 Good afternoon everyone. Thank you so much for joining us today for this applicant webinar for the funding opportunities related to investigator initiated research on genetic counseling processes and practices. My name is Nicole Lockhart and I'm a program director at the National Human Genome Research Institute and I'm joined today by two colleagues. Ebony Madden also of NHGRI and Lea Mechanic from the National Cancer Institute as well as several other colleagues from NHGRI who have been helping with this initiative in various ways and we're very excited that all of you are able to join us here today. First, just a few logistical notes. This webinar is being recorded. We will post the recording on the NHGRI website at genome.gov as a resource for potential applicants who are unable to attend today. All participants who are not panelists have been muted. However, please feel free to type your questions into the Q&A box. We will be monitoring that throughout. NHGRI staff may also enter links or additional resources into the chat box, such as URLs or our other things that may be helpful to you. And following this webinar, we will, in addition to posting the recording, we will also be updating the frequently asked questions to include any new questions that we received during this webinar. I'm going to give a brief presentation to start off, and then we will open it up for your questions in answer, for your questions through the Q&A box. So some of the classic reasons for genetic counseling have been related to things like family planning, which would be genetic counseling before you become pregnant to address concerns about factors that might affect your child or your ability to become pregnant. Risk assessment, counseling if you or a family member may be at risk for certain diseases or conditions. Understanding phenotype, counseling to address concerns if you or a family member are showing signs and symptoms of a disorder that may be genetic. As well as health management, genetic counseling for adults, including specialty areas such as cardiology, psychiatry, or oncology. As we enter the era of genomic counseling, genetic test results have moved from single gene tests to include small risk changes for common diseases and pharmacogenomics, and this is leading to more data to interpret. This test complexity led the American College of Medical Genetics and Genomics to recommend that genetics experts be made available for patient test results consultations. However, only 4,200 genetic counselors and about 1,300 clinical geneticists are currently employed in the United States, and this may be insufficient to meet current and potential future demand. A survey done by the National Society of Genetic Counselors in 2018 shows that the most common delivery method reported among genetic counselors continues to be in-person counseling, followed by phone, web-based or video, and group counseling. Please note that in this survey, respondents could indicate more than one delivery mode, and therefore the percentages add up to greater than 100 percent. As we see a 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-19, 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 health care decisions. The overall purpose of this request for applications is therefore to assess, innovate, scale, and or research the implementation of novel genetic counseling practices for genomic medicine. Also, the general purpose of the request for applications is to assess, innovate, scale, and or research the implementation of novel genetic counseling practices for genomic medicine. Also, to support investigator-initiated research using both the R01 and R21 mechanisms on how to optimize the genetic counseling processes, including, but not limited to, the communication of genomic results in the context of limited resources. Some research topics on various approaches to genetic counseling and genomic medicine could include developing and evaluating processes to triage communication of clinical genomes, assessing alternatives to in-person genetic counseling, including IT solutions, and developing and assessing methods to increase capacity for genetic counseling in underserved areas, evaluating and improving strategies to communicate genomic findings and update variant reclassifications, understanding needs of patients and stakeholders, and the impact of genetic counseling. And evaluating strategies to increase capacity for genetic counseling in underserved areas, evaluating and improving strategies to communicate genomic findings and update 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 and research workflows. These are meant just to be some examples of potential research topics, and this list is not exhaustive. Responsive applications would include research personnel with experience identifying and overcoming challenges in genetic counseling, and projects that are broadly applicable to genomic medicine. Of note, projects studying a specific disease area would have to yield generalizable or transferable findings that could be applied in other contexts. In addition, the National Cancer Institute is participating in the R01 funding opportunity. NCI is interested in applications that address managing germline findings in the context of tumor testing. In addition, NCI is interested in cancer-focused applications that consider utilization of remote or mobile-ready genetic counseling approaches, methods to assess the behavioral and psychosocial impact of genetic counseling and testing on the individual and or family to optimize clinical decision making, and strategies for training and supporting a workforce capable of improving case ascertainment, cascade screening, and follow-up care and healthcare systems. As I mentioned, there are two different funding mechanisms available for this request for applications. I'm sorry, I see that someone has raised their hand. If you can't hear me or something else needs to happen, I would ask one of the panelists to jump in and let me know. I can't see everything as well when I'm in screen-sharing mode. So, as I mentioned, there are two different funding mechanisms. The first is the R01 mechanism. The budget limit for the R01 is less than 500,000 direct costs per year with a project period of up to four years. Please note that preliminary data is required for an R01 application. In contrast, the R21 mechanism has a budget limit of less than 200,000 direct costs per year and a maximum of 400,000 direct costs for the entire period of the grant. The project period is up to three years, and preliminary data is not required. Important deadlines for you to keep in mind. The first is that the letters of intent are due September 28, 2020. Oh, sorry. Please note that letters of intent are not required in order to apply. You may apply even if you do not submit a letter of intent. However, the letters are very helpful in giving NIH staff an idea of about how many applications to expect and on what topics they might be, and that helps us plan better. Applications are due October 28, 2020, and the earliest start date for these awards would be August of 2021. Please note there will be a second receipt for new and or revised applications on July 8, 2021. Here we've listed a few of the frequently asked questions we've received so far that we think might be the most common. I'll go over a few of these very briefly and then we'll open it up to other questions you might have. The first is, can a genetic counselor consultant fulfill the need to have a person with genetic counseling experience on the team? Our answer would be no. A person or persons with genetic counseling experience needs to be an integral part of the research team, including being involved in research design, implementation, and analyses, not just providing advice and guidance. If submitting to the R-21 funding opportunity announcement, can budgets be 200,000 direct costs in each year for three years? No. Budget requests can be 200,000 direct costs in any given year, but cannot exceed 400,000 direct costs for the entire project if the R-21 is the mechanism you're applying for. What does the RFA requirement that project findings be broadly applicable to genomic medicine as a field and or yield generalizable findings mean? It is important that applicants describe how the project findings can be applicable across different genomic medicine disciplines and not only specific to given disease or discipline. Projects proposing to apply a genetic counseling strategy to a specific disease should demonstrate how the strategies or findings could be broadly applicable to genomic medicine. How many applications do you intend to fund? NHGRI anticipates to fund five to seven R-1 and R-21 awards across each of those two receipt dates. Dispounce will depend on the number of fundable applications in each receipt date as well as our available funding. NCI is planning to fund up to one R-1 award. NHGRI is interested in applications that are broadly applicable to genomic medicine as a field. Projects studying a specific disease or disease area should demonstrate how the strategy or finding is broadly applicable to genomic medicine. NCI is interested in cancer-focused applications addressing the interest areas specified in the RFA. Please note applicants are strongly encouraged to contact the program officers prior to submission in order to allow feedback on the how responsive the proposed research is. And those program officers or those of us on the call, myself, Ebony and Leia, please contact us before you submit. It is our intention to help you as much as we can, but we want to make sure your proposal is responsive prior to submission. Can a master's level genetic counselor serve as the principal investigator for these funding opportunities? Yes. Any individual with the skills, knowledge and resources necessary to carry out the proposed research as the program director or principal investigator is invited to work with his or her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. PI should have appropriate experience and training to lead the project. For these FOAs, investigators with substantial experience in genetic counseling, including identifying and overcoming challenges in the genetic counseling process, should be an integral part of the project. I've listed here some additional resources. We have one set of FAQs that is currently available on our website. And as I mentioned at the top of the webinar, we will update those if we receive new questions during this session. And we also will be posting a recording of this webinar again on the NHGRI website. Thank you so much for joining us today. I've listed here our email addresses, which you can also easily find online and within the RFA themselves. And please enter any questions you have into the Q&A box. I'm going to stop screen sharing so that I can see all of the questions a bit easier. And Ebony will lead us through and moderate the Q&A. Thank you all. Feel free to go ahead and start entering questions into the question and answer box. We have one question. You did go on the FAQs that we anticipate funding five to seven across the two receipt dates. But they're specifically asking how many grants do you anticipate funding in the October receipt date and then in the July receipt date. And I can answer that. Nicole, I don't know if you can hear me. Can anyone hear me? You can? Yes. Okay. And I can hear that. We actually, it really depends on the amount of fundable applications that we get for each receipt date. But we anticipate funding three to five applications for each receipt date. But as I said before, it really depends on the amount of fundable applications we receive. Okay. The next question is if a proposal involves cancer genetics, but it's not entirely oncology focused, will the program officers determine for which institute the opportunity will be considered, or can investigators suggest NHGRI versus NCI? So I'll answer and then Ebony and Leah can jump in if they disagree or have anything to add. This will be something that NIH staff will discuss together. As I mentioned, NCI is currently planning to fund only one R01 application and they are not participating in the R21 funding opportunity. And NHGRI is interested in research that is more broadly applicable. So if your application is focused on cancer genetics, within your application you might want to describe how your findings could be applicable or generalizable to other disease areas so that would allow both NCI and NHGRI to really see the significance of your proposed research. Is there anything to add? I think that covers it, Nicole. Thank you. And the next question is the letter of intent and binding. Can the aims change as the deadlines approach? The letter of intent is not binding. Very minimal information is requested and the letter of intent and if you need to change your title, if you need to bring on an additional collaborator between when you submit the letter and when you submit your application, that is fine. It's really just to allow us to do some amount of planning before the applications come in. Thank you. And can foreign institutions participate in this program? Yes, foreign applications or applications from foreign institutions are allowable under both the R01 and R21 funding opportunity. Abany, just because I know you handle more foreign applications than I do, would you like to or do you think it's important to talk a little bit about the additional information that's requested for foreign applications? Yes, so foreign institutions are able to apply for these RFAs, but as all of our applications that come in for U.S. funding, you have to show that you have resources or expertise that either the U.S. does not have or the research that you're doing cannot be done in the U.S. So that's one of the considerations for funding. And next question, is it possible that there will be an additional receipt dates for proposals that are originally submitted in July? That is not currently planned for. It could be possible. We initially are planning these two receipt dates. That's as far as our planning goes at this point. You could keep in mind that if you submitted in July, you probably, this is something you would want to talk to a program officer about, but if you wanted to revise your application, you could submit it to another funding opportunity such as another program announcement or perhaps a PAR program announcement with receipt and referral. That is something you would really want to talk to a program officer about before you take that step. But for this current RFA, we currently only have these two receipt dates approved and planned for. And should we reach out to all three program officers to discuss responsibility or just one of you? So I, Nicole, is handling the R21 inquiry. So if you know you're interested in an R21, please contact me. Ebony is handling R01 inquiries in conjunction with Leia if it's cancer related. So if you know it's cancer related, you can contact both Ebony and Leia together. Does that make sense, Ebony? And if it's R21s, you can reach out to me. Nicole and Ebony, this is Rudy. I just want to alert you to the fact that there are questions showing up in the chat. Oh, thank you, Rudy. I'll maybe, thank you. I really appreciate that once I exhaust the Q&A, I'll go to the chat to make sure we didn't miss anything. Thank you, Rudy. So, okay. Next, could you describe a bit about the different expectations of the R01 and R21? Okay. So there's a couple differences. The R01 obviously has a much larger budget and a longer project period available and requires preliminary data. The R21 is smaller and does not require preliminary data. This questionnaire also highlighted that R21s are sometimes used to support research that is more cutting edge, not just a smaller project, and I think that's true in many cases. Here, we did not really make a distinction in that same way. So if you look at the review criteria for the two mechanisms, they're very similar. So I think it really depends kind of on what projects you're thinking about in terms of how much time and funding you think you will need to successfully complete your project, as well as whether you have preliminary data already in hand or if this is really more of a pilot study. I don't know if anyone wants to add on to that if I'm missing a distinction there. I agree with your answer. As far as the cutting edge, I think people usually think about cutting edge because you don't have that preliminary data before you apply. But I think those are the two distinctions for R21 and R01s, and as Nicole explained, the length of time and the budget that you need to support your application, your research. So another one is if we don't plan to submit until the July date, do we still need to have the letter of intent submitted by September 28? No, you do not. The letters of intent typically do 30 days before the receipt date. So that would be 30 days prior to the July 2021 receipt date. And there's a question about what is the PAR you just referred to. I think you use that as an example. Yes, I use that as a general example that if you applied for the July 2021 date and there was not another receipt date under this RFA, there may be other funding opportunities that would be a good fit for you. It's hard to forecast what that might be because that would be, you know, about a year away. So then after you get your summary statement back, you would want to talk to your program officer about what might be reasonable options. And we could do that kind of in a more concrete way than we're able to do right now. And next question, what evidence is acceptable to show that research or expertise is not available in the US or very unlikely and only available at the foreign organization? And they said this is regard to eligibility of foreign education as a partner in the grant application. Can they be part of R21 application? So I think this is asking two questions. One, the evidence needed to fund a foreign institution. And that's just evidence. It's an example. If you are using an environment that we don't see in the US, like a low and middle income countries, we do not have those environments or, for instance, in certain countries, there are no genetic counselors explaining that in your application to show that that environment is not present in the US. And the expertise and experience of working with that environment is not available in the US. But then you asked a question in regard to a partner in the application. So if the principal institution, the PI comes from a US institution, and they partner with a foreign institution, and this is different that there's a foreign entity within. And so the grant will be granted to the principal institution, and then there'll be sub-awards to that foreign institution. And so you do not have to show evidence that it is not available in the US. And yes, they can be part of an R21 application. Both the R21 and the R01 are faced to allow foreign institutions to come in. And just to add one additional point, as you may be able to tell from Ebony's very detailed answer, a lot of the requirements for foreign applications can be quite specific and kind of depending on the circumstance. So you might want to follow up with us just to make sure we're understanding your question and that we're understanding your specific circumstance and that will allow us to provide better guidance. So if you feel like you didn't get enough from that answer, feel free to follow up with an additional question. Yes, and that's the case for all of our answers. If you need more clarification, please do not hesitate to reach out to us. We're happy to speak with you by email. I'm set up a webinar or a Webex or a phone call. The next question is, are there funds allowed to cover the cost of genetic counseling? Oh, I'm sorry, the cost of genetic testing. And I can answer that yes, you can request in your budget funds to cover the cost of genetic testing. And next question is there, is there any SBIR equivalent of this program? There is not currently an SBIR equivalent of this program. To reach out to us, we can connect you with the relevant program officers at NHGRI who could help discuss small business opportunities in this kind of space. Can I, can I add something on from the NCI side about the small business? There is a small business opportunity focused on tumor genomic testing. It's contract topic 419 and the applications for those are on October 26, but this is this would be focused on tumor testing. Thank you, Lea and Nicole. And so I'm moving to the chat box. And so if anybody asks questions in the Q&A, I'll go back to that to make sure that I've, that we've answered all the, all the questions in both. So I think we covered as the budget allowed to cover the cost of genetic testing, but then it was asked further if NCI will only fund one or one and it is funded in October then there is no need to resubmit in July if unfunded for a cancer project in the first go round. So you're asking if NCI only funds one application, is there even a reason to resubmit for the July receipt date if you have a cancer specific application? So I think this is a situation where an applicant should talk to the program director on their application after the review and to think about the best strategy. There may be other opportunities that we could reframe if there are no funds available, but this is something where I think it would best to be revisited once the summary statements available. And if the question was, if you were only planning to submit for the second July 2021 date and there were to be an application funded in the first round, did you are planning to apply for the second round? There I would again urge you to think about whether your study design and findings would allow the research to be generalizable. If you're in a cancer setting but your findings are still very relevant to other diseases and you're able to describe that clearly and make a strong case, then that may still be a good fit. So I would urge you to contact the program officers and really talk that through with us and we can help find the best, the best fit funding opportunity for your application. Thank you. And the next question is, since this is an RFA, does early investigator style supply? I would urge anyone to correct me if they think I'm wrong, but NIH is always interested in funding early stage investigators and new investigators. That's a broad goal within NIH. So that would certainly be a consideration when we're making our funding plan and kind of balancing our programmatic priorities. That is certainly something we would take into account is whether you are either a new investigator or an early stage investigator. And there are some questions that others have asked and so I'm not going to repeat those questions. If I missed a question as I have scrolled through, can you please retype it or repaste it in the chat or Q&A box? But I think I have exhausted the questions and I really appreciate all these questions and interests and please feel free to ask more. Some of, no question is too small for us. So, and if you feel more comfortable asking your questions privately, we're happy to do that as well. Okay, we're just holding on another minute or two in case someone is busy typing a question. So if you have a last minute question, this is the moment to type it in. Otherwise, if we don't receive anything else, then we will end a little bit early and give everyone a little bit of time back. But we'll just hold on for another two minutes or so in case someone is formulating something else. And we see all of your thank yous and we really appreciate them. Thank you for attending and thank you for your interest. Okay, um, again, I would reiterate at my niece. Thanks. I think we had a lot of good questions. We hope it was useful to everyone. And again, we will be updating our FAQs and posting a recording on the website and please feel free to reach out to us. If another question occurs to you, or if you would like to discuss your specific project in more detail, we'd be happy to review your specific aims and have a discussion that's more specific to your research proposal, either via email or via phone. And thank you so much, everyone. Have a wonderful afternoon and weekend. Thank you.