 Our next speaker is Lynn Janssen. Lynn A. Janssen is the inaugural holder of the Madeleine Brill Nelson Chair in Ethics Education in the Center for Ethics and Healthcare at Oregon Health and Science University. Before working at OHSU, Dr. Janssen was Director of the John J. Connolly Center for Medical Ethics at St. Vincent's Hospital in New York City, and the Director of the Bioethics Institute at New York Medical College. Dr. Janssen is also the Principal Investigator on a five-year R01 grant funded by the National Cancer Institute designed to study the impact of the optimistic bias on risk-benefit assessments by patient subjects who enroll in early-phase cancer trials. Today, Dr. Janssen will give a talk titled, Revisiting the Belmont Report, Two Models of Inform Consent. Please join me in welcoming Dr. Janssen. OK, thanks, Ellen. And are we in the afternoon now? Yeah, so good afternoon. I'm going to save this. I have no conflicts of interest. So today, my talk is going to center on informed consent in two different contexts. And I'm really glad to have followed Jerry and his talk, because his really hit on some real practical elements of informed consent. Mine is going to be slightly more theoretical, and we'll see whether at the end of the day our two opinions converge or go in different directions. I'm going to present some ideas that actually I advanced in a recent paper that I wrote that had to do with a collection of essays on revisiting the Belmont Report on the 40th anniversary of its publication. And a central claim in that paper rests on distinguishing informed consent as a moral principle from informed consent as a model. Informed consent understood as a moral principle is what philosophers and bioethicists frequently articulate. So typically, in formulating a moral principle of informed consent, a writer will try to identify a basic set of conditions or elements that are necessary for consent to be valid. So the authors of the Belmont Report, for example, they did exactly this when they articulated a general principle of informed consent that they then applied to the context of human subjects research. By contrast, what I'm calling a model of informed consent is going to be context-specific or context-sensitive from the start. So different models of informed consent are not what you're going to get if you just apply the same principle of informed consent to different contexts. And so this point is really crucial to my discussion, so I want to elaborate on it a little bit more. Models of informed consent, because they vary along several dimensions. And three of the dimensions can be mentioned here. First, models can be such that they impose different standards. So these are the requirements for consent to be valid. Right now, just to give an example, there's a lot of discussion about the standards of consent for sexual relations. People are urging that we move from a no means no standard to a standard of affirmative consent. And this has actually raised a lot of interesting kind of questions about how to characterize this standard in this context. Second models can impose the same standards, but they can assign different degrees of stringency to them. So for example, a model of informed consent that presents high risks of harm may impose a more demanding standard of disclosure than a model of consent in a context which imposes low risks of harm. So finally, the third element here would be that models can be distinguished by the way in which they impose different regulatory or enforcement mechanisms. So human subjects research, for example, is subject to IRB approval. But this kind of review process really wouldn't be appropriate in other contexts of informed consent. So models of informed consent, they differ along these different dimensions. They differ in terms of their standards, their stringency, and the mechanisms of regulatory oversight. And what I want to argue is that one can't determine what model of informed consent is appropriate for a particular context simply by reflecting on a moral principle of informed consent. Rather, one needs to know quite a lot more about the context and the functions of consent in that context before one can start to think intelligently about the standards, the stringency of the standards, and the regulatory oversight that's appropriate to it. And the normative functions are really marked on that second bullet point. So I actually hope that these points, the idea that there is a difference between a principle of informed consent and a model of informed consent are compelling to you. But they're not, I believe, sufficiently appreciated by most writers on informed consent in medicine and in research. And in fact, I think there's been a tendency to articulate a sort of single master principle of informed consent and then just apply it to both contexts of medicine and to research. But of course, once this is done, then all sorts of efforts are going to need to be made to tweak the requirements imposed by the principle so that it's going to fit better within the context in which you want to apply it. What I'm suggesting is a different, perhaps bolder, approach. I suggest that we should just stop trying to even articulate a general principle of informed consent. I suggest that we turn our attention, instead, directly to constructing models of informed consent. And this approach, as I said from the beginning, is going to be context-sensitive from the start. And it's my contention that this alternative approach will actually help to enable us to avoid certain kinds of errors, which I'll discuss in a moment. And these are errors that I think are often made in discussions of informed consent and clinical research. But my bold approach really does contrast fairly sharply with the approach that was taken by the authors of the Belmont Report. So what they did is they identified several basic elements of informed consent, disclosure, understanding, and voluntariness. And then they argued that these elements apply to both medicine and research. This one-size-fits-all principle approach can actually lead to mistakes, however. And the reason it can lead to mistakes is because medicine and research are fundamentally different contexts, even though they're both often carried out by health care professionals in health care settings. And the central reason why they're different contexts is actually familiar, I'm sure, to everyone in this room. Medicine is undertaken for the good of the patient, whereas research is undertaken for the good of science. Research, unlike medicine, is a context of potential exploitation. There's in research always this sort of standing background worry that research subjects are going to be used for the sake of scientific progress. Informed consent, of course, it can mute this worry about exploitation. People can and they do give consent to participate in research for the good of others. But it needs to be genuine consent, and it needs to be autonomous consent. And there are not these similar worries about exploitation in the context of medicine. For this reason, the protective and at least a protective function right away is not as salient in the context of medicine as it is in research. And this fact helps to explain why the standards of disclosure and understanding in the medical contexts are appropriately less stringent than they are in the research context. It also explains why research is subject to special kinds of regulatory oversight, such as IRB approval. In addition, and I think this probably might be a little bit more controversial, it can help to explain why there are different standards of informed consent for research and medicine. One such standard, I would suggest, might be something that we call appreciation. It requires that informed consent, in order to be valid, people must not just understand the relevant information, but they also must properly process it and apply it to themselves in their situation. So this is important. If you understand appreciation in this way as a sort of separate standard of the necessary informed consent, at least in the context of research, you're gonna see that appreciation is not merely a part of capacity as Applebaum and Grisso understood it. Rather, it's an additional requirement for valid consent. And appreciation, unlike understanding, can sometimes be compromised by various biases that have been studied by social psychologists. I actually have argued in other work that biases, such as the bias of unrealistic optimism, do impair informed consent. But my concern was with consent in the research context. I don't actually believe that biases pose a general problem to the kind of informed consent that's appropriate and that we care about in clinical medicine. The worry about a bias is that it can be used or played upon by others to advance their ends at the expense of others. But in medicine, the physician and the patient share the same end of promoting the patient's best medical interest. So the possibility that research has its own standards of informed consent, that the standards are more stringent than those appropriate to medicine, and that special regulatory mechanisms are called for to ensure informed consent, is actually obscured by the approach to informed consent that seeks to apply the same general principle of informed consent, both to the context of medicine and research. And I think it also sometimes leads people to make misguided recommendations or to commit certain mirroring errors, if you will. So for example, I recall reading a paper by Tom Beach. I mean, he wrote it back in 2011, but he was objecting that the context of medicine didn't have the same or similar kinds of strong regulatory IRB-like approval structures. Now I think one would really only be tempted to advance that kind of recommendation or be bothered by the lack of those structures in the context of medicine if one thought that informed consent in medicine should actually mirror informed consent and research. This sort of one's principle fits all approach but also is actually gonna lead people to reject the idea that biases might be a problem for consent to participate in research, right? Because we don't really worry about biases when it comes to medical treatment. In fact, actually on a personal, when I first began writing about biases, I myself did try to connect them and try to understand them within this sort of one general principle of informed consent that we have hanging out there. But actually to do so, I had to distort the principle quite a bit. So I'm just suggesting that shifting the focus from the principle of informed consent to models of informed consent can help us to avoid these sorts of mistakes and errors. Now, despite its advantages, I do suspect that some are going to have doubts about the workability of my proposal. I mean, is it really feasible? And so I just wanna conclude by responding to one important objection that the two models of informed consent idea can come across. I'm never really good with these slides. Anyway, so here we have the objection that in medicine and research, these two contexts actually are not as sharply differentiated as it might seem or as I'm making out. Indeed, they're actually becoming more and increasingly intertwined. Research trials often integrate therapeutic and experimental elements and that's just the case. And so one might wonder whether this sort of integration in effect to sort of merging of the medical and research contexts poses a real problem for my proposal. Definitely the authors of the Belmont report claim that if a medical practice included any research component at all, then it should be considered research. And I could follow that same approach, but I don't think it fits very well with the underlying idea that I've been proposing. To be sure, if a medical practice has a research component, then it will need to be subject to IRB approval. So I think the authors of the Belmont report are right about that. But if research trials become beneficent, then they're not potentially exploitative and the importance of the protective function of consent then diminishes, I think. This possibility, the possibility of a beneficent research trial has actually been invoked by some bioethicists to argue that research trials can be ethical even if the participants are under a therapeutic misconception or under the sway of an optimistic bias. Now I think that this is wrong, but the underlying idea is nonetheless compelling. Standards of informed consent for research are appropriately less demanding if the participants are looking at a favorable risk-benefit ratio. Of course there's a puzzle here too, I think, just to explore briefly. If research is genuinely beneficial to its participants, then why is it even being conducted? Why do research at all really, if we know that maybe it's benefiting the patient or that it is benefiting the patient? In fact we do research because there is always this element of uncertainty. Still, research trials do present a risk-benefit profile to their patient and this profile is more favorable to participants in some trials and others. So what I wanna say is that the burden is gonna be on the researcher to establish that his trial is genuinely beneficial to its participants and I actually do think that this burden is going to be hard to meet, but I'm gonna just wanna allow that the burden could be met. So my response to the objection, this objection that research and medicine can become intertwined and that thereby makes the two models of informed consent proposal ineligible is to really spotlight this emphasis on a risk-benefit profile. So the standard model of informed consent in medical care, the risk-benefit profile there is always gonna be favorable and we know it's just wrong to provide a treatment whose benefits don't justify their risks to a patient. For standard research trials, the risk-benefit profile is actually often unfavorable, but for trials that integrate experimental and therapeutic elements, the matter is going to actually be more complicated. Here we need to distinguish those trials to provide a favorable risk-benefit profile to each of their participants from those that do not. The former, you can see on the slide here, are going to appropriately fall under the model of informed consent for medicine and the latter would more appropriately fall under the model of informed consent for clinical research. The precise cut here is not actually a cut between medicine and research, but a cut between the practices that provide interventions that are in the interests of the participants from those that are not in the interests of the participants. The precise cut maps onto this research medicine cut pretty nicely, but it has the advantages of providing some guidance for practices that blur or merge this sort of research therapy divide. Anyway, that is my proposal. Working out the details of these two models is gonna require obviously more work. I've tried to do that here. I just wanted to give you all a sense of the main idea and what I've been working on lately in the area of informed consent. Thank you. I enjoyed your talk. Yeah, done, Louisville. I'm troubled by, well, this whole idea of beneficent research. I mean, how do you know it's beneficent if you truly have clinical equipoise? I mean, you don't. Right. And unfortunately, the assumption is made by the American public that like in technology, the latest and greatest is gonna be good for me. It's gonna cure me and my disease. And often takes, it's often substituted, offering an experimental trial to a cancer patient is substituted for what the real conversation you have to have is that they have life-limiting disease. And that's very troubling because people are assuming, without much discussion, that this is gonna be good for me. And I think sometimes we have to have the real conversation before we talk about research. Right, well, I agree. I'm troubled too by the notion of beneficent research. I encountered this claim constantly and that's why I wanted to include that as a potential objection to what I'm arguing for. But yeah, I think I'm in agreement. Thank you. Hi, Laney Ross. Great talk. The one thing that seemed to be missing from this talk was the difference in motives. So even if it's beneficent research, it's still about the motive is about promoting the advancement of science versus clinical care, which is the promotion of my health benefit. And that doesn't seem to be part of your modeling. You have these three criteria. You don't have motives as one of them. I have the three what? You know, you have three criteria that you gave, stringency, but you don't include motives. Yeah, so I actually, I agree. The motives of research are different from the motives of medical care. That's 100% true. What I'm really trying to argue at this moment is that precisely because those motives and those ends are different, that it makes sense to talk about different contexts for different models of informed consent in these different contexts. The fact that the motives are different is very relevant. But my main argument really, Laney, is that I want to move away from looking just specifically to a principle of informed consent, which I think we do, and trying to apply it to these different contexts with those elements that are attached to that principle, and instead look to more the normative functions of informed consent. What are those functions of informed consent that are motivating our concern about it in the first place? So the recognition that there are different motives really supports, I think, my argument that we really do need to think about informed consent for different contexts. So I don't think we're in disagreement. I did, you're right, I didn't explicitly state that, but the fact that we're talking about different contexts and not overlapping them is precisely because there are different motives in defining those concepts. I totally agree with everything you just said, but that also changes in how we interpret risk benefit because there are risks to clinical care as well, and sometimes some incredibly serious and negative harms that can happen from clinical care. But at the end of the day, the motives seems to me, so I agree with you, they should be split, but it makes it harder for me to see how they're merging in your last slide. Oh yeah, yeah, I don't actually think that they merged that easily. I only have that last slide because I'm trying to accommodate an objection that I think that one would pose against my account, and in fact, people have posed against my general approach toward research ethics and the optimistic bias. So I'm not defending that, I'm just responding to that objection and saying I want to allow for the possibility of that, but that's not my point, but thank you for helping me clarify that. I apologize, but I think we're gonna need to move on in the interest of time, so maybe you can ask your question. Can I just make a comment then? Can I just make a comment? Mike, Julie Korf from the University of Chicago.