Rudy Pozzatti: Okay, a couple more things that need to be
done in open session. This is the point -- we’ve reached the point, rather, of the council-initiated
discussion and again for our ad hocs, this is the point in the time where we stop and
are willing to listen to you. If there -- if you came here with a burning issue or an idea
this is where things come up, where you feedback to us. This is where the idea came from to
-- to have Phil Warren come and talk to the council. You might want to hear a report on,
if not one of the research activities here, a workshop or something else that you think
is appropriate to get information brought back to you. So at this point the floor is
yours and we’re all ears. Robert Nussbaum:
Now, I’d like to bring up a point. It’s off of a comment, I think, Eric you made in
your report about interaction with the FDA. I’m very, very concerned that the FDA inserting
itself into the implementation research of using genetic information and doing clinical
trials when you get -- when you use that information in patients. So beyond just CLEA. We’re
talking about the FDA. What I’ve seen happen in the, and a major concern in the newborn
sequencing program, is not so much, in fact, it’s not at all that the FDA is really telling
people what to do but there is a danger, and one of my colleagues brought this up, of self-censoring.
That people are changing their research projects, they’re changing their research direction
even though the FDA said they do not want that to happen. It’s happening because of
concern about the FDA insisting on a -- on an IED or other sorts of things. I -- I would
just like to bring up that maybe at the next meeting we could have more of a discussion
about the role of the FDA regulation in regulating genomics research.
Eric Green: So, we can do that. Would you like -- you
want this to be -- you want to hear from NHGRI staff who are interacting a lot with the FDA?
Would we want to invite somebody from the FDA to come talk?
Robert Nussbaum: I think --
Eric Green: What’s [unintelligible] imagining?
Robert Nussbaum: Well I’ve heard a bunch from Jonathan Gifflin
[spelled phonetically]. He’s been very helpful and terrific. He’s right there. I think
it would be a good idea to have a two-way conversation because at this point the conversation’s
been one-way from us to FDA. I would love to hear the FDA’s point of view and see
if we could actually have a dialogue. Eric Green:
Okay. Rudy Pozzatti:
So Jonathan’s going to give you a presentation tomorrow morning and we certainly heard this.
If you want to refine that discussion -- if you want to define what you want to hear from
us after Jonathan’s -- Eric Green:
So we’ll have continuation of this after tomorrow. DeeDee?
Deirdre Meldrum: It’d be helpful to have maybe some presentation
on future plans for technology development. Eric Green:
So where are we -- Jeff Schloss, where are we on -- we’ve had that on the possible
agenda I think multiple councils. Are we aiming for February now?
Jeff Schloss: We’re aiming for a concept clearance in
May because by that time we will have had a workshop or various, well, workshops in
one format or another. Eric Green:
So would we want -- Jeff Schloss:
That’s our plan at this point. Eric Green:
So would it be silly to have a presentation in February if we’re going to have a concept
in May? Jeff Schloss:
I think so. Eric Green:
Okay. So we’ll have -- we’ll be having some ongoing plan activities that will culminate
in a concept in May. Deirdre Meldrum:
But is this all sequencing technology that -- sequencing technologies or more broad --
Jeff Schloss: No, no. Sequencing technology will be included
in the discussion but we intend it to be broader. Deirdre Meldrum:
Okay, good. Eric Green:
Priscilla? Priscilla Crockett:
Yes, I have a suggestion in terms of interactions with other agencies or organizations about
bringing PCORnet to talk about their initiative and to speak about the bio-repository in particular.
Eric Green: Okay, we can look into that. I think we’ve
exhausted them. Rudy Pozzatti:
Very good, thank you. Let me draw your attention to three items of interest. You can find them
in the CB or link to the council open session agenda on the council’s webpage. These are
the quarterly reports from the American Society of Human Genetics, The Society of Genetic
Counselors and The American College of Genetics and Genomics. If you want to see about recent
activity and updates from those societies. And finally, I am required to read the conflict
of interest statement to you. This applies to the review of applications that will be
performed in the closed session. “You must leave the meeting room when applications submitted
by your organization are being individually discussed. In the case of state higher education
or other systems with multiple campuses, geographically separated, owned organization is intended
to mean the entire system except where determination has been made that the components are separate
organizations 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 from or involving your spouse,
child, recent student, recent teacher, professional collaborator with whom you have working -- with
whom you have worked closely, close personal friend or scientist with whom you had long
standing scientific personal differences. NHGRI staff will determine the appropriate
action based on rescentcy [spelled phonetically], frequency, and strength of such associations
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 -- individual
one, the on block action, your vote will not apply to any applications from any institution
fulfilling the criteria noted above.” Please sign the conflict of interest form
which has been provided to you in your folders. We will collect them at the end of the meeting.
So once Eric hits the gavel the open session will be concluded. We ask you to stick around
for five, 10 minutes for them to disconnect the cameras. We’ll come back to the second
closed session. Eric Green:
So we’ll start -- we’ll start that at about 6:00.
Rudy Pozzatti: Let’s say 6:00.
Eric Green: We’ll talk about what we’re going to do
from there. All right, I will close the open session. Thank you very much.
[end of transcript]