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Environmental
Health Perspectives Supplements Volume 110, Number 2, April 2002
Community Involvement in the Ethical Review of Genetic Research: Lessons
from American Indian and Alaska Native Populations
Richard R. Sharp1,2 and Morris W. Foster3
1National Institute of Environmental Health Sciences, National
Institutes of Health, Research Triangle Park, North Carolina, USA; 2Center
for the Study of Medical Ethics and Humanities, Duke University, Durham,
North Carolina, USA; 3Department of Anthropology, University
of Oklahoma, Norman, Oklahoma, USA
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Abstract
The National Bioethics Advisory Commission has proposed that regulatory
oversight for research with human subjects be extended beyond the protection
of individual research participants to include the protection of social
groups. To accomplish this, the commission recommends that investigators
and ethics review boards a) work directly with community representatives
to develop study methods that minimize potential group harms, b)
discuss group implications as part of the informed consent process, and
c) consider group harms in reporting research results. We examine
the utility of these recommendations in the context of research with American
Indian and Alaska Native communities. Because much attention has been
given to the question of how best to consult with members of these communities
in the design and conduct of research, we believe it behooves investigators
to consider the lessons to be learned from research involving American
Indians and Alaska Natives. After describing several difficulties surrounding
the application of the commission's approach to these research contexts,
we propose a research agenda to develop best practices for working with
local communities in the ethical assessment of epidemiologic and environmental
health research. Key words: ethics, indigenous populations, informed
consent, participatory research, research oversight. Environ Health
Perspect 110(suppl 2):145-148 (2002).
http://ehpnet1.niehs.nih.gov/docs/2002/suppl-2/145-148sharp/abstract.html
This article is part of the monograph Advancing Environmental
Justice through Community-Based Participatory Research.
Address correspondence to R.R. Sharp, NIEHS, PO Box
12233, Research Triangle Park, NC 27709-2233 USA. Telephone: (919) 541-3489.
Fax: (919) 541-4397. E-mail: sharp@niehs.nih.gov
The views expressed in this paper represent the opinions
of the authors alone and may not represent the positions of either the
National Institute of Environmental Health Sciences (NIEHS) or the National
Institutes of Health (NIH). Research was supported in part by the Division
of Intramural Research at NIEHS (RS) and NIH grant HG010302 (MF). The
authors thank M. Davis and M. Yudell for their helpful comments on earlier
versions of the paper.
Received 13 August 2001; accepted 6 February 2002.
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Introduction
Environmental health research can present challenges to institutional review
boards (IRBs) and others charged with protecting the rights and welfare of research
participants (1). Existing regulatory guidelines on research involving
human subjects were developed primarily for clinical investigations, making
their application to epidemiologic and community-based research problematic
(2). Where epidemiologic studies present limited risks to participants,
for example, clinical standards for informed consent may be inappropriate (3).
Conversely, in community-based studies that present risks to all community members,
existing regulatory standards focused on the protection of individual research
subjects may be insufficient (4).
Concerns of this second sort--that is, concerns about research-related harm
to identifiable communities--have been spurred on by advances in genetic technologies
(5). Studies of human genetic variation can present risks to all members
of a social group, not just those individuals who choose to participate in research
(6). Findings that associate an ethnic group with a genetic predisposition
to disease, for example, could lead to group discrimination or stigmatization
(7). Such risks have been the subject of much discussion surrounding
studies of the so-called breast cancer genes BRCA1 and BRCA2,
as some polymorphisms in these genes appear to be more common among persons
of Jewish ancestry, specifically Ashkenazi Jews (8). This finding creates
the possibility that all Ashkenazi Jews may be asked to pay higher insurance
premiums or face other more subtle forms of discrimination on the basis of the
apparent association between these genetic variants and increased risk of developing
breast cancer (9). These collective risks are not unique to genetic research,
however (10). Studies of population-specific characteristics, research
on stigmatizing behaviors in a particular community, or the identification of
local environmental contaminants can present risks to all members of a study
population. Nonetheless, current federal regulations governing research with
human subjects do not require researchers or ethics review boards to consider
potential harm to nonparticipants (11).
In response to this apparent regulatory gap, the National Bioethics Advisory
Commission (NBAC), a presidential commission on the protection of human subjects
in research, has proposed that regulatory oversight be extended to include the
protection of social groups (12). The NBAC recommendations, presented
in the report, "Research Involving Human Biological Materials: Ethical Issues
and Policy Guidance," maintain that in addition to considering potential risks
to individual research volunteers, investigators and review boards should consider
how to minimize group harms (Recommendation [Rec.] 17). When significant risk
to an identifiable community can be identified before a study has begun, the
commission suggests that researchers work directly with community representatives
to develop study methods that minimize the potential for harm (Rec. 17) and
discuss collective risks as part of the informed consent process (Rec. 18).
The commission also recommends that in reporting research results, investigators
and journal editors consider potential implications for social groups (Rec.
19).
The NBAC recommendations, if adopted by investigators and ethics review committees,
would significantly extend regulatory perspectives beyond their present focus
on risks to individual participants. Like other commentators on the protection
of human subjects in research (13-15), we support this regulatory
expansion. Developing additional oversight policies designed to protect identifiable
groups is an important part of acknowledging the broader social implications
of contemporary biomedical research and the need to think more expansively about
the consequences of research practices. Nonetheless, we also recognize that
soliciting community views regarding ethical conduct and responsible research
practices can be difficult (16,17).
In this article we describe some of the benefits and challenges of directly
involving communities in the ethical review of research. The analysis we propose
focuses on genetic research with American Indian and Alaska Native communities,
as several participatory models have been tried in these contexts (18).
We believe these experiences with indigenous communities can illuminate broader
ethical issues and practical challenges present in research studies involving
other historically disadvantaged communities. Because there have been few successful
examples of direct consultation with communities in the design of appropriate
ethical protections, we also propose a research agenda to develop best practices
for consulting local communities regarding the ethical conduct of epidemiologic
and environmental health research.
Protecting Communities from Research-Related Harm
As noted above, existing regulatory policies and ethical guidelines concentrate
on immediate risks to individual study participants and do not require researchers
or ethics review boards to consider potential harms to nonparticipants (11,19).
Thus, the recommendations proposed by the presidential commission represent
a significant departure from current regulatory perspectives. Nonetheless, a
compelling case can be made in support of the idea that when research studies
place nonparticipating members of social groups at risk, these potential harms
should be considered by persons conducting, reviewing, and participating in
research (4). The potential benefits of addressing collective research-related
harms include a more complete appreciation of the risks and benefits of research,
increased public confidence in the research enterprise, and the promotion of
increased diversity among research participants. Considering potential group
harms also demonstrates respect for the diverse social and cultural traditions
of many communities and acknowledges that research findings can disrupt social
relationships within and between communities. These considerations suggest that
protecting identifiable communities from research-related harm is a moral imperative
in conducting and reviewing research (20).
Under current federal regulations, ethics review boards are required to include
at least one community representative. There are times, however, when this is
inadequate and the involvement of community representatives requires more elaborate
consultation with members of the communities placed at risk, as often is the
case in research with American Indian and Alaska Native communities and studies
conducted outside the United States (21,22). In many cases, directly
involving members of identifiable social groups, particularly members of historically
underserved communities (e.g., communities of color, patient communities, or
occupational communities), in the ethical review of research can help identify
local risks that otherwise might go unnoticed.
A recent study of the effects of polychlorinated biphenyls on the health of
American Indians living along the St. Lawrence River illustrates some of the
potential benefits (and drawbacks) of soliciting community perspectives on the
ethical conduct of environmental health research (23). The cooperative
relationship between the Akwesasne people and scientists at State University
of New York (SUNY; Albany, NY) was based on three principles: mutual respect,
mutual equity, and mutual empowerment (24). These guiding principles
were jointly agreed upon by community representatives and members of the research
team from SUNY. Approval of the research was obtained from both the Akwesasne
community and individual research participants. Project goals were determined
jointly and designed to maximize data quality while simultaneously minimizing
the disruption of community activities. Community members were involved in the
project as research assistants, and after receiving proper training, these research
assistants collected tissue samples and conducted interviews. The SUNY researchers
believed the success of their research project was based largely upon the early
stage at which the cooperative relationship with the Akwesasne developed, the
formal approval of the study given by the Akwesasne, the participation of community
members as field staff, the involvement of community partners in communicating
research results, and shared authorship on the publication of research papers
and reports (25).
The success of projects like this illustrates how the commission's proposals
might be implemented and what benefits might be expected (26). Nonetheless,
we should acknowledge the limitations of this approach. In the following sections
we highlight two difficulties facing proposals to expand the scope of regulatory
oversight to include the protection of social groups: how best to anticipate
potential research-related harms to identifiable communities, and how best to
manage the many practical challenges of expanding an already overburdened regulatory
system. We again examine these two challenges in the context of research with
American Indian and Alaska Native communities, as research with indigenous communities,
particularly genetic research, has received considerable attention from commentators
on ethical issues in research. Although it would be a mistake to naïvely
generalize from these research settings to studies involving other identifiable
communities where very different social relationships may characterize collective
interests and concerns about biomedical and genetic research, we believe it
behooves us to consider the lessons to be learned from past experience with
American Indian and Alaska Native communities.
Anticipating and Assessing the Significance of Group
Harms
No protectionist policies or regulatory structures can fully embody their
guiding moral principles or anticipate all ethical issues that might emerge
over the course of a research study (27). Nevertheless, the protection
of nonparticipants and socially identifiable communities is particularly difficult
to capture in regulatory language because of problems surrounding the definition
of an affected community (28-31). Often, at the beginning of a study
it is not clear which particular social groups will be affected by the research--much
less how they might be affected. Similarly, there are numerous challenges surrounding
how best to capture abstract notions such as "respect for communities" in formal
research guidelines. As a result, investigators sincerely committed to conducting
research in an ethical and respectful manner (and who are familiar with guidelines
for ethical conduct in research) can nonetheless struggle with how to apply
these guidelines and principles in the context of their studies. These and related
problems are evident when one considers the commission's recommendations more
carefully.
The commission's recommendations hinge on the ability of researchers or IRB
members to anticipate collective research-related harms prospectively. Consider
Rec. 17, the most detailed of the commission's proposals pertaining to group
risks (12):
Research using stored human biological materials, even when not potentially
harmful to individuals from whom the samples are taken, may be potentially
harmful to groups associated with the individual. To the extent such potential
harms can be anticipated [emphasis added], investigators should to the
extent possible plan their research so as to minimize such harm and should
consult, when appropriate, representatives of the relevant groups regarding
study design. In addition, when research on unlinked samples that poses a
significant risk of group harm is otherwise eligible for exemption from IRB
review, the exemption should not be granted if IRB review might help the investigator
to design the study in such a way as to avoid those harms.
Although the type of community consultation proposed by the commission is
useful in addressing collective risks that have been identified prior to the
start of a study, this approach is limited by the fact that even experienced
researchers and IRB members can fail to anticipate significant research-related
risks before a study begins (4). For example, researchers and reviewers
can find it especially difficult to identify risks involving the disruption
of social relationships within communities of which they have little knowledge
or familiarity. Similarly, risks that researchers or review boards view as minor
may be viewed by study participants (or other members of the group placed at
risk) as substantial.
These difficulties can be seen in two examples from research with American
Indian and Alaska Native communities (32). Studies of population histories
and patterns of population migration can affect the legal standing of claims
made by sovereign Native American tribes for the repatriation of human remains
or the return of tribal artifacts held in federal museums (33). Researchers
unfamiliar with these repatriation efforts are unlikely to anticipate such potential
risks, although they may be quite salient to members of those communities. Similarly,
studies involving genetic markers found more commonly in American Indian and
Alaska Native populations can disrupt the social equilibrium that exists within
a community by revealing that participants and their families are more "European"
in ancestry than they themselves believe. Such findings have social consequences
in many indigenous communities, as the ability to occupy a political office
often is contingent upon establishing one's ancestry as sufficiently "Native"
(34). Here too, it is unlikely that researchers who are not themselves
members of these communities could anticipate such research-related risks or
fully appreciate their significance for the community and its members.
The challenge of identifying potential group harms is especially difficult
when researchers never have direct contact with members of the study population
(35,36). Because many types of environmental health research can be done
using information or biological samples that were collected for unrelated purposes
(e.g., epidemiologic studies based on previous exposure assessments), researchers
and the individuals from whom information or samples have been collected may
never interact with each other. Additionally, as new risks may present themselves
as the research progresses, it is important that consultation with members of
study populations continue throughout the process of data collection, analysis,
and reporting.
These difficulties highlight the importance of early and ongoing involvement
of community representatives in the review of research proposals. To the extent
that the commission's proposal depends upon the ability to anticipate group
harms at the beginning of a research study, and many local or population-specific
risks may still go unnoticed if there is significant sociocultural distance
between members of the research team and study participants, the commission's
recommendations are problematic. This is unfortunate, as it is precisely in
those circumstances where collective risks are difficult to identify prospectively
that the involvement of local study populations is most critical for minimizing
potential harm.
Expanding the Scope of Regulatory Oversight: Future Research
Needs
The expansion of regulatory oversight to include the protection of social
groups would have significant consequences for a regulatory system that many
believe is overburdened and undersupported (17,37). Thus, it is understandable
why the commission attempted to limit community involvement in the ethical review
of research to those studies in which significant group harms could be anticipated.
Interestingly, applying this anticipatory principle would not only preclude
the involvement of community representatives from some studies in which community
consultation is critical for the identification of collective risks (as noted
above) but would expand the scope of regulatory oversight to include many types
of research currently viewed as exempt (e.g., research using anonymous samples
from identifiable populations). This highlights a second challenge facing proposals
to involve community members in the ethical review of research, namely, how
to define the range of research studies where community consultation is needed.
One way to address this practical challenge is to concentrate on involving
community representatives at the earliest possible stage in the research process.
If this approach is used, attention should be given to the different methods
through which community views might be solicited. Because presumably some studies
require more involved community participation than others (because of the level
of collective risk presented), the question becomes which features of the community
and/or study can be used to determine the nature and extent of this involvement.
For example, researchers might solicit input from participating communities
through relatively informal mechanisms, through the identification of a subset
of community members that are broadly representative of community interests,
or by actively involving communities as research partners (4). In addition,
as the balance of research benefit and harm can change over the course of an
investigation, it is important to assess the effectiveness of various oversight
mechanisms in protecting group interests throughout the entire duration of a
research study. Examining the respective merits and problems with various approaches
to community consultation and partnership and describing best practices with
regard to each are essential to the continued development of policy in this
area.
Of particular importance are empirical studies assessing how various social,
religious, economic, cultural, and political communities view risks associated
with research. Presently, little is known about how members of various underserved
or marginalized communities weigh individual research risks against group risks,
how salient collective risks are in relation to other risks encountered in daily
life, or how individuals attempt to reconcile potential conflicts that may exist
between personal interests in research participation and collective opposition
to proposed research. Because not all collective harms carry the same weight--that
is, some group harms are more significant than others--it is important to assess
how members of historically underserved communities evaluate collective research-related
harms. Moreover, without such information it will be difficult, if not impossible,
to tailor oversight processes to specific communities.
There also is need for additional ethical and philosophical analysis of the
goals of involving community representatives in the review of research. Whereas
members of the presidential commission appear to view community involvement
as a supplemental method of identifying risks, others have described the involvement
of community representatives as something akin to seeking individual informed
consent (38). Proponents of this second perspective maintain that there
are reasons for involving community representatives in the review of research
that are distinct from efforts to protect such groups. For example, seeking
community advice can show respect for different cultural perspectives on how
to balance individual and group interests in research. Further conceptual analysis
is necessary to determine whether these are distinct value commitments and how
the various goals of community consultation are served to greater or lesser
degrees by different approaches to working with community representatives.
Another key area in which additional conceptual analysis is much needed concerns
the notion of collective harm. Like individual harms, research-related harms
to communities can be of two sorts--tangible and dignitary. Tangible collective
harms include discrimination or stigmatization of community members, loss of
social opportunities, and so forth. Dignitary harms to communities, by contrast,
involve violations of collective rights or disrespectful treatment of the affected
community. For example, using stored biological materials in a manner that the
community would find morally objectionable can constitute a dignitary harm not
only to the individuals who contributed those materials but to the community
as a whole. How to assess the ethical salience of dignitary harms to communities
and how to determine which of these harms are significant and which are not
remains largely unexplored in the philosophical literature on community consultation
in research.
In the final analysis, however, it is important to acknowledge in a very clear
and candid way that expanding the scope of federal oversight to include the
protection of identifiable communities will require a substantial investment
of resources. Indeed, it may be the case that the additional costs (and practical
difficulties) of developing these protections will result in fewer research
studies being conducted, raising difficult issues regarding the proper balance
between protectionist concerns and concerns for the advancement of knowledge.
Although considerations of cost and practicability are inevitable features of
biomedical research, we hope that these concerns are not allowed to trump discussions
surrounding the development of new regulatory policies. Additional empirical
data and conceptual analyses will be critical to resolving these questions about
when some type of community consultation is needed and how it can be best carried
out in the context of specific communities.
Conclusion
We have identified several challenges facing the expansion of regulatory oversight
to include the protection of identifiable communities. Sociocultural distance
between researchers and members of study populations can make it difficult to
identify and fully appreciate the significance of collective research-related
risks. This makes regulatory proposals based on the anticipation of collective
risks problematic. Implementing new oversight requirements also would place
significant strain on an already overburdened regulatory system. Thus, how to
accomplish this regulatory expansion is complicated by the need to develop clear
principles for determining when additional oversight mechanisms should apply.
These difficulties suggest that protecting social groups from research-related
harm is far more nuanced than the analysis suggested by the commission. Nevertheless,
the commission should be commended for its efforts. Their recommendations are
the first substantive attempt by a national advisory group to advance regulatory
protections beyond their current focus on individual risks and benefits. In
proposing this regulatory expansion, the commission has raised a number of profound
questions about how to balance individual and collective interests in research,
as well as questions about what the goals of research guidelines should be with
regard to meeting the needs of historically underserved communities. Thus, perhaps
the most significant contribution of the NBAC report will be its promotion of
continuing dialogue on the identification of risks to social groups, irrespective
of whether investigators or regulatory agencies choose to adopt the commission's
recommendations.
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Last Updated: March 27, 2002
