On June 20, 2007, in the first federal appeals court ruling to address a research participant’s right to control disposition of biological materials, the U.S. Court of Appeals for the Eighth Circuit issued a decision in Washington University v. Catalona. See 2007 WL 1758268 (8th Cir. June 20, 2007). The Court held that Washington University in St. Louis owns tissue and serum samples that its medical faculty collected in a tissue bank, and the donors have no property interest in or right to direct transfer of the materials.

The decision preserves a core understanding of organizations that maintain tissue banks: although federal and state informed-consent and privacy laws and regulations address their use, the specimens are generally, absent express assignment, regarded as the property of the institutions. Institutions that conduct tissue research are well advised to review informed consent forms and other communications to research participants for consistency with state gift law and other applicable law.

Background

Dr. William Catalona, a pre-eminent researcher on prostate cancer and at the time a member of the medical faculty at Washington University in St. Louis, had played a leading role in the University’s establishment of a prostate cancer bio-repository that over many years collected thousands of biological specimens. Id. at *1. Many of the donors were Dr. Catalona’s patients, and many others were not. Most of the informed consent forms signed by these research participants used the term “donation” to describe the biological sample’s transfer from the individual to the University and noted that the samples “may be used for research with our collaborators at [the University], other institutions, or companies.” Id. at *2. The consent forms also typically provided that by participating in the study, the individual “agree[s] to waive any claim [he] might have to the body tissues that [he] donate[s]” and also “waive[s] the right to any new materials or process developed through research involving [his] tissues.” Id. (alterations in original). Individuals were also told that their participation was voluntary and they could withdraw consent at any time. Id

In addition to the informed consent form, many specimen donors received a genetic research information brochure to review and sign. This brochure explained that the biological materials would be used by researchers at the University’s medical center, might be shared with other authorized researchers at other institutions, and could be used in studies currently in progress or studies conducted 10 or 20 years from now. The brochure, like the consent form, used the term “donation” to describe an individual’s participation. Id.

Legal Dispute

When Dr. Catalona left the University to join the medical faculty of another institution in 2003, he contacted thousands of research participants, without institutional review board (IRB) approval, and requested that they direct the University to transfer the participants’ biological materials to him at his new institution. The University sought a declaratory judgment that it -- and not Dr. Catalona -- owned the materials. A group of eight research participants who supported Dr. Catalona later were joined as defendants. In March 2006, the U.S. District Court for the Eastern District of Missouri concluded that the University owned the research specimens. Dr. Catalona and the eight research participants appealed.

The Eighth Circuit affirmed. The Court held that Washington University “owns the biological materials and neither Dr. Catalona nor any contributing individual has any ownership or proprietary right in the disputed biological materials.” The Court reached this conclusion as a matter of Missouri law, based on close analysis of language in consent forms and an informational brochure, the university’s material transfer agreements and intellectual property policy, and Dr. Catalona’s prior conduct. Although the opinion eschewed sweeping interpretation of federal regulations (it did not cite the federal policy on human subjects research, known as the Common Rule, or the influential Moore v. Regents of University of California, 51 Cal.3d 120, 793 P.2d 479 (1990), and Greenberg v. Miami Children’s Hospital Research Institute, Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003), decisions), it was consistent with the position asserted by Washington University and its amici that federal law and public policy do not support the research participants’ claim of ownership rights in biological materials contributed for research.

The Court declined to credit interpretations of the Common Rule that appellants argued supported their claimed rights. The Court did not, for example, adopt the appellants’ argument that the right to discontinue participation in research was, in the context of specimen research, tantamount to a right to return of one’s physical specimen. Nor did it decide whether a federal regulatory ban on “exculpatory clauses” in informed consent forms prohibited a waiver of ownership rights; the Court found it need not reach that issue because of the research participants’ clear intent to make a gift of their specimens to the university.

An amicus curiae brief filed by Hogan & Hartson on behalf of universities, medical centers and associations1 and an amicus brief filed by the American Cancer Society argued that creating ownership rights in research samples would have unwanted negative effects on important specimen research, and that such ownership rights were not needed to protect research participants in light of the safeguards afforded by the Common Rule and other federal law. The time for Dr. Catalona and the eight research participants to file a petition for rehearing or rehearing en banc has expired, and the judgment is now final.