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To the Editor: I am the physician-researcher formerly affiliated with Washington University in St Louis, Mo, whose legal case was discussed in the Health Law and Ethics article on ownership and use of tissue specimens for research.¹ Drs Hakimian and Korn got it backward in stating that I maintain that individuals enrolled in my research protocols during my tenure at Washington University " . . . waived their rights to their tissue samples through language in the informed consent document." To the contrary, it is my strong belief that, according to federal regulations, research participants cannot waive their rights to their tissue samples.²

Under the Code of Federal Regulations, obtaining identifiable private information or identifiable specimens under informed consent for research purposes constitutes human subjects research.³ Federal regulations state that research participants may withdraw from research at any time and for any reason and that they cannot waive this right.⁴ Because obtaining . . . [Full Text of this Article]

William J. Catalona, MD
wcatalona@nmff.org
Robert H. Lurie Comprehensive Cancer Center
Northwestern University Feinberg School of Medicine
Chicago, Ill

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