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In Reply: The case in which Dr Catalona is involved presents potentially important issues for academic researchers. For this reason, we described it briefly in our article on ownership of tissue samples, taking our information from documents filed with the district court, as noted in the article. Dr Catalona emphasizes in his letter that his lawsuit pertains to competing rights in a tissue collection rather than rights in research products derived from human tissue samples. We did not speculate about the merits of the case because the parties have neither presented all the underlying facts to the court nor argued their interpretations of applicable laws, and the court has not rendered a decision.

Our article analyzes the existing judicial decisions and the regulatory and ethical standards that affect ownership of tissue samples used for research. Federal regulations do not address ownership of tissue samples directly. Therefore, we suggest that . . . [Full Text of this Article]

Rina Hakimian, JD, MPH
rina.hakimian@psc.hhs.gov
US Department of Health and Human Services
Rockville, Md

David Korn, MD
Division of Biomedical and Health Sciences Research
Association of American Medical Colleges
Washington, DC

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