 Okay So at this point we're moving on to the portion of the open session called the council initiated discussion and I think All but the new members have seen this before this is where we sort of turn the control of the microphones over to you We're happy to hear suggestions for future reports or If there are trends out there that you want to draw to our attention or questions that you want to ask the staff So one of the things that came up today, and then it came up again in your report Eric was this issue of how to maintain Critical databases that are available for everybody. So I'm wondering Will you be commenting on that again at the future council meetings? There's just could you tell us a little bit more about what is there a formal process or is it just a Kind of a over the couple of cups of coffee discussion or what is so it's probably sign in between and anybody And on staff who have anything to contribute. Please walk up to a microphone, but there I Really feel Extensive amount of stress about this in part because It's not just me. It's not just any sheer eye, but there's a limit to what I can do to change this So there are several moving parts. My understanding by the way is Well immediately I can tell you that John Lurch as an IGMS director and myself and Phil Bourne as the new associate director for data science are all very Interested and we're interacting regularly to try to discuss how to sort of navigate this because we want to bring this to the attention of All the NIH leadership Francis Collins is aware of it But we actually think we need to put this out to a larger discussion of the Institute and Center directors Grantees of which are greatly affected by some of the things even two institutes might do for example I also know there is an inventory being developed of similar resources Supported by other institutes because we're just going to get if we know what we have at our Institute They know what's a GMS There certainly is interest there to get find out what else there is my understanding And that's why I'm looking if anybody can confirm it My understanding is that there is bd2k the big data to knowledge bd2k program is Planning a workshop and there's someone coming to a microphone maybe the understanding is that there will be a workshop in the near future, I don't know when but that's coming and Finally the last thing I'd say is that Phil and John and I are regularly interacting and are trying to get this teed up to present Probably in the next month or two To the Institute and Center directors to really raise this put up the flag and say this is really a problem At the corporate level and we need help and sort of thinking through it So so you just gave me an assignment Which I think whether you meant to or not is that I should make sure to come back and update you I mean I can't this is not on a strict timetable that I know this that but I I think I would naturally be updating Counsel about this, but I will write it down as something that I will definitively try to bring back to you as as things percolate along on Tina Maybe Carol can you loan a mic? Yeah, so I just wanted to add that we're really working at two different levels. So one is Within energy are I we're working with the large database resources. We're arranging a meeting of the large database resources to really analyze How this database resources work? The efficiency of what type of activities they are are they relevant to energy are I research or not or maybe they're Applicable across different institutes. So we're right now. We're collecting information And and that will help us decide what to do next and also have this discussions have more informed discussions about next steps the other thing we're doing is also to work at the NIH level with the bd2k office and Basically There are there is a working group. It's called the sustainability working group that has a number of Initiatives that we're evaluating One is the workshop and actually the workshop has been put on hold because we have been collecting There are already reports that can help us to make some decisions about things to test out for the future So and there is an RFI that is going to be out pretty soon and really it is to inquiry with the community about potential alternative funding models for the database resources We're talking about supplement projects to really encourage the large databases to To do some projects to improve interoperability of the resources So there is there are different type of activities many of which are exploratory at this point And so eventually long term We're probably what is going to be done is what what we're doing within NHGRI and what is going on a bd2k We'll converge and we'll inform all future discussions. That's a helpful way to frame it I like that and the way I was trying to frame it, but now I can probably say it even better Is that I think we do need to I think it's operating at two different levels I mean we are Internally looking grant by grant having discussions with the grantees sort of saying this is you know What's our conclusion? This is not sustainable. We need a different model and then at a whole different level I mean and it is very much the premise in some ways of The creation of the associate director for data science position Phil Bourne's recruitment also the premise behind big data to knowledge initiative Sort of the same thing at a corporate level. This is not sustainable We have to change the way we do business in biomedical research with respect to how we take care of data How we fund data resources how we fund all and so that's it a whole different sort of philosophical level Hopefully these things will converge, but we are doing it in both ways and Several of us are involved in both conversations But there's so many there's some immediate issues, but there's also some very clear cultural issues that we need to deal with Yeah, Bob one other issue really is This trying to strike a balance between it the data these things as as deliverables that we all need and Emphasizing innovation to improve and make them better and that I Can see how those are they're completely bound up together But in some ways one is much more the mission of the NIH than the other Yeah right and and the other thing you just mentioned I mean the other thing about this of course Which is why it gets to be such a hard problem and I can tell you that working with John and Phil We are engaging in conversations outside of NIH is that it's really not just I mean you're gonna tackle this problem It's really not just NIH alone, and it's not even in the United States It's not just NIH alone and then of course everything we're dealing with the way we're all connected This is a worldwide issue and it's not quite fair that NIH would be carrying as much water as we are in terms of Funding all these things when clearly there's an international stage, and they all contribute all this data and these resources to everybody So how we do that? I mean in some ways this almost becomes a challenge of the international funders Yeah, Hardy, so I have now said this to Philip born and Kathy Hudson, and I don't know who else so I'm just gonna say to you as Well, which is that in our report our Institute of Medicine report We say that all of NIH should do exactly what an ACRI has done in mandating data sharing to all its grantees And that NIH currently has the power to do that so There's a section of the report that points to the regulation under which NIH has the power and So I just wanted to say my piece once again about that And I completely agree with that But of course you do realize that could make this situation worse because then if all the data is shared and then The data resources for example and then all of a sudden we need more servers and we need more curators and more annotators And so that's where we want to be which is why this is a not sustainable problem because on the one hand We're asking for more data sharing and the genomic data sharing policy that is going into effect is Absolutely what we should be doing and yet it's going to exacerbate the problem of sustainability Yeah, no that's fair enough And one of the things that the I am report did not do deal well with is the cost problem And I think that's absolutely critical that said that's a good problem to have to have all these people from Other institutes actually sharing data Carol so I just you said Eric what I was Going to bring up which is Phil's doing a great job at reaching out outside of NIH to really get the Conversation to be much more global because it is not just an NIH problem And the solution could come from another place Or one a part of the solution could come from other agencies And so I think he's he's doing the right approach to address the sustainability question I will say it's been interesting In the last six months in all the strategic discussions around precision medicine I'm going to try to avoid saying that every problem we have we love onto the back of the precision medicine initiative because a lot of people are Already doing that I'm not doing that here what I am doing is as illustrating a point And that is it has been very interesting in the discussions leading up to the announcement that the private sector in particular the the Data experts, you know, you know the Googles and the Silicon Valley types Have have come running actually quite interested in the precision medicine initiative because of the data Excitement around it at the same time that means we've gotten into conversations with them And I say we I mean Phil born myself others and these are some these are some folks from you know big-name companies that have tackled some major big data issues and seldom and all of a sudden they're getting Pretty excited about biomedical big data more broadly obviously specifically precision medicine But so I think the hope fingers crossed is that that this will be an exciting enough problem that we it won't be the usual NIH funded suspects And that we would bring all new expertise to this and you know again I don't know what this looks like But it is just exciting to have some people that previously were really interested in you know more corporate oriented IT challenges now putting their their brains into this and you know Maybe the precision medicine initiative will get them into the problem or focus and then we'll get them involved in the more general set of sustainability issues Eric So on the topic of precision medicine The president's interest and enthusiasm is greatly appreciated and my guess is because of that and the fact that he's He's six years into the term or whatever things are going to move very quickly in the next six months and And I would hope an NHGRI will also have a major role in that And I would hope that you would come back to counsel periodically at a minimum at our next update But even in in the interim having specialized phone calls before things are committed to major things are committed to Without the addition of new monies With committed to without the addition of money. Yeah, yeah, yeah, there's a lot of questions about Well, how this will all play out and at what time frame and all that but as I said earlier I have every intent. I just can't imagine I won't be talking every single council meeting About the initiative, but you are right. Maybe some of it will happen so quickly We'll need to engage you between council meetings and and yeah, you know, that's quite possible other topics other requests for so Bob actually raised one issue and I wrote that down are there other Topics for future council meetings things you want updates about I mean obviously precision medicines data sustainability Other things that you haven't heard haven't heard about for a while And you really want an update about because we always take your advice It helps formulate the agenda for the open session in particular and one thing I guess we should mention is there are two workshops that will be in March and there'll be reports of those workshops coming to you in May Okay. All right. Well, you know how to find us and how to reach us Yeah, you know let me draw your attention to Two quarterly reports one from the National Society of Genetic Counselors and the other the American Society of Human Genetics and Then we're going to deal with the statement of understanding and Monica or Cheryl I don't know if either of you want to move your way to the front of the room in case there are questions Say again You don't have to come up if you don't want to The statement of understanding is something that we present to the council every February we do it at February because that's when the new members come on board and At the end of this discussion. I will ask you to accept the Statement or give us any modifications. You think are appropriate so there will be a vote on it This document is basically a description of how the council and NHGRI will interact It describes the council Responsibilities and it talks about the actions that the council can take it also describes the limits of our Administrative authorities, which is code speak for the things that we can do without bringing matters to the council's attention Or without seeking a vote from you It's a four-page document. It's a pretty simple read. I do a recommended for you to look at it I'm going to very quickly touch on the highlights I'm not going to ask you to vote on we're not going to stop and I'll read this together and I'm not going to read it out loud But give you a sense of what's in the report and if you have any questions we'll attempt to answer them So all applications have to undergo a Second level of review all applications that come in to NHGRI each round There are some exceptions to those types and this would include certain types of fellowships Contracts and interagency agreements the council doesn't see those If we don't list an application on the closed session agenda, it means it's being included in the on-block Vote which is taken at the end of the closed session There are certain kinds of applications that were required to bring to your your attention That doesn't necessarily mean we're going to discuss them at depth, but we're talking about large program project grants T32 institutional training grants Cooperative agreements, so you'll see things listed on the closed session agenda that we don't talk about that's why they're there Also Anything that comes from a foreign institution were required to bring to your attention and Special counsel review and we'll have a couple of examples of those tomorrow There are four actions that the council can take on when it comes time to reviewing applications You can concur with the IRG the initial review You can defer the application for re-review because it has come to the council's attention as a rebuttal or a Claim on the part of an applicant that there was a flaw in their initial review You can recommend the application for high program priority or low program priority Which is another way of saying voting out of score order or you can defer the Application because you need additional information you're requesting additional information Before you're going to make a determination about it NHGRI does have certain administrative responsibilities or Capabilities We do something each round called expedited council concurrence There are three council members. I think it's Bob and Jim and Tony Who serve as the ECC reps so about four or five weeks before the council meeting? They'll get a list of applications. These are largely not exclusively SB IR STTR type applications And they give us approval to take early action on them. It just allows us to speed up the award mechanism The award process rather You get a report in every council meeting It's in the ECB of the applications that have been approved For this round of ECC and you can see the ones that were awards were made from the previous council round So the information is there. We're not trying to hide it from you. We're just trying to expedite them staff authorities The staff has the authority to make administrative supplements on any existing grant up to $150,000 or 25% of the total cost of the application Now we've set a cap on that of one million dollars because 25% of a multi-million dollar grant would be a huge sum of money Again, you'll get a report each council rounds of the administrative awards that have been made by by staff and then there's actually a clause in there that says in the event of the catastrophe Active nature or pandemic flu that the council can meet by electronic means so teleconference in a secure website, etc so that in a nutshell is a summary of What's in the Statement of understanding are there any questions? No debate. Nothing you saw that's inflammatory there good There haven't been any substantive changes to the statement of understanding from what the veteran saw last year So can I have a motion to accept the statement in a second? all in favor Any opposed? Any abstentions? Thank you All right So our last action Before we close the open session and go into closed section session is for me to read the statement of conflict of interest And this applies to the applications that you're going to review 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 determination has been made that the components are separate organization for the purpose of 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 on any application from or Involving your spouse your child a recent student a recent teacher a Professional collaborator with whom you have worked closely a close personal friend Or a scientist with whom you have had long-standing scientific or personal differences The NHGRI staff will determine the appropriate action based on recency Frequency and strength of such associations or interest either positive or negative and will instruct you accordingly In council actions in which your vote on a block of applications without discussing any Individual application the so-called on-block action your vote will not apply to any application from an institution Fulfilling the criteria noted above Now in your folders are at the table. There should have been a conflict of interest form Please sign it and we'll collect them at the end of the day today. Okay, so you want to Gable us is done Okay, we are we are finished