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Report of a Symposium and Workshop
Annual Meeting of the American Association for the Advancement of Science
February 15, 1998 Philadelphia, Pennsylvania
EXECUTIVE
SUMMARY*
Introduction
In 1991, a project was proposed
by an international group of scientists to collect and store DNA information
from indigenous populations from around the world. This Human Genome Diversity
Project (HGDP) was intended to provide insight into the evolutionary history
of the human race and certain populations' susceptibilities to diseases. What
the project planners did not expect was an onslaught of criticism from the
indigenous groups. Just as the HGDP was getting underway, tribes from around
the world issued statements summarily denouncing the project and declaring
their refusal to participate. In response to these criticisms, members of
the North American Regional Committee of the HGDP organized a working group
to assess the ethical and legal issues of the project. The group produced
a Model Ethical Protocol (MEP) to guide discussions of ethical and legal issues
implicated in sample collection and to serve as a frame of reference for investigators,
Institutional Review Boards (IRBs), and potential funders.
The American Association for the Advancement
of Science (AAAS) organized a special one-day event at its February 1998 Annual
Meeting in Philadelphia, PA to address the cross-cultural ethical, legal,
and social issues associated with implementation of the proposed Human Genome
Diversity Project (HGDP). The event consisted of a morning symposium, which
included five formal presentations covering the nature and goals of the HGDP,
the issues it raises, and the role of the Model Ethical Protocol in guiding
and evaluating the research that would be carried out under the banner of
the HGDP. This was followed by a three-hour afternoon workshop convened to
address the controversies raised by the HGDP and to explore in an open forum
whether the provisions of the MEP adequately addresses those concerns. The
workshop participants included members of potentially affected populations,
members of the scientific community, journalists, and other interested persons
attending the AAAS Annual Meeting, which typically attracts a diverse, multidisciplinary
audience. In addition, four people representing the target research populations
of the HGDP were invited to attend this one-day event and contribute their
own perspectives to the proceedings. The workshop dialogue was able to bring
together differing points of view and, though no final consensus was reached
or intended, inferences can be made from the participants' reactions to both
the HGDP and the MEP.
The concerns raised by the indigenous groups
can be categorized into three main types of issues. First, concerns related
to the procedures for the collection and retention of DNA samples from the
study populations. Second, those pertaining to the intellectual property of
the communities sampled and the commercial exploitation of products developed
from the HGDP. And third, a concern about the potential uses and abuses of
the knowledge produced by the project, with fears that genetic information
could be used to foster prejudices or otherwise threaten the well-being of
the sampled populations. Failure to resolve the issues that have surfaced
during the early planning stages of the HGDP has created tension between scientists
and those they wish to study. It is important for the HGDP in particular,
and for science in general, to improve everyone's understanding of those issues,
to identify where differences exist, and to seek collaborative responses to
them. The sessions at the AAAS Annual Meeting were intended to be a step in
this direction.
The
Model Ethical Protocol
In response to the heavy criticism and to meet
head on the ethical challenges posed by the HGDP, the North American Regional
Committee prepared a Protocol for collecting DNA samples. (For the most recent
draft see http://www.stanford.edu/group/morrinst/Protocol.html)
The proposed Protocol deals with the ethical and legal issues that are raised
when DNA is collected from populations, not individuals, especially when those
populations may be scientifically illiterate and politically vulnerable. Although
the MEP is primarily intended to guide HGDP research conducted in North America,
it is likely to influence research practices in other parts of the world as
well. The current version has been formulated over the course of two years
and has not been adopted by either the North American Regional Committee (NARC),
the other regional committees of the HGDP, or the HGDP's international executive
committee; comments are still being sought.
The MEP is aimed at several audiences. First,
for scientists involved in the HGDP, the MEP presents "important principles
and rules, to show researchers non-obvious issues that may arise, and to discuss
usefully the complexities that may confront them in the field." Second, for
populations participating in the project, it should help them understand some
of the possible implications of participating, and give them more of a voice
in the project's implementation. Third, the MEP should be useful to IRBs or
other groups that review human subjects research in judging whether proposed
research projects have given sufficient consideration to the ethical issues
their work may raise, and whether their plans for informed consent are appropriate.
And fourth, the MEP is meant to guide the work of the NARC, such that activities
within North America or sponsored by North American institutions will not
be accepted as part of the HGDP unless they comply with these guidelines.
The NARC offers to provide assistance to scientists participating in the project
needing help in implementing the procedures set forth in the Protocol. The
three fundamental principles embedded in the MEP are: (1) informed consent;
(2) respect for the participating population's culture; and (3) adherence
to international standards of human rights. Considerable emphasis is placed
on explaining the nature and goals of the project to the potentially involved
communities, in the language appropriate for the population and in terms that
are relevant to its culture, and engaging them as partners in planning and
carrying out the research and not just as research subjects.
Other matters covered in the MEP include: the
selection of populations for inclusion in the project, including procedures
for contacting them; informed consent at both the individual and community
levels; concerns related to providing benefits, including medical services
produced by the project for use by the participating populations, and the
need to be sensitive to the fine line between an appropriate return for the
community's participation and inappropriate inducement that can vitiate the
community's informed consent; challenges to privacy and confidentiality for
both individuals and the community; education aimed at preempting efforts
to use the findings of the HGDP to promote prejudices related to race, ethnicity,
or religion; matters relating to ownership and control over the data collected
by the project; the partnering relationship that researchers should strive
to create between themselves and the communities that they study, which should
provide for the populations' involvement in the planning and conduct of the
research and include a plan for apprising them of the research results.
Symposium
The five speakers in the morning session addressed
different aspects of the HGDP and MEP. The symposium began with Kenneth K.
Kidd, Professor of Genetics, Psychiatry and Biology at Yale University School
of Medicine. He addressed the need for a HGDP, the scientific goals and possible
health benefits that could be derived from such a project, and some scientific
data and theories originating from current and past investigations of HGDP-type
research. He was followed by Frank C. Dukepoo, a Native American Geneticist
of Hope and Launa heritage in the Department of Biological Sciences at Northern
Arizona University. His talk offered a cultural context for assessing the
various arguments in support of and in opposition to the HGDP as expressed
by indigenous populations. The third speaker, Henry T. Greely, Professor of
Law at Stanford University Law School, who chaired the North American Regional
Committee of the HGDP, gave a presentation on the Model Ethical Protocol.
He reviewed some of the history behind its development, described the process
by which it has evolved, and highlighted its main provisions. A summary of
the assessment by the National Research Council of the National Academy of
Sciences of the type of research proposed by the HGDP was then presented by
the Chair of its Committee on Human Genome Diversity, William J. Schull, who
is Director of the Human Genetics Center at the University of Texas Health
Science Center, Houston. In the concluding presentation, Charles E. Riggs,
Jr., Associate Professor in the Department of Internal Medicine, University
of Iowa, addressed the issues related to the HGDP that would most likely be
scrutinized by an IRB.
Workshop
With the symposium as background, the afternoon
workshop examined more closely the ethical and social issues surrounding the
HGDP, the MEP as a source of ethical guidance to HGDP researchers and funders,
and the participation of study populations and scientists in the Protocol's
development and implementation. The workshop included three speakers from
the morning symposium as panelists (Frank C. Dukepoo, Henry T. Greely, and
Charles E. Riggs, Jr.) along with a moderator from AAAS. There were no formal
presentations; instead, an open exchange of views between the participants
and panelists was encouraged.
During the three-hour workshop many topics were
touched upon concerning both the ethics of HGDP research and whether the MEP
adequately addresses the issues that have arisen. Though the discussions followed
a path that ran freely from one question to the next, several main themes
emerged. These included: the expected or hoped for effect of the MEP; the
difficulties in obtaining informed consent; the benefits versus risks for
populations and individuals; potential involvement of the pharmaceuticals
and biotech industry; the compliance with and enforceability of the Protocol's
provisions; and the assessment and future status of the MEP.
It appears that the MEP has to a limited extent
already helped raise the standards of research practices in population genomic
studies, and has the potential to have a far greater impact in the future
if the HGDP goes forward or if it becomes more widely known and applied to
community research on its own merits. Nevertheless, whether the MEP goes far
enough, at least in the view of the target populations, remains uncertain,
and many groups continue to say that it does not. Some groups feel that the
members of the HGDP are making a sincere effort to address their concerns,
but the lack of basic enforcement mechanisms still remains a serious issue.
As reflected in the comments during the workshop, for certain groups there
may simply never be an acceptable research protocol. One of the main points
made during both the course of the morning and afternoon sessions was that,
whatever the decision of the population may be, it must be respected and accepted.
The scientific interests at stake always come secondary to those of the populations.
If a population does not wish to participate in the research then it must
be left alone.
It was pointed out during the workshop that perhaps
one of the greatest barriers to indigenous populations' involvement in the
HGDP is their complete lack of interest in the stated goals of the project.
Their understandable priority continues to be basic human rights, such as
access to improved health care, to better guarantee their own well-being and
survival. As stated in the Declaration of Indigenous Peoples of the Western
Hemisphere Regarding the HGDP (1995), "we demand that scientific endeavors
and resources be prioritized to support and improve social, economic and environmental
conditions of indigenous peoples in their environments, thereby improving
health conditions and raising the overall quality of life." Indeed, what benefits
might arise from the HGDP appear to be far removed from these priorities.
The HGDP's interest in evolution and history
is likely to often run contrary to some peoples differing perspectives of
their own histories and evolutions. Groups want to protect their own understanding
of who they are. They do not welcome the prospect of having their origin stories
corrected through genetic reductionism. It can already be predicted that the
outcomes of many studies will suggest that the received mythological charters
for some groups' identities are mistaken, and such findings could have a serious
impact on their sense of self worth and identity. Indigenous populations believe
that their origins are their own concept, which can be difficult for Western
scientists to understand.
Frank Dukepoo informed participants that the
Akwesasne Task Force on the Environment had written its own Protocol for Review
of Environmental and Scientific Research Proposals. This document was created
because the number of research projects being proposed by scientists was increasing
and the Akwesasne community wanted to protect itself and its future generations.
The protocol states that the review process for research projects "should
not be viewed in a negative way or be seen as an impediment to research. It
has been developed to serve as a guide to improve relations between the community
of Akwesasne and the scientists/researchers and to promote collaboration within
a framework of mutual trust and cooperation." This language is reminiscent
of the partnership concept in the MEP. The difference between the two is that
the Akwesasne Protocol goes one step further than the MEP in its required
level of community involvement and in the population's control of the research
and its results. Many scientists will find these guidelines to be a significant
departure from how they have conducted their investigations in the past. Whether
researchers will be willing to abide by such strict requirements remains to
be determined.
One of the greatest weaknesses of the MEP identified
during the workshop discussion is the lack of any mechanisms for assessment,
compliance and enforcement. Although regulations on research practices currently
exist, reported transgressions against research subjects continue to occur.
For investigations based in research institutions, as would most likely be
the case for the HGDP, it was pointed out by Charles Riggs during the symposium,
that much depends upon the tenor of the institution and the tenacity of the
chair and other members of the IRB. This creates some concern, since the IRB
system is currently under criticism for gaps in its capacity for protecting
subjects. And although the education of IRBs and funding agencies, as well
as new regulations, were suggested as necessary steps, no clear resolution
to this problem appears to be on the horizon.
The future of both the HGDP and the MEP in North
America is uncertain at this stage. As Henry Greely noted during the workshop,
the project is at a critical point as to whether it will proceed. The objections
of the indigenous populations appear to be as strong as ever despite attempts
by the NARC to address their concerns in the MEP. In the end, however, the
fate of the HGDP as a coordinated, systematic effort will likely be determined
by the funding agencies. Even if it does not come to fruition in its current
manifestation, it has brought serious ethical issues associated with population
genomic research to the attention of scientists, funding agencies, and the
public. Its legacy may well be that it has helped raise the consciousness
and sensitivity of scientists to the implications of their research on indigenous
populations.
Conclusion
The primary focus of the AAAS symposium and workshop
was on the MEP and its promise for addressing the ethical concerns that have
arisen as a response to the proposed HGDP. Although the MEP would only guide
investigations conducted in North America, it might also influence researchers
elsewhere around the world and eventually be adopted by other HGDP regional
committees. Its fate in North America, therefore, bears watching elsewhere
by those with a stake in the fortunes of the HGDP.
For more information,
contact: Mark
S. Frankel, Director, Scientific
Freedom, Responsibility and Law Program, AAAS, 1200 New York Avenue,
NW, Washington, DC 20005; ph. 202.326.6793; fax 202.289.4950
* The full report can be obtained here.
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