 Okay. Council initiated discussion. We had such an animated talk last time in September that I feel like this hardly needs an introduction. But for the viewers on Genome TV, at this point, we stopped talking and we start listening. We've been listening all along. We're really turning over the microphones to the council members. We're asking you for suggestions of talks you might like to hear at future council meetings or reports that you want to receive. You are not only advisors to NHGRI, but you're representatives of the research community. If you know of issues that you want to bring to our attention or you see something hurtling down the tracks that we need to be aware of, let us know. I'll just follow up on what I think I just said. I think that high throughput functional genomics is something we're going to have to think about. And I think it does actually give NHGRI an opportunity to sort of, I know there's a lot of basic science that goes on in NHGRI, but this is an area that nobody else has sort of grabbed yet, I think, and it is an important one. She has a mutation in an acromegaly gene. Somebody's going to have to figure out whether that's functional or not. And given how many variants there are in XAC or Nomad, it's not going to be one variant at a time. It can't be. So that's a challenge that somebody's going to have to grab hold of. And I will say that the Genomic Medicine Working Group starts to think about that in the last GM9. I lose track of the numbers, but I'm pretty sure it was 9, Terry, right? Yeah. So we thought about that a lot, and it is a challenge. Carol was in charge of that one, so you may want to say more, Carol. Well, this echoes a point that Aviv made to some of us over lunch, which was, I'm going to make that connection for you on Aviv's behalf. That we need now that we have ever more sophisticated ways of doing functional genomics through complex multi-factorial perturbations. This goes by the guys of functional genomics. It goes by the guys of directed genetics. It's long been a compliment to population genetics for inferring gene disease relationships and gene modifiers and all of that kind of thing we're talking about, which I think Dan is limiting. Population genetics is not likely to sort of solve a lot of these diseases, even if you were to sequence until you were blue. And so the discussion is, what else do we need to complement with that population-based strategy? And a lot of us feel, and I think we're seeing that in the literature, especially as of late, that directed genetics are a powerful compliment. And in fact, in the speaker's talk, I thought she had a very nice slide at one point. Of course, she's gone, and the slide is gone. But I thought she had a very nice slide at one point where she had on one half the slide population genetics, and she had sort of NHGRI writ large on that side of the slide. On the other side, she had functional genomics and, you know, CRISPR screens and that kind of thing. And I don't think she had writ NHGRI large on that side of the slide, and the question might be, why not? Well said. Thank you. I think the National Academy statement on gene editing and ethical issues, ethical social and policy issues, I don't know the exact title, but I believe that's coming out on February 14th. So assuming that's interesting, which I anticipate it will be, might be worthwhile to have a presentation from one of those committee members to hear about their statement. So that's due in April or May? February 14th later this week. Well, I think getting into the issue of functional genomics, but from a different perspective, it would be nice to hear about some of the other biomarker screens that you could directly correlate with genomic data. So, for example, the use of metabolomics. And I think this group has probably talked about proteomics before, but the nice thing about metabolomics is you're actually looking at the enzymes on the substrate. So you have some idea of enzyme, you can infer enzyme activity from that data and then compare it to sequence data. So I think some of those where there is a biological or a biochemical readout of the patient that you could directly, or the person you could directly compare to their genomic data would be a good fit for how could you extend the analysis of genomic data. Other thoughts or comments? All right. Thank you very much. I'm going to draw your attention to some announcements and reports. You can access these in the ECB, the Electronic Council Book, or go to the Council webpage. They're linked there. So these are reports from the American Society of Human Genetics, National Society of Genetic Counselors, and the American College of Medical Genetics and Genomics. These are their reports of activities and events over the preceding four or five months, what has occurred since September Council. If you're interested in the activity of those societies, I recommend those reports to you. Okay. It's the February Council meeting, and it's time to review the Statement of Understanding. So for the new Council members, the reason we do this at February is we have a new set of Council members, and we go over the Statement of Understanding, ask for any comments that you may have about it. What is the Statement of Understanding? It's a four-page document. I recommend it to all of you. It's relatively brief, pretty easy to understand. And it basically describes the business rules or how NHGRI will interact and work with Councils. It describes what your responsibilities are. It talks about the options that you have. And it lays out the staff authorities. What are the things that we must report to you and must discuss with you? What are the things that we have the authority to do without Council agreement or consulting of Council? So I'm going to very briefly dash through this. The document is in the Electronic Council Book. And if anybody has any questions or comments, I will attempt to answer them throwing a lifeline to our GAB branch, the Grants Administration branch. So let's see. There are certain types of applications that we are required to report to the Council. And let me be clear right away when I say report, it takes the form of listing them in the closed session agenda. To get to the closed session, you'll see the majority of the applications that are listed there will be discussed. But to report them to you means to list them in there. And there will be certain types such as those applications that have a human subjects concern that we will not be discussing with the Council. They are nonetheless reported to the Council. So program project grants, cooperative agreements, training grants, the Statement of Understanding lists the types of applications that are required to report to you. There are a few hundred other applications that have been received and reviewed. They're not the type that we're required to report. You can access them once you've been fully vetted and approved as a standing Council member, again through the ECB. What are the actions that the Council can take at a Council meeting when we get to the review of applications? Concur with the IRG, the initial review group, or not concur with it. You can defer the application for re-review because you've discovered some fundamental flaw or bias in the initial review of the application. You can recommend an application for high program priority, which means pay it out of order because the research is of such high priority to NHGRI, or low program priority. This has got a very good score, but for instance you already fund enough activity in this area and we concur that this application should be skipped. Or you can defer an application for a different reason. There's not enough information, or some key piece of information is missing from it. So those are the four things that Council can do in terms of taking actions on applications. We have the NHGRI staff has the authority to conduct what's called Expedited Council Concurrence, or ECC. Now there's a subcommittee of three people and let's see if I can remember. It's Gail and Jay, and who's my third ECC member? Brent, thank you Brent. About a month before the Council meeting, there's a list of applications that are sent to these three Council members. The applications are in the SBIR, STTR, a few training applications, and LC unsolicited applications. Now these are all funded by set-asides of funds. So even if you were to look at one of these and say well that's not the highest priority for NHGRI, we could not take that money and use it to pay another particular type of research project. So we're sending these to the ECC committee. We're asking for them to sign off on these and that allows the grants administration branch to spread their workload. Otherwise they're waiting for right after the Council meeting to get slammed by a bunch of newly approved grants. So there is a list that goes to the three Council members. They approve or they have the right to say there's something in this application that I would like to be reviewed at the Council meeting. So it's pulled off the ECC. Those of you that are not on the subcommittee, the list of grants that are on the ECC are presented, again available through electronic Council book. You can ask questions about any of those. Contact me or anybody else on the staff so I would like that particular application to be discussed. But that's early Council concurrence. Staff authorities. Staff has the authority to make supplements to existing awards that can be up to $150,000 or 25% of the total cost over all years of the award, Council approved award, whichever is greatest. There's a cap of $1 million. Some of our, for example, sequencing center grants has very, very large budgets. 25% of those would be quite high. So there's a million dollar cap. Staff can make these supplements without discussing them with Council as long as it fits under those guidelines. There is a list of the administrative actions that you will see at every Council meeting so you can see the supplements that have been made. Any that don't go above these limits will be brought to the Council for Council approval. Discussion and hopefully approval. Finally, in the event of some kind of catastrophe like a major snowstorm, which actually happened five years ago, we can implement a Council meeting electronically. So it may be a teleconference, it may be some sort of secure website, but we have the authority to execute the Council meeting in a fashion other than a face-to-face meeting. This meeting, precisely seven years ago, was my very first Council as director this February of 2010. Yep. And many of us were on the phone as well because we couldn't even get out of our driveways. 36 inches of snow, as I recall. So again, I recommend the statement of understanding. Everybody take a look at it. Are there any questions? I should have told you that the changes from the last statement were fairly minimal. We clarified that LCT32 institutional training grants could not be put on the ECC, and we tried to clean up some of the language about this issue of can we make a supplement to a grant that was not HG primary or HD was assigned as a secondary to it. The answer is no, we can't. It has to come to the Council. The verbiage there was somewhat awkward, but I made some minor wordsmithing there. Okay, if there aren't any questions, then I need a motion to accept the statement of understanding and a second, all in favor. Any opposed? Anyone abstaining? Thank you very much. One last bit. I have to recite the conflict of interest statement to you. And this applies to all the applications that will be reviewed in the closed session. You must leave the meeting room when applications submitted by your own organization are being individually discussed. In the case of state higher education or other systems with multiple campuses geographically separated, own organization is intended to mean the entire system except where a determination has been made that the components are separate organizations for the purpose of determining conflict of interest. You should avoid situations that could give rise to charges of conflict of interest, whether real or apparent. For example, you should not participate in the deliberations and actions of any application from or involving your spouse, child, a recent student, recent teacher, professional collaborator with whom you have worked closely, a close personal friend or a scientist with whom you have had longstanding scientific or personal differences. The NHGRI staff will determine the appropriate action based on recency, frequency, and strength of such associations or interests, either positive or negative, and will instruct you accordingly. In council actions in which you vote on a block of applications without discussing any individual one, the on-block action being one example, your vote will not apply to any application from any institution fulfilling the criteria noted above. There's a hard-copied conflict of interest document in your folder. Please sign it, leave it at the table, and we will pick it up. And I think that's it for the open session. Do you want to gavel us into closure? Thank you. Five minutes and let's reconvene. Well, probably 10 minutes, they have to disconnect the cameras.