Council-Initiated Discussion


Rudy Pozzatti:
Welcome back from lunch. We have just a few more things to do in the open session and
the first topic up is the so-called council initiated discussion. So I think you all know
the drill here that everything else about the council agenda is set by us, by NHGRI,
but we know in addition to being our advisors that you’re also representing the community,
so if you have issue that you would like to bring to our attention or things your colleagues
are telling you back at the home institutions that you think we should be aware of, if you
want to plant a seed or make a request for a future presentation at a council meeting
in the future, now’s the time to bring it up. Carol Bult:
So, this is not new, but going back again to I think something we said at last council
to have maybe FDA come back to us. I think there’s a strong interest in following up
on some of the meetings that we’ve had and now that they have the new person in charge
there it would be a good opportunity to have them come back to this group. Rudy Pozzatti:
So to prepare — we certainly can do that reach-out, but to prepare them what are the
specific issue or issues that you’d like to address? Carol Bult:
I think some of my colleagues here would probably have more insights into some of the regulatory
hurdles that are being faced and certainly will be barriers to implementation of genomic
medicine if there aren’t addressed. Robert Nussbaum:
[unintelligible] entire issue of laboratory develop test, but I think it’s very much
in flux right now. There’re some things in committee in Congress about whether FDA
should or shouldn’t do it, and so it — and I guess there’s a sort of self-imposed deadline
of May. If things don’t happen by the end of May they’re not going to happen at all,
because of election cycle, and so I’m not sure what the FDA could really say much at
this point. Maybe later they could. Male Speaker:
I wonder if we do bring the FDA back out if we ask them to tie together the — some thoughts
on precision medicine, and how their views may or may not change with the evolution of
precision medicine, and the initiative here. Eric Green:
Okay. Does any — Laura or Kristina, do you — anybody want to say anything about our
ongoing discussions, interactions with FDA and especially if we have a workshop coming
up related to IDEs as I talked about in my director’s report. Yeah, that’s on. Female Speaker:
Yeah, so we meet the — the Policy in Program and Analysis branch and the division of policy
communications and education, we have a regularly scheduled monthly meeting with most of the
people who are actually on the precision medicine team and we try to work through to address
the issues that are impacting the institute as well as trying to get a broader sense or
where we can help them move forward their thinking. We — on June 10, we actually have
a workshop scheduled on investigational device exemptions. My standard spiel has been it’s
not an existential workshop, but it’s as to whether or not IDEs are right or wrong,
but it’s more of a functional workshop so we can help our grantees work through the
process of whether or not you’re researching clue to significant or a non-significant device,
and if — significant risk device, and if it is a significant risk, how grantees can
work through the process. We continue to collect input from the institute and grantees if anyone
has questions we like to act as a liaison to try to facilitate those relationships,
and as for LDTs I know they’re working on regulations, and there isn’t anything set
in place as of the moment, so, hope that was helpful. Eric Green:
But we can certainly, you know, see how this plays out in the next few months, and certainly
figure out if there’s a right person or person group to bring over, so we will have
that on the list and decide the right time for it. I think Eric had the next agenda item. Male Speaker:
I’m struck over the last maybe two years of the parallel and even converging activities
between NHGRI and NHLBI, and I wonder if it would be good to have Gary come and talk to
us, you know, the word TOPMed was used this morning several times. My guess is there are
people around this table that have no idea what Top Med is, and I think there is a lot
that could be gained by more communication between the two councils. Eric Green:
Recently in Iraq with the [unintelligible] especially Adam and others on the staff, but
we can get council. We’ll have to figure out exactly when to do that, but yes, we will
have that on the list. We — [inaudible]. I think that’s a great suggestion. Rudy Pozzatti:
Okay. That’s a longer than usual five-second rule, but I just want to be sure. Certainly
if you have other thoughts on the flight home you can shoot an email to me and or Eric,
and we’ll put it in the queue as he suggests. Okay, rounding out the open session then let
me draw your attention to announcements and items of interest. There are two reports that
were sent to us, one from the American Society of Human Genetics, the other from the National
Society of Genetic Counselors. These two reports are their descriptions of the activities in
which those societies have been engaged since the February council meeting, so if you’re
tracking what goes on in those organizations I refer you to those two reports. Time for the beloved conflict of interest
chant; I’m going to go through it, and this is the conflict rules that apply to 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 that are geographically separated,
own organization is intended to mean the system except where a determination has been made
that the components are separate organizations for the purposes 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 an application from or involving your spouse, child, a recent student, recent teacher, or
mentor, 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. NHGRI staff will determine the appropriate
action based on recentcy [spelled phonetically], frequency, and strengths of such associations
or interests, either positive or negative, and will instruct you accordingly. In council
actions in which your vote on a block of applications without discussion about any individual application
be so-called on block action, your vote will not apply to any application from an institution
fulfilling any of the criteria noted above. So you’ll see there’s some new folders
at your seats. This contains the conflict of interest and disposal of confidential materials
form, which we’re providing to you. Please sign them. You can just leave them here at
your desk and we’ll collect them during one of the breaks. We have one other task before we close the
open session, and that is in September we will be introducing a new cohort of Program
Analysts. These are people that come for about a two-year stay at any NHGRI and so every
year we bring in half a new group of analysts, but it’s time to say goodbye to those that
are moving on. This is a very talented and dedicated group of people that have worked
with us for two years, and they’re going on to medical school, graduate school, in
a few cases the next job in their career paths. So we’d like to take a moment to acknowledge
them. When I call your name will you please rise: Julie Korsen, Hannah Naughton, Annie
Niehaus, Alex Lee, Brenda Iglesias, Casey Martin, and Kira Wong. So NHGRI program analysts,
class of 2016. Congratulations. [applause] Fare thee well and thank you for two years
of service. We hope you got as much out of it as we did out of you. So you want to gavel
us to closure? Eric Green:
I will. We will close this open session. Thank you all. Rudy Pozzatti:
And we’ll reconvene with the closed session in about 10 or 15 minutes. [end of transcript]

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