I'm delighted to welcome you here today to what I believe you will find a very stimulating and impact whole series of presentations our first I'd like to thank you organizers of this event. Which I love back here and many colleagues who have put together a tremendous series of I quest panel presentations and discussions that we all all of us have benefitted from. Today's topic is bioethics we have three speakers I'm going to really introduce each and asked them to turn around and weave to the crowd each for then share research for about fifteen minutes from the podium and then we'll all get together as a panel off for a few observations and discussion point and then we'll open it up to the entire i rew prairie continuing kind of patients and will conclude by one thirty P.M.. Will prove that you're with me. Is an associate professor in our School of Public Policy. Towards the intersection among public policy bioethics biomedical research and he has a particular interest in Pocus on ethically contentious technologies such as stem cell research nanotechnology in two thousand well he received a five year in a September your award. It's on graduate science education and the development of scientific careers He's the author of a book calling A Beginner's Guide which is an accessible introduction to the science of cloning and Brianna it's oneself as well as the associated ethical and policy controversies Aaron who did his Ph D. work in public affairs at Princeton who also has an extreme colossally from the University of Cambridge where he was a Churchill scholar and study competition and biology at the singer center developing. Algorithms to help analyze the human genome sequence so we're pleased to have Dr will be here to present on his continuing research. And secondly Dr Jennifer saying. Jennifer is assistant professor in the school of history and sociology and she did her Ph D. work in sociology at the universe you helped point San Francisco. Dr Singh specializes in medical sociology and science and technology studies investigating social cultural and political intersection of genetics Health and Society she worked in the budget industry as a molecular biologist at Genentech she's also been a public health researcher at the C.D.C. Dr C. also completed a book project multiple autism spectrum of ever could see and you know that science University of Minnesota press. Her current research is investigating historical social and political factors shaping definitions consequences of autism diagnosis she is also looking at barriers to arches and diagnosis and educational services based on intersecting inequality race ethnicity class and gender so we have Dr Singh on her research today and just in general that is. An associate professor in the School of Public Policy his research interests are introduces a primary drawing on fields including philosophy of science bioethics and environmental ethics philosophy of food yet thinks of emerging technologies and science and technology policy he's focused in particular on the role of values in science and the other stomach and ethical implications of the social organization of research. Dr Goodall received his him in history and philosophy. From the University of Notre Dame he's been a distinguished fellow at the Notre Dame Institute pretty unsteady and he was a costar our department classes at Yale University in Germany so very sad Dr little present here today I'd like to call Dr Levine to get him started I'm going to sit back here take a few discussion says each a very speaker's proceeds will then form a panel have here and continue the conversation. We'll try to use your slides just to. Well welcome and thank you to Jennifer who really organized this care all who organizes the whole series and Steve crosses office funds all the series through the fire Grant also to stand by the microphone please let me know if you you can hear me it's a pleasure to be here today to see a nice crowd to talk about bioethics with in Georgia Tech broadly and within the I know how to liberal arts in particular. And thanks also to reporter for the nice introduction the people are going to talk about today is on a second line of work that's looking at medical practice particularly in the field of assisted reproduction so it's a reproduction is in vitro part of the proliferation primarily so medical practices that help infertile parents try to have children in a particular talk about conflict of interest in the oversight of assisted reproduction using donated eggs I'll explain more about what all that means as we're going forward. But. I should note that the talk today is based on a paper that came out just a couple months ago this summer in the journal on medicine and ethics and also acknowledging my co-authors probably from west to West Virginia University School of Law and Michelle gallant problem and study part of the studies at Princeton. And I know it's a particular because I think it sort of exemplifies the interdisciplinary nature of the sort of some of our series this is very clearly a paper I would not have written on my own I'm OK You know my work this is actually quite different there is no novel empirical data or analysis here it's much more of a sort of systemic review and conceptual argument about the possibility of conflict of interest in the faculty the patients in this field and I thought was a nice paper for this conversation today. So first of bit of background what is a donation and so here we're talking specifically about a form of in vitro fertilization to get in vitro fertilization is an approach to medical probes that dates to about late making seventy's that helps infertile people have children this is a form of people protection where a third party typically a young woman aged twenty to thirty or so contributes her eggs to help the intended parents have children in the first it's just like the nation occurred in one nine hundred eighty three. Originally and donations were typically provided by no one donors so that woman who was donated would know the intended parents that has changed in nine hundred eighty seven the first anonymous and compensated donation occurred. And today a nation accounts for about twelve percent of all I.D.F. cycles in the United States yet it's not perfect in this industry but most of these are almost certainly anonymous and compensated no the term is a donation even though the woman who provided actually almost all cases are paid for their donation lots of debates and an interesting nuances of language going on your brothers use the sort of standard terms of people. So given this is a discussion of bioethics criteria I want to spend just a minute on the sort of broader high level bioethics questions that are relevant to the practice of of education and there's really two main questions that have articulated in the thirty or so years of this technology existed one is technology even morally acceptable is it ever. For people to use this it's a reproduction with eggs or you could have sperm here as well that are donated by a third party and there's no set answer to this although I think within the United States there's at least a tacit agreement that this is continuing and it's been ongoing for quite a period of time is not the case in other countries around the world necessarily which we can discuss more human a panel of people like but the arguments have been marshalled against. Third party reproduction in this area have to do with harms to family structure what does it mean to bring it back to material from a third party into the existing family and to you have that interview to a child. Potential for harm to children that result as to reproduction using these third party material and both of these could apply either to sperm or egg donation This is actually a very contemporary policy debate over the rights of children who were going to be produced through either egg or sperm donation to know that they were going to conceive and have access to the identifying information of their genetic parents in addition to the parents who were them. And then finally the third will hear hope risks to donors we can talk more about this unlike sperm donation which is a relatively low risk low effort activity egg donation is a fairly and they can base of intense medical procedure that carries a set of risks and some people worry that given these risks it's never really appropriate to ask women to participate in that process when the up but not a top for themselves but they're really doing this to help someone. The second hire a professional it's let's put aside the ethics of the overall practice it's happening as we saw on what how about recruit men and women and compensation of these donors and there's a very robust debate around the world over whether women should be paid to donate or provide their eggs for reproductive system reproduction and the arguments here tend to worry about things like qualification of joke material and potentially exploitation of the donors. I want to move from that high level into the specifics topic of the paper today and the talk and that's conflict of interest so much of your public familiar with the concept of a conflict of interest I don't want to dwell on it too much but just to highlight that this is a debate pick a topic a lot of policy attention this is a report here from the Institute of Medicine conflict of interest in medical research education and practices and they define a public interest as a set of circumstances that creates a risk the professional judgments are actions regarding a primary interest will be unduly influenced by a secondary interest sort of up on verbose definition here but basically what they're worried about if if you were a physician your primary interest is probably caring for your patients in if that is compromised or under only influenced by some other secondary interest making a profit when in a war professional recognition or someone that could be accomplished and that's the kind of thing this is medicine is concerned about here. So why would we be particularly concerned about this in the context of a donation I think Ari sort of hinted at this but again education is in the sort of category of practices that a person undertakes undertakes risks for the benefit of others so the woman who donates is not doing this primarily to benefit or so she might receive some payment for it or she might receive some personal satisfaction from it but the primary benefit is to a third party and so the fact that she's undertaking these potentially very serious risks somewhat to no one the potentially serious I think it's fair to say. Raises this concern but the real conflict comes here and the second point and this is a key position. Who is typically reproductive endocrinologist working to protect the clinic often serves both parties and by both parties here I mean the intended parents in the woman who is the egg donor are put May Well you treating the intended parents helping in the parent of a baby that's his or her primary interest and there's. Good reasons for this I'm not saying it's right but the intended parents are the ones who. Are quite are the ones who come to the physician and say I would like treatment they're the ones who paid the physician often a quite substantial payment out of pocket the physician's success. Ability as a physician is a value weighted based on whether or not her parents have a baby successfully right so outcomes evaluation payment all depend on the intended parents and what this does this leave to invite with the donor may really be seen much more as a supplier than a patient the woman provides eggs that are critical to the process which is often anonymous she doesn't pay in any way actually does he or her or her duty or her work and so she may be mistreated or not prioritized and in the prosecution and that's really the heart of the concern here I'm We also know that there is a fairly limited formal oversight here this is an industry that propriety of reasons we have a merely on voluntary guidelines the fertility doctors get together with some outside guidance but make a set of rules that they then say they should follow but don't always follow. The research think that's fact very interesting a powerful point of view but really raises risks if these fertility doctors are complicit that because their primary interest is their intended parents they may well set up voluntary guidelines. That institutionalize those conflicts and put actual donors or actual doors and a real disadvantage position. Still in the paper and I'm not going to go through this in great detail we look through the Indonesian process and then we review existing literature as well as try to fight gaps in the literature to understand whether conflict of interest is a problem here and so briefly you can think of the recruitment of an egg donor How is it that up a woman words about the possibility of becoming an egg donor thinks about that engages with clinics or donor agencies to make that decision to to donate or this could involve advertisements in newspapers billboards word of mouth all sorts of possibilities once that process started how is the donor screen. To make sure she is eligible she understands them and so on ultimately how does she give her informed consent to donate. And is that information sent that will lead serving the purpose of that. After those sort of preliminary steps there's the actual medical treatment and so here there is a what's called hormone stimulation so typically every month a healthy woman will produce one mature AG. In. I be up when I view a donation the woman is induced to what's called Super obviously and instead of producing one which are egg from one woman might produce eight ten twenty thirty or more healthy eggs and that's because of these hormone injections those eggs are then retrieved in a surgical procedure and then fertilized outside of the body and the test to a teenager of I.V. affable it's really a petri dish usually but the hormone stimulation in the retrieval process are medical procedures and run the risk of conflict of interest changing the way physicians act towards the donors and then finally what the medical procedure is over there is sort of a question of how well that donor is followed up with and why the herd and so on or if you just ignored in the aftermath and the physician turned his or her attention to you and the parents. Again I'm not going to some detail but basically I would say we argue in the paper that conflicts of interest may quite possibly affect all four of these components over there and maybe more seriously in some areas others. M L Just briefly give you three examples of evidence out there in the field that suggests conflict may be a problem in the way of disclosure of this is a paper that will be Alberto has a Ph D. student here in the room is the lead author on in that report and I are co-authors on the other three papers that are read but this is looking at Risk disclosure in the recruitment process so if you're right publishing an ad after advertisement sorry trying to convince a young woman to become an egg donor Do you disclose risks and I should. No it's not our idea that you should disclose risks the self or the guidelines say you should and in California statewide actually says you have to disclose. The short answer though where you just imply they don't. Is that people don't so you can see here outside of California only thirteen percent of adults who didn't procreate risk disclosure the stilt regulation doesn't work in this case and in fine in California works actually state watcha disclose only twenty seven percent of ads including appropriate closure turns out not only the Self relationship work state law doesn't actually work either which I think is a an interesting finding as well we don't know for sure this is a conflict of interest that's causing this problem but you can imagine a conflict where positions and clinics really want to as many donors as possible in their library in their database so they can recruit intended parents and that could lead to sort of this underplaying of the risk of this point in the process. So just two more quick examples this is the cover here is a really fascinating book that when I am a wing a sociologist at Yale wrote Sex sells the medical market for eggs and sperm she reports a lengthy ethnographic study of egg donor agencies and sperm banks and what's a fine and there is two things I want to highlight for our discussion today one she found that the screening process really focused not on the help or knowledge of the donor of informing them about the process but more on ensuring they were marketable so the clinics are doing all the screening but really using an opt in to all they're going to in a way that they can later sell them to intended parents and so that's get into this conflict when yes the clinics want donors so they can sell I.V.'s services to patients and even perhaps more problematic was she noted increasing pressure on clinic personnel to approve a donor at each step in the process so the screening goes on through the numerous stages from question here is to in person psychological evaluations what you found is the further you got in the process the harder it was for the clinic to say no don't do this. And it may be that there was more in the screenings are really the case where you can probably say you know this person isn't a good donor candidate but that wasn't what was happening. And then finally the last example and this goes to the actual medical treatment so I talked about the hormone stimulation earlier and you see there's a clear your point where the interest of birds among the physician in the intended parents in the donor over the number of eggs that are produced the more eggs that are produced the better for the physician in the intended parents because it increases the chance of having a successful baby it increases the chances of having additional embryos to free it and have more children later on it that the parents which is a little bit of a little clip but what five embryos is much better than two ten is probably better than five fiftieth's you know irrelevant and I'm not in better probably quite dangerous. The downside for the donor is that the more stimulation you get the more like you are risk of what's called a wage X.X. or a very hyper stimulation syndrome this is the well documented side effect of the drugs that people take to donate eggs the best literature out there suggests more than eighteen expert use substantially increases your risk of only just us without any corresponding benefit in the like that at least having one healthy baby there's not a great debt on your donation but paper that came up from some people the C.D.C. and Emory recently found that forty percent of voters in the United States produce twenty or more eggs and this went up too high at sixty plus ends and in some cases. The told the cycle so intended mothers have anything eggs on their own on average for much lower and only thirteen percent of cycles have twenty or more eggs that's not actually a fair comparison because the donor a younger and healthier and not infertile. But it suggests that there is certainly some concern here that donors are being overstimulated perhaps to help serve the interest of intended parents. Clint clinicians more so than their own interests so I suspect I'm close to out of time here so I'll just briefly conclude by saying we think about difference tragic. To mitigate this conflict of interest in the paper and these range from an outright ban this is a very strict stringent approach we model this on with all the stark a lot of the ban on positions are also it's illegal in United States for a physician to review for a patient to a clinic that he or she owns an interest in so if I was in an M. D. orthotics surgeon and I owned an X. ray Priscilla the I can't just start referring patients to my own facility and physical therapy lower the big problem with this a number of years ago if the essentially banned you could apply this sort of model to a donation but it would eliminate all the benefits of regulation and so we see reasons to be quite hesitant we talk a lot about mediation model so this is introducing a third party to help mitigate the conflict and I think this is a much better fit for it to make sure that it can be modeled on a living we're going donation so if any of you ever chose to donate a kidney to living organ donation you would have a third party representative that watch out for your interests throughout the entire medical procedure and that is a model that could be adopted education although without a lot of cost to the system that we conclude is not justified today but perhaps in the future and we alternately argue that improving the existing suppository framework is both most sort of these of all and you know most likely to work at this point in time and have some ideas in the paper on how to to do that including development some specific records onto a guideline on conflict or interest just like highlighting the issue adopting some disclosure requirements many of you probably had to disclose a conflict of interest or at least got a form saying you have no conflicts that at some point and I think actually most important is changing the reporting requirements such that the only outcome of the measure is no longer success but also some of the health outcomes for people like Donors who contribute to the process I think that would then give multiple all sorts of names that could be optimized and help clinics understand that making sure their daughter's health important matters as well so I will leave it there but look forward to the discussion in the Q. and A a while thank you. Tonight. I just want to thank for encouraging. Think about the panel that we have. In this great session and of course the willingness of Aaron and Justin and referred to participate and thank you all for being here today. So the work of a talk today about. Article I read science technology that really looks at the social. Implications of participating at its research so this is part of a larger project the book project that I'm working. That looks at this current activism around genetics research. As I'm for finding a gene for autism from scientists for a person factor. And the cost. That this research is having. That. I took on. Whether or not it's. A start I just wanted. My background and where I'm coming from in terms of my training in science. Or sociology and. You know my first career was in biotechnology working with the common. Despite or in fascination and. Really began to ask questions about ethical questions about the work I was doing in the lab is really. Asking these questions. About the impact they have on people says medical practices as well as you know the inequalities that helped her system that were going to make many of these very rich molecules that we were designing. To most patients so in need or you know if the pool's to intellectually these concerns I apply for a master's degree in Public Health the focus on the ethical legal the social implications of integrating genetics into public health and this was this problem was developed really in the flow of the. Course there was a lot of potential attentional sprinted upon. Her being you know treatments. And cures for. Which many of you know really happened to have. Dissipated. My training. That's in bioethics is really rooted in public health of course this. Was based on the development of the comet report in one nine hundred seventy nine which many of you know was a result of or in response to the public disclosure of the simple that study. This from ports and taken you know your ethics training to do any research know that it involves three fundamental principles which are uses guidelines to conduct research human subjects these include respect for person or autonomy in application form sent to her a little bit about the next and so do you know application of the sets and the risks and benefits of participation and then Justice or the. Costs and benefits in the application here is that there are procedures in homes in. The selection of research subjects. OK So all this framework is really useful and it's very important as a starting point point much of its application has been situated around issues of autonomy and informed consent and lets So around justice and issues of their distribution and. Furthermore it doesn't necessarily take into consideration how historical social cultural factors as well as the live moral experience can shape by the core problems alternative framework spacetime data from a critical social science perspectives really challenge me to think about. Think outside of the individual tenets this principle based approach to embrace what sociologists have referred to as a more critical bioethics or by affable imagine imagination so the research I'm sharing with you today. Show you could today provide comparable evidence of the social context in the more reasoning and that is within the parent's decision to participate in autism genetics research so it's based on interviews I conducted with twenty three sets of parents who participated in the science simplex collection so this is an autism genetic specific database that consists of over three thousand families who have one child diagnosed with autism. Participation trough a very full evaluation of the child and their parents as well as one and that sibling. The participation parents get what is called a research valuation child. Stick sustenance. For oxygen and that and parents were encouraged to use for. Education to to receive or call. Piper educational services. OK so and literature ask if politics really taking up research on the restrictions of applying abstract biomedical principles in genetics research however much of this research is in the context of a population or a national type genetic databases such as you say this is where everybody here participates. In the U.K. these qualitative investigations begin to rebuild a complex and contingent ways the general population donates to genetic databases and how decisions are really embedded in different situations circumstances and histories of individuals as well as community. The experience of participating in genetic epidemiology said that collect samples as part of the process offers a different set of purposes for participation such as the hope for personal gain. And the desire to help their family or themselves or their families in the future. And people who donate to disease specific tissue registries also participate help develop and maintain a sense of social solidarity with unity. So drawn from this research. And within the framework of a more critical bioethics the intention of this said it was really to investigate how people understand experience and construct a process donating. To a disease specific genetic database so in other words having people who are experiencing illness or really closely associate illness in this case parents. Negotiating decisions to participate in that it database and what are the circumstances that limit and are unable their involvement. So to. After this question I analyzed the various and overlapping narratives of participation from the perspective of parents or rather than a bioethics situated within the predominant application of autonomy or respect for persons the study really and covers a more context for Bioethics situated in live human experiences and how moral reasoning to participate is embedded institutional structures as well as social situations in my analysis identified three narratives the alchemists parents the obligated parents and the diagnostic parents these narratives of participation aren't necessarily mutually exclusive in fact they overlap with one another but they serve as a framework to really rebuild how parents experiences and their social situations shape their decisions to participate in the narratives of the altruistic parent viewed participation as an opportunity to help in the autism community so parents in the script described their willingness to help in any way regardless of the direct benefit that they would have for their family these narratives of altruism also conveyed an understanding that the S.O.C. The Simon simplex flexion. Would benefit the families in the future and many were aware that many years before anything genetic would be revealed much less help their family doubts wristed narrative was also tied to emotional experiences of living day to day with the child autism. And the challenges that their children face so for example as my mother describe it it's all relative if you've experienced this kind of situation with these kinds of difficulties I think that you want to do whatever you can make him and I think you want to do whatever you can to make the situation for someone else. A second set of narratives was the obligated in these narratives participation in the S.S.C. was viewed as a responsibility held by parents to help their child to anyway. Possible. Especially since there's a limited consensus on the causes of the treatments as well as the trajectories of autism So for example one parent doubt that participating in the S.S.C. was the easiest way to be involved she stated it helps alleviate some of the guilt that you feel as a parent but you're never doing enough to help your kid so at least in some small way I'm trying to help this pressure obligation and sense of guilt if not achieved is built the discourse surrounding the urgency placed on parents to get an early diagnosis to get a diagnosis as soon as possible so that treatment can be so that intensive therapy its can start as early as possible to alleviate symptoms of autism this discourse is also rooted in the current Neil liberal model of Medicine of the individual responsibility. So in these cases the moral obligation of parents to help their child can can somewhat obscure the risks and benefits of participating in this research the diagnostic parents or the third set of narratives and situated around the acquisition of the diagnostic evaluation in exchange for participation this was a significant anti enticement her parents and the price for a diagnostic evaluation can cost two thousand dollars and for parents who had didn't have a diagnosis before participating they might be in a wait list for that is at least a year long so parents have to wait to get a diagnosis parents were encouraged by the study investigator to use this evaluation to help all apply for new or continued eg educational services that are titled under the Individuals with Disabilities and education. So what set of parents and this group participated to get a definitive diagnosis for their child so these particular parents were new to the world of autism and they were seeking answers and so they saw this as an opportunity to to help their kid as one man. Stated this is what we wanted first and foremost with someone to say OK but he's autistic and then tell us what level he's capable of operating and you know evaluate him and kind of keep and kind of help us figure out what to do to get him the services needed early. Diagnostic narrative was based on parents whose children are ready to diagnosis and before the study but wanted an update on the progress of the child and whether they would qualify for additional services. So these narratives really demonstrate that there's various reasons parents participated in this study and it's you know it's a mixed it's a mixture of discourse around altruism obligation and the necessary The necessary for a diagnosis and within this context you know and surprising that these parents didn't have any concerns about the risks for privacy and they. Also at the same time didn't have very much knowledge about what the study pale when I asked them about what the study entailed the spike I think they signed like three different types of documents one for participating one for their blood donation one of the clinical information so there was a lot of exchange of them. However the narrative. Was placed here. OK However the narratives also reveal a contractual bioethics and moral reasoning to participate based on structural limits and social complexities in situations so these include a range of responsibilities parents to help their children and the greater autism community their hopes in genetic science and to provide social and medical legitimacy and their need for early diagnosis and such and access to services and treatments for ISIS. So the negotiations of responsibility. That parent compression and biomedical research were really evident throughout the narratives this responsibility with her tied like I said earlier to their emotional knowledge and experiences of parenting a child with autism which is which essentially reduced their perception of risk to minimal at the individual level parents negotiated responsibilities they had to their child by expecting that their participation would really operate some kind of practical help for example the diagnosis. For many parents offered half forward especially for parents who were receiving it for the first time at the family level parents were anticipating that genetic information would be helpful for their other unaffected siblings because it would offer some kind of information about the risk of having a child in the future. With autism at the community level the participation provide the parents with the opportunity to really help future families or a chance to help advance autism genetics research has also negotiated their responsibility and moral reasoning to participate based on the book they placed in genetics research so based on these narratives parents anticipated that the study would help determine the cause of autism the genetic cause of autism and create a better diagnosis for The Hobbit parents knowing the cause of the believe he'll experience by some parents that they did something wrong and would bring that sense of closure for the diagnostic parent finding the genetic hive uses a beautiful part of the process of legitimization and acceptance of A.S.D.. Without knowing the causes parents were at with some risk of being denied social medical as well as state recognition of the challenge of the experience rather child. Parents were also hoping that this research would lead to a better diagnostic tests to be used at an earlier age so these responses. Really underscore how involvement in genetic study was intertwined with somewhat unrealistic expectations and hopes that research Afghans would address major issues facing these families and in comparison to what was actually written in them or said document it's their goals are very narrow and you know I'm eighty what might actually be discovered in this process. The dynastic currency associated with autism really also brings up moral issues of recruitment and the debate delivery of a mental health diagnosis in biomedical research so in this study the diagnostic parrot really didn't think twice about being part of the genetic database in these parents that were most likely to have left the least amount of knowledge about what the research was about. This flat knowledge is understandable since such parents were primarily concerned with getting a proper guide says for their child. And receiving information of the results evaluation offered through the S.S.C. was also like the gold standard they used maybe twenty different instruments for me it was a really pulled sander coach because they wanted the basketball data to match the genetic research and so this could be construed as courses especially since qualification for educational services requires an artisan diagnosis. That's the also use the diagnostic currency of autism as a recruiting mapping as and so there's different ways to recruit folks and in some cases families who are on a wait list to get a diagnosis were recruited a study that's parents had to negotiate the risks of being in a genetic database you know indefinitely with the need for a diagnostic evaluation Henschel a helpful game the services this helps the tension to parents structural issues such as time. And they'll ability of clinicians to actually give a diagnosis but also a range of social factors that are that create access are that's why access to diagnosis treatment and educational services another troubling issue in this case study was the length of time for parents to actually get the research evaluation. After they participated some parents had been waiting six months for the work written report. Travelling with the lack of follow up with families once they received the report and how to interpret the valuation any parents even asked me how it's really hurt it because they were they were confused about it. As well as the lack of a really guide on how they cannot obtain services based on this new knowledge of what they have. OK so there is a participation in the study teacher a variety of Discourses parents really drawn to decide whether to participate in genetics research in the sense that it had to negotiate and grapple with what matters most for their family which often did not coincide with predefined. That's taking into account alternative perspective can really enhance our bioethical imagination to recognize and acknowledge meanings that are central to people living and experiencing illness as the number of disease specific genetic databases continues to grow these narratives can lend insight into the development of more sensitive and effective policies surrounding clinical genetics research further in Perkel research rooted in a specific site of knowledge production allows for a bottom up approach to uncovering what constitutes moral issues in this way I argue that sociology of science and technology studies can really enrich the field by. Taking into account social situations and. Structural it's constraints of living with illness and employment this has on the scientific and technological. Thank you I'm going to. Come out. Well. Thank. God. OK everybody. For. Your part of it because I'm here I'm not going to go pay her. More going to. Tell you some of my research interests and to describe a project that I have thought of going forward so I'm doing some more. Promissory thing as opposed to things. A little bit about the background and I am trying to do here I draw a lot in my research in general and in this project in the philosophy of science and science and technology studies on the value of leaving here for the research because if you are if you're known as the argument from inductive rest we know that scientific research is not the sort of neutral of error that it's sometimes professionally made out to be there are outliving decisions that must be made throughout the research process and a part of my research was well out where or how or what the implications of because they are going to be a little bit. The way in which I'm applying and applying the finds of discussions in this case and what I'm doing this right is to discuss the landscape of arrests in the variety of different risks and value judgments that are made by the Medical Reserve and I think you are focusing on the risks involved in defining diseases so defining it is even in the first place defining dition as being a. Such as infertility for example as Aaron mentioned Hillary is doing her. Issues or patients on an office is a decision involved and I just think diagnostic. Wander around. Adjusting diagnostic criteria for diseases there's lots of discussion now and worries about. Over diagnosis of disease so. This is. One of the things I'll be interested in here and hopefully and I have a question mark here but. Where I would like to go for this is to examine potential power policies for management of epidemic risks generally and in particular risks involved in the line. From go. So I mention this argument from inductive reskin I'll just give you this real quickly to give you a sort of play for some of the arguments for the claim that science is a is is and in a limited Lee value laden affair this is an argument to the style of Richard Rudner who was a philosopher of science and operations researcher back in the one nine hundred fifty S. So the argument goes like best the scientist quit scientist or the scientists and her role capacity as a scientist accepts or rejects hypotheses the. There's a purple heart of hearts or doing science but no scientific hypothesis is ever completely one hundred percent certainty verified and there's always some possibility that in the accepting or rejecting hypothesis we might be wrong and so the decision to accept or reject a hypothesis depends upon whether the evidence is sufficiently strong. But whether the evidence is sufficiently strong and this is Runner's words as a function of the Importance in a typically ethical sense of making a mistake in accepting or rejecting the hypothesis and therefore the scientific quayside makes value judgement has the same a little example of. Suppose the hypothesis in question that we're dealing with is the hypothesis that a particular pharmaceutical is not poxy. If this is the hypothesis in question then we are reasonably to demand a fairly high standard of evidence before accepting the hypothesis because the consequences of wrongly accepting it would be severe in this case given that large numbers of people might be taking a pharmaceutical on the other hand if the hypothesis in question that I mean his example of the machine stamped a lot of belt buckles is not defective in that case we need not apply such high standards of evidence before accepting the opposite because the consequences of wrong are not nearly so severe in this case. The general point here is that when it is that the decision to accept or reject the hypothesis is a decision that is made in the face of uncertainty and whenever one makes decisions in the face of uncertainty one at the very least presupposes a value judgment value judgments concerning. The various possible outcomes of the decision. So in this case what we have is value judgements concerning. The decision to its. To reject the hypothesis and in many of these cases it's worth pointing out now come back to this as we go forward that. The risks involved in being wrong either way in many cases following different parties. And this or this will become important later on but if you think about say the decision to. To accept the hypothesis that. That particular pharmaceutical is safe right wrongly accepting that hypothesis would fall to the risks of that fall largely on the public and the consumers who would be taking that drug right whereas the risk of wrongly rejecting the hypothesis or wrongly not affirming the hypothesis is a risk that. You could say falls more on the side of it was producing and have been having an interest in selling the drug so in many cases. It's not just that there are risks involved in these decisions but the risks fall on different parties. OK. Inductive risk is an important all right type of risk it's an important place in the research process where values play a role but it's far from the only one and a colleague of mine Rebecca Cooper and I are using the term Sam expressed as the risk of error that arises anywhere in our epistemic practices there are all kinds of decisions made throughout the research process that carry this kind of risk and one of the things that were kind of it was sort of spell out in the use of fairly precise about where these decisions are and what their what their outcomes are. Just three examples here data characterization choice of model organism and concept formation clearly there are risks involved in data characterization. So in the past I've done some research on on on the Vioxx episode that a case study on the by activists and that whole. Mass and one of the many controversies involved in that research concerned how to classify deaths that occurred in the context of clinical research. For example did this patient die from a heart attack or should we classify this as a cause of death I mean there are many instances in which it's unclear how to characterize data. And so there is risk involved here and again the risks tend to fall in different parties so it's not surprising that Merck which was particularly concerned about heart attacks. Tended to err on the side of classifying as a known cause of death opposed to heart attack but there is risk involved in a paraphrase ation. Choice of model organism So if you're doing. A toxicological study on on animals for the purpose of eventually knowing what the effects of this particular chemical or whatever is on a human being there's you have to choose a model organism choose an animal and there are risks involved in this A colleague of mine in Germany has done a study on. Research on the carcinogen and the facts of Bisphenol A is a chemical used in lots of. Industrial products and. The research on this and the question of whether or not and that pill is a carcinogen it or not and the outcome of this tends to all largely on funding lines so as of a couple years ago it was the case that ninety percent of government studies found in the sociate in between this chemical and. The camera which were presented on the back zero percent of industry funded studies. And the supply. I was that's well it turns out that. This was due largely to the choice of model organs. So in the industry funded studies. They chose a strand of rap that was particularly insensitive to estrogen and ask your dentist chemically very similar to two to Bisphenol A right whereas in the government study government funded studies they chose. A strand of route that was much more sensitive to Africa. There's no one right and so I got a pretty good shout to use this particular strain of rat right it's a decision that must be made in the face of uncertainty but there's risk involved again the risks tend to fall on different parties. And there are also risks in concept formation. Which it's because it is what I want to talk about for the rest of the time and in particular. Concepts of disease so I mentioned earlier there are these sort of general worries about overdiagnosis of disease there are sort of scary pictures on the cover of The Lancet in places like this recently. There are many reasons. Why. There might be a general trend toward over diagnosis of the those who are. Diagnostic tools that we have are much more sensitive now and so we're able to catch you know smaller and smaller prophecies going on by five. One potential cause of this sort of reason for this that people are worried about is over diagnosis of disease due to expanded disease definition or worries of very sort of a general trend of expanding disease definition that there's some evidence for this is just this one study done by morning and and colleagues where they reviewed publications between two thousand and thirteen that made decisions on disease definitions are good. I know if they are curious because these are common missions in the United States they found sixteen publications on fourteen common conditions that made such. Decisions. Ahead of them with widening definitions one opposed narrowing at five were unclear and they typically did this on the basis of no new evidence so it wasn't like OK with it we now learn exactly what he H.D. is or hypertension is and so we can adjust diagnostic criteria accordingly or typically in these cases expanding diagnostic criteria on the basis of. So why would this be why would they do this. For one very obvious and perfectly reasonable and justifiable motivation that when George Friedman for the second round if we expand say our criteria for hypertension then that will allow us to catch more people with hypertension and treat them before they experience serious symptoms from this perfectly understandable motivation for doing this there's also of course the perhaps more worrisome motivation of increasing profits for treatment because of course if you expand diagnostic criteria your TRUE. Click of a pen multiplying the number of people who have a disease and thereby multiplying. Same number of potential customers for the treatment and there are some worries that this is playing a role here so in the same study by Moynihan colleagues they looked at. Conflicts of interest disclosures out of the sixteen panels there were fourteen that disclosed conflicts of interest the average proportion of members. Of. These committees making these decisions with money for ties. And he was what seventy five percent. Among members with ties the median number of companies which they reported ties with seven and perhaps most worrisome twelve out of the fourteen committees that this close to one like her were chaired. By five hundred people hired in history. The point that I want to make here is I don't want to act like. You know there's some simple way to deal with this these are these are very complex decisions. But they are decisions that involve tradeoffs between rests and the risks again to some extent all in different parties so there has been to expand these definitions are diagnostic criteria ready with an increased risk of overtreatment that is increased risk of treating people for conditions that they were will never suffer symptoms from and exposing them to the risks of those treatments. And narrowing got conditions that definitions are diagnostic criteria of course increases the risk of under treatment. Again there's no there's no obvious way to balance these threats. But they are risks and they do we do need to have put some thought into how they ought to be balanced and so far this kind of goes off the page ultimately and this is again sort of a promise or what I hope we do in the near term is to look at policies that could help us to manage these risks in general I'm sort of interested in the and the very big question of policies at different levels of research that will help us manage the whole the variety of the landscape about the stem of risks that scientists face but in his project I want to look at this question of setting diagnostic criteria for diseases and looking at policy for. Open up an address to kill him with her cell phone. And an aunt. Fifteen minutes ago. Well I. Hope. It's safe. It's. All right first and over all absolutely just. The motivation for this series and also acknowledging that he has put together a very fascinating. Set of truth that evidence of. All of this series there's a lot of conversation about the role and value of the liberal arts in education and research couples many in economic and higher education policy circles. In this panel I think demonstrate here at Georgia Tech certainly certainly you know I've been out of college with the arts that this kind of work delivers fresh insects to our community in our society and through them my parents these insights into the realm of design and innovation and impact to advance the human condition and as. Yemen. Street how could we know the liberal arts as absolutely essential to the education of future generations and to the research mission of the university so congratulations once again to those who organize it for opportunity there and so there are make brief comments on each of the papers and then open up the conversation these are just sort of time and. I've described here noting that Dr Levine is pushing certain assumptions. About. How we regulate you know very complex and inches around this is the focus as we noted as I noted mean action and illustrate inductive marks the focus of his work is on contentious ethically contentious science and technology and here it might be tempting to say her pressure we know what the person with sponsibility and if we have a problem we have to watch and then we deal with the powerful end of story but as we see in this rich within the fifteen minutes we had which. Exploration of this study which brings together this introduce a planetary scholars there is much to be understood here much to be investigated both empirically and also in terms of the concept. Of the concept of the upgrade on the ground we see in the blink of an eye and hymns of human life and the early nineteen eighties to the present the possibility to engage in this egg donation assisted assisted reproduction and we see responses that are. Given the time span relatively minimal and way but. As investigation shows in affected worrisome we now says of the potential in this case focusing simply on the question of conflicts of interest and concern we have it risks an area that's ethically fraught in human experience and in society that is procreation an area also right that is the use of parts of bodies for the benefit of other people that of course is an ethically But concept we see it throughout human history explored in human society we have the notion of professionalism which has been the topic of executive writing and but the properties to the present and beyond and we have all these intersecting around this technology and science that have been able this practice to go forward in a very short period of time and we have real human beings who are being affected and the temptation might be again to sort of resort to that paradigm where we've got to have a while but what I observe in this research is a very nuanced examination of just where the risks arise just what their character is just hope we know what we don't know and what we need to. Where they're investigating and then at. These different models what would work best not a claim that this will work best for ever as this sort of exploration I think. Tells us these are dynamic problems the change over time driven by science and technology are the fundamental questions about our community and society being mean but we're constantly probably to evaluate what we can do that would be best know and it's interesting and I think that where these researchers and is in a recommendation for increased professional self-regulation I think that might be a topic for questions as we proceed. So no let's see how long did they take a better period here really tempted to talk out there that each will be seeing similarly question assumptions that in the theoretical ground of bioethics we have seen in principle they are not sort of invented out of nearly as they are right from my past experience human beings in society but she investigates again and holes in the US human beings and they would experience and what they mean for you in this very nuanced investigation of the secular science and technology that have advanced again very rapidly and I believe in human history that have tapped into what we now see through her words are these we held motivations of parents in this situation to do what they can for their children to honor their obligation to others and to attempt to find knowledge in a circumstance in which it is so cool not to understand. When of course we have similarly ethically rich circumstances of that fundamental bond of parent and child so once again we have an opportunity to see that in our future. Concept of how this research proceeds and how we should understand the experiences of those most affected we need to expand our thinking can text stories by working with her with this slight We need to expand our thinking he's taking the richness of with more experience and then proceed to think through what principle Flo flying high flying and with our sea and air are important to the research and its future progress. Moving on to Dr Bedell again similar themes here. Pushing past the idea that we have in science and technology the sort of headlines that we all clear to see and you know oftentimes in the professional journals as well as particularly press that suggested scientists have discovered something that technologists have invented something and here's the sort of bottom line instead as Dr Biddle explains drawing and has research in which stimulated by these are sort of fundamental questions about well how do we know there and what extent we know that and isn't it sort of baked into the human condition and social structures around it that certain knowledge is something hard to claim and hard to act on and in the circumstances in which we rationally do so we see the risks distributed and we hope to avoid those sorts of circumstances so Dr Goodall and his colleagues have again diving deeper. Insight into a problem. That affects human beings in our society and it's structured build up around it. Invites them to take a broader we'll get the whole process was hosing the breath again a complex situation and allow us to. More. Situated in an exacting sort of. Coding or where the best sly and opens the door once again thinking about it social structure is the impacts on human beings. And concepts we can use to help us organize are thinking about what our policy would punch be so again three papers that wonderfully indicate this as. Stimulating and. Now we get to the other it's. Not simply I mean directed to whomever you wish yes. Thanks Peter interesting question. Are there biological best practices and I think there are attempts but I think they're not as holistic as I think big they divide the field in different ways so there's a set of what you might call clinical ethics and so there's a part of ethics it's really in the hospital setting. The rise How should your set up professionals interact with by their patients in some ways this is what I mean I think we're going to have a lot of bioethics attention has gone into the development here and there are a lot of guidelines say there is a set of clear best practices but there is a closer sort of idea these are things we should think about here this is almost a set of practices that could be accredited we could pass help from one program to another. I think it's not as clear cut in the world of research ethics where you're thinking about biomedical research rather than health care. There's been progress but I don't think I think it's go back to the sociological here it depends a lot on the politics of the specific case it's not clear that the same thing applies to. Difference. You could make it I. Just. Talked about how everything's happening. Record. Pace it's really hard to keep up with the scientific technology and how their. Research questions. When I was working at Stanford. They developed. That could help researchers grapple with some of the questions because they're so. There you know it's just part of territory in terms of thinking. You know I think we're going through our research protocol you know what how do we even begin to start thinking about what can actually what is actually a. Contentious here and so it was a group that was helping researchers really think about their research. So that's why. We're not. Right that it's a hybrid private industry. It's very different than academic research. Or public. Were doing or. Think about educating the next generation. And. Certainly something. Boy an important. Question. Right yeah. Yeah right. Well and fortunately the people I interviewed a part of the process of recruitment was that they participated and so they were obviously. They obviously qualified to be part of the study so the kid was just. OK Right right but you bring up a very interesting question so I was just talking with that clinician who does lots of diagnosis and this is my next project is I'm very interested right here with. My next project really is looking at the process of diagnosis and what is a part of our conversation was and a question I had what happens. Parents that are just trying to get in here that get it and she said it's that they are very angry and mad she says she had to learn how to bring it differently where it's like it's you know what we're here to do is just help you figure out what it is your child needs that people get this idea that the diagnosis is going to give them something. And so I think that's an area where. I can because when you can travel as well that your question is interesting in definitions of matter a lot of low fertility and there are still debate over whether infertility itself should be treated as a disease and after all it's not a disease of one person but it is ease of some sort. Of people who want to have a child and so there have been big debates the World Health Organization declared it a busy relatively recent year on top of my head but that was seen as a big win for the infertility community going back to just an argument here really I don't. Think in this case it was pushed by disease advocates really hoping to. Fund it or to research and reimbursement in that sort of area so that's one area where the definition matters I think your second question is also quite interesting which is I did I talk about evolution in the concept of intended parents and sort of heterosexual norms which is how it is talked about in most of the literature but that obscures of course you could manage a growing chorus of women who are very bright they're going to increasing use in the United States around the world that's really one factor in that same sex couples trying to reproduce or security reproduce in different settings with yours or yours and others. In the. I'm not clear never thought through all of the shifting affects the spill. It's a big argument I was making about public interest in the recruitment of donors my sense is it's not a huge issue in that specific context it is a bigger issue in the. Parliament or regulation at large and I think it actually many cases the strategic choice to focus on the war just in the war policy at least controversial subset of A lot of tension hinted at this but procreation is a very. Good. Area of policy making this is touching on the U.S. on abortion politics and real politics all sorts of other issues and I think focusing the policy debate on. What in the world of. Reproductive advocates are essentially white upper middle class suburban couples works quite well for their attempt to go to Congress in and push for now that might be shortsighted in certain areas of the environment but I think that's the reality of how it played how that really affects the proper debate how that leaves people who are really relevant to the problem of the technology think they should have really been fully explored at least with my let's proper It may actually get better attention to some of these critical bioethics perspectives and from other others but I think there were considerations. Just so with that. We think that and I you know I'm sort of looking at the effects of. A disease class I think the concept of treatment but of course much harder to quantify but it also affects people's conceptions of similar types of others so. Instead of you know looking at a child's behavioral issues as some kind of relationship between a child and his or her classroom setting or something like that we don't look at it that way but in terms of you know what's that like. With the with the disease or a condition like that you know that's how the child thinks about himself or herself how others think about. This is very difficult. To describe. Very. Yeah. Yeah. Yeah. Yeah. So I mean so part of this is right it's a good question and. Part of this comes out of my work and philosophy of science where there's a lot of people of us in science who argue that science is about like and there are Dr argument and one of the points that I'm trying to make how do I make my colleagues record. Is that. There are. Many other decisions in the research process of sides of decision to accept or reject because on the basis of evidence and these. So it's not just inductive versus right you know it's over carrying on with her. From from that literature. But I mean I struggle with this a little bit in that we just think of risk in something that you know involves probabilities as are very. There are really it's not unreasonable to talk about these as for us I'm so I was you know the choice of a model organism that's. A decision that has to be made in place of uncertainty and it has so real. Real consequences. To the extent that. The outcome of the study has some bearing It's a policy. So I think that it's not unreasonable to use. The right. Objections to the. I mean we use the term so. Instead of just ambiguities or uncertainty I mean you could think about every. Step of things if there is such a thing as you have to do with our knowledge of. Using the term risk goes I think one of. Their real. Real consequences of this. You know just what we call. Someone made a wrong answer. He's. Done so we don't know the answer but. Not. Really a. Choice Yeah. RIGHT RIGHT RIGHT RIGHT RIGHT RIGHT I mean I think it does it does make sense in context to say this so if you're really interested in. Learning about the facts of Bisphenol A human being given to human beings credibly and sensitive to estrogen then that choice of a model. So I think you can't say it's right or are. Given a particular context or set of goals. Well it's. Any attempt to balance the presuppose. That. I was trying to make because I think that a lot of decisions are made. Consideration of what what these different effects are that you're talking about and what Which values are reflected by particular decisions so it has to be a lot more. Conscious reflection of. Neutral balance. I mean. This is a story. Where you know people. This sense of altruism. Certainty. But fifty years later what was the outcome was that really something worth the risk I don't know that something that could be. Said. Because we can't predict the future right. We can't study it sometime yesterday sort of perspective want to look at things are very difficult. And principle. And study. Your. Years ago but it really. Sort of thirty years ago started. One of the strongest are actually in the. Policy is that there's a lot of potential risk. Articulated part of the animal model. Biology but there is really very little long term study of. Ten years ago. That is that if someone is going to have to talk about it and said. It was really one of the risk exists or. Are real problems. The person. Would be I was just going to add to that and so. The participation in this database as well as other databases involves an entire family parents effect the child and could see. And so. There is that these parents are consenting for their children and so there might be potential implications in the future for these kids to say I don't really want to be part of this research and other and so this is something that's I mean. It is and see this is very problematic that these kids are being researched they. Say. It'll be interesting to see as. Well we've reached the end of our time. For a few minutes here and you view them I want to come up and. Join me in one and an ad.