Expanding the ethical analysis of biobanks

Journal of Law, Medicine and Ethics

Volumn 33, Issue 1, 2005, Pages 89-101

  Rothstein, Mark A ^a,b  

^a University of Louisville School of Medicine   (United States)

^b UNIVERSITY OF LOUISVILLE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCESS TO INFORMATION; ADMINISTRATIVE PERSONNEL; AUTHORITY; BIOINFORMATICS; BIOMEDICINE; COMMERCIAL PHENOMENA; CONFERENCE PAPER; FINANCIAL MANAGEMENT; HEALTH CARE FACILITY; HEALTH CARE POLICY; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; LEGAL LIABILITY; MEDICAL INFORMATION; MEDICAL RECORD; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; PRIVACY; RESEARCH ETHICS; RISK BENEFIT ANALYSIS;

EID: 17944366421     PISSN: 10731105     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2005.tb00213.x     Document Type: Conference Paper

References (76)

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2. De Code Genetics, using a database of donated samples, has announced preliminary advances in discovering the genetics of cardiovascular disease, schizophrenia, osteoporosis, and other disorders. See 〈www.decode.com〉 (last accessed February 1, 2005).
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9. In a nationwide interview survey of 2108 individuals, 83.1% said they were concerned about genetic discrimination. M. A. Rothstein and C. A. Hornung, "Public Attitudes," in Genetics and Life Insurance: Medical Underwriting and Social Policy (Cambridge, MA: MIT Press, 2004). In a survey of genetic counselors, patients' concerns about genetic discrimination were overshadowed by psychological and other concerns. See M. A. Hall and S. S. Rich, "Genetic Privacy Laws and Patients' Fear of Discrimination by Health Insurers: The View From Genetic Counselors," Journal of Law, Medicine & Ethics 28 (2000): 245-257.
10. In a nationwide interview survey of 2108 individuals, 83.1% said they were concerned about genetic discrimination. M. A. Rothstein and C. A. Hornung, "Public Attitudes," in Genetics and Life Insurance: Medical Underwriting and Social Policy (Cambridge, MA: MIT Press, 2004). In a survey of genetic counselors, patients' concerns about genetic discrimination were overshadowed by psychological and other concerns. See M. A. Hall and S. S. Rich, "Genetic Privacy Laws and Patients' Fear of Discrimination by Health Insurers: The View From Genetic Counselors," Journal of Law, Medicine & Ethics 28 (2000): 245-257.
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16. There is some evidence that these broader issues related to research are being considered by researchers, IRBs, research sponsors, and regulators. See generally, J. P. Kahn, A. C. Mastroianni, and J. Sugarman, eds., Beyond Consent: Seeking Justice in Research (New York: Oxford University Press, 1998).
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18. See R. F. Weir and R. S. Olick, The Stored Tissue Issue: Biomedical Research, Ethics and Law in the Era of Genomic Medicine (New York: Oxford University Press, 2004); T. Caulfield, R. E. G. Upshur, and A. Daar, "DNA Databanks and Consent: A Suggested Policy Option Involving an Authorization Model," BMC Medical Ethics 4 (2003): 1, available at 〈http://www. biomedcentral.com/1472-6939/4/1〉 (last visited February 1, 2005).
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20. 45 C.F.R. § 46.102(f).
21. Office for Human Research Protections, Department of Health and Human Services, Guidance on Research Involving Coded Private Information or Biological Specimens (August 10, 2004), available at 〈www.hhs.gov/ohrp/humansubjects/ guidance/cdebiol.pdf〉 (last accessed February 1, 2005).
22. For a further discussion, see E. W. Clayton, "Informed Consent and Biobanks," Journal of Law, Medicine & Ethics 33, no. 1 (2005): 15-21.
23. 45 C.F.R. §164.514(e).
24. OHRP, supra note 19.
25. Unfortunately, allowing research subjects to treat research on mental illness, HIV/AIDS, and other sensitive conditions separately may lead to reinforcing the stigma of the conditions, but efforts to reduce stigma should be directed elsewhere and should not trump the autonomy of research subjects.
26. Another way of structuring a "menu" would be to focus on the outcome of the research, such as research that could result in prenatal testing and research on behavioral traits.
27. National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, vol. 1 (Rockville, MD: U.S. Gov't Printing Office, 1999): at 64-66. See also H. T. Greely, "Breaking the Stalemate: A Prospective Regulatory Framework for Unforeseen Research Uses of Human Tissue Samples and Health Information," Wake Forest Law Review 34 (1999): 737-66. The menu approach would require the use of information technology capable of tracking restrictions on the use of donated samples.
28. National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, vol. 1 (Rockville, MD: U.S. Gov't Printing Office, 1999): at 64-66. See also H. T. Greely, "Breaking the Stalemate: A Prospective Regulatory Framework for Unforeseen Research Uses of Human Tissue Samples and Health Information," Wake Forest Law Review 34 (1999): 737-66. The menu approach would require the use of information technology capable of tracking restrictions on the use of donated samples.
29. E. W. Clayton, supra note 20.
30. 45 C.F.R. Parts 160, 164.
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33. I b i d.
34. It is easy to imagine a situation in which a cancer patient consents to donate his or her surgically excised tumor to a biobank on the express condition that neither the biobank nor any researcher associated with the biobank will ever contact the individual again. Because current HIPAA rules would require additional authorizations for each research protocol, the biobank would have to violate the individual's express wishes or discard the sample.
35. 45 C.F.R. § 164.508(c).
36. 45 C.F.R. § 164.508(c)(1)(v).
37. 45 C.F.R. § 164.528(a)(iv).
38. See supra note 23.
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45. Of course, to the extent that medical research advances the state of the art, then patients and the public also benefit.
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51. See, e.g., L. S. Cahill, "Genetics, Commodification, and Social Justice in the Globalization Era," Kennedy Institute of Ethics Journal 11 (2001): 221-238.
52. See H. T. Greely, "The Control of Genetic Research: Involving the 'Groups Between,'" Houston Law Review 33 (1997): 1397-1430; Z. Q. Khan, "Colonialism Revisited: Insights into the Human Genome Diversity Project," Journal of Law & Social Challenges 3 (1999): 89-115.
53. See H. T. Greely, "The Control of Genetic Research: Involving the 'Groups Between,'" Houston Law Review 33 (1997): 1397-1430; Z. Q. Khan, "Colonialism Revisited: Insights into the Human Genome Diversity Project," Journal of Law & Social Challenges 3 (1999): 89-115.
54. See NIH News Advisory, Background on Ethical and Sampling Issues Raised by the International HapMap Project, available at 〈http://genome.gov/page. cfm?pageID=10005337〉 (last visited February 1, 2005).
55. See, e.g., M. W. Foster et al., "A Model Agreement for Genetic Research in Socially Identifiable Populations," American Journal of Human Genetics 63 (1998): 696-702.
56. See M. R. Anderlik and M. A. Rothstein, "Canavan Decision Favors Researchers Over Families," Journal of Law, Medicine & Ethics 31, no. 3 (2003): 450-454.
57. L. B. Andrews, "Harnessingthe Benefits of Biobanks," Journal of Law, Medicine & Ethics 33, no 1 (2005): 22-30.
58. HUGO Ethical, Legal, and Social Issues Committee Report to HUGO Council, Statement on the Principled Conduct of Genetics Research, Recommendation 9, March 21, 1996, at 〈http://www.gene.ucl.ac.uk/hugo/conduct.htm〉 (last visited February 1, 2005).
59. See Andrews, supra note 52, at 30, n. 47.
60. Greenberg v. Miami Children's Hosp., 264 F.Supp.2d 1064 (S.D. Fla. 2003).
61. Moore v. Regents of the Univ. of Cal., 793 P.2d 479 (Cal. 1990).
62. Greenberg v. Miami Children's Hosp., 264 F.Supp.2d 1064 (S.D. Fla. 2003).
63. M. Deschênes and C. Sallée, "Accountability in Population Biobanking: Comparative Approaches," Journal of Law, Medicine & Ethics 33, no. 1 (2005): 40-53.
64. Williams and Schroeder, supra note 46.
65. Id. at 98 (emphasis in original).
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71. Moore v. Regents of Univ. of Cal., 793 P.2d 479 (Cal. 1990).
72. In 1951, Henrietta Lacks died of ovarian cancer, and without her knowledge or consent her tissue was made into a cell line that has been used by researchers for over 50 years. See H. A. Washington, "Henrietta Lacks - An Unsung Hero," Emerge, Oct. 1994, at 29.
73. Greenberg v. Miami Children's Hosp., 264 F. Supp. 1064 (S.D. Fla. 2003).
74. For a description of the background of this pending case, see R. Dalton, "When Two Tribes Go to War," Nature 430 (2004): 500-502.
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