 Okay, so we're going to go through five concepts. Dave, you want to come up please? So before NHGRI or any Institute at NIH can publish a funding opportunity announcement that has a set aside of funds associated with it, it must undergo concept clearance in an open or public meeting. Now we use the open session of the council for every funding opportunity, whether it's an RFA that has funds associated with it or not just so our council is aware of all the research programs that we are supporting. So we're going to begin with the LC program announcements for R01, R03 and R21 applications. This is a PAR and Dave Kaufman, program director in genomes and society is going to give the presentation. Thank you. Hello everyone, I'm presenting the division of genomics and societies concept to renew the three ethical, legal and social implications research program funding announcements. We're seeking to renew these current announcements for the R01, R03 and R21 mechanisms which are expiring this July. The purpose of these funding announcements is to continue serving as the main mechanisms to support investigator initiated research on the ethical, legal and social implications of human genetics and genomics which we finally refer to as LC research. Applications to all three of these PARs address four broad areas that surround genetics and genomics. The first is genomics and sociocultural structures and values. The second is genomic research design and implementation. The third is genomic healthcare and the fourth is genomics at the institutional and systems level. Details about each of these areas can be found on the LC research program website and I'll post that link, that links at the bottom of the slide and I'll post it in the chat when I get back to my seat. But I'll also say a little bit more about that fourth area systems in just a moment. As in the past applications that come into these PARs from multi-disciplinary teams are expected and encouraged and applicants can use a single method or mixed methods in response. Depending on their project. Applications can use empirical qualitative and quantitative methods and conceptual legal and normative approaches. The direct involvement of key stakeholders is encouraged where it's appropriate but not required. And we're expecting robust involvement from other NIH institutes and centers based on the conversations we've had so far, which we're very excited about. I did just want to give you a few minor updates that are being proposed. First, just a bit more about the broad research area, genomics at the institutional and systems level. This area will be new to the PARs. It wasn't in the 2019 announcements but it has been represented on our web pages and in our presentations about our research interests since 2021. The area collects and highlights questions from the three other areas and explores the interplay and influences between genetics and genomics and institutions, government systems and other organized stakeholders. For example, we might look at genomic technologies effects on human rights law or how the news media frame and influence genomic research or the role of genomic data used in the courtroom. Those are just a few examples. You can see lots more again on that web page that I'll link to. The second minor update is that as genomic society both continue to change as we've been talking about, we need to bring new viewpoints and expertise to define the LC issues and help address them. So the PARs will explicitly emphasize broadening the wide array of disciplines and lived experiences that are represented among our applicants and grantees. Third, we recognize that successful community-oriented projects may require longer project periods. This could be community-based research or anything where a good deal of community engagement is required. And that may require more time than LC grants typically allow for. So for example, we typically limit R01 applications to four years or less of funding. And as many of you know, a typical R21 lasts for two years. To address the issue that community-oriented projects may need more time, the new R01 PAR will encourage applicants who proposed community-oriented work who anticipate needing a fifth year of support will encourage them to contact program officials prior to submission to discuss appropriate project length and budget which could include a fifth year. For the R21s, we'll be seeking NIH permission that's we're asking NIH permission, not councils. We have to ask NIH. If they will allow us to entertain requests for three-year R21s rather than two-year R21s. Applicants to both the R01 and R21 will be instructed to contact program early on if they anticipate needing an extended project period. And final decisions about the project period and the budgets will be at the discretion of program as they are today. Finally, to improve the understanding and use of demographic population descriptors, for example, measures of race and ethnicity, to improve the understanding and use of those in LC research, applicants are going to be required to propose demographic variables to be collected, to explain the purpose of those variables in their data analysis plans, and to briefly justify that proposed plan. We hope that asking for that information is going to improve the transparency around the use of these variables and improve all of our understanding about how they could, should, and might be used. That is, I'd like to thank my colleagues for their help and guidance, and that concludes my formal presentation. I'd be happy to take questions and discuss the concept with council. Lisa Parker, please. Sure, thank you. And this question may be slightly out of order in the sense it might be better addressed after our next presentation of a concept, but I wanted to relate the two as they both have to do with LC to ask the following question. And the most succinct way is to refer to the second concept clearance, where there's a statement that genomic science and medicine is the established focus of the LC research program. And yet some of the examples that I think you gave when you were elaborating on institutional level and one might say, yeah, institutional and systems level considerations. One might even say genomics and social cultural structures might move beyond medicine. So how is this expansion or expansive understanding going to be negotiated and communicated with potential applicants? Well, Lisa, we've been communicating it for quite some time. I don't think any of these topics are particularly new. And as I noted, the new area really is mostly a result or not mostly, but the questions that we pose as sample questions come from the research questions that we've been posting for years. And so I think the reason that we are emphasizing those interests in the LC pars is because we see, and we saw this in the 2020 strategic plan, the beginning of that plan starts by saying genomics is really not limited to NHGRI anymore. It is all over NIH. We hear questions about the LC of genomics coming from colleagues, various different places. And of course, as genomics, as genomic data are easier to create, other people are using them for lots of different things that are not medical. So we thought it was a more than appropriate time to sort of re-emphasize, I think, and draw attention. And we'll, as we talk about the new pars, we will make it clear that this area is out there and continue to talk about it and try to generate interest among a diverse array of scholars, some of who may not consider themselves LC researchers. I hope that's helpful. Laura. Oh. I need you. So thank you for presenting this and this area of research, I think, is critically important. As I look at some of the LC research, I'm really struck by how quickly we are building our scientific base, but yet how slowly we are implementing our genomic findings. And I'm wondering kind of how you are thinking about that because I think that there's really this disconnect between the two of them. Well, I mean, I don't mean to make light of this at all. It's a great question. I mean, I think some people might say that LC is maybe the reason that there's slower implementation than we might like to see. You know, we sort of joke that some people see LC as the brakes on the Lamborghini and no one buys Lamborghini for the brakes. So, you know, but I think that it can be frustrating and LC isn't just about tapping the brakes and waving our arms and saying no. And we very much intend to re-emphasize the idea that LC is here not just to ask questions, but to help address the issues that are existing so that we can implement in ways that benefit broad segments of the population. Kyle, did you have your hand up? No. Kyle, did you have your hand up? I did. Yeah, just a few comments. First of all, in response to Lisa's question about area, implications not in medicine. I think, you know, it's sort of inherent to our work, even if the NIH viewed health in a very narrow sense, LC is about the implications of the science and the implications don't just, they're not just limited to health. And so anytime we're exploring, you know, what are the downstream effects of the science that's being done, we really need to think about it. It's implications outside of health as well. Let's just sort of, I think, the eye in LC requires that. Yeah, otherwise, Dave, I just wanted to voice my very strong support for what's being proposed for these kind of, you know, slight revisions to the plan about how parts have gone in the past. I think extending the duration of time addresses a major concern that's been expressed, you know, all over the place about the way research, funding accommodates or fails to accommodate community engagement. So I think this is really a great step in the right direction. Our 21s in two years, it's really hard to do anything, you know, in two years. So, and especially if there's community engagement. So I think that's a especially valuable move. I think the, not the expansion, but at least the recognition of systems issues as an important part of LC is a really critical move. I think that's really well thought out as well. Yeah, and so I will just say in response to Laura's point that, you know, there has and continues to be quite a bit of embedded LC research, which I think is the portfolio for the LC program really needs both the embedded effort and the independent effort. Some of the LC work that's about pushing down the gas and not tapping the break happens in that embedded work where you're really helping to solve challenges that this sort of group collaborating together is encountering and having LC folks at the table, both to do original research as part of that embedded effort and also to sort of help address challenges is really a critical role for LC to play in an HGRI's portfolio, but this independent work separate from embedded settings, typically, I mean, most of the parts fund that kind of work is really important to sort of move into new areas and areas where, you know, there's really not embedded work happening yet. So in any case, just wanted to voice my strong support for this renewal. Other questions or comments from council? Okay, can I get a motion to approve the concept? Second, all in favor? Anyone opposed? Anyone wishing to abstain? Thank you very much. Oh, are you abstaining, Judy? I was advised to because I was not here for the formal presentation. Understood, you didn't hear the whole presentation. Okay, that's appropriate for the end part. Right, thank you very much. Okay, thank you, Dave. Thanks so much, everyone. Thank you, council. Nicole, you wanna come up, please?