Panel Comment: Why the Use of Anonymous Samples for Research Matters

45 C.F.R. § 46.101–.409 (1994).

Annas G.J. Glantz L.H. Roche P.A. , The Genetic Privacy Act and Commentary (Boston: Boston University School of Public Health, 1995): § 131(d)(2).

Id. at 53–54. It is difficult to know what constitutes privacy interests, because that term is not defined either in the GPA or in the accompanying Commentary.

Id. § 131(g).

Hernnstein R.J. Murray C. , The Bell Curve: Intelligence and Class Structure in American Life (New York: Free Press, 1994); and Fraser S. , ed., The Bell Curve Wars: Race, Intelligence and the Future of America (New York: Basic Books, 1995).

Nelkin D. Tancredi L. , Dangerous Diagnostics: The Social Power of Biological Information (New York: Basic Books, 1989); Alper J.S. Beckwith J. , “Genetic Fatalism and Social Policy: The Implications of Behavior Genetics Research,” Yale Journal of Biology and Medicine, 66 (1993): 511–24; Anonymous, “Genetic Expectations,” Nature, 373 (1995): 644; Horgan J. , “Eugenics Revisited,” Scientific American, 268, no. 6 (1993): 122–31; Kevles D.J. , “Vital Essences and Human Wholeness: The Social Readings of Biological Information,” Southern California Law Review, 65 (1991): 255–78; Maddox J. , “Wilful Public Misunderstanding of Genetics,” Nature, 364 (1993): 281; Rose S. , “The Rise of Neurogenetic Determinism,” Nature, 373 (1995): 380–82; and Rose S. , “Neurogenetic Determinism,” Science, 265 (1994): 1159.

For a particularly thoughtful analysis of similar issues in the context of anonymous HIV-seroprevalence testing, see Kopelman L.M. , “Informed Consent and Anonymous Tissue Samples: The Case of HIV Seroprevalence Studies,” Journal of Medicine and Philosophy, 19 (1994): 525–52.

See generally Lippman A. , “Prenatal Genetic Testing and Screening: Constructing Needs and Reinforcing Inequities,” American Journal of Law & Medicine, XVII (1991): 15–50; see also supra note 6.

“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” 45 C.F.R. § 46.102(1) (1994) (italics original).

45 C.F.R. § 46.116(d)(1).

Somatic or acquired mutations are an exception. This distinction, however, is not always clear in practice because some mutations that are frequently observed to be acquired, such as those in p53, may also be present in some individuals' germ line, as is observed in the families affected by Li-Fraumeni syndrome.

Heyman S.J. , “Foundations of the Duty to Rescue,” Vanderbilt Law Review, 47 (1994): 6730–755.

Callahan D. , “Bioethics: Private Choice and Public Good,” Hastings Center Report, 24, no. 3 (1994): 28–29.

45 C.F.R. § 46.101(b)(4).

Kopelman , supra note 7; and Clayton E.W. , “Informed Consent for Genetic Research on Stored Tissue Samples,” JAMA, 274 (1995): 1786–92.

Kopelman , supra note 7; and Clayton , supra note 15.