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Involving Study Populations in the Review of Genetic Research

Published online by Cambridge University Press:  01 January 2021

Richard R. Sharp  and
Morris W. Foster
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Extract

Research on human genetic variation can present collective risks to all members of a socially identifiable group. Research that associates race or ethnicity with a genetic disposition to disease, for example, presents risks of group discrimination and stigmatization. To better protect against these risks, some have proposed supplemental community-based reviews of research on genetic differences between populations. The assumption behind these appeals is that involving members of study populations in the review process can help to identify and minimize collective risks that otherwise could go unnoticed. In contrast to this position, critics have argued that supplemental community-based reviews are unnecessary, impractical, and morally problematic. This paper is our attempt to advance this debate by distinguishing the various goals of community review and the forms that it can take.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 28 , Issue 1 , Spring 2000 , pp. 41 - 51
Copyright
Copyright © American Society of Law, Medicine and Ethics 2000

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References

Scriver, C.R. Beaudet, A.L. Sly, W.S. Valle, D., eds., The Metabolic and Molecular Bases of Inherited Disease, 7th ed. (New York: McGraw-Hill, 1995); King, R.A.R.A. Rotter, J.I. Motulsky, A.G., The Genetic Basis of Common Diseases (New York: Oxford University Press , 1992).Google Scholar
Haines, J.L. Pericak-Vance, M.A., eds., Approaches to Gene Mapping in Complex Human Diseases (New York: John A. Wiley & Sons, 1988); Schafer, A.J. Hawkins, J.R., “DNA Variation and the Future of Human Genetics,” Nature Biotechnology, 16 (1988): 33–39Google Scholar
Brown, P.O. Hartwell, L., “Genomics and Human Disease—Variations on Variation,” Nature Genetics, 18 (1988): 9193; Collins, F.S. Guyer, M.S. Chakravarti, A., “Variations on a Theme: Cataloging Human DNA Sequence Variation,” Science, 278 (1997): 1580–1581.Google Scholar
Khoury, M.J., “Genetic Epidemiology and the Future of Disease Prevention and Public Health,” Epidemiology Review, 19 (1997): 175–180; Gottesman, M.M. Collins, F.S., “The Role of the Human Genome Project in Disease Prevention,” Preventive Medicine, 23 (1994): 591–594.Google Scholar
Sharp, R.R. Barrett, J.C., “The Environmental Genome Project and Bioethics,” Kennedy Institute of Ethics Journal 9 (1999): 175–188; National Research Council, Evaluating Human Genetic Diversity (Washington, DC: National Academy Press, 1997); Samet, J.M. Bailey, L.A., “Environmental Population Screening,” in Rothstein, M.A., ed., Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (New Haven: Yale University Press, 1997): 197–211; Soskolne C.L., “Ethical, Social, and Legal Issues Surrounding Studies of Susceptible Populations and Individuals,” Environmental Health Perspectives, 105 (1997): 837–841; Baird A.P., “Identifying People's Genes: Ethical Aspects of DNA Sampling in Populations,” Perspectives in Biology and Medicine, 38 (1995): 159–166; McPherson E.C., “Ethical Implications of the Human Genome Diversity Project,” NursingConnections, 8 (1995): 36–43.Google Scholar
Caplan, A.L., “Handle with Care: Race, Class, and Genetics,” in Murphy, T.F. Lappe, M.A., eds., Justice and the Human Genome Project (Berkeley: University of California Press, 1994): 30–45; King, P.A., “Race, Justice, and Research,” in Kahn, J. Mastroianni, A. Sugarman, J., eds., Beyond Consent: Seeking Justice in Research (New York: Oxford University Press, 1998): 88–110.Google Scholar
Stolberg, S.G., “Concern Among Jews is Heightened as Scientists Deepen Gene Studies,” New York Times, April 22, 1998, at A24; Struewing, J. Hartge, P. Wacholder, S. Baker, S. Berlin, M. McAdams, M. Timmerman, M., “The Risk of Cancer Associated with Specific Mutations of BRCA1 and BRCA2 Among Ashkenazi Jews,” N. Engl. J Med., 336 (1997): 1401–1408.Google Scholar
Foster, M.W. Sharp, R.R. Freeman, W.L. Chino, M. Bernsten, D. Carter, T.H., “The Role of Community Review in Evaluating the Risks of Human Genetic Variation Research,” American Journal of Human Genetics, 64 (1999): 1719–1727; Foster, M.W. Bersten, D. Carter, T.H., “A Model Agreement for Genetic Research in Socially Identifiable Populations,” American Journal of Human Genetics, 63 (1998): 696–702; Foster, M.W. Eisenbraun, A.J. Carter, T.H., “Genetic Screening of Targeted Subpopulations: The Role of Communal Discourse in Evaluating Sociocultural Implications,” Genetic Testing, 1 (1997/98.): 269–274; Greely, H.T., “The Control of Genetic Research: Involving the ‘Groups Between,’” Houston Law Review, 33 (1997): 1397–1430; North American Regional Committee of the Human Genome Diversity Project, “Proposed Model Ethical Protocol for Collecting DNA Samples,” Houston Law Review, 33 (1997): 1431–1473; Human Genome Diversity Committee of the Human Genome Organisation, The Human Genome Diversity Project: Summary Document (London: Human Genome Organisation, 1994).CrossRefGoogle Scholar
Human Genome Diversity Committee of the Human Genome Organisation, supra note 8.Google Scholar
National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (Rockville, MD: U.S. Government Printing Office, 1999).Google Scholar
Juengst, E.T., “Groups as Gatekeepers to Genomic Research: Conceptually Confusing, Morally Hazardous, and Practically Useless,” Kennedy Institute of Ethics Journal, 8 (1998): 183–200.CrossRefGoogle Scholar
Reilly, P.R., “Rethinking Risks to Human Subjects in Genetic Research,” American Journal of Human Genetics, 63 (1998): 682–685.Google Scholar
Juengst, supra note 11.Google Scholar
Reilly, supra note 12.Google Scholar
National Research Council, supra note 5.Google Scholar
Reilly, P.R. Page, D.C., “We're Off to See the Genome,” Nature Genetics, 20 (1998): 15–17.Google Scholar
Reilly, supra note 12.Google Scholar
Juengst, supra note 11; North American Regional Committee of the Human Genome Diversity Project, supra note 9.Google Scholar
Freeman, W.L., “The Role of Community in Research with Stored Tissue Samples,” in Weir, R. F., ed., Stored Tissue Samples: Ethical, Legal, and Public Policy Implications (Iowa City: University of Iowa Press, 1998): 267–294.Google Scholar
Foster, Sharp supra note 8.Google Scholar
Foster, Eisenbraun supra note 8.Google Scholar
We prefer the term “review” because it has both evaluative and non-evaluative associations. Depending on the context, to “review” a proposal can mean to survey the issues it presents or evaluate its merits. Hence, , community review can be seen as including both formal evaluations (e.g. group consent), as well as other methods of surveying potential risks to socially identifiable groups that stop short of comprehensive evaluations (e.g. community consultation).Google Scholar
A “study population” is a collection of individuals defined by researchers. We use the term “community” to describe a set of persons who share a set of common interests and who interact with each other socially (perhaps only indirectly). Thus, most study populations are comprised of many communities.Google Scholar
In this paper we consider the role of community review in relation to the study of genetic differences between populations. This includes many types of disease-susceptibility research, as well as anthropologic research that makes use of genetic differences to track the movement of populations over time. Nonetheless, much of what is said about community review and its role in identifying collective research-related risks also applies to other types of research. Many types of behavioral research, sociological research, and research on stigmatizing conditions that appear to be more prevalent in some populations and not others, implicate the same considerations discussed here in connection with genetic research. Arguably, whenever researchers attempt to make scientific claims about socially defined groups, that research can present collective risks to members of those groups.Google Scholar
National Bioethics Advisory Commission, supra note 10.Google Scholar
Foster, Bersten supra note 8.Google Scholar
Foster, Sharp supra note 8; Greely, supra note 8; and Freeman, supra note 19.Google Scholar
Foster, M.W. Sharp, R.R., “Genetic Research and Culturally Specific Risks: One Size Does Not Fit All,” Trends in Genetics, 16 (2000): 93–95.Google Scholar
Canada Tri-Council Working Group on Ethics, Code of Conduct for Research Involving Humans, (Ottawa: Minister of Supply and Services, 1997).Google Scholar
North American Regional Committee of the Human Genome Diversity Project, supra note 8.Google Scholar
Foster, Bersten supra note 8.Google Scholar
American Indian Law Center, Model Tribal Research Code, 2nd edition, (Albuquerque, NM: American Indian Law Center, 1994); Cornwall, A. Jewkes, R., “What is Participatory Research?” Social Science and Medicine, 41 (1995): 1667–1676; Hatch, J. Moss, N. Saran, A. Presley-Cantrell, L. Mallory, C., “Community Research: Partnership in Black Communities,” American Journal of Preventive Medicine, 9 (1993): 27–31; Macaulay, A.C. Commanda, L. Freeman, W.L. Gibson, N. McCabe, M.L. Robbins, C.M. Twohig, P.L., “Responsible Research with Communities: A Review of Participatory Research in Primary Care,” British Medical Journal (in press); Macaulay, A.C. Delormier, T. McComber, A.M. Cross, E.J. Potvin, L.P. Paradis, G., “Participatory Research with Native Community of Kahnawake Creates Innovative Code of Research Ethics,” Canadian Journal of Public Health, 89 (1998): 105–108; Maddocks, I., “Ethics in Aboriginal Research: A Model for Minorities or for All?” Medical Journal of Australia, 157 (1992): 553–555; Weijer, C., “Protecting Communities in Research: Philosophical and Pragmatic Challenges,” Cambridge Quarterly of Healthcare Ethics, 8 (1999): 501–513.CrossRefGoogle Scholar
National Research Council, supra note 5; North American Regional Committee of the Human Genome Diversity Project, supra note 8.Google Scholar
For example, some Institutional Review Boards have considerable experience identifying and assessing external risks to minority populations.Google Scholar
Foster, Sharp supra note 8.Google Scholar
Grounds, R.A., “The Yuchi Community and the Human Genome Diversity Project,” Cultural Survival Quarterly (Summer 1996): 64–68.Google Scholar
Reilly, supra note 12; Reilly, Page, supra note 16.Google Scholar
Reilly, supra note 12.Google Scholar
Parker, L.S., “Bioethics for Human Geneticists: Models for Reasoning and Methods for Teaching,” American Journal of Human Genetics, 54 (1994): 137–147.Google Scholar
Meslin, E.M. Thomson, E.J. Boyer, J.T., “The Ethical, Legal, and Social Implications Research Program at the National Human Genome Research Institute,” Kennedy Institute of Ethics Journal, 7 (1997): 291–298; Marshall, E., “The Genome Program's Conscience,” Science, 274 (1996): 488–490.Google Scholar
Andrews, L.B. Fullarton, J.E. Holtzman, N.A. Motulsky, A.G., eds., Assessing Genetic Risks: Implications for Health and Social Policy (Washington, D.C.: National Academy Press, 1994); NIH Office of Protection from Research Risks, “Human Genetic Research,” in Protecting Human Research Subjects: Institutional Review Board Guidebook (Washington, DC: US Government Printing Office, 1993).Google Scholar
Andrews, L.B., “Gen-Etiquette: Genetic Information, Family Relationships, and Adoption,” in Rothstein, M.A., ed., Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (New Haven: Yale University Press, 1997): 255–280.Google Scholar
Reilly, supra note 12.Google Scholar
Foster, Sharp supra note 8.Google Scholar
Freeman, supra note 19.Google Scholar
Personal correspondence, Freeman, William L., Chairperson, Indian Health Service Headquarters IRB.Google Scholar
Foster, Sharp supra note 8.Google Scholar
Juengst, supra note 11; Reilly, supra note 12.Google Scholar
Juengst, supra note 11.Google Scholar
National Research Council, supra note 5; Juengst, supra note 11.Google Scholar
Juengst, supra note 11; Reilly, supra note 12.Google Scholar
Reilly, supra note 12.Google Scholar
Juengst, supra note 11; Reilly, Page, supra note 16.Google Scholar
Juengst, supra note 11.Google Scholar
LaVeist, T.A., “Why We Should Continue to Study Race … But Do a Better Job: An Essay on Race, Racism and Health,” Ethnicity and Disease, 6 (1996): 21–29.Google Scholar
Osborne, N.G. Feit, M.D., “The Use of Race in Medical Research,” JAMA, 267 (1992): 275–279.Google Scholar
Juengst, supra note 11.Google Scholar
Keil, J.E. Sutherland, S.E. Knapp, R.G. Tyler, H.A., “Does Equal Socioeconomic Status in Black and White Men Mean Equal Risk of Mortality?” American Journal of Public Health, 82 (1992): 1133–1139.Google Scholar