Hostname: page-component-78c5997874-mlc7c Total loading time: 0 Render date: 2024-11-15T01:55:56.558Z Has data issue: false hasContentIssue false
  • English
  • Français

The Role of IRBs in Research Involving Commerical Biobanks

Published online by Cambridge University Press:  01 January 2021

Mark A. Rothstein
Get access Rights & Permissions [Opens in a new window]

Extract

In the post-genome world of biomedical research, an increasingly common research strategy is to focus on large repositories of biological specimens. There are now several well-known efforts to compile vast collections of biological materials, reanalyze extant samples, collect new ones, and link the samples to medical records. The significant issues of law, ethics, and policy raised by these research activities usually are heightened when commercial enterprises play a leading role in accumulating and distributing the samples. Emerging companies are not only compiling repositories for their own use, but some companies are positioning themselves to act as intermediaries, developing vast biobanks for sale to a wide range of other researchers.

Type
Currents in Contemporary Ethics
Information
Journal of Law, Medicine & Ethics , Volume 30 , Issue 1 , Spring 2002 , pp. 105 - 108
Copyright
Copyright © American Society of Law, Medicine and Ethics 2002

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

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. and Glass, K.C., “Commercialization of Genetic Research and Public Policy,” Science, 286 (1999): 2277-78.Google Scholar
42 U.S.C. §§ 300gg—300gg-2 (2000).Google Scholar
45 C.F.R. § 164.501 (protected health information) (2001).Google Scholar
45 C.F.R. § 160.203(b) (2001).Google Scholar
45 C.F.R. § 164.508 (2001).Google Scholar
45 C.F.R. § 164.508(c) (2001).Google Scholar
45 C.F.R. § 164.512(i) (2001).Google Scholar
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.Google Scholar
Id. at 64 (Recommendation 7).Google Scholar
See American Medical Association, “Section 8.031, Conflicts of Interest: Biomedical Research,” Code of Medical Ethics (Chicago: American Medical Association, 2000–2001).Google Scholar
See NBAC, supra note 8, at 64–66 (Recommendation 9). See generally Greely, supra note 1.Google Scholar
See Juengst, E.T., “Commentary: What ‘Community Review’ Can and Cannot Do,” Journal of Law, Medicine & Ethics, 28 (2000): 52–66; Sharp, R.S. and Foster, M.W., “Involving Study Populations in the Review of Genetic Research,” Journal of Law, Medicine & Ethics, 28 (2000): 41-51.CrossRefGoogle Scholar
See, e.g., Moore v. Regents of the Univ. of Cal., 793 E2d 479 (Cal. 1990).Google Scholar