Washington University v Catalona | Analysis

Washington University, a prominent private research university located in St. Louis, Missouri, houses its own medical school, including a Division of Urologic Surgery (Division). Within the Division, physicians treat patients, teach students and residents, and conduct medical research on urologic diseases such as prostate cancer. [1] Dr. William Catalona, a highly esteemed urologist and researcher employed by Washington University, was instrumental in assisting the University in establishing and growing its Genitor-Urinary Repository, which houses approximately 100,000 biological samples. [2] In 2003, Dr. Catalona left Washington University and accepted a position at Northwestern University, where he intended to continue his prostate cancer research. Prior to his departure, Dr. Catalona sent a letter to approximately 60,000 research participants notifying them of his departure and requesting that recipients sign and return a form requesting that Washington University release their biological samples to Dr. Catalona. Approximately 6,000 subjects returned the signed forms. [3] Washington University asserted that it, not Dr. Catalona or the individuals who provided the samples, owned the samples. Washington University sued to establish its ownership of the biological samples. [4]

PROCESS

In March of 2006, the U.S. District Court for the Eastern District of Missouri held that, Washington University owns the biological samples and the clinical data associated therewith, and that the research participants did not retain any interest in or ownership rights beyond the right to withdraw their clinical samples from the repository. Washington University successfully prevented Dr. Catalona from transferring the clinical samples to Northwestern University. [5]

An appeal was lodged by Dr. Catalona to the U.S. Court of Appeals for the Eighth Circuit, and the Eighth Circuit upheld the district court’s ruling on June 20, 2007. [6]

The Eighth Circuit held that individuals who make an informed and voluntary decision to contribute their biological materials to a particular research institution for the purpose of medical research do not retain any ownership interest allowing such individuals to direct or authorize the transfer of such materials to a third party. [7] The court ruled that Washington University held sole ownership of the biological samples, and Dr. Catalona could not transfer the samples to a third party, even if he had the donors’ permission. [8]

The court examined whether the research participants intended to part with the “right and dominion over the [biological samples] immediately and irrevocably.” The court reasoned that the research participants must have intended to give the samples, irrevocably, to Washington University, because the research participants signed consent documents on university letterhead that characterized the transfer as a voluntary “donation” for use in studies by “Dr. William J. Catalona and/or colleagues,” and received a brochure that characterized the samples as a “free and generous gift.” [9] The court wrote that research participants “unquestionably delivered their biological materials” to the university, and the university “retained absolute possession.” The court reached the conclusion that the research participants possessed present intent to make the gift to the university and delivered the samples, and that the university accepted the gift. [10]

The court did acknowledge that the research participants had a right to withdraw by destroying their samples from the database, but did not conclude that a right to transfer the samples can be implied from the right to withdraw. [11] The court noted that all informed consent forms expressly stated that research participants could discontinue their participation by having their samples destroyed upon request, but they did not state that participants could request return or transfer of their samples. [12] Furthermore, the court highlighted that some federal and state regulations prohibit the return of biological samples to research participants. [13]

Various factors supported the court’s finding that Dr. Catalona did not hold an interest in the samples. First, numerous material transfer agreements and research agreements that both the university and Dr. Catalona had signed acknowledged the university’s sole ownership of the biological samples. [14] Second, the university’s intellectual property policy, to which Dr. Catalona was subject when he collected the biological samples, stated that “all intellectual property (including…tangible research property) shall be owned by the University if significant University resources were used or if it is created pursuant to a research project funded through corporate, federal or external sponsors administered by the University.” [15] Finally, the university provided the majority of the funding for the maintenance and operation of the repository, and the remainder of the funding came from public and private grants to the university. [16]

Dr. Catalona and a group of his research participants filed a petition for a writ of certiorari, requesting the Supreme Court to review the Eighth Circuit’s holding that donors of biological samples obtained in the course of biomedical research did not have a right to transfer ownership of such samples for one research institution to another. More specifically, their petition asked the Supreme Court to consider whether the federal Common Rule, which protects human subjects in federally funded research, prohibited the research participants from waiving their rights to their biological samples. The Common Rule prohibits institutions from obtaining consent for medical research on human subjects by using “any exculpatory language through which the subject…is made to waive or appear to waive any of the subject’s legal rights.” [17] Dr. Catalona’s research participants signed a consent form that stated: “By consenting to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research.” In essence, Dr. Catalona asked the Supreme Court to rule that the Common Rule prohibited the university from asking the research participants to waive their ownership rights, and therefore the research participants still owned the samples and could direct their future disposition. [18]

The Eastern District of Missouri addressed the exculpatory language argument, finding that the Common Rule’s exculpatory language prohibition was limited to waivers or releases of liability, not ownership. The Eighth Circuit had not considered the effect or validity of such waiver language, because it felt such analysis was unnecessary in the context of a gift. [19]

The research participants also filed a petition for writ of certiorari, asking the Supreme Court to consider the Common Rule issue from their perspective. In their petition, the research participants argue that they “expressly relied on the Common Rule to prevent a finding of transferred ownership.” [20] They emphasized to the Supreme Court the potential adverse implications of the Eighth Circuit’s ruling, such as the sale of biological samples to for-profit institutions that might release the research participants’ genetic information, or the use of a research participant’s sample for further research in a field that the participant does not support. Importantly, the research participants warned the Supreme Court that if the Eighth Circuit’s decision is not overturned, research participants will be less likely to contribute their samples to a repository, since they will, in effect, be forced to relinquish control of their samples, and if they do contribute, they will be more likely to exercise their right to destroy the sample once it has been used for a narrowly framed purpose. [21]

ISSUES

Centralized Repository

At many institutions, individual investigators, individual clinical departments or other entities separately maintain biological samples and clinical data. Institutional officials and researchers often fail to communicate the existence of these samples and do not maintain proper documentation to demonstrate ownership. [22] The lack of centralized oversight and control: (1) undermines institutional claims of ownership; 2) hampers institutional efforts to make sure that biological samples are collected pursuant to compliant consent and authorization policies, procedures and applicable law; and 3) may impede researchers’ ability to lawfully use the biological samples for future research if the samples are not collected and maintained appropriately. [23] Institutions should conduct an internal audit to determine where biological samples and clinical data are currently stored and what ownership documentation exists. They should consolidate such samples and data into a central repository that is established, maintained and controlled pursuant to institutional policies and procedures. [24]

Intellectual Property Policies and Agreement Provisions

As noted by the Eighth Circuit, the agreements to which both Dr. Catalona and Washington University were a party expressly stated that samples were owned by Washington University. [25] The university’s intellectual property policies also expressly stated that “tangible research property” is owned by the university. The court’s reliance on these factors demonstrates the importance of laying the groundwork for any ownership claims through the use of express policy and agreement language. [26] Institutions should revisit their intellectual property policies and intellectual property agreement provisions to confirm that they expressly secure the institution’s ownership rights to biological samples and associated clinical data vis a vis clinicians and researchers.

Informed Consent and Authorization

A properly worded clinical care and research informed consent and Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104-191) authorization are essential. [27] Institutions will need to carefully balance the competing messages of the Eighth Circuit and the Common Rule concerning the ability of patients and research participants to transfer their ownership rights to their tissue. [28] Institutions need to review their informed consent and HIPAA authorization forms, as well as their HIPAA policies, procedures and forms to confirm that they (1) properly characterize any transfer of biological samples or clinical data as a donative gift, and state to whom the materials are transferred in order to provide the institution with flexibility to use the biological samples and data; and (2) make clear that individuals only retain the right to withdraw their biological samples from the research at any time, and language that appears to waive the subject’s rights should be carefully reviewed in light of the Common Rule’s prohibition against exculpatory language. [29] The review for these purposes should also focus on whether the form clearly allows use of specimens for research (particularly if the form is a consent for clinical care as opposed to research). Centralized Repository at many institutions, individual investigators, individual clinical departments or other entities separately maintain biological samples and clinical data. Institutional officials and researchers often fail to communicate the existence of these samples and do not maintain proper documentation to demonstrate ownership.

The lack of centralized oversight and control: (1) undermines institutional claims of ownership; 2) hampers institutional efforts to make sure that biological samples are collected pursuant to compliant consent and authorization policies, procedures and applicable law; and 3) may impede researchers’ ability to lawfully use the biological samples for future research if the samples are not collected and maintained appropriately. Institutions should conduct an internal audit to determine where biological samples and clinical data are currently stored and what ownership documentation exists. [30]

Ownership of Biological Materials

Do individuals who make an informed decision to contribute their biological materials voluntarily to a particular research institution for the purpose of medical research retain an ownership interest allowing the individuals to direct or authorize the transfer of such materials to a third party? Under the facts of this case, the answer is no.

As the debate continues and key legal and ethical questions are addressed, universities, hospitals and research institutions should take steps to confirm that (a) their repositories comply with applicable law, (b) policies and procedures are in place with respect to necessary consent and authorization for creation and use of tissue and data repositories, and (c) intellectual property ownership expectations are clear and understood by patients, clinicians and researchers. [31]

JUDICIAL REASONING

In deeming Washington University the owner of the biological samples, the district court found all research participants donated their biological materials to the university as inter vivos gifts. [32] In addressing this issue, the court quoted the substantive law of Missouri, which defines an inter vivos gift as “a voluntary transfer of property by the owner to another, without any consideration or compensation as an incentive or motive for the transaction.”. [33] As the party claiming the existence of an inter vivos gift, Washington University bears the burden to prove by clear and convincing evidence there was (1) present intent of the donor to make a gift, (2) delivery of the property by the donor to the donee, and (3) acceptance of the gift by the donee, whose ownership takes effect immediately and absolutely. [34] The research participants unquestionably delivered their biological samples to Washington University at the time of their donation.

RESULT & ORDER

For the foregoing reasons, the court affirmed the well-reasoned opinion and judgment of the district court.

ANALYSIS OF THE DECISION

The court stated that the “sole issue determinative” of the lawsuit is ownership and ruled that Washington University was the sole and exclusive owner of all biological samples and associated clinical data in the Repository and that investigators and research participants have no legally recognized ownership right. [35]

Under Missouri law, the court found that it is “well-established that exclusive possession and control of personal property is prima facie evidence of ownership and anyone else claiming such property bears the burden of proof.” [36] The court found that it was “undisputed” that Washington University had been in “exclusive possession” of the Repository, in part because the University was solely responsible for the maintenance of the Repository housed on University property and because the University signed all material transfer agreements pursuant to which outside parties could request samples from the Repository for research at the discretion of the University. Further, the court noted that the University had consistently asserted its ownership interests in the materials stored in the Repository through its intellectual property policy. [37] The court stated that the University “alone bears all legal, regulatory and compliance risks associated with respect to all research done in connection” with the Repository. It found no compelling federal authority prohibiting Washington University from asserting an ownership interest in the samples in the informed consent pursuant to which the research participants provided the samples. [38]

The court characterized the research participants as providing an “inter vivos” gift to the University. The court rejected Dr. Catalona’s arguments that (a) the exculpatory language in the informed consent forms invalidated the gift, and (b) that the research participants’ right to discontinue participation included a right to control and transfer the provided samples. In addition to setting forth the legal basis for its conclusion, the court also outlined public policy considerations supporting its decision. [39] First, “medical research can only advance if access to these materials by the scientific community is not thwarted by public agendas,” and such open access is best assured by placing responsibility for and authority over biological samples with institutions. [40] Second, if research participants were able to direct all future uses and recipients of biological samples they provided, biological samples “would become nothing more than chattel going to the highest bidder.” [41] Third, it is “antithetical to the goals of science and public health to allow research participants to direct the recipient or beneficiary of the sample” and doing so would be “tantamount to a blood donor being able to dictate that his/her blood can only be infused into a person of a certain ethnic background.” [42] The court’s public policy discussion also suggests the view that institutional rather than individual ownership would avoid the buying and selling of human tissue to the highest bidder. [43]