Awareness and Acceptable Practices: IRB and Researcher Reflections on the Havasupai Lawsuit

AJOB Primary Research

Volumn 4, Issue 4, 2013, Pages 55-63

  Garrison, Nanibaa' A ^a   Cho, Mildred K ^a  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Havasupai; informed consent; institutional review boards; research ethics

Indexed keywords

EID: 84883545892     PISSN: 21507716     EISSN: 21507724     Source Type: Journal    
DOI: 10.1080/21507716.2013.770104     Document Type: Article

References (31)

1. Blue Ridge Institute for Medical Research. 2010. NIH awards to medical schools by rank fiscal year 2009, Blue Ridge Institute for Medical Research 2009. Available at: http://www.brimr.org/NIH_Awards/2009/NIH_Awards_2009.htm (accessed August 27, 2010)
2. Bommersbach, J. 2008. Arizona's broken arrow Available at: http://www.phoenixmag.com/lifestyle/200811/arizona-s-broken-arrow
3. Carmichael, M. 2011. Newborn screening: A spot of trouble. Nature, 475 (7355): 156 - 158.
4. Carmichael, M. 2011. Newborn screening: A spot of trouble. Nature, 475 (7355): 156 - 158.
5. Cho, M. K., Tobin, S. L., Greely, H. T., McCormick, J., Boyce, A. and Magnus, D. 2008. Strangers at the benchside: Research ethics consultation. American Journal of Bioethics, 8 (3): 4 - 13.
6. Dalton, R. 2004. When two tribes go to war. Nature, 430 (6999): 500 - 502.
7. Department of Health and Human Services. 2005. " Protection of human subjects ". In Title 45, Code of Federal Regulations, Part 46, ed. Department of Health and Human Services, Washington, DC: U.S. Department of Health and Human Services, National Institutes of Health, Office for Protection from Research Risks.
8. Department of Health and Human Services. 2011. Human subjects research protections: Enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Fed. Reg., 76: 44512 - 44531.
9. Edwards, K. L., Lemke, A. A. Trinidad, S. B. 2011. Attitudes toward genetic research review: results from a survey of human genetics researchers. Public Health Genomics, 14 (6): 337 - 345.
10. Greely, H. T. 1998. Legal, ethical, and social issues in human genome research. Annual Review of Anthropology, 27: 473 - 502.
11. Greely, H. T. 2001. Informed consent and other ethical issues in human population genetics. Annual Review of Genetics, 35: 785 - 800.
12. Harmon, A. 2006. " DNA gatherers hit snag: Tribes don't trust them ". In New York Times December 10. Available at: http://www.nytimes.com/2006/12/10/us/10dna.html
13. Harmon, A. 2010. " Indian tribe wins fight to limit research of its DNA ". In New York Times April 22, Available at: http://www.nytimes.com/2010/04/22/us/22dna.html
14. Harry, D. 2009. The Human Genome Diversity Project and its implications for indigenous peoples, Indigenous Peoples' Council on Biocolonialism 1995. Available at: http://www.ipcb.org/publications/briefing_papers/files/hgdp.html (accessed November 26, 2009)
15. Hart, S. and Sobraske, K. A. 2003. Investigative report concerning the medical genetics project at Havasupai. Arizona State University Law Library, December 23. Photocopy of investigative report available at the Arizona State University Ross-Blakey Law Library, Reserves.
16. Havard, M., Cho, M. K. and Magnus, D. 2012. Triggers for research ethics consultation. Science Translational Medicine, 4 (118): 118cm1
17. 2004. Havasupai Tribe of the Havasupai Reservation v. Arizona Board of Regents and Therese Ann Markow, Coconino County, Superior Court of Arizona.
18. Ladd, J. M., Lappe, M. D., McCormick, J. B., Boyce, A. M. and Cho, M. K. 2009. The "how" and "whys" of research: Life scientists' views of accountability. Journal of Medical Ethics, 35 (12): 762 - 767.
19. Lakes, K. D., Vaughan, E., Jones, M., Burke, W., Baker, D. and Swanson, J. M. 2012. Diverse perceptions of the informed consent process: Implications for the recruitment and participation of diverse communities in the National Children's Study. American Journal of Community Psychology, 49 (1-2): 215 - 232.
20. Ludman, E. J., Fullerton, S. M. Spangler, L. 2010. Glad you asked: Participants' opinions of re-consent for dbGaP data submission. Journal of Empirical Research on Human Research Ethics, 5 (3): 9 - 16.
21. McCormick, J. B., Boyce, A. M. and Cho, M. K. 2009. Biomedical scientists' perceptions of ethical and social implications: is there a role for research ethics consultation?. PLoS One, 4 (3): e4659
22. McInnes, R. R. 2011. 2010 Presidential address: Culture: The silent language geneticists must learn-Genetic research with indigenous populations. American Journal of Human Genetics, 88 (3): 254 - 261.
23. Mello, M. M. and Wolf, L. E. 2010. The Havasupai Indian tribe case-Lessons for research involving stored biologic samples. New England Journal of Medicine, 363 (3): 204 - 207.
24. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1978. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research, Washington, DC: Department of Health, Education, and Welfare. DHEW Publication no. (OS) 78-0012
25. Public Responsibility in Medicine and Research. 2010. The Havasupai settlement: Implications for HRPPs, IRBs, and researchers, Public Responsibility in Medicine and Research (PRIM&R). Available at: http://www.primr.org/Conferences.aspx?id=8631 (retrieved February 22, 2012)
26. Reverby, S. M. 2009. Examining Tuskegee: The infamous syphilis study and its legacy, Chapel Hill: University of North Carolina Press.
27. Scharff, D. P., Mathews, K. J., Jackson, P., Hoffsuemmer, J., Martin, E. and Edwards, D. 2010. More than Tuskegee: Understanding mistrust about research participation. Journal of the National Medical Association, 21: 879 - 897.
28. Silberman, G. and Kahn, K. L. 2011. Burdens on research imposed by institutional review boards: The state of the evidence and its implications for regulatory reform. Milbank Quarterly, 89 (4): 599 - 627.
29. Skloot, R. 2010. The immortal life of Henrietta Lacks, New York, NY: Random House.
30. Tarini, B. A., Goldenberg, A., Singer, D., Clark, S. J., Butchart, A. and Davis, M. M. 2010. Not without my permission: Parents' willingness to permit use of newborn screening samples for research. Public Health Genomics, 13 (3): 125 - 130.
31. Trinidad, S. B., Fullerton, S. M., Ludman, E. J., Jarvik, G. P., Larson, E. B. and Burke, W. 2011. Research ethics. Research practice and participant preferences: the growing gulf. Science, 331 (6015): 287 - 288.