1 00:00:13,113 --> 00:00:15,916 So to start with it as a basic idea. 2 00:00:15,916 --> 00:00:18,478 Consent is something that's very familiar 3 00:00:18,478 --> 00:00:19,353 to all of us. 4 00:00:19,353 --> 00:00:22,389 It's a moral and legal protection 5 00:00:22,890 --> 00:00:25,443 from unauthorized invasions of one's body 6 00:00:25,443 --> 00:00:26,627 or one's property. 7 00:00:27,094 --> 00:00:29,612 And it has a very strong facilitative 8 00:00:29,612 --> 00:00:30,497 moral power. 9 00:00:30,697 --> 00:00:31,231 In other words, 10 00:00:31,231 --> 00:00:33,714 it makes things permissible that otherwise would not be 11 00:00:33,714 --> 00:00:34,301 permissible. 12 00:00:34,735 --> 00:00:37,037 So, for example, 13 00:00:37,037 --> 00:00:38,372 I could borrow your car. 14 00:00:38,372 --> 00:00:39,973 I can agree to have sex with you. 15 00:00:39,973 --> 00:00:41,642 I can have my blood drawn. 16 00:00:41,642 --> 00:00:43,911 If I give consent, all of those things 17 00:00:43,911 --> 00:00:45,045 without my consent 18 00:00:45,412 --> 00:00:49,016 would be robbery, rape, 19 00:00:49,383 --> 00:00:52,352 and bodily assault. 20 00:00:52,753 --> 00:00:55,289 And it's a very well entrenched concept 21 00:00:55,289 --> 00:00:57,902 in our society and in many societies around the 22 00:00:57,902 --> 00:00:58,292 world. 23 00:00:59,026 --> 00:01:01,253 In, in our values, in our jurisprudence 24 00:01:01,253 --> 00:01:02,396 and in health care. 25 00:01:02,763 --> 00:01:05,699 So it's a very common concept. 26 00:01:05,699 --> 00:01:08,602 Now, interestingly, in health care, 27 00:01:08,602 --> 00:01:10,271 in both medical care and in research, 28 00:01:10,271 --> 00:01:11,805 we don't just talk about consent. 29 00:01:12,172 --> 00:01:14,574 We talk about informed consent. 30 00:01:14,574 --> 00:01:18,029 And that just means basically that the 31 00:01:18,029 --> 00:01:20,847 the authorization, the consent 32 00:01:20,847 --> 00:01:23,943 that we give is based on understanding, 33 00:01:23,943 --> 00:01:26,086 what the activity entails. 34 00:01:26,086 --> 00:01:28,488 So you might wish that that was true for all consent. 35 00:01:28,488 --> 00:01:30,958 And maybe it is true for most kinds of consent. 36 00:01:30,958 --> 00:01:34,261 But in the health care we don't talk about consent. 37 00:01:34,261 --> 00:01:36,596 We talk about informed consent. 38 00:01:36,596 --> 00:01:40,702 And so and you probably know it is a legal, regulatory and 39 00:01:40,702 --> 00:01:41,268 ethical 40 00:01:41,268 --> 00:01:45,242 requirement in most health care and in most research with human 41 00:01:45,242 --> 00:01:45,872 subjects. 42 00:01:47,307 --> 00:01:50,777 It's also and you've heard this, I'm sure, before, a process. 43 00:01:50,777 --> 00:01:52,814 It's a process of reasoned decision 44 00:01:52,814 --> 00:01:53,280 making. 45 00:01:53,280 --> 00:01:54,715 It is not a form. 46 00:01:54,715 --> 00:01:56,550 It is not a single episode 47 00:01:56,550 --> 00:01:59,494 in the trajectory of delivery of health care or 48 00:01:59,494 --> 00:02:00,120 research. 49 00:02:00,721 --> 00:02:04,978 And in a very classic textbook that Ruth Fagan and Tom Beecham 50 00:02:04,978 --> 00:02:05,459 wrote, 51 00:02:05,459 --> 00:02:09,500 more than 30 years ago now, they describe it, it is called 52 00:02:09,500 --> 00:02:10,197 The Fear. 53 00:02:10,197 --> 00:02:13,333 The book is called The History and Theory of Informed Consent. 54 00:02:13,900 --> 00:02:17,337 They describe informed consent as autonomous authorization. 55 00:02:17,738 --> 00:02:20,941 So that's an important concept to sort of keep in mind 56 00:02:22,743 --> 00:02:25,379 ethically. 57 00:02:25,379 --> 00:02:28,382 The idea of informed consent is based on a notion of respect 58 00:02:28,382 --> 00:02:31,523 for autonomy, for people's capacity 59 00:02:31,523 --> 00:02:34,755 and right to define their own goals 60 00:02:35,088 --> 00:02:38,058 and make choices consistent with those goals. 61 00:02:38,058 --> 00:02:40,801 And in a lot of the literature, this second quote is from the 62 00:02:40,801 --> 00:02:41,161 Belmont 63 00:02:41,161 --> 00:02:41,962 Report. 64 00:02:41,962 --> 00:02:45,399 This sort of idea is reiterated in one way or another, 65 00:02:45,699 --> 00:02:47,812 but it is tied to informed consent 66 00:02:47,812 --> 00:02:50,237 in the Belmont Report very explicitly. 67 00:02:50,237 --> 00:02:52,436 So respect for persons requires that 68 00:02:52,436 --> 00:02:54,941 subjects, to the degree they're capable, 69 00:02:54,941 --> 00:02:56,652 be given the opportunity to choose 70 00:02:56,652 --> 00:02:58,211 what shall not happen to them. 71 00:02:58,612 --> 00:03:00,647 And this happens through informed consent. 72 00:03:01,748 --> 00:03:02,449 There is also a 73 00:03:02,449 --> 00:03:05,196 sort of special importance to the ethical injunction 74 00:03:05,196 --> 00:03:05,619 against 75 00:03:05,619 --> 00:03:07,489 using people for the benefit of others 76 00:03:07,489 --> 00:03:08,622 without their consent. 77 00:03:09,089 --> 00:03:13,293 So sometimes you can do things with somebody for their consent. 78 00:03:13,293 --> 00:03:14,428 I mean, for their benefit. 79 00:03:14,428 --> 00:03:16,656 Excuse me without consent, but you're asking people to do 80 00:03:16,656 --> 00:03:16,930 things 81 00:03:16,930 --> 00:03:19,812 for the benefit of others, so you really need their consent 82 00:03:19,812 --> 00:03:20,300 to do so. 83 00:03:20,934 --> 00:03:23,676 And as we talked about last week, 84 00:03:23,676 --> 00:03:25,172 informed consent, 85 00:03:25,472 --> 00:03:28,208 although critically important for, for 86 00:03:28,208 --> 00:03:31,178 ethical research, is only one 87 00:03:31,178 --> 00:03:33,213 aspect of conducting ethical research. 88 00:03:33,213 --> 00:03:35,856 And if you remember my eight principles, 89 00:03:35,856 --> 00:03:36,583 it's like, 90 00:03:36,950 --> 00:03:39,953 you know, seven out of eight in order. 91 00:03:42,322 --> 00:03:43,857 It is required. 92 00:03:43,857 --> 00:03:44,357 Excuse me. 93 00:03:44,357 --> 00:03:46,745 By virtually all codes of research 94 00:03:46,745 --> 00:03:49,062 ethics and regulations and laws. 95 00:03:49,329 --> 00:03:51,085 Although there are some exceptions 96 00:03:51,085 --> 00:03:53,100 and there are some limited exceptions, 97 00:03:53,667 --> 00:03:57,360 and that includes the US federal regulations, the 98 00:03:57,360 --> 00:03:58,038 excepted 99 00:03:58,638 --> 00:04:01,341 Helsinki science, and most 100 00:04:01,341 --> 00:04:04,711 national, state and institutional requirements. 101 00:04:04,711 --> 00:04:07,481 Talk about informed consent in research. 102 00:04:09,149 --> 00:04:09,816 It's interesting 103 00:04:09,816 --> 00:04:11,978 to look at the language of the US 104 00:04:11,978 --> 00:04:13,353 federal regulations, 105 00:04:13,353 --> 00:04:16,356 because it helps us understand certain things about what 106 00:04:16,857 --> 00:04:19,559 the expectation and requirements are. 107 00:04:19,559 --> 00:04:21,704 So this basically says you can enroll 108 00:04:21,704 --> 00:04:24,197 somebody's research unless you've obtained 109 00:04:24,197 --> 00:04:26,327 their legally valid or legally effective, 110 00:04:26,327 --> 00:04:27,834 excuse me, informed consent. 111 00:04:28,201 --> 00:04:30,537 And that that has to be prospective 112 00:04:30,537 --> 00:04:32,472 and it has to be documented. 113 00:04:32,472 --> 00:04:34,808 So those are important things. 114 00:04:34,808 --> 00:04:37,144 This is a statement from an FDA guidance 115 00:04:37,144 --> 00:04:40,113 that came out a few years ago, or I guess just last year. 116 00:04:41,047 --> 00:04:42,215 It was revised last year. 117 00:04:42,215 --> 00:04:43,850 That's what it was. 118 00:04:43,850 --> 00:04:46,086 And I like it because it gives you 119 00:04:46,086 --> 00:04:49,168 the sort of full flavor of what's involved in this 120 00:04:49,168 --> 00:04:49,723 process. 121 00:04:49,990 --> 00:04:52,529 So it's providing a prospective subject 122 00:04:52,529 --> 00:04:55,328 or their legally authorized representative 123 00:04:55,629 --> 00:04:58,123 with adequate information so that they can make a 124 00:04:58,123 --> 00:04:58,632 decision, 125 00:04:59,232 --> 00:05:01,802 facilitating their understanding, 126 00:05:01,802 --> 00:05:05,539 giving them an opportunity to ask questions and to consider 127 00:05:05,539 --> 00:05:08,781 whether to participate, obtaining their voluntary 128 00:05:08,781 --> 00:05:09,509 agreement, 129 00:05:09,709 --> 00:05:13,181 and then continuing to provide information 130 00:05:13,181 --> 00:05:15,081 as as indicated there. 131 00:05:15,081 --> 00:05:16,683 As things change one way or the other. 132 00:05:18,985 --> 00:05:21,321 Sorry, I don't know why my voice is 133 00:05:21,321 --> 00:05:22,122 doing that. 134 00:05:22,122 --> 00:05:25,125 So if you take this paragraph, 135 00:05:25,759 --> 00:05:28,562 it it boils down to into the three things 136 00:05:28,562 --> 00:05:31,598 in the middle and that is information 137 00:05:31,598 --> 00:05:34,287 disclosure, comprehension or understanding and voluntary 138 00:05:34,287 --> 00:05:34,768 decision. 139 00:05:35,202 --> 00:05:37,144 Now, I put two other things on this list 140 00:05:37,144 --> 00:05:39,039 because there are critically important 141 00:05:39,039 --> 00:05:41,708 to thinking about how we think about informed 142 00:05:41,708 --> 00:05:42,242 consent. 143 00:05:42,242 --> 00:05:44,327 One is we have to be sure that the persons 144 00:05:44,327 --> 00:05:46,313 that we're talking to have the capacity 145 00:05:46,313 --> 00:05:47,314 to give consent. 146 00:05:47,314 --> 00:05:48,527 And you're going to hear from Scott 147 00:05:48,527 --> 00:05:49,082 right after me. 148 00:05:49,082 --> 00:05:51,418 So I'm not going to talk about that 149 00:05:51,418 --> 00:05:51,952 at all. 150 00:05:51,952 --> 00:05:54,347 And then, as you saw in the regulatory 151 00:05:54,347 --> 00:05:57,057 language, there needs to be documentation. 152 00:05:57,057 --> 00:06:00,160 So there needs to be some authorization of consent. 153 00:06:00,160 --> 00:06:02,162 Usually it's a written signature. 154 00:06:02,162 --> 00:06:04,764 There's a lot of debate about that. And there's a lot of, 155 00:06:06,032 --> 00:06:06,933 other options. 156 00:06:06,933 --> 00:06:09,757 But that's it's it's an important thing that needs to 157 00:06:09,757 --> 00:06:09,970 be. 158 00:06:09,970 --> 00:06:11,972 There needs to be some documentation. 159 00:06:11,972 --> 00:06:14,068 So I'm going to talk about the three 160 00:06:14,068 --> 00:06:14,941 in the middle. 161 00:06:15,609 --> 00:06:18,011 First starting with information disclosure. 162 00:06:18,011 --> 00:06:19,813 There's an interesting challenge. 163 00:06:19,813 --> 00:06:23,761 And that is trying to decide what information should be 164 00:06:23,761 --> 00:06:24,551 disclosed. 165 00:06:25,051 --> 00:06:26,994 What is important what's adequate 166 00:06:26,994 --> 00:06:29,055 for the person to make a decision? 167 00:06:29,055 --> 00:06:31,283 What's understandable, what's relevant 168 00:06:31,283 --> 00:06:33,393 to them, what's accessible to them. 169 00:06:33,793 --> 00:06:36,514 And this is an interestingly difficult 170 00:06:36,514 --> 00:06:37,230 challenge 171 00:06:37,530 --> 00:06:41,334 in the context of research, which is often quite complex. 172 00:06:42,168 --> 00:06:44,104 And then there's the second part of disclosure. 173 00:06:44,104 --> 00:06:46,363 And that is how should that information 174 00:06:46,363 --> 00:06:47,173 be presented? 175 00:06:48,608 --> 00:06:52,468 Oftentimes we see written consent documents as one way of 176 00:06:52,468 --> 00:06:53,213 presenting 177 00:06:53,213 --> 00:06:55,732 information, almost always accompanied 178 00:06:55,732 --> 00:06:58,385 by somebody talking to the participant. 179 00:06:58,652 --> 00:07:01,140 Sometimes other kinds of information or 180 00:07:01,140 --> 00:07:03,757 educational materials, videos, whatever. 181 00:07:04,257 --> 00:07:05,592 It could be one on one. 182 00:07:05,592 --> 00:07:07,627 It could be groups, it could be all kinds of things. 183 00:07:07,627 --> 00:07:10,163 And those all matter in terms of, 184 00:07:10,163 --> 00:07:12,913 how information is disclosed and how a person might receive 185 00:07:12,913 --> 00:07:13,099 it. 186 00:07:15,201 --> 00:07:16,636 The regulatory 187 00:07:16,636 --> 00:07:18,710 language, again goes like go back to that 188 00:07:18,710 --> 00:07:19,773 for for two reasons. 189 00:07:19,773 --> 00:07:22,423 One is it says it should be in language 190 00:07:22,423 --> 00:07:25,278 understandable to the subject or the law. 191 00:07:25,779 --> 00:07:27,814 And how do you figure that out? 192 00:07:27,814 --> 00:07:28,948 Well, you have to figure out 193 00:07:28,948 --> 00:07:31,405 what a reasonable person that's that's like the people 194 00:07:31,405 --> 00:07:31,951 that you're 195 00:07:31,951 --> 00:07:33,910 inviting to participate in research 196 00:07:33,910 --> 00:07:35,588 might want to know and might, 197 00:07:36,623 --> 00:07:39,358 be able to understand and how to present it in that 198 00:07:39,358 --> 00:07:39,626 way. 199 00:07:41,328 --> 00:07:44,264 The regulations also, 200 00:07:44,264 --> 00:07:46,833 revised in 2018, 201 00:07:46,833 --> 00:07:50,503 added an additional requirements for informed consent 202 00:07:50,503 --> 00:07:54,607 that consent forms, for example, have to begin with a concise 203 00:07:54,874 --> 00:07:57,334 and focused presentation of the key 204 00:07:57,334 --> 00:07:58,178 information 205 00:07:59,245 --> 00:08:02,456 organized in a way that people can comprehend or that 206 00:08:02,456 --> 00:08:03,183 facilitates 207 00:08:03,183 --> 00:08:06,152 comprehension, but insufficient detail 208 00:08:06,486 --> 00:08:10,357 so that you know, they get the whole list. 209 00:08:10,357 --> 00:08:12,258 I mean, it's not just a list of facts, 210 00:08:12,258 --> 00:08:14,160 it's a it's a detailed list of facts. 211 00:08:14,361 --> 00:08:16,968 So this is an interesting sort of a little 212 00:08:16,968 --> 00:08:19,265 bit of a conflictual challenge here. 213 00:08:19,599 --> 00:08:21,757 You know, you want concise information, 214 00:08:21,757 --> 00:08:23,803 but you want an insufficient detail. 215 00:08:24,337 --> 00:08:26,199 And there's plenty of recognition 216 00:08:26,199 --> 00:08:28,174 in this came out of a new guidance 217 00:08:28,174 --> 00:08:29,748 that was just published by the World 218 00:08:29,748 --> 00:08:31,277 Health Organization just recently. 219 00:08:32,979 --> 00:08:34,381 That basically 220 00:08:34,381 --> 00:08:38,051 says, and a lot of people, agree with this, it's essential 221 00:08:38,051 --> 00:08:40,254 that potential recruited participants 222 00:08:40,254 --> 00:08:41,921 are appropriately informed. 223 00:08:41,921 --> 00:08:44,924 But presenting exhaustive 224 00:08:44,924 --> 00:08:48,595 or excessive detail can work against a subjective 225 00:08:49,095 --> 00:08:53,066 by overwhelming, confusing, or disconcerting participants. 226 00:08:53,066 --> 00:08:55,124 And so that's the sort of challenge 227 00:08:55,124 --> 00:08:56,536 in terms of disclosure. 228 00:08:57,170 --> 00:08:59,038 So how are we doing? 229 00:08:59,038 --> 00:09:00,535 Well, there's been a lot of research 230 00:09:00,535 --> 00:09:01,741 that's looked into how we do 231 00:09:01,741 --> 00:09:03,376 one research informed consent. 232 00:09:03,376 --> 00:09:06,079 And I just put some references here. 233 00:09:06,079 --> 00:09:08,500 But basically the overall conclusion of the 234 00:09:08,500 --> 00:09:08,782 data 235 00:09:08,782 --> 00:09:11,603 that has been collected about these, about 236 00:09:11,603 --> 00:09:13,953 consent is that, in consent forms, 237 00:09:13,953 --> 00:09:17,323 the reading level is really high and higher 238 00:09:17,323 --> 00:09:20,326 than what people 239 00:09:21,027 --> 00:09:22,362 believe is the average 240 00:09:22,362 --> 00:09:25,256 reading level of the US population, 241 00:09:25,256 --> 00:09:26,166 and higher 242 00:09:26,166 --> 00:09:29,523 than eighth grade, which is what a lot of the guidance 243 00:09:29,523 --> 00:09:30,270 recommends. 244 00:09:30,270 --> 00:09:32,071 We write it at that level. 245 00:09:32,071 --> 00:09:34,327 So the reading level is high, consent 246 00:09:34,327 --> 00:09:35,241 forms are long 247 00:09:35,675 --> 00:09:38,778 and they've actually increased in length over time. 248 00:09:38,778 --> 00:09:42,060 So if you look at, you know, consent forms from 35 249 00:09:42,060 --> 00:09:42,782 years ago, 250 00:09:43,083 --> 00:09:45,685 they might be five, six pages. 251 00:09:45,685 --> 00:09:49,089 Now they're 25 or sometimes higher pages. 252 00:09:49,089 --> 00:09:53,500 So they're quite long and, and take a while to read and sort of 253 00:09:53,500 --> 00:09:54,060 absorb. 254 00:09:54,794 --> 00:09:56,402 And then there've been a few studies 255 00:09:56,402 --> 00:09:57,831 that have looked at okay, given 256 00:09:57,831 --> 00:09:59,599 that they're long and complex, 257 00:09:59,599 --> 00:10:02,035 do they have everything in there that they're supposed to have? 258 00:10:02,035 --> 00:10:03,303 And the answer is no. 259 00:10:03,303 --> 00:10:05,572 They sometimes are missing information 260 00:10:05,572 --> 00:10:08,783 that is believed to be relevant or even required by the 261 00:10:08,783 --> 00:10:09,542 regulations. 262 00:10:10,143 --> 00:10:12,717 So we're not doing so great on the consent 263 00:10:12,717 --> 00:10:13,146 forms. 264 00:10:13,413 --> 00:10:17,097 There's also really interesting and unanswered questions about 265 00:10:17,097 --> 00:10:17,750 the effect 266 00:10:18,218 --> 00:10:21,354 of how information is disclosed 267 00:10:21,354 --> 00:10:24,157 on how people understand it or receive it. 268 00:10:24,157 --> 00:10:26,262 Now, you might imagine the sort of, 269 00:10:26,262 --> 00:10:28,728 you know, ideal is somebody sitting down 270 00:10:28,962 --> 00:10:31,741 one on one with somebody having a conversation, giving 271 00:10:31,741 --> 00:10:31,998 them 272 00:10:31,998 --> 00:10:34,424 information, letting them ask questions 273 00:10:34,424 --> 00:10:35,668 and, discussing it. 274 00:10:35,668 --> 00:10:36,870 And that does happen. 275 00:10:36,870 --> 00:10:39,572 It definitely happens, but it doesn't always happen. 276 00:10:39,572 --> 00:10:41,896 So I love to tell a story that happened 277 00:10:41,896 --> 00:10:43,743 to me years ago, on a consult. 278 00:10:43,743 --> 00:10:45,545 It was a young man who had come, 279 00:10:47,347 --> 00:10:50,350 from far away for a very, 280 00:10:51,985 --> 00:10:56,623 complicated protocol that was going to treat his. 281 00:10:56,623 --> 00:11:00,943 He had a kind of cancer, and the it would require him to be 282 00:11:00,943 --> 00:11:01,895 hospitalized 283 00:11:01,895 --> 00:11:05,278 for several weeks and receive infusions 284 00:11:05,278 --> 00:11:07,534 of this novel, substance. 285 00:11:08,434 --> 00:11:12,405 But the idea was it might spare his arm. 286 00:11:12,405 --> 00:11:15,208 He had a tumor in his arm, and he was an artist. 287 00:11:15,208 --> 00:11:18,504 And he was really, you know, he didn't care about anything 288 00:11:18,504 --> 00:11:18,845 else, 289 00:11:18,845 --> 00:11:22,792 really, except sparing his arm so he could continue to do his 290 00:11:22,792 --> 00:11:23,116 art. 291 00:11:23,917 --> 00:11:27,353 So the scenario was he was sitting in a room. 292 00:11:27,854 --> 00:11:29,355 I was there with him. 293 00:11:29,355 --> 00:11:32,125 There were three investigators who came in. 294 00:11:32,125 --> 00:11:34,561 They all stood. He sat. 295 00:11:34,561 --> 00:11:38,097 They gave him lots of information. 296 00:11:38,097 --> 00:11:40,854 I mean, they bombarded him with information in a certain 297 00:11:40,854 --> 00:11:41,100 way. 298 00:11:41,301 --> 00:11:44,037 And in the middle of this conversation, 299 00:11:44,037 --> 00:11:46,072 they they each had pagers on 300 00:11:46,072 --> 00:11:47,073 the pagers would go off. 301 00:11:47,073 --> 00:11:48,497 One would go out in the other room, 302 00:11:48,497 --> 00:11:50,043 just answer the pager, come back and, 303 00:11:50,043 --> 00:11:52,211 you know, in and out. So it was like 304 00:11:53,646 --> 00:11:54,414 felt like 305 00:11:54,414 --> 00:11:57,617 dumping information on this guy who was sitting down. 306 00:11:58,051 --> 00:11:59,736 And then when they were finished, 307 00:11:59,736 --> 00:12:01,421 they said, do you want to do it? 308 00:12:02,555 --> 00:12:05,091 And, I remember 309 00:12:05,091 --> 00:12:08,161 feeling like, whoa, you know, 310 00:12:08,161 --> 00:12:11,965 too much information, too much aggressive information. 311 00:12:11,965 --> 00:12:15,036 And he needs some time and some space to just kind of 312 00:12:15,036 --> 00:12:15,268 sit 313 00:12:15,268 --> 00:12:18,871 with it, ask questions, think about it, etc.. 314 00:12:19,238 --> 00:12:22,241 And that wasn't the plan, at least at that moment. 315 00:12:22,241 --> 00:12:23,876 We did give him that opportunity. 316 00:12:23,876 --> 00:12:27,280 But it also the reality of how 317 00:12:27,580 --> 00:12:30,383 how information is presented is very critical. 318 00:12:30,383 --> 00:12:31,945 And then the other thing is, of course, 319 00:12:31,945 --> 00:12:32,585 we have people, 320 00:12:32,585 --> 00:12:34,095 many people who are participating 321 00:12:34,095 --> 00:12:35,788 in research who are in dire straits. 322 00:12:36,189 --> 00:12:38,091 They're in distress, they're in pain. 323 00:12:38,091 --> 00:12:39,959 They have headaches. They they're confused. 324 00:12:39,959 --> 00:12:44,063 I mean, these are all realities of the clinical situations 325 00:12:44,063 --> 00:12:47,500 in which we're often presenting information to people 326 00:12:47,767 --> 00:12:51,037 and how hoping that they can then use it to make a decision. 327 00:12:51,270 --> 00:12:52,772 So these are really critical. 328 00:12:54,273 --> 00:12:56,476 Questions about who does it, 329 00:12:56,476 --> 00:12:59,348 where, when and how the information is 330 00:12:59,348 --> 00:13:00,179 disclosed. 331 00:13:01,614 --> 00:13:04,402 Of course, in recent years, this was this came out of an 332 00:13:04,402 --> 00:13:04,651 FDA, 333 00:13:05,184 --> 00:13:07,795 guidance, I mean, a sorry Federal Register 334 00:13:07,795 --> 00:13:09,722 guidance about eight years ago 335 00:13:10,089 --> 00:13:12,992 that basically said informed 336 00:13:12,992 --> 00:13:15,520 consent doesn't have to be on a piece of 337 00:13:15,520 --> 00:13:15,962 paper. 338 00:13:16,229 --> 00:13:18,097 It doesn't have to start with a piece of paper that you 339 00:13:18,097 --> 00:13:21,334 then talk to somebody about it can be electronic. 340 00:13:21,334 --> 00:13:24,643 It can be, you know, all kinds of electronic text, 341 00:13:24,643 --> 00:13:25,304 graphics, 342 00:13:25,304 --> 00:13:28,875 audio, video, podcasts, interactive sites, etc.. 343 00:13:29,676 --> 00:13:33,813 And so this is another way to disclose information. 344 00:13:34,080 --> 00:13:36,176 And the question is, is this, you know, 345 00:13:36,176 --> 00:13:38,217 how does this help people understand? 346 00:13:38,217 --> 00:13:41,220 Does it help people understand better or not so much better? 347 00:13:42,822 --> 00:13:45,425 So what are some of the challenges with disclosure? 348 00:13:46,392 --> 00:13:48,366 I've already mentioned determining that 349 00:13:48,366 --> 00:13:49,429 what is the relevant 350 00:13:49,429 --> 00:13:51,520 information and context to disclose 351 00:13:51,520 --> 00:13:53,433 in order to facilitate decision 352 00:13:53,433 --> 00:13:55,334 making is is a challenge. 353 00:13:55,334 --> 00:13:57,408 I mean, scientific information, research 354 00:13:57,408 --> 00:13:58,705 information is sometimes 355 00:13:58,705 --> 00:14:00,239 quite complicated. 356 00:14:00,239 --> 00:14:01,945 The other thing is that written consent 357 00:14:01,945 --> 00:14:03,476 forms or written consent documents 358 00:14:03,476 --> 00:14:05,411 serve multiple purposes. 359 00:14:05,411 --> 00:14:07,257 They not only are designed to help 360 00:14:07,257 --> 00:14:09,482 somebody get information that they need, 361 00:14:09,782 --> 00:14:11,507 but they also protect the institution 362 00:14:11,507 --> 00:14:12,952 and protect the investigators. 363 00:14:14,253 --> 00:14:16,211 So that's a really important thing 364 00:14:16,211 --> 00:14:17,190 to keep in mind, 365 00:14:17,190 --> 00:14:18,872 someone said, and it's attributed 366 00:14:18,872 --> 00:14:20,860 to different people if you look it up. 367 00:14:20,860 --> 00:14:24,210 But basically, easy reading is damn hard 368 00:14:24,210 --> 00:14:24,964 writing. 369 00:14:24,964 --> 00:14:26,588 I don't know if any of you have tried 370 00:14:26,588 --> 00:14:28,167 to write something in one paragraph 371 00:14:28,468 --> 00:14:30,703 that you really want to write in four pages. 372 00:14:30,703 --> 00:14:32,672 It's hard, and it's hard to make it 373 00:14:32,672 --> 00:14:33,573 understandable. 374 00:14:34,507 --> 00:14:35,641 And then 375 00:14:35,641 --> 00:14:37,984 ironically, I think, but maybe not 376 00:14:37,984 --> 00:14:38,811 completely. 377 00:14:38,811 --> 00:14:41,814 Unsurprisingly, institutions, sponsors, 378 00:14:41,814 --> 00:14:45,485 investigators, and even IRBs often want more. 379 00:14:45,485 --> 00:14:48,644 They want more information, more detailed information, and 380 00:14:48,644 --> 00:14:49,188 therefore 381 00:14:50,156 --> 00:14:52,202 consent forms actually get longer and more 382 00:14:52,202 --> 00:14:52,592 complex 383 00:14:52,592 --> 00:14:55,561 based on those inputs. 384 00:14:55,862 --> 00:14:56,095 Okay. 385 00:14:56,095 --> 00:14:58,101 The second, all right, information is 386 00:14:58,101 --> 00:14:58,698 disclosed. 387 00:14:58,698 --> 00:15:01,291 The second important part of informed consent is 388 00:15:01,291 --> 00:15:02,101 understanding. 389 00:15:02,568 --> 00:15:04,403 And we all know 390 00:15:04,403 --> 00:15:06,606 that, you know, when you hear information, 391 00:15:06,606 --> 00:15:08,074 even when you're listening, 392 00:15:08,374 --> 00:15:10,747 there's only a sort of, little bit, 393 00:15:10,747 --> 00:15:12,578 I guess is the right word. 394 00:15:12,945 --> 00:15:14,647 And where am I? 395 00:15:14,647 --> 00:15:15,982 Here we go. 396 00:15:15,982 --> 00:15:17,984 That part in the middle. 397 00:15:17,984 --> 00:15:21,020 Where, where are you really understanding? 398 00:15:21,020 --> 00:15:24,023 So understanding is 399 00:15:24,590 --> 00:15:27,649 important, but it can't be expected 400 00:15:27,649 --> 00:15:30,096 that everything you're told 401 00:15:30,096 --> 00:15:32,265 is something you understand. 402 00:15:32,265 --> 00:15:34,703 So the questions that really plague the 403 00:15:34,703 --> 00:15:37,203 sort of process of informed consent is, 404 00:15:38,938 --> 00:15:42,175 what and how much should participants 405 00:15:42,175 --> 00:15:45,678 understand in order to, to really give valid consent? 406 00:15:46,512 --> 00:15:48,603 This is a question that people have 407 00:15:48,603 --> 00:15:50,216 debated in the literature. 408 00:15:50,817 --> 00:15:52,600 Joe Milam, who used to be in our group 409 00:15:52,600 --> 00:15:53,586 with Danielle Brown, 410 00:15:53,586 --> 00:15:56,059 which I've written a number of page papers 411 00:15:56,059 --> 00:15:56,589 on this, 412 00:15:56,856 --> 00:16:00,126 suggesting a fairly minimal understanding 413 00:16:00,126 --> 00:16:03,763 that, is consistent with valid informed consent. 414 00:16:04,730 --> 00:16:07,733 There's also a question about how should we, 415 00:16:07,733 --> 00:16:09,896 how should we and how do we assess 416 00:16:09,896 --> 00:16:11,804 whether people do understand. 417 00:16:12,338 --> 00:16:15,681 So I've seen the full gamut of the example 418 00:16:15,681 --> 00:16:18,945 that I gave you, you know, are you okay? 419 00:16:18,945 --> 00:16:20,613 You want to do it without even. 420 00:16:20,613 --> 00:16:21,981 Do you have any questions? 421 00:16:21,981 --> 00:16:24,217 Sometimes people say, do you have any questions? 422 00:16:24,217 --> 00:16:26,886 Sometimes in some studies, people, 423 00:16:26,886 --> 00:16:29,689 investigators, research teams use quizzes. 424 00:16:29,689 --> 00:16:30,690 They have written quizzes. 425 00:16:30,690 --> 00:16:33,025 And people have to get a certain 426 00:16:33,025 --> 00:16:36,195 percentage right in order to demonstrate understanding. 427 00:16:36,195 --> 00:16:38,163 So there's a wide range of how we do it 428 00:16:38,163 --> 00:16:40,233 is a question about how should we do it. 429 00:16:40,933 --> 00:16:43,344 And then there's a question about what happens or what 430 00:16:43,344 --> 00:16:43,970 should happen 431 00:16:43,970 --> 00:16:45,571 when participants don't understand. 432 00:16:45,571 --> 00:16:47,940 And then the question again goes back to the first one. 433 00:16:47,940 --> 00:16:50,507 If they don't understand what they don't understand 434 00:16:50,507 --> 00:16:51,010 anything, 435 00:16:51,010 --> 00:16:53,446 they understand certain things, but not other things. 436 00:16:53,446 --> 00:16:55,070 And, you know, should they be able to 437 00:16:55,070 --> 00:16:55,948 participate or not? 438 00:16:55,948 --> 00:16:57,950 And it doesn't depend on the study. 439 00:16:57,950 --> 00:17:00,553 These are hard questions to answer. 440 00:17:00,553 --> 00:17:03,550 Again, there's been a fair amount of research on informed 441 00:17:03,550 --> 00:17:04,023 consent, 442 00:17:04,357 --> 00:17:06,988 which is basically concluded overall 443 00:17:06,988 --> 00:17:08,961 that research participants 444 00:17:08,961 --> 00:17:11,488 have variable understanding of the studies 445 00:17:11,488 --> 00:17:13,232 that they have consented to. 446 00:17:13,232 --> 00:17:15,560 So they've consented there in the study, 447 00:17:15,560 --> 00:17:18,004 somebody interviews them or surveys them, 448 00:17:18,504 --> 00:17:20,315 to figure out what they've understood, 449 00:17:20,315 --> 00:17:21,841 and they understand some things 450 00:17:21,841 --> 00:17:24,210 and not other things. And that's basically the 451 00:17:25,244 --> 00:17:27,229 all of the data suggests that that's 452 00:17:27,229 --> 00:17:27,780 the case. 453 00:17:27,780 --> 00:17:29,849 And the range is quite striking. 454 00:17:29,849 --> 00:17:31,776 If you look at some of these down 455 00:17:31,776 --> 00:17:33,819 here, research purpose and nature, 456 00:17:33,819 --> 00:17:36,889 sometimes as low as 27% understand it, 457 00:17:36,889 --> 00:17:39,674 sometimes 100% understand it of risks, 458 00:17:39,674 --> 00:17:41,360 the same kind of range 459 00:17:41,761 --> 00:17:45,731 of randomization and placebo use is often lower. 460 00:17:45,731 --> 00:17:48,367 People understand that less well in general 461 00:17:48,367 --> 00:17:49,869 than they do some of these other things. 462 00:17:49,869 --> 00:17:52,972 But still there's there's quite a range. 463 00:17:52,972 --> 00:17:55,144 There's also been a couple of meta 464 00:17:55,144 --> 00:17:55,975 analyzes of, 465 00:17:56,275 --> 00:17:58,878 informed consent studies to try to show 466 00:17:58,878 --> 00:18:01,347 what people do or do not understand. 467 00:18:01,347 --> 00:18:02,846 This is a busy slide, and I'm going 468 00:18:02,846 --> 00:18:04,216 to show you another busy slide. 469 00:18:04,216 --> 00:18:06,118 Two takeaways from this slide. 470 00:18:06,118 --> 00:18:09,121 Nothing really approaches 100%. 471 00:18:09,388 --> 00:18:11,123 That's one thing to notice. 472 00:18:11,123 --> 00:18:14,489 And you can see that there are several things like 473 00:18:14,489 --> 00:18:15,027 placebo 474 00:18:15,027 --> 00:18:18,497 randomization and alternative treatments 475 00:18:18,965 --> 00:18:22,101 that are, you know, closer to 50%. 476 00:18:22,101 --> 00:18:24,036 So that's that's a little bit 477 00:18:24,036 --> 00:18:25,037 disconcerting. 478 00:18:26,606 --> 00:18:26,906 There's 479 00:18:26,906 --> 00:18:29,909 this was a meta analysis that was published 480 00:18:29,909 --> 00:18:32,998 in 2015, based on data that had been collected to that 481 00:18:32,998 --> 00:18:33,512 to date. 482 00:18:33,813 --> 00:18:36,816 There was a second one published just this year, 483 00:18:36,816 --> 00:18:39,285 which used some of the same methodology. 484 00:18:39,285 --> 00:18:42,555 And this is basically you can see the numbers there. 485 00:18:42,555 --> 00:18:46,158 They're not much different than the other meta analyzes. 486 00:18:46,826 --> 00:18:51,063 And what these authors concluded actually, 487 00:18:51,464 --> 00:18:54,533 is that the results show that most participants 488 00:18:54,533 --> 00:18:57,088 understood the fundamental components 489 00:18:57,088 --> 00:18:58,537 of informed consent, 490 00:18:58,537 --> 00:19:00,804 meaning study, nature, voluntariness, 491 00:19:00,804 --> 00:19:02,642 and freedom to withdraw most. 492 00:19:03,342 --> 00:19:04,777 That's a question mark. 493 00:19:04,777 --> 00:19:09,448 But other things like placebo and the ability to name 494 00:19:09,448 --> 00:19:12,451 at least one risk was much lower. 495 00:19:15,121 --> 00:19:16,022 So what if sex 496 00:19:16,022 --> 00:19:18,474 understanding what makes people understand 497 00:19:18,474 --> 00:19:19,291 more or less. 498 00:19:19,291 --> 00:19:20,846 And there's a lot of things, of course. 499 00:19:20,846 --> 00:19:22,161 There's process related factors. 500 00:19:22,161 --> 00:19:24,271 What they're told with what they're given 501 00:19:24,271 --> 00:19:25,197 information about 502 00:19:25,197 --> 00:19:27,550 has to affect what they understand, 503 00:19:27,550 --> 00:19:29,702 as does how and by whom and how 504 00:19:29,702 --> 00:19:33,305 well they listened or read that impacts how they 505 00:19:33,305 --> 00:19:34,206 understand. 506 00:19:34,473 --> 00:19:36,435 But there's a number of those factors 507 00:19:36,435 --> 00:19:38,344 that have been shown in studies to, 508 00:19:39,378 --> 00:19:40,112 influence 509 00:19:40,112 --> 00:19:43,149 the understanding of research participants, 510 00:19:43,149 --> 00:19:45,925 including some of these won't surprise you 511 00:19:45,925 --> 00:19:46,719 at all age. 512 00:19:47,453 --> 00:19:50,189 Older people understand less education. 513 00:19:50,189 --> 00:19:52,815 Less and less educated people understand 514 00:19:52,815 --> 00:19:54,193 less people in pain. 515 00:19:54,660 --> 00:19:56,941 People who have cognitive impairment, 516 00:19:56,941 --> 00:19:59,098 people who are under stress, those 517 00:19:59,665 --> 00:20:01,885 those those factors are associated 518 00:20:01,885 --> 00:20:02,668 with lower, 519 00:20:03,936 --> 00:20:06,272 lower levels of understanding. 520 00:20:06,272 --> 00:20:08,540 And then there's a really important 521 00:20:08,540 --> 00:20:09,642 and a little bit 522 00:20:09,642 --> 00:20:12,645 still unexplored aspect of 523 00:20:13,045 --> 00:20:14,952 what impacts understanding research 524 00:20:14,952 --> 00:20:15,714 participants. 525 00:20:15,714 --> 00:20:18,851 And that is what I call expectations and familiarity. 526 00:20:19,151 --> 00:20:21,270 So thinking about the motivations, 527 00:20:21,270 --> 00:20:23,389 why do people enroll in research? 528 00:20:23,389 --> 00:20:25,064 What do they think is going to happen 529 00:20:25,064 --> 00:20:26,559 before they get any information? 530 00:20:26,792 --> 00:20:28,994 Why do they do it that influences 531 00:20:28,994 --> 00:20:30,654 what they're willing to listen to 532 00:20:30,654 --> 00:20:32,465 and what they end up understanding? 533 00:20:32,965 --> 00:20:35,101 There's also, of course, cultural views. 534 00:20:35,101 --> 00:20:37,028 There are, therapeutic misconceptions, 535 00:20:37,028 --> 00:20:38,804 which I'll talk about in a second, 536 00:20:38,804 --> 00:20:40,873 and other related understandings. 537 00:20:42,141 --> 00:20:44,510 Importantly, thinking about 538 00:20:44,510 --> 00:20:46,712 both disclosure and understanding is helpful 539 00:20:46,712 --> 00:20:49,715 to think about health literacy, 540 00:20:49,982 --> 00:20:51,684 and health literacy. 541 00:20:51,684 --> 00:20:54,386 This is U.S data, 542 00:20:54,386 --> 00:20:57,556 and this comes from both the National Library of Medicine 543 00:20:57,556 --> 00:21:00,366 and this other organization that I can't think of the name 544 00:21:00,366 --> 00:21:00,559 of. 545 00:21:01,227 --> 00:21:02,707 Anyway, they agreed on the numbers, 546 00:21:02,707 --> 00:21:04,230 so I just put them both down there. 547 00:21:05,397 --> 00:21:09,144 Basically, they say nearly nine out of ten 548 00:21:09,144 --> 00:21:09,769 adults 549 00:21:10,269 --> 00:21:12,838 struggle with health literacy, 550 00:21:12,838 --> 00:21:17,076 and even people with otherwise good literacy skills, people 551 00:21:17,076 --> 00:21:19,408 who can read and write and calculate, 552 00:21:19,408 --> 00:21:21,614 they may have low health literacy. 553 00:21:22,148 --> 00:21:24,116 And I find that really interesting. 554 00:21:24,116 --> 00:21:27,620 And I suspect that you will know people like I do smart 555 00:21:27,620 --> 00:21:31,157 people who are masters in their domain of the world, 556 00:21:31,524 --> 00:21:34,193 who just don't understand much at all about health. 557 00:21:34,193 --> 00:21:35,694 And it's quite interesting. 558 00:21:35,694 --> 00:21:38,430 But this has to influence how people 559 00:21:38,430 --> 00:21:41,167 understand the kinds of information 560 00:21:41,433 --> 00:21:43,884 that we're providing to them in the context of making 561 00:21:43,884 --> 00:21:44,670 decisions about, 562 00:21:45,638 --> 00:21:47,840 research participation. 563 00:21:47,840 --> 00:21:49,602 Dave Wendler, who you're going to hear 564 00:21:49,602 --> 00:21:50,576 from in this course, 565 00:21:50,576 --> 00:21:53,296 published a paper now, gosh, more than ten years 566 00:21:53,296 --> 00:21:53,579 ago, 567 00:21:54,413 --> 00:21:58,450 where he suggested that how much people understand 568 00:21:58,450 --> 00:22:00,819 and how we assess understanding 569 00:22:00,819 --> 00:22:03,822 should vary by the level of risk to the participant. 570 00:22:04,356 --> 00:22:07,493 So I'm not sure 571 00:22:07,493 --> 00:22:10,496 which one of these works better. 572 00:22:13,232 --> 00:22:16,202 Can I I don't know how to use the arrow, 573 00:22:16,402 --> 00:22:18,270 so I'm not going to do it. 574 00:22:18,270 --> 00:22:18,871 That's okay. 575 00:22:18,871 --> 00:22:21,907 I'll just say if you look at the 576 00:22:21,907 --> 00:22:24,843 row that says understanding, 577 00:22:24,843 --> 00:22:28,113 he will he recommended that if it's low risk, 578 00:22:28,113 --> 00:22:30,449 you can just assume that people understand it 579 00:22:30,449 --> 00:22:32,484 and that they're competent to understand it. 580 00:22:32,484 --> 00:22:36,121 If it's moderate, or high risk with potential benefit, 581 00:22:36,121 --> 00:22:39,166 you might do an informal or brief formal assessment of 582 00:22:39,166 --> 00:22:39,391 how 583 00:22:39,592 --> 00:22:40,960 how much they understand. 584 00:22:40,960 --> 00:22:42,127 But the higher the risk. 585 00:22:42,127 --> 00:22:45,331 Or if it's high risk with little or no potential benefit, 586 00:22:45,664 --> 00:22:47,853 then you really need a higher threshold 587 00:22:47,853 --> 00:22:49,368 of knowing that the person 588 00:22:49,368 --> 00:22:51,452 understands the details of the study 589 00:22:51,452 --> 00:22:53,305 that you're presenting to them. 590 00:22:54,707 --> 00:22:55,441 I agree with that. 591 00:22:55,441 --> 00:22:57,409 By the way. 592 00:22:57,409 --> 00:23:00,079 So what happens if there is misunderstanding? 593 00:23:00,079 --> 00:23:02,197 Well, first of all, there's there are 594 00:23:02,197 --> 00:23:04,316 different kinds of misunderstanding. 595 00:23:04,316 --> 00:23:06,852 And that's helpful to sort of think through. 596 00:23:06,852 --> 00:23:09,153 So a lot of people focus on the therapeutic 597 00:23:09,153 --> 00:23:09,955 misconception, 598 00:23:10,256 --> 00:23:13,325 which is basically not recognizing 599 00:23:13,325 --> 00:23:16,829 that research is different than regular clinical care. 600 00:23:16,829 --> 00:23:18,806 And I'm going to give you a definition 601 00:23:18,806 --> 00:23:19,898 of that in a minute. 602 00:23:19,898 --> 00:23:22,034 But there are other kinds of misunderstandings. 603 00:23:22,034 --> 00:23:23,708 So some people actually understand 604 00:23:23,708 --> 00:23:25,037 that research is research, 605 00:23:25,271 --> 00:23:28,274 but they miss estimate either 606 00:23:28,274 --> 00:23:31,310 the level of benefit for the level of risk or both. 607 00:23:32,311 --> 00:23:36,201 And that could be problematic if they think this is, you know, 608 00:23:36,201 --> 00:23:36,515 100% 609 00:23:36,782 --> 00:23:41,186 beneficial or and it's, you know, completely unknown 610 00:23:41,186 --> 00:23:42,951 or the expectation is it'll be 5% 611 00:23:42,951 --> 00:23:44,823 beneficial or, you know, whatever. 612 00:23:44,823 --> 00:23:47,876 So understanding that kind of a misunderstanding is important 613 00:23:47,876 --> 00:23:48,127 too. 614 00:23:48,661 --> 00:23:50,763 And then there's been a whole bunch of 615 00:23:50,763 --> 00:23:53,032 literature on the influence of optimism. 616 00:23:54,033 --> 00:23:55,501 There are people who, 617 00:23:55,501 --> 00:23:59,772 because of their expectations and their hopefulness, they say, 618 00:24:00,072 --> 00:24:03,050 but I remember a guy years ago who said, okay, I get it, I get 619 00:24:03,050 --> 00:24:03,242 it. 620 00:24:03,542 --> 00:24:05,444 This is brand new. First in human. 621 00:24:05,444 --> 00:24:06,945 I don't know if it's going to help me at all. 622 00:24:06,945 --> 00:24:08,307 I don't know if it's going to work 623 00:24:08,307 --> 00:24:09,948 in anybody, but I'm going to be the one. 624 00:24:10,382 --> 00:24:12,942 And so that kind of optimism can be 625 00:24:12,942 --> 00:24:15,721 certainly natural for certain people, 626 00:24:15,721 --> 00:24:20,693 but it also can accompany misunderstanding of the details. 627 00:24:20,693 --> 00:24:23,762 So sort of separating what's hope. 628 00:24:23,762 --> 00:24:25,831 That's that's okay with hope. 629 00:24:25,831 --> 00:24:28,667 That's unrealistic. 630 00:24:28,667 --> 00:24:30,202 It's also in the literature 631 00:24:30,202 --> 00:24:33,172 that has been a really important distinction, 632 00:24:33,172 --> 00:24:37,061 which I think is helpful to know between knowledge of relevant 633 00:24:37,061 --> 00:24:37,876 information, 634 00:24:38,210 --> 00:24:40,295 which could be seen as understanding 635 00:24:40,295 --> 00:24:42,381 and appreciation of how it applies. 636 00:24:42,815 --> 00:24:46,051 So the classic example is a study 637 00:24:46,051 --> 00:24:49,855 that led to the terminology of therapeutic misconception, 638 00:24:50,956 --> 00:24:53,173 a group of people who have schizophrenia 639 00:24:53,173 --> 00:24:54,059 who are joining 640 00:24:54,059 --> 00:24:56,067 a placebo controlled trial of an 641 00:24:56,067 --> 00:24:57,196 intervention, and 642 00:24:58,263 --> 00:25:00,699 the interviews that were done with these individuals 643 00:25:00,699 --> 00:25:02,954 after the consent process was finished, 644 00:25:02,954 --> 00:25:04,803 they actually had a pretty good 645 00:25:04,803 --> 00:25:06,271 understanding of the facts. 646 00:25:06,271 --> 00:25:08,040 You know, this is a randomized trial. 647 00:25:08,040 --> 00:25:09,775 Half the people are going to get, 648 00:25:09,775 --> 00:25:11,539 you know, the experimental drug, half 649 00:25:11,539 --> 00:25:12,778 are going to get placebo. 650 00:25:13,912 --> 00:25:15,714 I forget the other facts, but they basically had 651 00:25:15,714 --> 00:25:17,378 a pretty good understanding of the facts, 652 00:25:17,378 --> 00:25:18,717 and they could recite them back. 653 00:25:18,984 --> 00:25:20,682 And then they said, oh, but my doctor 654 00:25:20,682 --> 00:25:22,654 is going to make sure that I get the drug. 655 00:25:23,188 --> 00:25:26,959 So that's the difference between knowledge of facts or 656 00:25:27,993 --> 00:25:29,962 to recite the facts and appreciation 657 00:25:29,962 --> 00:25:32,364 of how those facts might apply to an 658 00:25:32,364 --> 00:25:33,098 individual 659 00:25:34,133 --> 00:25:36,368 themself. 660 00:25:36,368 --> 00:25:38,390 And Paul Applebaum was the person who 661 00:25:38,390 --> 00:25:40,739 coined the term therapeutic misconception. 662 00:25:41,073 --> 00:25:43,475 And what he said in the early papers 663 00:25:43,475 --> 00:25:46,345 was it's when a research participant fails 664 00:25:46,345 --> 00:25:49,815 to recognize how individualized medical care 665 00:25:50,682 --> 00:25:52,259 that is the physician's obligation 666 00:25:52,259 --> 00:25:54,253 to make medical decisions in the patient's 667 00:25:54,253 --> 00:25:56,668 best interests might be compromised 668 00:25:56,668 --> 00:25:58,323 by research procedures, 669 00:25:58,323 --> 00:26:00,827 because research often has a protocol 670 00:26:00,827 --> 00:26:03,195 which dictates who gets what, how, 671 00:26:03,195 --> 00:26:04,596 what doses they get, etc. 672 00:26:04,596 --> 00:26:07,599 it's not decided by the individual physician 673 00:26:08,033 --> 00:26:10,502 based on the individual person's needs. 674 00:26:10,502 --> 00:26:14,626 And Appelbaum and colleagues go on to make the point in many 675 00:26:14,626 --> 00:26:15,107 papers 676 00:26:15,507 --> 00:26:18,744 that failure to to recognize these differences 677 00:26:19,311 --> 00:26:21,367 and negates the ability to provide 678 00:26:21,367 --> 00:26:23,182 meaningful, informed consent. 679 00:26:23,182 --> 00:26:25,141 So this is a type of misunderstanding 680 00:26:25,141 --> 00:26:27,419 that they claim makes it impossible to get 681 00:26:27,419 --> 00:26:28,420 valid informed consent. 682 00:26:29,955 --> 00:26:30,255 There has 683 00:26:30,255 --> 00:26:34,126 also been a number of studies that have tried to look at 684 00:26:34,126 --> 00:26:36,489 what could we do to improve understanding 685 00:26:36,489 --> 00:26:38,564 in the context of informed consent. 686 00:26:39,031 --> 00:26:42,000 And there were two, two, sort of, 687 00:26:44,703 --> 00:26:47,372 surveys, systematic reviews, sorry, 688 00:26:47,372 --> 00:26:51,662 that categorized the types of studies into these 689 00:26:51,662 --> 00:26:52,377 groups. 690 00:26:52,377 --> 00:26:54,046 And I think they're quite 691 00:26:54,046 --> 00:26:57,165 telling even today, even though most of these are both old 692 00:26:57,165 --> 00:26:57,649 studies. 693 00:26:57,649 --> 00:26:59,618 So we need a new one. 694 00:26:59,618 --> 00:27:03,088 But they compared studies that tested multimedia, 695 00:27:04,323 --> 00:27:06,925 interventions to try to improve understanding with enhanced 696 00:27:06,925 --> 00:27:09,359 consent forms meeting different styles 697 00:27:09,359 --> 00:27:10,896 or shorter or whatever. 698 00:27:11,296 --> 00:27:14,233 Extended discussion, test feedback, 699 00:27:14,233 --> 00:27:17,371 and a bunch of other mixed and misleading 700 00:27:17,371 --> 00:27:18,136 misleads. 701 00:27:18,437 --> 00:27:21,440 What do you think works the best? 702 00:27:23,342 --> 00:27:24,343 And the ideas? 703 00:27:24,343 --> 00:27:26,678 I'm looking at the people in the room 704 00:27:26,678 --> 00:27:27,513 I know you know, 705 00:27:29,014 --> 00:27:32,184 and this extended discussion. 706 00:27:32,184 --> 00:27:33,352 Shocking, right? 707 00:27:33,352 --> 00:27:35,967 The more you talk to somebody about what's happening, the 708 00:27:35,967 --> 00:27:36,288 better 709 00:27:36,288 --> 00:27:37,022 they understand it. 710 00:27:37,022 --> 00:27:38,852 And that although there were only 711 00:27:38,852 --> 00:27:40,626 a few studies in that category, 712 00:27:40,626 --> 00:27:42,304 there was clearly better understanding 713 00:27:42,304 --> 00:27:43,629 from that than anything else. 714 00:27:43,929 --> 00:27:46,363 And, you know, there are ways in which that 715 00:27:46,363 --> 00:27:47,099 makes sense. 716 00:27:47,432 --> 00:27:50,485 There's also resource questions that limit 717 00:27:50,485 --> 00:27:51,503 how much time 718 00:27:51,503 --> 00:27:53,038 we can spend talking to people. 719 00:27:53,038 --> 00:27:54,822 So I mean, it's not a it's not like, 720 00:27:54,822 --> 00:27:56,308 okay, now we know what to do. 721 00:27:56,308 --> 00:27:58,143 Let's do it. 722 00:27:58,143 --> 00:28:01,413 One of the interesting thing is that the, 723 00:28:02,548 --> 00:28:04,816 both of these meta analyzes said 724 00:28:04,816 --> 00:28:06,948 enhanced consent forms might work, 725 00:28:06,948 --> 00:28:08,954 but we need a randomized trial. 726 00:28:08,954 --> 00:28:13,158 So our group did a number of randomized studies 727 00:28:13,158 --> 00:28:16,161 where we took we did three different versions 728 00:28:16,161 --> 00:28:16,628 of it, 729 00:28:18,230 --> 00:28:18,730 with healthy 730 00:28:18,730 --> 00:28:22,763 volunteers in phase one drug studies with healthy 731 00:28:22,763 --> 00:28:23,669 volunteers 732 00:28:23,669 --> 00:28:26,672 and flu vaccine studies, and with 733 00:28:27,806 --> 00:28:31,076 persons who have HIV in a multinational treatment 734 00:28:31,076 --> 00:28:31,543 study. 735 00:28:32,010 --> 00:28:34,477 And all together, you know, the healthy volunteer 736 00:28:34,477 --> 00:28:34,880 studies 737 00:28:34,880 --> 00:28:38,283 were about 100 or 130 people, and each one in the, 738 00:28:40,385 --> 00:28:42,721 HIV study was about 4000 people. 739 00:28:42,721 --> 00:28:46,358 We randomized them to get the standard consent form 740 00:28:47,025 --> 00:28:49,728 or a shorter, simpler, 741 00:28:49,728 --> 00:28:52,364 lower reading level consent form. 742 00:28:52,364 --> 00:28:56,568 And the amazing thing is, it didn't make a difference. 743 00:28:57,436 --> 00:29:00,806 They most people understood 744 00:29:01,440 --> 00:29:03,592 certain things better than other things, 745 00:29:03,592 --> 00:29:04,776 but the shorter forms 746 00:29:04,776 --> 00:29:06,935 didn't help them to understand more, 747 00:29:06,935 --> 00:29:08,614 which is quite interesting. 748 00:29:09,448 --> 00:29:11,989 There's also been some studies that have been done more 749 00:29:11,989 --> 00:29:12,451 recently. 750 00:29:12,718 --> 00:29:14,615 Holly was involved with one of them 751 00:29:14,615 --> 00:29:16,188 where they randomized people 752 00:29:16,188 --> 00:29:19,726 to three different formats, and actually people exposed to 753 00:29:19,726 --> 00:29:20,092 video 754 00:29:20,592 --> 00:29:23,595 understood more and had more satisfaction. 755 00:29:23,595 --> 00:29:26,910 There are other studies that similarly showed that even 756 00:29:26,910 --> 00:29:27,332 though 757 00:29:27,566 --> 00:29:29,502 and in some cases, even though video 758 00:29:29,502 --> 00:29:31,169 kind of presentations and data 759 00:29:31,169 --> 00:29:32,371 doesn't always improve, 760 00:29:34,172 --> 00:29:35,107 understanding 761 00:29:35,107 --> 00:29:38,143 as measured by the tests that measure them. 762 00:29:38,143 --> 00:29:41,246 But it's some but it does improve satisfaction 763 00:29:41,246 --> 00:29:44,249 and it does improve engagement with the information. 764 00:29:44,549 --> 00:29:47,519 So now I think that's interesting to 765 00:29:47,519 --> 00:29:50,522 and then people are looking at this, 766 00:29:50,522 --> 00:29:52,745 you know, web based and interactive 767 00:29:52,745 --> 00:29:53,825 kinds of methods 768 00:29:53,825 --> 00:29:56,862 and how much they might, 769 00:29:56,862 --> 00:29:59,865 increase understanding. 770 00:30:00,432 --> 00:30:03,435 So I'll just say what we don't want to, but. 771 00:30:04,503 --> 00:30:07,906 So the third pillar is voluntary choice. 772 00:30:08,340 --> 00:30:11,343 So disclose information people understand 773 00:30:11,643 --> 00:30:14,312 hopefully enough to be able to make an informed decision. 774 00:30:14,312 --> 00:30:16,581 And then they have to make a voluntary choice. 775 00:30:16,581 --> 00:30:19,751 And interestingly, 776 00:30:19,751 --> 00:30:21,753 this one I think has gotten 777 00:30:21,753 --> 00:30:24,417 the least amount of attention in the literature on informed 778 00:30:24,417 --> 00:30:24,823 consent. 779 00:30:24,823 --> 00:30:26,322 And I think it's really interesting 780 00:30:26,322 --> 00:30:27,993 to think about what a voluntary choice 781 00:30:27,993 --> 00:30:31,063 is, because we make choices every day. 782 00:30:31,063 --> 00:30:31,863 We make choices, 783 00:30:33,565 --> 00:30:35,000 hopefully voluntarily, 784 00:30:35,000 --> 00:30:38,303 but they're based on our experiences, 785 00:30:38,737 --> 00:30:41,940 our expectations, the kinds of things 786 00:30:41,940 --> 00:30:45,010 that our network of supporters 787 00:30:45,010 --> 00:30:46,011 push for. 788 00:30:46,011 --> 00:30:47,592 I mean, there are a lot of things that 789 00:30:47,592 --> 00:30:49,381 influence how we make decisions every day. 790 00:30:49,681 --> 00:30:51,950 And yet I wouldn't call them not voluntary. 791 00:30:51,950 --> 00:30:52,551 Right? 792 00:30:52,551 --> 00:30:54,926 So thinking about how do you think about a 793 00:30:54,926 --> 00:30:55,887 voluntary choice 794 00:30:55,887 --> 00:30:58,558 within the context of research is not, 795 00:30:58,558 --> 00:31:00,525 completely straightforward. 796 00:31:01,393 --> 00:31:03,962 The, regular 797 00:31:03,962 --> 00:31:06,075 regulatory language and the literature 798 00:31:06,075 --> 00:31:08,133 suggests that there are three things 799 00:31:08,133 --> 00:31:10,853 we have to avoid in order for a choice 800 00:31:10,853 --> 00:31:12,070 to be voluntary. 801 00:31:12,437 --> 00:31:14,072 There should be no deception, 802 00:31:14,072 --> 00:31:16,925 there should be no coercion, and there should be no undue 803 00:31:16,925 --> 00:31:17,476 influence. 804 00:31:17,876 --> 00:31:20,149 And so understanding what those terms mean 805 00:31:20,149 --> 00:31:21,880 is helpful to sort of thinking, 806 00:31:21,880 --> 00:31:24,114 okay, well how do we make sure it's 807 00:31:24,114 --> 00:31:24,816 voluntary. 808 00:31:24,816 --> 00:31:27,352 So deception of course is concealing or 809 00:31:27,352 --> 00:31:30,655 distorting the truth in order to in order to mislead. 810 00:31:31,256 --> 00:31:34,519 And I mentioned Joe Milam and Danielle Brown, which they 811 00:31:34,519 --> 00:31:35,160 talk about 812 00:31:35,160 --> 00:31:37,834 in one of their papers, something called fraudulent 813 00:31:37,834 --> 00:31:38,463 disclosure, 814 00:31:38,897 --> 00:31:41,277 which is like withholding information or 815 00:31:41,277 --> 00:31:43,835 sometimes just presenting it in a way that 816 00:31:45,303 --> 00:31:47,498 is not factually incorrect, but is 817 00:31:47,498 --> 00:31:48,273 misleading. 818 00:31:48,507 --> 00:31:51,109 And that's that's deception. 819 00:31:51,109 --> 00:31:53,678 Coercion is compelling. 820 00:31:53,678 --> 00:31:56,244 Somebody to do something against their 821 00:31:56,244 --> 00:31:56,581 will 822 00:31:56,581 --> 00:31:59,286 by threatening them, threatening to make them worse 823 00:31:59,286 --> 00:31:59,551 off. 824 00:32:00,085 --> 00:32:02,893 And there certainly are examples of coercion in in 825 00:32:02,893 --> 00:32:03,455 research. 826 00:32:03,455 --> 00:32:05,844 But I think probably not that many 827 00:32:05,844 --> 00:32:08,093 that we could probably identify 828 00:32:09,628 --> 00:32:11,830 that interestingly. 829 00:32:11,830 --> 00:32:14,733 So I find interesting one is this undue influence 830 00:32:14,733 --> 00:32:17,302 which people define as an offer. 831 00:32:17,302 --> 00:32:18,537 So it's not a threat. 832 00:32:18,537 --> 00:32:19,504 It's not coercive. 833 00:32:19,504 --> 00:32:22,541 It's an offer that distorts somebody's judgment 834 00:32:23,008 --> 00:32:26,311 or entices them to do something that they actually 835 00:32:27,779 --> 00:32:30,594 it's against their interests or they really don't want to do 836 00:32:30,594 --> 00:32:30,782 it. 837 00:32:31,449 --> 00:32:34,452 And this is tricky too, because if you think about, 838 00:32:34,753 --> 00:32:38,023 you know, if you give somebody an incentive to do something 839 00:32:38,623 --> 00:32:42,327 that's not necessarily an undue incentive, right? 840 00:32:42,327 --> 00:32:46,531 If you get paid to come to work, you're not unduly being 841 00:32:46,531 --> 00:32:47,432 influenced. 842 00:32:48,366 --> 00:32:50,862 So there's a line between what an incentive 843 00:32:50,862 --> 00:32:51,036 is 844 00:32:51,036 --> 00:32:54,329 and what's okay as an incentive and what's excessive or 845 00:32:54,329 --> 00:32:55,407 inappropriate or, 846 00:32:56,842 --> 00:32:59,311 makes people do things against their own interests 847 00:32:59,311 --> 00:33:02,280 or distorts their judgment. 848 00:33:02,881 --> 00:33:06,218 What could influence voluntariness in research? 849 00:33:06,218 --> 00:33:09,356 Well, certainly things like dependent position or power 850 00:33:09,356 --> 00:33:10,155 relationship. 851 00:33:10,155 --> 00:33:12,617 So if you're dependent position, meaning, 852 00:33:12,617 --> 00:33:13,758 your boss asks you 853 00:33:13,758 --> 00:33:17,195 to participate in a study or maybe even your doctor, 854 00:33:18,230 --> 00:33:21,600 for somebody you feel subservient 855 00:33:21,600 --> 00:33:24,456 to in some way, in a power relationship, 856 00:33:24,456 --> 00:33:25,170 pressure. 857 00:33:25,370 --> 00:33:27,239 And these are all overlap. 858 00:33:27,239 --> 00:33:30,542 A little bit pressure from somebody can also influence 859 00:33:30,542 --> 00:33:33,912 your voluntariness in terms of making a decision. 860 00:33:34,279 --> 00:33:36,848 And that could be from a number of sources. 861 00:33:36,848 --> 00:33:39,375 It could be from the research team, could also be from your 862 00:33:39,375 --> 00:33:39,718 family. 863 00:33:39,718 --> 00:33:42,287 It could be from your friends, it could be from, 864 00:33:42,287 --> 00:33:44,189 you know, the fact that you have no money. 865 00:33:44,189 --> 00:33:46,460 I mean, there are ways in which pressure 866 00:33:46,460 --> 00:33:47,993 comes from lots of things. 867 00:33:48,793 --> 00:33:50,448 Trust in the health care providers 868 00:33:50,448 --> 00:33:52,297 is one that people worry about there. 869 00:33:52,297 --> 00:33:53,531 But I know lots. 870 00:33:53,531 --> 00:33:55,400 There are several studies that suggest that people 871 00:33:55,400 --> 00:33:57,335 who make decisions about participating in research 872 00:33:57,335 --> 00:34:00,338 make them based on my doctor told me to do it, 873 00:34:00,872 --> 00:34:03,441 and without really paying attention 874 00:34:03,441 --> 00:34:05,160 to what's being asked of them or what 875 00:34:05,160 --> 00:34:06,878 the risks and benefits might entail. 876 00:34:07,746 --> 00:34:11,098 And this is, there's again, a small amount 877 00:34:11,098 --> 00:34:13,652 of literature on the dual role. 878 00:34:13,652 --> 00:34:17,556 So a physician who is also part of a study 879 00:34:17,789 --> 00:34:21,159 inviting their patients to be part of the study, 880 00:34:21,393 --> 00:34:24,396 that sort of is a at least precariously, 881 00:34:25,263 --> 00:34:27,432 influence on voluntariness. 882 00:34:28,833 --> 00:34:29,901 Then there's some other things 883 00:34:29,901 --> 00:34:32,438 that people worry about, but I think they're less 884 00:34:32,438 --> 00:34:32,904 clearly, 885 00:34:33,972 --> 00:34:36,074 direct influences on voluntariness. 886 00:34:36,074 --> 00:34:37,175 So one of the ones that 887 00:34:37,175 --> 00:34:39,771 I've been interested in over many years is restricted 888 00:34:39,771 --> 00:34:40,211 choices. 889 00:34:40,211 --> 00:34:42,999 Now, if you don't have a lot of alternatives for doing 890 00:34:42,999 --> 00:34:43,515 something 891 00:34:43,748 --> 00:34:45,780 and you decide, this is what I want to do, 892 00:34:45,780 --> 00:34:46,651 does that make it 893 00:34:46,651 --> 00:34:49,575 less voluntary than it would be if you had a whole bunch of 894 00:34:49,575 --> 00:34:50,021 choices? 895 00:34:50,588 --> 00:34:51,623 I don't think so. 896 00:34:51,623 --> 00:34:54,064 But some people do that, you know, you 897 00:34:54,064 --> 00:34:56,761 have to sort of put the context in there. 898 00:34:56,761 --> 00:34:58,843 And the same way with illness, you know, 899 00:34:58,843 --> 00:35:00,665 if you're sick, you may have less, 900 00:35:01,600 --> 00:35:03,134 you may feel like you have less choices. 901 00:35:03,134 --> 00:35:07,272 You may have less, interest in, making choices. 902 00:35:07,272 --> 00:35:09,841 You may put more trust in your providers. 903 00:35:09,841 --> 00:35:11,926 There could be lots of things that would influence your 904 00:35:11,926 --> 00:35:12,344 ability to 905 00:35:12,344 --> 00:35:13,478 make a voluntary choice, 906 00:35:14,679 --> 00:35:16,548 in addition to 907 00:35:16,548 --> 00:35:19,004 not confusion, but less clarity on the 908 00:35:19,004 --> 00:35:19,651 concepts. 909 00:35:19,985 --> 00:35:23,254 There's also it's less clear how you measure voluntariness. 910 00:35:23,254 --> 00:35:25,924 So there's a couple of studies that I think are useful 911 00:35:25,924 --> 00:35:27,611 for a couple things to think about that 912 00:35:27,611 --> 00:35:29,427 are useful, that you can find in studies. 913 00:35:29,928 --> 00:35:32,931 One is do people report feeling pressure from others? 914 00:35:33,264 --> 00:35:37,081 And for the most part, people, the number of people who report 915 00:35:37,081 --> 00:35:37,636 pressure 916 00:35:37,636 --> 00:35:39,836 from others, including family members 917 00:35:39,836 --> 00:35:41,740 and and doctors, is pretty low. 918 00:35:42,173 --> 00:35:45,176 But in many studies, people report pressure from 919 00:35:45,543 --> 00:35:47,979 the fact that they have a disease. 920 00:35:47,979 --> 00:35:49,080 You know, they really feel like 921 00:35:49,080 --> 00:35:51,797 they have to do something and that feels like pressure to 922 00:35:51,797 --> 00:35:52,083 them. 923 00:35:52,550 --> 00:35:55,286 There's a question about, do people know they can quit 924 00:35:55,286 --> 00:35:57,088 or that it's a voluntary choice? 925 00:35:57,088 --> 00:35:59,758 And again, the range is all over the place. 926 00:35:59,758 --> 00:36:01,582 And then you could look at numbers 927 00:36:01,582 --> 00:36:03,728 of who actually declines, who's offered 928 00:36:03,728 --> 00:36:05,574 study, who's offered participation 929 00:36:05,574 --> 00:36:07,365 and doesn't doesn't participate. 930 00:36:10,368 --> 00:36:11,202 The Coleman 931 00:36:11,202 --> 00:36:14,172 and Doug Watson are, well, again, 932 00:36:14,172 --> 00:36:17,175 a few years back did an interesting, 933 00:36:18,043 --> 00:36:20,742 paper in the Journal of Empirical Research 934 00:36:20,742 --> 00:36:22,414 on Human Research Ethics, 935 00:36:22,414 --> 00:36:24,971 where they talked about how to measure 936 00:36:24,971 --> 00:36:26,317 voluntariness. And, 937 00:36:27,419 --> 00:36:30,468 they basically said there's some indication of how 938 00:36:30,468 --> 00:36:30,955 we can, 939 00:36:32,023 --> 00:36:33,812 measure it, but we really don't have any 940 00:36:33,812 --> 00:36:34,259 consensus 941 00:36:34,259 --> 00:36:36,999 on how we understand whether something is voluntary 942 00:36:36,999 --> 00:36:37,429 or not. 943 00:36:38,129 --> 00:36:40,632 And then we have these data that I've showed you already. 944 00:36:40,632 --> 00:36:44,869 And if you look at, for example, the two inside that circle, 945 00:36:44,869 --> 00:36:46,521 voluntary nature of participation 946 00:36:46,521 --> 00:36:48,373 and freedom to withdraw at any time, 947 00:36:49,140 --> 00:36:51,363 you know, you might say, okay, 75% 948 00:36:51,363 --> 00:36:53,912 more or less know that those are true, 949 00:36:54,245 --> 00:36:56,214 but then these 25% don't. 950 00:36:56,214 --> 00:36:59,665 And so the question is, is that good enough or should we be 951 00:36:59,665 --> 00:37:00,952 doing better on that? 952 00:37:02,487 --> 00:37:05,623 So informed consent is complex. 953 00:37:05,623 --> 00:37:07,926 There's enduring challenges. 954 00:37:07,926 --> 00:37:10,995 And it's affected by a number of different things. 955 00:37:10,995 --> 00:37:13,574 Some of which I've mentioned. And you're going to hear about 956 00:37:13,574 --> 00:37:13,832 more. 957 00:37:13,832 --> 00:37:16,668 I just want to spend five minutes is all I have left 958 00:37:16,668 --> 00:37:18,136 to talk about some of the changes. 959 00:37:18,136 --> 00:37:22,073 So we've had certainly, lots of kinds of research 960 00:37:22,073 --> 00:37:25,393 that have grown in recent years, like biobanks and data 961 00:37:25,393 --> 00:37:26,177 repositories 962 00:37:26,177 --> 00:37:28,786 and research with big data, pragmatic trials and 963 00:37:28,786 --> 00:37:29,981 decentralized trials. 964 00:37:30,248 --> 00:37:32,884 All of these pros, 965 00:37:32,884 --> 00:37:34,686 I don't know if challenges is too strong of a word, 966 00:37:34,686 --> 00:37:37,755 but you have to think carefully about how you get consent 967 00:37:37,755 --> 00:37:39,714 in these contexts, which is different 968 00:37:39,714 --> 00:37:41,726 than the sort of traditional sit down 969 00:37:41,726 --> 00:37:44,825 with somebody in a clinic and to ask them to join a 970 00:37:44,825 --> 00:37:45,797 clinical trial. 971 00:37:46,498 --> 00:37:49,027 And of course, as I've already alluded to, 972 00:37:49,027 --> 00:37:51,136 there are lots of ways to exchange 973 00:37:51,136 --> 00:37:53,076 information and to get verification 974 00:37:53,076 --> 00:37:54,739 and authorization of consent, 975 00:37:55,140 --> 00:37:59,310 including electronic devices, apps, web interfaces, etc. 976 00:37:59,711 --> 00:38:00,678 all of these, 977 00:38:02,680 --> 00:38:06,618 are offer advantages in certain ways, 978 00:38:06,618 --> 00:38:09,621 but also offer some challenges in certain ways. 979 00:38:10,755 --> 00:38:14,859 Despite the way that consent is obtained, 980 00:38:15,160 --> 00:38:18,463 whether it's on the old fashioned paper 981 00:38:18,463 --> 00:38:21,301 sitting down with a participant in a room, 982 00:38:21,301 --> 00:38:23,868 or it's through a decentralized trial 983 00:38:23,868 --> 00:38:26,852 and there's an app and there's a remote interaction or 984 00:38:26,852 --> 00:38:27,405 whatever, 985 00:38:27,739 --> 00:38:30,804 there's still require you still have to think through 986 00:38:30,804 --> 00:38:31,209 what's 987 00:38:31,209 --> 00:38:33,195 the information we're going to be giving, 988 00:38:33,195 --> 00:38:34,746 what's the disclosure elements? 989 00:38:35,914 --> 00:38:38,082 How do we, 990 00:38:38,082 --> 00:38:39,681 first decide how much people have 991 00:38:39,681 --> 00:38:41,619 to understand in order to give consent? 992 00:38:41,619 --> 00:38:44,622 And how do we assess whether they are understanding 993 00:38:44,822 --> 00:38:46,818 and how do we know if it's voluntary 994 00:38:46,818 --> 00:38:48,259 and some of these remote? 995 00:38:49,894 --> 00:38:51,963 Methods of obtaining consent 996 00:38:51,963 --> 00:38:55,433 offer convenience to people and opportunities 997 00:38:55,433 --> 00:38:57,435 that they might not otherwise have, 998 00:38:57,435 --> 00:38:59,326 but it also offers some challenges 999 00:38:59,326 --> 00:39:00,271 in these domains 1000 00:39:00,271 --> 00:39:01,851 because you don't see the person, 1001 00:39:01,851 --> 00:39:03,575 you can't read their body language. 1002 00:39:03,875 --> 00:39:06,500 You have to identify their sorry, verify 1003 00:39:06,500 --> 00:39:07,879 their identity even. 1004 00:39:08,246 --> 00:39:09,864 I mean, there's different challenges 1005 00:39:09,864 --> 00:39:11,482 that come with how do you know that 1006 00:39:11,482 --> 00:39:14,100 something is voluntary when you can't even see the 1007 00:39:14,100 --> 00:39:14,519 person? 1008 00:39:17,522 --> 00:39:19,324 So that's the end 1009 00:39:19,324 --> 00:39:21,893 I messed up, I'll let you read this too. 1010 00:39:21,893 --> 00:39:22,160 That's.