Council Initiated Discussion (February 2013) – Eric Green


Rudy Pozzatti:
We’re in the home stretch here in terms of wrapping up the open session. Next in line
is council initiated discussion. I’ll just point out we have a couple of announcements
to make. I have to go over the MOU, the memorandum of understanding, and then read the chant,
the conflict of interested document to you. Bear in mind we have a few other things to
do. The council-initiated discussion will be led by Eric. It’s generally when we ask
of the council what are the items that you’re thinking about. We’ve been driving this agenda
so far. What are the items that are hot in your mind? We sometimes ask the council if
they want to hear reports from us at May, or September, or subsequent council rounds,
so, floor’s open. Eric Green:
And either topics you want to talk about now or you want to plant seeds of things that
we didn’t cover at this open session you’d like to hear about in future council meetings. Robert Nussbaum:
I’ll just say as a new member that I’m very impressed with the spectrum and the breadth
of the kinds of applications that you are looking for and you are funding. I mean, you
really are covering the gamut of the reorganization pieces that you described, and I just find
it very impressive. Male Speaker:
Thanks. Robert Nussbaum:
At the risk of sounding like, what do you call it, a plant? Or a — [laughter] Or a sycophant or something, I’m not sure
what it is, happy camper. Happy camper. Eric Green:
Comments, questions, requests, thoughts. Rudy Pozzatti:
You can also sleep on it and give us something tomorrow morning, if you’d rather. Eric Green:
Yeah, do you want to say — if we’re — I mean, one thing, Rudy, you anticipate a May
council, it’s going to be a particularly busy one, or not as busy? I mean, partially, it
helps to frame how many things we can squeeze into a council meeting. I forgot what it looks
like. Rudy Pozzatti:
We have maybe four RFAs coming, so there’ll be more to do. Eric Green:
But it really is very helpful for us to hear from you of things you want updates about,
because especially months in advance, it gives us time to prepare for it and think it through. So, yeah, Howard. Howard McLeod:
This might be heresy, but it seems like the list of — I thought — seems like the list
of approved clearances is greater than can ever be actually put out there to be funded.
So things we’ve cleared in the past, there’s too many of them. Is there — just program
handle that or does something that comes back to us to — to unclear some — Eric Green:
First of all, give us a little more detail, what do you mean by that? Howard McLeod:
Well, if you look at the — there’s documents that we’ve looked at before that looked at
the past council meetings and concepts that have been cleared, and — but yet are not
yet RFAs that — out on the street. And it seems like there are more cleared concepts
than can hope to be funded in the current environment. And I’m just unclear, how — I’ve
use the word clear too many times, but how does one deal with that? Like, what is our
responsibility to help you have fewer of those on the books? Eric Green:
Let me try to make a first pass at that, and I’m eyeing Teri and Jeff, who are the program
division directors that are sort of often in these conversations about these priorities,
and especially their new roles as division directors. First thing, let me remind you that this council’s
advice previously, when there were, you know, healthy discussion around things that we should
or should not be doing, came to the conclusion that it probably was better to err on the
side of approving some concepts as long as we wouldn’t be angry with council at the other
end of it when they actually saw what came — if there was debate around whether the
time was right for something or not, as long as we were comfortable getting the feedback
by the time you actually looked at the grants to say, you know what, you originally penciled
in $3 million of stuff for this RFA, but we only think there’s $2 million with funded.
And so our collective decision was to err on the side of having you approve it, having
us go for it, and giving you the ability to make recommendations to us that we’re pruning
at the end. So, by definition, that might mean that we will let more out, theoretically,
out of the gates than we actually could fund. I think the second thing playing into your
question may also reflect some of our budget projections, which have, because of the current
circumstance we find ourselves in, are extremely conservative. So while you think that all
these things cannot be funded, those are based on you know, big assumptions, based on possibilities
that may or may not come to pass. And if they don’t come to pass, actually, we will be very
comfortable. But it’s all based on assumptions not only for this year but for next year.
So I don’t think it’s as bad as you think it might be. But there will be some challenges.
I mean, there will be challenges. Howard McLeod:
I was going to say, thinking — there was — I wasn’t trying to quantitate badness,
but rather, just wasn’t sure about the process. I think we would all be delighted to not have
to de-clear, or whatever the right word is, concept. So I just wasn’t sure what it involves. Eric Green:
No, we don’t see you having to de-clear anything but we do see the — and again, and I think
there’s going to be some things that’ll be coming up that you’ll — we will want your
feedback about the set of grants that come in in RFA, and just because we’ve penciled
in x number of dollars, if you don’t think there’s x number of dollars worth of good
stuff to fund, we will want to hear that from you because we all decided collectively it
was better to do that than to be too conservative up front. Teri and Jeff, do you want to add anything
to that? Male Speaker:
I’ll add one thing, because I think last year there was a case where there’d been an approved
concept clearance but the RFA had never been issued, so it’s the opposite of the problem
you’re suggesting, where we’re not sure how good the things are that’ll come in but we’ll
take a look. In that case, there was interest in a concept clearance but there was a decision
made at the program level or internally that we don’t have the funds to request proposals
in that area. And I think it would be useful to hear if there’s any things in that situation
right now, where it’s come up by council, council’s been enthusiastic, but program feels
like there’s not funds to support an actual RFA. Jeffery Schloss:
And so I’m just going to say we are working out the processes to do this internally. We
were really making it up as we were going a year and a half ago. That was the first
time we went through that kind of exercise. I think we have the process improved a little
bit now, and that’s among the information that we plan to bring to you every council
round. Male Speaker:
Are there any things like that right now, approved clearances that have not made it
to RFA? Jeffery Schloss:
One example that I think you’re thinking of, but that just meant we didn’t have money the
last fiscal year. But it’s back — but it’s on the list and
it’s in draft and it’s going to go out, and it’s on the list potentially for next year. Mark Guyer:
And I think that example was one of the reasons that, in discussions with you, the decision
was made to delay the final decision until you really see what the — so, the decision
at that point, we were more working under the lines of, if we clear something for $5
million, we basically got to keep $ million on the books instead of being willing to put
more on the books and then make the decision at the time of the applications. Eric Green:
Okay. Other questions, comments, thoughts, requests? Okay, seeing none. Rudy Pozzatti:
Okay, so back to the agenda. Under announcements and item of interest, there are two reports
that were sent to NHGRI. They’re available on our website for the council open session. First is from the American College of Medical
Genetics and Genomics. It’s their report to the council. There are several items of interest.
I’ll draw your attention to their position statement on public disclosure of clinically
relevant genome variants. And the second is the quarterly report from the National Society
of Genetic Counselors. So, it’s time to go through the memorandum
of understanding. And Monica, come on up. Come up and have a seat on the side. Eric Green:
Should she sit here? Rudy Pozzatti:
No, she can be on — you can be at that chair in case you need to use the microphone. So the memorandum of understanding, for those
new members of the council, in the simplest terms, and I probably do a disservice to what
the document really represents, but it’s basically a description of how we’re going to conduct
business with you; what things we are required to report to you, what actions we can take
with your consent, and without your consent or your knowledge. It’s all spelled out in
the MOU. I’m not going to sit here and read it to you. There are two changes that have
been made to the MOU, and those I will draw to your attention. Again, I don’t think you’ll
be surprised by these because you’ve already seen an example of the first. The first change is the requirement to conduct
special council review of any application where the principal investigator, if he or
she receives that award, would then have more than $1 million a year in direct costs from
any number of active current grants. So that’s been added to the MOU, that we are now obligated
to bring those to council and to have that review be conducted. The second issue is the matter of the expedited
council concurrence. This is an NIH-wide ECC, we’re now calling it. This is an NIH-wide
phenomenon. It allows the institute to bring certain application types to a subset of the
council members of the council. In the case of NHGRI, it’s SBIR and STTR applications.
The current members of the ECC committee, I guess we’ll informally call them that, are
Deedee [spelled phonetically] and Jim, and we will conscript someone from the new incoming
class so there’ll be three council members. So, we will bring these applications to this
subcommittee about one month before each council meeting, and they essentially perform the
same process that’s done in a full and open council meeting. We give a report to you.
There is a report in the ECB that shows you the list of applications. Fundamentally, what
ECC does is it allows us, if we want to make an accelerated award, we can basically get
started early on those applications, okay? Any questions about the ECC process, or any
other aspect of the MOU? Great. I think we’re down, then, to the conflict
of interest statement, which I am obligated to read to you. There is a document in your
— did you get folders or just — yes, okay. There is a conflict of interest document in
your folder. You might want to do it at this time, or as we break between the open and
close session, please sign it. Comfort will come around and collect it from you. This will certify that in a review of applications
conducted by the national advisory council for the human genome research on February
12, 2013, I absented myself and did not participate in the discussion of, nor vote on, any application
in which I, or to my knowledge, my spouse, minor child, or close professional associate
has a financial interest, nor on any application from an organization or institution where
I am an employee, consultant, officer, director, or trustee, or am negotiating for employment
or otherwise have a financial interest. In council actions in which we voted on a block
of applications without discussing any individual one, the so-called “en bloc” vote being an
example, my vote did not apply to any application from any institution fulfilling the criteria
in the preceding paragraph, or that which I just read to you. So, at this point I think we’re ready to close
the open session of council, and we’ll turn off the cameras. You can run to the bathroom
for five or 10 minutes, and let’s re-adjourn to deal with a couple of applications before
we quit for the day, okay?

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