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.
The case stems from Catalona’s 2003 departure from Washington University in St. Louis's School of Medicine for a faculty position at Northwestern University. Since 1983, Catalona, a researcher and prostate cancer surgeon, had, along with his colleagues, solicited blood and tissue samples from patients to be used for prostate cancer research.
As the decision describes, upon leaving Washington University, Catalona sent a letter to an estimated 50,000 to 60,000 patients and their relatives, along with other research subjects, requesting their permission to transfer their donated samples to his care. In an attached release form, he asked individuals to sign on to a statement that reads, in part, “Please release all of my samples to Dr. Catalona at Northwestern University upon his request. I have entrusted these samples to Dr. Catalona to be used only at his direction and with his express consent for research projects.” About 6,000 individuals returned completed forms.
Using Missouri law governing gifts as its guide, the court found that the research subjects had in fact bestowed their samples as gifts to Washington University. Each research subject signed a consent form bearing Washington University’s logo, and a related informational brochure indicated that a donated sample -- "a free and generous gift" -- could be shared with outside researchers without any further authorization: In short, the decision reads, the brochure informed the subjects that “they would relinquish or abandon the right to designate the particular destination of their biological materials upon agreeing to participate in a medical research study.”
While research subjects did maintain the right to request that their samples be destroyed at any time, “it is evident,” the court wrote, that the subjects had no right to either physically repossess the materials or authorize their transfer.
Furthermore, the court found, Catalona himself had destroyed and used biological samples while at Washington without apparently seeing a need for further authorization from the patients to whom he is now attempting to ascribe an ownership interest. “Whatever rights or interests the [research participants] retained following their donation of biological materials,” the court found, “the right to direct or authorize the transfer of their biological materials from WU to another entity was not one of them.”
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.
Catalona declined to comment Wednesday, but his lawyer, Gene C. Schaerr, of the Washington-based firm Winston & Strawn, indicated that Catalona was building his own collection of samples at Northwestern. “We’re disappointed that the court did not reverse but we are heartened by the fact that the court’s analysis was different than the district court’s analysis, the trial court’s analysis. The trial court had ruled that the individual patients who attempted to transfer their tissues to Dr. Catalona had no rights at all other than the right to decide not to give any more tissues for research,” Schaerr said.
“But the court of appeals, as part of their analysis, implicitly rejected that view and recognized that not only do patients have the right not to give additional tissues but they also have the right to direct that the tissues not be used for research. That’s from our perspective a very significant ruling by the court.”
Schaerr did not know Wednesday whether Catalona would appeal.
“If the court had decided this in favor [of Catalona], it really would have upset the balance in biomedical research,” said Alex Dreier, a partner with the Washington-based law firm Hogan & Hartson. Dreier wrote an amicus brief on behalf of a number of research institutions and higher education associations supporting Washington University in the case in August.
“The court’s decision in this case confirmed what the general understanding has been in the research community," Dreier said. "The importance of the decision is that it reaffirms the status quo and that what could have been a real upheaval didn’t happen.”