISH THAT THIS IS FOR 3382 02:06:06,440 --> 02:06:07,240 RESEARCH PURPOSES. 3383 02:06:07,240 --> 02:06:09,640 AND THAT OTHERWISE AN INPATIENT 3384 02:06:09,640 --> 02:06:12,440 STAY IS NOT CLINICAL INDICATED. 3385 02:06:12,440 --> 02:06:15,400 SHE IS NOT AWARE OF ALTERNATIVE 3386 02:06:15,400 --> 02:06:17,000 TREATMENTS AVAILABLE TO HER IN 3387 02:06:17,000 --> 02:06:19,520 THE COMMUNITY, AND THE ADVOCATE 3388 02:06:19,520 --> 02:06:20,600 DISCUSSES DIFFERENCE BETWEEN 3389 02:06:20,600 --> 02:06:24,160 RESEARCH AND CLINICAL CARE WITH 3390 02:06:24,160 --> 02:06:24,360 THEM. 3391 02:06:24,360 --> 02:06:26,080 M CONTINUES TO HAVE DIFFICULTY 3392 02:06:26,080 --> 02:06:26,880 APPRECIATING DIFFERENCE BETWEEN 3393 02:06:26,880 --> 02:06:29,960 THE TWO BUT IS WILLING TO 3394 02:06:29,960 --> 02:06:30,280 ENROLL. 3395 02:06:30,280 --> 02:06:32,920 HERE IS WHERE SLIDO COMES IN, 3396 02:06:32,920 --> 02:06:33,840 EVERYBODY. 3397 02:06:33,840 --> 02:06:35,560 THE QUESTION IS, DO YOU THINK 3398 02:06:35,560 --> 02:06:38,680 THAT M HAS THE CAPACITY TO 3399 02:06:38,680 --> 02:06:42,760 PROVIDE INFORMED CONSENT AT THIS 3400 02:06:42,760 --> 02:06:43,160 TIME? 3401 02:06:43,160 --> 02:06:44,040 SO, QUICK YES/NO. 3402 02:06:44,040 --> 02:06:45,560 LET US KNOW WHAT YOU THINK. 3403 02:06:45,560 --> 02:06:48,200 WE'LL TAKE IT FROM THERE. 3404 02:06:48,200 --> 02:06:51,160 WE'LL SEE HOW GOOD YOU ARE AT 3405 02:06:51,160 --> 02:06:54,320 BEING A CONSENT ASSESSOR. 3406 02:06:54,320 --> 02:06:57,120 SEND YOUR C.V.s, IF YOU ANSWER 3407 02:06:57,120 --> 02:06:58,480 CORRECTLY, WHICH WE'LL FIND OUT 3408 02:06:58,480 --> 02:06:59,800 IN A MOMENT. 3409 02:06:59,800 --> 02:07:01,200 SO WE'LL GIVE A COUPLE MINUTES 3410 02:07:01,200 --> 02:07:02,600 TO JOIN. 3411 02:07:02,600 --> 02:07:04,880 AND THEN WE'RE GOING TO SORT OF 3412 02:07:04,880 --> 02:07:07,760 TALK THROUGH THE THINGS TO 3413 02:07:07,760 --> 02:07:09,960 CONSIDER. 3414 02:07:09,960 --> 02:07:16,960 3415 02:07:16,960 --> 02:07:17,640 3416 02:07:17,640 --> 02:07:20,120 SO, TURNS OUT EVERYBODY, 3417 02:07:20,120 --> 02:07:20,800 EVERYBODY WHO RESPONDED, THINKS 3418 02:07:20,800 --> 02:07:22,880 SHE DOESN'T HAVE THE CAPACITY TO 3419 02:07:22,880 --> 02:07:25,080 PROVIDE CONSENT AT THIS TIME, 3420 02:07:25,080 --> 02:07:26,440 WHICH IS THE CORRECT ANSWER. 3421 02:07:26,440 --> 02:07:27,840 WE'RE GOING TO TALK ABOUT WHY 3422 02:07:27,840 --> 02:07:30,120 THAT'S THE CASE. 3423 02:07:30,120 --> 02:07:33,080 NEXT SLIDE, CONOR. 3424 02:07:33,080 --> 02:07:35,400 SO, WHY DON'T YOU START WITH THE 3425 02:07:35,400 --> 02:07:38,600 SORTS OF THINGS WE SHOULD BE 3426 02:07:38,600 --> 02:07:38,960 THINKING ABOUT. 3427 02:07:38,960 --> 02:07:40,800 >>THE POINTS TO CONSIDER WOULD 3428 02:07:40,800 --> 02:07:41,720 BE ALTERNATIVE STANDARD 3429 02:07:41,720 --> 02:07:43,640 TREATMENTS ARE AVAILABLE IN THE 3430 02:07:43,640 --> 02:07:43,960 COMMUNITY. 3431 02:07:43,960 --> 02:07:45,600 THAT'S REALLY IMPORTANT TO LET 3432 02:07:45,600 --> 02:07:46,760 SOMEONE KNOW THAT THEY HAVE A 3433 02:07:46,760 --> 02:07:50,280 CHOICE, THAT THIS IS NOT THE 3434 02:07:50,280 --> 02:07:51,840 ONLY AVAILABLE OPTION FOR THEM. 3435 02:07:51,840 --> 02:07:53,360 THEY CAN HELP WITH RESEARCH, 3436 02:07:53,360 --> 02:07:55,080 HELP THE FUTURE, BUT IN ORDER TO 3437 02:07:55,080 --> 02:07:56,320 GET TREATMENT THEY DO NOT HAVE 3438 02:07:56,320 --> 02:07:57,720 TO COME HERE TO PARTICIPATE IN 3439 02:07:57,720 --> 02:07:59,080 THE STUDY SO WE WOULD WANT TO 3440 02:07:59,080 --> 02:08:00,760 MAKE SURE THIS PERSON WAS VERY 3441 02:08:00,760 --> 02:08:01,720 AWARE OF THAT. 3442 02:08:01,720 --> 02:08:04,920 AND THAT LEADS US TO THINK ABOUT 3443 02:08:04,920 --> 02:08:05,840 THE THERAPEUTIC MISCONCEPTION, 3444 02:08:05,840 --> 02:08:07,640 ENSURING SHE WOULD KNOW THE 3445 02:08:07,640 --> 02:08:08,320 DIFFERENCE BETWEEN THAT. 3446 02:08:08,320 --> 02:08:11,320 THE LEVEL OF RISK AND DELAY OF 3447 02:08:11,320 --> 02:08:12,880 TREATMENT MAKING SURE SHE'S 3448 02:08:12,880 --> 02:08:18,080 AWARE, IN THIS CASE COMING OFF 3449 02:08:18,080 --> 02:08:19,160 OF HER MEDS, THEN DELAYING IN 3450 02:08:19,160 --> 02:08:20,760 HAVING TREATMENT OFFERED TO HER 3451 02:08:20,760 --> 02:08:22,800 DEPENDING ON LENGTH OF STUDY WE 3452 02:08:22,800 --> 02:08:24,560 DO HAVE ONE SIMILAR, IT COULD BE 3453 02:08:24,560 --> 02:08:28,000 SEVERAL MONTHS BEFORE THEY GO 3454 02:08:28,000 --> 02:08:29,680 BACK ON MEDICATION, HELPFUL TO 3455 02:08:29,680 --> 02:08:30,920 THEM FROM THE COMMUNITY. 3456 02:08:30,920 --> 02:08:32,520 THAT'S PART OF THE REASONING 3457 02:08:32,520 --> 02:08:33,240 PIECE, APPRECIATING HOW LONG 3458 02:08:33,240 --> 02:08:36,080 THEY ARE GOING TO BE OFF THEIR 3459 02:08:36,080 --> 02:08:37,360 MEDICATIONS, MAKING SURE SHE'S 3460 02:08:37,360 --> 02:08:39,280 CLEAR ABOUT THAT. 3461 02:08:39,280 --> 02:08:39,960 THERE'S NO DIRECT BENEFIT, 3462 02:08:39,960 --> 02:08:42,200 AGAIN, THIS IS ABOUT HELPING THE 3463 02:08:42,200 --> 02:08:42,560 FUTURE. 3464 02:08:42,560 --> 02:08:44,280 ONE OF THE THINGS THAT I 3465 02:08:44,280 --> 02:08:47,520 FREQUENTLY SAY IN THIS SORT OF 3466 02:08:47,520 --> 02:08:49,560 CAPACITY ASSESSMENT IS THAT 3467 02:08:49,560 --> 02:08:51,760 YOU'RE UNDERGOING SCANS, TALKED 3468 02:08:51,760 --> 02:08:54,000 ABOUT PET AND MRI, UNDERGOING A 3469 02:08:54,000 --> 02:08:55,360 PET OR MRI SCAN HELPS RESEARCH 3470 02:08:55,360 --> 02:08:57,600 IN THE FUTURE, IT'S NOT GROWING 3471 02:08:57,600 --> 02:08:58,880 TO TREAT YOUR SCHIZOPHRENIA. 3472 02:08:58,880 --> 02:09:00,880 YOU'RE HELPING SOMEONE ELSE, NOT 3473 02:09:00,880 --> 02:09:01,680 GETTING MEDICATION. 3474 02:09:01,680 --> 02:09:03,760 SO THAT SOMETIMES IS MAKING IT 3475 02:09:03,760 --> 02:09:07,440 CONCRETE LIKE THAT, IT CAN BE 3476 02:09:07,440 --> 02:09:09,240 HELPFUL TO INDIVIDUALS. 3477 02:09:09,240 --> 02:09:11,240 DIFFERENCE BETWEEN RESEARCH AND 3478 02:09:11,240 --> 02:09:13,480 CLINICAL CARE, THE THERAPEUTIC 3479 02:09:13,480 --> 02:09:14,480 MISCONCEPTION, SOME PEOPLE MAY 3480 02:09:14,480 --> 02:09:16,080 VERY WELL WANT TO COME HERE 3481 02:09:16,080 --> 02:09:17,280 FULLY UNDERSTANDING THEY ARE NOT 3482 02:09:17,280 --> 02:09:19,760 GOING TO GET ANY DIRECT BENEFIT 3483 02:09:19,760 --> 02:09:22,160 BUT THEY SAY I CAN GET MORE 3484 02:09:22,160 --> 02:09:24,320 INFORMATION ABOUT MY OWN 3485 02:09:24,320 --> 02:09:26,560 PERSONAL MEDICAL PROFILE FROM 3486 02:09:26,560 --> 02:09:28,560 PEOPLE THAT HAVE DONE THIS THAT 3487 02:09:28,560 --> 02:09:28,880 ARE EXPERT. 3488 02:09:28,880 --> 02:09:30,400 ONE OF THE QUESTIONS THAT I 3489 02:09:30,400 --> 02:09:32,320 WOULD ALSO BE TALKING WITH HER 3490 02:09:32,320 --> 02:09:35,520 ABOUT, WHY DOES SHE WANT TO DO 3491 02:09:35,520 --> 02:09:36,160 THIS? 3492 02:09:36,160 --> 02:09:37,680 FLESHING THAT OUT MORE, AND AT 3493 02:09:37,680 --> 02:09:39,680 THIS POINT ONE OF THE THINGS 3494 02:09:39,680 --> 02:09:42,520 THAT WOULD HAPPEN IS WE WOULD 3495 02:09:42,520 --> 02:09:44,120 SAY, YES, THAT SHE DOESN'T 3496 02:09:44,120 --> 02:09:45,240 POSSESS ENOUGH CAPACITY REALLY 3497 02:09:45,240 --> 02:09:47,040 TO GIVE HER OWN PERSONAL CONSENT 3498 02:09:47,040 --> 02:09:50,760 AND THEN IT WOULD BE A 3499 02:09:50,760 --> 02:09:51,600 CONVERSATION WITH THE 3500 02:09:51,600 --> 02:09:52,560 INVESTIGATOR AT THAT POINT, DO 3501 02:09:52,560 --> 02:09:54,720 YOU WANT TO PROVIDE MORE 3502 02:09:54,720 --> 02:09:56,320 EDUCATION FOR THIS INDIVIDUAL, 3503 02:09:56,320 --> 02:09:57,320 HELP THEM UNDERSTAND MORE ABOUT 3504 02:09:57,320 --> 02:09:58,080 THIS STUDY? 3505 02:09:58,080 --> 02:10:03,120 AND WE CERTAINLY HAVE SEEN THAT 3506 02:10:03,120 --> 02:10:04,120 HAPPEN SIGNIFICANTLY, ABSOLUTELY 3507 02:10:04,120 --> 02:10:06,240 HAVE SEEN, AGAIN, THIS 3508 02:10:06,240 --> 02:10:07,000 PARTICULAR STUDY, THESE FOLKS, 3509 02:10:07,000 --> 02:10:08,360 THIS INDIVIDUAL WOULD BE STAYING 3510 02:10:08,360 --> 02:10:09,640 ON THE INPATIENT UNIT SO THERE 3511 02:10:09,640 --> 02:10:12,240 WOULD BE A LOT OF TIME TO DO 3512 02:10:12,240 --> 02:10:13,240 MORE EDUCATION WITH THEM, 3513 02:10:13,240 --> 02:10:14,520 NURSING STAFF WOULD BE HELPFUL 3514 02:10:14,520 --> 02:10:15,480 WITH THAT. 3515 02:10:15,480 --> 02:10:17,720 WE WOULD NOT PERSONALLY DO THAT 3516 02:10:17,720 --> 02:10:19,480 KIND OF EDUCATION BECAUSE THAT 3517 02:10:19,480 --> 02:10:21,080 WOULD BE CONSIDERED A CONFLICT, 3518 02:10:21,080 --> 02:10:22,720 BUT THE NURSING STAFF WOULD DO A 3519 02:10:22,720 --> 02:10:24,280 VERY GOOD JOB. 3520 02:10:24,280 --> 02:10:25,920 WE CERTAINLY HAVE HAD MANY 3521 02:10:25,920 --> 02:10:27,480 PEOPLE WHERE THAT'S HAPPENED. 3522 02:10:27,480 --> 02:10:29,040 THEY JUST DID NOT HAVE ENOUGH 3523 02:10:29,040 --> 02:10:30,640 GOOD UNDERSTANDING FOR US TO 3524 02:10:30,640 --> 02:10:33,040 FEEL CONFIDENT THEY HAD CAPACITY 3525 02:10:33,040 --> 02:10:34,360 TO GIVE THEIR OWN CONSENT BUT 3526 02:10:34,360 --> 02:10:37,040 AFTER SEVERAL WEEKS OF FURTHER 3527 02:10:37,040 --> 02:10:38,480 EDUCATION, TALKING WITH THEM, BY 3528 02:10:38,480 --> 02:10:40,080 THAT POINT THEY HAD A MUCH 3529 02:10:40,080 --> 02:10:43,280 CLEARER AND BETTER UNDERSTANDING 3530 02:10:43,280 --> 02:10:45,000 AND CLEARLY HAD CAPACITY, IF 3531 02:10:45,000 --> 02:10:48,040 THEY WANTED TO DO IT AT THAT 3532 02:10:48,040 --> 02:10:48,920 POINT. 3533 02:10:48,920 --> 02:10:51,080 >>I'LL ADD THE BIOETHICS 3534 02:10:51,080 --> 02:10:52,640 FACULTY ALSO DULLS CAPACITY 3535 02:10:52,640 --> 02:10:54,360 ASSESSMENTS MORE LIKE THE 3536 02:10:54,360 --> 02:10:56,960 GENERIC ONES THAT CAROL 3537 02:10:56,960 --> 02:10:57,360 MENTIONED. 3538 02:10:57,360 --> 02:10:59,200 THE ONES THAT WE'RE TALKING 3539 02:10:59,200 --> 02:11:02,720 ABOUT NOW, THAT ARE OFTEN IN THE 3540 02:11:02,720 --> 02:11:05,120 RESPONSIBILITY OF NIMH, IT'S 3541 02:11:05,120 --> 02:11:06,360 LIKE EVERYBODY GETS THIS 3542 02:11:06,360 --> 02:11:06,680 ASSESSMENT. 3543 02:11:06,680 --> 02:11:08,520 ALL THE PATIENTS WHO MIGHT BE 3544 02:11:08,520 --> 02:11:10,760 ELIGIBLE FOR THAT TRIAL WOULD 3545 02:11:10,760 --> 02:11:15,320 HAVE THIS ASSESSMENT DONE. 3546 02:11:15,320 --> 02:11:18,600 ANOTHER-- THE RESEARCHERS KNOW 3547 02:11:18,600 --> 02:11:18,920 THAT, RIGHT? 3548 02:11:18,920 --> 02:11:22,240 LIKE THEY KNOW HSPU IS GOING TO 3549 02:11:22,240 --> 02:11:23,320 BE INVOLVED. 3550 02:11:23,320 --> 02:11:25,840 WHEN WE DO IT SOMETIMES IT'S 3551 02:11:25,840 --> 02:11:28,840 ALWAYS UP TO THE INVESTIGATOR TO 3552 02:11:28,840 --> 02:11:31,440 DECIDE WHETHER OR NOT A CAPACITY 3553 02:11:31,440 --> 02:11:34,800 ASSESSMENT IS NEEDED. 3554 02:11:34,800 --> 02:11:36,720 SO, FOR US, WHAT SOMETIMES 3555 02:11:36,720 --> 02:11:38,520 HAPPENS IS INVESTIGATOR WILL 3556 02:11:38,520 --> 02:11:42,520 CALL US, AND THEY WILL SAY, 3557 02:11:42,520 --> 02:11:44,200 SO-AND-SO IS COMING TO THE 3558 02:11:44,200 --> 02:11:46,680 CLINIC, WE'VE TALKED TO THEM ON 3559 02:11:46,680 --> 02:11:49,040 THE PHONE, AND WE'RE NOT SURE 3560 02:11:49,040 --> 02:11:50,360 ABOUT THEIR CAPACITY. 3561 02:11:50,360 --> 02:11:53,720 CAN YOU COME AND ASSESS THEIR 3562 02:11:53,720 --> 02:11:56,240 CAPACITY? 3563 02:11:56,240 --> 02:11:57,920 IF THEY CALLED AND SAID I KNOW 3564 02:11:57,920 --> 02:12:00,560 THEY WILL BE ABLE TO CONSENT, I 3565 02:12:00,560 --> 02:12:04,240 WOULD SAY, WELL, YOU DON'T NEED 3566 02:12:04,240 --> 02:12:07,120 US BECAUSE YOU MAKE THAT CALL. 3567 02:12:07,120 --> 02:12:08,920 YOU, THE INVESTIGATOR, HAVE THAT 3568 02:12:08,920 --> 02:12:10,280 RESPONSIBILITY. 3569 02:12:10,280 --> 02:12:11,440 IF YOU'RE UNSURE, WE'RE ALWAYS 3570 02:12:11,440 --> 02:12:11,920 AVAILABLE. 3571 02:12:11,920 --> 02:12:14,400 IF YOU'RE SURE THEY DON'T HAVE 3572 02:12:14,400 --> 02:12:17,160 THE CAPACITY, YOU DON'T NEED US 3573 02:12:17,160 --> 02:12:18,920 BECAUSE IF THAT'S CLEAR, THERE'S 3574 02:12:18,920 --> 02:12:22,280 REALLY NO ROLE FOR ASSESSING 3575 02:12:22,280 --> 02:12:23,760 CAPACITY. 3576 02:12:23,760 --> 02:12:25,240 SO, WE STRONGLY ENCOURAGE 3577 02:12:25,240 --> 02:12:27,200 INVESTIGATORS WHENEVER THERE'S A 3578 02:12:27,200 --> 02:12:29,520 QUESTION ABOUT THE CAPACITY THAT 3579 02:12:29,520 --> 02:12:32,120 WE ARE A RESOURCE, HSPU IS A 3580 02:12:32,120 --> 02:12:33,160 RESOURCE, AND THEY SHOULD FEEL 3581 02:12:33,160 --> 02:12:36,720 FREE TO REACH OUT TO US TO HELP 3582 02:12:36,720 --> 02:12:40,960 THEM WITH THAT ASSESSMENT. 3583 02:12:40,960 --> 02:12:43,360 AND THEN, YEAH, ANOTHER POSSIBLE 3584 02:12:43,360 --> 02:12:45,400 OUTCOME, I JUST WANTED TO PICK 3585 02:12:45,400 --> 02:12:48,160 UP ON, IS THAT WE SAY NO, I'M 3586 02:12:48,160 --> 02:12:51,600 SORRY, M, YOU CAN'T BE IN THE 3587 02:12:51,600 --> 02:12:52,160 STUDY. 3588 02:12:52,160 --> 02:12:52,360 RIGHT? 3589 02:12:52,360 --> 02:12:56,960 BECAUSE EVEN IF WE DID THAT 3590 02:12:56,960 --> 02:13:00,880 ADDITIONAL EDUCATION, SHE STILL 3591 02:13:00,880 --> 02:13:02,360 MAY NOT UNDERSTAND THESE KEY 3592 02:13:02,360 --> 02:13:03,720 POINTS, RIGHT? 3593 02:13:03,720 --> 02:13:06,800 AND SO SHE WOULD THEN BE TOLD 3594 02:13:06,800 --> 02:13:08,680 SHE'S NOT ELIGIBLE TO ENROLL 3595 02:13:08,680 --> 02:13:11,600 BECAUSE SHE CAN'T PROVIDE 3596 02:13:11,600 --> 02:13:13,960 INFORMED CONSENT. 3597 02:13:13,960 --> 02:13:15,560 THIS IS SOMETIMES TRICKY WHEN 3598 02:13:15,560 --> 02:13:18,320 SOMEONE MIGHT BE COMING HERE TO 3599 02:13:18,320 --> 02:13:19,960 THE CLINICAL CENTER BECAUSE IF 3600 02:13:19,960 --> 02:13:21,040 YOU ENROLL IN A CLINICAL TRIAL 3601 02:13:21,040 --> 02:13:23,360 HERE AT THE CLINICAL CENTER, 3602 02:13:23,360 --> 02:13:24,360 IT'S FREE. 3603 02:13:24,360 --> 02:13:28,600 YOUR CARE IS AT NO COST TO YOU. 3604 02:13:28,600 --> 02:13:31,200 SO, IN MY TIME, I'VE ONLY ONCE 3605 02:13:31,200 --> 02:13:33,480 HAD THE EXPERIENCE OF SOMEONE 3606 02:13:33,480 --> 02:13:35,880 BEING QUITE UPSET THAT THEY 3607 02:13:35,880 --> 02:13:39,120 WOULDN'T BE ABLE TO ENROLL 3608 02:13:39,120 --> 02:13:40,640 BECAUSE IN THIS CASE THE 3609 02:13:40,640 --> 02:13:43,360 PARTICULAR PATIENT DIDN'T HAVE 3610 02:13:43,360 --> 02:13:46,040 CAPACITY, THE PARTNER OF THE 3611 02:13:46,040 --> 02:13:48,200 PERSON WAS UPSET THAT THE PERSON 3612 02:13:48,200 --> 02:13:50,880 COULDN'T BE ENROLLED IN THE 3613 02:13:50,880 --> 02:13:52,200 STUDY BECAUSE THEY KNEW THAT IT 3614 02:13:52,200 --> 02:13:56,000 WOULD BE FREE HERE SO JUST A 3615 02:13:56,000 --> 02:13:57,720 LAYER OF COMPLICATION WHEN IN 3616 02:13:57,720 --> 02:13:59,760 THE UNITED STATES NOT EVERYBODY 3617 02:13:59,760 --> 02:14:02,080 HAS ACCESS TO HEALTH CARE AND 3618 02:14:02,080 --> 02:14:02,800 HEALTH INSURANCE. 3619 02:14:02,800 --> 02:14:04,160 >>ANOTHER POINT TOO, THAT'S 3620 02:14:04,160 --> 02:14:05,600 WHERE IT'S IMPORTANT TO KNOW 3621 02:14:05,600 --> 02:14:07,000 WHAT YOUR PROTOCOL ALLOWS. 3622 02:14:07,000 --> 02:14:09,040 THIS PARTICULAR PROTOCOL DID NOT 3623 02:14:09,040 --> 02:14:10,240 ALLOW FOR SURROGATE CONSENT. 3624 02:14:10,240 --> 02:14:13,280 YOU HAVE TO KNOW WHAT IS ALLOWED 3625 02:14:13,280 --> 02:14:15,400 WITHIN YOUR PROTOCOL, WHETHER 3626 02:14:15,400 --> 02:14:17,760 IT'S ALREADY BEEN PUT INTO THE 3627 02:14:17,760 --> 02:14:19,120 PROTOCOL, IT'S ALREADY BEEN 3628 02:14:19,120 --> 02:14:22,160 APPROVED BY THE IRB, OR 3629 02:14:22,160 --> 02:14:24,280 DEPENDING ON THE HIERARCHY OF 3630 02:14:24,280 --> 02:14:27,360 POTENTIAL SURROGATES WHAT THE 3631 02:14:27,360 --> 02:14:28,320 RISK/BENEFIT LEVEL IS, WHETHER 3632 02:14:28,320 --> 02:14:32,600 YOU WOULD BE ALLOWED TO HAVE A 3633 02:14:32,600 --> 02:14:32,920 SURROGATE. 3634 02:14:32,920 --> 02:14:36,680 THERE WOULD NOT BE AN OPTION 3635 02:14:36,680 --> 02:14:37,880 BEYOND THEM HAVING CAPACITY TO 3636 02:14:37,880 --> 02:14:38,680 GIVE THEIR CONSENT. 3637 02:14:38,680 --> 02:14:41,440 THEY COULD NOT STAY IN THAT 3638 02:14:41,440 --> 02:14:41,680 PROTOCOL. 3639 02:14:41,680 --> 02:14:43,320 >>WHY DON'T WE -- WE HAVE 3640 02:14:43,320 --> 02:14:44,160 PLENTY OF TIME. 3641 02:14:44,160 --> 02:14:48,200 WE HAVE LOTS OF FLEXIBILITY. 3642 02:14:48,200 --> 02:14:51,280 SO LET'S SAY THIS STUDY DID 3643 02:14:51,280 --> 02:14:52,000 ALLOW A SURROGATE. 3644 02:14:52,000 --> 02:14:55,480 WHAT WOULD BE THE NEXT STEP FOR 3645 02:14:55,480 --> 02:14:58,640 YOU IN HELPING THE RESEARCH TEAM 3646 02:14:58,640 --> 02:15:00,880 DECIDE WHETHER THAT CAN HAPPEN, 3647 02:15:00,880 --> 02:15:06,600 WHETHER THAT SURROGATE CAN BE 3648 02:15:06,600 --> 02:15:06,920 DESIGNATED. 3649 02:15:06,920 --> 02:15:08,720 >>WE HAVE TO TO SEE IF THE 3650 02:15:08,720 --> 02:15:15,040 PERSON HAS ALREADY SIGNED AN 3651 02:15:15,040 --> 02:15:18,680 ADVANCE DIRECTIVE OR A 3652 02:15:18,680 --> 02:15:19,360 GUARDIANSHIP OR SOMEONE WITH 3653 02:15:19,360 --> 02:15:19,680 THEM. 3654 02:15:19,680 --> 02:15:20,760 >>THEIR SPOUSE, FOR EXAMPLE. 3655 02:15:20,760 --> 02:15:22,040 >>FOR EXAMPLE THEY HAD BROUGHT 3656 02:15:22,040 --> 02:15:23,680 THE PAPERWORK WITH THEM FROM THE 3657 02:15:23,680 --> 02:15:25,560 OUTSIDE AND IT HAD BEEN 3658 02:15:25,560 --> 02:15:26,480 REVIEWED. 3659 02:15:26,480 --> 02:15:28,240 YES, THEY HAD SPECIFICALLY NAMED 3660 02:15:28,240 --> 02:15:30,160 THEIR SPOUSE, THEN WE WOULD MAKE 3661 02:15:30,160 --> 02:15:31,840 SURE THAT RESEARCH WAS COVERED 3662 02:15:31,840 --> 02:15:32,880 UNDER THAT AND THEN WE WOULD 3663 02:15:32,880 --> 02:15:35,160 WANT TO TALK WITH THE SURROGATE, 3664 02:15:35,160 --> 02:15:38,440 WITH THE SPOUSE, TO MAKE SURE 3665 02:15:38,440 --> 02:15:41,280 THAT -- WE'RE NOT DOING A 3666 02:15:41,280 --> 02:15:42,200 CAPACITY ASSESSMENT PER SE BUT 3667 02:15:42,200 --> 02:15:45,000 WE WANT TO MAKE SURE THEY KNOW 3668 02:15:45,000 --> 02:15:46,280 THEIR ROLE AND RESPONSIBILITIES 3669 02:15:46,280 --> 02:15:47,880 IN TERMS OF ADVOCATING AND 3670 02:15:47,880 --> 02:15:49,160 SPEAKING ON BEHALF OF THIS 3671 02:15:49,160 --> 02:15:50,280 PERSON. 3672 02:15:50,280 --> 02:15:54,240 ONE OF THE THINGS THAT WE TALK 3673 02:15:54,240 --> 02:15:56,480 TO THEM ABOUT WHAT IS YOUR 3674 02:15:56,480 --> 02:15:57,440 UNDERSTANDING OF TASKS AND 3675 02:15:57,440 --> 02:15:58,480 WHAT'S GOING TO HAPPEN, THIS IS 3676 02:15:58,480 --> 02:16:00,360 NOT A DIRECT BENEFIT TYPE OF 3677 02:16:00,360 --> 02:16:02,520 STUDY, BECAUSE THEY ARE 3678 02:16:02,520 --> 02:16:03,600 REPRESENTING THEIR WISHES WE 3679 02:16:03,600 --> 02:16:05,320 WANT TO MAKE SURE THEY KNOW THE 3680 02:16:05,320 --> 02:16:06,560 THRESHOLD FOR SAYING NO TO 3681 02:16:06,560 --> 02:16:07,760 THINGS. 3682 02:16:07,760 --> 02:16:09,200 WE WANT TO MAKE SURE THEY ARE 3683 02:16:09,200 --> 02:16:10,960 COMFORTABLE SPEAKING UP ON THE 3684 02:16:10,960 --> 02:16:11,360 PERSON'S BEHALF. 3685 02:16:11,360 --> 02:16:13,280 YOU KNOW THIS PERSON BETTER THAN 3686 02:16:13,280 --> 02:16:13,600 ANYONE. 3687 02:16:13,600 --> 02:16:15,440 THE TEAM IS GOING TO RELY ON YOU 3688 02:16:15,440 --> 02:16:17,640 TO SPEAK UP AND SAY, YOU KNOW, 3689 02:16:17,640 --> 02:16:21,040 FOR EXAMPLE LIKE AN MRI, THEY 3690 02:16:21,040 --> 02:16:22,320 ARE CLAUSTROPHOBIC, I NEED TO BE 3691 02:16:22,320 --> 02:16:23,560 CLOSE BY, NOT SURE THIS IS GOING 3692 02:16:23,560 --> 02:16:25,240 TO WORK, CAN WE PRACTICE, THOSE 3693 02:16:25,240 --> 02:16:27,160 SORTS OF THINGS, THEY ARE 3694 02:16:27,160 --> 02:16:27,880 ADVOCATING. 3695 02:16:27,880 --> 02:16:30,720 WE WANT TO MAKE SURE THEY ARE 3696 02:16:30,720 --> 02:16:31,440 COMFORTABLE SPEAKING ON THEIR 3697 02:16:31,440 --> 02:16:35,120 BEE BEHALF AND SPEAKING UP IF 3698 02:16:35,120 --> 02:16:36,360 SOMETHING NEEDS TO BE STOPPED AT 3699 02:16:36,360 --> 02:16:38,040 THAT POINT. 3700 02:16:38,040 --> 02:16:40,200 >>IN AN INPATIENT SETTING THAT 3701 02:16:40,200 --> 02:16:44,160 MAY MEAN BEING AVAILABLE BEFORE 3702 02:16:44,160 --> 02:16:47,480 PARTICULAR PROCEDURES, ON AN 3703 02:16:47,480 --> 02:16:48,240 OUTWAISHT -- IN AN OUTPATIENT 3704 02:16:48,240 --> 02:16:50,240 TRIAL YOU MAY BE RESPONSIBLE FOR 3705 02:16:50,240 --> 02:16:52,400 BRINGING THEM BACK AND FORTH TO 3706 02:16:52,400 --> 02:16:54,360 THE CLINIC OR KNOWING WHEN THEY 3707 02:16:54,360 --> 02:16:56,440 ARE NOT WILLING TO COME BACK AND 3708 02:16:56,440 --> 02:16:59,440 FORTH, SO I LIKE YOUR TERM OF 3709 02:16:59,440 --> 02:17:00,120 ADVOCATE. 3710 02:17:00,120 --> 02:17:06,240 THEY REALLY ARE THE ADVOCATE OF 3711 02:17:06,240 --> 02:17:07,000 THE SUBJECT. 3712 02:17:07,000 --> 02:17:08,560 >>IT DOESN'T END AT SIGNING THE 3713 02:17:08,560 --> 02:17:09,480 PAPER, THEY HAVE TO BE WILLING 3714 02:17:09,480 --> 02:17:11,520 TO BE WITH THEM TO ADVOCATE FOR 3715 02:17:11,520 --> 02:17:12,840 HOWEVER SHORT OR LONG THAT MAY 3716 02:17:12,840 --> 02:17:13,160 BE. 3717 02:17:13,160 --> 02:17:16,960 >>WHY DON'T WE GO TO THE NEXT 3718 02:17:16,960 --> 02:17:17,760 ONE, CONOR. 3719 02:17:17,760 --> 02:17:19,280 SO, HOW ABOUT YOU READ THIS 3720 02:17:19,280 --> 02:17:22,640 PART, I'LL READ THE NEXT PART. 3721 02:17:22,640 --> 02:17:22,920 >>OKAY. 3722 02:17:22,920 --> 02:17:23,560 INVESTIGATORS SUBMIT A PROTOCOL 3723 02:17:23,560 --> 02:17:28,280 TO THE IRB TO STUDY THE SIGNS, 3724 02:17:28,280 --> 02:17:31,040 SYMPTOMS, COURSE OF ALZHEIMER'S 3725 02:17:31,040 --> 02:17:32,360 DISEASE, A LONGITUDINAL NATURAL 3726 02:17:32,360 --> 02:17:33,720 HISTORY DESIGN INVOLVING PET 3727 02:17:33,720 --> 02:17:39,400 SCANS WITH INVESTIGATIONAL 3728 02:17:39,400 --> 02:17:41,240 LIGAND AND MEMORY ASSESSMENTS. 3729 02:17:41,240 --> 02:17:41,720 CURRENT TREATMENT AND 3730 02:17:41,720 --> 02:17:43,720 MEDICATIONS WILL NOT BE CHANGED. 3731 02:17:43,720 --> 02:17:45,120 STUDY REQUIRES TWO OUTPATIENT 3732 02:17:45,120 --> 02:17:47,840 VISITS A YEAR FOR FIVE YEARS. 3733 02:17:47,840 --> 02:17:50,360 THE IRB HAS DETERMINED THAT THE 3734 02:17:50,360 --> 02:17:52,840 PROTOCOL ONE IS MORE THE MINIMAL 3735 02:17:52,840 --> 02:17:56,200 RISK, HAS NO PROSPECT OF DIRECT 3736 02:17:56,200 --> 02:17:57,760 BENEFIT, ALLOWS FOR SURROGATE 3737 02:17:57,760 --> 02:17:59,440 CONSENT, AND REQUIRES AN 3738 02:17:59,440 --> 02:18:02,240 INDEPENDENT CAPACITY ASSESSMENT 3739 02:18:02,240 --> 02:18:04,920 AND IF NEEDED, ABILITY TO ASSIGN 3740 02:18:04,920 --> 02:18:06,560 SURROGATE ASSESSMENT AND 3741 02:18:06,560 --> 02:18:08,600 APPROPRIATENESS OF SURROGATE 3742 02:18:08,600 --> 02:18:08,880 ASSESSMENT. 3743 02:18:08,880 --> 02:18:09,920 >>HERE IS VIGNETTE 2. 3744 02:18:09,920 --> 02:18:12,800 NEXT SLIDE, CON HE WERE. 3745 02:18:12,800 --> 02:18:15,400 T IS A 70-YEAR-OLD DIAGNOSED 3746 02:18:15,400 --> 02:18:16,720 WITH ALZHEIMER'S, ELIGIBLE TO 3747 02:18:16,720 --> 02:18:18,720 ENROLL IN THE STUDY. 3748 02:18:18,720 --> 02:18:20,360 DURING THE CAPACITY ASSESSMENT, 3749 02:18:20,360 --> 02:18:22,480 HE STATES HE UNDERSTANDS THE 3750 02:18:22,480 --> 02:18:23,240 RESEARCHERS ARE STUDYING 3751 02:18:23,240 --> 02:18:25,920 DEMENTIA AND WILL ASK HIM TO 3752 02:18:25,920 --> 02:18:30,680 PARTICIPATE IN A PET SCAN WITH 3753 02:18:30,680 --> 02:18:33,280 AN EXPERIMENTAL LIGAND. 3754 02:18:33,280 --> 02:18:34,240 AND SOME MRIs AND 3755 02:18:34,240 --> 02:18:35,120 NEUROPSYCHOLOGICAL TESTING, HE 3756 02:18:35,120 --> 02:18:40,000 WILL BE RELYING ON HIS SPOUSE TO 3757 02:18:40,000 --> 02:18:43,280 GET HIM TO OUTPATIENT 3758 02:18:43,280 --> 02:18:45,400 APPOINTMENTS, STATES HE KNOWS 3759 02:18:45,400 --> 02:18:52,320 PARTICIPATING WILL NOT CURE HIS 3760 02:18:52,320 --> 02:18:54,040 DEMENTIA, CONCERN FOR CHILDREN'S 3761 02:18:54,040 --> 02:18:56,160 RISK OF INHERITING IT MOTIVATES 3762 02:18:56,160 --> 02:18:57,480 HIM TO CONTRIBUTE TO POSSIBLE 3763 02:18:57,480 --> 02:19:00,040 FUTURE TREATMENT FOR OTHERS. 3764 02:19:00,040 --> 02:19:02,920 THE QUESTION, ARM YOUR SLIDO, IS 3765 02:19:02,920 --> 02:19:06,440 DO YOU THINK T HAS THE CAPACITY 3766 02:19:06,440 --> 02:19:08,400 TO PROVIDE INFORMED CONSENT AT 3767 02:19:08,400 --> 02:19:10,240 THIS TIME? LET US KNOW WHAT YOU 3768 02:19:10,240 --> 02:19:12,640 THINK. 3769 02:19:12,640 --> 02:19:19,120 3770 02:19:19,120 --> 02:19:20,920 3771 02:19:20,920 --> 02:19:25,520 I THINK WE HAVE TO NEIGHBORING 3772 02:19:25,520 --> 02:19:27,160 -- MAKE THESE HARDER IN THE 3773 02:19:27,160 --> 02:19:28,160 FUTURE, CAROL. 3774 02:19:28,160 --> 02:19:33,080 WE HAVE DISSENT OR DIFFERENCE IN 3775 02:19:33,080 --> 02:19:35,000 OPINION. 3776 02:19:35,000 --> 02:19:38,120 WE'LL GIVE FOLKS A COUPLE MORE 3777 02:19:38,120 --> 02:19:39,160 MINUTES, OR ANOTHER MINUTE I 3778 02:19:39,160 --> 02:19:41,760 WOULD SAY. 3779 02:19:41,760 --> 02:19:49,200 3780 02:19:49,200 --> 02:19:50,400 OKAY, GREAT. 3781 02:19:50,400 --> 02:19:51,280 PRETTY OVERWHELMING PEOPLE SAID 3782 02:19:51,280 --> 02:19:56,680 YES BUT A FEW PEOPLE SAID NO. 3783 02:19:56,680 --> 02:19:58,440 THEY DIDN'T THINK HE HAS 3784 02:19:58,440 --> 02:20:02,160 CAPACITY TO MAKE THE INFORMED 3785 02:20:02,160 --> 02:20:03,560 CONSENT DECISION. 3786 02:20:03,560 --> 02:20:04,720 NEXT SLIDE, CONOR. 3787 02:20:04,720 --> 02:20:08,840 WHY DON'T YOU TALK ABOUT THE 3788 02:20:08,840 --> 02:20:10,720 POINTS TO CONSIDER. 3789 02:20:10,720 --> 02:20:12,000 >>DOESN'T INVOLVE CHANGE IN 3790 02:20:12,000 --> 02:20:13,040 CURRENT TREATMENT, I THINK 3791 02:20:13,040 --> 02:20:13,840 THAT'S REALLY HELPFUL. 3792 02:20:13,840 --> 02:20:19,800 THIS PERSON COULD COME AND 3793 02:20:19,800 --> 02:20:21,800 PARTICIPATE IN RESEARCH ABOUT 3794 02:20:21,800 --> 02:20:25,600 ALZHEIMER'S DISEASE, WOULD NOT 3795 02:20:25,600 --> 02:20:27,440 HAVE TO STOP ALZHEIMER'S DISEASE 3796 02:20:27,440 --> 02:20:29,400 MEDICATION OR BEHAVIORAL HEALTH 3797 02:20:29,400 --> 02:20:30,720 MEDICATIONS, BECAUSE THIS IS A 3798 02:20:30,720 --> 02:20:32,600 LONG STUDY, FIVE YEARS. 3799 02:20:32,600 --> 02:20:34,240 THAT'S REALLY HELPFUL THEY CAN 3800 02:20:34,240 --> 02:20:36,200 STAY ON. 3801 02:20:36,200 --> 02:20:37,480 IT APPEARED HE UNDERSTOOD THAT. 3802 02:20:37,480 --> 02:20:39,640 HOW FAR APART ARE THE RESEARCH 3803 02:20:39,640 --> 02:20:40,000 PROCEDURES? 3804 02:20:40,000 --> 02:20:41,440 IT'S A LONG TIME. 3805 02:20:41,440 --> 02:20:43,120 ONE OF THE THINGS THAT YOU HAVE 3806 02:20:43,120 --> 02:20:44,400 TO TAKE INTO CONSIDERATION IS 3807 02:20:44,400 --> 02:20:49,360 THE VERY NATURE OF THE DISEASE, 3808 02:20:49,360 --> 02:20:51,720 ALZHEIMER'S DISEASE, IT'S 3809 02:20:51,720 --> 02:20:53,240 DEMENTIA, IT'S PROGRESSIVE. 3810 02:20:53,240 --> 02:20:54,120 COGNITIVE ABILITIES ARE GOING TO 3811 02:20:54,120 --> 02:20:57,080 BE DETERIORATING OVER TIME. 3812 02:20:57,080 --> 02:20:58,680 WE KNOW THAT THERE ARE SOME 3813 02:20:58,680 --> 02:21:00,200 PROGRESSIONS ARE FASTER THAN 3814 02:21:00,200 --> 02:21:01,400 OTHERS, THERE'S DIFFERENT PHASES 3815 02:21:01,400 --> 02:21:02,840 AND STAGES OF THE DISEASE BUT 3816 02:21:02,840 --> 02:21:04,320 ONE OF THE THINGS RESEARCHERS 3817 02:21:04,320 --> 02:21:06,600 WANT TO TAKE INTO ACCOUNT IS 3818 02:21:06,600 --> 02:21:08,360 THIS PERSON HAS CAPACITY NOW, 3819 02:21:08,360 --> 02:21:12,240 PERHAPS WE WANT TO GO AHEAD AND 3820 02:21:12,240 --> 02:21:13,120 FORMALIZE AND ADVANCE DIRECTIVE 3821 02:21:13,120 --> 02:21:14,280 KNOWING THINGS WILL CHANGE IN 3822 02:21:14,280 --> 02:21:16,160 THE FUTURE AND THEY COULD DO 3823 02:21:16,160 --> 02:21:17,920 THIS WHILE THEY'VE GOT CAPACITY 3824 02:21:17,920 --> 02:21:19,840 TO GIVE CONSENT. 3825 02:21:19,840 --> 02:21:21,480 YOU CAN ASSESS THEM FOR ABILITY, 3826 02:21:21,480 --> 02:21:24,560 AT THAT POINT THE MERE FACT THEY 3827 02:21:24,560 --> 02:21:25,920 HAVE CAPACITY TO GIVE CONSENT 3828 02:21:25,920 --> 02:21:26,960 YOU COULD AUTOMATICALLY HAVE 3829 02:21:26,960 --> 02:21:30,280 THEM FILL OUT THE ADVANCE 3830 02:21:30,280 --> 02:21:31,880 DIRECTIVE, NAMING WHOEVER IT IS, 3831 02:21:31,880 --> 02:21:33,920 I ASSUME THEIR SPOUSE, NAMING 3832 02:21:33,920 --> 02:21:35,000 THEM SPECIFICALLY THAT GOES INTO 3833 02:21:35,000 --> 02:21:36,120 THE MEDICAL RECORD SO PEOPLE 3834 02:21:36,120 --> 02:21:37,520 WOULD HAVE THAT ON HAND. 3835 02:21:37,520 --> 02:21:40,320 THEY WOULDN'T HAVE TO GO THROUGH 3836 02:21:40,320 --> 02:21:41,960 THAT TYPE OF ASSESSMENT AGAIN IN 3837 02:21:41,960 --> 02:21:44,280 TERMS OF WHO COULD GIVE CONSENT 3838 02:21:44,280 --> 02:21:45,200 FOR THEM. 3839 02:21:45,200 --> 02:21:47,360 AND AGAIN WHAT IF HIS CAPACITY 3840 02:21:47,360 --> 02:21:47,800 CHANGES? 3841 02:21:47,800 --> 02:21:50,600 THEN AS HE COMES IN, EACH TIME, 3842 02:21:50,600 --> 02:21:54,640 WE HAD A STUDY LIKE THIS BEFORE 3843 02:21:54,640 --> 02:21:55,440 WITH ALZHEIMER'S FOLKS, THERE 3844 02:21:55,440 --> 02:21:57,480 WAS SIX MONTHS IN BETWEEN 3845 02:21:57,480 --> 02:21:58,480 DIFFERENT VISITS. 3846 02:21:58,480 --> 02:21:59,840 INVESTIGATOR WOULD HAVE US 3847 02:21:59,840 --> 02:22:01,720 ASSESS CAPACITY EVERY TIME AND 3848 02:22:01,720 --> 02:22:03,720 AT SOME POINT PEOPLE DID NOT 3849 02:22:03,720 --> 02:22:06,600 HAVE CAPACITY TO GIVE CONSENT 3850 02:22:06,600 --> 02:22:07,840 AND YOU WOULD ALREADY HAVE IT IN 3851 02:22:07,840 --> 02:22:09,960 PLACE FOR THE SPOUSE TO 3852 02:22:09,960 --> 02:22:12,720 OFFICIALLY BE ABLE TO GIVE 3853 02:22:12,720 --> 02:22:16,240 SURROGATE CONSENT. 3854 02:22:16,240 --> 02:22:19,600 >>I JUMPED THE GUN. 3855 02:22:19,600 --> 02:22:24,400 SO, JUST TO SORT OF HIGHLIGHT, 3856 02:22:24,400 --> 02:22:25,600 RIGHT? 3857 02:22:25,600 --> 02:22:28,320 THOSE KEY POINTS THAT THERE WERE 3858 02:22:28,320 --> 02:22:29,440 KEY POINTS, THAT T UNDERSTOOD 3859 02:22:29,440 --> 02:22:31,840 EVEN THOUGH HE HAS ALZHEIMER'S, 3860 02:22:31,840 --> 02:22:33,080 THAT M COULDN'T. 3861 02:22:33,080 --> 02:22:35,800 AND I JUST WANT TO POINT OUT 3862 02:22:35,800 --> 02:22:38,720 THAT IT MAY HAVE NOTHING TO DO 3863 02:22:38,720 --> 02:22:41,560 WITH THEIR DIAGNOSIS, THAT T 3864 02:22:41,560 --> 02:22:43,720 MIGHT BE EARLY IN HIS 3865 02:22:43,720 --> 02:22:48,040 ALZHEIMER'S, AND HAS THE SORT OF 3866 02:22:48,040 --> 02:22:49,760 MOMENTARY CLARITY OR NOT 3867 02:22:49,760 --> 02:22:53,000 MOMENTARY BUT LIKE LET'S SAY ON 3868 02:22:53,000 --> 02:22:56,200 THIS DAY, HE CLEARLY HAS 3869 02:22:56,200 --> 02:22:56,960 CAPACITY, CLEARLY UNDERSTANDS 3870 02:22:56,960 --> 02:22:59,960 WHAT'S BEING ASKED OF HIM. 3871 02:22:59,960 --> 02:23:03,680 AND IN THIS CASE THEN THAT HIS 3872 02:23:03,680 --> 02:23:05,040 SPOUSE, RIGHT, AND THE RESEARCH 3873 02:23:05,040 --> 02:23:08,240 TEAM WILL BE SORT OF, YOU KNOW, 3874 02:23:08,240 --> 02:23:10,840 KEEPING TRACK, KNOWING THAT HIS 3875 02:23:10,840 --> 02:23:11,760 ALZHEIMER'S MAY PROGRESS. 3876 02:23:11,760 --> 02:23:16,480 I STILL DON'T THINK WE KNOW HOW 3877 02:23:16,480 --> 02:23:17,920 DEMENTIA PROGRESSES IN EVERY 3878 02:23:17,920 --> 02:23:20,080 SINGLE PERSON, SO IT'S ALSO A 3879 02:23:20,080 --> 02:23:21,600 SORT OF REMINDER TO THE TEAM 3880 02:23:21,600 --> 02:23:22,640 THAT IT'S SOMETHING THAT THEY 3881 02:23:22,640 --> 02:23:27,680 ARE GOING TO BE MONITORING OVER 3882 02:23:27,680 --> 02:23:28,320 TIME. 3883 02:23:28,320 --> 02:23:29,880 TO PREPARE THE SPOUSE IN THIS 3884 02:23:29,880 --> 02:23:33,400 CASE THAT WE MAY NEED TO CALL ON 3885 02:23:33,400 --> 02:23:36,720 HIM OR HER TO PROVIDE. 3886 02:23:36,720 --> 02:23:38,160 >>WE HAD ONE SITUATION WHEN WE 3887 02:23:38,160 --> 02:23:40,200 WERE DOING ALZHEIMER'S WORK, 3888 02:23:40,200 --> 02:23:41,560 JUST AS A COUNTER TO THAT. 3889 02:23:41,560 --> 02:23:41,960 >>YEAH, PLEASE. 3890 02:23:41,960 --> 02:23:42,880 >>IT WAS A GENTLEMAN WHO 3891 02:23:42,880 --> 02:23:46,280 BROUGHT HIS WIFE IN. 3892 02:23:46,280 --> 02:23:49,600 SHE WAS MUCH MORE IMPAIRED, DID 3893 02:23:49,600 --> 02:23:50,600 NOT HAVE CAPACITY. 3894 02:23:50,600 --> 02:23:52,360 THEY DID ALLOW FOR SURROGATE 3895 02:23:52,360 --> 02:23:55,160 CONSENT BUT SHE DID NOT WANT TO 3896 02:23:55,160 --> 02:23:56,600 PARTICIPATE AND SHE DIDN'T 3897 02:23:56,600 --> 02:23:58,000 UNDERSTAND EXACTLY WHAT WAS 3898 02:23:58,000 --> 02:23:58,720 INVOLVED IN THIS STUDY, HOW LONG 3899 02:23:58,720 --> 02:24:01,920 IT WAS GOING TO BE, SHE KNEW SHE 3900 02:24:01,920 --> 02:24:04,200 WAS IMPAIRED BUT SHE WAS VERY 3901 02:24:04,200 --> 02:24:04,720 CLEAR. 3902 02:24:04,720 --> 02:24:05,080 SHE WAS AFRAID. 3903 02:24:05,080 --> 02:24:06,600 SHE DID NOT WANT TO DO IT. 3904 02:24:06,600 --> 02:24:07,760 IT WAS DIFFICULT BECAUSE THE 3905 02:24:07,760 --> 02:24:09,760 HUSBAND VERY MUCH WANTED HER TO 3906 02:24:09,760 --> 02:24:10,120 BE HERE. 3907 02:24:10,120 --> 02:24:11,840 IT WAS NOT FOR DIRECT BENEFIT 3908 02:24:11,840 --> 02:24:14,680 BUT I THINK WHAT HE WAS LOOKING 3909 02:24:14,680 --> 02:24:16,680 FOR WAS CLARIFICATION OF 3910 02:24:16,680 --> 02:24:17,480 DIAGNOSIS TO SOME DEGREE. 3911 02:24:17,480 --> 02:24:20,960 IT WAS A LONG CONVERSATION WITH 3912 02:24:20,960 --> 02:24:22,040 THE INVESTIGATOR, THE 3913 02:24:22,040 --> 02:24:23,480 INVESTIGATOR SAID WE CAN'T GO 3914 02:24:23,480 --> 02:24:24,960 FORWARD, EVEN THOUGH SHE DOESN'T 3915 02:24:24,960 --> 02:24:27,480 HAVE CAPACITY TO GIVE CONSENT 3916 02:24:27,480 --> 02:24:29,120 SHE'S MAKING IT CLEAR HER CHOICE 3917 02:24:29,120 --> 02:24:30,840 IS NO NOT PARTICIPATE. 3918 02:24:30,840 --> 02:24:31,520 SHE'S CLEARLY DISSENTING. 3919 02:24:31,520 --> 02:24:32,200 WE HONORED THAT. 3920 02:24:32,200 --> 02:24:33,720 IT WAS IMPORTANT AT THAT POINT 3921 02:24:33,720 --> 02:24:35,240 TO GIVE HIM SOME INFORMATION 3922 02:24:35,240 --> 02:24:38,080 WHERE HE COULD GO IN THE 3923 02:24:38,080 --> 02:24:40,040 COMMUNITY POTENTIALLY, DIFFERENT 3924 02:24:40,040 --> 02:24:40,680 SERVICES AND RESOURCES FOR WHAT 3925 02:24:40,680 --> 02:24:42,440 HE WAS LOOKING FOR. 3926 02:24:42,440 --> 02:24:45,000 >>AND THAT QUESTION CAME UP 3927 02:24:45,000 --> 02:24:48,120 EARLIER ABOUT, YOU KNOW, 3928 02:24:48,120 --> 02:24:49,640 RESPECTING DISSENT, RIGHT IN 3929 02:24:49,640 --> 02:24:49,800 THE. 3930 02:24:49,800 --> 02:24:50,320 >>ABSOLUTELY. 3931 02:24:50,320 --> 02:24:53,040 >>IN THIS CASE IT'S VERY CLEAR 3932 02:24:53,040 --> 02:24:54,520 THAT THE PERSON, DESPITE THE 3933 02:24:54,520 --> 02:24:57,320 OPTION OF HAVING A SURROGATE, IT 3934 02:24:57,320 --> 02:24:59,880 PUTS EVERYBODY IN A VERY 3935 02:24:59,880 --> 02:25:03,160 CHALLENGING POSITION, RIGHT? 3936 02:25:03,160 --> 02:25:05,840 YOU CAN'T SORT OF DISCOUNT HER 3937 02:25:05,840 --> 02:25:07,840 CLEAR SORT OF HEARTFELT IN THIS 3938 02:25:07,840 --> 02:25:13,320 CASE BECAUSE SHE WAS AFRAID 3939 02:25:13,320 --> 02:25:15,000 CHOICE OR CONSIDERATION. 3940 02:25:15,000 --> 02:25:17,520 I THINK WE'RE AT THE END. 3941 02:25:17,520 --> 02:25:18,640 YES, DISCUSSION. 3942 02:25:18,640 --> 02:25:22,120 SO, I DIDN'T KNOW -- GREAT. 3943 02:25:22,120 --> 02:25:23,880 KIKO HAS A QUESTION. 3944 02:25:23,880 --> 02:25:27,280 I'M THE LAST SPEAKER, JUST AS AN 3945 02:25:27,280 --> 02:25:27,920 FYI. 3946 02:25:27,920 --> 02:25:29,920 MY PRESENTATION IS RELATIVELY 3947 02:25:29,920 --> 02:25:30,520 BRIEF. 3948 02:25:30,520 --> 02:25:31,720 SO WE'LL TAKE THIS QUESTION AND 3949 02:25:31,720 --> 02:25:33,920 IF FOLKS OUT THERE IN THE 3950 02:25:33,920 --> 02:25:34,960 VIRTUAL LAND HAVE QUESTIONS, 3951 02:25:34,960 --> 02:25:37,040 FEEL FREE TO SEND THEM ALONG. 3952 02:25:37,040 --> 02:25:37,920 >>THANK YOU. 3953 02:25:37,920 --> 02:25:39,880 I HAVE TWO QUESTIONS. 3954 02:25:39,880 --> 02:25:44,400 SO FIRST ONE, DO YOU HEAR ME 3955 02:25:44,400 --> 02:25:44,600 OKAY? 3956 02:25:44,600 --> 02:25:47,600 THE FIRST QUESTION IS ABOUT THE 3957 02:25:47,600 --> 02:25:49,640 LAST CASE OF ALZHEIMER'S 3958 02:25:49,640 --> 02:25:51,240 DISEASE. 3959 02:25:51,240 --> 02:25:53,760 SO, I THINK TYPICAL SURROGATE 3960 02:25:53,760 --> 02:25:56,440 DECISION MAKERS ARE SPOUSE, AND 3961 02:25:56,440 --> 02:25:57,560 SPOUSE THEMSELVES ARE ABOUT THE 3962 02:25:57,560 --> 02:25:58,680 SAME AGE. 3963 02:25:58,680 --> 02:26:03,720 AND IT'S A LONG STUDY. 3964 02:26:03,720 --> 02:26:08,760 SO, IF YOU HAVE SOME EXPERIENCE, 3965 02:26:08,760 --> 02:26:12,160 I START TO WONDER ABOUT THE 3966 02:26:12,160 --> 02:26:13,720 SPOUSE'S CAPACITY, BECAUSE IT 3967 02:26:13,720 --> 02:26:14,640 GOES AROUND, AROUND. 3968 02:26:14,640 --> 02:26:15,760 SO THAT'S ONE QUESTION. 3969 02:26:15,760 --> 02:26:24,080 THE OTHER IS MORE FOR HOLLY THAT 3970 02:26:24,080 --> 02:26:27,520 REGULAR IRB CASE. 3971 02:26:27,520 --> 02:26:27,960 >>GENERIC. 3972 02:26:27,960 --> 02:26:29,800 >>GENERIC CONSULT. 3973 02:26:29,800 --> 02:26:32,880 YOU SAID IF RESEARCHERS ARE SURE 3974 02:26:32,880 --> 02:26:37,200 THAT NONE OF THIS POTENTIAL 3975 02:26:37,200 --> 02:26:37,760 PARTICIPANT COULD CONSENTV 3976 02:26:37,760 --> 02:26:40,160 CAPACITY, DON'T COME TO US, IF 3977 02:26:40,160 --> 02:26:41,560 YOU'RE SURE THEY CAN NOT, DON'T 3978 02:26:41,560 --> 02:26:44,200 COME TO US, JUST ONLY THE CASE 3979 02:26:44,200 --> 02:26:45,560 THAT YOU'RE NOT SURE, WE ARE 3980 02:26:45,560 --> 02:26:47,200 HERE FOR YOU. 3981 02:26:47,200 --> 02:26:53,160 BUT ISN'T IT A LITTLE BIT 3982 02:26:53,160 --> 02:26:55,440 RELYING ON THE VIRTUE OF THE 3983 02:26:55,440 --> 02:26:57,000 INVESTIGATORS. 3984 02:26:57,000 --> 02:26:57,240 >>YES. 3985 02:26:57,240 --> 02:26:58,560 >>BECAUSE INVESTIGATORS HAVE 3986 02:26:58,560 --> 02:27:00,680 INTEREST TO ENROLL. 3987 02:27:00,680 --> 02:27:06,280 AND THEN THEY WANT TO HAVE THE 3988 02:27:06,280 --> 02:27:07,360 STUDY PARTICIPANTS QUICKLY, A 3989 02:27:07,360 --> 02:27:09,120 LOT, AS MANY AS THEY WANT. 3990 02:27:09,120 --> 02:27:12,520 IS THERE ANY ISSUE THERE THAT 3991 02:27:12,520 --> 02:27:14,560 THERE'S NO THIRD PARTY 3992 02:27:14,560 --> 02:27:16,760 ASSESSMENT RELYING ON THE GOOD 3993 02:27:16,760 --> 02:27:18,960 PART OF THE INVESTIGATORS? 3994 02:27:18,960 --> 02:27:21,200 >>YEAH, SO I'LL START THERE. 3995 02:27:21,200 --> 02:27:26,120 IT'S A REALLY GREAT POINT, AND 3996 02:27:26,120 --> 02:27:28,280 WE SELDOM -- I CAN'T THINK OF 3997 02:27:28,280 --> 02:27:31,560 ANY SITUATION WHERE I HAVE SAID 3998 02:27:31,560 --> 02:27:34,600 DON'T -- I'M NOT COMING, RIGHT? 3999 02:27:34,600 --> 02:27:36,680 I ALWAYS ERR, IF A RESEARCHER 4000 02:27:36,680 --> 02:27:38,480 CALLS US THAT BASICALLY MEANS 4001 02:27:38,480 --> 02:27:41,520 THEY ARE NOT SURE, RIGHT, SO AND 4002 02:27:41,520 --> 02:27:45,400 THEN WE TALK THROUGH AND THEN 4003 02:27:45,400 --> 02:27:45,960 DETERMINE, RIGHT? 4004 02:27:45,960 --> 02:27:48,400 BUT THERE ARE, AS YOU SAY, THERE 4005 02:27:48,400 --> 02:27:50,200 ARE LOTS OF CASES WHERE THE 4006 02:27:50,200 --> 02:27:53,520 RESEARCHER MAY NOT BE PICKING UP 4007 02:27:53,520 --> 02:27:59,200 THAT PHONE. 4008 02:27:59,200 --> 02:28:02,240 IN MY EXPERIENCE, THE RESEARCH 4009 02:28:02,240 --> 02:28:04,160 ASSISTANTS OR RESEARCH 4010 02:28:04,160 --> 02:28:05,920 ASSOCIATES ARE THE MOST LIKELY 4011 02:28:05,920 --> 02:28:08,920 PERSON TO HAVE SORT OF HAD A 4012 02:28:08,920 --> 02:28:10,120 PERSONAL CONVERSATION WITH THE 4013 02:28:10,120 --> 02:28:13,080 PATIENT OR SOMETIMES WITH THE 4014 02:28:13,080 --> 02:28:15,360 SPOUSE AND THE PATIENT, AND THEY 4015 02:28:15,360 --> 02:28:17,680 TOO CAN CALL US AND/OR RECOMMEND 4016 02:28:17,680 --> 02:28:23,960 TO THE INVESTIGATOR TO CALL US. 4017 02:28:23,960 --> 02:28:28,680 SO, I'M NOT -- MAYBE I SHOULD 4018 02:28:28,680 --> 02:28:29,960 BE BUT I'M NOT CONCERNED ABOUT 4019 02:28:29,960 --> 02:28:32,680 THE ABILITY TO MAKE THE YES/NO 4020 02:28:32,680 --> 02:28:34,560 QUESTION AND I HOPE THEY SEE US 4021 02:28:34,560 --> 02:28:41,080 AS AN ASSET AND COME TO US. 4022 02:28:41,080 --> 02:28:42,160 THE ALTERNATIVE HSP MOD WHERE 4023 02:28:42,160 --> 02:28:45,680 WILL WE SAY EVERY PARTICIPANT 4024 02:28:45,680 --> 02:28:46,720 NEEDS A CAPACITY ASSESSMENT 4025 02:28:46,720 --> 02:28:48,920 AFTER THE RESEARCH IS EXPLAINED 4026 02:28:48,920 --> 02:28:52,640 TO THEM, AND WE WOULD HAVE TO BE 4027 02:28:52,640 --> 02:28:54,240 DOING THAT 24/7 WHICH WOULD BE 4028 02:28:54,240 --> 02:28:55,560 REALLY HARD TO DO. 4029 02:28:55,560 --> 02:28:57,880 BUT IT'S A REALLY GREAT POINT, 4030 02:28:57,880 --> 02:28:59,640 RIGHT? WE ARE RELYING ON THE 4031 02:28:59,640 --> 02:29:02,760 INVESTIGATORS AND THE STUDY TEAM 4032 02:29:02,760 --> 02:29:07,840 TO SAY THIS IS NOT CLEAR, WE 4033 02:29:07,840 --> 02:29:12,480 NEED TO CALL BIOETHICS. 4034 02:29:12,480 --> 02:29:12,800 >>TERMS. 4035 02:29:12,800 --> 02:29:14,720 OTHER POINT ABOUT THE 4036 02:29:14,720 --> 02:29:15,960 ALZHEIMER'S INDIVIDUAL, I WILL 4037 02:29:15,960 --> 02:29:19,280 SAY JUST AS AN ASIDE WE DO SEE 4038 02:29:19,280 --> 02:29:21,680 VARIOUS -- I SAW VARIOUS 4039 02:29:21,680 --> 02:29:24,960 SCENARIOS, I WORKED FOR THE 4040 02:29:24,960 --> 02:29:25,920 AGING INSTITUTE BEFORE I CAME TO 4041 02:29:25,920 --> 02:29:29,800 MENTAL HEALTH AND WAS INVOLVED 4042 02:29:29,800 --> 02:29:31,440 WITH ALZHEIMER'S THERE, ADULT 4043 02:29:31,440 --> 02:29:32,280 CHILDREN WOULD BRING A FAMILY 4044 02:29:32,280 --> 02:29:33,720 MEMBER IN, ALSO A SPOUSE. 4045 02:29:33,720 --> 02:29:35,560 ONE OF THE THINGS WE HAVE TALKED 4046 02:29:35,560 --> 02:29:39,720 ABOUT IS THE IDEA THAT UNLIKE 4047 02:29:39,720 --> 02:29:42,840 OTHER TYPES OF ILLNESSES SOMEONE 4048 02:29:42,840 --> 02:29:44,360 WITH ALZHEIMER'S DISEASE MOST 4049 02:29:44,360 --> 02:29:45,840 LIKELY HAD CAPACITY, MOST OF 4050 02:29:45,840 --> 02:29:46,760 THEIR LIFE. 4051 02:29:46,760 --> 02:29:47,720 >>YES. 4052 02:29:47,720 --> 02:29:48,920 >>SO A SPOUSE WHO WOULD HAVE 4053 02:29:48,920 --> 02:29:51,880 KNOWN THEM FOR A NUMBER OF YEARS 4054 02:29:51,880 --> 02:29:53,520 TYPICALLY, THEY WOULD HAVE SEEN 4055 02:29:53,520 --> 02:29:54,840 WHAT THEIR PREFERENCES WERE, 4056 02:29:54,840 --> 02:29:56,280 WHAT THEIR WISHES WERE ABOUT 4057 02:29:56,280 --> 02:29:58,280 THIS SORT OF THING, WOULD HAVE 4058 02:29:58,280 --> 02:29:59,040 POTENTIALLY HAD CONVERSATIONS 4059 02:29:59,040 --> 02:29:59,960 ABOUT IT. 4060 02:29:59,960 --> 02:30:01,960 THEY COULD REALLY FILL IN SOME 4061 02:30:01,960 --> 02:30:03,160 OF THAT INFORMATION FOR US. 4062 02:30:03,160 --> 02:30:05,120 WHAT WOULD THEY HAVE WANTED TO 4063 02:30:05,120 --> 02:30:07,200 DO, AS YOU'VE KNOWN THEM FOR THE 4064 02:30:07,200 --> 02:30:09,480 LAST 40 OR SO YEARS. 4065 02:30:09,480 --> 02:30:12,760 IN TERMS OF POTENTIAL SURROGATE, 4066 02:30:12,760 --> 02:30:13,960 HAVING CONCERNS ABOUT, YOU KNOW, 4067 02:30:13,960 --> 02:30:18,360 THEIR CAPACITY, I THINK WHAT 4068 02:30:18,360 --> 02:30:20,560 THAT WOULD CALL IN TO -- IT 4069 02:30:20,560 --> 02:30:22,000 WOULD HAVE US STOP, TAKE A 4070 02:30:22,000 --> 02:30:23,360 BREATH, START TALKING WITH THE 4071 02:30:23,360 --> 02:30:24,480 INVESTIGATOR BECAUSE IT COULD BE 4072 02:30:24,480 --> 02:30:25,840 SOMETHING WHERE THE INVESTIGATOR 4073 02:30:25,840 --> 02:30:28,680 BEFORE WE EVEN COME IN MIGHT BE 4074 02:30:28,680 --> 02:30:29,840 SAYING TO US, YOU KNOW, YOU'RE 4075 02:30:29,840 --> 02:30:32,120 GOING TO BE ASSESSING THIS 4076 02:30:32,120 --> 02:30:36,440 PERSON BUT I'VE GOT CONCERN 4077 02:30:36,440 --> 02:30:38,960 CLINICALLY THEY BE PICKING UP 4078 02:30:38,960 --> 02:30:40,600 THINGS WITH THE PERSON THAT 4079 02:30:40,600 --> 02:30:42,000 BROUGHT THEM ABOUT, WHAT ARE 4080 02:30:42,000 --> 02:30:43,880 THEY CONCERNED ABOUT, WE COULD 4081 02:30:43,880 --> 02:30:45,840 SIT DOWN AND DOING THE SURROGATE 4082 02:30:45,840 --> 02:30:47,840 ASSESSMENT AT THAT POINT IN TIME 4083 02:30:47,840 --> 02:30:50,000 WHILE IT'S NOT LIKE A FULL BLOWN 4084 02:30:50,000 --> 02:30:51,720 CAPACITY ASSESSMENT LIKE WHAT WE 4085 02:30:51,720 --> 02:30:53,920 DO WITH PARTICIPANT WE WOULD BE 4086 02:30:53,920 --> 02:30:55,160 ASKING THEM ABOUT WHAT'S YOUR 4087 02:30:55,160 --> 02:30:56,200 UNDERSTANDING ABOUT WHAT THIS 4088 02:30:56,200 --> 02:30:57,400 STUDY IS ABOUT. 4089 02:30:57,400 --> 02:30:58,600 WHAT ARE SOME THINGS THEY ARE 4090 02:30:58,600 --> 02:30:59,600 GOING TO ASK YOUR LOVED ONE, 4091 02:30:59,600 --> 02:31:00,920 YOUR PERSON TO DO THAT YOU'RE 4092 02:31:00,920 --> 02:31:01,800 GOING TO REPRESENT? 4093 02:31:01,800 --> 02:31:04,280 AND WE COULD HAVE THAT KIND OF 4094 02:31:04,280 --> 02:31:05,040 CONVERSATION WITH THEM. 4095 02:31:05,040 --> 02:31:06,360 I THINK THAT'S ONE OF THE 4096 02:31:06,360 --> 02:31:08,400 IMPORTANT THINGS IS EVEN THOUGH 4097 02:31:08,400 --> 02:31:11,160 WE'VE GOT THESE QUESTIONS HERE, 4098 02:31:11,160 --> 02:31:12,040 WE'RE WRITING DOWN ANSWERS, WE 4099 02:31:12,040 --> 02:31:16,400 DON'T WANT TO MAKE IT A CHECK A 4100 02:31:16,400 --> 02:31:17,080 CHECKLIST. 4101 02:31:17,080 --> 02:31:18,960 IT'S IMPORTANT TO FLOW AS A 4102 02:31:18,960 --> 02:31:19,360 CONVERSATION. 4103 02:31:19,360 --> 02:31:21,640 THE MORE COMFORTABLE SOMEBODY 4104 02:31:21,640 --> 02:31:23,920 IS, THAT'S HELPFUL TO US IN 4105 02:31:23,920 --> 02:31:27,960 GETTING MORE INFORMATION ABOUT 4106 02:31:27,960 --> 02:31:29,200 WHAT'S HAPPENING WITH THEM. 4107 02:31:29,200 --> 02:31:30,880 I'VE NOT COME ACROSS A SURROGATE 4108 02:31:30,880 --> 02:31:34,000 THAT DID NOT HAVE THAT ABILITY 4109 02:31:34,000 --> 02:31:35,200 IN AN ALZHEIMER'S STUDY. 4110 02:31:35,200 --> 02:31:37,320 THERE WAS ANOTHER ONE WITH 4111 02:31:37,320 --> 02:31:39,000 PEOPLE WITH PSYCHOTIC DISORDERS, 4112 02:31:39,000 --> 02:31:42,240 AND THERE WAS A PERSON THAT HAD 4113 02:31:42,240 --> 02:31:44,000 COME IN WITH PARTICIPANT, IT WAS 4114 02:31:44,000 --> 02:31:46,040 REALLY CLEAR THAT THAT PERSON 4115 02:31:46,040 --> 02:31:47,880 WAS NOT GOING TO SERVE WELL AS A 4116 02:31:47,880 --> 02:31:48,600 SURROGATE. 4117 02:31:48,600 --> 02:31:50,120 SO THAT WAS VERY, VERY CLEAR, 4118 02:31:50,120 --> 02:31:53,400 IT'S MORE KIND OF THE SUBTLE 4119 02:31:53,400 --> 02:31:54,360 DIFFERENCES TO MAKE SURE YOU 4120 02:31:54,360 --> 02:31:56,160 WERE AS CLEAR AS YOU COULD BE, 4121 02:31:56,160 --> 02:31:58,600 IF YOU WERE SAYING THIS PERSON 4122 02:31:58,600 --> 02:31:59,920 COULD NOT PROVIDE SURROGATE 4123 02:31:59,920 --> 02:32:03,920 CONSENT YOU WOULD HAVE TO 4124 02:32:03,920 --> 02:32:04,960 CLINICALLY MAKE SURE YOU WERE 4125 02:32:04,960 --> 02:32:05,960 VERY THOROUGH IN QUESTIONS YOU 4126 02:32:05,960 --> 02:32:07,960 WERE ASKING AND KIND OF 4127 02:32:07,960 --> 02:32:09,720 RESPONSES YOU WERE GETTING AND 4128 02:32:09,720 --> 02:32:12,440 EXPLAINING TO THAT PERSON IT 4129 02:32:12,440 --> 02:32:15,160 COULD BE IF THERE WERE CONCERNS 4130 02:32:15,160 --> 02:32:16,680 ABOUT THAT INDIVIDUAL, THERE MAY 4131 02:32:16,680 --> 02:32:19,160 BE AN ADULT CHILD THEY HAD OR 4132 02:32:19,160 --> 02:32:22,240 SOMEONE ELSE THE POTENTIAL 4133 02:32:22,240 --> 02:32:24,760 PARTICIPANT COULD ACTUALLY HAVE 4134 02:32:24,760 --> 02:32:26,600 THEM SERVE IN THAT STEAD 4135 02:32:26,600 --> 02:32:26,800 INSTEAD. 4136 02:32:26,800 --> 02:32:30,040 IT'S NOT A CLEAR BACK AND 4137 02:32:30,040 --> 02:32:31,400 WHITENS. 4138 02:32:31,400 --> 02:32:32,600 IT'S THAT GRAY AREA THAT'S 4139 02:32:32,600 --> 02:32:35,120 HARDER BECAUSE YOU HAVE TO ASK 4140 02:32:35,120 --> 02:32:36,720 QUESTIONS, GET FEEDBACK AND 4141 02:32:36,720 --> 02:32:42,400 SPEND TIME WITH IT AND HAVE 4142 02:32:42,400 --> 02:32:43,440 CONSULTATION WITH YOUR TEAM. 4143 02:32:43,440 --> 02:32:43,720 >>GREAT. 4144 02:32:43,720 --> 02:32:50,600 THANK YOU FOR JOINING US, CAROL. 4145 02:32:50,600 --> 02:32:53,840 >>THANK YOU. 4146 02:32:53,840 --> 02:32:56,080 >>I'M GOING TO FINISH WITH JUST 4147 02:32:56,080 --> 02:33:01,400 A COUPLE THOUGHTS ABOUT INFORMED 4148 02:33:01,400 --> 02:33:04,200 CONSENT, REALLY DRAWING OR WHAT 4149 02:33:04,200 --> 02:33:06,000 DR. GRADY ALREADY SHARED. 4150 02:33:06,000 --> 02:33:08,920 THANK YOU, CONOR. 4151 02:33:08,920 --> 02:33:11,040 SO, I'M CALLING THIS NUTS AND 4152 02:33:11,040 --> 02:33:14,080 BOLTS BECAUSE I REALLY JUST WANT 4153 02:33:14,080 --> 02:33:17,240 TO GIVE YOU A RESOURCE THAT YOU 4154 02:33:17,240 --> 02:33:20,200 CAN, YOU KNOW, TAKE AND HAVE IN 4155 02:33:20,200 --> 02:33:22,760 HAND WHEN THINKING ABOUT CONSENT 4156 02:33:22,760 --> 02:33:23,120 FORMS. 4157 02:33:23,120 --> 02:33:26,280 MY DISCLAIMER, YOU'VE ALL SEEN 4158 02:33:26,280 --> 02:33:26,920 THAT. 4159 02:33:26,920 --> 02:33:28,520 SO, QUICK, CONSENT IS A PROCESS, 4160 02:33:28,520 --> 02:33:29,800 NOT A FORM. 4161 02:33:29,800 --> 02:33:31,720 AND THE INFORMED CONSENT PROCESS 4162 02:33:31,720 --> 02:33:34,640 IS ONLY ONE OPPORTUNITY AMONG 4163 02:33:34,640 --> 02:33:38,800 MANY TO CONVEY RESPECT TO 4164 02:33:38,800 --> 02:33:39,640 POTENTIAL SUBJECTS. 4165 02:33:39,640 --> 02:33:43,280 KEEP THAT IN MIND. 4166 02:33:43,280 --> 02:33:44,720 WHAT I'M GOING TO DO, VERY 4167 02:33:44,720 --> 02:33:46,720 QUICKLY, YOU'LL HAVE THIS AS 4168 02:33:46,720 --> 02:33:49,240 SOMETHING YOU CAN PUT IN YOUR 4169 02:33:49,240 --> 02:33:50,400 POCKET, IT'S A POWERPOINT, SO 4170 02:33:50,400 --> 02:33:53,080 MAYBE NOT, BUT I'LL SEND IT AS A 4171 02:33:53,080 --> 02:33:53,720 DOCUMENT. 4172 02:33:53,720 --> 02:33:56,200 WE'LL TALK ABOUT FORM AND 4173 02:33:56,200 --> 02:33:56,960 UNDERSTANDING. 4174 02:33:56,960 --> 02:33:59,560 AND AS I SAID, DR. GRADY ALREADY 4175 02:33:59,560 --> 02:34:01,920 HIGHLIGHTED A NUMBER OF THESE 4176 02:34:01,920 --> 02:34:02,400 THINGS. 4177 02:34:02,400 --> 02:34:06,320 BUT THESE ARE REALLY KEY THINGS 4178 02:34:06,320 --> 02:34:07,720 THAT AS POTENTIAL INVESTIGATORS 4179 02:34:07,720 --> 02:34:09,840 AND STUDY TEAM MEMBERS SHOULD 4180 02:34:09,840 --> 02:34:12,240 KEEP IN MIND WHEN YOU ARE 4181 02:34:12,240 --> 02:34:15,040 DRAFTING YOUR CONSENT FORMS. 4182 02:34:15,040 --> 02:34:17,760 SO, SHORT SENTENCES. 4183 02:34:17,760 --> 02:34:18,560 SHORT WORDS. 4184 02:34:18,560 --> 02:34:20,720 SIMPLIFYING TEXT. 4185 02:34:20,720 --> 02:34:24,360 STATING THE MAIN IDEAS, ONE IDEA 4186 02:34:24,360 --> 02:34:25,920 PER PARAGRAPH, CLEARLY STATE THE 4187 02:34:25,920 --> 02:34:26,800 PURPOSE. 4188 02:34:26,800 --> 02:34:28,440 WHEN I SAT ON AN -- THIS WAS 4189 02:34:28,440 --> 02:34:31,840 MANY YEARS AGO, I WAS STILL AT 4190 02:34:31,840 --> 02:34:35,480 JOHNS HOPKINS, I SAT ON THE 4191 02:34:35,480 --> 02:34:38,840 NHGRI INTRAMURAL IRB HERE AT THE 4192 02:34:38,840 --> 02:34:40,360 CLINICAL CENTER, AND ONE OF THE 4193 02:34:40,360 --> 02:34:46,920 MEMBERS OF THE IRB WHO WAS AN 4194 02:34:46,920 --> 02:34:48,000 UNAFFILIATED MEMBER, SHE ON THE 4195 02:34:48,000 --> 02:34:49,880 SIDE OR AS PART OF HER LIFE DID 4196 02:34:49,880 --> 02:34:54,640 A LOT OF ADULT LITERACY 4197 02:34:54,640 --> 02:34:55,000 TRAINING. 4198 02:34:55,000 --> 02:34:56,520 WHEN WE HAD CONSENT FORMS SHE 4199 02:34:56,520 --> 02:34:59,640 WOULD TAKE THOSE FORMS TO HER 4200 02:34:59,640 --> 02:35:01,640 ADULT LITERACY CLIENTS AND HAVE 4201 02:35:01,640 --> 02:35:03,160 THEM CIRCLE ALL THE WORDS THEY 4202 02:35:03,160 --> 02:35:04,640 DIDN'T UNDERSTAND. 4203 02:35:04,640 --> 02:35:08,760 SHE WOULD BRING THAT FORM TO THE 4204 02:35:08,760 --> 02:35:10,000 IRB MEETING AND SAY THESE ARE 4205 02:35:10,000 --> 02:35:11,960 THE WORDS THAT MY STUDENTS DON'T 4206 02:35:11,960 --> 02:35:12,360 UNDERSTAND. 4207 02:35:12,360 --> 02:35:16,120 WE'VE GOT TO DO A BETTER JOB 4208 02:35:16,120 --> 02:35:19,000 EXPLAINING THESE PARTICULAR 4209 02:35:19,000 --> 02:35:19,240 ITEMS. 4210 02:35:19,240 --> 02:35:22,040 SO, PRESENT CLEAR SEQUENCE OF 4211 02:35:22,040 --> 02:35:22,280 EVENTS. 4212 02:35:22,280 --> 02:35:22,880 AVOID IRRELEVANT INFORMATION, 4213 02:35:22,880 --> 02:35:24,280 THIS IS REALLY IMPORTANT, RIGHT? 4214 02:35:24,280 --> 02:35:27,560 WE'VE TALKED ABOUT THE FACT THAT 4215 02:35:27,560 --> 02:35:30,720 THESE FORMS ARE 20 PAGES LONG. 4216 02:35:30,720 --> 02:35:32,600 DOES THE INFORMATION BELONG IN 4217 02:35:32,600 --> 02:35:36,040 THE CONSENT FORM? 4218 02:35:36,040 --> 02:35:38,840 AVOID LEGAL JARGON, TRY TO WRITE 4219 02:35:38,840 --> 02:35:40,760 IN A CONVERSATIONAL STYLE AND IN 4220 02:35:40,760 --> 02:35:43,240 ACTIVE VOICE. 4221 02:35:43,240 --> 02:35:45,600 AND AS CHRISTINE MENTIONED, I 4222 02:35:45,600 --> 02:35:48,040 WILL REITERATE, THERE IS NO 4223 02:35:48,040 --> 02:35:52,040 CLASS IN MEDICAL SCHOOL OR PhD 4224 02:35:52,040 --> 02:35:54,840 school for how to write a good 4225 02:35:54,840 --> 02:35:56,600 consent form. 4226 02:35:56,600 --> 02:35:58,800 AND SO, WE, THE ROYAL WE, ARE 4227 02:35:58,800 --> 02:36:00,080 ALL TRAINED TO WRITE ARTICLES 4228 02:36:00,080 --> 02:36:01,680 THAT WILL BE PUBLISHED IN THE 4229 02:36:01,680 --> 02:36:04,200 NEW ENGLAND JOURNAL OF MEDICINE. 4230 02:36:04,200 --> 02:36:06,920 THIS IS NOT THAT, RIGHT? 4231 02:36:06,920 --> 02:36:08,520 OFTEN I HAVE SEEN CONSENT FORMS 4232 02:36:08,520 --> 02:36:13,040 THAT ARE BASICALLY WRITTEN FOR 4233 02:36:13,040 --> 02:36:15,840 THE NEGM AUDIENCE, NOT THE 4234 02:36:15,840 --> 02:36:17,040 POTENTIAL SUBJECT COMING IN FOR 4235 02:36:17,040 --> 02:36:18,600 THE TRIAL. 4236 02:36:18,600 --> 02:36:19,880 BE CONSISTENT. 4237 02:36:19,880 --> 02:36:21,600 THIS IS ANOTHER THING, SO WHEN 4238 02:36:21,600 --> 02:36:24,160 WE ALL LEARNED TO WRITE WE'RE 4239 02:36:24,160 --> 02:36:27,400 ENCOURAGED TO USE DIFFERENT 4240 02:36:27,400 --> 02:36:29,320 WORDS TO CONVEY SIMILAR 4241 02:36:29,320 --> 02:36:30,040 SENTIMENTS OR TERMS. 4242 02:36:30,040 --> 02:36:32,960 THAT'S NOT A GOOD THING TO DO IN 4243 02:36:32,960 --> 02:36:33,800 A CONSENT FORM. 4244 02:36:33,800 --> 02:36:35,560 PICK A WORD AND STICK WITH IT. 4245 02:36:35,560 --> 02:36:37,440 USE THAT WORD TO DESCRIBE THE 4246 02:36:37,440 --> 02:36:39,280 THING YOU WANT TO CONVEY BECAUSE 4247 02:36:39,280 --> 02:36:44,080 IF YOU START USING OTHER WORDS 4248 02:36:44,080 --> 02:36:46,760 LIKE MEDICATION, THERAPEUTIC, 4249 02:36:46,760 --> 02:36:48,080 TREATMENT, DRUG, MEDICINE, WHEN 4250 02:36:48,080 --> 02:36:49,800 YOU'RE REFERRING EACH TIME TO 4251 02:36:49,800 --> 02:36:52,360 THE STUDY DRUG, THAT CAN BE VERY 4252 02:36:52,360 --> 02:36:54,920 CONFUSING TO THE SUBJECT. 4253 02:36:54,920 --> 02:36:57,520 THIS ONE, KNOW YOUR AUDIENCE, IS 4254 02:36:57,520 --> 02:37:00,200 A REALLY IMPORTANT ONE, RIGHT? 4255 02:37:00,200 --> 02:37:05,160 IF YOU'RE DOING A STUDY WHERE 4256 02:37:05,160 --> 02:37:06,800 YOU'RE ENROLLING MD/PHDs AT 4257 02:37:06,800 --> 02:37:07,720 THE CLINICAL CENTER MAYBE YOU 4258 02:37:07,720 --> 02:37:10,840 DON'T HAVE TO WORRY ABOUT WHAT 4259 02:37:10,840 --> 02:37:15,240 I'M TELLING US BECAUSE THEY READ 4260 02:37:15,240 --> 02:37:16,120 NEW ENGLAND JOURNAL OF MEDICINE, 4261 02:37:16,120 --> 02:37:19,520 THEY WILL UNDERSTAND WHAT YOU'RE 4262 02:37:19,520 --> 02:37:20,160 SAYING. 4263 02:37:20,160 --> 02:37:24,880 BUT IF YOUR GROUP OF SUBJECTS 4264 02:37:24,880 --> 02:37:29,640 ARE LIKELY TO NOT BE LITERATE IN 4265 02:37:29,640 --> 02:37:31,040 HEALTH AND/OR IN RESEARCH, IT'S 4266 02:37:31,040 --> 02:37:35,600 REALLY IMPORTANT TO TAKE MANY OF 4267 02:37:35,600 --> 02:37:36,280 THESE MESSAGES TO HEART. 4268 02:37:36,280 --> 02:37:37,960 AS I MENTIONED EARLIER, HAVE THE 4269 02:37:37,960 --> 02:37:39,560 FORMS REVIEWED BY A PATIENT. 4270 02:37:39,560 --> 02:37:41,880 IF YOU HAVE DRAFTED IT AND DON'T 4271 02:37:41,880 --> 02:37:45,560 KNOW IF IT'S GOING TO BE 4272 02:37:45,560 --> 02:37:46,360 UNDERSTANDABLE, YOU CAN ALWAYS 4273 02:37:46,360 --> 02:37:48,200 ASK SOMEONE LIKE THE PERSON 4274 02:37:48,200 --> 02:37:49,600 YOU'RE PLANNING TO RECRUIT OR 4275 02:37:49,600 --> 02:37:50,680 FAMILY MEMBER OR GRANDMOTHER. 4276 02:37:50,680 --> 02:37:52,280 THAT'S A FAMILY MEMBER. 4277 02:37:52,280 --> 02:37:55,400 BUT YOU COULD ASK SOMEONE TO 4278 02:37:55,400 --> 02:37:58,520 READ IT. 4279 02:37:58,520 --> 02:38:00,400 IN TERMS OF FORMAT, WHAT YOU 4280 02:38:00,400 --> 02:38:01,680 IMAGINE IN YOUR HEAD, THE 4281 02:38:01,680 --> 02:38:03,040 AVERAGE CONSENT FORM TO LOOK 4282 02:38:03,040 --> 02:38:05,840 LIKE, IS PROBABLY THE SAME AS 4283 02:38:05,840 --> 02:38:06,240 MINE. 4284 02:38:06,240 --> 02:38:09,080 A SINGLE PAGE, SINGLE SPACED, 4285 02:38:09,080 --> 02:38:11,560 LOTS OF WORDS. 4286 02:38:11,560 --> 02:38:14,440 AND WE KNOW FROM ADULT LEARNING 4287 02:38:14,440 --> 02:38:15,600 THOSE AREN'T CONDUCIVE TO 4288 02:38:15,600 --> 02:38:16,720 UNDERSTANDING. 4289 02:38:16,720 --> 02:38:20,600 SO WE WANT TO USE A READABLE 4290 02:38:20,600 --> 02:38:22,240 TYPE STYLE, MAYBE NOT "NEW YORK 4291 02:38:22,240 --> 02:38:27,400 TIMES," WHATEVER THAT ONE IS. 4292 02:38:27,400 --> 02:38:29,080 USE BIG LETTERS. 4293 02:38:29,080 --> 02:38:31,080 20 PAGES IS TOO LONG BUT IT 4294 02:38:31,080 --> 02:38:34,400 MIGHT BE PERFECTLY RIGHT IF 4295 02:38:34,400 --> 02:38:37,000 YOU'RE USING A BIG-SIZE TEXT SO 4296 02:38:37,000 --> 02:38:39,560 IT'S EASY TO READ, YOU'RE USING 4297 02:38:39,560 --> 02:38:42,320 A READABLE TYPE STYLE, USE UPPER 4298 02:38:42,320 --> 02:38:44,400 AND LOWER CASE. 4299 02:38:44,400 --> 02:38:45,680 IT CAN BE CONFUSING, SOMEONE 4300 02:38:45,680 --> 02:38:47,640 MIGHT THINK YOU'RE YELLING IF 4301 02:38:47,640 --> 02:38:53,000 IT'S IN ALL CAPS. 4302 02:38:53,000 --> 02:38:55,000 DOUBLE SPACE, SPACE BETWEEN 4303 02:38:55,000 --> 02:38:55,280 SECTIONS. 4304 02:38:55,280 --> 02:38:57,000 WE TALK ABOUT 20 PAGES IS TOO 4305 02:38:57,000 --> 02:39:07,560 MANY, 20 PAGES OF SINGLE-SPACE 4306 02:39:10,680 --> 02:39:12,640 NARRATIVE, GENERALLY THAT'S VERY 4307 02:39:12,640 --> 02:39:13,040 BAD. 4308 02:39:13,040 --> 02:39:15,760 YOU CAN DO SIMPLE THINGS TO 4309 02:39:15,760 --> 02:39:17,680 INCREASE READABILITY. 4310 02:39:17,680 --> 02:39:20,640 USING HEADERS, QUESTION/ANSWER 4311 02:39:20,640 --> 02:39:21,520 FORMAT. 4312 02:39:21,520 --> 02:39:24,040 USE LISTS, BOXES, TABLES, RIGHT? 4313 02:39:24,040 --> 02:39:25,920 WE ALL KNOW RDA, IF YOU LOOK AT 4314 02:39:25,920 --> 02:39:29,080 A BOX OF CEREAL, THERE'S THE RDA 4315 02:39:29,080 --> 02:39:30,160 MESSAGE ON THERE. 4316 02:39:30,160 --> 02:39:33,200 WE ALREADY KNOW PUTTING THINGS 4317 02:39:33,200 --> 02:39:35,880 IN BOXES LIKE THAT IS A GOOD WAY 4318 02:39:35,880 --> 02:39:37,600 TO CONVEY IMPORTANT INFORMATION. 4319 02:39:37,600 --> 02:39:40,240 SO WE CAN USE THOSE SORTS OF 4320 02:39:40,240 --> 02:39:43,680 THINGS AS EXAMPLES. 4321 02:39:43,680 --> 02:39:47,640 SO, AS DR. GRADY MENTIONED, 4322 02:39:47,640 --> 02:39:49,680 UNDERSTANDING IS IMPROVED SO 4323 02:39:49,680 --> 02:39:53,360 YOU'VE GOT THIS AWESOME FORM, 4324 02:39:53,360 --> 02:39:55,520 THE FORM I THINK, I'VE DECIDED 4325 02:39:55,520 --> 02:39:56,200 IT'S AWESOME. 4326 02:39:56,200 --> 02:39:59,000 WE KNOW THAT ONCE YOU HAVE THAT 4327 02:39:59,000 --> 02:40:01,680 FORM, THAT THE CONSENT FORM IS 4328 02:40:01,680 --> 02:40:04,200 JUST ONE PART. 4329 02:40:04,200 --> 02:40:05,880 AND WE KNOW THAT UNDERSTANDING 4330 02:40:05,880 --> 02:40:11,080 IS IMPROVED WHEN PATIENTS OR 4331 02:40:11,080 --> 02:40:12,520 SUBJECTS MUST VERBALIZE 4332 02:40:12,520 --> 02:40:13,040 INFORMATION. 4333 02:40:13,040 --> 02:40:16,240 DR. GRADY MENTIONED A 4334 02:40:16,240 --> 02:40:17,120 DISCUSSION, RIGHT? 4335 02:40:17,120 --> 02:40:18,440 IMAGINE, RIGHT, IT'S NOT ME 4336 02:40:18,440 --> 02:40:19,840 STANDING HERE TALKING AT YOU. 4337 02:40:19,840 --> 02:40:22,040 THIS ISN'T A DISCUSSION. 4338 02:40:22,040 --> 02:40:23,720 I'M LECTURING AT YOU. 4339 02:40:23,720 --> 02:40:26,160 A DISCUSSION HAS BACK AND FORTH, 4340 02:40:26,160 --> 02:40:26,880 RIGHT? 4341 02:40:26,880 --> 02:40:29,040 AND WE'LL GET TO HOW I THINK TO 4342 02:40:29,040 --> 02:40:31,840 ENCOURAGE THAT IN A MOMENT. 4343 02:40:31,840 --> 02:40:34,080 AND UNDERSTANDING IS IMPROVED BY 4344 02:40:34,080 --> 02:40:36,200 ADMINISTRATION QUIZZES AND 4345 02:40:36,200 --> 02:40:37,400 CORRECTING INACCURATE RESPONSES, 4346 02:40:37,400 --> 02:40:39,120 BUT YOU'RE BASICALLY TEACHING TO 4347 02:40:39,120 --> 02:40:40,640 THE TEST. 4348 02:40:40,640 --> 02:40:44,760 IF I GIVE YOU A 10-QUESTION 4349 02:40:44,760 --> 02:40:48,200 TRUE/FALSE QUIZ AND FIVE OF THEM 4350 02:40:48,200 --> 02:40:52,080 ARE TRUE, FIVE ARE FALSE, GET 4351 02:40:52,080 --> 02:40:53,600 THREE OR FOUR WRONG, IF I TEACH 4352 02:40:53,600 --> 02:40:56,400 TO THAT TEST AND GIVE YOU THE 4353 02:40:56,400 --> 02:40:58,440 SAME TEST HIGHLY LIKELY YOU'RE 4354 02:40:58,440 --> 02:41:00,360 GOING TO GET 100%. 4355 02:41:00,360 --> 02:41:00,800 RIGHT? 4356 02:41:00,800 --> 02:41:02,960 SO, I WOULD SAY, YES, IT MIGHT 4357 02:41:02,960 --> 02:41:05,520 BE IMPROVED BUT I'M NOT SURE I 4358 02:41:05,520 --> 02:41:07,440 LIKE THAT ARE TYPE MUCH 4359 02:41:07,440 --> 02:41:08,400 IMPROVEMENT BECAUSE I'M NOT 4360 02:41:08,400 --> 02:41:11,240 REALLY SURE HOW SUSTAINABLE THAT 4361 02:41:11,240 --> 02:41:11,680 IS. 4362 02:41:11,680 --> 02:41:14,120 IF I WAS THE KING OF THE WORLD, 4363 02:41:14,120 --> 02:41:17,960 QUEEN OF THE WORLD, HERE IS WHAT 4364 02:41:17,960 --> 02:41:23,120 I WANT ALL OF YOU TO DO. 4365 02:41:23,120 --> 02:41:24,240 YOU'VE GONE THROUGH THE CONSENT 4366 02:41:24,240 --> 02:41:24,560 FORM. 4367 02:41:24,560 --> 02:41:27,840 NOW YOU'RE GOING TO START A 4368 02:41:27,840 --> 02:41:30,400 CONVERSATION WITH THE POTENTIAL 4369 02:41:30,400 --> 02:41:30,640 SUBJECT. 4370 02:41:30,640 --> 02:41:31,560 FIRST, THESE ARE QUESTIONS YOU 4371 02:41:31,560 --> 02:41:32,200 COULD ASK. 4372 02:41:32,200 --> 02:41:34,200 OF COURSE YOU CAN CHANGE THEM IF 4373 02:41:34,200 --> 02:41:35,520 YOU WOULD LIKE BUT THESE ARE THE 4374 02:41:35,520 --> 02:41:37,720 ONES I THINK ARE REALLY 4375 02:41:37,720 --> 02:41:38,000 IMPORTANT. 4376 02:41:38,000 --> 02:41:39,120 IF YOU'RE GOING TO TELL A FRIEND 4377 02:41:39,120 --> 02:41:41,280 WHAT THE STUDY IS ABOUT, WHAT 4378 02:41:41,280 --> 02:41:42,840 WOULD YOU SAY? 4379 02:41:42,840 --> 02:41:45,960 AND IN ADVANCE, KNOW WHAT A GOOD 4380 02:41:45,960 --> 02:41:46,440 ANSWER IS. 4381 02:41:46,440 --> 02:41:47,640 RIGHT? 4382 02:41:47,640 --> 02:41:49,080 IF YOU DON'T DO THAT, YOU'RE 4383 02:41:49,080 --> 02:41:52,160 GOING TO BE LIKE, YEAH, THAT'S 4384 02:41:52,160 --> 02:41:53,520 CLOSE ENOUGH, NEXT QUESTION. 4385 02:41:53,520 --> 02:41:54,680 SO PREPARE. 4386 02:41:54,680 --> 02:41:56,640 MAYBE WITH YOUR STUDY TEAM. 4387 02:41:56,640 --> 02:41:59,400 WHAT DO WE THINK A GOOD ANSWER 4388 02:41:59,400 --> 02:42:01,080 TO THIS QUESTION IS? 4389 02:42:01,080 --> 02:42:02,280 AND IF THEY SAY SOMETHING THAT'S 4390 02:42:02,280 --> 02:42:05,680 NOT QUITE RIGHT YOU HAVE AN 4391 02:42:05,680 --> 02:42:06,880 OPPORTUNITY TO ENGAGE THEM IN 4392 02:42:06,880 --> 02:42:09,120 CONVERSATION ABOUT WHAT'S REALLY 4393 02:42:09,120 --> 02:42:10,640 GOING TO HAPPEN. 4394 02:42:10,640 --> 02:42:11,760 PROCEDURES, WHAT ARE MAIN THINGS 4395 02:42:11,760 --> 02:42:13,680 YOU'LL DO OR WILL HAPPEN TO YOU 4396 02:42:13,680 --> 02:42:15,720 WHILE YOU'RE IN THE STUDY. 4397 02:42:15,720 --> 02:42:18,680 IF RANDOMIZATION IS INVOLVED, A 4398 02:42:18,680 --> 02:42:19,400 COUPLE QUESTIONS ABOUT THAT. 4399 02:42:19,400 --> 02:42:20,760 WHAT ARE THE BAD THINGS THAT 4400 02:42:20,760 --> 02:42:21,440 MIGHT HAPPEN TO YOU? 4401 02:42:21,440 --> 02:42:25,040 WHAT ARE THE GOOD THINGS THAT 4402 02:42:25,040 --> 02:42:26,360 MIGHT HAPPEN TO YOU? 4403 02:42:26,360 --> 02:42:27,040 WHAT WILL HAPPEN IF YOU DECIDE 4404 02:42:27,040 --> 02:42:28,920 NOT TO BE IN THE STUDY ANYMORE. 4405 02:42:28,920 --> 02:42:30,640 WHAT HAPPENS IF YOU CHANGE YOUR 4406 02:42:30,640 --> 02:42:31,720 MIND, RIGHT? 4407 02:42:31,720 --> 02:42:34,600 AND YOU KNOW IN ADVANCE THAT THE 4408 02:42:34,600 --> 02:42:36,200 ANSWER TO THE LAST ONE ISN'T THE 4409 02:42:36,200 --> 02:42:39,280 DOCTOR IS GOING TO BE REALLY MAD 4410 02:42:39,280 --> 02:42:39,480 AT ME. 4411 02:42:39,480 --> 02:42:41,120 THE ANSWER IS, I CAN ALWAYS 4412 02:42:41,120 --> 02:42:42,520 CHANGE MY MIND. 4413 02:42:42,520 --> 02:42:46,440 I'LL LET YOU KNOW. 4414 02:42:46,440 --> 02:42:50,320 SO, PLEASE THINK ABOUT USING 4415 02:42:50,320 --> 02:42:52,280 THAT IN YOUR ENGAGEMENT AROUND 4416 02:42:52,280 --> 02:42:54,000 INFORMED CONSENT. 4417 02:42:54,000 --> 02:42:56,200 AND I'M JUST ENDING WHERE I 4418 02:42:56,200 --> 02:42:59,040 STARTED, CONSENT IS A PROCESS, 4419 02:42:59,040 --> 02:42:59,680 NOT A FORM. 4420 02:42:59,680 --> 02:43:02,160 A REMINDER THAT IT'S NOT THE 4421 02:43:02,160 --> 02:43:04,840 ONLY WAY TO CONVEY RESPECT TO 4422 02:43:04,840 --> 02:43:05,960 YOUR SUBJECTS. 4423 02:43:05,960 --> 02:43:07,840 IT'S ONE OF THE FIRST WAYS. 4424 02:43:07,840 --> 02:43:10,840 BUT YOU SHOULD BE RESPECTFUL IN 4425 02:43:10,840 --> 02:43:12,480 YOUR RECRUITMENT, RESPECTFUL IN 4426 02:43:12,480 --> 02:43:15,920 HOW YOU REACH OUT TO REMIND THEM 4427 02:43:15,920 --> 02:43:16,960 OF FOLLOW-UP APPOINTMENTS, 4428 02:43:16,960 --> 02:43:18,280 GIVING THEM THE RESULTS OF THE 4429 02:43:18,280 --> 02:43:22,360 STUDY IN THE LONG RUN. 4430 02:43:22,360 --> 02:43:24,080 SO, I'VE EXHAUSTED OUR TIME 4431 02:43:24,080 --> 02:43:25,080 TOGETHER TODAY. 4432 02:43:25,080 --> 02:43:28,440 I HOPE YOU'RE LEAVING WITH A LOT 4433 02:43:28,440 --> 02:43:30,400 MORE INFORMATION IN YOUR BRAINS 4434 02:43:30,400 --> 02:43:32,280 AROUND INFORMED CONSENT. 4435 02:43:32,280 --> 02:43:35,800 AND WE WILL RETURN NEXT WEEK 4436 02:43:35,800 --> 02:43:37,160 WHERE OUR TOPIC IS GENETICS, AND 4437 02:43:37,160 --> 02:43:46,080 WE WILL HAVE THREE GUESTS, LEILA 4438 02:43:46,080 --> 02:43:49,120 JAMAL, BEN BERKMAN, AND KATRINA 4439 02:43:49,120 --> 02:43:50,920 CLAW, UNIVERSITY OF COLORADO AND 4440 02:43:50,920 --> 02:43:52,680 MEMBER OF THE NAVAJO TRIBE WHO 4441 02:43:52,680 --> 02:43:56,120 WILL TALK ABOUT ENROLLMENT OF 4442 02:43:56,120 --> 02:43:58,440 NATIVE POPULATIONS IN RESEARCH, 4443 02:43:58,440 --> 02:44:00,000 GENETICS RESEARCH IN PARTICULAR. 4444 02:44:00,000 --> 02:44:01,880 THANK YOU ALL. 4445 02:44:01,880 --> 00:00:00,000 THAT'S IT FOR TODAY.