1 00:00:00,007 --> 00:00:05,167 Welcome everybody to this to this special public website. 2 00:00:05,167 --> 00:00:11,627 It's it's a great honour to be to be doing this and to be introducing us. 3 00:00:11,627 --> 00:00:22,027 I would say a little bit about actually just a second, but I first want to explain this sort of the way in which we want to conduct this review. 4 00:00:22,027 --> 00:00:28,027 So for information being so, the talk is being recorded. 5 00:00:28,027 --> 00:00:38,887 And so Robyn has set the cameras and mikes to muted, except thankfully, mine and Alex as well. 6 00:00:38,887 --> 00:00:47,617 Thankfully, I presume you, Nugent, and that will be like that for the duration of the tour and then she will on news people's minds. 7 00:00:47,617 --> 00:00:54,547 So please continue off a bit further discussion until I call on the while it is so the 8 00:00:54,547 --> 00:01:00,967 questions are not going to be recorded just so you don't need to worry about that. 9 00:01:00,967 --> 00:01:11,527 The way in which you will do well will do the questions is if you can type in the chat that you had a question, that's the preferred route. 10 00:01:11,527 --> 00:01:16,387 And then that will give me a sense of the order and I'll call on you in that order and 11 00:01:16,387 --> 00:01:24,337 then you can unmute yourself and put your camera on if you want so that we can chat. 12 00:01:24,337 --> 00:01:34,987 If you prefer me to read out the question and then write it in the chat, and that's that's perfectly acceptable, I'll say this again in just a minute. 13 00:01:34,987 --> 00:01:43,897 I'm sorry at the end of the end of the tunnel. So it's it's really great that you have it here tonight. 14 00:01:43,897 --> 00:01:51,547 This afternoon in the US, Verizon, other today, wherever else you are. 15 00:01:51,547 --> 00:02:02,377 Alex is the caller Al West, professor of ethics and philosophy and the director of the Centre for Ethics and Policy at Carnegie Mellon University. 16 00:02:02,377 --> 00:02:04,567 He's recently got a lot of attention. 17 00:02:04,567 --> 00:02:13,537 I think you would describe this as a lot of attention for your paper with Jonathan Karl Kimmelman on against pandemic research exception, 18 00:02:13,537 --> 00:02:23,587 which read Science in 2020. But he's in the sort of research ethics community and this community very well known and very well thought about. 19 00:02:23,587 --> 00:02:30,877 So it's great that he's here to talk about his new book. I'll hand it over to Alex. 20 00:02:30,877 --> 00:02:36,647 Joe, thank you very much. 21 00:02:36,647 --> 00:02:46,487 All right, well, thank you, Mark, for that generous introduction and for inviting me to be here and also thanks to Robin for all, 22 00:02:46,487 --> 00:02:51,997 for helping me navigate Microsoft Teams, which I am not really used to doing. 23 00:02:51,997 --> 00:03:04,427 I try to talk for aim for about 40 minutes or so, and then hopefully that will leave us plenty of time for questions and answers. 24 00:03:04,427 --> 00:03:10,127 So the topic for the talk today is justice and the egalitarian research imperative and the 25 00:03:10,127 --> 00:03:18,227 egalitarian research imperative is a sort of a central feature of my book for the common good, 26 00:03:18,227 --> 00:03:23,057 the philosophical foundations of research ethics that was just published by Oxford University Press. 27 00:03:23,057 --> 00:03:25,637 And it's it's free and open access. 28 00:03:25,637 --> 00:03:36,107 The PDF is if you want to download it from Oxford or from my home page, so I'm going to try to do three things today. 29 00:03:36,107 --> 00:03:44,177 The first is talk about the parochialism of research ethics of Orthodox research ethics where it comes from, 30 00:03:44,177 --> 00:03:55,037 both mostly conceptually a bit historically, and how it really eviscerate the rule for justice in research ethics. 31 00:03:55,037 --> 00:04:00,377 And after that first part of the talk, I'll then add, and in the first part, 32 00:04:00,377 --> 00:04:07,307 I want to show how that has a really pernicious effect on what I'll call the cognitive ecosystem of research ethics, 33 00:04:07,307 --> 00:04:13,007 which is sort of the way questions get framed what what views are taken as being central, 34 00:04:13,007 --> 00:04:21,857 what it would require to answer a question, the kinds of concepts the WHO the stakeholders are, who are seen as being central. 35 00:04:21,857 --> 00:04:27,437 After that early part of the talk, then I'll transition to talking about the egalitarian research imperative, 36 00:04:27,437 --> 00:04:32,267 and I'll argue that there is a research imperative. There's an imperative to carry out research with humans. 37 00:04:32,267 --> 00:04:39,377 That's very different from the kind of imperative that you'll see that shaped the the historical origins of research ethics. 38 00:04:39,377 --> 00:04:40,637 And after that section, 39 00:04:40,637 --> 00:04:50,117 then I'll talk a little bit about what the implications are of this sort of new approach to the foundations of research ethics. 40 00:04:50,117 --> 00:04:56,417 So the first part is the origins of this parochialism, as I want to call it. 41 00:04:56,417 --> 00:04:59,777 So I think it's really important to see that in the United States, 42 00:04:59,777 --> 00:05:08,987 at least the birth of research ethics was really driven by a reaction against two things. 43 00:05:08,987 --> 00:05:16,877 So first, there was a shared perception that there is an inherent dilemma at the heart of research with human participants, 44 00:05:16,877 --> 00:05:21,587 and the fundamental problem was how to navigate this dilemma. 45 00:05:21,587 --> 00:05:27,887 And there was a fear that an imperative to carry out research that was grounded in a social 46 00:05:27,887 --> 00:05:34,037 imperative would wind up justifying an abrogation of the rights and interests of individuals. 47 00:05:34,037 --> 00:05:38,147 So that's what I want to try to show in this first section. 48 00:05:38,147 --> 00:05:43,277 I'm trying to motivate and persuade you of this idea. 49 00:05:43,277 --> 00:05:47,287 And then after I do that, we'll see some of the implications of this. 50 00:05:47,287 --> 00:05:52,457 So part of what I want to say when I argue at length in the book that, you know, 51 00:05:52,457 --> 00:05:56,567 the conceptual ecosystem of Orthodox research ethics is really narrow. 52 00:05:56,567 --> 00:06:04,547 It treats research as a kind of private transaction between two main stakeholders, researchers and study participants. 53 00:06:04,547 --> 00:06:07,937 It centres protectionism and paternalism, 54 00:06:07,937 --> 00:06:16,547 so the be the moral crucible of research ethics takes place at the interface between researchers and participants. 55 00:06:16,547 --> 00:06:23,997 And the main focus for research ethics in terms of an audience is usually the IRP, whose job it is to kind of paternalistic. 56 00:06:23,997 --> 00:06:31,307 We manage the relationship between these two stakeholders. It primarily treats research as a kind of functional role. 57 00:06:31,307 --> 00:06:35,867 That's a role like the doctor patient relationship or like the role of the doctor. 58 00:06:35,867 --> 00:06:44,897 There's the role of the researcher. So the functional role, it's something that you can take on and that can conflict with other social roles. 59 00:06:44,897 --> 00:06:51,917 And that really ignores the degree to which research is a social undertaking between a lot of different stakeholders. 60 00:06:51,917 --> 00:07:00,957 And so we'll see why that's important later on. It also disconnects research from a bunch of larger social purposes. 61 00:07:00,957 --> 00:07:08,187 Part of how justice then gets disconnected in research from how research ethics sort of is disconnected 62 00:07:08,187 --> 00:07:14,487 from issues of justice and in particular issues of justice in this larger social context. 63 00:07:14,487 --> 00:07:21,837 So those those are the themes to keep your eye out for now as I try to persuade you of each of these ideas in this first part. 64 00:07:21,837 --> 00:07:28,357 So I want to take you back to the the heady days of April 1967. 65 00:07:28,357 --> 00:07:36,567 You know, it's meeting call about the changing mores of biomedical research held at the American College of Physicians. 66 00:07:36,567 --> 00:07:47,037 So, you know, this is it. The time right before the institution of the common rule the creation of a common rule in the United States 67 00:07:47,037 --> 00:07:53,607 when there is disagreement about what the norms should be for governing biomedical and behavioural research. 68 00:07:53,607 --> 00:08:00,597 And in his opening remarks, the famous researcher, Walsh McDermott, opens with this bombshell. 69 00:08:00,597 --> 00:08:09,507 He says when the needs of society come into a head on conflict with the rights of an individual, somebody has to play God. 70 00:08:09,507 --> 00:08:22,437 And the whole point of McDermott's remarks is that society enforces the social good over the individual good in a wide range of contexts, 71 00:08:22,437 --> 00:08:27,747 and there is an inherent dilemma in research with human subjects. 72 00:08:27,747 --> 00:08:33,927 We can't both advance the social good and respect the good of the individual, and in that case, 73 00:08:33,927 --> 00:08:42,277 researchers need to be empowered to advance the social good, even if it comes at the cost of the individual participant. 74 00:08:42,277 --> 00:08:51,497 So he has this precedent or this sort of, you know, particular quote where he says starting, I suppose, with the Yellow Fever studies in Havana, 75 00:08:51,497 --> 00:09:03,757 famous set of studies by the renowned American researcher Walter Reed, we have seen large social payoffs from certain experiments in humans. 76 00:09:03,757 --> 00:09:08,017 And there's no reason to doubt that this process could continue. 77 00:09:08,017 --> 00:09:15,727 However, then, he says, once this demonstration was made, we could no longer maintain in strict honesty that in a study of disease, 78 00:09:15,727 --> 00:09:21,307 the interests of the individual are invariably paramount. 79 00:09:21,307 --> 00:09:24,267 So part of what McDermott is taking, you know, 80 00:09:24,267 --> 00:09:31,867 in his sights here is the declaration of Helsinki that has as one of its claims that the interests of the individual, 81 00:09:31,867 --> 00:09:38,617 you know, have to be and the physician's concern for the interests of the individual have to be paramount. 82 00:09:38,617 --> 00:09:43,207 He says I believe that it's been most unwise to try to extend the principle of a government 83 00:09:43,207 --> 00:09:51,257 of laws and not of men into areas of such great ethical subtlety as clinical investigation. 84 00:09:51,257 --> 00:10:00,317 So, McDermott, I give you this as a way of just trying to say there was a view before the institution sort of the 85 00:10:00,317 --> 00:10:05,537 current before the creation of the current institutions rules and regulations in the United States. 86 00:10:05,537 --> 00:10:09,287 There was a view that there was a social imperative to carry out research that that 87 00:10:09,287 --> 00:10:14,117 imperative was grounded in the great social benefits that research could create, 88 00:10:14,117 --> 00:10:18,947 and it rested on a particular view of the relationship between society and the individual. 89 00:10:18,947 --> 00:10:25,187 So this is another quote from McDermott. You know, it says society has rights too, 90 00:10:25,187 --> 00:10:32,597 and it is preferable that the power to enforce these rights over the rights of the individual will be institutionalised. 91 00:10:32,597 --> 00:10:43,067 And then he talks about how it's important that to ensure the rights of society, an arbitrary judgement must sometimes be made against an individual. 92 00:10:43,067 --> 00:10:50,657 And this is it takes you back to the the head. The quote that eat the statement that he used to open the conference that researchers should be 93 00:10:50,657 --> 00:10:57,827 empowered to make that arbitrary judgement sometime in order to advance the right of society. 94 00:10:57,827 --> 00:11:05,237 Now, part of the problem with the way McDermott frames the issue and and sort of in a certain sense, 95 00:11:05,237 --> 00:11:10,007 one of the refreshing things about McDermott is that unlike other famous researchers of the day, 96 00:11:10,007 --> 00:11:16,637 he says the quiet part out loud when a lot of other people are content to kind of beat around the bush. 97 00:11:16,637 --> 00:11:23,837 But you know, McDermott's comments really echo arguments that we saw at the Nuremberg trial. 98 00:11:23,837 --> 00:11:30,767 Not that many years earlier, just a few decades earlier. And, you know, in the Nuremberg trials, 99 00:11:30,767 --> 00:11:38,447 Survation is Robert Salacious had argued the attorney had argued on behalf of one of the defendants, Dr. Carl Brand. 100 00:11:38,447 --> 00:11:45,077 But there was no meaningful distinction between conscription for military service and research that in each case, 101 00:11:45,077 --> 00:11:48,647 individual sacrifice is required for the common good. 102 00:11:48,647 --> 00:11:58,247 And it's not unreasonable to exact even the ultimate sacrifice from a person if that's necessary to advance the greater good. 103 00:11:58,247 --> 00:12:04,877 There were seven of the 23 defendants at Nuremberg were sentenced to death for crimes against humanity, 104 00:12:04,877 --> 00:12:12,767 including Carl Brandt, in one of the things that Brandt said. He said science under them in, you know, within science. 105 00:12:12,767 --> 00:12:22,547 Under the Nazi regime, the demands of society were placed above every individual human being as an entity and this entity, 106 00:12:22,547 --> 00:12:28,577 the human being, became completely used in the interests of that society. 107 00:12:28,577 --> 00:12:33,827 So you can sort of see Nuremberg as a repudiation of this idea. 108 00:12:33,827 --> 00:12:42,287 But of course, you know, the Nuremberg and the Nembhard code had very little indirect influence on sort of the course of research 109 00:12:42,287 --> 00:12:49,007 and research ethics in the United States up until the period that we're that we're talking about. 110 00:12:49,007 --> 00:13:00,977 So shortly after McDermott's fiery opening publishes his groundbreaking paper, rightly influential. 111 00:13:00,977 --> 00:13:10,097 So, you know, I think any most people who take a research ethics class probably have to read at least some, if not all, of this paper. 112 00:13:10,097 --> 00:13:13,907 And in it, Jonas makes this really fascinating argument. 113 00:13:13,907 --> 00:13:20,447 He says society easily survives the normal toll of sickness and disease. 114 00:13:20,447 --> 00:13:27,227 And so as a result, sickness and disease really is a threat to the individual, not to society. 115 00:13:27,227 --> 00:13:33,677 And so for that reason, Jonas argues, there's no social imperative to carry out research. 116 00:13:33,677 --> 00:13:38,687 It's a noble private vocation, like being a musician. 117 00:13:38,687 --> 00:13:46,187 And if you're a musician, you might bring joy and pleasure to the lives of hundreds of thousands or millions of people. 118 00:13:46,187 --> 00:13:49,877 If you're if you're famous, like Yo-Yo Ma or something like that. 119 00:13:49,877 --> 00:14:01,007 But it isn't the case that you can use the institutions and the coercive power of society in order to promote this private undertaking. 120 00:14:01,007 --> 00:14:13,067 In order to avoid the kind of totalitarian consequences that Jonah saw in the position that McDermott was articulating. 121 00:14:13,067 --> 00:14:20,057 As he wants to demote research from an activity that serves the social, 122 00:14:20,057 --> 00:14:28,877 the interests of society to an activity that serves the interests of individuals, and that becomes a kind of private, optional undertaking. 123 00:14:28,877 --> 00:14:32,507 So what you see here now, so what does this piece I keep coming back to? 124 00:14:32,507 --> 00:14:37,967 So some of you will know this is the front piece two halves as Leviathan. So this is the state, right? 125 00:14:37,967 --> 00:14:46,607 And in what looks like it's chainmail is actually a little tiny images of individuals who comprise the state. 126 00:14:46,607 --> 00:14:49,517 So we have two very different views. 127 00:14:49,517 --> 00:14:56,837 We have the same conception of the relationship between the individual and the state, between individual and the collective. 128 00:14:56,837 --> 00:15:01,637 But we have two different conceptions now of the relative interests at stake. 129 00:15:01,637 --> 00:15:11,087 On the one hand, you have McDermott, who says society has rights and it can exact a toll from some of its skin cells as it 130 00:15:11,087 --> 00:15:17,237 were in order to produce medical progress through research with human participants. 131 00:15:17,237 --> 00:15:24,617 On the other side, you have Jonas who says, you know, cancer if cancer, heart disease and other organic non-contagious ills, 132 00:15:24,617 --> 00:15:27,977 especially those tending to strike the old more than the villain, 133 00:15:27,977 --> 00:15:33,767 continue to exact their toll at the normal rate of incidents, including the toll of private anguish and misery. 134 00:15:33,767 --> 00:15:36,237 Society can go on flourishing in every way, 135 00:15:36,237 --> 00:15:43,697 so society has no no concern about the the normal rate of disease that sort of pluck off individuals here and there. 136 00:15:43,697 --> 00:15:55,537 And so the society doesn't have a legitimate claim to use its coercive force in order to promote the kind of progress that medical research promotes. 137 00:15:55,537 --> 00:16:05,257 Interestingly, on this position now, if you have a pandemic like we're in now with COVID, 138 00:16:05,257 --> 00:16:12,187 then it can be the case that if proper functioning of society is endangered, 139 00:16:12,187 --> 00:16:17,257 then both of these views would line up right then I think then in his article, 140 00:16:17,257 --> 00:16:25,747 Jonas talked about how it might be the case, then that its emergency powers society can take steps to preserve itself, 141 00:16:25,747 --> 00:16:30,607 that that fall much more closely into the line that McDermott is running. 142 00:16:30,607 --> 00:16:36,657 And I suggest later, I think that is also part of a problem here. 143 00:16:36,657 --> 00:16:45,207 So the onus is paper comes out in 1969, during this time in the United States, the Tuskegee syphilis study is happening. 144 00:16:45,207 --> 00:16:51,687 This the United States public health study of 400 black men with syphilis, the 200 controls in Alabama. 145 00:16:51,687 --> 00:16:58,707 It involves deception, denial of treatment. No measures are deployed to stop the spread of a communicable disease that the public 146 00:16:58,707 --> 00:17:05,607 health service has a social obligation to know to stop the spread and to control. 147 00:17:05,607 --> 00:17:13,527 In 1969, as a blue ribbon panel that is convened to review the study and with but with all but one dissent votes 148 00:17:13,527 --> 00:17:21,807 unanimously to continue the study until it breaks into the headlines and and the popular press grab hold of it. 149 00:17:21,807 --> 00:17:28,947 And the scandal leads to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, 150 00:17:28,947 --> 00:17:34,587 and the National Commission is what creates the common rule and the whole set of institutions 151 00:17:34,587 --> 00:17:39,687 and guidelines and rules that we that that constitute Orthodox research ethics today. 152 00:17:39,687 --> 00:17:45,537 Actually, the National Commission produced the Belmont report that we'll talk about in a little bit. 153 00:17:45,537 --> 00:17:56,687 The historical point here is relevant because it shifts the balance almost entirely in favour of Jones's position. 154 00:17:56,687 --> 00:18:03,017 And a hand in glove now, the work of the National Commission, there's a kind of administrative convenience, 155 00:18:03,017 --> 00:18:13,457 we want to try to make some rules that would prevent this kind of systematic abuse is as simple and easily as we can. 156 00:18:13,457 --> 00:18:19,367 And so Jones's philosophical position gives the conceptual philosophical cover 157 00:18:19,367 --> 00:18:24,497 for this position that's motivated by administrative convenience to some degree. 158 00:18:24,497 --> 00:18:31,607 So without a social imperative, research is sort of treated now as a kind of optional undertaking. 159 00:18:31,607 --> 00:18:35,847 And so everything gets focussed on what I call the IRG triangle now. 160 00:18:35,847 --> 00:18:39,767 So our rulemaking talks about researchers, 161 00:18:39,767 --> 00:18:44,897 the relationships to participants and how the IRB is going to insert itself in this 162 00:18:44,897 --> 00:18:52,727 relationship in order to protect participants from abuse at the hands of researchers. 163 00:18:52,727 --> 00:18:57,617 So this is where you get now in this in this administrative convenience, 164 00:18:57,617 --> 00:19:01,727 you get research treated as a functional role because we need to know when are 165 00:19:01,727 --> 00:19:05,777 individuals functioning as physicians and when are they functioning as researchers? 166 00:19:05,777 --> 00:19:11,477 So we know which set of moral requirements should govern their conduct. 167 00:19:11,477 --> 00:19:13,547 So, so the, you know, 168 00:19:13,547 --> 00:19:24,077 the Belmont report and subsequent rulemaking annunciate criteria to distinguish when an individual is occupying one social role rather than another. 169 00:19:24,077 --> 00:19:30,287 So we talk about, you know, is your purpose to fulfil your fiduciary duty to the patient who's in front of you? 170 00:19:30,287 --> 00:19:35,807 Or are you trying to gather generalisable data? What are the means that you're using? 171 00:19:35,807 --> 00:19:39,227 Are you using established effective means to benefit your patient? 172 00:19:39,227 --> 00:19:46,957 Are you deploying novel interventions under conditions such as randomisation that are designed to evaluate efficacy? 173 00:19:46,957 --> 00:19:53,867 And then what kind of discretion do you have if you're in this fiduciary role where you're providing treatment? 174 00:19:53,867 --> 00:20:00,767 You have broad latitude to use your professional judgement to advance the interests of the patient in front of you. 175 00:20:00,767 --> 00:20:10,997 But if you're if you're in this information generating role, then you're required to secure a prospective research review. 176 00:20:10,997 --> 00:20:18,767 So part of what this does, though, this this framing of the ethical issues as living within the R.B. Triangle, 177 00:20:18,767 --> 00:20:26,237 it eviscerates any role for the for the value of justice. 178 00:20:26,237 --> 00:20:36,357 People, I have I've given talks in places and had people say I didn't realise justice was even a value that was in the Belmont report. 179 00:20:36,357 --> 00:20:38,937 Is one of the key values in the Belmont report. 180 00:20:38,937 --> 00:20:52,407 But it's the least well developed and in the conceptual ecosystem of Orthodox research ethics, justice really has no distinctive role to play. 181 00:20:52,407 --> 00:20:59,007 If you're if you have the background assumption and we're talking about private parties in a way that's 182 00:20:59,007 --> 00:21:08,937 tacitly disconnected from larger social purposes and from other social institutions other than the IRP, 183 00:21:08,937 --> 00:21:18,677 then there's not really much work for justice to do. I'd say well. 184 00:21:18,677 --> 00:21:20,337 It went the wrong direction. 185 00:21:20,337 --> 00:21:29,227 You might say, well, that's that's a little bit unfair, but we can look at an example from the Belmont report to try to drive this point home. 186 00:21:29,227 --> 00:21:38,307 You know, so within Belmont, beneficence are justice over the same domain and a certain sense of the bottom line. 187 00:21:38,307 --> 00:21:40,977 They do effectively the same thing. 188 00:21:40,977 --> 00:21:48,357 When justice is introduced, we're told Will this is about who ought to receive the benefits of research and bear its burdens. 189 00:21:48,357 --> 00:21:56,067 And beneficence is ultimately about the distribution of benefits and burdens in research across different individuals. 190 00:21:56,067 --> 00:21:59,997 That's why it's possible when we're talking about risk benefit, 191 00:21:59,997 --> 00:22:06,867 that the risks to some individuals can be outweighed by the possibility of benefits that will accrue to other individuals. 192 00:22:06,867 --> 00:22:14,807 So both of these values are treated as operating over the distribution of benefits and burdens to different individuals. 193 00:22:14,807 --> 00:22:19,077 Justice, we're told, equals ought to be treated equally. 194 00:22:19,077 --> 00:22:27,267 That kind of sort of the conceptual definition of justice going back to Aristotle, at least, but there's no specification of the space of equality. 195 00:22:27,267 --> 00:22:33,897 So we're not told what to what, what space we ought to ensure that people are treated equally in. 196 00:22:33,897 --> 00:22:38,457 That question is left unanswered in Belmont, except in beneficence. 197 00:22:38,457 --> 00:22:43,827 That question is answered because you give equal treatment to people in the space of welfare. 198 00:22:43,827 --> 00:22:53,007 And that's why you're allowed to allow risks to the welfare of people in one group to be offset by welfare to the beneficiaries of research, 199 00:22:53,007 --> 00:22:57,207 so long as there's enough welfare that that's generated. 200 00:22:57,207 --> 00:23:04,807 So the point I want to make is even though these view these values. 201 00:23:04,807 --> 00:23:10,237 And there's really not much content to the value of justice, as it's articulated in Belmont, 202 00:23:10,237 --> 00:23:15,287 but there's pretty substantial content content to the value of beneficence. 203 00:23:15,287 --> 00:23:21,517 So now if you take a requirement of justice that's enunciated in the Belmont report. 204 00:23:21,517 --> 00:23:26,017 Right. So one of them is that, you know, 205 00:23:26,017 --> 00:23:35,977 that there should be a prohibition on recruiting favoured populations for beneficial research and undesirable populations for risky research. 206 00:23:35,977 --> 00:23:40,207 Well, if you say that value is grounded in issues of justice, 207 00:23:40,207 --> 00:23:44,707 the ground is very difficult to explain from the standpoint of justice because they're just 208 00:23:44,707 --> 00:23:50,647 not that much granularity or texture to the way justice is explained in the Belmont report. 209 00:23:50,647 --> 00:24:04,627 But you can explain and justify this prohibition on the basis of the two other pillars of Orthodox research ethics, right? 210 00:24:04,627 --> 00:24:09,997 And as an application of both beneficence and autonomy, because you could say, listen, 211 00:24:09,997 --> 00:24:16,747 if we draw primarily from marginalised groups for quote unquote risky research, 212 00:24:16,747 --> 00:24:21,727 well, those are groups that are already more likely to have a higher burden of disease. 213 00:24:21,727 --> 00:24:28,657 They're already likely to have far fewer resources available to them to manage adverse events that might arise. 214 00:24:28,657 --> 00:24:32,857 They're more likely to have more precarious health and welfare on a general level. 215 00:24:32,857 --> 00:24:44,887 And so the outcomes of imposition of risk on marginalised groups are likely to be worse than if you impose the same risk on less marginalised groups. 216 00:24:44,887 --> 00:24:48,487 So that's a straightforward application of beneficence. 217 00:24:48,487 --> 00:24:57,307 And then it's far less likely you're far less likely to secure consent from marginalised groups 218 00:24:57,307 --> 00:25:04,087 for that kind of research in the absence of force fraud or insufficiently informed consent. 219 00:25:04,087 --> 00:25:12,577 So, you know, all of the things that could be seen as being wrong with disproportionate, 220 00:25:12,577 --> 00:25:19,057 disproportionately recruiting vulnerable populations can be explained by beneficence and autonomy. 221 00:25:19,057 --> 00:25:27,607 And it's not really clear what the substance of justice is in Belmont that would provide an alternative explanation. 222 00:25:27,607 --> 00:25:33,877 We really see the absence of justice then as time goes by, and in the 1990s, you know, 223 00:25:33,877 --> 00:25:42,517 late '90s and then the subsequent decades when controversies in international research come to the fore. 224 00:25:42,517 --> 00:25:50,857 So there are three requirements that get articulated as governing international research that there should be an adequate standard of care, 225 00:25:50,857 --> 00:25:55,357 that that research should be responsiveness to host community health needs and priorities, 226 00:25:55,357 --> 00:26:00,467 and that there's a duty to provide post-trial access in documents like the C OMS guidelines. 227 00:26:00,467 --> 00:26:09,247 These these requirements are grounded in the value of justice, but without a substantive account of justice in these space. 228 00:26:09,247 --> 00:26:18,457 A number of commentators argue that these values seem are these requirements seem arbitrary and unjustified at best. 229 00:26:18,457 --> 00:26:25,567 And then Alan Wertheimer, in some recent work, has a trenchant argument where he says they're also Pereda inferior. 230 00:26:25,567 --> 00:26:30,247 They raise the cost of conducting research in low and middle income country populations 231 00:26:30,247 --> 00:26:36,037 that might benefit from research that doesn't satisfy one or more of these conditions, 232 00:26:36,037 --> 00:26:39,907 but not conducting research there doesn't make anybody better off. 233 00:26:39,907 --> 00:26:50,557 So by protecting people, Wertheimer argues, we could be making them worse off just by denying them opportunities to advance some of their interests. 234 00:26:50,557 --> 00:26:56,137 Even though the research in which they're participating might be relevant to other communities 235 00:26:56,137 --> 00:27:02,287 where they might get sort of the direct benefits of participation rather than post-trial access, 236 00:27:02,287 --> 00:27:09,967 and where the standard of care they receive might be much lower than it would be in other places. 237 00:27:09,967 --> 00:27:15,617 And so I think part of the controversy then that's happened about the norms that ought to govern international 238 00:27:15,617 --> 00:27:23,917 research is the is a result of the vacuum that was created by grounding these requirements on justice, 239 00:27:23,917 --> 00:27:30,777 but without having an actual substantive account of justice to do the work that's required. 240 00:27:30,777 --> 00:27:40,197 You also see now in this in this ecosystem that results, you know, the tolerance for what I've called in other places, self-defeating practises. 241 00:27:40,197 --> 00:27:45,927 And you really see this with COVID. COVID illustrates this an asymmetric concern. 242 00:27:45,927 --> 00:27:51,057 The risks that participants might be exposed to in research. 243 00:27:51,057 --> 00:28:04,227 But then the sort of, you know, there's not an offsetting concern for the widespread tolerance for the use of validated interventions 244 00:28:04,227 --> 00:28:10,017 out of beneficent intent where that doesn't necessarily translate into beneficial outcomes. 245 00:28:10,017 --> 00:28:10,167 You know, 246 00:28:10,167 --> 00:28:18,847 so this is a list of the interventions at the beginning of the pandemic that people thought maybe these things will have some therapeutic effect. 247 00:28:18,847 --> 00:28:24,527 You know, you see ivermectin here, you see chloroquine and hydroxychloroquine. 248 00:28:24,527 --> 00:28:34,027 The beginning of the pandemic, Dieter Route, who ran one of the first quite poorly designed studies of hydroxychloroquine. 249 00:28:34,027 --> 00:28:38,497 In an interview, he says, I'm not going to tell somebody, Listen, today's not your lucky day, 250 00:28:38,497 --> 00:28:43,957 you're going to be getting the placebo, you're going to be dying, he told the reporter. 251 00:28:43,957 --> 00:28:52,567 Root said he believes it's unnecessary and unethical. The randomised controlled trials are RCTs of treatments for a deadly infectious disease. 252 00:28:52,567 --> 00:29:00,217 So what you see here is it's, you know, Root saying, basically it would be unethical for me to deny people hydroxychloroquine. 253 00:29:00,217 --> 00:29:04,357 But of course, you have other clinicians who think it would be unethical of them to provide 254 00:29:04,357 --> 00:29:08,977 hydroxychloroquine to patients since its efficacy hasn't been invalidated. 255 00:29:08,977 --> 00:29:13,897 So you have a social status, the right state of affairs in which some people are getting. 256 00:29:13,897 --> 00:29:19,027 Some clinicians are providing this intervention. Other clinicians are not providing this intervention, 257 00:29:19,027 --> 00:29:26,347 but a bunch of people think that that the risks that we would be exposing people to in research 258 00:29:26,347 --> 00:29:30,937 if we randomise them to those interventions are somehow worse than the default state of affairs, 259 00:29:30,937 --> 00:29:39,947 of just giving those interventions directly to people without generating the information where we know whether they're efficacious are not. 260 00:29:39,947 --> 00:29:46,187 You have other instances, you know, so people in the United States know when they ran ads, 261 00:29:46,187 --> 00:29:52,547 some of the this is the product consortium that was looking at convalescent plasma and in their advertisements, 262 00:29:52,547 --> 00:29:56,657 they say if you survived COVID 19, then you're the heroes that we need. 263 00:29:56,657 --> 00:30:01,007 The plasma that's in your blood can literally save lives. 264 00:30:01,007 --> 00:30:05,327 But we have to act fast, so please donate. So, you know, here are the assertion. 265 00:30:05,327 --> 00:30:10,187 Basically, I mean, if you go further down on this web page, I took this from, they would say, we all, you know, 266 00:30:10,187 --> 00:30:15,767 we want you to donate so that we can run some of the studies that might be necessary to evaluate, 267 00:30:15,767 --> 00:30:23,597 you know, the clinical merits of convalescent plasma. But they're basically telling you in the advertisements, Hey, this can literally save lives. 268 00:30:23,597 --> 00:30:28,127 Well, if it can, if we already know that, why would we need to run trials and if we need to run trials, 269 00:30:28,127 --> 00:30:37,177 why are we telling people that this will save your life? And the results, of course, right, are really not very rosy. 270 00:30:37,177 --> 00:30:48,337 Clinicians used hydroxychloroquine with therapeutic intent on a large scale, but the recovery trial showed that amongst patients with COVID 19, 271 00:30:48,337 --> 00:30:55,597 those who received hydroxychloroquine didn't have a lower incidence of death at 28 days than those who received usual care. 272 00:30:55,597 --> 00:31:03,037 They did have a longer hospital duration. And then there were some populations that were more likely to progress to the 273 00:31:03,037 --> 00:31:08,667 outcomes of mechanical ventilation or death than people in the usual care group. 274 00:31:08,667 --> 00:31:13,117 Yet things that weren't quite as bad with convalescent plasma in the United States, 275 00:31:13,117 --> 00:31:19,177 100000 people received convalescent plasma outside the context of a clinical trial. 276 00:31:19,177 --> 00:31:26,647 But again, recovery says there was no significant difference between convalescent plasma and the usual care group. 277 00:31:26,647 --> 00:31:34,897 So it didn't seem like it was harmful, but it certainly absorbed the time, energy and resources of a wide range of people. 278 00:31:34,897 --> 00:31:50,307 For for no clinical benefit. So to summarise in this section, then the the aversion to linking biomedical research to important purposes of the state, 279 00:31:50,307 --> 00:32:00,107 relegating it to a kind of private activity now that that gets evaluated within the narrow confines of the IRP triangle. 280 00:32:00,107 --> 00:32:09,607 Results in this ecosystem that has all these problems, you have a narrow set of stakeholders with a narrow focus on one point, right? 281 00:32:09,607 --> 00:32:14,947 I IRB review is one point in a much larger process where many more stakeholders 282 00:32:14,947 --> 00:32:18,757 have already made decisions about what the protocol is going to look like, 283 00:32:18,757 --> 00:32:23,767 what the study is going in, what what questions are going to be asked and answered. 284 00:32:23,767 --> 00:32:30,217 There's the invisibility. The knowledge that research produces and its relationship to a bunch of social 285 00:32:30,217 --> 00:32:36,607 systems are basically invisible within this within this cognitive ecosystem, 286 00:32:36,607 --> 00:32:44,677 other than the idea that there needs to be social value to research a concept that up until very recently was not, well explicated. 287 00:32:44,677 --> 00:32:53,227 Social institutions are invisible, even though research calls them into action and and the information that it 288 00:32:53,227 --> 00:32:57,787 generates is supposed to feed back into them and their ability to function. 289 00:32:57,787 --> 00:33:00,997 There's a keen awareness of risks inside research, 290 00:33:00,997 --> 00:33:09,427 but a far greater tolerance for unfound practise on a large scale outside of research and no social imperative 291 00:33:09,427 --> 00:33:16,387 to close knowledge gaps between the health priorities of a community and the ability of the communities, 292 00:33:16,387 --> 00:33:22,027 its social or health care institutions to meet those needs or to rectify inequalities in the 293 00:33:22,027 --> 00:33:29,237 ability of those systems to address the health needs of the diverse populations that they serve. 294 00:33:29,237 --> 00:33:32,987 OK, so so that's the critical part. 295 00:33:32,987 --> 00:33:40,997 Now I want to talk about, I do want to defend a research imperative, but it's very different from the ones that we've seen before. 296 00:33:40,997 --> 00:33:48,517 So in the prior debate? This assumption that the common good is really the good of a collective, 297 00:33:48,517 --> 00:33:57,547 it's the good of society where in several different ways that can be represented as something that's quite distinct from the good of the individual. 298 00:33:57,547 --> 00:34:03,637 And then what you saw was, yeah, this the state has a right or this collective has a right to progress or know the collective 299 00:34:03,637 --> 00:34:07,657 doesn't have a right to progress because the collective isn't really harmed by sickness, 300 00:34:07,657 --> 00:34:11,177 injury and disease. Only individuals are. 301 00:34:11,177 --> 00:34:16,157 So part of what I argued for in the book is that there's just a fundamentally different way of conceiving of the 302 00:34:16,157 --> 00:34:23,327 common good so that rather than putting the collective on one side and the individual on the other and then debating, 303 00:34:23,327 --> 00:34:28,727 you know, whose interests are are are paramount, we should see the common good. 304 00:34:28,727 --> 00:34:33,047 And I think there's also a very I try to argue there's a long tradition of for for views like this, 305 00:34:33,047 --> 00:34:35,957 the common good as a set of what I call basic interests, 306 00:34:35,957 --> 00:34:41,537 a set of interests that all persons share in being able to develop and exercise the intellectual 307 00:34:41,537 --> 00:34:47,147 and effective and social and physical capabilities that they require to formulate, 308 00:34:47,147 --> 00:34:50,027 pursue and revise a meaningful life plan. 309 00:34:50,027 --> 00:34:59,267 So in that sense, you know, in a diverse, free, open society, people will pursue a lot of different First Order life plans, right? 310 00:34:59,267 --> 00:35:07,367 They want to be musicians or scientists or, you know, or occupy a bunch of different occupations or pursue faith traditions and so on. 311 00:35:07,367 --> 00:35:11,987 Those are part of the first order conception of the good that they want to advance. 312 00:35:11,987 --> 00:35:15,227 And we they differ in very many ways as a result, 313 00:35:15,227 --> 00:35:25,307 but they share in common they are what Rawls calls the highest order interest in being able to formulate, pursue and revise a life plan. 314 00:35:25,307 --> 00:35:31,867 And that is an interest that's common to all of the persons in such a community. 315 00:35:31,867 --> 00:35:43,687 We in a just social order. Institutions of society have to function in order to secure the common good in this new or in this other sense. 316 00:35:43,687 --> 00:35:52,417 In other words, the basic institutions of society have to function to secure for each person their basic interest in being able to formulate, 317 00:35:52,417 --> 00:36:00,067 pursue and revise a life plan. And so basic interests now can be threatened by a wider range of things. 318 00:36:00,067 --> 00:36:05,647 Sickness, injury and disease threaten people's ability to the cognitive, 319 00:36:05,647 --> 00:36:10,747 affective or physical abilities that they need to pursue some reasonable life plan. 320 00:36:10,747 --> 00:36:15,607 So do poverty and ignorance, prejudice, animus and lots of other things. 321 00:36:15,607 --> 00:36:20,167 So for our purposes, I'll stick to sickness, injury and disease. 322 00:36:20,167 --> 00:36:28,717 But this is why, right? The effect of sickness, injury and disease on this shared interest and this shared interest as being sort of the 323 00:36:28,717 --> 00:36:34,777 focus of what a just society is supposed to help secure for individuals is what grounds 324 00:36:34,777 --> 00:36:42,517 now a notion of justice that takes research away out of the sphere of a private activity 325 00:36:42,517 --> 00:36:48,277 and puts it in the sphere of social activity that produces a unique public good. 326 00:36:48,277 --> 00:36:56,947 So this is a unique public good because research with humans is often the only way to generate the information that we need to 327 00:36:56,947 --> 00:37:05,887 bridge gaps between the ability of individuals to function in this basic way and the capacity of health related social systems, 328 00:37:05,887 --> 00:37:12,487 public health, individual health live close to client health system to function in ways that will 329 00:37:12,487 --> 00:37:19,087 safeguard and support and advance those those abilities of individuals effectively, 330 00:37:19,087 --> 00:37:26,527 efficiently but also equitably. So in order to be able to do that in order for health systems to be able to effectively, 331 00:37:26,527 --> 00:37:33,787 efficiently and equitably advance the basic interests of people in those communities, we have to understand the aetiology of disease. 332 00:37:33,787 --> 00:37:40,507 We have to understand the disease mechanisms so that we can intervene on it to try to prevent the spread, 333 00:37:40,507 --> 00:37:45,427 to try to manage this disease spread or progression of disease, 334 00:37:45,427 --> 00:37:55,227 or provide treatment to patients to either cure them or mitigate morbidity and mortality. 335 00:37:55,227 --> 00:38:01,617 So this is the the the first part of the social imperative that social institutions 336 00:38:01,617 --> 00:38:06,117 of a just state have to secure the life and liberty and welfare of their members. 337 00:38:06,117 --> 00:38:15,027 The feeling that function in the face of uncertainty requires the knowledge necessary to safeguard health and to make equitable, 338 00:38:15,027 --> 00:38:25,407 efficient and effective use of the wide range of social resources that go into creating the social systems that fulfil this function. 339 00:38:25,407 --> 00:38:31,497 And so, you know, a central claim of the book is that there's an imperative to conduct research that closes these 340 00:38:31,497 --> 00:38:37,317 knowledge gaps that will enable health systems to secure the basic interests of community members. 341 00:38:37,317 --> 00:38:49,767 So in that sense, for there is a sense which I'm arguing for a claim that that fell out of fashion after the work of the National Commission. 342 00:38:49,767 --> 00:39:03,027 But I want to be extremely clear lots of the people who flirt with this idea also fall into the very, you know, dichotomy that McDermott postulated, 343 00:39:03,027 --> 00:39:13,197 and they come very close to basically saying, yes, it's like, you know, society can exact these tremendous, tremendous toll from individuals. 344 00:39:13,197 --> 00:39:19,947 And I want to say, no, this social imperative does not licence domination in a just social order. 345 00:39:19,947 --> 00:39:26,307 Basic institutions of society must function to secure the common good, i.e. each person's basic interests. 346 00:39:26,307 --> 00:39:31,017 And so now we have to think of research not as a social role, 347 00:39:31,017 --> 00:39:38,037 but as a scheme of mutual cooperation that is just one element within this much larger social division of labour. 348 00:39:38,037 --> 00:39:43,827 So research is an activity that gets extended across time. It involves multiple stakeholders. 349 00:39:43,827 --> 00:39:52,917 It calls into action various social institutions, whether they're funding institutions, regulatory institutions, health care, providing institutions. 350 00:39:52,917 --> 00:40:01,717 And it also generates the information it feeds back into those institutions and shapes their ability to function. 351 00:40:01,717 --> 00:40:08,917 So the second part of the social imperative, this isn't an external constraint on that first imperative. 352 00:40:08,917 --> 00:40:15,787 It's an implication, internal implication of that imperative at understanding research as a social, 353 00:40:15,787 --> 00:40:22,957 as a scheme of social cooperation that must be organised on terms that respect the status of individuals 354 00:40:22,957 --> 00:40:29,737 as free and equal means that there's also an imperative to sure to ensure that it's a voluntary 355 00:40:29,737 --> 00:40:36,487 undertaking undertaken with free and informed consent in the same way that society requires the 356 00:40:36,487 --> 00:40:43,657 widespread participation of people who occupy many different social roles like voluntary firefighters, 357 00:40:43,657 --> 00:40:46,027 paramedics and other people. 358 00:40:46,027 --> 00:40:58,927 We want to organise the role of study participant in the same way a voluntary pathway through which people can make a contribution to the common good. 359 00:40:58,927 --> 00:41:03,937 Part of the way that we secure the credible assurance those people that they won't be 360 00:41:03,937 --> 00:41:08,167 an arbitrary decision made against them in order to advance the common good to use. 361 00:41:08,167 --> 00:41:15,517 McDermott's phrase is you have prospective review to eliminate unnecessary risk to ensure an appropriate baseline 362 00:41:15,517 --> 00:41:24,177 of care is provided within medical research and also have provisions that prohibit domination and abuse. 363 00:41:24,177 --> 00:41:32,037 So, so this point I was making free societies require many social functions to fill in the important social obligations, right? 364 00:41:32,037 --> 00:41:37,257 We need teachers. We can't get rid of ignorance. We can't combat ignorance without teachers. 365 00:41:37,257 --> 00:41:39,027 We need physicians. We need researchers, 366 00:41:39,027 --> 00:41:46,827 many volunteer firefighters and paramedics in all these people that provide important social services on which our health and welfare depend. 367 00:41:46,827 --> 00:41:54,837 And then what we do is we try to shape those social institutions so that individuals can see that social role as an avenue 368 00:41:54,837 --> 00:42:02,247 through which they can advance their own first order of conception of the common good and as a way that in doing that, 369 00:42:02,247 --> 00:42:09,537 they can contribute to the common good. And so it's a direct implication of this way of thinking about the research imperative. 370 00:42:09,537 --> 00:42:13,257 The research participation has to be organised research parties. 371 00:42:13,257 --> 00:42:18,377 Yeah. On this same idea. 372 00:42:18,377 --> 00:42:26,637 Shape the role of research participation as something where people can see it as an avenue to contribute to the common good. 373 00:42:26,637 --> 00:42:38,857 Without necessarily making themselves vulnerable to the kind of domination and abuse that McDermott thought was essential and inevitable. 374 00:42:38,857 --> 00:42:43,437 It's true there are a lot of thorny issues in research where you might say, Well, 375 00:42:43,437 --> 00:42:47,637 you know, what does that mean in terms of the way we think about research risk? 376 00:42:47,637 --> 00:42:51,597 I'm not going to go into that here. So there are two long chapters in the book. 377 00:42:51,597 --> 00:42:54,627 But, you know, I argue in the book that, you know, 378 00:42:54,627 --> 00:43:03,447 there's for a framework for evaluating risk that satisfies a bunch of really stringent ethical principles that can ensure social value, 379 00:43:03,447 --> 00:43:09,417 equal concern for individuals, equal concern for the welfare of people inside and outside of these trials, 380 00:43:09,417 --> 00:43:16,767 and a prohibition against impermissible gambles where basically impermissible gambles are the sort of thing where you say, 381 00:43:16,767 --> 00:43:19,797 If I'm not allowed to do something directly to you, 382 00:43:19,797 --> 00:43:28,987 I shouldn't be able to make it permissible for me to do that by just reducing the probability that the same outcome would occur to you. 383 00:43:28,987 --> 00:43:36,067 OK, so I'm almost done, and now we can talk about, you know, we had a larger conversation. 384 00:43:36,067 --> 00:43:42,917 But I wanted to say something about what the implications are then for for the field. 385 00:43:42,917 --> 00:43:46,897 So if you think about international research as an example, now, 386 00:43:46,897 --> 00:43:57,037 these common requirements from the OMS guidelines that really didn't have a clear normative foundation now have a much more solid foundation. 387 00:43:57,037 --> 00:44:02,507 The responsiveness requirement is itself a direct requirement of justice. 388 00:44:02,507 --> 00:44:10,417 You research must be responsive to the health needs and priorities of host populations to ensure that research activities produce 389 00:44:10,417 --> 00:44:17,857 the knowledge that is needed to enhance the ability of the institutions in those communities to understand and address the 390 00:44:17,857 --> 00:44:24,037 health needs of the people who live in those communities because they have a fundamental moral claim on the basic institutions 391 00:44:24,037 --> 00:44:32,847 of their society that they should work to advance their fundamental interests in being able to pursue a reasonable life plan. 392 00:44:32,847 --> 00:44:41,777 The requirement to provide an adequate standard of care. Larry, to respect participants is free and equal. 393 00:44:41,777 --> 00:44:47,387 They have to be guaranteed a level of care that doesn't fall below what can be attained and sustained for 394 00:44:47,387 --> 00:44:55,577 them within the set of basic institutions that provide social services to everyone in their community. 395 00:44:55,577 --> 00:45:01,907 And the requirement for post-trial access is just an implication that if you generate new knowledge, 396 00:45:01,907 --> 00:45:09,137 it's not going to safeguard the health of anyone unless it is integrated into the social systems that have, 397 00:45:09,137 --> 00:45:15,697 as their social function, safeguarding the health and welfare of people. 398 00:45:15,697 --> 00:45:20,857 Another implication of this view is that the IRIB triangle and the traditional view that, 399 00:45:20,857 --> 00:45:27,727 like people, scholars in research ethics are primarily speaking to researchers or IRB members. 400 00:45:27,727 --> 00:45:36,397 We have to we have to broaden the set of stakeholders that we are talking to because we have to broaden that are 401 00:45:36,397 --> 00:45:45,697 the realisation that many different stakeholders make decisions upstream of IRB review and downstream of study, 402 00:45:45,697 --> 00:45:53,407 study, conduct and study completion that affect responsiveness and and the availability 403 00:45:53,407 --> 00:45:58,027 of the knowledge and the interventions that are developed within research. 404 00:45:58,027 --> 00:46:08,467 So funders and sponsors, crows and researchers, maybe they are more typical and host communities and study participants. 405 00:46:08,467 --> 00:46:17,257 Regulators in IRB members. But, you know, lawmakers set the incentives in terms of patent law. 406 00:46:17,257 --> 00:46:24,937 Patent protection. IP protection that incentivise private and public actors to invest their time, 407 00:46:24,937 --> 00:46:32,677 energy and resources in determining which questions and where they put their time, energy and resources. 408 00:46:32,677 --> 00:46:39,877 So lawmakers and policymakers have to be some sort of a fundamental interlocutor for research 409 00:46:39,877 --> 00:46:45,277 ethics when it comes to thinking about what the priority research questions ought to be. 410 00:46:45,277 --> 00:46:50,617 Journal editors and professional societies, health systems, clinicians, 411 00:46:50,617 --> 00:46:57,637 patients and future researchers may be part of the reason for ensuring the quality of scientific 412 00:46:57,637 --> 00:47:04,717 research is not about the risks that poor quality research might impose on study participants. 413 00:47:04,717 --> 00:47:16,147 That's sort of how you have to funnel and frame issues about scientific quality in the sort of the current research ethics ecosystem. 414 00:47:16,147 --> 00:47:23,467 But, you know, research the information that studies produce is consumed by a wide range of stakeholders, 415 00:47:23,467 --> 00:47:26,497 health systems, clinicians and future researchers. 416 00:47:26,497 --> 00:47:35,027 And so they rely on that the quality of that evidence in order to fulfil social obligations that they have. 417 00:47:35,027 --> 00:47:40,967 So we have to move also away from a protectionist view where the primary function 418 00:47:40,967 --> 00:47:45,827 of research ethics is protectionism to one where the idea is the primary 419 00:47:45,827 --> 00:47:56,177 view of research ethics is to ensure that this scheme of social cooperation cannot be co-opted by any particular stakeholder to advance their narrow, 420 00:47:56,177 --> 00:48:06,407 parochial interests at the expense of the common good. So a lot of stakeholders in in in research engage partly to advance parochial interests. 421 00:48:06,407 --> 00:48:14,427 Profit promotion, access to novel treatments. The prestige of being a research institution. 422 00:48:14,427 --> 00:48:24,997 I think it should work to constrain and align these interests as much as possible with the common good, and I've got a long chapter about how. 423 00:48:24,997 --> 00:48:28,207 Framing the IRP review in protectionist terms, 424 00:48:28,207 --> 00:48:36,457 disconnects it from some of its actual important functions where it really does work to ensure that the cooperation amongst these 425 00:48:36,457 --> 00:48:47,177 different stakeholders is is aligned with producing higher quality research as well as protecting the interests of study participants. 426 00:48:47,177 --> 00:48:57,457 You know, FDA or EMA or other regular, you know, other institutions that set regulatory standards for safety and efficacy choices endpoint in a trial. 427 00:48:57,457 --> 00:49:07,387 The study design A lot of these questions now pose these questions beyond the confines of the single protocol to the IRP. 428 00:49:07,387 --> 00:49:13,477 So Jonathan Kimmelman and then Jonathan Kimmelman and I have together have done research 429 00:49:13,477 --> 00:49:18,817 on portfolio level questions questions that aren't just about individual study protocols, 430 00:49:18,817 --> 00:49:20,947 but whole sets of study protocols. 431 00:49:20,947 --> 00:49:29,127 Well, those things become very salient in this wider formulation precisely because they implicate the efficiency with we. 432 00:49:29,127 --> 00:49:36,847 Research uses scarce resources, including how many people are required in order to answer a question. 433 00:49:36,847 --> 00:49:46,297 The bandwidth of information that research produces about a question whether that which stakeholder is that information is really useful for. 434 00:49:46,297 --> 00:49:53,377 And then finally, as I said, law and policymakers need to be a fundamental focus, 435 00:49:53,377 --> 00:50:03,907 both in terms of how they set domestic research priorities and how we engage in our research, our collaborative research abroad. 436 00:50:03,907 --> 00:50:09,577 And I think vaccine equity and the fundamental problems that we're having right now 437 00:50:09,577 --> 00:50:16,237 around vaccine equity sort of shine a light on how this whole ecosystem of we had to. 438 00:50:16,237 --> 00:50:20,737 We had to answer a novel question. We generated now a new resource. 439 00:50:20,737 --> 00:50:25,687 And now we've got to carry out the difficult work of equity of making that resource available to all 440 00:50:25,687 --> 00:50:32,737 of the communities that require it in order to secure the basic interests of their community members. 441 00:50:32,737 --> 00:50:40,987 So in conclusion, I are you in the critical part of the book that the boundaries of research ethics are arbitrarily narrow. 442 00:50:40,987 --> 00:50:45,517 A bunch of current requirements seem arbitrary and self-defeating. 443 00:50:45,517 --> 00:50:52,867 There are a whole raft of stakeholders who exert concrete and real influence on the way research is done, 444 00:50:52,867 --> 00:51:00,307 but who are basically invisible and whose conduct is invisible within Orthodox research ethics and the relationship of research 445 00:51:00,307 --> 00:51:09,057 to important social institutions and the moral responsibility of those institutions is far less visible than it ought to be. 446 00:51:09,057 --> 00:51:17,557 In place of this, I offer a much broader conception of research as a social activity spread across time involving multiple stakeholders. 447 00:51:17,557 --> 00:51:22,147 It's one element within a much larger division of social labour in this position. 448 00:51:22,147 --> 00:51:24,787 Issues of justice becomes central. 449 00:51:24,787 --> 00:51:33,367 Some of the existing requirements that sort of are put forward without solid justifications are given a much more coherent foundation. 450 00:51:33,367 --> 00:51:38,017 The full range of ethical issues now that are salient to the conduct of research can be 451 00:51:38,017 --> 00:51:43,447 framed while considering the duties of a much more comprehensive set of stakeholders. 452 00:51:43,447 --> 00:51:50,167 The dependence and the influence of important social institutions on research is central, 453 00:51:50,167 --> 00:52:00,937 and it allows us to provide get rid of the asymmetry so that we can frame the harms of unwarranted diversity of health practises. 454 00:52:00,937 --> 00:52:06,937 As salient as the risks that are carried out in research where we can see one of the fundamental 455 00:52:06,937 --> 00:52:13,387 goals of research is to address unwarranted diversity as a kind of uncertainty that we 456 00:52:13,387 --> 00:52:18,847 want to eliminate in order to create institutions that more effectively and efficiently and 457 00:52:18,847 --> 00:52:27,067 equity equitably advance the basic interests of the people who rely on them to function. 458 00:52:27,067 --> 00:52:28,927 OK, so thanks very much. 459 00:52:28,927 --> 00:52:38,133 And as I said, the book is free and open access from Oxford University Press, and I am really looking forward to our conversation.