ABSTRACT
The existing EELS literature has usefully identified the scope of ethical issues posed by pharmacogenetic and pharmacogenomic research. The time has come for in-depth examination of particular ethical issues. The involvement of racial and ethnic communities in pharmacogenetic and pharmacogenomic research is contentious precisely because it touches upon the science and politics of studying racial and ethnic difference. To date, the ethics literature has not seriously taken account of the fact that such research impinges upon the interests of communities, and that taking such interests seriously requires that we both protect and empower communities in research. We propose a framework that rests upon the recognition that communities are heterogeneous human associations and differing policies are appropriate for differing communities. Community consent and consultation and community consultation alone are neither appropriate nor required for all pharmacogenetic and pharmacogenomic research. Rather, application of these policy protections must take into account particulars of both planned research and the communities involved.
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References
Alcade MG, Rothstein MA . Pharmacogenomics: ethical concerns for research and pharmacy practice. Am J Health-Syst Pharmacol 2002; 59: 2239–2240.
Rothstein MA, Epps PG . Ethical and legal implications of pharmacogenomics. Nat Rev Genet 2001; 2: 228–231.
Issa AM . Ethical considerations in clinical pharmacogenomics research. TiPS 2000; 21: 247–249.
Buchanan A, Califano A, Kahn J, McPherson E, Robertson J, Brody B . Pharmacogenetics: ethical issues and policy options. Kennedy Inst Ethics J 2002; 12: 1–15.
Lipton P . Pharmacogenetics: the ethical issues. Pharmacogenomics J 2003; 3: 14–16.
Carlini EJ, Raftogianis RB, Wood TC, Jin F, Zheng W, Rebbeck TR, Weinshilboum RM . Sulfation pharmacogenetics: SULT1A1 and SULT 1A2 allele frequencies in Caucasian, Chinese and African American subjects. Pharmacogenetics 2001; 11: 57–68.
Yu MC, Skipper PL, Taghizadeh K, Tannenbaum SR, Chan KK, Henderson BE, Ross RK . Acetylator phenotype, aminobiphenyl–hemoglobin adduct levels, and bladder cancer risk in White, Black, and Asian men in Los Angeles, California. J Natl Cancer Inst 1994; 86: 712–716.
Ameyaw MM, Regaterio F, Li T, Liu X, Tariq M, Mobarek A, Thornton N, Folayan GO, Githang'a J, Indala A, Ofori-Adjei D, Price-Evans DA, McLeod HL . MDR1 pharmacoogenetics: frequency of the C3435T mutation in exon 26 is significantly influenced by ethnicity. Pharmacogenetics 2001; 11: 217–221.
Wood AJ . Racial differences in the response to drugs—pointers to genetic differences. N Engl J Med 2001; 344: 1394–1396.
Schwartz RS . Racial profiling in medical research. N Engl J Med 2001; 344: 1392–1393.
Rothstein MA, Epps PG . Pharmacogenomics and the (ir)relevance of race. Pharmacogenomics J 2001; 1: 104–108.
Burchard EG, Ziv E, Coyle N, Gomez SL, Tang H, Karter AJ, Mountain JL, Perez-Stable EJ, Sheppard D, Risch N . The importance of race and ethnic background in biomedical research and clinical practice. N Eng J Med 2003; 348: 1170–1175.
Foster MW, Sharp RR, Mulvihill JJ . Pharmacogenetics, race, and ethnicity: social identities and individualized medical care. Ther Drug Mon 2001; 23: 232–238.
Foster MW, Sharp RR . Race, ethnicity, and genomics: social classifications as proxies of biological heterogeneity. Genome Res 2002; 12: 844–850.
NIGMS Human Genetic Cell Repository. Website: http://locus.umdnj.edu/nigms/ date accessed: September 21 2003.
Pharmacogenetics Research Network. Research funding. Website: http://www.nigms.nih.gov/pharmacogenetics/prnsupp_abstracts.html date accessed: September 21 2003.
Goldstein A, Weiss R, Howard U . Plans genetic database: school says data on African Americans could lead to better medical care. Washington Post 2003; May 28: A6.
Roses AD . Pharmacogenetics and the future of drug development and delivery. Lancet 2000; 355: 1358–1361.
Lindpaintner K . Pharmacogenetics and the future of medical practice. Br J Clin Pharmacol 2002; 54: 221–230.
Goldstein DB . Pharmacogenetics in the laboratory and the clinic. N Engl J Med 2003; 348: 553–556.
Tsai YJ, Hoyme HE . Pharmacogenomics: the future of drug therapy. Clin Genet 2002; 62: 257–264, at 262.
Noah L . The coming pharmacogenomics revolution: tailoring drugs to fit patients' genetic profiles. Jurimetrics 2002; 43: 1–28, at 2.
Robertson JA . Consent and privacy in pharmacogenetic testing. Nat Genet 2001; 28: 207–209.
Robertson JA, Brody B, Buchanan A, Kahn J, McPherson E . Pharmacogenetic challenges for the health care system. Health Aff 2002; 21: 155–167.
Beskow LM, Burke W, Merz JF, Barr PA, Terry S, Penchaszadeh VB, Gostin LO, Gwinn M, Khoury MJ . Informed consent for population-based research involving genetics. JAMA 2001; 286: 2315–2321.
Struewing JP, Hartge P, Wacholder S, Baker SM, Berlin M, McAdams M, Timmerman MM, Brody LC, Tucker MA . The risk of cancer associated with specific mutations of BRCA1 and BRCA2 among Ashkenazi Jews. N Engl J Med 1997; 336: 1401–1408.
Lehrman S . Jewish leaders seek genetic guidelines. Nature 1997; 389: 322.
Nuffield Council on Bioethics. Pharmacogenetics: Ethical Issues—Consultation Paper. Nuffield Council on Bioethics: London 2002.
Consortium on Pharmacogenetics (Buchanan A, McPherson E, Brody BA, Califano A, Kahn J, McCullough N, Robertson JA). Pharmacogenetics: Ethical and Regulatory Issues in Research and Clinical Practice, Consortium on Pharmacogenetics; 2002. Online: www.bioethics.umn.edu/news/pharm_report.pdf Date accessed: September 21 2003.
Weijer C . Protecting communities in research: philosophical and pragmatic challenges. Cambridge Q Healthcare Ethics 1999; 8: 501–513.
Canada Tri-Council Working Group on Ethics. Code of Conduct for Research Involving Humans (draft). Minister of Supply and Services: Ottawa 1996.
Foster MW, Bernsten D, Carter TH . A model agreement for genetic research in socially identifiable populations. Am J Hum Genet 1998; 63: 696–702.
Weijer C, Emanuel EJ . Protecting communities in biomedical research. Science 2000; 289: 1142–1144.
Weijer C, Goldsand G, Emanuel EJ . Protecting communities in research: current guidelines and limits of extrapolation. Nat Genet 1999; 23: 275–280.
Levine C, Dubler NN, Levine RJ . Building a new consensus: ethical principles and policies for clinical research on HIV/AIDS. IRB: Rev Hum Subjects Res 1991; 13: 1–17.
Macaulay AC, Delormier T, McComber AM, Cross EJ, Potvin LP, Paradis G, Kirby RL, Saad-Haddad C, Desrosiers S . Participatory research with native community of Kahnawake creates innovative code of research ethics. Can J Public Health 1998; 89: 105–108.
Spiers HR . Community consultation and AIDS clinical trials, part I. IRB: Rev Hum Subjects Res 1991; 13: 7–10.
NIGMS Human Genetic Cell Repository. Website: http://locus.umdnj.edu/nigms/ Date accessed: September 21 2003.
Weir RF, Horton JR . DNA banking and informed consent—part 1. IRB: Rev Hum Subjects Res 1995; 17: 1–4.
Weir RF, Horton JR . DNA banking and informed consent—part 2. IRB: Rev Hum Subjects Res 1995; 17: 1–8.
O'Neill O . Medical and scientific uses of human tissue. J Med Ethics 1996; 22: 5.
National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance: Report and Recommendations, National Bioethics Advisory Commission: Rockville, MD; 1999, Website: http://www.georgetown.edu/research/nrcbl/nbac/hbm.pdf Date accessed: September 21 2003.
Policy for the responsible collection, storage, and research use of samples from identified populations for the NIGMS Human Genetic Cell Repository. Website: http://locus.umdnj.edu/nigms/comm/submit/collpolicy.html Date accessed: September 21 2003.
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Charles Weijer is Associate Professor in the Departments of Bioethics and Surgery at Dalhousie University. A Canadian Institutes of Health Research Investigator Award and Operating Grant support his work in research ethics. He is a Fellow of the Hastings Center and a Fellow of the Royal College of Physicians and Surgeons of Canada.
Paul B Miller is a student in law and philosophy at the University of Toronto, a Junior Fellow of Massey College in Toronto, and a research assistant at the University of Toronto and Dalhousie University. He is supported by a doctoral fellowship from the Social Sciences and Humanities Research Council of Canada.
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Weijer, C., Miller, P. Protecting communities in pharmacogenetic and pharmacogenomic research. Pharmacogenomics J 4, 9–16 (2004). https://doi.org/10.1038/sj.tpj.6500219
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DOI: https://doi.org/10.1038/sj.tpj.6500219
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