 Valerie Gutman Cook is a visiting fellow at DePaul University College of Law and the Director of Law and Ethics at the McLean Center. Her research focuses on the interactions between technological and medical advances and various areas of the law. Professor Cook serves as the Chair of the ABA Special Committee on Bioethics and the Law and Co-Chair of the Law Affinity Group for the American Society for Bioethics and the Humanities. She also teaches the fellows law class now. And I'm so proud and pleased to introduce Valerie Cook. Hi, so I'm going to be speaking on the title is Autonomy for All, Informed Consent Parity in Treatment and Research. It's an honor to be presenting again this year at the at this fellowship. Thank you Dr. Siegler. And I'm particularly excited about this project because it really came out of discussions that I had in my first two years here teaching the fellows. And so it's really just an honor to be able now to start presenting this work to you guys. So I'm just going to use this. There we go. So a patient who is harmed by her doctor due to a lack of informed consent has what's considered to be a right to recover. In other words, she can sue her doctor for failure to provide informed consent. However, such a right does not exist in the research context. So it does not extend to a research participant who is harmed due to a failure of informed consent by the investigator in the research protocol. And this is due to historical and well established disconnect between medical treatment and human subjects research. So the project that I'm discussing today really seeks to do three things. The first is to identify the reason or reasons that there's this difference between informed consent and treatment and research. The second is to clarify why I believe that this distinction is, if it ever was, no longer supportable. And then the third is to offer at least one, if not perhaps two, alternative normative approaches to rectifying this problem. So, as the slide goes into, at the heart of most of the distinctions between research and treatment are the goals of each. We have in treatment, the goal of treatment is the best interests of the patient, doing the best that we can to serve their health. On the other hand, in research, the goal is to produce generalizable knowledge. So there is just at the heart of these two enterprises an inherent tension. And sometimes when we see an almost impossibility of serving both at the same time. So due to these divergent goals, the mechanisms for ensuring informed consent in the two contexts have evolved separately, but kind of simultaneously. So the law as it relates, and this is just a very brief history, there's a lot more there, but these are sort of the key moments. But the law as it relates to harms that arise in the treatment context, with regard to failures of doctors to disclose the potential risks of a treatment, have developed judicially. That means they've developed via judicial opinions, judge written opinions that make up what we know as the common law. In contrast, due to notable scandals that we are all aware of in the mid 20th century, both in the US and abroad, the laws it relates to the oversight of and consent to research has developed statutorily through legislation and regulation. So in the context of treatment, failure to provide informed consent is premised in common law, which requires both a duty conferring relationship between the doctor and the patient, and then breach of that duty. So premised on the duty that arises out of the doctor-patient relationship is become a basic tenet of tort law that a physician who breaches that duty, such that the patient who is harmed by her doctor due to a failure of informed consent, has judicial recourse, or what's known as a private right of action. And the case law that we've seen is often based on the primacy of patient autonomy, the patient's right to make one's own medical decisions based on voluntary decisions based on full information. And this private right of action provides an independent review of negligent care. So the private right of action therefore actually serves a dual role. The first is to deter bad actors, so it has a deterrent effect on physicians, perhaps to not disclose information that would be material to a patient's decision to pursue or not pursue a specific intervention. And it also compensates the victim when they are harmed due to this failure of informed consent. But no similar private right of action exists for research participants who are harmed as a result of an investigator's failure to provide informed consent. And the federal regulations that govern human subjects research, the common rule primarily, but there's also the FDA regulations as well, they provide no recourse for these individuals. They only allow for an investigator to lose research funding when they fail to follow the informed consent rules that are contained in the regulations. So this means that there's only a deterrent effect on the bad actor while there's no compensation for the injured participant. And refusal to find a private right of action in the courts is often based on the fact that there is no legally recognized duty conferring relationship between the investigator and the participant, something I call here the IPR, although I'm sure there are other ways, other things that we can call it, but investigator-participant relationship. In other words, there's no legally enunciated or recognized duty of the investigator to benefit the research participant. Instead, the primary goal of the research is to advance research, to advance generalizable knowledge. So importantly, as a general rule, therefore, courts have not found a duty conferring relationship between the investigator and the research participant absent a pre-existing doctor-patient relationship. So I bring this up because people who are familiar with the law in this area love to argue this point with me whenever I present it. But the legal rule is that where a duty of care under a doctor-patient relationship already exists, a court may extend that duty of care to include research activities undertaken by the physician. And that's what we see in cases like the very famous Moore case in California. But no such duty exists where the investigator is just that, the investigator. So why, and there is one exception case that I can get into, but I do believe that's an outlier. So no such duty exists when the investigator is just the investigator, and why is there historically no private right of action for informed consent? Well for one, besides the fact that the common rule does not explicitly say there is, courts have actually refused to extend the federal regulations to or to find within them any sort of duty conferring relationship. So therefore they found that there's no private right of action for failure of informed consent in research. Second, courts have expressed unwillingness to extend this private right of action for informed consent in research because of a fear that this is going to somehow chill research. But I believe that this distinction between research and treatment in the context of informed consent is based in historic artifact. And therefore even if this differential treatment was perhaps justifiable in the past, I don't believe it is anymore. Advances in research technology require a new approach. For one, the investigator-participant relationship is changing. And thereby making the line between treatment and research less well defined. So in fact, I've identified here at least one scenario that I believe further complicates the or sheds light on this evolving and changing IPR, the evolving relationship here. And that is the emerging duty, and this was mentioned just a couple of talks ago, the emerging duty to disclose research findings. And this is based on the emergence of genetic testing technologies, the proliferation of research involving biological samples, and the escalating use of medical imaging. So there is a building consensus. It's not entirely as Dr. Kuhler mentioned. This is not the rule yet. But there is a building consensus that there is some sort of duty to disclose to participants of research the secondary or incidental findings that are discovered during the course of research that are not premised in the original purpose of the research. And so this emerging duty to participants may represent what I consider to be a pretty significant shift in the IPR by identifying what might be seen now as some sort of duty conferring relationship between the investigator and the participant. And it may signify a new approach to how the law should approach this relationship. So in light of these changes, courts may be less likely to be able to rely on the distinction between treatment and research goals as a justification for different standards for recovery for nondisclosure of material information. So the distinction between the duties owed to patients and the duties owed to research participants, I believe, is less sustainable. And as a general rule, both the DPR and the IPR have problems of information asymmetry and risks. And throughout the last two days, we've actually recognized patient vulnerability of fair share. And I do believe that in many cases, research participants may be even considered more vulnerable in some situations. And in fact, research participants are not presented with the attendant potential benefits of an intervention that patients are and investigators may be more likely than physicians to have conflicting goals. So importantly, and this comes back to the title of my presentation, the principle of autonomy or respect for persons necessitates similar treatment for all three of these scenarios that I'm exploring. The failure of informed consent and treatment, the failure of informed consent and research, and the disclosure of secondary or incidental research findings in research. So based on the consistently applied principle of not treating persons as mere means to an end, in order to make future autonomous and informed decisions, both the patient and the participant have the right to know the risks of an intervention and the information discovered about him or her during the course of research. So how do we rectify this problem that I've identified? Well, I think we have two options. The first alternative, which I've written a fair share about, is that in today's circumstances in which research projects pose a similar threat to patient autonomy as does medical interventions, I believe that these circumstances support a private right of action for research participants who, like patients, are harmed by a failure to provide informed consent. So research participants under this argument or this alternative should have access to a private right of action against investigators who fail to provide informed consent, similar to the access patients have to a private right of action against doctors who do the same. An extending a private right of action for lack of informed consent to research may provide the necessary protections against the serious threat to patient autonomy that modern research can pose. The current approach, the loss of research funding, is a necessary but not sufficient approach in light of the evolving research model. A private right of action, again, serves that dual approach, dual purpose. It deters bad behavior and it compensates the victim. Okay, so I'm a lawyer. I'm arguing for more law. We shouldn't be that surprised about that. That could perhaps lead to more litigation. But alternatively, I'm thinking about something completely different. So the other alternative that I'm currently exploring and is even more radical, I think, in response to the lack of parity and informed consent to research and treatment. And that's the elimination of liability for failure to provide informed consent to medical treatment. I'm not saying we don't have informed consent to medical treatment. I'm talking about specifically liability in the tort that we might be familiar with and from that was derived out of Canterbury versus Spence and are actually even earlier than that in the late 50s and then onward. So this would, although, but even though this was really established the tort of informed consent, maybe in the late 50s and really established in the 1970s, it's still in legal terms one of the newest causes of action out there. But despite it's being sort of new by historical accounts, it's pretty firmly entrenched in the law and it's intended to ensure patient autonomy and patient's autonomous decision making. So this proposed response would transform and overturn a pretty complex and historically entrenched area of the law, one upon which a lot of medical practice for better or worse can sometimes be based. However, it's commonly argued that the informed consent process in the medical context has actually been co-opted by the legal community in an effort to protect healthcare workers from liability and that it no longer serves that lofty goal of ensuring autonomous informed decision making and protecting patient self-determination by ensuring the treatment decisions are voluntary and informed. So, I probably will stop there, but oh, one more thing. So for more, I did want to flag, so the first article is the article that I do argue for a private right of action and go through it in a little bit more detail. The second piece is actually a letter in response to the Notice for Proposed Rulemaking to revise the common rule that I published in last year or the beginning of the year with a law professor at University of Houston Law Center. And that addresses both for proposed changes to the common rule proposing that there be some sort of right to recover for informed consent and other research harms in the research context, but actually also addresses consent to biospecimen research. So I figured I would just flag that as well. So thank you. That was fascinating. It looks like Lainey may have a question for you. Hi, Lainey University of Chicago. That was wonderful. So I'm still stuck on like your third slide where you said that there is no duty, that there's no researcher, research participant duty. Your phrasing was like a legally sanctioned. Yes, a legally recognized duty conferring relationship. So how would one... Except in one case that I purposely did not mention by name for your... But how would that be established? Because I'm sitting here reading the Nuremberg Code where it's very clear that they think that there's a legal duty. And in fact, it's almost stronger than what we heard this morning with the surgeons because in the surgical lectures we heard this morning how they often turf getting informed consent to the residents. And here they wrote in the Nuremberg Code, the duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. Absolutely. So to be clear, thank you. And this gives me a great opportunity to clarify because I don't mean to say that there aren't responsibilities and duties. There are. I mean, the common rule says that there are duties, so you have to get informed consent to research and there are all sorts of things that you have to do. There's actually... Well, I'm... Oh, never mind. I have a slide that actually goes through the specific responsibilities for informed consent and research that are required under the common rule. That said, courts have not recognized... So in order to prevail on a tort claim for informed consent, you have... There are four elements. The first element is that there has to be a duty conferring relationship that is recognized by the courts. That relationship is not recognized by the court. So there might be the duties, but there's not the... It's not recognized. Many courts have actually refused to find, in fact, that the common rule confers such a duty conferring relationship such that then they can go forward with the other steps of finding that there's a breach, finding that there was the causation, and finding that there was actual harm or damages. And so there is the one case out of Maryland that found a special relationship, right, Grimes, between the researcher and the research participant. Every other case that's considered Grimes, and they call it a special relationship, which has a special legal meaning to it, it's beyond just the regular... It's beyond even the accepted norm of the doctor-patient relationship. It's kind of this higher echelon duty relationship, sorry. And every court that has considered Grimes when it's come in front of them to find that maybe there's this important has turned it down, has knocked it out, so there is no such thing, there's no special relationship here. And so if they can't get to the relationship, you can't get to the duty, you can't get the rest of the way there. So can I ask a follow-up on this? Does that mean... Does that change if the patient believes that their researcher is their doctor? Yes, and that's the point that I was making before when I referenced the Moore case, because when you do have the physician who then, say, refers their patient to a research protocol or somehow is also the researcher in their... Like they weren't the doctor before. Yes, where the physician wears two hats. Yeah, the physician wears two hats. Yes, in those cases, courts are more likely to find that there is some sort of relationship there than... But that's really usually based on this conflict between... That's perceived between the doctor and the patient, that the doctor has... The physician who has a conflict of interest there, like we see in the Moore case. So hi, September Williams from San Francisco. You kind of touched on it. So I came across a situation where I was asked about mandatory biopsy for non-small cell cancers in people who were way out in late phase of treatment. And I raised the question immediately, well, are you the doctor or are you the researcher in this case? And if you're the doctor, what is the courage, the component to that? And what does that do to the validity of that informed consent? So the biopsy is purely for user purposes? And they're mandatory in order to be enrolled in trials in order to have late stage therapies. And so the non-small cell cancer is the one that sticks in my mind, but I've seen some others too. So ideas? I think that that's... Again, we're still at that place now where we have the researcher and the physician wearing two hats becoming the researcher. I suppose he's not the researcher himself. He is in order to get his patient enrolled. Well, the enrollment is for therapy that he will basically be a part of. So it's a... It may be a way to test the validity of this in relationship to coercion. Absolutely. And I think obviously the questions of informed consent and autonomous decision-making and all of those things become heightened when there's a potential conflict. I think there's more of a definitive relationship there. So really what I'm talking about in these cases are the researcher-qual researcher, someone who is independently engaging in a research protocol and recruiting, however, he or she might be recruiting to bring the participants into the research protocol and then are harmed due to a failure of informed consent. Okay. All right. Just a couple more minutes. So Dr. Bronner and then we'll make room for Dr. Siegler. Don't worry. Getting quite the lineup of questions. Yeah, it seems to me if you're really interested in protecting patients and making research safe and ethical, that the work needs to be done in the IRB in setting up protocols that people have shown that informed consent really doesn't protect patients. It seems to me that if you're going to add this whole notion of legal avenues for patients that it's going to open the same quagmire of malpractice and research as well, now have to get malpractice insurance and it's just created another industry for lawyers and expert witnesses. So yes and no, I agree to some extent that it is opening up and this is why I said, you know, a lawyer arguing for more law, more regulation, of course, you know, but not surprising there. But I don't believe, first of all, an informed consent claim on its own, and this is actually an argument both for and against eliminating informed consent and treatment. It is very hard to recover informed consent, even in treatment. It's very rarely, if ever, brought as an independent claim. It's usually a tag along claim on top of others. So if somebody's harmed, they're already bringing a case informed consent or no informed consent claim. And proving all of those elements is incredibly difficult. So I don't anticipate seeing this mass rush to the courthouse by saying now you have a right to recover informed informed consent in research because we haven't really seen that in treatment because of how difficult it is to prove, because you have to show causation and damages and damages are even more difficult to prove, I think, in the research context than they are in the treatment context. So yes, there's always the concern about more tort liability, increased tort liability. I'm the daughter of two physicians. I talk about this and they sort of kind of want to kick me out of the house. So I get it. We want to avoid increased court time for physicians, for especially when they don't deserve to be in court. But at the same time, when you're talking about really egregious informed consent issues, problems that happen, harms that occur due to a failure of informed consent, the fact that we aren't allowing people to be compensated to be made whole. I mean, there's no even requirement, actually, that there be compensation for any research related harms to patients, sorry, to participants. If we were to do that, if we were to impose that, that would render my argument moot. And we could do that as a no fault system. So it wouldn't increase medical malpractice, court time, all of that stuff as well. Dr. Siegler. Valerie, thank you so much. I totally agree with your conclusion that these two relationships, therapeutic relationship and investigative relationship, ought to be seen on the same plane, rather than giving up the liability for the doctoration relationship. But I have to admit that I was not entirely aware of what you've taught us this afternoon. I just want to get straight. If the Tuskegee case came up today, and 150 or 200 participants, not patients, participants, showed how injured they were by a lack of consent, lack of information that penicillin was available for the final 50 or 20 years, that those people would not have a legal claim for damages. It has never been tested in court. That case settled two years after everything was brought to light. Had that case actually been tested in the court of law, I'm guessing I would not be standing up here making the same argument. I think that there would have been some sort of precedential decision that then we would say, okay, now this is such a scandal. This is such a terrible thing that's happened to a huge portion of our population that's going to cause immense distrust in the research enterprise that we need to make sure that people are compensated for their harms, and that can deter future bad action. Of course, we know that the Belmont report and all that came right after too. So now we have all of those. So again, that deterrent effect, that chilling research argument, I think would be sort of as well, because we already have a deterrent effect from the rules that emerged out of the Belmont report common rule, et cetera. Thank you. Thank you very much. Perhaps it only chills bad research. Anyway, last on our topic today, Lynn Janssen is the inaugural holder of the Madeleine Brill Nelson Chair in Ethics Education in the Center for Ethics in Healthcare at the Oregon Health Sciences University. She worked as a registered nurse before earning a doctorate in political science at Columbia University and completing the Ethics Fellowship at the McLean Center. She's editor of Death in the Clinic and is associate editor of the journal Theoretical Medicine and Bioethics. She has published widely on medical and research ethics. Please help me welcome Lynn Janssen.