 Next up is the Renewal for the Center for Elsie Resources and Analysis, or CERA, and Nicole Lockhart, Program Director in Genomics and Society, will present the concept. Okay. Good afternoon, everyone. Today, I will be presenting a concept clearance for the Renewal of the Center for Elsie Resources and Analysis, or CERA, on behalf of the Ethical Legal and Social Implications Research Program and my colleagues listed here. CERA was originally designed as a means to address several challenges related to the field of Elsie research. Despite broad applicability, Elsie research findings are often less known and utilized outside of NHGRI programs. And while the diversity of disciplines and methodologies employed in Elsie research is one of the strengths of the field, this diversity leads to Elsie research being widely dispersed, with currently over 400 different journals represented in our Elsie database. Elsie research products, including data collection instruments, analytical techniques, study materials, research findings, publications, and other study materials, are not always shared and can be difficult to locate. Prior to CERA, there was no established means of sharing Elsie research tools or products. Finally, a widely accessible and easily located platform for Elsie research products would improve rigor, reproducibility, efficiency, and potentially public benefit. The current iteration of CERA was funded in 2019 for the first time as a five-year award to Stanford University and Columbia University. The CERA portal, Elsie Hub, was launched in the fall of 2020. The proposed renewal would build upon work to date with three primary goals. The first, to provide Elsie researchers with an established and stable platform to share Elsie research products related to genomics. The second, to curate and synthesize Elsie research. And the third, to facilitate and collaborate, collaborations and uptake of Elsie research. In terms of the first goal, CERA will provide Elsie researchers with an established and stable platform to share their research tools and products. The center will collect, index, store, and make available Elsie research products. CERA will collect and organize information on where and how to access Elsie research data, metadata, and the corresponding Elsie research products, and present this information in a searchable and easily accessible format. In terms of curation and synthesis, it will plan and facilitate the development of broad overviews of Elsie scholarship through methods such as curation, meta-analysis, and literature review. CERA will develop curated resources on both new and persistent issues. CERA will consult and engage a broad array of experts involved in Elsie research as part of this curation process. CERA will facilitate research collaborations and uptake of Elsie research by convening multi-disciplinary researchers and stakeholders and conducting outreach and dissemination activities. The audience for these activities will be Elsie researchers and other stakeholders in genomics across all career stages. The goals of these activities will be to broaden Elsie partnerships through translation, dissemination, and outreach activities that connect Elsie researchers and their findings to a wide range of stakeholders who may find them useful. To increase and use Elsie research by researchers and other stakeholders from a broad range of disciplines, professional backgrounds, and lived experiences. And to inform Elsie researchers about the expanding genomic landscape. This proposed center would bring together Elsie research tools and products from across NHGRI and add value by further synthesizing and collating research on key topics. CERA will increase the availability, accessibility, and usability of Elsie resources to a broad spectrum of potential users which may be particularly important for trainees, new and early stage investigators, and researchers who may have fewer institutional resources. While CERA will not replace existing NHGRI coordinating centers, it will provide a central resource of Elsie tools, products, and expertise that could be consulted by and coordinated with other NHGRI programs. We are planning this as an open competition RFA, resulting in a single U24 award beginning in FY24 with up to $6 million in direct costs across the five-year project period and direct costs within each year not to exceed $1.5 million per year. And we are currently in the process of consulting with other institute centers and offices about potential co-funding. I would like to thank all the members of the Elsie research program listed here, and I'd be happy to take any questions from council about this renewal. Thank you, Nicole. Gayle, you want to start us off, please? Thank you. Yeah. Well, first of all, you know, I'm very excited about this concept. And I think when we look at, you know, Elsie hub and the resources being put in one place, you know, my reaction is, boy, we should have done this, you know, a long time ago. So I'll be honest that I'm a strong supporter and have a bias here. I did want to hear a little bit more. I think one of the things that I'm enthusiastic about, and it builds on Vence's, you know, discussion earlier is that the concept calls for more attention to stakeholder engagement and more attention to diverse engagement. And I was just wondering how you considered those two things interacting. I think it's a really interesting question, Gayle. And I think that's something we would maybe ask applicants to speak to in their proposal in terms of thinking about that because we have kind of two different groups. We have stakeholders within the Elsie research and genomics community for whom maybe the center is providing things like research tools, surveys, you know, curated data on a particular topic. But then there are other, you know, more community-based organizations, perhaps, or other groups that may have an interest. And so I think that is something that has been challenging is trying to think about how broad the scope of the center should be. And but you could imagine they could also do things like help folks understand how to do community engagement. They could provide resources, that kind of thing. I think when we're asking them to think about how they're going to do that kind of third aim, that third goal, thinking about collaborations, that that's really where we would want the applicant to describe what they're thinking so we can, you know, figure out what they're bringing to the table, how they would be successful. This is something where we want to really build on what's been done so far, you know, take what's worked well and then just kind of try and keep making this effort successful. Thanks, Nicole. Kyle, go ahead, please. Hey, Nicole, not really a question again, sorry. But I did just want to, you know, voice my support for this, for making this an open competition in this next round. Certainly no critique of the existing awardees, but I think just as a matter of principle, keeping this as an open competition for the next round makes a lot of sense. And I think it's one of those settings where encouraging, you know, create a thought and kind of new ideas is really important. So because I think this is still an area where it's very much in flux about what are the best ways to make this information available and to organize things so that the ELSI community and others can make use of it. So I think, yeah, just keeping this open to encourage that kind of creativity is really a great move. And I'm supportive of this renewal. OK, thank you, Kyle. Other questions or comments? Oh, go ahead, please. And Lisa. Lisa was first, so she should go first. OK, Lisa, you're next. All right. Since this builds a little bit on Kyle's comments and my previous comment, I'm glad to go next. I agree with Kyle about standards, best practices being very much in flux. This is a true opportunity and room for creativity. At the same time, I would be interested to understand how continuity and building on the successes thus far will be insured. I assume that that would be something that you might want to see applicants speak to, or maybe it's not. And then I also wanted to just ask about whether given, for example, Dave's response to my previous question, whether it really does make sense to say that the focus of the CERA will be on LC of advances in genomic science and medicine, or whether it makes sense to expand that at all. Thanks. Yeah, to take your second question first. Yeah, I think that's definitely something we will clarify in the RFA. We don't want it to be that narrow of a focus. That sentence was more intended to point out that there does need to be a focus on genomics. This is not trying to be the center for the LC of everything. We can't tackle the LC of everything, right? So it's not going to be, you know, all neuroscience and organ transplantation and everything that could be there. It does need to have a genomics scope. But we will clarify that LC always has been broader than that, thinking, you know, an anticipatory nature. And as Kyle pointed out, thinking about implications of how genomics can be used more broadly and how that impacts how society views genomics. I think we certainly want to capture that. And I think the current center is doing that and we just need to to be more careful in our language. And once we're outside that three pages, I feel like we can we can make that clear. As honestly, honestly, I think deleting and medicine would clarify everything that you just said and would capture it. Just because, yes, this current Sarah has moved in that direction and fairly strongly recently, I think one wouldn't want that particular phrase to be read as a criticism of that or an attempt to redirect away from the behavioral, the educational, the multiple different uses that can be made of genomics, including genomics, sort of focused initially on medicine, but that gets brought into other areas. Sorry to interrupt. That's fine. That was helpful. And to your first point, building on current efforts and current success, we did in the original RFA require that everything be portable and transferred should the award need to be moved. So we do have that, you know, clearly specified. And that's something that we are thinking a lot about as we kind of prepare for writing a funding opportunity announcement. What do we want to build upon? Where are things that could be strengthened? We're really, you know, putting a lot of effort into those kinds of considerations. We do currently have an external scientific panel for this program. And so that's another source of, you know, guidance and advice and just having another set of eyes really thinking in depth about both what's going on and maybe what should be the future. Olga, I completely agree with all the comments. Very supportive. I think this is an incredibly important area, obviously. And I really like Lisa's point about making sure that it's not just limited to the medicine. I think that's what you guys intend anyway. One sort of additional comment is and I don't know how much you have in terms of, you know, how much leeway you have in terms of the evaluate with the panels or but I think it's really important that also the potential users are part of the evaluation of this, right? So that it's not just the experts in the field, which is obviously important. But having thought about this aspect of in a slightly different but related area of entering into a new area and trying to find the data. I mean, it's it's incredibly frustrating and impossible. And just I think we really need to start thinking if we want more individuals and labs to enter the into these really important domains, we need to make it. So I think this effort is incredibly important. I just think it's important to also have evaluators or maybe like this is what a potential user would look like, who is not in the area already and might be able to enter. Yeah, that's definitely something we're intending is to really have those kind of evaluation criteria. So we're having different user groups thinking about, you know, does this meet their needs? Are there things we're missing and having that really built into the program so that we can have it meet the needs of various different groups? Because we intend we would like it to be used, not just by LC researchers, but by others in the genomics community who might be coming to the center for a very different purpose. If the car. Thanks. I had two questions. One is that as you prepared the RFA, what kind of feedback would you want from the community so that your RFA is informed by that? It seems it's generally positive. But I was wondering whether there's more specific areas of feedback you could gather so that you increase the utility of this program in its second phase. And the second question was in the in the document provided, there's a reference to Anvil. How do you see that collaboration with Anvil? Thank you. OK, so to the first question, I will admit I'm not entirely sure how to answer that just because we do need to be very careful when we're actively writing an RFA of of making sure we're not being swayed by particular groups or only providing access to particular people. So I think what we would largely do is rely on, for example, comments that have been made by the external scientific panel previously, results from the current center that they've, you know, their survey results, their prior us, you know, work with particular user groups and then our own assessment based on progress reports, semi-annual reports, those kinds of things. And the RFA will, you know, largely kind of lay out where we want them to go or where we think they should go. And then they will be, as with any application, they will have to think about how the best way to get there. But I would be a little hesitant to seek too much community input at this point. This is something we've also talked about with our council working group, you know, talking about what resources they feel are important for the LC research community. So we've kind of tried to do that in various different ways. But I, if other people within extramural have suggestions, I'd be happy to listen to them. But it is kind of this this sensitive point where we actively have a concept approved in our writing and RFA where we want to make sure we're being completely fair to any potential applicants. Nicole, just since you asked, I would I would agree with you that it's this part of what we're doing right now is through this open discussion putting it forward to community discussion and hearing from council. It's an open thing. People could email, you know, Nicole and she can then filter through, etc. But we don't actively seek input from specific people during this period of time because it is really designed that way in the process to go into sort of our using the information we've collected to date to make an informed RFA. Thank you, Carolyn. That was a shorter and more direct answer than my I'm scared about that answer to your second question. We envision working with Anvil in cases where perhaps and, you know, with the new DMS policy, if there are LC researchers who have deposited data there, for example, we would we envision that one kind of role Syrah could play going forward is linking where LC research data is deposited with research tools. So if an investigator does a particular study, they have a publication, they have a survey and the data lives in Anvil, a Syrah could say, here are these these different things that are all related to each other and make it much easier to find. One of the challenges is that there are existing repositories where LC research data can be shared. But because so many different methodologies are used, it's not really one place. And so we want to kind of play a role in making that easier to find. Even if they're not hosting all the data, it's a place you can go and figure out where the data lives, find the survey that generated the data, find the publication that resulted from it, kind of have that all pulled together as opposed to having to go look and, you know, maybe four different repositories. Other questions or comments from Council? OK, can I get a motion to approve the concept? Second, all in favor? Anyone opposed? Anyone wishing to abstain? OK, thank you, Nicole.