| Print this pagePatients and research participants ask about the litigation brought by Washington University (WU) against Dr. Catalona and 6000 patients and research participants (patients) concerning the ownership of their research samples. *
On October 18, 2007, Dr. Catalona and his patients filed separate petitions** with the United States Supreme Court requesting that the Court review the decision of the Eighth Circuit Court of Appeals.
The primary question presented by both petitions is whether the federal regulations governing all human subjects research preempt Missouri property law. This is a landmark case presenting questions as fundamental and important as those the Supreme Court has faced in the areas of reproductive choice and euthanasia.
Dr. Catalona, while at WU from 1976 to 2003, oversaw research that asked thousands of men to provide tissue samples from cancerous prostate glands, while also collecting blood samples from those patients and their families. These patients generally lacked independent knowledge about the risks and benefits of providing samples, making the decision to allow the use of their samples only after consultation with University personnel about their rights that were memorialized in consent forms drafted by the University.
The consent forms provided that the patients could end their participation in research at any point, bar further use of their samples and even insist that their samples be destroyed. None of the consent forms ever stated that the University would become owner of their samples.
When Dr. Catalona left WU for Northwestern University, more than 6,000 patients directed WU to transfer their samples to Dr. Catalona at Northwestern. WU refused and sued Dr. Catalona in federal court, arguing under state common law that WU retained sole title to the samples.
In response, Dr. Catalona and the patients pointed to federal law that governs all federally funded medical research under which the so-called "Common Rule" protects patient rights and ensures informed consent.
The Common Rule provides that no informed consent document may include any language through which the subject is made to waive or appear to waive any of his legal rights. An example provided by the Office for Human Research Protections (OHRP) of prohibited language to help interpret this rule is: "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 research." And the OHRP has required another research university to remove nearly identical language from their consent forms.
The federal district court discounted the federal agency's guidance entirely and ruled in favor of WU. The U.S. Court of Appeals for the Eighth Circuit stated that the patients did have the right to request their samples be destroyed or not used in research, but affirmed the district court’s ruling that the University had acquired ownership of the samples, - and did so without devoting a word of its opinion to the federal regulations or the OHRP guidance. In so ruling, the courts disregarded the fact that federal regulations governing much of the medical research in this country prohibit such a transfer of ownership.
Dr. Catalona and the patients believe the U.S. Supreme court should grant a review of this case because the Eighth Circuit has established a precedent with breathtaking consequences for all who have ever provided (or might provide) tissue and blood samples for medical research. The Eighth circuit’s unprecedented refusal to recognize and enforce the limitations set by the federal regulations will be cited across the country as a justification of assertions by research institutions of ownership of samples that contain extraordinarily sensitive personal information, and which have both tremendous commercial value and tremendous potential harm to research participants. That precedent should not be allowed.
Clearly, Missouri state property law collides with binding federal regulations in this case. The Supreme Court has made clear that under the Supremacy Clause of the U.S. Constitution, state law is preempted when it conflicts with federal regulations.
With outright ownership of the samples, WU would not be restricted from other actions, including: selling them, posting information from the samples on the Internet, or attempting to "anonymize" (remove all personal identifying information from) the samples so that the volunteers would not be able to seek to withdraw their consent. The samples could then be used for purposes other than the study of prostate cancer, including research or commercial use of the samples in ways not contemplated by the patients when deciding to participate in research.
Moreover, as biological research becomes increasingly sophisticated, the risk that he samples will be used for morally sensitive endeavors not approved by research participants, or used to reveal private information about them, increases as well. Thus, under these current rulings, patients who have ever provided samples for research in the past or would provide them in the future would have no protection against having their samples used for research to which they might object.
Just prior to the filing of the petitions, the prestigious Institute of Medicine released the results of a Harris Poll they commissioned that are considered representative of the total adult US adult population of 255 million persons.
58% of those surveyed felt that the privacy of personal health information (PHI) is not protected well enough today by federal and state laws and organizational practices. 8% had been asked to have their PHI used in research and decided not to participate.
Of these who declined to participate, the reason for 30% was that they were concerned that their PHI would not be kept private or confidential, and 22% didn't have trust in people or organization who conduct the research.
Only 1% said that researchers would be free to use PHI without their consent. Only 8% would be willing to give a general consent in advance to use their PHI without consent.
Only 19% said their consent would not be needed as long as the PHI was de-identified and supervised by an institutional review board. 38% would want each research study seeking to use their PHI to first get their specific consent. 80% wanted to know what the purposes of the research would be before they would consent. 62% would want to know the specific research and who would be running it before they could decide whether they trusted them or not. 67% felt they could be discriminated against for health insurance, 56% for life insurance, and 44% for employment.
If this ruling is not reversed, the effects on potential research participants will be profound. Individuals will be far less likely to consent in the first place if they are asked to give up all ownership and control of their own tissues, without any way of knowing how they will be used or whether they will be sold.
Thus, much of the public has very strong privacy perspectives in the health area, and the majority does not believe current law and organizational policies provide enough privacy protection. We, the people, are justifiably concerned about this issue.
*Previous updates are included in all issues of QUEST for the past 3 years and are available on Dr. Catalona’s website, www.drcatalona.com under "Litigation Updates."
**Links to full text of the petitions for certiorari for Dr. Catalona and the patients can be found on the homepage of www.drcatalona.com