Skip to main content
Log in

Ethical Issues in Tissue Banking for Research: The Prospects and Pitfalls of Setting International Standards

  • Published:
Theoretical Medicine and Bioethics Aims and scope Submit manuscript

Abstract

Bauer, Taub, and Parsi's review of an international sample of standards on informed consent, confidentiality, commercialization, and quality of research in tissue banking reveals that no clear national or international consensus exists for these issues. The authors' response to the lack of uniformity in the meaning, scope, and ethical significance of the policies they examined is to call for the creation of uniform ethical guidelines. This raises questions about whether harmonization should consist of voluntary international standards or international regulations that include an official oversight mechanism and sanctions for noncompliance, and about who should participate in the harmonization process. Moreover, the normative assumptions and political dynamics that shape global policymaking need to be addressed. This commentary explores the policy implications and normative questions raised by the idea of international ethical guidelines for the use of biotechnologies and biotechnological resources such as stored samples of human tissue.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

REFERENCES

  • Anderlik, Mary R. “Commercial Biobanks and Genetic Research: Ethical and Legal Issues.” American Journal of Pharmacogenomics 3,no. 3 (2003): 203–215.

    Google Scholar 

  • Bonnicksen, Andrea L. Crafting a Cloning Policy. Washington, DC: Georgetown University Press, 2002.

    Google Scholar 

  • Booth, Paul M. “FDA Implementation of Standards Developed by the International Conference on Harmonisation.” 53 Food and Drug Law Journal 203 (1997).

    Google Scholar 

  • Brennan, Troyen A. “Proposed Revisions to the Declaration of Helsinki — Will They Weaken the Ethical Principles Underlying Human Research?” New England Journal of Medicine 341 (1999): 527–531.

    Google Scholar 

  • Center for Genetics and Society, Genetic Crossroads #36, The Newsletter of the Center for Genetics and Society 2003. Special Report on the UN Cloning Treaty Negotiations. Human Cloning, the United Nations, and Beyond, http://www.genetics-and-society.org/policies/international/2003unreport.html.

  • Center for Global Ethics, http://astro.temple.edu/~;dialogue/geth.htm (accessed ■).

  • Chandler, David. “Universal Ethics and Elite Politics: The Limits of Normative Human Rights Theory.” The International Journal of Human Rights 5,no 4. (2001): 72–89.

    Google Scholar 

  • de Bary, William Theodore and Tu Weiming, eds. Confusianism and Human Rights. New York: Columbia University Press, 1997.

    Google Scholar 

  • Dickenson, Donna L. “Cross-Cultural Issues in European Bioethics.” Bioethics 13,no. 2 (1999): 249–255.

    Google Scholar 

  • Dunne, Tim and Nicholas J. Wheeler, eds. Human Rights in Global Politics. Cambridge: Cambridge University Press, 1999.

    Google Scholar 

  • Eiseman, Elisa and Susanne B. Haga. Handbook of Human Tissue Sources: A National Resource of Human Tissue Samples. RAND, 1999.

  • Engle, Karen. “Culture and Human Rights: The Asian Values Debate in Context.” International Law and Politics 32 (2000): 291–333.

    Google Scholar 

  • Forsythe, David P. Human Rights in International Relations. Cambridge: Cambridge University Press, 2000.

    Google Scholar 

  • Fox, Diana J. “Women's Human Rights in Africa: Beyond the Debate over the Universality or Relativity of Human Rights.” http://web.africa.ufl.edu/asq/v2/v2i3a2.htm (accessed ■).

  • Frank, Thomas M. “Are Human Rights Universal?” Foreign Affairs 80 (2001): 191–204.

    Google Scholar 

  • Ghai, Yash. “Universalism and Relativism: Human Rights as a Framework for Negotiating Interethnic Claims.” 21 Cardozo Law Review 1095 (2000).

    Google Scholar 

  • Glendon, Mary Ann. A World Made New: Eleanor Roosevelt and the Universal Declaration of Human Rights. New York: Random House, 2001.

    Google Scholar 

  • Guttmacher, Alan E. and Collins Francis S. “Genomic Medicine — A Primer.” New England Journal of Medicine 347,no. 19 (2002): 1512–1520.

    Google Scholar 

  • Hernandez-Truyol, Berta Esperanza. “Women's Rights as Human Rights — Rules, Realities and the Role of Culture: A Formula for Reform.” 21 Brooklyn Journal of International Law 605 (1996).

    Google Scholar 

  • Hottois, Gilbert. “A Philosophical and Critical Analysis of the European Convention in Bioethics.” Journal of Medicine and Philosophy 25,no. 2 (2000): 133–146.

    Google Scholar 

  • Ignatieff, Michael. “The Attack on Human Rights.” Foreign Affairs 80,no. 6 (2001): 102–136.

    Google Scholar 

  • Institute for Global Ethics, http://www.globalethics.org/ (accessed ■).

  • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The Future of ICH — Revised 2000. Statement by the ICH Steering Committee on the Occasion of the Fifth International Conference on Harmonisation, 9–11 November 2000, San Diego. http://www.ifpma.org/ich1.html.

  • Ivanova, Maria A. “Partnerships, International Organizations, and Global Environmental Governance.” In Progress or Peril? Partnerships and Networks in Global Environmental Governance. The Post-Johannesburg Agenda, (edited by) Jan Martin Witte, Charlotte Streck, and Thorsten Benner. Washington, DC/Berlin: GPPi, 2003. http://www.gppi.net/cms/private/733fcce3b8a12af6d33ae-343955d9269Progress%20or%20Peril%20Ivanova.pdf.

    Google Scholar 

  • Kaiser, Jocelyn. “Population Databases Boom, From Iceland to the U.S.” Science 298 (2002): 1158–1161.

    Google Scholar 

  • Karim, Salim S. Abdool. “Placebo Controls in HIV Perinatal Transmission Trials: A South African's Viewpoint.” American Journal of Public Health 88,no. 4 (1998): 564–566.

    Google Scholar 

  • knop.pdf (accessed ■).

  • Macklin, Ruth. Against Relativism. New York: Oxford University Press, 1999.

    Google Scholar 

  • Madison, G.B. “China in a Globalizing World: Reconciling the Universal with the Particular.” Dialogue and Universalism 11–12 (2002): 51–79.

    Google Scholar 

  • McElderry, Kevin. Germany Anguishes over Embryonic Life in Cloning Debate. Agence France Press, 2003.

  • Meijer, Martha. Dealing with Human Rights: Asian and Western Views on the Value of Human Rights. Bloomfield, CT: Kumarian Press, 2001.

    Google Scholar 

  • Miller, Michelle D. “The Informed-Consent Policy of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: Knowledge is the Best Medicine.” 30 Cornell International Law Journal 203 (1997).

    Google Scholar 

  • National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance. Rockville, MD, 1999.

  • Patman, Robert G. Universal Human Rights? New York: St Martin's Press, 2000.

    Google Scholar 

  • Perry, Michael J. The Idea of Human Rights. New York: Oxford University Press, 1998.

    Google Scholar 

  • Reinicke, Wolfgang H. “The Other World Wide Web: Global Public Policy Networks.” Foreign Policy (Winter 1999): 44–57.

  • Ryan, Ann E. “Protecting the Rights of Pediatric Research Subjects in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.” 23 Fordham International Law Journal 848 (2000).

    Google Scholar 

  • Salter, Brian, and Mavis Jones. “Regulating Human Genetics: The Changing Politics of Biotechnology Governance in the European Union.” http://www.uea.ac.uk/~x514/research/governance/Polbio.pdf (accessed ■).

  • Sass, Hans-Martin. “Introduction: European Bioethics on a Rocky Road.” Journal of Medicine and Philosophy 26,no. 3 (2001): 215–224.

    Google Scholar 

  • Susser, Mervyn. “Editor's Note: The Prevention of Perinatal HIV Transmission in the Less-Developed World.” American Journal of Public Health 88,no. 4 (1998): 547–548.

    Google Scholar 

  • Taylor, Allyn L. “Globalization and Biotechnology: UNESCO and an International Strategy to Advance Human Rights and Public Health.” American Journal of Law and Medicine 15 (1999): 479–541.

    Google Scholar 

  • United Kingdom, Department of Health. An Interim Statement on the Use of Human Organs and Tissue. 2003. http://www.doh.gov.uk/tissue/interimstatement.htm

  • United Nations Treaty Collection. Treaty Reference Guide. http://untreaty.un.org/English/guide/pdf (accessed ■).

  • U.S. Department of State, International Information Programs. Fact Sheet: The United States Rejoins UNESCO. 27 September 2003. http://usinfo.state.gov/topical/pol/usandun/03092200.htm.

  • Varmus, Harold and David Satcher. “Ethical Complexities of Conducting Research in Developing Countries.” New England Journal of Medicine 337,no. 14 (1997): 1003–1005.

    Google Scholar 

  • Venter, Christine Mary. “The New South African Constitution: Facing the Challenges of Women's Rights and Cultural Rights in Post-Apartheid South Africa.” Journal of Legislation 21 (1995): 1–22.

    Google Scholar 

  • Victor, David G., Kal Raustiala, and Eugene B. Skolnikoff, eds. The Implementation and Effectiveness of Environmental Commitments: Theory and Practice. Cambridge: MIT Press, 1998.

    Google Scholar 

  • Waltz, Susan, “Universalizing Human Rights: The Role of Small States in the Construction of the Universal Declaration of Human Rights.” Human Rights Quarterly 23 (2001): 44–72.

    Google Scholar 

  • Whitman, Jim. “Global Dynamics and the Limits of Global Governance.” Global Society 17,no. 3 (2003): 253–272.

    Google Scholar 

  • Whitney R. Harris Institute for Global Legal Studies. Washington University School of Law. http://ls.wustl.edu/igls/.

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Maschke, K.J., Murray, T.H. Ethical Issues in Tissue Banking for Research: The Prospects and Pitfalls of Setting International Standards. Theor Med Bioeth 25, 143–155 (2004). https://doi.org/10.1023/B:META.0000033773.44765.7c

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1023/B:META.0000033773.44765.7c

Navigation