NHGRI Division of Genomics and Society and the ELSI Research Program – Lawrence Brody
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NHGRI Division of Genomics and Society and the ELSI Research Program – Lawrence Brody

Lawrence Brody:
Okay, now my brother. Switching hats. Rudy Pozzatti:
Now Larry’s twin brother. I believe this came up in a council-initiated discussion from
a few rounds back, that once Larry was identified to fill the position of Division Director
for Genomic Society that you would like to hear a presentation about his thought for
the future research program in that division. And I think among other things Larry is going
to tell you about that. Lawrence Brody:
Okay. I don’t — I think I was here when the query for this came up, I don’t remember who
actually asked. It might have been you. Rudy Pozzatti:
Not sure. Was it? Lawrence Brody:
Okay. So I don’t have a brother, by the way. Two sisters. So what I thought I would do,
and I know that we’ve been here a long time, is give you kind of a brief flyover of the
division, because, although some of you have been here long enough to have heard this from
the point when Eric started the proposed reorganization to actually happening, I wasn’t involved in
most of that. So, and I know some of you are new. So I am now the division director for the
division of genomics society, I’ll talk a little bit about the mandate for the division
and talk about staff activities and some of the projections and some of where I see things
going. This is going to be relatively high level presentation, as opposed to getting
down into the portfolio and individual grants, and things like that. As some of you who have
been here for Eric’s tenure know, that the institute reorganized itself into several
different divisions. And you’ve just heard from people from the division of genomic sciences,
Teri just started the morning division of medicine, this is the division of genomics
in society, the vision that I have and at least shared with I think most of the people
in the genome institute is that this division really is wrapping around quite a few of the
others, and interconnected with the others. And that’s what I really, one of the goals
I’ve had since I started is to make that happen. I excluded the division of management
extramural operations because they’re more detail oriented. Really fortunate the four leaf clover was
because this division was set up and co-run for a year or so by Mark and Karen. And I
was really lucky because they basically — to all the people in the slide kind of stocked
the kitchen and set the table, and now we’re ready to go cooking. Mark and Karen are still around, they faded
a little bit more from where I’m sitting, but they’re still around and still available,
and that’s actually a major resource to have in case we have questions and Karen still
comes to staff meetings. The permanent staff for the division are our two long termers,
Gene McEwin [spelled phonetically] is in the back and Joy Boyer, and one relatively new
comer, Nicole, and Dave Hoffman, who is the newest person here. So these are your four
program directors for the program. And we’ve been recently joined by two new, who you met
earlier today, Alex Lee, and Annie Nehouse [spelled phonetically], who are program analysts
who split their time between our division and other divisions. So this is a pretty cool
team that I actually have. We have 40-some years’ worth of genome experience collected
on this slide, or more than 40-some years. There is also the GSWG, which if you’re wondering
what that is, Genomics in Society Working Group, which is attached to the division,
just as some of the other divisions have advisory working groups, and you will hear more in
a few minutes from Pamela Sankar [spelled phonetically] who is chairing the Genomic
in Society Working Group, that working group met and was formed before I started in the
division. So I — in fact my first day in the division was a meeting they had, and I
— was a very big immersion. You could think about the division from the
funding point of view, and if you looked at this kind of view, the dollars in the division
essentially the dollars mostly go into the ELSI grant portfolio, of the total dollars
associated with the division. That program, as you know, has about five percent set aside
from the extramural research budget, and just a little bit bigger than the small business
set aside and then 2014 was about 18 million dollars that went into extramural grants. This is what the grant portfolio looked like
if you added together for a couple of years’ worth. I just want to highlight that this
is the cumulative dollar amount, this is the amount that went into R01s p50s which I’ll
get to in a second, and R21s are this green slice of the pie. So we are more than half
investigator-initiated activities in this particular divisions. So it’s somewhat the
reciprocal of the rest of the institute. If you look at the number of grants, R01s
and R21s, which are relatively small grants, and there’s a — let’s see what color it
is — R03s, those wedges of the pie make up most of the grant numbers for this division.
Also note that these numbers are relatively small. We’re a small institute, it’s a small
division. 32 R1s, 12 R21s over this interval. If you — and Teri started with the pies and
the bars, I’ll stick with the pies and the bars. If you look at the different fiscal
years, this is how the grant funds are broken down. CEERs for those of you who don’t know
are Center for Excellence in ELSI Research, they were established about a decade ago — I
don’t know the exact date. These are infrastructure building training and some small pilot projects
type of work, so this would be into the RFA kind of category. The investigator initiated,
this gold pie as I mentioned is about 60 percent of the portfolio. There are other consortium
that are RFA-driven, some of which are not funded from the Genomic Society budget, they
are funded from other budgets, so at the ELSI program actually has more funds going into
it, mostly from these imbedded ELSI programs, some of which are funded by other divisions.
And so you can think of ELSI as having investigator initiated grants, this infrastructure and
training building that we have, and then as you’ve heard twice, and I think Phil also
mentioned it, that the field is mature enough and ELSI is well-known as a brand and as a
discipline, that they can get imbedded and built into these other programs as they go
forward. Sometimes the division contributes to that, sometimes the original person — or
the original group doing it funds those parts. This was to highlight where we stand, I’m
sure you’ve seen this slide before, there’s genome, and I highlighted in blue the CIDR
member institutes that my brother just talked about. Only to remind me to talk about trans-institute
efforts. And so on of the things that we’re pushing and that I’d like to push even further
is trans institute efforts in the ELSI realm, we already have several different institute
s that have signed on to our program announcement, and so you can find exactly their specific
questions on our website, the individuals in these blue institutes who oversee the CIDR
program, a lot of them are the same ones who oversee the ELSI portfolio, so we already
have a known in to most of these individuals. Part of the goal for the next couple of years
is to work with other institutes to have this be done in a more coherent fashion. One example that we are doing right now, and
I’ll leave the details out, is there’s a big institute doing a large clinical trial that
involves genomic testing, very, very obviously expensive clinical trial. We are now teaming
up with them to build an ELSI component — smaller ELSI component directly into that trial, so
we can find out, asking questions about what do people think about, what’s the best way
to deliver this information, and that’s going to go off with that other institute in a partnership. The other way to think of it is the funding
view of the entire NIH. This is not to scale, but I couldn’t fit the typeset in here if
I made the genome society budget to scale with the NIH budget. But we really hope to
be able to spread this wealth by taking the kind of questions we can come up with and
help the investigator with background, and the staff here to help the other institutes
to explore the areas when they either recognize it or when we point it out to them that they
really ought to take a look at some of these ELSI issues in their grant portfolios. Obviously,
neither of these are to scale. The other way to look at the division is staff
time. So this is roughly to scale, would estimate that the staff probably spends about 60 percent
of their time — or going forward once we’re at full strength, about 60 percent of their
time on grants management and the other is in these mandates that came with this written
in the charter, the division and I strongly support is to do other services. And I’ll
give you an example of what we’ve don’t just in the last couple of years, some of it in
the last couple of months. This is part of the mandate, we collaborate
with other extramural research divisions, that’s not been a problem, not been a problem
to collaborate with other divisions, especially the division of genomic medicine and the policy,
communications, and education branch, I would say that between Laura and Derick and Ben,
if he’s still here, in that branch, if we were any closer we’d be sharing toothbrushes.
Because we really spend a lot of time talking about what each other division, so there’s
no soloing when it comes to these divisions. We also do collaborations consulting with
other institutes, and I’ll just give a — and nationally, internationally, I’ll just give
an example of those. Oh, this is within NIH, within NHGRI there have been connections,
weekly meetings and joint meetings once a month with the policy, communication, and
education divisions, a fair bit of interaction. We have imbedded programs that are a part
of genomic medicine, and even genome sciences as you’ve heard a little bit is starting to
dip into ELSI to a certain extent. On the NIH as a whole we spend time talking
with the office of the director, office science policy. We do work with individuals in the
intramural research program. NIH has a bioethics department which is an intramural program,
but also has international and national outreach. And we actually in our own institute we have
a bioethics core, and we interact with all the people in each of these elements. These
are some of just the committees and consults that have been done in the last couple, some
of the six months, so the office of the director, I find myself in building one a lot, where
Francis’ office is in various capacities to help out, and NCI was doing stuff jointly
with us, these are consults that various people in the division were asked to weigh in so
you get a call from mental health, “We’re doing this program, we need some advice on
what to do in the particular ELSI component.” And the people in the division have also done
consults for AIDS research and boarding [spelled phonetically], other agencies, this is a fair
bit of time, to my surprise there is a fair bit of need out there for getting at least
some primer on ELSI issues. So a couple HHS secretaries came in and the FDA, CDC, those
are all within HHS. I spent some time with the FBI, DHS, air force,
army, doing consults and we also had some other people from policy go to some of those.
I went to one meeting that had no name tags and no attendee list, and it didn’t strike
me until afterward, that that was probably on purpose. I do have an email list, but — it’s
surprising having spent time with those that are interested in both the technology and
the ethical and legal issues related to genetics. And so if you think genetics is just medicine,
it’s not. These people are all wondering what to do with it. We’ve consulted with the Presidential Commission
on Bioethics, which is, weighs in on lots of these topics and Thursday I’m going to
talk to staffers at the senate building, and later in the fall we’ve been asked to take
part in a workshop that NASA is holding because they’re doing genomic sequencing on astronauts
who obviously are to be anonymous. And they’re interested in what some of the issues are. We also work with non-governmental organizations.
A fair number of U.S. and foreign academic institutions call the program and say, “We
need help with this particular grant or this particular informed consent style,” so this
is the consult kind of activity. These are a couple of other organizations
that the staff have worked with. They worked with ASHG, The Genetic Alliance, National
Congress of American Indians, and now Global Alliance for Genomic Health. So we’re starting
to have the, ELSI clearly has an established brand, it is and established discipline, the
division is starting to have the same kind of thing in a slightly different way. So that
will lead us to trying to work on the balance, balance within the grant portfolio, I personally
think it’s pretty close to where it should be, but this is not my decision alone. I think
it would be hard to answer some of these ELSI questions on the timescale it takes to do
concept clearance, RFAs, reviews, and cycle through all of that. There is a discussion as to how much ELSI
research should be imbedded versus free standing and there’s advocates of both sides. I really
like the imbedded model and there’s other who say that may lead to a conflict, obviously
if we do both we don’t have to worry about choosing sides, but how much in each realm. And then on of the other goals is, how much
time do we spend on ELSI research done by other research institutes, who in theory will
be the people who will get all the credit? I’m not worried about credit, I’m worried
about getting the answers right, and you could imagine if the FBI gets something terrible
wrong about genetics, the whole field is going to pay, so we want to make sure that we get
all of that done correctly. Some of the goals that I mentioned that I
will be pushing for the next couple of years is expand the base of what I’d call magnetism.
People just either are attracted to it or they realize they need it. I think that’s
different form going out and saying, you do this, and that’s just not my style, and it’s
probably not the best way to get things done. So far there have been a lot of traction in
people saying, “Yes, we’d like to get together and talk about what the issues are in the
ELSI area.” We, as mentioned — Pamela briefly mentioned this — we probably need to increase
the volume of investigators initiated grants that go through the study session, I’d like
to widen the trainee pipeline as the amount of ELSI research gets done is expanding, we’re
suddenly realizing that the pipework of trainees that we build ten, fifteen years ago, there’s
not enough of them to deal with the new research. So we probably have to slowly open up the
spigot a little bit on the training pipeline. Clearly with strategic plan there’s a lot
of issues related to genomic medicine that fall into the preview of this division. And
this is a difficult one to do in a really tactical way or strategic way, but we hope
that the division itself can increase international cooperation and either find out what’s going
on elsewhere, or at least let them know what we’re doing here. And so those would be the goals that I have
for the next couple of years. That’s all I prepared, I don’t know if I addressed the
issues that you guys wanted to hear about, but I’m still here and willing to do that. Rudy Pozzatti:
Questions for Larry? Bob. Robert Nussbaum:
Larry I’m wondering if you could, you had a long list of all the various agencies that
you’ve interacted with, including the anonymous, and I’m wondering about OHRP, and the role,
the extent to which your office is involved in informing OHRP which then perhaps or not
disseminates out to all the individual IRBs about genomics in particular. Lawrence Brody:
It’s a good question, I’d have to say since we’ve been doing this for about ten months
now, and I have not personally interacted with OHRP. And maybe I don’t know if any of
the staff want to talk about past interactions with them. Gene it looks like she wants to
stand up, but– [inaudible commentary] Robert Nussbaum:
You know, I bring it up because I’ve heard from a number of IRBs that they feel a lack
of guidance and educational material from OHRP central to help the deal with the approval
of, or the evaluation of human experimentation, or applications involved in genomics. Lawrence Brody:
In genomics in general, not even really high-end stuff. I can address one thing that came up
when we, when I started it was asked within the first month, do we have a database of
good protocols, or examples, and I said that this divisions does do that, but the division
of policy for communication and education does it, and that website’s almost revamped,
but I don’t think it’s ready to launch, we’ll be launching shortly. So that’s — [inaudible commentary] Lawrence Brody:
Tomorrow. Female Speaker:
That’s what I was going to say too, is that we do have a lot of interactions with OHRP,
but most of them are indirect because a lot of it goes through the policy office because
we work closely with them we do have input. Lawrence Brody:
But that’s a, I take that suggestion pretty seriously, it’s a good one. We could look
at, we are helping some of, the office of the director has a bioethics grant portfolio,
and we are helping chip into that and they’re, one of their focus is can we have central
IRPs. Which I know for anyone who’s done a multicenter study would really like. Cathleen? Kathleen Calzone:
I wonder if you had any interaction with the VA? Lawrence Brody:
We have not, is Teri still here? Oh there she is. So the institute has — and one of
the things we try not to do is there is a lot of overlap, and so when we have one person
dealing with the VA. We don’t have another, so I don’t know if you want to address… [inaudible commentary] Teri Manolio:
We’ve had a number of interactions with the VA, mainly with, around a number of studies
that we’re planning and discussing, nothing in regard to this in particular, but, I don’t
know what the specific question was. Kathleen Calzone:
Million veterans? Teri Manolio:
So yeah we interact mainly on a consultative basis, Bob, actually, I believe, is still
on their advisory board, and so we get consultations from Bob as well. But they’ll sometimes contact
us about what type of platform to use, things like that. Beyond that, they’re not looking
for a lot of advice and we’re here to help them, but we can’t really barge in on their
program. I don’t know, Bob, if you wanted to comment on that? Robert Nussbaum:
There’s actually been precious little discussion oh ELSI issues that the million veterans’
advisory committee truly focused on. Recruitment, technical issues, consent to some extent,
so I take that back, they have talked about consent, but there are a lot of other issues
that have really not been approached. Amy McGuire:
Yeah, so thank you, Larry. So I feel like a theme for today is sort of this idea of
trying to drum up co-sponsorship from other institutes and looking for additional funding
sources, and it sounds like the Genomics in Society Group, division, is interested in
that too, and thinks that it’s important. And we’ve had a lot of conversations about
that in the past, and I know that there’s been some difficulty in getting other institutes
to dedicate money to this type of research. Is there a plan in place, or what’s kind of
the strategy going forward with regard to that, and the –? Lawrence Brody:
So it’s a retail strategy where you go wither by a particular project, or go through a contact
at a given institute. So there’s two ways that you can do it: you can add something
to a project that they already have, or we can have them add money into grants that come
though study session. The staff has spent — Joy and Gene have spent a lot of time cultivating
the institutes that like to say we’ll sign on to the announcement as our grants come
though we’ll look and see if we’ll fund them. So that, I don’t know how much more we can
push that because some of the institutes are resistant. The — when it’s in their own self-interest,
to expand this and do it not to reinvent the wheel that seems an easier opening that usually
is in the context of existing projects, or projects that are on the drawing board. And
so those outreach to the ICs, and we have a list of every IC and every person who we
have that is a contact and some scores next to them as to how amenable they are too. That’s
something that we’ll revisit on a cycling basis. There isn’t really a stick that you can do
unless it comes from building one that you can say, “You will do this across the campus.”
So it has to all be done voluntary, and usually it’s done by personal relationships, or people
coming to us because we have the brand and they know that we have the expertise. Don’t
have a systematic stick to do that. Chanita Hughes Halbert:
Okay, thanks, Larry. Your presentation was really informative to help give us the sense
of the extensive amount of consultations that your division does and I’ll just say is very
extensive. What I was wondering about was for your goals slide, and I guess I’ll ask
it in two different ways. For your goals slide, how would you prioritize goals in terms of
what you want to achieve for the division? And then relatedly, consultation is I think
a very important and useful activity, but I was wondering about if within the division
you all have articulated a specific set of scientific goals and priorities. Like the
genomic medicine sequencing, that kind of stuff, sort of making society issues related
to those kind of broad areas. Lawrence Brody:
So as you heard in the morning, this is a cross cutting type thing, and when we do map,
we do have that, and I took those slides out because they’re incredibly complicated when
you have the strategic plan going this way and the things cross cutting that way. We
are planning and it’s kind of a — bullet point four is to really align it to the strategic
plan to a certain degree, but also to retain the flexibility if things emerge that we didn’t
think about. And I probably — this is my knee speaking — I’m probably more pragmatic
about taking on practical issues, and I’ll give you an example in that we had a real
strong interest from someone in looking at a new pre-implantation diagnosis technique
that was going to cost $50,000 a shot, but could be really technically amazing. We had
someone who was going to look into whether or not noninvasive prenatal testing was going
to be offered to every woman of any age regardless of risk status. I think that one — the one
with my right hand would have bigger impact, but when you’re running an investigator initiated
program, they have to some through the study session to be scored. So we can — and part of what I do is I go
around and talk to people and encourage them to submit applications, but I don’t highly,
this is not a micromanaged portfolio, because we have to be able to fund things as they
emerge, so we mapped the alignment, if we don’t get applications in specific areas,
we can take some of the budget and carve it off into an RFA to help manage that. If I
do that right now we’ll be eating into the investigator initiated a little bit too much. Carol Bult:
So, Larry, are there specific initiatives directed at bringing in the perspective of
patient advocacy groups into the ELSI discussions around genomic medicine? Lawrence Brody:
Initiatives that we’ve funded, or just that it’s done in a lot of places because it’s
been thought to be a good idea? You mean do we fund, I don’t know if we funded in the
last couple of months, and I’ll look to the folks in the back to know if we’ve funded
in the past, investigation into the role of having patient advocate’s representatives
present. Okay. I can say I’ve been on review panels when
they have been present and it’s been very cool. Rudy Pozzatti:
Other questions for Larry? All right, thank you very much, Larry, and let’s move along
to Pamela Sankar’s presentation about the genomics in society.

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