Hostname: page-component-78c5997874-v9fdk Total loading time: 0 Render date: 2024-11-08T06:24:21.893Z Has data issue: false hasContentIssue false

Bridging the Divide between Genomic Science and Indigenous Peoples

Published online by Cambridge University Press:  01 January 2021

Extract

The new science of genomics endeavors to chart the genomes of individuals around the world, with the dual goals of understanding the role genetic factors play in human health and solving problems of disease and disability. From the perspective of indigenous peoples and developing countries, the promises and perils of genomic science appear against a backdrop of global health disparity and political vulnerability. These conditions pose a dilemma for many communities when attempting to decide about participating in genomic research or any other biomedical research. Genomic research offers the possibility of improved technologies for managing the acute and chronic diseases that plague their members. Yet, the history of biomedical research among people in indigenous and developing nations offers salient examples of unethical practice, misuse of data and failed promises. This dilemma creates risks for communities who decide either to participate or not to participate in genomic science research.

Type
Independent
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

O'Neill Institute for National and Global Health Law on the Internet, Developing a Framework to Guide Genomic Data Sharing and Reciprocal Benefits to Developing Countries and Indigenous Peoples: A Colloquium, available at <http://aspe.hhs.gov/sp/reports/2009/genshare/report.shtml> (last visited August 5, 2010); MacIntosh, C., “Indigenous Self-Determination and Research on Human Genetic Material: A Consideration of the Relevance of Debates on Patents and Informed Consent, and the Political Demands on Researchers,” Health Law Journal 13, no. 13 (2005): 213251.Google Scholar
Id. (O'Neill Institute).Google Scholar
Reardon, J., Race to the Finish: Identity and Governance in an Age of Genomics (Princeton: Princeton University Press, 2005); Tallbear, K., “Narratives of Race and Indigeneity in the Genographic Project,” Journal of Law, Medicine & Ethics 35, no. 3 (2007): 412424; Harmon, A., “DNA Gatherers Hit a Snag: The Tribes Don't Trust Them,” New York Times, December 10, 2006, at Al.Google Scholar
Health and Social Services Committee, Navajo Nation Council, HSSCAP-20-02 (2002).Google Scholar
Jones, D. S., “The Health Care Experiments at Many Farms: The Navajo, Tuberculosis, and the Limits of Modern Medicine, 1952–1962,” Bulletin of the History of Medicine 76, No. 4 (2002): 749790.CrossRefGoogle Scholar
Seguin, B. et al., “Genomics, Public Health and Developing Countries: The Case of the Mexican National Institute of Genomic Medicine,” Nature Reviews Genetics (October 2008): S5S9. This paper reflects the joint effort of colloquium participants, staff of the O'Neill Institute, and staff of the Personalized Healthcare Initiative. Researchers from the O'Neill Institute and the Personalized Healthcare Initiative began investigating the open literature to better understand the context and content of the colloquium before the colloquium. Without in any way attempting to preempt discussion during the colloquium, we sought to identify common concerns about genomic science, clarify lessons learned from past experience and briefly compare formal codes, guidelines and protocols that have been developed to regulate research and healthcare related to genomic science among indigenous people and developing countries. The colloquium developed through short presentations from each participant on the general topics of “Hearing the Indigenous Perspective,” “Hearing the Perspectives of Developing Countries,” and “Implications for Healthcare and Genomic Science” with open discussion following the talks on each topic. After hearing and initially discussing the ideas of all participants, the colloquium continued by identifying and suggesting approaches to key issues that had emerged from its work. This discussion formulated the four key topics discussed in the body of this paper. The O'Neill Institute prepared and submitted a colloquium report entitled “Thematic Analysis of Colloquium” in partial fulfillment of its obligation to the Personalized Healthcare Initiative, Department of Health and Human Services who helped support the colloquium. The O'Neill Institute sent drafts of the colloquium report to all participants for review, comment and revision. The final report reflected the perspectives of all participants who have received a copy for their own records. We have supplemented the background research and colloquium discussion with additional material drawn from the literature and available databases about relevant topics in writing this paper.Google Scholar
Twelve international thought leaders gathered at Georgetown University to discuss these issues in January 2009 in a colloquium jointly sponsored by the Personalized Health Care Initiative, Department of Health and Human Services and the O'Neill Institute of National and Global Health Law Georgetown University. Participants included Doris Cook, Theresa Cullen, Jacinta Elston, Tonya Gonnella Frichner, James M. Galloway, Bette Keltner Jacobs, Gerardo Jimenez-Sanchez, Ted Mala, Clifton A. Poodry, Charles Rotimi, Rodrigue Takoudjou, and Ian Wronski. Representatives from the O'Neill Institute included Kimberly Bassett, Katherine Cherry, Jeff Collmann, Julie DeLoia, Charles H. Evans, Jr., Kevin Fitzgerald, S.J., and Jason Roffenbender. Gregory J. Downing, Jennifer Weisman, and Jessica Nadler represented the Personalized Health Care Initiative.Google Scholar
Sharp, R. R. and Foster, M. W., “An Analysis of Research Guidelines on the Collection and Use of Human Biological Materials from American Indian and Alaskan Native Communities,” Jurimetrics 42 (2002): 165186.Google Scholar
Human Genome Organization, Ethical, Legal, and Social Issues Committee Statement on the Principled Conduct of Genetic Research, HUGO Ethical, Legal, and Social Issues Committee Report to HUGO Council, 1996.Google Scholar
United Nations Educational, Scientific and Cultural Organization, Universal Declaration on the Human Genome and Human Rights, November 11, 1997.Google Scholar
Human Genome Diversity Project, Model Ethical Protocol for Collecting DNA Samples, 1997.Google Scholar
Australian Institute of Aboriginal and Torres Strait Islander Studies, Guidelines for Ethical Research in Indigenous Studies, May 2009.Google Scholar
Indian Health Service, IHS Guidelines for Implementing and Complying With HIS Policy on Specimens, March 31, 2001.Google Scholar
American Medical Association, Code of Medical Ethics: E-2.079 Safeguards in the Use of DNA Databanks in Genomic Research, 2001.Google Scholar
World Health Organization, Indigenous Peoples and Participatory Health Research, 2002.Google Scholar
National Health and Medical Research Council, Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Research, 2003.Google Scholar
United Nations Educational, Scientific and Cultural Organizations, International Declaration on Human Genetic Data, Adopted October 16, 2003.Google Scholar
National Institute of General Medical Sciences, Policy for the Responsible Collection, Storage and Research Use of Samples From Named Populations for the NIGMS Human Genetic Cell Repository, August 25, 2004.Google Scholar
United Nations Educational Scientific and Cultural Organization, Preliminary Draft Declaration on Universal Norms on Bioethics, February 9, 2005.CrossRefGoogle Scholar
Canadian Institutes of Health Research, CIHR Guidelines for Health Research Involving Aboriginal People, Ottawa, Canada, May 2007, available at <http://www.cihr-irsc.gc.ca/e/29134.html> (last visited August 4, 2010).+(last+visited+August+4,+2010).>Google Scholar
Id., at 36.Google Scholar
Id., at 37.Google Scholar
See CIHR, Id., at 36.Google Scholar
See CIHR, supra, note 22, at 3.Google Scholar
United Nations, Declaration on the Rights of Indigenous Peoples 61/295, 2007.Google Scholar
Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects, 2002.Google Scholar
See United Nations, supra, note 28.Google Scholar
See CIHR, supra, note 22, at 20.Google Scholar
Id., at 13.Google Scholar
Id., at 2.Google Scholar
Id., at 19.Google Scholar
Id., at 12.Google Scholar
See Seguin, et al., supra, note 8.Google Scholar
Id.; Lara-Alvarez, C. et al., “Ethical, Legal and Social Aspects of the Mexican Genomic Variability Project,” Abstract Human Genome Organization Workshop (2008); Sharp, R. and Foster, M., “Involving Study Populations in the Review of Genetic Research,” Journal of Law, Medicine & Ethics 28, no. 1 (2000): 4151.Google Scholar
Id. (Lara-Alvarez, et al.); see Seguin, et al., supra, note 8.Google Scholar
Smith-Morris, C., “Autonomous Individuals or Self-Determined Communities? The Changing Ethics of Research among Native Americans,” Human Organization 66, no. 3 (2007): 327336.CrossRefGoogle Scholar
Brugge, D. and Missaghian, M., “Protecting the Navajo People through Tribal Regulation of Research,” Science and Engineering Ethics 12, no. 3 (2006): 491507.CrossRefGoogle Scholar
Becenti-Pigman, B. et al., Research Policies, Processes and Protocol, Appendix H, Navajo Nation Human Research Review Board (2008), available at <http://depts.washington.edu/deptgh/docs/Appendix_H2DNavajo_Nation_HRRB_Proto-col-2.pdf> (last visited August 4, 2010).Google Scholar
These approaches to “community consent” differ from the concept of “group consent” initially proposed by the Model Ethical Protocol (MEP) of the Human Genome Diversity project. The key difference lies in the fundamental justification for the two consents and the entities to which they apply. Community consent derives from sociological criteria of community sovereignty, self-governance, and self-determination. The MEP concept of group consent derives from biological criteria that do not necessarily overlap with extant social groups and, as Reardon notes, poses fundamental questions about who defines the “group,” by what criteria, and for what research purpose (see Reardon, , supra, note 3). In practice, the researchers defined the “groups” using criteria defined by the research protocol. In contrast, the procedures of community consent apply when indigenous research subjects live under the jurisdiction of some kind of self-governing indigenous community that defines the community using self-determined criteria of citizenship. Membership in the community rather than sampling criteria in a research protocol define the scope of consent procedures. The CIHR Guidelines give a range of circumstances to which the procedures of community consent might apply in varying ways. The Guidelines acknowledge the possibility that the procedures of community consent may not apply to research conducted with individuals living outside the jurisdiction of a self-governing indigenous community (see CIHR, supra, note 22).Google Scholar
Burhansstipanov, L. et al., “Native American Cancer Education: Genetics and Cultural Issues,” Journal of Cancer Education 16, no. 3 (2001): 142145; Dignan, M. et al., “Successful Implementation of Genetic Education for Native Americans Workshops at National Conferences,” Genetics 169 (February 2005): 517521.Google Scholar
Id. (Burhansstipanov, et al.)Google Scholar
See Dignan, et al., supra, note 44.Google Scholar
U.S. Department of Education, National Center for Education Statistics, NCES Number 92097 (1992); NCES Number 93292 (1993); NCES Number 94115 (1995); NCES Number 96133 (1996); NCES Number 98015 (1997); NCES Number 1999036 (1998); NCES Number 200031 (1999); NCES Number 2001034 (2000); NCES Number 2002130 (2001); NCES Number 2003061 (2002); NCES Number 2005017 (2003); NCES Number 2006005 (2004); NCES Number 2006030 (2005); NCES Number 2007017 (2006); NCES Number 2008023 (2007); NCES Number 2009021 (2008), available at <http://nces.ed.gov/programs/digest/> (last visited August 4, 2010).+(last+visited+August+4,+2010).>Google Scholar
National Science Foundation, “Tribal Colleges and Universities Program,” available at <http://www.nsf.gov/funding/pgm_summ.jsp?pims_id=5483> (last visited August 4, 2010).+(last+visited+August+4,+2010).>Google Scholar
National Human Genome Research Institute, “Minority Action Plan,” available at <http://www.genome.gov/l4514228> (last visited August 4, 2010).+(last+visited+August+4,+2010).>Google Scholar
Association of American Indian Physicians, “About AAIP,” available at <http://www.aaip.org/?page=Overview> (last visited August 4, 2010).+(last+visited+August+4,+2010).>Google Scholar
Society for Advancing Hispanics/Chicanos & Native Americans in Science, “Historical Overview,” available at <http://www.sacnas.org/historicalOverview.cfm> (last visited August 4, 2010).+(last+visited+August+4,+2010).>Google Scholar
American Indian Science and Engineering Society, “About Us,” available at <http://www.aises.org/AboutUs> (last visited August 4, 2010).+(last+visited+August+4,+2010).>Google Scholar
See Smith-Morris, , supra, note 39.Google Scholar
Communities not interested in training as scientists should, however, also be able to benefit from genomic research. The Amish provide a strong example of a community fully interested in participating in genomic research, but not necessarily interested in training as scientists. Ruder, K., “Genomics in Amish Country,” Genomic News Network, July 23, 2004.Google Scholar
Cargo, M. et al., “Community Governance of the Kahnawake Schools Diabetes Prevention Project, Kahnawake Territory, Mohawk Nation, Canada,” Health Promotion International 18, no. 3 (2003): 177187.CrossRefGoogle Scholar
Macauley, A. et al., “Community Empowerment for the Primary Prevention of Type 2 Diabetes: Kanien'kehá: Ka (Mohawk) Ways for the Kahnawake School Diabetes Prevention Project,” in Leal Ferreira, M. and Chesley Lang, G., eds., Indigenous Peoples and Diabetes: Community Empowerment and Wellness, (Durham: North Carolina Press, 2006).Google Scholar
Id.; Grignon, J., Wong, K. A., and Seifer, S. D., Ensuring Community-Level Research Protections, Proceedings of the 2007 Educational Conference Call Series on Institutional Review Boards and Ethical Issues in Research (Seattle, WA: Community-Campus Partnerships for Health, 2008).Google Scholar
See Macauley, et al., supra, note 57.Google Scholar
National Health and Medical Research Council, The NHMRC Road Map: A Strategic Framework for Improving Aboriginal and Torres Strait Islander Health through Research and Final Report of Community Consultations on the NHMRC Road Map, available at <http://www.nhmrc.gov.au/publications/synopses/r28syn.htm> (last visited August 4, 2010).+(last+visited+August+4,+2010).>Google Scholar
National Institutes of Health, Update on the Requirement for Instruction in the Responsible Conduct of Research, available at <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html> (last visited August 4, 2010).+(last+visited+August+4,+2010).>Google Scholar
White, R., Putting Risk in Perspective: Black Teenage Lives in the Era of AIDS (Maryland: Rowman & Littlefield Publishers, Inc., 1999).Google Scholar
Health Insurance Portability and Accountability Act of 1996, available at <http://www.cms.hhs.gov/hipaageninfo/down-loads/hipaalaw.pdf> (last visited August 4, 2010).+(last+visited+August+4,+2010).>Google Scholar
See CIHR, supra, note 22, at 5.Google Scholar
Id., at 28.Google Scholar
Harmon, A., “‘Informed Consent’ and the Ethics of DNA Research,” New York Times, April 23, 2010; Harmon, A., “Indian Tribe Wins Fight to Limit Research of Its DNA,” New York Times, April 21, 2010.Google Scholar
National Health and Medical Research Council, Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research, Australian Health Ethics Committee, 2003.Google Scholar