If a research subject donates a piece of tissue or some blood for the good of research, does that individual maintain the right to transfer ownership of his or her own biomedical sample to, say, a scientist departing for another research university, some time down the road?
That was the “pivotal inquiry” before the U.S. Court of Appeals for the Eighth Circuit in Washington University v. William J. Catalona, a case watched closely by research universities across the country. In a ruling Wednesday, the court upheld a lower court’s decision and offered the first appellate level answer to the thorny question of where a research subject’s rights to a sample stop and institutional rights begin. The standard assumption university hospitals have always worked from is that research subjects do not maintain a continuing right to direct the use of the samples they’ve signed over — or, this case asks, do they?
Research university leaders can breathe easy. In short, the decision reads, “the answer is no.” And given the timing, that simple answer is especially significant, as more and more institutions have invested heavily in biomedical research centers and blood and tissue banks in recent years....
In a statement Wednesday, Washington University commended the appellate court’s unanimous decision affirming the lower court ruling “that the donors made a gift to Washington University and, therefore, the blood and serum samples belong to the institution.”
“Today’s decision affirms the critical role of research institutions, through the establishment of ethical review boards, to protect donors from unregulated and potentially conflicting solicitations for their donated tissues. The ruling also maintains the integrity of the repository and provides the best opportunity for this extensive collection of tissues to be used to advance scientists’ understanding of prostate cancer,” the statement reads.
Washington University also pledged in its statement to continue to share tissues in the repository on a peer-review basis with outside scientists, including Catalona.
Thursday, June 21, 2007
Inside Higher Ed :