 Okay, so let's move on to the fourth concept. It's again, another RFA titled, Investigate or Initiate Research on Genetic Counseling Processes and Practice. And Ebony Madden, Program Director in the Division of Genomic Medicine will give the presentation. Go ahead, Ebony. Thanks, Rudy. Good afternoon. I'm presenting on behalf of my colleagues that are listed here. Nicole Lockhart and I are co-leads on this initiative. Next slide. So the classical reasons for genetic counseling have been family planning, genetic counseling before you become pregnant to address concerns about factors that might affect your child or your ability to become pregnant. Risk assessment, genetic counseling if you or a family member may be at risk for certain diseases or disorders. Understanding a phenotype to address concerns if you or a family member are showing signs or symptoms of a disorder that might be genetic. And health management, genetic counseling for adults which classically included specialty areas such as cardiology, psychiatry, and oncology. Next slide. So we're now in the era of genomic medicine which puts us in the era of genomic counseling. Genetic test results have moved from single gene tests to include small risk changes for common diseases and pharmacogenetics. So this text complexity has led to ACMG to recommend that genetic experts be made available for patient test result consultations. Yes, yet based on employment estimates derived from professional memberships and certification we have about 4,200 genetic counselors and 1,300 clinical geneticists currently employed in the US. This number is insufficient to meet current and potential feature demand. Next slide. A survey done by the National Society of Genetic Counselors shows that the most common delivery method reported among genetic counselors is still in-person followed by phone, web-based video, and group counseling. Note that the survey respondents could indicate more than one service delivery model. Therefore, the percentages on this slide add up to more than a hundred percent. As we shift from classic genetic services to more genetic results integrated into the EHR we will need more efficient strategies for genetic counseling to provide genomic test results. In addition, there is a predicted growth in telehealth post COVID since CMS is now incentivizing physicians to reduce the load on face-to-face care. At the same time, counselors will still need to provide the emotional support patients need as complex genetic information is translated into sometimes difficult healthcare decisions. Next slide. So we are proposing this concept Investigative Initiative research on genetic counseling processes and practices. The purpose of the concept is to assess, innovate, scale, and or research the implementation of novel genetic counseling practices for genomic medicine. We will support investigator initiated research on how to optimize the genetic counseling processes. Next slide. Research topics on various approaches to genetic counseling and genetic medicine could include developing and evaluating processes to triage communication of clinical genomes, assessing alternatives to in-person genetic counseling, developing and assessing methods to increase capacity for genetic counseling in underserved areas, evaluating and improving strategies to communicate genomic findings and updating variant reclassifications, understanding needs of patients and stakeholders and the impact of genetic counseling processes on patient outcomes and evaluating strategies for including genetic counseling processes in clinical research workflows. Next slide. Responsive applications would include research personnel with experience identifying and overcoming challenges in genetic counseling and projects should be broadly applicable to genomic medicine. Projects setting a specific disease area would need to yield generalizable findings. Next slide. We have current activities in this area in our existing genomic medicine consortia. We have activities within the working groups that are relevant to genetic counseling practices and program staff will ensure that research efforts are complementary and findings are shared. In addition, the All of Us research program recently funded a genetic counseling resource. We had discussions with the All of Us program staff and we were developing this concept, as we were developing this concept and NHGRI and All of Us program staff have agreed to continue to discuss opportunities to share common resources or approaches between the two efforts, including holding joint meetings when feasible. NCI also supports some research related to genetic counseling, but its focus is cancer specific. I wanna know the NCI has approval to participate in this initiative, but funding will depend on the outcome of peer review and NCI leadership approval of the funding plan. Next slide. So if approved, we will have three complementary RBAs, R01s up to 500,000 direct cost per year with project period up to four years, R21s up to 200,000 direct cost per year with a maximum of 400,000 per grant, the project period up to three years, and we will have small business innovative research awards R41s and R43s up to 200,000 direct costs for up to one year. We plan to have two receipt dates to allow a chance for resubmissions and we're planning for about seven to nine awards across all mechanisms for the total cost across the initiative up to $5 million per year. Next slide. If this is approved, we hope to get the RBAs out as soon as possible and applications will be due in November of 2020. They will be brought back to you next May. We plan to have a second round with applications due in July 2021 with council review in February of 2022. Next slide. We'd like to thank you for your time and consideration of this concept and we're happy to answer any questions or suggestions that you may have. The discussants that we have for the concept are Jeff Bakken, Wendy Chung, and Sharon Pawn. Jeff, do you want to come in and ask questions first? Sure, thanks, Ebony. Very supportive of this concept. This is probably much overdue and obviously addresses longstanding issues with both the availability of counseling and efficacy and efficiency. So this is terrific. I do think a strength is the focus on counseling and professionals who provide genetic counseling as opposed to genetic counselors per se. I had to read through of course the whole statement and it is clear I think with the current draft but I think a little different emphasis within the text might be helpful there but I think it's a strength again that it's addressing all those different professionals that are involved in providing counseling. I think the budget levels are good for some really substantive projects. Very much like the notion of having separate lines for R1s and R21s. I think a lot of the proposals coming in in this vein may well be the type that won't have pilot data and may be smaller in scale. I think my only substantive comments have to do with the examples offered and a lot of good examples there. I think there's a significant emphasis on communication strategies in different contexts as you might anticipate. I think there's a couple other domains that I'd be interested in. I think should be within the scope or I hope are within the scope of this and one is play the economic models for funding counseling, issues around licensing, issues around billing. I think are probably critical for making sure these services are provided in an appropriate way. Second thing is as I understand from our genetic counseling program or our state that the majority of genetic counselors as professionals are being employed by industry. So I think that's a particularly interesting model from a variety of perspectives and it might be interesting to at least have a note in there that there would be a welcome of proposals that sort of looked at that domain of counseling services. And then lastly, I think there's a real opportunity to foster work on all the ethical, legal and social issues that are part of counseling. They really address a lot of very complicated ethical issues. And so sort of highlight that as part of examples of the types of projects that could be funded through this mechanism, I think from my perspective would be welcome. So thanks again. Thank you, Jeff. Those are great suggestions. Wendy? Yeah, so I agree with everything that Jeff said and I'll just underscore a couple of things. So I think within the era of COVID, I think certainly many of us have learned to do things in different ways and that's going to do well in terms of this RFA. I think people are creative and starting to think about these solutions as well. But I just wanna underscore what Jeff said, which is that one of the blockers for some of the solutions that probably are effective are the licensing issues and being able to figure that out. It's good that there will be a grant as an opportunity which won't have to deal with some of the reimbursement issues but some of the licensing issues are still going to be an issue. I also, given that there are going to be many of these grants out there, I think one important thing is going to be assessing how effective any of these strategies are and to the extent that there's the ability to have measures that could be used across studies. You can compare apples to apples is a strength and opportunity I think that program staff will have and it also could apply across some of the other genomic studies, ignite, emerge, other things. And so hopefully having really robust measures of outcomes I think is gonna be important to test this. And then finally, just to realize that not everyone won't be served by one single solution and just one of the things that's become apparent to me is that individuals across the diversity may not have the same access in terms of technology. Distance certainly will be improved by some of the technologies we might use but there are other folks in terms of their ability to use digital equipment or just health literacy in general where we might develop certain instruments or certain supports that may not work equally well for everyone. So I think it's important as these studies go out to figure out for whom the solutions work and that may not work for everyone and that's okay but as we're studying effectiveness to figure out for whom they're effective and who they're not. Thank you, Wendy, great points. And last Sharon and anyone else who wants to comment or make suggestions. Yeah, I also think it's a really important area to support and a little bit following up with Jeff and we talked a little bit earlier. I do think it's important to consider how to leverage the current genetic counseling and medical geneticists who I'm sorry to say we're left off the description of the RFA. Currently do counseling and how to leverage that and perhaps take pieces of it to use by other healthcare providers. I don't think we're trying to replace genetic counselors here. I think we're trying to leverage and make the best use of a limited workforce. There is a comment in the three piece that you really want investigators with experience in genetic counseling research. And that gave me a little hesitation. There are actually a lot of experts in communication who I would love to bring into this field and might have great preliminary data in nursing communication, physician communication that might get scared off by that description. So I would think about perhaps generalizing that you want for the R01 investigators that have a significant relevant experience even if it's not directly related to genetic counseling. Because in my experience in our own projects where we've brought those people in, they often really provide substantial expertise that we didn't have and really allow us to do the research in a better way. Thank you, Sharon. And I think when we were considered that we just wanted to make sure genetic counselors were part of the team and that other investigators who are not classical genetic counselors would be able to come in of their own. And so we just wanted to make sure that we could compare the existing strategies to some novel strategies. And so we wanted to make sure they had those experts there who understood those existing strategies. Right, and maybe it could just be worded that that part of the final RFA could be worded a little different. Yeah, that's a great suggestion. Thank you. Okay, I have Howard Chang and Jonathan Haynes in the queue. So Howard, go ahead. Sure, so Ebony, thank you for that presentation. I think this is an important topic area and I'm supportive of it. I want to react to Jeff's comment about genetic counselors working in the industry. And in fact, I think that perhaps most of the genetic testing in the US now is happening through direct to consumer kits. And then there's some limited amount of sort of guidance or genetic counseling happening through industry. And that might be the principle route by which then patients would refer to physician specialists and their own dedicated genetic counselors. So it seems that this is an aspect that working with industry is something that we want to incorporate into this RFA and certainly not exclude. Essentially you can think of it as this is a massive experiment going on already that different companies do different things to communicate their genetic testing results. We are not benefiting from collecting that information and how people react to it. And so if there's a way to kind of somehow capture that, it seems that we'd be very valuable. Thank you, Howard. Jonathan. Right, I actually have two questions. I think that the first is just getting a little bit more information of how this coordinates with and it's different from the existing activities and like Klingon and Caesar and Emerge. So and I encourage program staff who are part of the Caesar, Klingon and Emerge to speak up, but those activities do have genetic counselors involved and they're reporting back results. This initiative is looking at different strategies and how to make them more efficient now that we are giving back all this information. So I don't think those, even though that's incorporated in those programs as part of the programs, they are not researching those strategies and looking at those different outcomes. That's not quite correct. So we have an aim of ours where we're comparing telemedicine to in-person with our genetic counselors and with the communication expert. They're not the main part of anyone's project. They're definitely pieces of the Caesar project. Yeah, thank you for that clarification, Sharon. And that's the point as we want this done on a broader scale where there are pieces of different projects, but we wanted to look at these different strategies on a broader scale. And Lucia or Erin or Rob, I don't know if you have any comments on what's going on beside your programs. Yeah, this is Terry. They may not be unmuted and able to speak. I would agree with what you said, Ebony. And Sharon, you're right. There are small components within some of our consortia where they may be a little bit larger, but we're trying to do this on a larger scale because we're seeing the value of it in those consortia. So trying to build on that. And this is Lucia. I would add, so there are individual Caesar sites that have efforts or kind of little projects within their aims like Sharon mentioned, but they're not coordinated necessarily across the sites. And I think since Caesar was funded in 2017, so there will be likely to be different ideas for newer models or innovative models that will arise from investigator initiated ideas as well. So I think the idea is to also provide some funding for those new ideas. Right, so I guess my point is to both coordinate with some of those activities that are ongoing and leverage them to the extent that they can be leveraged through some ongoing things. So I think that's very good. And I am very supportive of this. My second question is very different and a bit more logistical. Why are there only two submission dates? Well, we're starting out with two submission dates. We wanna see how this works out. We're open to renewing this effort and continuing if it's a success and it looks like, but we're hoping this is a jumpstart and they can always come into the parent or one announcement, but if this does seem successful, I think we will talk internally about renewing it and having more submission dates possible. Yeah, and I guess that's my point is if this does seem to be successful and there's some good outcomes there that we'd want the opportunity to be able to continue some of those activities. Thank you, Jonathan. Other comments from council? Thank you, Terry had a comment. Thank you, Jeff. No, I just wanted to point out as well that this initial round and the second one that allows for revision and resubmission are really intended to work together. And so the idea is to kind of get them started roughly at the same time and have them meet and develop guidelines and best practices for the field. So thereafter, we may have a more generalized and disseminated approach. Okay, if there are no other comments or questions, can I have a motion to approve the concept? So moved. The second? Second. Fall in favor. Anyone opposed? Anyone wanting to abstain? Okay, thank you very much. Thank you, Ebony.