 Okay. This is, as Rudy said, the concept clearance for the re-issuance of the Centers of Excellence in LC Research or CIR program request for applications. CIR program was established in 2003. There are three primary goals. The first is create transdisciplinary research teams that can integrate behavioral, social sciences, legal, and humanities research and genomic research efforts. The third goal is to facilitate the translation of research findings so that they can be used to inform health research and public policies and practices. And the third goal is to train the next generation of LC researchers with a special emphasis on recruiting and retaining underrepresented and underserved minorities. Traditionally, we've used the P-50 or CIR full center grant mechanism and a P-20 or planning grant mechanism. So this is just a very, hopefully, quick history of the funding of the program. We've issued the RFA four times. This would be the fifth issuance. We issued it in 2003, 2006, 2009, and 2012 for funding in 2004, 7, 10, and 13. So in 2004, we funded the first set of CIR grants and the full centers are in yellow. When they're renewed, it's in dark orange. When we bridge funded, it's in light orange and the planning grants are in green. So in 2004, we funded the first full centers at Case Western, Duke, Stanford, and the University of Washington. We funded three planning grants at University of North Carolina, Harvard, and Howard. In 2007, we funded two P-50s. One was a conversion, a successful conversion of the planning grant at UNC into a full center grant. And the other was a new center grant at University of Pennsylvania. We did not, that year, issue a request of applications for the planning grants. In 2010, the first class of centers renewed for their second four or five years. So that was Case Western, Duke, Stanford, and UW. And then we also funded two new planning grants at Columbia and Oregon Health Sciences University. In 2013, the UNC center grant was renewed and the Columbia grant made a successful transition to a full P-50. And we funded three new centers at Hopkins, Kaiser UCF, and University of Utah. One reason I put this up was to make the point that the planning grants don't always make a successful transition to a full center grant. So you can see it's about 40% of the time. Also just to give you a sense, Council recommended that we keep this year program to less than a third of the LC set-aside budget. So in 2014, we funded five full centers and three planning grants for 5.8 million, which was about 32% of the LC set-aside. So we feel this has been a successful program. They've established productive transdisciplinary research teams that have been involved in the integration of a broad spectrum of LC and genomic research. A number of RCR investigators are serving as principal investigators, investigators or consultants on a lot of the big genomic medicine projects, Emerge, Caesar, and more recently, the newborn sequencing grants. They've provided resources for policy makers. The teams have written policy briefs and white papers that have been used to inform both state and federal legislation. And they've provided expert testimony to Congress, the state legislatures, president's bioethics commission, and a number of advisory commissions, federal advisory commissions, and they've also served as chairs and members of those commissions. In the training department, they've about 100 graduate and postdoctoral students and junior faculty members have gone through center training and mentoring programs. Only 25% of these trainees have been members of minority or underserved populations. I'd also mentioned that our centers have done some outreach and training efforts at the undergraduate level as well, and they've found that that's been a very successful way of recruiting and retaining minority students to bring them into the pipeline. Many of the graduate students in postdocs have transitioned to tenure track positions and a number are now PIs on their own NIH research grants. Also, I'd just say through the work they've done across academic disciplines at their institutions, they've generated a fair amount of support for this kind of broad spectrum interdisciplinary work. Okay, each time we've issued the RFA, we make changes. And they're usually, well, they're always to address the fact that genomic research is moving so quickly and also the ELSI program itself is growing and evolving. So this chart really lays out the changes we're proposing for the 2015 RFA over the last RFA which was issued in 2012. So in 2012, we had strongly encouraged applicants to develop a single project as the main focus for their research and this was to ensure that the research that they were describing was proposed in enough detail that the peer reviewers could really assess its scientific merit. Concerns had been raised that there wasn't enough detail to really review what was happening at the centers. And so we made this shift to try to put more meat on the bones as it were. This was a noble effort, but after we did it we got a lot of feedback from the centers and from others in the community feeling that this really narrowed the focus too much and it inhibited their ability to be more agile and to respond to emerging issues. So for the new RFA, we're giving a little bit more flexibility in the research design. They can propose a single project if they'd like or a series of more tightly interwoven projects that are built around a well-defined theme that is not too broadly focused. So we're trying to hit the sweet spot here and get enough meat on the bones but not limit them too much. The second change we're making and this is really to address how rapidly genomic medicine is moving. And what we're suggesting is rather than having the sears go for five years with a five-year renewal, we're proposing a four-year original grant with a four-year renewal. This will enable the sears to turn over more rapidly and hopefully we'll be able to fund additional sears. In that same vein, we are proposing to limit the direct costs. Did my mic fall off? Is it working now? Sorry about that. You didn't miss anything important. So in 2015, we're proposing to limit the direct cost to $650,000 a year instead of $750,000. And again, this is to allow for more rapid turnover in the sears and hopefully to fund additional sears. In the training department, traditionally we've focused on postdoctoral training but as I mentioned, the sears have found that training across the full pipeline is actually a very effective way, particularly to bring in underserved and minority populations. And as Eric mentioned, we've also just recently issued a T32 institutional training program for LC training for pre-docs and postdocs. So the hope is that this center training will complement the more structured traditional T32 training. The final change is really just mechanical. We're going with the RM1 mechanism rather than the P50 because it allows for a better integrated application. We are not going to issue a planning grant solicitation at this point and it's really just being done so that we can synchronize the grants, the existing and new sears, though we will consider issuing a planning RFA in the future. Today, this request for applications is open to all applicants. We do expect the planning grantees will submit applications but we're also expecting to get applications from a number of other institutes that's been our experience in the past and we fully expect that this time. We're hoping to set aside $3 million to fund up to three sears. We have been talking to a number of other ICs that are interested in participating and if they can get permission to participate and can actually set aside funds, we're hoping to be able to fund additional centers. And finally, this is just the timeline. We're looking at a March 2015 release. Applications should be received this summer, probably reviewed during the fall. We'll come back to council in February 2016 or a spring 2016 start date. And I think Amy, are you on the phone? Yes, I'm here, sorry. That's fine. I was going to give Amy the first crack at this since the person on the phone often gets left off. Thanks, Joy. Yeah, so I mean, I think this looks great. I'm very supportive of this year's program continuing and I think that there were several changes made to the RFA in response to the last cycle that are in the positive direction. I think this move away from focusing on one large research project is a really positive move and it allows for sort of centers to develop around doing smaller projects around a given topic, which I think is probably better for a center-oriented grant than having a large sort of R01 type grant being funded. So I think that provides more flexibility and is good. And the way the RFA is written right now around that leaves it a little bit open. And so I mean, I would even encourage more structure around that in terms of saying you want people to focus on a particular topic area, but that they should be doing multiple sort of smaller projects in that topic area. I think the four years of funding, the reduced funding, the reduced time for the renewal and the reduced budget is probably okay because what I see as being necessary for the more long-term infrastructure for the seers is really the training programs that get set up and run. And now with the new 232 program, that might help sort of those centers that are doing extensive training programs to be able to sustain those training programs and that infrastructure for a longer period of time. I do think there may be some questions about eligibility. And one of the things that came up that we've discussed is whether we have the original five seers now that are going to be expiring after their five-year renewal period and whether those institutions are eligible to go back in and whether individuals who are involved in those programs, either as PI or as co-investigators are eligible to apply for new seers. So I think some clarity around that might be really helpful for those groups. And then I guess the last thing that I just wanted to bring up for conversation is, you know, one of the things that I thought a lot about is how do the P20s and the P50s sort of work together? So, you know, I think obviously the, I don't know what the expectations are or what the instructions are to the review panel about P20s that are going up for P50s, you mentioned, Joy, that not all of the P20s are successfully transitioned into P50s. And on the one hand, I think if you've invested sort of the money and the resources into a planning grant, you would hope that they would be successful in developing a full center and continue to get funding as a full center. On the other hand, I hear that there's a real desire to have other groups sort of apply straight out for a P50 without previously having a planning grant. And so I think there's a little bit of a tension there. You want the planning grants to be successful, but you want other people to come in and be competitive. And I guess it's never been really clear to me what the value of the P20 is during that time. Are they doing sort of independent work that if they just finish after those, whatever, how many years, three years or so that they have the P20, it's been a good use of money. Or if they don't really transition into a P50, then it's really not a good use of money. And it's having the P20 really get people in a position to be more successful once they get a P50. And I don't know the answer to that, but I think it's probably worth a discussion to see sort of how to play out with each other because it's kind of an odd transition or non-transition period. So those are kind of my preliminary thoughts and comments on this. But overall, I think it's a great program. I'm glad that we're continuing to support it. And I think some of the changes that were made are really positive. Okay. I think what I'll do is just go to Chnita and Artie, and then we can start addressing some of the questions you raised. Thank you. So I agree. I'm also very enthusiastic about this concept, and I'm glad to see that there's continued support for this program within the LC program. I do think that changing the focus and scope of the work that's proposed to a broader set of themes rather than a specific research project is a good way to go. As I remember, the work that we did at Penn, ours was within the framework. It was a broader concept, and I think that worked really well, at least at our center. I share many of the reactions that Amy says, so I won't repeat all those. But I will say that, particular to the training, I think this has been one of the programs that has been very successful. And I just wonder, I think it's important to sort of document and discuss what the metrics for success would be in terms of measuring training within this program and to make sure that it's consistent with the metrics that are established in the education and training branch. And then I do want to say, I mean, I've seen the dollar amount that's budgeted, the three million, is that per center or total or? That's total. It would be about a million a center. So I just wonder, given, I know budget is an issue, but I just wonder about how that compares to what we're investing in terms of this particular funding mechanism rather to other things outside of the LC program. I know LC has a specific set of side of money, and I get that, I understand that, and that we have to work within those means. But I think it'd be useful to have some conversation about how to support this from other components of NHGRI. It seems like three million for these centers just seems really low relative to the millions that are invested in the sequencing centers and other initiatives. So I think that's something we should talk about as a group. I'm going to go to Artie first and then. Sure. So I have been a beneficiary of the SEAR funding since 2004, SEAR for the last 10 years. So with that potential conflict of interest on the table, I will comment that I think it's been extremely useful for purposes of setting up an infrastructure of researchers who work in this area. I happen to be at a law school and I've had three, well, two and a half, I suppose, students who've gone on to tenure track law positions as a consequence of the SEAR funding. So I think it's been very useful in that regard. I also concur with Amy and Chanita in saying that I think that our center has always been very broadly defined in the general intellectual property space. And so the consequence of that has been extremely broad interest from across the university, from the law school, which is my school, the business school, the public policy school, the basic science groups. We've had just a part of it has to do with our SEAR director, Bob Cooke-Deegan, who's just an extraordinary network builder. But in addition, the consequence of having a broad umbrella has been extreme interdisciplinarity, which I think going forward, I would suggest it would be a real virtue of the SEAR process and to sound a theme that I think I'm a little bit of a broken record on. I think it would be real, at least our center was able to draw upon the expertise not only of scholars and the humanities, but also in the more quantitative social sciences, so political science and economics were well represented in our center. And I don't see political scientists and economists necessarily well represented across the board in the LC group. I think that would be an extremely useful set of people to have going forward, particularly because, as we might imagine, much as we're all excited about personalized and precision medicine, it also has the potential to be quite costly. And an economist's perspective on that set of issues would be extremely useful. Great. We agree completely. And Dan, did you have a question or comment? I wanted to make a comment about the investment in LC issues. I mean, there's a big investment in SEASER. There's a big investment in EMERGE that focuses on those issues as well, so it's not like this is the only LC initiative that we're working on. I understand that. I understand that clearly. But I think that when you look at the dollar amount that's specific for this program, which is, I think we would all agree, is probably one of the flagship programs of LC. I mean, that seems low to me. Well, we will hope to keep it around 33%. So the $3 million is just the new grants we're funding. So hopefully, it won't say that low. Going back to the eligibility of existing centers, this has been a question that we've talked about, and we would love to get council input. Our feeling was that once an institution had a center grant, they really shouldn't be coming back in for a second center grant, even if it is a different set of investigators. Simply because we really want to spread the wealth, we'd like to see these take hold at institutions across the country, rather than being concentrated in a single institution. And I don't know if council has an opinion about that or whether that seems like a reasonable approach. I don't know that much about LC research, but in other contexts, it's extremely difficult to build a program, build a training program, and then dismantle it in four years. But I understand the desires to spread the wealth, and I was wondering if a compromise would be two cycles. They do get two cycles. I'm sorry if I didn't make that clear, for a total of eight years. OK. Yeah. So I know it might sound. I mean, I think that's actually very generous that they've had two cycles to be competitive. And I would like, I'm in favor of limiting the participation or not allowing those who've had two cycles of funding to come to apply. Because I think that in my mind, at this point, they should be ready to, either the institution should be investing in it, or there should be other sources of funding that are sustaining it. So I agree with that. So I hear an institutional restriction. Is that what you're talking about? I guess. It sounds harsh to put it that way. But I mean, I think that I guess what I would like to have happened is that people would say, OK, we've had this for two rounds of funding. I know that won't happen, perhaps. But then I say, you cannot apply. I would like for them to recognize that they shouldn't apply. Right. I just am mindful of the fact that that Joyce phone's going to start ringing as soon as we vote. And people are going to ask if they can collaborate on someone else's center. I think that they can collaborate, but not going in as a lead institution, I think, is appropriate. OK, that's a helpful clarification. Yeah, Bob. Do I wonder, do you know in some of the groups that their funding has ended, that indeed the program has continued, even after the funding has ended, and how it's being supported, or did it not continue? They're actually the first class are just now ending, 2014 was the end of their funding cycle. And so I think the indications are that at some institutions they'll probably continue. And we're hoping that some of those institutions will actually come in for the T32 training grants to kind of provide some continuing support. But I think that's not going to happen at every institution. It's just like the P20 grants, the planning grants. Sometimes it takes, and sometimes it doesn't. It has a lot to do with the principal investigator if they're staying engaged, or if they're moving on to other things. So my question was very similar to Bob's in that. Is part of the criteria for applying for one of these things a plan for sustainability beyond the time frame for which they're qualified for funding? Right, and in fact, that's required for the renewal applications that they have to have a plan for how they will continue institutional support. Yes? So I have a question related to, so after they've been established for eight years, where do they get their funding then, in general, in the NIH? So where are those other sources for these investigators? Right, as I mentioned, a lot of them are actually involved in these large NHGRI genomic medicine projects. So some of their funding is coming from that source. Some of them come in for LC grants, for RO1s, R21s, other grants. And some are funded by other institutions at NIH. They also get funding from other sources, the Greenwald Foundation, sometimes NSF, even. So I guess that comes back to Chinita's question around, if I'm interpreting correctly what you said, are there enough resources to support the investigators afterwards? Was that your comment about the relative ratio between the different programs? No, my comment was just about the $1 amount. It wasn't about if there are enough resources outside of it. It was just about the $1 amount that's available within the program to support this initiative. Joy, this is Amy. Given the line of questioning, I wonder, because you haven't really had experience with centers ending up until now. And the first five are kind of ending after their renewal cycle now. And I wonder if it would be possible to gather some data on where are they getting supported from, how much funding, what's the level of funding, is the infrastructure staying in place, or is it disbanding, or what's happening with those centers? Because that might be useful information. That's a great idea. We will make that. So other questions? Just to state the counterpoint, you spend eight years building these wonderful programs that I guess there's also kind of a shame in letting them, if they're unable to kind of find other means of support easily, letting them kind of dismantle when these might be the best places for these programs over longer periods. I'm not quite sure how to balance it. But our hope is obviously that they continue to get support through other sources. Did I answer all your questions, Amy? Yeah, I think you did. I mean, I think the only point that's really not a question was just thinking a little carefully about the transition or not from P20s to P50s. And I don't think there's a question to answer there. I think it's a difficult balance, because I guess the question is, what is the utility of the P20s? Is it worth it to continue to have a P20 program? Is it a good use of funding, or should that money be invested more in the P50 centers? And if it is a good use of funding, that balance between wanting to, hoping that those P20s are successful into turning into P50s, but on the other hand, encouraging people, they're giving three P50s, there's been three P20s, and sort of making it clear to the community whether who should be applying for those P50s. And I think it's a hard balance. Yeah, well, I think our experience is that the P20s that did successfully convert, this would be at Columbia and UNC, the centers really had a head start. It was a real advantage to have had a P20. And I would say that the investment has paid off, even though only 40% of them make it. And the P20s are relatively inexpensive investment. And I'd second what you said, having been at UNC, it was a huge leg up in being able to then do a successful application. So my recollection from 10 years ago, because I was involved in the initial review, was that the idea behind the P20, there wasn't enough money to do a lot of research to generate a lot of preliminary data. The idea was to allow people to come together and start talking because they didn't have those natural interactions, and they were supposed to be very, very multidisciplinary. I don't know if that's still the case 10 years on, but that was the purpose then. Absolutely. Any other questions? Do we need to take a vote? Yep, we sure do. So can I get a motion to approve the concept? And a second. All in favor? Any opposed? I'm sorry, you opposed? Okay. And the people on the phone, David, are you still with us? All right, Val, are you with us? If you're on mute, then send me your vote by email. This is Amy. Oh, Amy. Okay, you approve, thank you. Yeah. Okay, thank you, Joey. All right, next up, Adam. He's gonna go through four concepts. Now, we're not gonna incarcerate you through all of that, so I'll alert you to the fact that we will take a break somewhere close to three o'clock. It all depends on the timing of how quickly Adam moves through them. So, Adam, you're going to give a bit of an overview, but you're gonna go through the concepts one at a time and we'll stop for a vote, correct? Yep. Okay, so this is a series of four concepts on the genome sequencing program.