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Pamela Sankar: So I wanted to update you on the -- what's
been going on with the Genomics and Society working group. If people recall, we started
this working group because there was a change in the organization of NHGRI, which led to
moving around where the ELSI Research Program was. So the ELSI Research Program, initially,
was in the Division of Extramural Research, and when the reorganization was undertaken,
it -- there was a new division created, and the ELSI Research Program is now in the Division
of Genomics and Society. So the changes that have gone on are sort of around the ELSI Program.
The ELSI Program as a research program remains intact as an independent research program,
and the challenge was more how to change the way the Institute was dealing more broadly
with issues associated with genomics and society.
So just to show you the differences between the two organizations. ELSI is, as you can
see here, still primarily -- it is a research program that focuses on the ethical, legal,
and social implications of genetic and genomic research, and in so doing, they fund and encourage,
manage research grants, and also hold conferences about these issues, and create research consortia
and policy conferences to deal with them, and the budget is a set-aside from the NHGRI
budget.
The Genomics and Society group has ELSI in it, but then adds, or, say, emphasizes more
clearly certain elements, and one would be importantly to bring these issues and integrate
them broadly across NHGRI, so stimulate and enhance genomics, and another is to deal with
collaborations with the Division of Communication Policy and Education to make sure or to facilitate
better the link between ELSI Research and possible policy applications, and also the
need for certain policy, and perhaps getting a response from the ELSI Research community
to help -- to help inform that policy. The budget remains the same, however, so -- let's
see here.
Part of what's going on here of course is there's a -- there was a bureaucratic motivation
to do this in the sense of as part of the restructuring of the management and the organization
internally to NHGRI, but also importantly, it also is a recognition of how many new problems
and new events, things that have happened -- the red arrow refers to the point at which
the genome is mapped, and so if you look to the left side, yes, there were issues that
ELSI was dealing with, primarily, in the beginning, very much focused on issues that came out
of research. And as we move over to the right, there's much more going on. It's genomics.
The genome's been mapped. We have many more issues going on, and a lot of these things
are dealt -- need to be dealt with in terms of broader patient population as things move
into clinics and other -- new populations like the newborn -- or the non-invasive prenatal
diagnosis, things like that. So there's new populations that are beginning to be affected.
So as genomics is starting to really percolate through the health care system, the issues
are growing and are slightly -- are changing in nature, and that's part of the reason to
have this new division.
This is just something -- it's out of a draft paper that I have that's not out yet, but
I just thought it would be interesting here to look at. So this is based on an analysis
through Medline of using the MeSH terms related to ELSI, not ELSI itself as a MeSH term. And
if you go back to 1986 to 1990, so before the genome, there were about 1,600 articles
that might have fallen into those categories, and in the most recent set, 2006 to 2010,
there's over 10,000. So that's just -- it's just a way to express -- it's a way to represent
what we all know is happening anyway. I think that that is just interesting, and it's about
a sevenfold increase, and more or less the same with -- if you run the line of genetic
research, it parallels it very clearly, so I thought that was just an interesting way
to see what's been happening.
So the idea, then, of having the -- of creating the division and putting ELSI inside the division
was to address this issue of being able to broaden and expand the way that NHGRI is dealing
with these issues, and the idea is that these -- the Division of Genomics and Society addresses
problems that exist across the whole range of kinds of research, and moving into clinics,
and kinds of projects that NHGRI takes on. And this is from the strategic plan -- the
bench to bedside graphic that we have.
This is a slide that I was debating about putting it in or not. It was the first draft
of a slide. I didn't do the second draft, and I actually kind of liked -- right here.
It's very static, and what I was going to try to do was, like, move on and sort of show
how these changes would actually be made, make it more dynamic, more synthetic, more
holistic, but I actually sort of thought this might be a better way to stop the -- to just
have it only go this far at this point because this is where we are. These are the connections
that have to be made. This is a challenge. This is static at this point. I mean, yes,
there are, already existing, an enormous amount of work that goes on. ELSI Research Program
staff do not just work only on research. They do a lot of work. They have a lot of alliances
already with these groups, but I thought that this would be sort of just a historical point
to come back to in a year, and see if the next diagram has a more synergistic or holistic
appearance to it.
So the question is how do we get from what this looks like to an ideal of something more
integrated? And so that was part of the reason that the Genetics and Society working group
was established, and so the idea was that it would provide input about the ELSI Research
Program, and also talk very specifically -- and I'll talk a little bit more about that in
a second -- about how to think about the balance of ELSI Research initiatives, how they should
be put together, investigator-initiated versus program-initiated, and the best use of limited
budgetary and staff resources. I mean, that's an important theme that runs across this,
and that is that all of these changes at this point are taking place absent a -- we have
an acting director in Mark Guyer for the Genomics and Society Division, but we don't have a
permanent director, and the idea is that these changes are, at this point, taking place without
budgetary changes. So there's a lot of sort of conceptual work that needs to be made in
terms of thinking about priorities.
So also to -- that the working group should be able to help advise about things coming
down -- coming down the pike, what might be going on, policy landscape, genomic medicine,
and then this was -- this is one of the important things to identify ways that the new division
can work more effectively across NHGRI with the other -- the research and policy components,
and then also to think about synergy or collaboration between NHGRI and other institutes, and also
going out to national and international.
So this is -- one more, sorry -- identifies issues that are more appropriately -- this
is an important one -- more appropriately addressed by other NIH institutes, or other
agencies and organizations. And this has been one of the problems because as genetic and
genomic research has expanded, and has more and more institutes, and more and more people
are interested in taking this on and using it as a way to understand their particular
field, they also encounter more of the ELSI-related issues, but they have not -- the other institutes
have not themselves established an office to deal with ELSI issues. So that while it's
welcome and very encouraging that all of the other institutes have embraced this sort of
research, it is a burden on the ELSI Research staff to be the primary, if not sole, repository
of expertise on these issues vis-à-vis all of NIH.
So we put together a working group, and got some excellent people to serve. This is a
working group of council, and so there needs to be at least one member of council on it,
and there are three right now, including myself, and Amy, and David Williams. David and I are
rotating off fairly soon, so Amy will be [laughs] the representative. And this has been a great
group to work with so far. We've had some phone calls, and we've had some meetings.
The first meeting was in April, and what we did, more than one might expect for a group,
was really try to concentrate on explaining to them very basic facts about the organization
of NHGRI, and the relationship between ELSI and NHGRI and what the reorganization did,
so -- because part of what they will need to do initially has to do with sorting out
how to move the division forward, and that requires understanding the division -- the
place of the division within the institute. So we had talks by Mark Guyer, and Eric Green,
and Jean McEwen, and Joy Boyer about NHGRI reorganization, the goals and mandates of
the division, and the history and organization of challenges of the ELSI Program, and of
ELSI budget and finance.
So we spent the first day going over a lot of very basic things, and I don't think that
anybody in the group, other than those of us who are now on council, I don't think there's
anybody in the group who had been on council ever, meaning that some people had been on
study section, some people still are, but there was a need to have a lot of these conversations.
People were not really aware of a lot of the details.
So on the second day, we had two discussions to move this along, and the first one was
about talking about program priorities, research program priorities, and this is important
for several reasons, but partially because the way that priorities have been set in the
past has been primarily through the strategic planning process, and there's a sense that
it doesn't necessarily address the details of the ELSI mandate as closely as it should.
And so there was a lot of talk about how to figure out a better, more effective means
for creating ELSI Research Program priorities. And then we also talked about how to talk
about the evolving field of ELSI, how to improve the program balance between research-related
and service-oriented activities. This is at the crux of a lot of the challenge of moving
from just the ELSI Program to officially putting it inside of a division where the division
officially has the responsibilities for working with people who are working on policy and
things like that that are really not research activities, and so how do we handle that challenge
in a way that's appropriate, and that maintains the excellence of the research program?
And so one idea that the working group was proposing was to figure out how some of the
duties that have been taken on by the ELSI staff can be transferred out, and whether
or not there's a way to grow those skills more broadly, for instance, within NHGRI,
some of the skills that they bring to the conversation.
On the second day, we talked about how to integrate ELSI research into genomic research
and policy, and this is a part of the whole story because, again, as there is more and
more research being done on genomics, the question is what's the best way for ELSI to
track that, to parallel that. So you can have an embedded program where there -- members
of the research team who are ELSI-identified; you can have a parallel program where they
are funded through parallel RFAs. You can leave it to the R01 mechanism. So there are
a lot of different ways, and so whether there should be imbedded, independent, service-oriented,
scholarly; different modes of integrating ELSI research into genomics.
And then what we next started to talk about what how to assess the value of an embedded
ELSI component because there's been some success with this recently, and so is this a good
-- a good -- a good mechanism to use. And so we started to talk about, well, how would
you know? How would you know whether it's a good thing? And so we started to try to
talk about should there -- should we try to create a list of standardized questions that
could be applied for all new programs that would help the ELSI group assess what would
be the best way for ELSI to become integrated into various research programs. So we haven't
actually come up with a list yet, but the proposal is that we can. I mean, it will be
based on those -- the middle section. I think maybe Karen -- is Karen here, Rothenberg?
Yes, okay. So maybe Karen can speak to this a little bit more. This was the session that
she chaired. But these were some of the ideas that we came up with about how to -- how you
could go about trying to ask those questions and make those decisions.
So that was the second day, and we will move forward. We're having phone calls in between,
but the next time we can figure out a time to meet is in November, and in November, the
working group members themselves will start to do presentations. So the first time around
we really had the staff of ELSI and the staff of NHGRI in a -- in the role of educating
the members of the working group, and now the working group people themselves are going
to pair up and come up with their different assignments of the issues that we talked about
in those two discussions, and we're going to focus in on at least two areas and start
to decide how the working group can best address them, whether it will be through a set of
recommendations, through a report; we haven't exactly decided the mechanism. But this is
all -- so what we're focusing on now is the relationship between ELSI and the division,
and on ELSI and how to improve or how to have the priority setting process be as effective
as possible within ELSI. And then the goal, eventually, is to move on, and to have a much
more broad -- a broader sort of take on initiatives about how ELSI should be addressed. But this
is where we're starting.
And then the other things that we'll do at that meeting is that we'll get a report on
the ELSI training efforts which is important because the CEER Program is the first group's
-- first people who got their CEER -- first institutions to get their CEERs will be moving
out of that. It's just five years and five years and out, and so they've been very effective
as training mechanisms. So what -- I mean, yes, there are other ones being funded, but
what to do with those universities that have created some really excellent training programs.
Update on the division director search, and we'll also have presentations from Intramural
Program from the Communications in Education and Policy, and from the Bioethics Core Intramural
Program -- that's a typo. So the issue being, again, more of an educational piece so that
the working group members can have a sense of what the infrastructure is and what these
other offices are.
So I think this has gone very well so far, and I want to thank the ELSI and NHGRI leadership
and staff who have helped us out and been very, very generous with their time and their
resources. And any questions?
Eric Green: Okay. Thank you, Pamela.
Pamela Sankar: [affirmative]
Eric Green: Questions? Comments? Discussion? Amy, do you
want to -- as a member of the working group, do you want to add anything or --
Amy McGuire: No, I think that was -- I think that was very
helpful. It's a great group of people. I think the -- my understanding is that the goal is
for this to be kind of a longstanding group that, you know, we don't always get into the
weeds of the ELSI Program in this council meeting because the -- it's such a small portion
of the portfolio, so the idea is to kind of serve as an advisory council to the staff
for that program. So I think it's so far the first meeting -- Pamela did a great job, and
it was very -- it was very helpful, I think, for all the members.
Lon Cardon: Just a quick question out of interest. You
noted on one of the days you -- it was a discussion of one of the evolving interest points of
ELSI, and I just wanted to -- are there hot buttons that you came up with that you'd like
to share?
Pamela Sankar: What the conversation was about more was how
to standardize, or how to make the process of doing that --
Lon Cardon: Oh, okay.
Pamela Sankar: -- and how to integrate that so that that's
an ongoing capacity. But maybe Amy, or Karen, or anybody else has -- no. Okay.
Amy McGuire: I would just also say that I think the group
very much was in agreement that we would welcome sort of questions or direction from this group
in terms of our activities because I think -- you know, there's a lot of issues that
come up in terms of sort of there's this 5 percent set-aside, and it's kind of its own
autonomous, independent thing, but we're starting to see ELSI get integrated more into some
of these other programs outside of that set-aside budget, and thinking about how much to do
that, and where to do that, and what is appropriate, and so I think, as we get ready to meet in
November, past this meeting people have suggestions of things that they would like for us to tackle,
I think -- I don't mean to speak for you Pamela --
Pamela Sankar: No, no, no. That's --
Amy McGuire: I think the group is very --
Pamela Sankar: -- that's fine.
Amy McGuire: -- very open to --
Pamela Sankar: [affirmative]
Amy McGuire: -- getting feedback.
Eric Green: I'm -- I mean, I should also add maybe a few
things. I mean, keep in mind I've been very open about this -- creating this new division
from the beginning, and that this is sort of, you know, wet clay. Even some of the things
that you see from Pamela's presentation or hear me talk about before, there are some
ideas about how this new division can be something even beyond just the ELSI Research Program
classically defined, and, clearly, I -- I'm trying to set up an opportunity so that when
the first permanent director is identified, part of the attraction I would think of being
that individual would be to be able to create something and take this division in a direction
beyond what it has done traditionally in the ELSI Research Program, either within the ELSI
Research or things around it, or as other things that would fall under the general umbrella
of Genomics and Society.
So I -- part of my reason for wanting to get this working group up and going, and functional,
and interactive, and thinking about stuff is so that when a new director is -- you know,
the first director is identified, that individual now has a good group to immediately interact
with and to bring -- so I'm fully convinced that once a director's in place, there will
be things this working group will be doing that we can't anticipate right now.