1 00:00:11,979 --> 00:00:12,479 I'm going to 2 00:00:12,479 --> 00:00:15,582 spend our last, session for today. 3 00:00:15,582 --> 00:00:18,295 Last lecture for today on a little more 4 00:00:18,295 --> 00:00:20,521 on institutional review boards. 5 00:00:22,422 --> 00:00:23,724 Here's my disclaimer again. 6 00:00:23,724 --> 00:00:26,326 You'll see that again. 7 00:00:26,326 --> 00:00:29,396 So there are, 8 00:00:29,396 --> 00:00:31,798 in my opinion and the opinion of others, 9 00:00:31,798 --> 00:00:35,168 at least two really important pillars 10 00:00:35,168 --> 00:00:37,504 in the protection of human subjects 11 00:00:37,504 --> 00:00:38,171 research. 12 00:00:38,972 --> 00:00:40,936 One is the Institutional Review Board, 13 00:00:40,936 --> 00:00:42,175 which we'll talk about. 14 00:00:42,175 --> 00:00:45,178 And the second is informed consent. 15 00:00:45,379 --> 00:00:49,416 The institutional review boards responsibility 16 00:00:49,416 --> 00:00:52,104 is to make sure that the research 17 00:00:52,104 --> 00:00:54,955 that they review is not too risky, 18 00:00:55,322 --> 00:00:58,892 respects the participants recruit notes in a way 19 00:00:58,892 --> 00:01:02,329 that's equitably, appropriate, etc.. 20 00:01:02,763 --> 00:01:05,365 So one can assume 21 00:01:05,365 --> 00:01:08,368 or the system is set up so that one can assume 22 00:01:08,568 --> 00:01:10,958 that if the Institutional Review Board 23 00:01:10,958 --> 00:01:13,473 has reviewed and approved the research, 24 00:01:13,974 --> 00:01:18,040 it's considered safe for an individual to 25 00:01:18,040 --> 00:01:21,114 then provide informed consent. 26 00:01:22,249 --> 00:01:22,616 If we 27 00:01:22,616 --> 00:01:25,652 didn't have institutional review boards, right, investigators 28 00:01:25,652 --> 00:01:29,370 could go directly to individuals and ask them to be in their 29 00:01:29,370 --> 00:01:29,990 research. 30 00:01:30,590 --> 00:01:33,827 We saw some examples of how that can go wrong. 31 00:01:35,128 --> 00:01:37,030 But just a reminder that 32 00:01:37,030 --> 00:01:40,867 when we talk about how the system protects 33 00:01:40,867 --> 00:01:42,946 human subjects, we're going to talk 34 00:01:42,946 --> 00:01:44,371 about the review board. 35 00:01:44,371 --> 00:01:47,368 And then next week we have a whole day on informed 36 00:01:47,368 --> 00:01:47,908 consent. 37 00:01:47,908 --> 00:01:50,143 Doctor Grady will be back. 38 00:01:50,143 --> 00:01:52,734 Doctor Scott Kim, also on our faculty will be 39 00:01:52,734 --> 00:01:53,080 back, 40 00:01:53,080 --> 00:01:55,370 and we'll have someone from the National 41 00:01:55,370 --> 00:01:56,917 Institute of Mental Health 42 00:01:56,917 --> 00:02:00,531 talking about how they assess capacity here at the clinical 43 00:02:00,531 --> 00:02:01,021 center. 44 00:02:02,189 --> 00:02:04,673 So here are the sort of key points 45 00:02:04,673 --> 00:02:06,426 that I want you to get. 46 00:02:06,426 --> 00:02:08,564 And, if you don't get anything else, 47 00:02:08,564 --> 00:02:10,464 these are the important things. 48 00:02:10,931 --> 00:02:15,802 So first, IRBs are responsible for their review 49 00:02:15,802 --> 00:02:18,927 and oversight of all human subject 50 00:02:18,927 --> 00:02:20,674 research conducted 51 00:02:21,408 --> 00:02:26,441 in the United States at an academic medical center 52 00:02:26,441 --> 00:02:27,347 that has 53 00:02:28,882 --> 00:02:30,651 sought and gained a 54 00:02:30,651 --> 00:02:32,837 federal wide assurance from the Office 55 00:02:32,837 --> 00:02:34,621 of Human Research Protections. 56 00:02:34,621 --> 00:02:37,457 That's the HHS level. 57 00:02:37,457 --> 00:02:42,270 Office to review all research that happens at their 58 00:02:42,270 --> 00:02:43,497 institution. 59 00:02:43,497 --> 00:02:46,233 And I'll talk a little more about that. 60 00:02:46,233 --> 00:02:49,603 But I wanted to just make the point that 61 00:02:50,737 --> 00:02:53,607 outside of the United States, 62 00:02:53,607 --> 00:02:57,778 these bodies are called ethical review boards, 63 00:02:58,078 --> 00:03:01,434 independent ethics committees, research ethics committees, 64 00:03:01,434 --> 00:03:01,782 etc.. 65 00:03:01,782 --> 00:03:04,748 So for those of you who are in places 66 00:03:04,748 --> 00:03:07,154 other than the United States, 67 00:03:07,154 --> 00:03:10,924 a lot of what I'm going to cover is similar to what 68 00:03:11,258 --> 00:03:15,562 these boards do in other countries today. 69 00:03:15,862 --> 00:03:20,434 Most countries that actively are engaged or 70 00:03:20,434 --> 00:03:22,386 their investigators are actually engaged 71 00:03:22,386 --> 00:03:23,703 in human subject research, 72 00:03:24,004 --> 00:03:27,808 have some sort of review and oversight mechanism 73 00:03:28,108 --> 00:03:32,679 to protect the citizens of their country or their region. 74 00:03:34,715 --> 00:03:35,082 In the 75 00:03:35,082 --> 00:03:38,505 United States, IRBs are guided in their 76 00:03:38,505 --> 00:03:39,119 review 77 00:03:39,119 --> 00:03:42,622 by those two federal regulations that doctor Grady mentioned. 78 00:03:43,123 --> 00:03:46,293 There's one that covers all of HHS 79 00:03:46,293 --> 00:03:50,831 and the key component of that of 4645 80 00:03:51,031 --> 00:03:56,369 for a life road around 45 CFR 46 also applies to. 81 00:03:56,369 --> 00:03:59,583 That's called the common rule because it 82 00:03:59,583 --> 00:04:02,876 applies to 17 other federal departments. 83 00:04:03,376 --> 00:04:06,046 So the Department of Energy, 84 00:04:06,046 --> 00:04:08,882 the Department of 85 00:04:08,882 --> 00:04:11,384 Housing and Urban Development, etc., 86 00:04:11,384 --> 00:04:14,855 so the key federal regulations 87 00:04:14,855 --> 00:04:17,858 in the United States are the HHS ones. 88 00:04:17,858 --> 00:04:20,961 And when it comes to the review and approval of drugs, 89 00:04:20,961 --> 00:04:22,863 the FDA kicks in as well. 90 00:04:22,863 --> 00:04:25,232 And they're very similar. 91 00:04:25,232 --> 00:04:28,235 IRBs in the United States are local, 92 00:04:28,235 --> 00:04:30,415 meaning that every academic medical 93 00:04:30,415 --> 00:04:31,037 institute 94 00:04:31,037 --> 00:04:35,922 that is conducting human subject research has a local IRB or 95 00:04:35,922 --> 00:04:37,144 multiple IRBs. 96 00:04:37,477 --> 00:04:39,346 I used to work at Johns Hopkins. 97 00:04:39,346 --> 00:04:42,282 I sat on a medical school IRB. 98 00:04:42,282 --> 00:04:45,819 There were seven IRBs to review 99 00:04:46,019 --> 00:04:49,031 and approve all the research that was happening at the 100 00:04:49,031 --> 00:04:49,756 institution, 101 00:04:50,090 --> 00:04:52,280 and they were all local in the sense 102 00:04:52,280 --> 00:04:53,193 that we needed 103 00:04:53,193 --> 00:04:55,065 seven to keep up with the amount of 104 00:04:55,065 --> 00:04:56,563 research that was going on. 105 00:04:58,498 --> 00:04:59,966 Those local groups can 106 00:04:59,966 --> 00:05:02,209 develop their own policy and practice 107 00:05:02,209 --> 00:05:04,271 based on the federal regulations. 108 00:05:04,271 --> 00:05:08,236 They can be more strict, but the set of regulations are the 109 00:05:08,236 --> 00:05:08,909 baseline. 110 00:05:09,509 --> 00:05:14,376 And outside of the US, IRBs are sometimes local, sometimes 111 00:05:14,376 --> 00:05:15,215 regional. 112 00:05:15,215 --> 00:05:20,287 So, in the UK it's done by regions. 113 00:05:20,720 --> 00:05:23,757 In other countries there is a national IAB. 114 00:05:23,957 --> 00:05:27,661 In Uganda, for example, there are both local committees, 115 00:05:28,128 --> 00:05:31,577 attached to academic institutions 116 00:05:31,577 --> 00:05:33,667 and a national IRB. 117 00:05:33,667 --> 00:05:36,315 So all to say for those of you out there 118 00:05:36,315 --> 00:05:37,838 who are not in the US, 119 00:05:38,305 --> 00:05:41,803 you might want to find out how the system works in your 120 00:05:41,803 --> 00:05:42,375 setting. 121 00:05:43,710 --> 00:05:46,780 And the one thing I wanted to say is, 122 00:05:47,214 --> 00:05:51,006 if you're doing research and you have a question and you 123 00:05:51,006 --> 00:05:51,751 don't know 124 00:05:51,751 --> 00:05:55,237 if it needs to be your research, it needs to be submitted to the 125 00:05:55,237 --> 00:05:55,455 IRB 126 00:05:55,455 --> 00:05:57,457 or how to think about the research 127 00:05:57,457 --> 00:05:58,458 you're planning. 128 00:05:58,792 --> 00:06:00,026 Ask them. 129 00:06:00,026 --> 00:06:02,796 They are there to help investigators 130 00:06:02,796 --> 00:06:05,552 navigate their research and to make sure 131 00:06:05,552 --> 00:06:08,101 that it meets the ethical standards. 132 00:06:08,101 --> 00:06:12,606 So when in doubt, go and find that institution, 133 00:06:12,606 --> 00:06:15,428 whether it's local, regional, national 134 00:06:15,428 --> 00:06:17,210 and ask them questions. 135 00:06:18,144 --> 00:06:20,313 So this is just a reiteration 136 00:06:20,313 --> 00:06:24,117 of that independent review ethical requirement. 137 00:06:24,551 --> 00:06:28,555 And the IRB is meant to review the research. 138 00:06:28,955 --> 00:06:33,084 And it's meant to be reviewed by individuals who are not 139 00:06:33,084 --> 00:06:34,928 conducting the research. 140 00:06:35,996 --> 00:06:36,529 The goal 141 00:06:36,529 --> 00:06:40,533 is to assure some public and social accountability. 142 00:06:40,533 --> 00:06:41,334 Right. 143 00:06:41,334 --> 00:06:44,337 If you are thinking about enrolling in research, 144 00:06:44,838 --> 00:06:47,374 you may have no idea what an IRB is. 145 00:06:47,374 --> 00:06:49,774 But if you did know what an AI IRB 146 00:06:49,774 --> 00:06:52,245 is, that would give you some sense 147 00:06:52,245 --> 00:06:55,482 that a learned body has reviewed 148 00:06:55,482 --> 00:06:58,485 the research and considered it safe. 149 00:06:58,485 --> 00:07:01,212 The IRB is also there to minimize 150 00:07:01,212 --> 00:07:02,122 the impact 151 00:07:02,122 --> 00:07:05,258 of potential researcher conflict of interest. 152 00:07:06,493 --> 00:07:08,985 And this is a just a great quote that I 153 00:07:08,985 --> 00:07:09,496 really, 154 00:07:09,729 --> 00:07:12,432 I use every time I talk about IRBs 155 00:07:12,432 --> 00:07:15,635 from Edgar and Rosman back in 1995. 156 00:07:16,236 --> 00:07:18,798 Unquestionably, their very existence 157 00:07:18,798 --> 00:07:21,574 has tempered the inevitable propensity 158 00:07:21,574 --> 00:07:24,082 of researchers to pursue investigations 159 00:07:24,082 --> 00:07:26,846 without dispassionately weighing the risks 160 00:07:27,847 --> 00:07:31,043 they are asking others to assume or fully informing their 161 00:07:31,043 --> 00:07:32,052 subjects of them. 162 00:07:32,385 --> 00:07:35,755 So another way to say this is just that 163 00:07:35,755 --> 00:07:39,225 IRBs exist, hopefully in their mind. 164 00:07:39,693 --> 00:07:43,003 Remind investigators that they have to think about 165 00:07:43,003 --> 00:07:43,863 the subjects 166 00:07:43,863 --> 00:07:47,934 and their research, and that there is a body that is going to 167 00:07:47,934 --> 00:07:48,468 review. 168 00:07:48,468 --> 00:07:51,639 So on one hand, you know, investigators 169 00:07:51,639 --> 00:07:54,240 might think, oh my gosh, right. 170 00:07:54,240 --> 00:07:56,109 This might be a cure. 171 00:07:56,109 --> 00:07:59,346 They might overestimate the potential benefit. 172 00:07:59,713 --> 00:08:02,157 That's why you have the Institutional 173 00:08:02,157 --> 00:08:03,016 Review Board 174 00:08:03,249 --> 00:08:06,924 to address that sort of inherent personal 175 00:08:06,924 --> 00:08:07,821 conflict. 176 00:08:07,821 --> 00:08:08,488 Right. 177 00:08:08,488 --> 00:08:12,332 If I'm doing a research project, of course I think it's going to 178 00:08:12,332 --> 00:08:12,692 work. 179 00:08:13,059 --> 00:08:17,293 But we do the research in order to find out if it 180 00:08:17,293 --> 00:08:17,897 works. 181 00:08:17,897 --> 00:08:20,767 If we knew it worked, we wouldn't have to do research. 182 00:08:20,767 --> 00:08:23,703 So the IRB says, hey, this is exciting. 183 00:08:23,703 --> 00:08:24,204 Let's make 184 00:08:24,204 --> 00:08:26,318 sure the plan is scientifically sound 185 00:08:26,318 --> 00:08:28,375 and appropriately protect subjects. 186 00:08:28,375 --> 00:08:30,076 So they're bit of a guardrail 187 00:08:30,076 --> 00:08:32,982 for investigators when it comes to conflict of 188 00:08:32,982 --> 00:08:33,613 interest. 189 00:08:34,714 --> 00:08:36,316 I'm just going to touch on a 190 00:08:36,316 --> 00:08:40,153 number of key components of what I IRBs do. 191 00:08:41,221 --> 00:08:43,056 Happy to answer questions. 192 00:08:43,056 --> 00:08:49,062 And as will always be the case, we have put readings on canvas. 193 00:08:49,062 --> 00:08:51,829 For those of you who want to learn more about 194 00:08:51,829 --> 00:08:52,198 IRBs, 195 00:08:52,198 --> 00:08:55,722 there are articles about IRBs, so if you have questions about 196 00:08:55,722 --> 00:08:56,069 them, 197 00:08:56,069 --> 00:08:58,067 you can ask them today or ask them 198 00:08:58,067 --> 00:09:00,006 as we move forward in the class. 199 00:09:01,074 --> 00:09:03,443 So what is their role? 200 00:09:03,443 --> 00:09:06,046 As I said, their role is to review 201 00:09:06,046 --> 00:09:09,349 and oversee all the human subject research 202 00:09:09,349 --> 00:09:12,352 that's happening at an individual institution 203 00:09:13,286 --> 00:09:16,322 and in the United States, the IRB. 204 00:09:16,322 --> 00:09:19,248 When I say institutional review board, I'm 205 00:09:19,248 --> 00:09:21,895 referring to the group of individuals 206 00:09:22,128 --> 00:09:24,660 who are brought together to review 207 00:09:24,660 --> 00:09:27,267 a particular protocol or protocols 208 00:09:27,634 --> 00:09:31,818 and decide whether or not they ought to be approved or 209 00:09:31,818 --> 00:09:32,205 not. 210 00:09:33,072 --> 00:09:37,877 Often in the United States, IRBs are just one component 211 00:09:37,877 --> 00:09:41,166 of what's referred to as the Human Research Protection 212 00:09:41,166 --> 00:09:41,714 Program. 213 00:09:42,148 --> 00:09:47,120 So some institutions have IRBs, but there has to be 214 00:09:47,120 --> 00:09:50,957 an administrative infrastructure for that IRB to be supported. 215 00:09:51,324 --> 00:09:55,094 And so I may refer to today and moving forward, 216 00:09:55,495 --> 00:09:58,516 the Human Research Protection Program 217 00:09:58,516 --> 00:09:59,332 to convey 218 00:09:59,332 --> 00:10:03,292 the sort of administrative body that's in charge in the United 219 00:10:03,292 --> 00:10:03,803 States, 220 00:10:03,803 --> 00:10:07,129 according to the federal regulations, IRBs 221 00:10:07,129 --> 00:10:09,742 must have at least five members. 222 00:10:10,310 --> 00:10:16,349 And the, there are requirements for those five members. 223 00:10:16,816 --> 00:10:19,352 One of them has to be unaffiliated 224 00:10:19,352 --> 00:10:22,113 with the institution, and one has to be a 225 00:10:22,113 --> 00:10:23,123 non-scientist. 226 00:10:24,123 --> 00:10:24,524 When I'm 227 00:10:24,524 --> 00:10:26,888 not teaching, I do a lot of empirical 228 00:10:26,888 --> 00:10:27,527 research, 229 00:10:27,760 --> 00:10:31,898 about research ethics and worked on a study 230 00:10:32,298 --> 00:10:36,171 a couple of years ago where most IRBs have only one 231 00:10:36,171 --> 00:10:36,703 person 232 00:10:37,070 --> 00:10:40,673 who is both unaffiliated and a non-scientist. 233 00:10:41,007 --> 00:10:43,630 So that means there's only one person 234 00:10:43,630 --> 00:10:46,112 who is probably is not a physician 235 00:10:46,412 --> 00:10:49,382 or a PhD trained scientist. 236 00:10:49,816 --> 00:10:50,583 That's hard. 237 00:10:50,583 --> 00:10:54,557 I'm sorry to be the only person who's not a scientist in the 238 00:10:54,557 --> 00:10:54,954 room. 239 00:10:56,122 --> 00:10:57,911 Some countries, like New Zealand, for 240 00:10:57,911 --> 00:10:59,893 example, have very different approaches. 241 00:11:00,260 --> 00:11:02,706 Their equivalent institutional review 242 00:11:02,706 --> 00:11:03,897 board has to have 243 00:11:04,230 --> 00:11:08,535 one more member of the community than there are scientists. 244 00:11:08,535 --> 00:11:12,257 So if there are four scientists, they have to have five community 245 00:11:12,257 --> 00:11:12,772 members. 246 00:11:12,772 --> 00:11:16,268 So different countries have, set up their systems in 247 00:11:16,268 --> 00:11:17,277 different ways 248 00:11:17,277 --> 00:11:19,899 to make sure that sort of voice is at the 249 00:11:19,899 --> 00:11:20,346 table. 250 00:11:21,247 --> 00:11:23,383 There are a number of challenges 251 00:11:23,383 --> 00:11:26,635 in sort of essential to an institutional review 252 00:11:26,635 --> 00:11:27,120 board. 253 00:11:27,453 --> 00:11:30,089 One is the individual conflict of interest. 254 00:11:30,089 --> 00:11:32,978 So we can sort of quickly deal with that 255 00:11:32,978 --> 00:11:35,361 with IRBs if I'm doing research. 256 00:11:35,361 --> 00:11:37,131 So I happen to be on the IRB here 257 00:11:37,131 --> 00:11:38,364 at the Clinical Center 258 00:11:38,932 --> 00:11:41,734 when I submit my research to the IRB, 259 00:11:41,734 --> 00:11:45,605 I can't be on the IRB when my research is reviewed. 260 00:11:45,605 --> 00:11:45,972 Right. 261 00:11:45,972 --> 00:11:49,142 So that's a pretty clear way to remove 262 00:11:49,142 --> 00:11:51,049 the conflict of interest that I would have 263 00:11:51,049 --> 00:11:52,412 if I was sitting in the room. 264 00:11:52,412 --> 00:11:54,072 Of course, I would say it's awesome 265 00:11:54,072 --> 00:11:55,448 and it needs to be approved. 266 00:11:56,883 --> 00:11:58,151 Or let's say my 267 00:11:58,151 --> 00:12:01,296 supervisor, Doctor Grady, is my supervisor, 268 00:12:01,296 --> 00:12:01,955 Christy. 269 00:12:01,955 --> 00:12:04,286 I'm working with Christine on a project 270 00:12:04,286 --> 00:12:06,259 and her project comes to my IRB. 271 00:12:07,293 --> 00:12:09,425 I'm going to raise my hand and say, 272 00:12:09,425 --> 00:12:11,130 everybody, this is my boss. 273 00:12:11,598 --> 00:12:13,566 She has a supervisory role over me. 274 00:12:13,566 --> 00:12:16,161 I don't feel like I'm the best person to review 275 00:12:16,161 --> 00:12:16,603 there's 276 00:12:16,603 --> 00:12:21,107 so I can self recuse myself from the deliberations. 277 00:12:21,841 --> 00:12:26,012 Now the outside of the NIH, 278 00:12:27,213 --> 00:12:29,901 almost all research conducted at academic 279 00:12:29,901 --> 00:12:30,950 medical centers 280 00:12:30,950 --> 00:12:33,525 is funded by the National Institutes of 281 00:12:33,525 --> 00:12:34,053 Health. 282 00:12:34,787 --> 00:12:38,424 And so imagine you are an IRB member 283 00:12:38,658 --> 00:12:41,761 at Johns Hopkins as an example. 284 00:12:43,596 --> 00:12:45,198 What happens is, 285 00:12:45,198 --> 00:12:49,435 if your grant to the NIH is funded, 286 00:12:49,869 --> 00:12:52,672 it is then reviewed by the Institute 287 00:12:52,672 --> 00:12:56,342 review Board at your institution before it can be implemented. 288 00:12:58,244 --> 00:13:01,247 If the IRB is the sort of, 289 00:13:02,181 --> 00:13:04,751 only thing between the research 290 00:13:04,751 --> 00:13:08,889 getting done and the, you know, getting the 291 00:13:08,889 --> 00:13:09,756 funding, 292 00:13:10,423 --> 00:13:14,605 then the IRB itself has a conflict of interest, 293 00:13:14,605 --> 00:13:15,228 right? 294 00:13:15,228 --> 00:13:17,453 That if the IRB doesn't approve it, 295 00:13:17,453 --> 00:13:19,932 the institution doesn't get the money. 296 00:13:20,466 --> 00:13:23,032 Now, that's not to say that therefore 297 00:13:23,032 --> 00:13:24,003 all our views 298 00:13:24,003 --> 00:13:27,073 are essentially conflicted and can't do their job. 299 00:13:27,440 --> 00:13:29,976 Fortunately, that doesn't mean that. 300 00:13:29,976 --> 00:13:32,979 But I make that point just because 301 00:13:33,346 --> 00:13:36,315 there are conflicts of interest and tensions. 302 00:13:36,315 --> 00:13:38,180 When we talk about ethics, when we talk 303 00:13:38,180 --> 00:13:39,852 about the infrastructure developed 304 00:13:39,852 --> 00:13:42,855 to sort of over, you know, overview 305 00:13:42,855 --> 00:13:45,858 to oversee the ethics in, 306 00:13:46,225 --> 00:13:50,209 any sort of, you know, any sort of system set 307 00:13:50,209 --> 00:13:50,563 up. 308 00:13:50,563 --> 00:13:53,700 So institutional review boards informed consent. 309 00:13:53,700 --> 00:13:54,067 Right. 310 00:13:54,067 --> 00:13:57,003 Again, really quick digression to informed consent. 311 00:13:57,003 --> 00:13:58,604 I'm the investigator. 312 00:13:58,604 --> 00:14:01,040 You're someone who I want to enroll in your study. 313 00:14:02,709 --> 00:14:05,478 I might have the incentive to not tell you 314 00:14:05,478 --> 00:14:07,924 about the really problematic risk, 315 00:14:07,924 --> 00:14:10,083 even though it's in the form. 316 00:14:10,083 --> 00:14:12,897 I'm not going to point it out because I really want you to 317 00:14:12,897 --> 00:14:13,286 enroll. 318 00:14:13,519 --> 00:14:16,322 So only to say, this will be a 319 00:14:16,322 --> 00:14:19,352 theme as we move forward, that there are going to be 320 00:14:19,352 --> 00:14:19,992 challenges 321 00:14:20,293 --> 00:14:23,427 even when we set up systems to hopefully make the system 322 00:14:23,427 --> 00:14:23,763 work. 323 00:14:24,897 --> 00:14:26,933 And then group dynamic dynamics 324 00:14:26,933 --> 00:14:29,936 is another issue that relates to IRB. 325 00:14:29,936 --> 00:14:34,284 So I've served on many IRBs over the many years of my 326 00:14:34,284 --> 00:14:34,941 career, 327 00:14:35,341 --> 00:14:38,344 and they are 328 00:14:38,344 --> 00:14:40,980 bodies that sometimes have been together 329 00:14:40,980 --> 00:14:44,183 for ten, 15 more years. 330 00:14:44,484 --> 00:14:47,386 Some IRBs don't have any term limits, 331 00:14:47,386 --> 00:14:50,389 so you can sort of 332 00:14:50,389 --> 00:14:53,259 encounter observer drift 333 00:14:53,259 --> 00:14:55,928 or sort of everyone cedes to this person 334 00:14:55,928 --> 00:14:57,463 when it comes to that, 335 00:14:57,463 --> 00:15:00,600 or the chair has a lot of say or sway. 336 00:15:00,800 --> 00:15:04,570 So there are things that any group 337 00:15:04,570 --> 00:15:07,707 that's together for a long time may encounter. 338 00:15:07,707 --> 00:15:10,810 Because of that, some IRBs do set term limits. 339 00:15:10,810 --> 00:15:14,180 So when I was at the School of Public Health at Hopkins, 340 00:15:14,447 --> 00:15:16,708 you could you would serve for three years 341 00:15:16,708 --> 00:15:18,417 and then you would rotate off. 342 00:15:18,417 --> 00:15:21,993 So the group was always had some carryover 343 00:15:21,993 --> 00:15:22,588 or not 344 00:15:22,588 --> 00:15:24,486 everybody sorry, not everybody's term 345 00:15:24,486 --> 00:15:26,025 limit ended at the same time. 346 00:15:26,359 --> 00:15:28,329 But that's a way to sort of address 347 00:15:28,329 --> 00:15:29,061 both needing 348 00:15:29,061 --> 00:15:32,574 the expertise and avoiding sort of groupthink 349 00:15:32,574 --> 00:15:33,432 attitudes. 350 00:15:34,700 --> 00:15:36,969 So why do we need this IRB? 351 00:15:36,969 --> 00:15:39,672 I've already alluded to this. 352 00:15:39,672 --> 00:15:42,608 The IRB needs to review 353 00:15:42,608 --> 00:15:45,878 any research that is funded by the NIH. 354 00:15:46,913 --> 00:15:49,916 Many other funders require ethics review. 355 00:15:50,516 --> 00:15:53,853 And that federal wide assurance that I mentioned before, 356 00:15:54,153 --> 00:15:57,156 when an academic medical center 357 00:15:57,623 --> 00:16:00,045 sets up a federal right assurance with the federal 358 00:16:00,045 --> 00:16:00,626 government, 359 00:16:00,960 --> 00:16:03,963 they say in their documentation, 360 00:16:03,963 --> 00:16:06,699 I will review all the research 361 00:16:06,699 --> 00:16:09,546 at my institution, regardless of the source of 362 00:16:09,546 --> 00:16:10,102 funding. 363 00:16:10,803 --> 00:16:13,641 So that means that at an academic 364 00:16:13,641 --> 00:16:16,909 medical center, all research, whether 365 00:16:16,909 --> 00:16:20,052 NIH funded, gates funded, self-funded, 366 00:16:20,052 --> 00:16:22,782 discretionary, fund funded, etc. 367 00:16:23,182 --> 00:16:24,550 it is all reviewed. 368 00:16:24,550 --> 00:16:27,560 So you can't escape quote unquote 369 00:16:27,560 --> 00:16:28,654 the review, 370 00:16:29,155 --> 00:16:33,533 by getting funding from a source other than the National 371 00:16:33,533 --> 00:16:34,393 Institutes 372 00:16:34,393 --> 00:16:38,405 of Health, when you're in the US and the FDA also requires IP 373 00:16:38,405 --> 00:16:38,931 review. 374 00:16:38,931 --> 00:16:43,575 So all pharmaceutical companies who hope to send a package of 375 00:16:43,575 --> 00:16:44,337 materials 376 00:16:44,337 --> 00:16:47,270 for marketing their drug in the future, 377 00:16:47,270 --> 00:16:49,075 the FDA's going to say, 378 00:16:49,375 --> 00:16:52,712 did you have an IRB review, all of these clinical protocols, 379 00:16:52,712 --> 00:16:55,281 and you need to be able to say of course I did 380 00:16:56,582 --> 00:16:56,816 this. 381 00:16:56,816 --> 00:17:00,152 Is that federal wide assurance that I just mentioned and just 382 00:17:00,152 --> 00:17:00,753 reiterates 383 00:17:01,053 --> 00:17:05,024 this idea that it review, you agree to review all, 384 00:17:07,059 --> 00:17:09,487 you review all research, regardless of 385 00:17:09,487 --> 00:17:10,062 funding. 386 00:17:10,396 --> 00:17:13,399 And two other things about this FHWa. 387 00:17:13,966 --> 00:17:19,105 One is that institutions outside of the United States 388 00:17:19,472 --> 00:17:22,975 can request a federal wide assurance. 389 00:17:23,342 --> 00:17:25,545 It's kind of weird, but it happens. 390 00:17:25,545 --> 00:17:28,419 And in that federal wide assurance, 391 00:17:28,419 --> 00:17:29,815 you have to note 392 00:17:30,016 --> 00:17:33,149 which regulation, which ethical code you're going 393 00:17:33,149 --> 00:17:33,853 to follow. 394 00:17:34,120 --> 00:17:35,488 In the United States. 395 00:17:35,488 --> 00:17:38,190 It's almost always the Belmont Report. 396 00:17:38,190 --> 00:17:41,110 And in international organizations, often 397 00:17:41,110 --> 00:17:44,030 they'll say the Declaration of Helsinki, 398 00:17:44,030 --> 00:17:46,073 because they don't have the Belmont Report 399 00:17:46,073 --> 00:17:46,365 done. 400 00:17:46,365 --> 00:17:48,067 The report is U.S. centric. 401 00:17:48,067 --> 00:17:51,137 Declaration of Helsinki is meant to be international. 402 00:17:51,804 --> 00:17:53,782 So you have to state at least what 403 00:17:53,782 --> 00:17:56,108 standard you're using as your baseline. 404 00:17:57,243 --> 00:17:58,277 So in terms of 405 00:17:58,277 --> 00:18:01,329 responsibilities, Doctor Grady mentioned these really 406 00:18:01,329 --> 00:18:01,847 quickly. 407 00:18:02,214 --> 00:18:06,252 These are the review criteria in the federal regulations. 408 00:18:06,552 --> 00:18:09,689 And I want you to notice that this 409 00:18:10,122 --> 00:18:13,292 this is verbatim, okay. 410 00:18:13,292 --> 00:18:16,362 This is all the direction that the IRB gets. 411 00:18:16,996 --> 00:18:19,356 Risks must be minimized reasonable 412 00:18:19,356 --> 00:18:21,300 when compared with benefit. 413 00:18:21,667 --> 00:18:22,034 Right. 414 00:18:22,034 --> 00:18:25,938 So there's a lot of discretion and a lot of responsibility 415 00:18:25,938 --> 00:18:29,216 on behalf of the IRB to figure out 416 00:18:29,216 --> 00:18:31,143 what are the risks. 417 00:18:31,577 --> 00:18:32,645 Are they minimized? 418 00:18:32,645 --> 00:18:34,447 How are we going to do that. 419 00:18:34,447 --> 00:18:35,581 Are they reasonable. 420 00:18:35,581 --> 00:18:38,284 What are the benefits. Are they in balance. 421 00:18:38,284 --> 00:18:41,354 So the regulations just don't 422 00:18:41,354 --> 00:18:45,758 give IRBs a lot of help, which means that most IRBs 423 00:18:45,758 --> 00:18:50,196 develop policies for their investigators 424 00:18:50,196 --> 00:18:53,199 and IRB members to follow. 425 00:18:53,666 --> 00:18:56,402 These are the additional review criteria. 426 00:18:56,402 --> 00:18:59,672 So most IRBs will obviously make sure 427 00:18:59,672 --> 00:19:02,741 that they tick a box related to each one of these 428 00:19:02,741 --> 00:19:03,242 things. 429 00:19:03,242 --> 00:19:06,885 We have checked and made sure that each of these things is 430 00:19:06,885 --> 00:19:07,513 true, but 431 00:19:08,280 --> 00:19:10,201 checking the box that safety monitoring 432 00:19:10,201 --> 00:19:11,384 provisions are in place 433 00:19:11,651 --> 00:19:14,918 isn't the same as looking at the provisions and making 434 00:19:14,918 --> 00:19:15,221 sure 435 00:19:15,221 --> 00:19:18,224 that you're confident that those will, 436 00:19:18,224 --> 00:19:20,722 in fact, be adequate for monitoring 437 00:19:20,722 --> 00:19:21,293 safety. 438 00:19:23,863 --> 00:19:25,731 There's additional criteria. 439 00:19:25,731 --> 00:19:28,640 So in addition to the local policy, 440 00:19:28,640 --> 00:19:30,302 NIH has guidelines. 441 00:19:30,302 --> 00:19:32,148 So we have a bunch of guidelines, 442 00:19:32,148 --> 00:19:34,273 for example, related to the inclusion 443 00:19:34,273 --> 00:19:38,811 of women, minorities, children, people who are older. 444 00:19:39,512 --> 00:19:42,415 So if a project is 445 00:19:42,415 --> 00:19:45,918 funded by the NIH, the IRB ought to be making sure 446 00:19:45,918 --> 00:19:49,522 that it is compliant with those NIH guidelines. 447 00:19:49,855 --> 00:19:53,426 Some states have particular or laws for IRB. 448 00:19:53,426 --> 00:19:55,860 So in Maryland, we would need to know 449 00:19:55,860 --> 00:19:58,097 what the Maryland state laws are. 450 00:19:58,531 --> 00:20:00,908 And Kristi mentioned the National 451 00:20:00,908 --> 00:20:01,701 Commission 452 00:20:01,701 --> 00:20:05,971 that was pulled together after the National Research Act. 453 00:20:06,972 --> 00:20:09,662 They put out a lot of recommendations 454 00:20:09,662 --> 00:20:11,043 and all subsequent 455 00:20:11,043 --> 00:20:14,713 national commissions have been created. 456 00:20:14,713 --> 00:20:15,448 Big reports, 457 00:20:15,448 --> 00:20:17,984 many of them are on the shelf in my office 458 00:20:17,984 --> 00:20:20,219 that add additional recommendations. 459 00:20:20,219 --> 00:20:24,390 So it's up to the IRB to decide, are we going to follow 460 00:20:24,390 --> 00:20:25,257 those recommendations? 461 00:20:25,257 --> 00:20:27,084 Should we use those recommendations 462 00:20:27,084 --> 00:20:28,494 to draft our local policy. 463 00:20:28,494 --> 00:20:32,364 So plenty to incorporate now 464 00:20:33,466 --> 00:20:37,203 what IRBs need to do is review research. 465 00:20:37,436 --> 00:20:39,560 And this is how research is defined 466 00:20:39,560 --> 00:20:40,773 in the regulations. 467 00:20:41,207 --> 00:20:44,977 A systematic investigation, including research, development, 468 00:20:44,977 --> 00:20:49,037 testing and evaluation design to contribute to generalizable 469 00:20:49,037 --> 00:20:49,782 knowledge. 470 00:20:49,782 --> 00:20:53,285 So that should remind you of scientific validity. 471 00:20:53,719 --> 00:20:56,555 So the idea here is that 472 00:20:56,555 --> 00:20:59,792 if you're doing this you have to go to the IRB. 473 00:21:00,626 --> 00:21:03,395 Now this creates some concerns. 474 00:21:03,395 --> 00:21:07,266 So I do a lot of qualitative research. 475 00:21:07,733 --> 00:21:11,070 My intent is not to contribute to generalizable knowledge. 476 00:21:11,403 --> 00:21:14,740 I'm exploring a phenomenon in order to identify themes 477 00:21:14,740 --> 00:21:16,769 and patterns that might be transferable 478 00:21:16,769 --> 00:21:17,810 to another setting. 479 00:21:18,210 --> 00:21:20,012 Am I doing research? 480 00:21:20,012 --> 00:21:21,113 Absolutely. 481 00:21:21,113 --> 00:21:24,416 So this is what's written in the code. 482 00:21:24,750 --> 00:21:27,239 But I IRBs need to be thinking about what 483 00:21:27,239 --> 00:21:29,789 does that really mean for my institution? 484 00:21:29,789 --> 00:21:32,199 If there's people like Holly, I don't want 485 00:21:32,199 --> 00:21:34,093 her research not to be reviewed. 486 00:21:34,093 --> 00:21:35,261 So we've got to make sure 487 00:21:35,261 --> 00:21:37,821 that everyone knows we're reviewing qualitative work 488 00:21:37,821 --> 00:21:38,264 as well. 489 00:21:38,697 --> 00:21:40,887 So these are the potential categories 490 00:21:40,887 --> 00:21:41,834 that the IRB is 491 00:21:41,834 --> 00:21:45,004 going to, apply to your research. 492 00:21:45,004 --> 00:21:48,232 One, they can say it's not human subject research and 493 00:21:48,232 --> 00:21:48,841 therefore 494 00:21:48,841 --> 00:21:52,760 you're not required to follow all of the rules and 495 00:21:52,760 --> 00:21:53,779 regulations. 496 00:21:54,246 --> 00:21:57,483 Some research is exempt from IRB review. 497 00:21:57,983 --> 00:22:00,019 You still have to submit your research 498 00:22:00,019 --> 00:22:02,821 to the IRB for them to determine that it's 499 00:22:02,821 --> 00:22:03,355 exempt. 500 00:22:03,756 --> 00:22:06,568 But one thing that all of the categories have 501 00:22:06,568 --> 00:22:07,193 in common 502 00:22:07,193 --> 00:22:10,362 is that it is no more than minimal risk, 503 00:22:10,362 --> 00:22:12,876 and it meets one of those criteria, 504 00:22:12,876 --> 00:22:15,534 the one that is most relevant to me, 505 00:22:15,534 --> 00:22:18,674 and those of my colleagues here at the Department of 506 00:22:18,674 --> 00:22:19,338 Bioethics, 507 00:22:19,338 --> 00:22:22,441 is that it's data collected without identifiers. 508 00:22:22,441 --> 00:22:24,588 So if I did a survey of all of you, 509 00:22:24,588 --> 00:22:26,612 about what you eat for breakfast 510 00:22:26,612 --> 00:22:29,615 this morning, social value quite low, 511 00:22:29,882 --> 00:22:31,872 but I would say we're going to do this 512 00:22:31,872 --> 00:22:34,019 and I'm not going to collect your names. 513 00:22:34,019 --> 00:22:36,584 I just want you to answer the questions 514 00:22:36,584 --> 00:22:38,490 that would qualify as exempt 515 00:22:38,490 --> 00:22:40,949 from IAB review, though they shouldn't approve it because 516 00:22:40,949 --> 00:22:42,027 there's no social value. 517 00:22:43,662 --> 00:22:45,564 The next category is expedited. 518 00:22:45,564 --> 00:22:49,368 Review expedited in this case doesn't mean faster, 519 00:22:49,702 --> 00:22:52,140 but it means that the research you're 520 00:22:52,140 --> 00:22:54,974 submitting is no more than a minimal risk, 521 00:22:55,541 --> 00:22:58,428 and it can be reviewed by a chairperson 522 00:22:58,428 --> 00:23:00,279 or experienced reviewer. 523 00:23:00,279 --> 00:23:03,048 So technically, it could be faster. 524 00:23:03,048 --> 00:23:05,184 It's not always faster. 525 00:23:05,184 --> 00:23:08,065 And then the final and sort of most important category as it 526 00:23:08,065 --> 00:23:08,354 comes 527 00:23:08,354 --> 00:23:10,808 when it comes to IRB is, is research 528 00:23:10,808 --> 00:23:13,058 that has more than minimal risk. 529 00:23:13,058 --> 00:23:15,303 So if your research has more than minimal 530 00:23:15,303 --> 00:23:17,329 risk and that's, you know, physical, 531 00:23:17,329 --> 00:23:20,799 psychological, etc., it has to be reviewed by a full 532 00:23:20,799 --> 00:23:21,533 committee. 533 00:23:22,868 --> 00:23:26,038 And that initial protocol 534 00:23:26,038 --> 00:23:28,438 that you submit goes through first 535 00:23:28,438 --> 00:23:30,909 and initial administrative review. 536 00:23:31,343 --> 00:23:34,713 This little diagram here is to just highlight 537 00:23:34,713 --> 00:23:39,918 that the IRB is separate from the administrative staff 538 00:23:39,918 --> 00:23:43,055 that are staffing the human research program. 539 00:23:43,389 --> 00:23:45,491 They're reviewing the research plan. 540 00:23:45,491 --> 00:23:48,120 And anything that's the potential subject 541 00:23:48,120 --> 00:23:48,761 will see. 542 00:23:48,961 --> 00:23:52,264 So that includes the consent the advertisements. 543 00:23:52,598 --> 00:23:56,735 And they also coordinate other ancillary reviews. 544 00:23:56,735 --> 00:24:00,272 So if there's a review of the pharmaceuticals 545 00:24:00,272 --> 00:24:03,099 or review of radiation or a review of Conflict of 546 00:24:03,099 --> 00:24:03,676 Interest, 547 00:24:04,109 --> 00:24:06,645 this group is coordinating that review 548 00:24:06,645 --> 00:24:09,114 and that'll be relevant in a second. 549 00:24:09,915 --> 00:24:13,052 Then the research goes to the IRB. 550 00:24:13,552 --> 00:24:15,120 They deliberate again. 551 00:24:15,120 --> 00:24:16,622 That's this group of experts. 552 00:24:16,622 --> 00:24:18,357 There's at least five of them. 553 00:24:18,357 --> 00:24:20,259 And they can do a couple of things. 554 00:24:20,259 --> 00:24:24,129 They can approve approve with stipulations 555 00:24:24,129 --> 00:24:26,065 defer or disapprove. 556 00:24:27,333 --> 00:24:29,935 In my experience, 557 00:24:29,935 --> 00:24:33,272 IRBs almost never disapprove. 558 00:24:33,605 --> 00:24:36,608 And part of that is because investigators 559 00:24:36,608 --> 00:24:39,244 these days know that their research 560 00:24:39,244 --> 00:24:42,142 has to sort of be at a particular standard 561 00:24:42,142 --> 00:24:44,350 in order to even be considered. 562 00:24:45,117 --> 00:24:48,287 Some research is deferred when there's sort 563 00:24:48,287 --> 00:24:52,891 of a big problem, it's on its way to approval. 564 00:24:52,891 --> 00:24:56,307 But they forgot to talk about how they're recruiting their 565 00:24:56,307 --> 00:24:56,895 subjects, 566 00:24:56,895 --> 00:24:59,574 or they forgot to include information 567 00:24:59,574 --> 00:25:00,733 about the risks 568 00:25:00,733 --> 00:25:03,736 that they're going to expose the subjects to 569 00:25:04,203 --> 00:25:06,572 approve with stipulations might just be something 570 00:25:06,572 --> 00:25:09,608 as as straightforward as you're approved, 571 00:25:09,608 --> 00:25:11,483 but you have to accept the revisions 572 00:25:11,483 --> 00:25:13,045 we made to your consent form. 573 00:25:13,912 --> 00:25:16,482 Straight up approval is also 574 00:25:16,482 --> 00:25:19,485 very seldom the case. 575 00:25:20,319 --> 00:25:23,489 When so when I was at, 576 00:25:23,489 --> 00:25:25,090 the School of Public Health at Johns 577 00:25:25,090 --> 00:25:25,491 Hopkins, 578 00:25:25,491 --> 00:25:28,727 you are all too young, probably to remember this, but 579 00:25:29,328 --> 00:25:33,232 the School of Medicine at Johns Hopkins was closed. 580 00:25:33,232 --> 00:25:36,301 Their IRB was shut down after a healthy 581 00:25:36,301 --> 00:25:39,571 volunteer died in an asthma study. 582 00:25:40,839 --> 00:25:42,474 One of the things that they said, 583 00:25:42,474 --> 00:25:47,312 oh, HRP who closed it down said is you have to re review 584 00:25:47,312 --> 00:25:50,766 all the research that you're conducting, thousands of 585 00:25:50,766 --> 00:25:51,483 protocols. 586 00:25:51,784 --> 00:25:54,787 A subset of those were, 587 00:25:56,054 --> 00:25:56,588 being 588 00:25:56,588 --> 00:25:59,017 conducted by School of Public Health 589 00:25:59,017 --> 00:25:59,625 faculty. 590 00:26:00,125 --> 00:26:04,225 I was on the group that had to that got to review all of that 591 00:26:04,225 --> 00:26:04,897 research. 592 00:26:04,897 --> 00:26:07,466 There were more than 50 protocols. 593 00:26:07,466 --> 00:26:10,469 We approved one without stipulations. 594 00:26:10,936 --> 00:26:14,200 All the others had some sort of stipulation that we wanted 595 00:26:14,200 --> 00:26:14,706 changed. 596 00:26:14,706 --> 00:26:19,510 So all to say that most research is going to be approved with 597 00:26:19,510 --> 00:26:20,612 stipulations, 598 00:26:20,612 --> 00:26:23,143 there's going to be something that the IRB is going to want 599 00:26:23,143 --> 00:26:23,615 you to do. 600 00:26:25,083 --> 00:26:27,180 The other things that IRBs do are 601 00:26:27,180 --> 00:26:29,721 they're in charge of continuing review. 602 00:26:29,721 --> 00:26:33,645 So for those protocols reviewed by a full committee, the 603 00:26:33,645 --> 00:26:34,626 investigators 604 00:26:34,626 --> 00:26:37,629 have to come back to the IRB and give an update 605 00:26:38,096 --> 00:26:41,099 if you're going to change your study. 606 00:26:41,099 --> 00:26:44,824 And the general rule is if you're going to change the 607 00:26:44,824 --> 00:26:45,737 risk benefit 608 00:26:46,705 --> 00:26:47,973 assessment for the 609 00:26:47,973 --> 00:26:50,891 subjects, then you have to amend your 610 00:26:50,891 --> 00:26:51,443 study. 611 00:26:51,443 --> 00:26:54,913 So, for example, if you're doing imagine 612 00:26:54,913 --> 00:26:57,950 you're doing a study where you have 613 00:26:57,950 --> 00:27:03,288 your plan is to take one biopsy from a colon 614 00:27:03,989 --> 00:27:06,992 during a clinically indicated colon. AP 615 00:27:08,193 --> 00:27:10,748 but you've realized that's not enough, 616 00:27:10,748 --> 00:27:12,698 and you need a second sample 617 00:27:12,931 --> 00:27:14,854 that would clearly shift the risk 618 00:27:14,854 --> 00:27:17,069 benefit balance for the participants. 619 00:27:17,336 --> 00:27:20,491 So you would have to amend your study 620 00:27:20,491 --> 00:27:22,708 and send that to the IRB. 621 00:27:22,708 --> 00:27:25,844 They have to approve that before you could actually expose anyone 622 00:27:25,844 --> 00:27:26,278 to that. 623 00:27:27,546 --> 00:27:29,381 Second biopsy. 624 00:27:29,381 --> 00:27:31,628 So I want to spend just one minute, 2 625 00:27:31,628 --> 00:27:32,417 or 3 minutes 626 00:27:32,417 --> 00:27:35,888 on a present policy issue. 627 00:27:36,388 --> 00:27:39,858 So a number of years ago, both the NIH 628 00:27:39,858 --> 00:27:43,562 and HHS put in a policy that said, 629 00:27:44,029 --> 00:27:46,832 if you're conducting multi-site research 630 00:27:46,832 --> 00:27:50,068 in the United States, you need or you can 631 00:27:50,068 --> 00:27:53,639 and you need to identify a single IRB of record. 632 00:27:54,273 --> 00:27:56,375 And so back to my little, 633 00:27:57,709 --> 00:27:59,811 diagram here 634 00:27:59,811 --> 00:28:03,620 for the single IRB policy, if you were conducting a 635 00:28:03,620 --> 00:28:04,516 multicenter 636 00:28:04,516 --> 00:28:09,154 trial here, I have five sites and a coordinating center. 637 00:28:09,154 --> 00:28:12,090 This is sort of, you know, 638 00:28:12,090 --> 00:28:14,914 like many trials, like an average oncology 639 00:28:14,914 --> 00:28:16,728 trial or something, right? 640 00:28:16,728 --> 00:28:19,731 You have a coordinating center and you have five sites 641 00:28:19,731 --> 00:28:21,884 that are recruiting cancer patients 642 00:28:21,884 --> 00:28:22,868 into the study. 643 00:28:23,402 --> 00:28:26,801 That meant that you would have one IRB review by the 644 00:28:26,801 --> 00:28:28,173 coordinating center, 645 00:28:28,473 --> 00:28:31,299 and five IRB reviews each of those sites 646 00:28:31,299 --> 00:28:33,912 would do one, which added up to six. 647 00:28:34,446 --> 00:28:37,649 And investigators did not like this at all 648 00:28:38,016 --> 00:28:41,019 because it created delays 649 00:28:41,253 --> 00:28:43,515 that meant they couldn't do their research, 650 00:28:43,515 --> 00:28:43,989 identify 651 00:28:43,989 --> 00:28:47,793 the most appropriate effective intervention, etc. 652 00:28:48,393 --> 00:28:53,298 so in response, NIH and HHS decided 653 00:28:53,298 --> 00:28:56,368 that they would require 654 00:28:56,368 --> 00:28:59,171 that there be a single IRB of record. 655 00:28:59,171 --> 00:29:02,737 So now what this means is the core netting center, or 656 00:29:02,737 --> 00:29:03,275 the IRB 657 00:29:03,275 --> 00:29:06,576 or the institution designated conducts 658 00:29:06,576 --> 00:29:07,879 one IRB review 659 00:29:08,380 --> 00:29:10,882 and the five individual sites 660 00:29:10,882 --> 00:29:14,486 say to that IRB, we will do whatever you say. 661 00:29:14,486 --> 00:29:16,321 Your approval will be our approval. 662 00:29:17,356 --> 00:29:20,301 Now, one challenge with that which I tried to 663 00:29:20,301 --> 00:29:20,759 convey 664 00:29:20,759 --> 00:29:23,929 with these little lines is that that doesn't 665 00:29:24,563 --> 00:29:28,300 relieve that local institutions from doing all those other 666 00:29:28,300 --> 00:29:31,870 reviews, conflict of interest, radiation, pharmaceuticals. 667 00:29:31,870 --> 00:29:37,275 So the policy has been in place for a number of years now. 668 00:29:37,275 --> 00:29:39,978 There are evaluations under way. 669 00:29:39,978 --> 00:29:43,615 The outcomes are unclear whether it in fact 670 00:29:43,615 --> 00:29:46,618 makes the system more efficient. 671 00:29:47,252 --> 00:29:50,822 And there's been a lot of work in developing things 672 00:29:50,822 --> 00:29:55,362 like the smart IRB, which is a way that individual 673 00:29:55,362 --> 00:29:56,361 institutes 674 00:29:56,762 --> 00:29:59,953 can learn about how to best coordinate 675 00:29:59,953 --> 00:30:01,800 with other sites. So, 676 00:30:02,968 --> 00:30:04,803 we'll see where it goes. 677 00:30:04,803 --> 00:30:08,807 But that's a current issue in IRB policy. 678 00:30:09,207 --> 00:30:11,243 And here's my summary slide. 679 00:30:11,243 --> 00:30:13,339 When in doubt about your research, 680 00:30:13,339 --> 00:30:14,880 ask your local committee 681 00:30:14,880 --> 00:30:17,555 because they are the best situated 682 00:30:17,555 --> 00:30:20,152 to answer any of your questions.