The Role of IRBs in Research Involving Commerical Biobanks

See, e.g., Greely H.T. , “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;.

Knoppers B.M. Hirtle M. Glass K.C. , “Commercialization of Genetic Research and Public Policy,” Science, 286 (1999):2277–78.

42 U.S.C. §§ 300gg—300gg-2 (2000).

45 C.F.R. § 164.501 (protected health information) (2001).

45 C.F.R. § 160.203(b) (2001).

45 C.F.R. § 164.508 (2001).

45 C.F.R. § 164.508(c) (2001).

45 C.F.R. § 164.512(i) (2001).

National Bioethics Advisory Commission (NBAC), Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, vol. 1 (Rockville, Maryland: U.S. Gov't Printing Office, 1999): at 64–65.

Id. at 64 (Recommendation 7).

See American Medical Association, “Section 8.031, Conflicts of Interest: Biomedical Research,” Code of Medical Ethics (Chicago: American Medical Association, 2000–2001).

See NBAC, supra note 8, at 64–66 (Recommendation 9)

See generally Greely, supra note 1.

See Juengst E.T. , “Commentary: What ‘Community Review’ Can and Cannot Do,” Journal of Law, Medicine & Ethics, 28 (2000): 52–66;.

Sharp R.S. Foster M.W. , “Involving Study Populations in the Review of Genetic Research,” Journal of Law, Medicine & Ethics, 28 (2000): 41–51.

See, e.g., Moore v. Regents of the Univ. of Cal., 793 P.2d 479 (Cal. 1990).