In a unanimous decision, the 8th U.S. Circuit Court of Appeals upheld a lower court ruling that tissue and blood samples donated to Washington University School of Medicine in St. Louis for prostate cancer research belong to the institution. The three-judge panel said the donors voluntarily made a gift to Washington University when they donated their biological samples and, therefore, the specimens belong to the school.
“We are extremely pleased by today’s decision,” says Larry Shapiro, M.D., executive vice chancellor for medical affairs and dean of the School of Medicine. “The ruling will allow important research into the causes of prostate cancer to continue, with the goal of developing new cures.”
The decision protects the rights of research participants by ensuring they are not exposed to misleading and potentially competing solicitations for their previously donated tissues from scientists, physicians or commercial research companies who want control over the samples. The ruling also maintains the integrity of the biorepository, one of the world’s largest collected for prostate cancer research. The ruling “creates the best opportunity for this extensive collection of tissues to be used to advance understanding of the disease,” Shapiro adds.
The legal proceedings had halted researchers’ use of the repository, but the new ruling means that scientists at Washington University and elsewhere will again have access to the samples for research.
The case centers on whether tissue donors can reclaim their donated samples and give them to a researcher or an institution other than Washington University. William Catalona, M.D., a doctor involved in research using the biorepository, and some research participants said tissue donors had a right to require that the samples be forwarded to Catalona at Northwestern University, where he had assumed a faculty position after resigning from Washington University.
In 2003, the University filed suit against Catalona to ask the federal court to determine who should control the donated samples stored in Washington University’s biorepository.
“Dr. Catalona initially claimed that all the prostate tumor samples in the University’s repository belonged to him because his name appeared on many of the consent forms as principal investigator,” says Michael Cannon, executive vice chancellor and Washington University general counsel. “Dr. Catalona then changed his legal strategy, asserting that donors are the sole owners and should be able to redirect the tissues to him. He sent unauthorized new consent forms to some 50,000 research participants asking them to have their samples transferred to him. For this reason, Washington University asked the federal district court to make a determination of who controlled the biorepository.”
In the appellate court ruling, the judges said the district court properly ruled that the research participants made informed and voluntary decisions to participate in prostate cancer research and donate their biological samples to Washington University as gifts. “This voluntary transfer of tissue and blood samples to Washington University – without any consideration or compensation as an incentive for doing so – demonstrates Washington University owns the biological samples currently housed in the biorepository,” the appellate panel wrote.
The court also pointed out that Catalona himself while at Washington University had signed numerous agreements acknowledging the University’s ownership of the biological samples and that he routinely ordered the destruction of samples to make room for new donations and did so without the research participants’ knowledge or consent.
“Dr. Catalona’s habitual destruction of samples, in a manner consistent with apparent indifference to any proprietary interest of the donors, is at odds with his later assertion the research participants own the biological materials,” the opinion states.
Based on this decision, Washington University will resume sharing the tissues in the repository with its own scientists and those at other institutions who want to conduct promising research using the samples, including Catalona. Proposals will be evaluated on a peer-review basis by a panel of Washington University researchers.
“We are grateful to the many thousands of volunteers who donated their tissue for prostate cancer research,” Shapiro says. “Their samples are a generous gift and a vital resource. With this case behind us, we will return to using the tissue to better understand this devastating disease and to search for cures.”
The consulting attorneys who worked with Cannon and others from Washington University’s in-house legal team are Thomas Wack at Bryan Cave LLP and Robert Long at Covington & Burling LLP.
Washington University School of Medicine’s full-time and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked fourth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.