Abstract
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 publication. 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 communities, such as Ashkenazi Jews, analysis suggests substantial problems in extending these guidelines in toto beyond the aboriginal communities for which they were developed.
This is a preview of subscription content, access via your institution
Relevant articles
Open Access articles citing this article.
-
Community involvement in biomedical research conducted in the global health context; what can be done to make it really matter?
BMC Medical Ethics Open Access 15 June 2018
-
Seeking consent for research with indigenous communities: a systematic review
BMC Medical Ethics Open Access 22 October 2016
-
How Can We Do it Right? Ethical Uncertainty in Swedish Sami Research
Journal of Academic Ethics Open Access 12 August 2016
Access options
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
Struewing, J.P. et al. The carrier frequency of the BRCA1 185delAG mutation is approximately 1 percent in Ashkenazi Jewish individuals. Nature Genet. 11, 198–200 (1995).
Laken, S.J. et al. Familial colorectal cancer in Ashkenazim due to a hypermutable tract in APC. Nature Genet. 17, 79–83 (1997).
Lehrman, S. Jewish leaders seek genetic guidelines. Nature 389, 322 (1997).
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. OPRR Reports April 18, 1–8 (1979).
Levine, R.J. Ethics and Regulation of Clinical Research (Yale University Press, New Haven, 1988).
Department of Health and Human Services. Protection of Human Subjects. Tile 45, Code of Federal Regulation, Part 46: Revised June 18, 1991: 46.111(a)(3).
Levine, R.J. Validity of consent procedures in technologically developing countries. in Human Experimentation and Medical Ethics: Proceedings of the XV CIOMS Round Table Conference (eds Bankowski, Z. & Howard-Jones, N.) 16–30 (Council for International Organizations of Medical Sciences, Geneva, 1982).
McCarthy, C. A North American perspective. in Ethics and Research on Human Subjects: International Guidelines (eds Bankowski, Z. & Levine, R.J.) 208–211 (Council for International Organizations of Medical Sciences, Geneva, 1993).
Weijer, C. Protecting communities in research: philosophical and pragmatic challenges. Camb. Q. Healthc. Ethics 8, 501–513 (1999).
Department of Health and Human Services. Protection of human subjects; informed consent and waiver of informed consent requirements in certain emergency research; final rules. Federal Register 61, 51497–51533 (1996).
National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (Rockville, Maryland, 1999).
Canada Tri-Council Working Group on Ethics. Code of Conduct for Research Involving Humans (draft) (Minister of Supply and Services, Ottawa, 1996).
Canada Tri-Council Working Group on Ethics. Code of Conduct for Research Involving Humans ('final' version) (Minister of Supply and Services, Ottawa, 1997).
Maddocks, I. Ethics in aboriginal research: a model for minorities or for all? Med. J. Aust. 157, 553–555 (1992).
Aboriginal Health Research Ethics Committee of South Australia. Inaugural Bulletin (Australia, 1989).
Menzies School of Health Research. Health Research Guidelines: Aboriginal Communities in the Northern Territory (Darwin, Australia, 1989).
Australia National Health and Medical Research Council. Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Research (National Health and Medical Research Council, Australia, 1991) (Publication no. E13).
Aboriginal Health Research Ethics Committee of South Australia. Ethical Considerations for Health Related Research Involving Aboriginal People (Australia, 1998).
Association of Canadian Universities for Northern Studies. Ethical Principles for the Conduct of Research in the North (Association of Canadian Universities for Northern Studies, Ottawa, 1982).
Canada Royal Commission on Aboriginal Peoples. Ethical guidelines for research. in Integrated Research Plan Appendix B (Royal Commission on Aboriginal Peoples, Ottawa, 1993).
Kahnawake Schools Diabetes Prevention Project. Code of Research Ethics (Kahnawake Territory, Mohawk Nation, Canada, 1996).
Council of the American Anthropological Association. Principles of Professional Responsibility (American Anthropological Association, USA, 1971).
American Public Health Association Task Force. National Arctic Health Science Policy (American Public Health Association, Washington, 1984).
American Indian Law Center. Model Tribal Research Code (American Indian Law Center, Albuquerque, 1994).
Interagency Arctic Research Policy Committee. Principle for the conduct of research in the arctic. Arctic Res. United States 9, 56–57 (1995).
American Anthropological Association. Code of Ethics (American Anthropological Association, Arlington, 1997).
Inuit Circumpolar Conference. Proceedings of a conference on a northern foreign policy for Canada. (The Canadian Polar Commission and the Canadian Centre for Global Security in association with the Inuit Circumpolar Conference and the Canadian Arctic Resources Committee, Ottawa, 1994).
Council for International Organizations of Medical Sciences. International Guidelines for Ethical Review of Epidemiological Studies (Council for International Organizations of Medical Sciences, Geneva, 1991).
Levine, C., Dubler, N.N. & Levine, R.J. Building a new consensus: ethical principles and policies for clinical research on HIV/AIDS. IRB: A Review of Human Subjects Research 13, 1–17 (1991).
Freedman, B. Scientific value and validity as ethical requirements for research: a proposed explication. IRB: A Review of Human Subjects Research 9, 7–10 (1987).
Appelbaum, P.S., Lidz, C.W. & Meisel, A. Informed Consent: Legal Theory and Clinical Practice (Oxford University Press, New York, 1987).
Macaulay, A.C. et al. Participatory research with native community of Kahnawake creates innovative code of research ethics. Can. J. Public Health 89, 105–108 (1998).
Medical Research Council of Canada, Natural Sciences Engineering Research Council of Canada & Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (Public Works and Government Services Canada, Ottawa, 1998).
North American Regional Committee of the Human Genome Diversity Project. Model protocol: proposed model ethical protocol for collecting DNA samples. Houston Law Review 33, 1431–1473 (1997).
Acknowledgements
We thank T. Beauchamp, W. Freedman, J. Kaufert, I. Maddocks, A. Wichman and B. Zinman. This work was supported by the Department of Clinical Bioethics, Warren G. Magneson Clinical Center, National Institutes of Health, a Medical Research Council of Canada Scholar Award and Operating Grant (to C.W.), and a Dalhousie University Clinical Scholar Award (to C.W.). The opinions in this article are the authors' and do not necessarily reflect the views or policies of the Department of Health.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Weijer, C., Goldsand, G. & Emanuel, E. Protecting communities in research: current guidelines and limits of extrapolation. Nat Genet 23, 275–280 (1999). https://doi.org/10.1038/15455
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1038/15455
This article is cited by
-
Community involvement in biomedical research conducted in the global health context; what can be done to make it really matter?
BMC Medical Ethics (2018)
-
Seeking consent for research with indigenous communities: a systematic review
BMC Medical Ethics (2016)
-
Typology of diaspora entrepreneurship: Case studies in Uzbekistan
Journal of International Entrepreneurship (2016)
-
How Can We Do it Right? Ethical Uncertainty in Swedish Sami Research
Journal of Academic Ethics (2016)