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Aaron Goldenberg: It was a news story, and they interviewed
a mom who had two sons. Her husband had died of Huntington's disease, and she had two sons.
And they asked her whether or not she wanted to get them tested, and she said that she
had wanted -- that she didn't want to get them tested, and that one of her reasons was
because -- and she said this in a joking way -- she only had enough money to send one of
them to college.
James Watson: The last thing I'd like to say is that as
we get this -- these genetic messages, there will be ethical considerations that will come
up. And in sort of helping to lead this program, I want to place considerable emphasis that
as we accumulate this knowledge, that the public is protected from misuse.
Aaron Goldenberg: The screen kind of went black at that point,
and I -- it immediately hit me. And I said, "This is -- there's a lot here."
Jean McEwen: The fact that genetic information is inherently
predictive, so that, you know, our DNA tells us some things about what may happen to us
in the future.
James Watson: I think from the very start, NIH initiate
discussions so that as this knowledge is accumulated, the public is prepared to deal with it.
Aaron Goldenberg: There's something here that needs to be talked
about, that needs to be brought out, that there are implications of genetic research
that maybe go beyond the ways that we typically think of science and technology, and the integration
of those sciences into clinical applications.
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Robert Cook-Deegan: When Jim Watson, at his press conference,
who announced his becoming the director of the then Office of Human Genome Research,
kind of sprung on the NIH administration that he was going to devote a certain fraction
of his budget to thinking about the ethical and social implications of doing the science
and applying the science, that seemed like it was kind of a natural decision to make.
Nancy Wexler: I thought that Jim Watson, really, was the
only human being on the planet that could have done it because Jim had the most impeccable
molecular credentials. You know, nobody would accuse him of being a soft scientist.
Patricia King: I thought it was -- I thought it was a great
idea that Jim Watson saw, at the very outset, the need to spend money, thinking hard and
seriously about legal, ethical, and social issues.
Jean McEwen: The ELSI program was established at the beginning
of the Human Genome Project to basically anticipate and address the ethical, legal, and social
issues that would be coming up as a result of the genetic research, to try to anticipate
them before they actually arose so that we can come up with policy options to address
them.
Patricia King: And I thought it was about time.
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Jean McEwen: Basically, almost from the beginning, 5 percent
of the extramural research budget at the Genome Institution has been set aside for the ELSI
program to conduct this kind of research.
Joy Boyer: The ELSI Research Program, since 1990, has
a cumulative budget of about $300 million, and that goes through 2012. So that's 22 years.
Over that time, we've funded 470-ish individual projects.
Jean McEwen: A lot of the research that the ELSI program
supports is really geared toward providing sort of an evidence base on which we can develop
really good policy options to address these kinds of issues, both policy options for the
research community, in terms of how the research is conducted; policy options for the clinical
community, in terms of how the information is used in the clinic; and also broader social
policy, the ways that genetic information can and will be used in various other parts
of society.
Karen Rothenberg: It's supported the ability to study those
questions empirically, quantitatively, qualitatively, and with that, I think that's enabled the
science to move forward without being subject to moratoriums.
Joy Boyer: The ELSI program is really a research program.
And so we fund research that informs those discussions. I think the discussions take
place naturally. You know, people are concerned about these issues. And what the ELSI research
program does is it actually funds researchers to produce data.
Wylie Burke: The availability of research funding made
it much more possible to pursue many ELSI questions empirically, and that has added,
in a very important way, to the kind of data, to the richness of the data we have available,
to think about what we call "ELSI questions." I think the ELSI research program is a model
for NIH.
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Jean McEwen: Supporting research is really just a part
of what we do in the ELSI program. The other big part of what we do is that we really serve
as sort of ELSI consultants to the other people in the extramural division at the Genome Institute,
advising them on a lot of the big community resource genomics projects that are underway.
Some examples would be the International HapMap Project, the 1,000 Genomes Project. Now the
-- you know, some of the Common Fund projects that NHGRI is heavily involved in.
Joy Boyer: I think the ELSI program is often called on
to provide expertise in the development of new projects. And I think that's become much
more prevalent over the last several years. And the way -- the way it usually works is
one of the program directors who's handling one of the projects, be it HapMap, or Human
Microbiome Project, or 1,000 Genomes, actually approaches one of us and says, "You know,
I think there may be an issue here that might be problematic, and we'd like your input on
how to handle it."
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Mildred Cho: I think that ELSI issues are actually really
accessible to members of the general public, perhaps even more so than the more technical
issues around genomics research or biomedical research, because people, I think, have an
intuitive sense of the existence of ethical questions, and perhaps have had their own
experiences that lead them to raise those ethical questions on their own.
Robert Cook-Deegan: Everybody has, I think, a tighter grasp or
a more intuitive grasp, I think, many times of what we call the ELSI issues than they
do of the science itself, although they immediately see the linkages between this fast movement
of the new technologies and the ethical issues that they're going to pose as you use those
tools in the real word.
Mildred Cho: And a lot of the questions come up, because
for both the medical conditions and the things that we think of less traditionally as medical
conditions, they're very hard to define. So it's hard to define things like "intelligence."
What does that mean?
Robert Cook-Deegan: They're going to find that the questions are
going to get asked are not, "How do you sequence DNA?" but "How are we going to make sense
of all that stuff? And if this DNA stuff really matters, does it mean I'm going to get sick,"
or -- "And if I'm going to get sick, how am I going to know that?" and "Who's going to
tell me that?"
Mildred Cho: I think a lot of the questions that are raised
about genomics and its application and research generally are more -- perhaps more pointed
when you talk about traits such as behavior, which are sometimes thought of as being part
of health care and sometimes not. And so one of the reasons why we're interested in behavior,
defined broadly, is because the ethical issues and the social issues.
Wylie Burke: How much do people understand about ELSI issues?
My sense of it is that there is a lot of common sense understanding of the difficulties that
we deal with in ELSI. There's a lot of intuitive thinking about it, not necessarily informed
by a lot of sophisticated science understanding, but a common sense understanding.
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Robert Cook-Deegan: That's another legacy of NHGRI, is that when
you do all this super cool science, you have a research program to think about it, and
also a social network that connects that research to the people doing the science, and doing
the applications, and doing the translational work. I don't think other parts of NIH or
other parts of the federal government have done as good a job of that as in NHGRI.
Wylie Burke: NHGRI has played a tremendously important
role, I think, in research around bioethics, around policy-relevant questions, around social
implications of science. By having a designated ELSI program, they created an opportunity
for researchers to pursue questions, but I think equally important, to expand the scope.
Joy Boyer: I think the greatest success is really establishing
this community of researchers, establishing the expertise in this area, because I think
that expertise, regardless of the research that's done, is having a big impact on genomic
research, and I think on all research.
Eric Juengst: I think the Human Genome Institute has had
a critical role in creating this community of scholars, now going into its second generation,
as our trainees come online, of people who take as their academic vocation, paying serious
attention to the questions that genomic research raises.
Karen Rothenberg: The NHGRI and the NIH are seen as the international
leaders with respect to looking at the ethical, legal, and social implications of genetics
and genomics. We set the bar for the world.
Robert Cook-Deegan: So, in a way, the U.S., probably without being
fully conscious about it, what became the NHGRI also became the model for how to do
ELSI research at these other places all over the world.
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