Washington Univ. v. Catalona, 437 F. Supp.2d 985(E.D. Mo. 2006), aff’d 490 F.3d 667 (8th Cir. 2007).
Unanswered Questions after Greenberg… If the research subjects don’t own their tissue samples, who does?
Dr. Catalona, a respected urologic surgeon at Washington University, conducted prostate cancer by collecting blood and tissue samples from his surgical patients for research use. He helped to establish the Genito-Urinary (GU) Repository at Wash U. to hold the collected samples. Patients contributing to repository executed informed consent forms. In 2003, Dr. Catalona transferred to Northwestern University and sought to take the GU Repositorysamples with him. Wash U. filed a law suit to establish ownership.
- The Court held that individuals who make an informed, voluntary decision to contribute their biological materials to a particular research institution for the purpose of medical research do not retain an ownership interest in those materials.
- • Individuals cannot direct or authorize the transfer of their biological materials to a third party.
- – Under Missouri law, the Washington University exhibited ownership.– The contributions were inter vivos gifts to Washington University.
- – Pursuant to the informed consent forms, patients retained only the right to withdraw