 Our next speaker is Mary Simmerling, Vice President of Quality and Safety at New York Presbyterian Hospital. She's also on the Faculty and the Department of Medicine, Healthcare Policy and Research, as well as Public Health. Dr. Simmerling is an expert in human organ transplant ethics with extensive publication and great international influence. She's worked with the Ministry of Health of China in their efforts to regulate organ transplants and abolish organ trafficking. She's also worked a lot with human subjects protection so again this overlap of research and transplant. Mary. So it's a great be back in Chicago. I want to thank Laney and Mark for inviting me and also the McLean family for making this possible again this year. It's great to be here. So I usually put a lot of text in my slides because I'm a philosopher by training and today I tried something a little bit different. I have images of text in my slides so we'll see how that goes. So I want to focus today on some of the potential financial and social complications from living organ donation and in particular as they relate to post donation satisfaction with life. So we saw earlier that Mark talked about his paper from 1989 and I also want to go back and talk about this paper. This is actually the paper that was the basis of my entire dissertation in organ transplant ethics. So although it's 27 years old now I think that the key ethical issues focus the focus of it really remain important issues for us today and most especially the issues of consent. So I think that the three main issues that Mark and his colleagues identified in this paper have to do with balancing risks and benefits donor recipients selection and informed consent and their discussions of the risk and benefits to living donors and the importance of voluntary informed consent really help us tell the story of how our thinking on these issues in general has evolved in the last 25 years. So for those of you who haven't read it, Mark did mention some of the key concepts of it. The way that I look at this piece is that it's fundamentally about the moral and regulatory path to introducing new and innovative medical interventions with unknown risks and areas where there are precious few alternatives and significant mortality. And in this case it has additional complication that the risks that are being introduced are being introduced to a healthy person who is motivated by a strong desire to save the life of their child. And at the time, the question that came up more often than not in this case was who would say no? Who could say no? So it's interesting to reflect on Megan's presentation with that in mind. Both in this paper and in general, the potential risks to donors have really solely been focused on medical risks for a long time of the procedure itself. And I know that Laney mentioned that and so did Dick. And conversely, the potential benefits to donors have really been thought to be primarily psychological. And in the case of a successful transplant from a parent to a child, the donation that Singer and colleagues noted in this paper was that it could include, quote, extreme satisfaction in having saved the life of your child. And the risks and benefits of donation are important not only because of the fact that they indeed form the basis of the justification for living donation itself, but because of the critical role they play being the information piece of informed consent. As we've heard from the presenters before me, that's not the only part of consent that matters. The voluntariness of the consent is also really essential. So with regard to safeguarding the voluntariness of consent, Singer and colleagues in this paper identified three potential countervailing pressures, external pressures, pressures related to the urgency of donation and internal pressures the donor might him or herself feel. And importantly, they identified that these pressures were really important in the decision-making process. So they established a protocol to mitigate the pressures by selecting recipients who are not in urgent need of a transplant by creating a state decision-making process over a period of time. And this was intended to remove the urgency of the situation, but also the urgency of the decision-making process in the timeframe. Aspects of this protocol continue to be used as a gold standard for the informed consent process even today and also in the form of donor advocates and waiting periods. So what do we know now that's different than 25 years ago? Well, we know some more about the medical risk associated with donation, although as Lainey and others have mentioned, the long-term data remain very limited. We also know that there are a lot of non-medical risk factors that maybe we should be considering as risks. There's now a substantial body of research that establishes that there are additional factors besides the non-medical risks of the nation procedure that are also important in informed consent decision-making, including post-donation quality of life and also more recently, post-donation satisfaction with life. So I'm going to focus on satisfaction with life. Satisfaction with life is different and distinct from quality of life because it focuses subjective and psychological and measures the personal judgments one has about one's own life. And it aims to identify the gap between what one would expect one's life to be like given the choices one has made and what one's actual lived life is like right now. And so if we think about this and the responsibility for voluntary informed consent for living donors, it really requires we put them in the best possible position not only to assess the risk and benefits associated with donation, but also to be able to apply those judgments to their own life and their own circumstances. Recent research by Messerschmitt and colleagues published in 2014 identify some of the factors that impact post-donation satisfaction with life. And although the findings of their study are limited in a number of ways, there's an absence of a pre-donation assessment of satisfaction with life and absence of candidates who chose not to donate, which would be an important thing to a important group to hear from, reliance on recalled experiences that range over a number of years from five years to 48 years. And a sample that is less racially and ethically diverse than and more related to the recipients than most of the US living donor population. Still some of their findings suggest that data related to post-nation satisfaction with life among this cohort of donors deserves more attention and maybe generalizable to other types of living donors. So what they found is that overwhelmingly the majority of donors, 85% in fact, not only reported being satisfied with their lives, but that satisfaction was significantly associated with their recalled donation experience. In fact, some of them even achieved the extreme satisfaction that Singer and colleagues referenced in their paper and said that the donation experience was, quote, the high point of their lives. But there are others who are less satisfied, including some who wished they hadn't donated. And the reasons for the differences between those who believed donation had a negative impact on their lives and their satisfaction with their lives really merits further consideration. So again, satisfaction with life is distinctive because it's a subjective measure of the difference between the judgments about one's lives of what one had expected and perhaps one should have expected given the choice one has made and what they're actually experiencing. So some of measurements and colleagues finding, substantiate and inform concerns related to both informed consent and voluntary aspects of consent, including motivations to donate and how they may or may not be related to recipient outcomes. What they found is that donors who were pressured to donate or conversely felt pressured not to donate had lower scores of satisfaction with their life. Moreover, while the pressure to donate or not was related to lower satisfaction with life, they found that recipient outcome was not associated with any changes in satisfaction with life. This reconfirms that the voluntaryness of the informed consent process is paramount and suggests that providing willing donor candidates the opportunity to donate is in itself important, regardless of whether their decision to donate achieves the ultimate goal of improving, extending or saving the life of the recipient. And again, this is consistent with what Singer and colleagues speculated in 1989 that's important that we safeguard the voluntaryness of the consent process by establishing protocols to mitigate pressures on donor candidates to donate or not. And also, even if transplantation fails, the donor may take comfort in the knowledge of having done everything possible they could to save a life. I want to turn now to some of the informational aspects of informed consent with a focus on the risks. Measure Smith and colleagues also found that financial burdens associated with donation were associated with lower satisfaction with life. And donors who reported financial burdens because of the donation, whether there was problems paying bills, whether they had to take unpaid medical leave from work to donate, or whether they had to take an extended time to get back to work, reported lower satisfaction with life scores. And while this isn't surprising, it's, I think, an important observation of the study and I want to connect it to yet another McLean Center alumni's work, Peter Ubell. So Ubell and colleagues recently published about toxic costs and risks as side effects from, side effects that should be considered informed consent discussions. So they recommend that as part of full disclosure of patients, out-of-pocket costs associated with medical intervention should be considered as side effects and explicitly included in discussions about the risks and benefits of particular interventions. They suggest patients should be informed about potential financial costs associated with interventions so they can be allowed to decide for themselves whether the potential benefits outweigh those risks slash costs. In the context of living or donation, information about potential financial burdens of donation may play an important role in judgments about the risk-benefit assessment potential living donors make and so I think should be included in the informed consent process. However, as Ubell and colleagues note, these costs are often uncertain in general and they may therefore be difficult to describe. And I think that this may be particularly true in the context of living organ donation where the donor patient is an otherwise healthy person taking on financial and other risks that he or she would not otherwise face. And I think the available tools, and I'll show you one here, the live donor toolkit from AST, the available tools and information intended to help potential donors estimate and understand these costs are really of limited value due to the number of variables and unknowns in this context, not the least of which are the costs of potential additional care and the risks of losing insurance. There's a website, Living Donor 101 that estimates the costs for the out-of-pocket costs between $550 and $22,000. So you can see that that range is pretty wide. The completeness of the voluntary informed consent of living donors really remains essential to the permissibility of living donor transplantation. And while the calculus potential donors use in making judgments about the risks and benefits of donation and the impact of those decisions on their own lives and circumstances remains poorly understood, the donation experience seems to impact donor satisfaction with life in measurable and meaningful ways. In some context, the experience may enhance our satisfaction with life and in others that might diminish it. But getting a better understanding of the factors that impact post-donation satisfaction with life will further improve the informed consent process. This information may also position us to be better able to anticipate and also mitigate factors that have a negative impact on donor satisfaction with life and support those that enhance it. And in this way, it may also help us to close the current gaps between donors' expectations of what their lives will be like after donation and their actual experiences of what their life is like. Thank you very much. I don't know if I have time for questions.