Abstract
Based on a general review of international, representative tissue banking policies that were described in the medical, ethics, and legal literature, this paper reviews the range of standards, both conceptually and in existing regulations, relevant to four main factors:(1) commercialization, (2) confidentiality, (3) informed consent, and (4) quality of research. These four factors were selected as reflective of some of the major ethical considerations that arise in the conduct of tissue banking research. The authors emphasize that any policy or ethical guidelines designed to regulate tissue bank research should address all four factors. Whenever this sort of research is conducted between several institutions or several countries, the paper suggests that the relevant entities work collaboratively to harmonize their standards.
Similar content being viewed by others
REFERENCES
American Association of Tissue Banks. “Ethical Guidelines for Commercial Activities and Advertising.” (September 11, 1996). Available at: http://www.aatb.org/guidelines.htm.
Ashburn T.T., Wilson S.K. and Eisenstein, B.I. “Human Tissue Research in the Genomic Era of Medicine: Balancing Individual and Societal Interests.” Archives of Internal Medicine 160 (2000): 3377–3384.
British Association of Tissue Banking. “General Standards for Tissue Banking.” (September 29, 1999). Available at: http://www.batb.org.uk/general1.htm.
Council on Ethical and Judicial Affairs, American Medical Association. Code of Medical Ethics: Current Opinions with Annotations. Chicago, IL: AMA Press, 2002.
cd/banks1-1ter.htm.
Department of Health and Human Services, Office of the Secretary. “Standards for Privacy of Individually Identifiable Health Information.” 45 CFR Parts 160 through 164. Available at: http://www.cms.hhs.gov/hipaa/hipaa2/regulations/privacy/finalrule/PvcTxt01.asp.
Department of Health and Human Services. “Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing.” Federal Register 66 (January 19, 2001): Rules and Regulations. Available at: http://www.fda.gov/cber/rules/frtisreg011901.pdf.
group_ethics/docs/avis11_en.pdf.
Greely H.T. “Breaking the Stalemate: A Regulating Framework for Unforeseen Research Uses of Human Tissue Samples and Health Information.” Wake Forest L Rev 34 (1999): 737–766.
Hogle L.F. Recovering the Nation's Body: Cultural Memory; Medicine; and the Politics of Redemption. New Brunswick, NJ: Rutgers University Press, 1999.
Indech B. “The International Harmonization of Human Tissue Regulation: Regulatory Control over Human Tissue Use and Tissue Banking in Select Countries and the Current State of International Harmonization Efforts.” Food and Law Journal 55 (2000): 343–372.
Josefson D. “Human Tissue for Sale: What Are the Costs?” Western Journal of Medicine 5 (2000): 302–303.
Josefson D. “US Hospitals to Ask Patients for Right to Sell Their Tissue.” British Medical Journal 321 (2000): 653.
Mahoney J.D. “The Market for Human Tissue.” Virginia Law Review 86 (2000): 163–223.
Martin J.B. and Kasper D.L. “In Whose Best Interest? Breaching the Academic-Industrial Wall.” New England Journal of Medicine 343 (2000): 1646–1649.
guide_fin.pdf.
Murray T.H. and Mehlman M.J., eds. Encyclopedia of Ethical; Legal; and Policy Issues in Biotechnology. New York: John Wiley and Sons, 2000.
National Organ Transplant Act, 1984. Pub L. No. 98-507, 3 USC *301.
Nelkin D. and Andrews L. “Homo Economicus: Commercialization of Body Tissue in the Age of Biotechnology.” Hastings Center Report 28 (1998): 30–39.
Swan J.P. Academic Scientist and the Pharmaceutical Industry. Baltimore: The John Hopkins University Press, 1988.
Wagner D. “Property Rights in the Human Body: The Commercialization of Organ Transplantation and Biotechnology.” Duquesne Law Review 33 (1995): 931–958.
Weir R.F., ed. Stored Tissue Samples: Ethical; Legal; and Public Policy Implications. Iowa City: University of Iowa Press, 1998.
Womack C. and Gray N. “Human Research Tissue Banks in the U.K. National Health Service: Law, Ethics, Controls and Constraints.” British Journal of Biomedical Science 55 (2000): 250–253.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Bauer, K., Taub, S. & Parsi, K. Ethical Issues in Tissue Banking for Research: A Brief Review of Existing Organizational Policies. Theor Med Bioeth 25, 113–142 (2004). https://doi.org/10.1023/B:META.0000033772.84738.ad
Issue Date:
DOI: https://doi.org/10.1023/B:META.0000033772.84738.ad