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Federal Court Says University Is Custodian of Biospecimens
Federal agencies are not the only ones grappling with issues of biospecimen ownership: the courts are weighing in as well. In April 2006, a U.S. District Court judge in St. Louis ruled that Washington University "owns all biological materials, including but not limited to blood, tissue, and DNA samples" in a large prostate tissue bank collected by urologist William Catalona, M.D., over nearly 30 years. Catalona had sued the university to move the tissue samples with him to Northwestern University in Chicago in 2003.
The ruling could have far-reaching consequences. It sets a precedent that universities are the custodians of biospecimen resources, not individual investigators or the people who donated their tissue for research. The judge ruled that when individuals donate biospecimens for medical research they give up ownership rights over the tissue.
Judge Stephen Limbaugh wrote "there is little dispute as to the scarcity of the legal precedent to assist the Court in addressing the situation." Nonetheless, the Judge cited two previous cases, in Florida and California, where the courts had ruled that research participants surrender ownership of any biological materials they contribute to medical research.
Catalona has appealed, and the issues it raises are far from settled.
"It's a little unnerving to think that every state could set its own precedent," said Carolyn Compton, M.D., Ph.D., director of the Office of Biorepositories and Biospecimen Research at NCI. "This may go up to the federal level."
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