commentary nature genetics • volume 23 • november 1999 275 Protecting communities in research: current guidelines and limits of extrapolation Charles Weijer 1 , Gary Goldsand 2 & Ezekiel J. Emanuel 3 1 Department of Bioethics, Dalhousie University, Halifax, Nova Scotia, Canada. 2 Joint Centre for Bioethics, University of Toronto, Toronto, Ontario, Canada. 3 Department of Clinical Bioethics, Warren G. Magnusen Clinical Center, National Institutes of Health, Bethesda, Maryland, USA. Correspondence should be addressed to C.W. (e-mail: Charles.Weijer@dal.ca). Recent cancer genetics studies documented a high prevalence of particular genetic mutations predisposing Ashkenazi Jews to breast, ovarian and colon cancers 1,2 . In response, an editorial expressed concern that “anyone with a Jewish-sounding name could face discrimination in insurance and employment as com- panies struggle to keep down health-care costs,” 3 and some Jew- ish leaders in the United States have called for the development of guidelines to protect the Ashkenazi community. Developing pro- tections for communities in research is complicated by several fundamental issues, including ambiguity as to what constitutes a community in need of protection, disagreements about multicul- turalism and uncertainty as to what these protections should be. Codifying protections for communities in research is a dialectical process that will require addressing these issues by proposing and refining potential safeguards based on conceptual reflection and practical experience. To begin the process of determining whether protections for communities are appropriate and what their substance should be, we critically examine well-established guidelines protecting aboriginal communities participating in biomedical research. These guidelines make a logical starting point for our enquiry for two reasons. First, while protections for communities in research are controversial and remain open to question, there is at least general agreement that aboriginal communities are distinct com- munities with common interests in need of protection. Second, the highly cohesive nature of these communities makes it likely that the requirements articulated represent the most extensive set of possible protections for a community in research. Accordingly, two fundamental questions need addressing. What is the scope of protections for aboriginal communities? To what extent can such protections extend to other types of communities? Limitations of current regulations The predominant framework for analysing ethical issues in clini- cal research is articulated in The Belmont Report 4 . It identifies three ethical principles to govern research on human beings: respect for persons, beneficence and justice. Although widely cited, The Belmont Report has been criticized for overemphasiz- ing individual rights and failing to take into account important human relationships found in the family and the community 5 . Indeed, the word ‘community’ is not mentioned once in The Bel- mont Report. This lack of attention to community is reflected in the Common Rule (45 CFR 46), which focuses only on individual research subjects and vulnerable groups, such as the mentally ill and educationally disadvantaged people, insofar as they might be wrongfully included in or excluded from research participation 6 . To remedy this situation, some have argued for the adoption of a new ethical principle of respect for communities 7–9 . A reasonable formulation of the principle of respect for communities confers on the researcher an obligation to respect the values and interests of the community in research and, wherever possible, to protect the community from harm. Indeed, some official bodies have begun studying and propos- ing protections for communities. Recent Food and Drug Admin- istration (FDA) regulations permitting the waiver of consent in certain emergency research requires investigators to consult with the community before a study is initiated 10 . The National Bioethics Advisory Commission (NBAC) now recommends that research involving stored tissue and DNA samples that poses risks to a particular community requires consultation with that group 11 . Similarly, in Canada, part of the 1996 draft national guidelines developed by the Tri-Council Working Group on Ethics for research involving human subjects set out standards for research involving collectivities, including aboriginal groups and people infected with HIV (refs 12,13). Existing guidelines for protecting communities So far, most guidelines for the protection of communities in research have been written for research involving aboriginal communities and peoples. We use the term ‘aboriginal peoples’ to apply to American Indians, Alaska Natives, Canadian First- Nations and Inuit Peoples, Australian Aborigines, Torres Strait As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher- community partnership and span the phases of a research project, from protocol development to pub- lication. The complete list of 23 protections may apply to those few non-aboriginal communities, such as the Amish, that are highly cohesive. Although some protections may be applicable to less-cohesive com- munities, such as Ashkenazi Jews, analysis suggests substantial problems in extending these guidelines in toto beyond the aboriginal communities for which they were developed. © 1999 Nature America Inc. • http://genetics.nature.com © 1999 Nature America Inc. • http://genetics.nature.com