 Thank you very much and it is indeed the right report. I was sitting back there panicking because the file was misnamed but this this is it. This is 2017. So indeed, let's get the screen, sorry. Yes, so these are indeed the members of our working group and we have since I last reported three new members including Jeff Botkin, Sandra Lee and Melanie Myers and Rudy had just introduced those of our working group who are also on council. The website for our working group obviously describes our charges and I'll organize today's report in relation to these responsibilities. The first is to provide input about the LC research program and its research priorities and in this regard we reviewed three aspects of the LC research portfolio. Embedded LC research, the duration of our one projects and the relationship of LC and health services research. I will also report on a couple of steps that we took as a group to encourage high quality applications to the research program. In my last report I talked about the fact that the group had articulated criteria or features of projects indicating when embedded research is warranted or is most appropriate. We used these criteria to review embedded LC research that's research where an LC issues, ethical, legal and social issues are incorporated into the design and conduct of a larger project or initiative. This review included looking at, I'll go back, yeah, included examining CSER to which the LC research program contributes approximately $500,000 per year and NSITE, a program to which it makes actually no financial contribution. We also reviewed the Emerge Network and the LC component of its work across its three phases. We determined that the majority of embedded research has been successful and has afforded positive return on the investment of the LC program funds and the time and the effort of the LC community researchers and program staff. We recommend that embedded research projects continue to be monitored for the effective functioning within the larger research project as well as their impact and productivity beyond the host project. To this end we suggest that future discussion of the working group might usefully explore development of metrics to evaluate the impact and productivity of embedded research because metrics that are employed in other contexts may not fully capture the value of this embedded research. This value may include its contribution to developing infrastructure for future LC research or its influence in both the LC community and the genomic research and clinical practice communities. Metrics employing observational and narrative approaches that note changes over time in practices and that note the experience of project investigators may capture impact alongside numerical measures like the number of publications. The working group also stressed that the need for the quality of proposed embedded research projects to be consistently incorporated into the overall priority score during peer review. We were asked to review the duration of R01 projects and discuss the appropriate period for such R01s. The NHGRI default is to fund R01s for three years with limited exception for longer awards. The rationale for this three year default is the fast paced nature of the field and the constantly changing technology. The question posed to us was whether this is an appropriate default for LC R01s. We discussed the circumstances that might justify a longer award period such as longitudinal or multi-site studies and the startup curve of new investigators. After reviewing the portfolio, the working group recommends that the project period should correspond to the proposed research question and methods and that applicants should be encouraged to discuss the appropriate peer project length with program staff prior to submission. And we noted that this may be especially important for new investigators in order to avoid there being a sense of or a reality of an in-crowd that's in the know and realizes that there could be exceptions to the apparent three-year rule. With the encouragement of council, we continued to explore the question of the appropriate relationship between LC research and health services research. While health services research is traditionally a large-scale effort requiring multi-year commitments and is thus expensive, there are topics we believe in health services research that have significant LC impact components and implications. Our discussion elucidated that health services research could provide data that call for normative analysis or that are needed to refine or strengthen the empirical components of LC study. We noted that conceptual research may inform or clarify components of health services research and that health services research embedded research projects may encourage the collection of longitudinal data with LC input into research questions and study design, thereby catalyzing subsequent LC research to address important normative issues that require longitudinal data to be collected for us to engage in that analysis. We recommend that the Division of Genomics and Society should promote health services research and LC research in other institutes and centers with other divisions and within the LC research program when this is appropriate and possible. We also recommend that the working group and LC research staff might usefully continue to discuss ways to encourage LC research on findings from health services research and projects that conceptualize health services issues and analyze their normative foundations and implications. To help encourage high quality applications from investigators, including those who are not familiar with grant writing and the process of NIH grant review, the working group encouraged LC program staff to post to the program's website sample applications and summary statements. This has been done as you can see and you can go there and visit and read and we are very grateful to the generous investigators who shared their applications and the summary statements they received. We hope that this effort may expand the pool of applicants as well as encourage those who already consider themselves to be members of the LC community. Then further, to expand that community, members of the working group proposed and participated in panels at the American Society for Bioethics and Humanities, the main bioethics LC oriented professional society meeting, and we discussed activities of the LC research program. We also are currently revising an article explaining the content, methods, and value of empirical, normative, and conceptual LC research with the intent of better informing our colleagues, specifically genomic scientists, about what we do, and why. The group also plans to publish announcements or explainers about the LC research program at professional and multidisciplinary meetings and in professional society newsletters. Now, finally, I will report on our activities in response to the charge that the working group should identify emerging issues or gaps in knowledge related to the ever-changing landscape of genomics and genomic medicine, as well as to find points of potential synergy between NHGRI and other institutes and organizations. The Precision Medicine Initiative presents opportunities for synergistic activities of NHGRI and leads us to identify gaps in knowledge and new issues warranting LC research. We were pleased to be informed of developments in the early days of the PMI by Joni Ruder, Director of the Division of Programs and Strategic Implementation of the PMI, and in turn, the working group offered its interdisciplinary expertise to assist in the initiative's design and launch. As many of you know, we drafted a memo in 2015 that was subsequently endorsed by Council urging that the PMI attend to issues of ethical, legal, and social import. In December of 2016, Genetics and Medicine published a commentary by the working group, which is an extension of that memo demonstrating the need for LC research in relation to the activities of the PMIs, all of us research program, and outlining an agenda for potential PMI-related LC research. The working group stressed that additional resources and additional research are needed because the PMI presents issues that are in addition to those already represented not only in the LC research portfolio, but also represented by the foci of the Centers for Excellence in LC research. On behalf of the working group, I attended the Sears annual meeting this past fall, and the range of issues being addressed within those Centers, which is illustrated only partially on this slide, demonstrates that the field is thriving and responding to emerging technologies and scientific questions, and is anticipating new issues and opportunities. Among those Centers coming to the end of their funding as Sears, discussion included ways of sustaining the infrastructure that they have built, and then those retiring or transitioning Sears and new Sears also discussed attention to training new LC investigators, increasing diversity among those investigators, and tracking the success of their increasingly diverse career paths. We note that many LC investigators or trainees, I should say, like other trainees within NIH, are not necessarily going into the typical tenure track positions, but are infiltrating and spreading LC attention in a variety of career paths. So to conclude, oh, and I will also point out that this image, which I took from Columbia's newsletter, which I happened to run across because they did a nice little feature blurb about the PMI commentary the working group had done. Anyway, I think it's a lovely bridge there of the DNA between the transitioning and retiring centers and down to the new ones. So we have the retirees in italics above and those new folks coming in. To conclude, I'd like to express the enthusiasm of the GSWG for the work of the division and of the LC research program and recognize the vibrant activity of the whole field, the interdisciplinary field of LC investigators, and especially the vast substantive and geographic impact of the LC research program. To this end, I wanted to point, as Eric did earlier today, to the fourth LC Congress that will be held in Connecticut in June. As he said, 190 proposals were submitted from 68 institutions and these included 28 international submissions representing 10 countries outside the US. So finally, I would like to thank the staff of the division and the LC research program and I will attempt to address your questions if I may. Thank you, Lisa. Questions? These are other things. Yes. Yeah, thanks, Lisa. Very interesting. I want to go back to one of your earlier slides where you talked about the need to develop metrics or to think more about metrics for the LC field. And at the same time, you made comments to the extent that the working group had assessed the embedded program to be successful. So I want to just hear what your, how the group looked at metrics in that particular context to make that determination. Right. So I think we, our assessment of success was based in large measure on metrics that are traditionally used of productivity in terms of publications, impact. But I, and I'll speak personally, having served on the advisory group to emerge the scientific advisory panel and then representing some of what I witnessed across three phases there to the working group and also talked about, and hence my reference to a narrative approach, the kinds of statements that investigators, and by that I mean, you know, scientists, not necessarily the LC investigators, the kinds of statements that they would make about the impact that the LC projects had on their work and how they had to change practices or were brought up short by a finding of some of the LC research and, and again, had to change practices or think about things in a, in a different way. And I think that it, in looking back, were, you know, at reviewing existing or completed embedded research, it was a combination of publications, citations, you know, public impact and, and references of this embedded research, but we also began to get a hint of, we thought that was really important, too. We're investigators in a meeting or, you know, not exactly in private, but not out in the published literature. We're saying, hey, this changed what we did. And in some ways we think that, that that is, I won't say more important, but at least as important as some of the articles, you know, that came out of, you know, best practices that emerged, emerged from Emerge or from Cesar or, or others. Yeah. I'd just like to add to that as somebody who worked on a Cesar project for the last five years at UNC, because I think equally important. Well, first of all, I really think that metrics, that this is really a tremendous opportunity to think about metrics in a, in a little bit more systematic way. I certainly agree with you about some of them, but, but I think the other really important part of this is the bidirectionality of the learning and influence and so on, because I think these opportunities with Emerge and Cesar and Insight provide something for LC researchers that they may or may not have experienced in the past. It's a, it's a great opportunity to be part of a team to, you know, go deeply into understanding what happens, you know, between collecting specimens and, you know, getting a final judgment about pathogenicity. So for me personally, and I think for a lot of people I've interacted with that, that those opportunities would not have happened, except in the instance where an investigator would, would be, you know, generous about inviting somebody into the project. So this was mandated, these, these embedded efforts. And, and so if we move forward with these kinds of things, I think there's really not such difficult ways to develop assessment of lessons learned on all sides. And two comments in response. One is that about the requirement that these, in some cases there was this requirement for an embedded project and we speak to the importance of having good solid peer review of those projects that are proposed, or if they're not specific standalone projects, the challenge and yet the importance of being able to evaluate the quality of what's proposed if it's woven through a scientific project or a clinical implementation project. There I think some of the metrics for reviewing a good project are very much the same as in the LC study section with the same, you know, positives of that and challenges of that. But I think there, I think the metrics maybe are a little bit more clear. I think looking back to try to measure impact is harder and, or at least is more unusual. We don't have stated metrics for that except for, you know, counting numbers of publications and citations. And it was very interesting. One of the panels at the American Society of Bioethics and Humanities, there were some, as I mentioned, there were how-to panels about the LC research program and talk to program staff and a little bit of cheerleading and a lot of education about that to people who weren't necessarily in the know. There was also a, I thought, terrific panel that was really intellectually substantive wrestling with the question that I think the field broadly of LC, bioethics, health law, so on, has wrestled with for a long time of, you know, do the ethicists become handmaidens to a project? Is there a risk of co-optation? How can there be a good collaboration that's really, as you say, bi-directional and mutually informative on this spectrum from doing the bidding of and reviewing consent forms to being the ethics police, neither of which do LC investigators want to be doing. What is the appropriate balance and especially the appropriate distance and the appropriate embeddedness? And it was truly one of the, well it was a very good discussion, I think, at that meeting. And I think catalyzing that discussion in itself is a very valuable thing for embedded research to have done. Shanita. Along those lines, I wondered if you could talk about, talk more about the manuscript that's under development, about normative research and how that fits within the portfolio. Right. So this manuscript in development, which you may have seen some, at least notes on or draft of, but not everyone did, it is born of attempting to articulate within the working group, but for an audience outside the working group, of what we mean by normative and what mean we mean by conceptual research. Pamela Sankar, our former chair and I sat down and we're working on a draft of this to pass back to our colleagues and realized that Pamela has always thought of normative and conceptual as being very, very similar and I, in my draft, was teasing the two apart. And suggesting that there's more of a meaning-making aspect of the conceptual and more of a prescriptive or analysis of values, descriptive analysis of values or prescriptive based on values recommendation, claim, that was the normative side. And so one aspect of this manuscript is to talk about those two different types of research. We also wrestle with the challenge that normative and conceptual research can be characterized as I just did in terms of what I'd call its content, but also its methodology and that it's different from laboratory science, epidemiology or empirical bioethics of doing a survey or doing a qualitative study of preferences or values or perspectives or uptake of a genetic test that it may involve legal analysis, normative analysis, and I'll go and that it may involve staking a claim in the beginning. Some scientists might say it's a matter of assuming what you want to prove, which is heresy, but the research then is does my claim stand up to real critical scrutiny and argument, sometimes argument on a panel, sometimes sitting and thinking very hard as a philosopher or as an ethicist or doing historical analysis to see whether that claim can be supported and trying to explain those sorts of issues for the benefit of people who, I'm a philosopher who asked me how do you do research if you don't collect any data? How do you get to be a professor? To explain to folks who think of research solely in terms of data collection and analysis solely, but that's the methodology, that is the goal of the paper and it will also and one reason it's been delayed is we've realized we also need to talk about that norm of empirical research and then go on and talk about what we consider to be distinctive. Thank you. One of the questions I had and maybe I may enlist Jay to comment on this, I mean it relates to the paper you and Pamela wrote in Genetics and Medicine about precision medicine initiative, Jay was on the original working group. I thought maybe you said it but I missed it, that you've given that paper I guess to one of the one of the major program directors there. Has that gotten traction in terms of any real programmatic development as part of the program? I don't know how much was actually written about if anything and think it was one of the disappointments is that the working group really never dealt very much with LC-like research within PMI, is that a fair, is that a fair statement Jay, pretty much, so I'm just curious is there any traction, any real traction as opposed to just being aware of your paper? Right, because it's the second time they've been given this because I gave the original letter from Doris Bye Council to the then leadership. Yes, so one point of clarification, it would not be accurate to say that it's a paper that Pamela and I wrote. Oh great, but you're an author. It's an artifact of where you where you publish that you get to list two names. So it is a product of the working group discussion and the real question though about is there traction? I think there is and there's been some discussion of it, however I don't think there's been discussion that I've heard from the people we'd really like to hear discussing it, working group and so on. I would also suggest that if I remember correctly December 6th or December 16th was not the best time between and events of the fall and events of December of holidays and so on to have kind of that kind of discussion taken up. I think there were a lot of distractions but I we are hopeful and we are going to be discussing. We have a working group call coming up this Friday and we'll be talking about what we can do to try to have the the agenda that we sketched. I mean it's not a point-by-point this is what should be done but trying to characterize a research agenda. We're going to talk about how to try to increase its traction or its impact. Thank you very much. Thank you. So we had kind of a late lunch break on the other hand the cafeteria is going to close upstairs but let's be respectful of Dr. Bianchi's time because she's here to speak to you. Can I ask people how fast they can get up the elevator back five minutes? Take the other elevator. I can lead a charge up the stairs. Can we be back in five minutes please? Alright. I'm going to break.