 It's a delight to welcome you all to the 30th annual McLean Center Conference. The center was started in 1984, and the first conference was held four years later in 1988. The inspiration for both the center and the conference was Mrs. Dorothy Jean McLean, who was a great believer in the power of education and of the importance of supporting education. DJ's legacy lives on in our program through our fellowship training, which remains the oldest and largest ethics fellowship training program in the world. Over the last 35 years, we've trained just under 500 ethics fellows. This year's group of 35 includes people with clinical backgrounds in medicine, surgery, theatrics, OB-GYNE, psychiatry, nursing, and chaplaincy. Our fellows this year come from China, South Korea, Japan, Italy, Canada, and of course the U.S. Let me introduce the moderator for the first panel. The moderator for the first panel, which will be on surgical, panel on surgical ethics, is Dr. Megan Collins. Megan Collins is an associate professor of ophthalmology at the Wilmer Eye Institute at Johns Hopkins, where she's also on the faculty of the Berman Institute of Bioethics. Professor Collins specializes in pediatric ophthalmology. She received a medical degree here at the University of Chicago, where she was also a McLean Center Fellow. Megan helped start the Johns Hopkins school-based eye care team, which recently won the Jenny Pomeroy Award for excellence in vision and public health for their work addressing vision problems in high poverty schools, particularly among younger children. Dr. Collins is published widely on pediatric ophthalmology and clinical ethics, with research papers appearing in JAMA, the American Journal of Ophthalmology, and the New England Journal. Today, Megan will be moderating our panel on surgical ethics, and later today this afternoon she'll be giving a talk that her talk is entitled School-Based Eye Care, Where Ophthalmology, Public Health, and Ethics Meet. Please join me in giving a warm welcome to our moderator, Professor Megan Collins. Good morning, everyone. I'm pleased to be introducing this esteemed panel today, starting with Dr. Elisa Gordon. She's a professor in the Department of Surgery, the Division of Transplantation, as well as the Center for Healthcare Studies, Center for Bioethics and Medical Humanities at Northwestern University's Feinberg School of Medicine. She's completed her doctorate in medical anthropology from Case Western, as well as completing the McLean Center Fellowship in Clinical Medical Ethics, I think 1999, which was actually the first year that I came to be Merck's research assistant, so a couple years ago now. After completing the fellowship, she also completed her master's in public health. I'm combining. I have two different versions here. Her research interests include ethics of organ transplantation, health disparities in access to health care and health outcomes, health literacy, informed consent, self-care and chronic illness management. She currently serves as the chair of the UNOS Ethics Committee and associate editor for the American Journal of Transplantation. Today she's going to be talking to us about patients' perspectives on informed consent for deceased donor organ intervention research. Please join me in welcoming Dr. Gordon. Okay. Good morning, everyone. It's a pleasure to be here. Can you hear me okay? All right. Great. I wanted to thank Dr. Siegler for the kind opportunity to be here. It's a pleasure to be here. I wanted to, first of all, acknowledge my funding, the Greenwell Foundation. All right. As many of you know, with organ transplantation, there's a huge waiting list and a really big organ shortage with over 100,000 people waiting for an organ transplant. That's perhaps the most well-known problem with regard to transplantation. Another key problem is that the organ quality declines as soon as you start to remove it from a deceased donor and then you place it in the recipient, but then it still keeps declining over time. The median survival of a kidney, for example, is about 10 years. There's a kind of research called deceased donor organ intervention research, which I kind of use organ research, that aims to increase the quantity and quality of organs used for transplant. It's designed to minimize organ injury as well as optimize organ functionality. Here are a couple examples of this kind of organ research. You can cool down the donor's body to better preserve organs before you retrieve the organs. You can give a blood pressure lowering drug to a donor before organ retrieval and so on. Such kind of research could be done either in the donor or after you've removed the organ, ex vivo, or upon the recipient after the recipient has accepted the organ. Right now, the donor intervention research is really under regulatory and ethical scrutiny. Let me tell you the story of what has happened in recent years. There was a transplant surgeon, Dr. Neiman, who had in 2015 tested a new kind of research called where he took kidneys from deceased donors and exposed them to hypothermia compared to normothermia to see which intervention resulted in less delayed graft function post-transplant. Now, a word about this research got out and subsequently public citizen, a public advocacy organization, they learned about this research and they wrote a letter to the Office of Human Research Protections in 2016 and they were really upset about it. They're like, this study violates human subjects protections because kidney transplant recipients were not informed about the research organs that they had just received, okay? So like in any other kind of research study, you know, any person would be informed of any kind of research that they would be exposed to. So subsequently, the Department of Health and Human Services stopped all of this kind of organ research in which recipients were receiving such organs. Such research is generally pursuing or is continuing elsewhere. And the National Academies of Science convened a conference in 2016 and 2017. They met multiple times to figure out what do we do in this kind of circumstance. And no regulations have been established as far as informed consent for organ research pertaining to informed consent among transplant recipients of such organs. So here's kind of where we are with this debate at this time. So the question is like should candidates, transplant candidates that is provide research informed consent, okay? That's in addition to standard clinical informed consent for the transplant surgery. Should they provide research informed consent in addition to accept a research organ, okay? And when should they provide it? And what if the research is just very minimal risk, okay? Should they still be required to provide such consent? How do we inform transplant candidates in a timely manner? And now time is of the essence. So remember as soon as you pull out, you retrieve an organ, it starts declining. You've got to quickly get it into the recipient. So there's this ethical tension. You've got beneficence here in terms of you want to keep the research going because you want to help the community of transplant candidates and provide potentially more organs that function better to more people. On the other hand, you've got respect for persons. Where you've got to make sure that there's ample time for informed consent. But as time progresses, there's a chance of delaying organ placement and increasing the ischemic time, which can cause a decline in the organ. Another key informed consent problem is that there may be many studies going on at a given time throughout the country. But not all transplant centers may be privy or aware of what those studies entail. So how is it possible for transplant clinicians, the surgeons and nephrologists, the transplant coordinators to inform transplant candidates at three in the morning what the nature of that study entails? Okay, so they may not be able to adequately inform patients about each research. So in essence, informed consent in this context could actually be impractical and even harmful to the organ. So there's this really great study that was done to assess attitudes about informed consent across IRBs in the country, transplant surgeons, as well as organ procurement organizations. And you can see a real split in perceptions about these. This issue of informed consent among these three groups. So on one hand, you have IRBs who are much more restrictive or protective. Put it that way, more protective of ensuring that informed consent occurs. On the other hand, you have the OPO constituents who are much more proscience and less concerned about informed consent. And then in the middle, you have the surgeon. So overall, the transplant community about 87% supports informing candidates about organ research studies, but not necessarily obtaining consent per se. And so one of the problems with where we are in the field is that no research has investigated the patient perspective as of yet. So this is where I conducted this multi-site study to assess the kidney, liver, heart, and lung weight-listed transplant candidates' perceptions about what counts as a quality informed consent for intervention research. So this included a multidisciplinary research team at University of Pennsylvania and at Northwestern. And we included just adult transplant candidates and we recruited people through telephone and mail letter. And we conducted semi-structured telephone interviews with a number of open and closed-ended questions, really about their expectations for donor intervention research informed consent, their information needs, perceptions of risk, and their intentions to participate in intervention research. And we performed qualitative thematic analysis. So our participants included 61 individuals, pretty well evenly across each of these organ groups. And first of all, I'll mention some of the results. So these are some of the preliminary findings. We're still in the midst of analysis. But I want to share with you some of the highlights of our results so far. So overall, the vast majority, 93, regarded organ research is very worthwhile. And they found that, look, this will provide greater organ availability, faster access to organs. They might receive a better quality organ, and they are supportive of helping others with regard to participating in science and possibly improving organ preservation techniques. Now, what was interesting with regard to risks is that many viewed the risks of accepting a research organ is pretty much the same as a risk of accepting any other organ, okay? But, so there were some generic kinds of concerns like, oh, the organ won't work, I'm concerned about the donor's lifestyle, possibility of transmitting infection. On the other hand, there were some concerns about accepting these kinds of research organs. So maybe the intervention itself might end up damaging the organ, because that is a possibility since it is research. And we don't know necessarily if the intervention could benefit or harm the organ. It might be the case that the organs won't work due to this intervention, or there might be some side effects. We also asked about the information needs to make informed decisions. So again, there's this kind of generic like any information that people would need for any organ, like the quality of the organ. I want to know about the donor's lifestyle, the cause of death, the time that the organ was out of the donor. And there were some specific research study types of information needs. Like they want to know that the status of this organ was a research organ. Okay, this is really important. And they also wanted to know the nature of the intervention. What was done to the organ? What was the mode of the preservation used? Was it a cooling down hypothermia? Was it the use of drugs? How long did the intervention take before organs were placed into the recipient? What was the progress of the research done to date? Where are we in the study? And so we asked people what was their likelihood of accepting a research organ and let's see, does this work here? Good, okay, so you can see here that for the most part, the majority were pretty likely to accept a research organ. And what we did in this kind of little experiment here and how we asked the question was we adjusted the age of the organ donor to represent or signify lowering quality of the organ. So that applies in the case of kidneys, for example, in particular. Where you see a higher rate, 81% would be likely to accept a 30-year-old, which is really good quality. And as the donor gets older and older, the willingness declines and the less likelihood, people become less likely to accept it. All right, so what were some of the factors that influenced people to accept a research organ? Well, we found a variety of factors. One was the patient's health at the time of the organ offer. Now remember, these are all candidates, so they're hypothetically thinking about this. But they're like, many of us are still in pretty good health. So I'd rather not accept it now. I'd rather wait until I'm actually very, very vulnerable. So others would accept it because they felt like I really want to improve my quality of life right away. For some who would accept it, risk was really not a concern for them. For others, they really wanted to rely on the physician's recommendation, their trust in the physician to help make the call. And others just wanted some more information about the research study before they could decide. Here are a couple quotations that represent some of these perspectives. So I won't read out the whole quote for you, but just to highlight the part in red here. So this one lung transplant candidate just recently saw their pulmonologist. So recognizing that I'm still in relatively good health, I'd be more reluctant to accept an organ that, I'll use the word, might be compromised, okay? So that person seemed to think that they were doing okay at that time. On the other hand, here's a liver patient who I think that I would just want whatever you got because I know when they transplant livers that you're really sick before they ever really transplant your liver. So this person's much more in great need. Those who express trust in their physicians and researchers, one person said, I believe that they would be doing responsible research and they wouldn't be putting something in me that was high risk. And so I'm very likely to go along with it. We also asked people about their desire to be informed before accepting a research organ and here we see that for the most part, I would say about 80% in this category and 80% of this category were very much, they would either need to know or want to know. We really wanted to get refined here about people's requirements for informed consent. And in both of these cases, we just made it a very blanket kind of you would be accepting an organ but there wouldn't be much further involvement. Now, here's something that's minimal risk, having the involvement in the sense of your medical records being reviewed, right? Well, this amounts to about half, 50 to 60% or so would say that they would want to know. And then when it came down to clinical lab tests, maybe like that were already done for their clinical care, even still about half would need or want to know about accepting a research organ. So for those who more generally they found that it was important to make an informed decision that they be informed, they want to know what to expect. Those who said it wasn't necessary, they had trust in their physician or they were just desperate to accept an organ anyway. Those who form medical record review, they again emphasize privacy concerns. But others who didn't really see the need for being informed for medical chart review, they're like, that's not invasive. It doesn't really matter. The research is gonna happen anyway and or they want to help with research. So those who were in favor of being informed, well, it's my private information that's going out. I just need to be cognizant of the fact that it's going out, okay. Those who felt like they didn't need to be informed if there was a medical chart review, this one person said, I do not consider it comprehensive and mass chart review as an invasive procedure. I think the privacy issue is as less of a priority to be honest than does an invasiveness of putting a new organ into my body or to performing any medical procedure on my person. This heart transplant candidate said kind of a different perspective, not in favor of being informed. Like I said, if the doctor thinks it's good enough, that is good enough for me and this way we can speed up the time frame of not trashing out a heart by having a big to do before they put it in. So it seems like this patient was very aware of the need to be mindful of the time considerations here. We also asked about what's the optimal time to obtain informed consent or disclose information. So we separated this out between informing candidates and giving consent. And for the most part, people preferred at the time of weight listing and they could respond in multiple categories here. So at weight listing was predominant, also at the organ offer was common. And then giving consent at the time of weight listing and fewer at the time of organ offer. So just to wrap up here, there were a variety of perspectives about informed consent and the needs that patients had. But overall, there seemed to be a preference for research informed consent for research organs. And this is the case even in the context of medical chart review or minimal risk type of research. And they also preferred that the timing of informed consent occur as early as weight listing and again at the organ offer which may occur at 3 in the morning. Many do want to know that the organ is a research organ. And I think this is a very important finding in light of the National Academies of Science conference conclusions. And the OPO group who was against the process of informing people in order to expedite the whole process of organ placement. We unexpectedly found that information needs prioritized. Really the lifestyle of the donor like any other organ rather than focusing on organ research. We also found that many would decline the research organ, but not because of a lack of trust in the physician, but more because they didn't really perceive that they were in dire straits in terms of needing an organ at that very time, okay? And many, not unexpectedly though, many placed great amounts of trust in their transplant team. This study raises concerns about whether human subjects protections are adequate. Given their trust in the physician to inform them, will the physician be adequately prepared to give that information, given the nature of this kind of research occurring nationally? So just to conclude here, I know we're running out of time. We need to accommodate the patient's preferences for research informed consent into the consent process in order to foster patient centered care. Organ procurement organizations and transplant professionals need to work out ways to efficiently obtain informed consent, working with the patient's preferences. Otherwise, there is a concern that's already been expressed out there through that public citizen letter, a concern about public trust that might be jeopardized, which could ultimately jeopardize the organ donation and transplant system. So I'd like to recognize my research team and thank you all for listening. Does anyone have any questions? Hi, Elise. I'm ecstatic that you all have actually finally done this research. So I was on an alliance committee probably before 2015 to really look at a way to do research with both organ donors and organ recipients. And most of us around the table were saying exactly what you found when you actually talked to people. What we came up with was going to be really expensive, which I think is why none of us happened. We feel like we need a central IRB to do all organ donor organ to cover all of it. And then it all has to go on a website and that is open to everybody, but especially to all the potential organ recipients so they can see exactly what research is being done across the country that they might end up having to do and that we would have some sort of consent process at the time that they sign that they want to be on the donor list. Because at 3 AM, we've got a liver for you, but it had research done on it is the wrong time to be asking that question. So really, but I think the solutions are going to be expensive. I think they're necessary to do and I think it's time to do it. That's not really it. Thank you, Tracy. So just a little addition here. As part of the interview, we also asked people, would you be interested in looking at a website as you're describing? Because that was one of the IOM recommendations and many people were very interested in looking at that. So thank you for your comment.