 Okay, let's move on then. We have several presentations and reports to present to the Council today. And two of them will be, there are two working groups of Council, and we're going to hear from both of them today. Our first speaker is Lisa Parker from the University of Pittsburgh. Dr. Parker is Associate Professor in the Department of Human Genetics in the Graduate School of Public Health. She is also the Director of the Masters of Arts Program in Bioethics in the Center of Bioethics and Health Law. Lisa has been a member of the ELSI community since the turn of the century, at least that's how far back she and I go in the peer review process. She's done innumerable reviews with me for the ELSI research program. Lisa is the current Chair of the Genomics and Society Working Group of Council, and she's here today to present the annual report of the working group. Lisa? Very good. Thank you for having me and allowing me to report on all that we've been doing in the past year. I would like to begin with a list of our membership and to highlight that we have three new members, Barbara Bernhardt, Shanita Hughes-Helbert, and David Vinstra. As you know, three of the council members are also part of the working group, Shanita, Amy McGuire, and Artie Rye. The working group's website describes the group's charge for points. Most of what I'll report on today responds to the first charge that's listed there, namely to provide input about the ELSI research program, the ethical, legal, social implications research program, including input about its research priorities, balance between investigator-initiated and program-initiated research, and use of limited budgetary and staff resources. To this end, we reviewed and were very pleased with the ELSI program's training activities. In fiscal years 2012-14, approximately 12% of the ELSI budget was devoted to training and career development activities, supported through a variety of mechanisms, including the Center for Excellence, the SEERS, the Career Development Awards, various stage fellowship awards, the Fs, and education projects to enhance research infrastructure with the Fogarty International Training Program in Research Ethics, and the Minority Supplements. We are also very pleased that ELSI program is now participating in the T32 institutional training mechanism, and that this fall applications, new applications for new SEERS and for T32s are being reviewed in preparation for the February Council meeting. We also reviewed the success rates of new and early stage investigators seeking LCRR1s, and we're very pleased with those success rates. We reviewed the research portfolio balance, and are pleased with the balance between investigator initiated and program initiated research, roughly a 50-50 balance. The ELSI research program is opportunistic in the most positive sense of that term in taking advantage of opportunities for parallel and embedded research, an example of the parallel research the LCRFA released in parallel to a larger initiative would be the H3Africa LCRFA, you saw H3Africa presented before. We also discussed embedded LC research, such as CSER and EMERG, about which you have heard today, and based on this fairly detailed discussion, we were able to articulate this guidance that productively embedded LC research should be a true research partnership, that LC investigators should not be involved merely to consult on human subjects related issues, and that an LC research component is most appropriate when the research in which it's embedded raises novel or important LC issues, when inclusion of LC partners fosters collaborative relationships and builds infrastructure for future research and research relationships, and thus when the inclusion of such component affords significant benefit. We reviewed the balance between empirical LC research and normative and conceptual research. We found that the balance seems to us quite appropriate, and we would like to encourage more applications of both types. To that end, we drafted our thoughts about the nature and importance of normative and conceptual research, the type of research that is probably most foreign to most of those who are thinking about NIH funding, and a commentary on this topic is an ongoing writing project of the working group. What we thought, it's just a beginning framework, is to explain that normative and conceptual research can be characterized in two ways. First, by the methods involved, that they're non-empirical methods. This would be, for example, legal scholarship, philosophical and historical analysis, the methods of the humanities. But that also normative and conceptual research can be characterized by the research questions it addresses. These are questions that cannot be addressed solely or primarily by analyzing empirical data because the questions are about values and meaning, and some examples of those drawn from the LC research webpage would be, for example, research on the normative factors underlying concepts of risk and benefit, human identity, personhood, health and disease, free will and responsibility. In relation to the second charge to the working group listed at its website, to provide input in light of changes in genomics, genomic medicine, and the policy landscape aiming to identify emerging issues or gaps, we drafted the memo that you, the council, endorsed last May regarding the importance of conducting and funding rigorous research on LC issues associated with the planning and implementation of the precision medicine initiative. Then building on the content of that memo, we've drafted a commentary that's currently under review at Genetics and Medicine. Finally, there are three ongoing projects, additional projects of the working group that I would like to report. First, to encourage submission of applications to the LC research program, we wanted to support staff efforts in this regard by ourselves as a working group engaging in outreach to communities of LC investigators, in particular communities of potential new investigators. This would then include making some presentations at the American Society for Bioethics and Humanities meeting in October in Houston this fall, but also at other professional meetings and disciplinary meetings and publications to help bring the opportunity of applying for LC research support through professional journals and other disciplines. A second undertaking is the working group has recommended development of website guidance regarding development of LC research proposals. This would be, as we conceptualize it, and as we are very grateful the LC program staff is executing it. This would be modeled on the tutorials and samples that are available on the NIAD website, and that may include sample proposals, some discussion of aspects of those proposals, and some presentation and discussion of summary statements as well. So this is in process, and we're not quite sure what it will look like and precisely what will be included, but the model for it is similar to or is the model for it is the NIAD website. Finally, the working group is engaged in discussion to examine opportunities for LC research on the implementation of genomics in healthcare, and I know that this is a topic that was raised and discussed a little bit when Pamela Sankar gave a report to council last year at about this time. So the working group has been discussing this, and what can certainly be said at this stage is that we realize that a wide range of health services research data is relevant to understanding and anticipating and addressing the ethical, legal, social, and policy implications of using genomics to promote health. In our discussions, we have also become increasingly aware of how hard it is to draw a line demarcating health services research, and at the same time, we recognize that the scope and the cost of what is traditionally considered to be health services research could very easily outstrip the current LC research program budget, as it's currently funded. This would be traditionally conceived research that involves large data collection efforts, and that is therefore of a large scale and a large cost. In light of these factors, there are two undertakings that we can report. One is reporting on activities of NHGRI staff. Staff from the Division of Genomics in Society and from the Division of Genomic Medicine have met and planned to meet regularly, perhaps quarterly or so, to explore health services research opportunities and support in the institute in NHGRI. And the working group will continue to discuss these issues and explore ways to encourage LC research on the findings of health services research, projects conceptualizing health services issues and analyzing their normative foundations and implications. So we're thinking, we're talking in and around small to intermediate-sized projects focused on issues associated with the clinical translation, such as perhaps modeling studies, policy studies, methods development work that we can encourage and that we think would be valuable and that will not completely overtake the other important issues associated with progress in genomics. So before I take questions, I would like to express the gratitude of the working group to counsel for this opportunity and especially to the division staff for their support of our efforts and for their work on behalf of the public's interest in LC research and concerns. Thank you and questions. Janita? So thank you for the presentation. That was a really great overview of the work that we're doing. I wondered if you could talk a little bit more about the initiatives related to our thought process about precision medicine, given that that's sort of one of the key sort of interests at NHGRI and NIH overall. So a little bit more about what the working group has been and in some sense will be thinking about. I think we regret that we didn't have the recently promulgated document to respond to and I think it would be most appropriate. The thing we could say with certainty is that everyone was feeling excited and little frustrated by not knowing what we might be responding to working with and so on. And so I think at the early stage when we met in April, we thought that trying to support the infrastructure for examining issues as they emerge and as that initiative takes place was in some sense the best that we could do at that time. And so I do think that responding to the initiative as it takes shape is going to be one of the ongoing discussions. And so that's really important because we, this council approved, I forget what it is, our sort of perspective about where LC issues and how LC issues should be considered from the perspective of NHGRI. But also we sort of, I think it was great that we took some initiative to prepare a report that was submitted, it was submitted to JAMA, did he submit it there? The report? Of council or of our manuscript that we... From the working group? From the working group. Okay, you have dual roles here, so I wasn't sure. That is currently under review at Genetics and Medicine. And so I agree with you, I think it was important to in effect try to be out, it's hard to be out ahead of something that no one quite knows what it is yet. But we made the best attempt that we could. Thank you for mentioning that. Other amplifications or questions? Right, thank you. Hold on, Gail. Oh, I'm sorry. Please use your microphone, Gail. I apologize. Yeah, I just was raising my hand. So thank you, Lisa. That was really interesting. So I have a question about how the working group addresses the difference. I think it's really important to think about the boundary between health services research, cost-effective analysis, behavioral economics, all these things which are becoming incredibly more important as Genomic Medicine develops, and the LC program. I've always thought that the S and LC included social in the broadest sense, and Genomics and Society includes economics. And so I've always had a war with Jim Evans who's not here to defend himself about that. And I wonder what your working group, how, you know, what, I mean, you mentioned it a little bit and you said it's some, there's some differences of opinion, but could you speak a little more, because that is apparently a different area of funding. And I'm not trying to introduce her for before I'm even officially on, but I'm just really curious about that, because I really do see them as being so incredibly intertwined. Right. I think, although there probably are some differences of opinion among members of the working group, there are a few things that we agree upon. And one is what you just articulated. And I think that is this point of consensus that these issues are part of the S, that health services, that concern for cost, that interest in the actual, you know, behavioral aspect of responding to genomic information and so on, is part of the S. To do good, rigorous, valid research in the kind of traditional health services model with large numbers that you would need to be able to actually draw some valid conclusions from the behaviors or responses that you're studying and so on. We are also, I think, in agreement that the current ELSI budget cannot support that. And that to do so would in fact, I mean, to try would probably be, maybe it's overstepping to say, you know, unsuccessful, it might be, but I think what we can agree on is that it would overtake everything else that we still think there are some other important issues to continue to examine in the portfolio. So what to do? I think that's one reason that there's in effect a call for additional funding to do the kind of research associated with implementation, clinical translation of genomics such as, you know, is eventually envisioned by the precision medicine. I think that that's one thing we're talking about and that's one call that we were making. And then also to really dig down in the next year and try to identify ways of articulating, I'll use the word doable projects that are at a sort of a philosopher, more meta level that don't get in the trenches of large-scale data collection but nevertheless can really contribute foundationally to health services research, analysis of costs, analysis of the relevance of behavioral response to the rollout of genomic medicine and try to contribute in that way. Artie. So Gail, I have not been, I hesitate to speak because I have not unfortunately had the bandwidth to be very intimately involved with Genomic Society but I am on the group and I can tell you that David Veenstra who is at the University of Washington, right? Yes. Yes. He's a member of the group as well and this is his area. So, you know, I mean, my sense is that this is why in part he is a member of the group. Think about what could be done feasibly with respect to cost reference issues in particular. I mean, it's really, and he's part of the seizure, the seizure consortium as well and it just feels like this is ripe for the embedded ELSI and, you know, the funding of that is, comes from many spots, not just the ELSI program I understand. So, I guess, and I think Gail that that's one reason that we did feel some confidence and consensus around those criteria for doing embedded research to say this is a real opportunity for these larger scale programs to do the S research or the S, the social, the economic, the behavioral in that context but that ELSI on its own could certainly not do that. Yeah, and not just then to be a part of those initiatives as hadn't made too good scientific research but actually engage in the ELSI research along with collaborators. Other questions or comments? All right, Lisa, thank you very much. Thank you. We're at the lunch hour. So, you all know the drill then new council members follow some of the veterans one flight up, procure your lunch and please be back at one o'clock to resume the open session. Thank you.