Ethical issues in tissue banking for research: the prospects and pitfalls of setting international standards.

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.