AAMC Reporter: June 2006

Viewpoint: "Court Ruling on Tissue Repository Favorably Impacts Research Institutions"

Larry J. Shapiro, M.D., Executive Vice Chancellor for Medical Affairs and Dean, Washington University School of Medicine in St. Louis

Washington University School of Medicine in St. Louis was recently involved in a legal case that has implications for medical centers, research institutions, tissue repositories, and blood banks nationwide. The case involved a lengthy trial over who owns and has rights to blood and tissue samples donated to the university for prostate cancer research.

Issues arose when William Catalona, a former faculty member, wanted to take the samples with him to another medical center. In his quest for the samples, Dr. Catalona mailed consent forms directly to research participants — without the permission of the institution or the required approval of the institutional review board — seeking authorization to have their tissues transferred to him. Many patients signed the forms.  

On the surface, this may sound like a simple request. Unfortunately, it was not. Removing the tissue from the repository would have a negative impact researchers at Washington University and elsewhere who were using it to study prostate cancer. In addition, the university had paid for and maintained the repository since its beginnings with many other physicians' patients donating tissue to it.

When Catalona interfered with the transfer of tissue from this repository to the National Cancer Institute for a research study, the university asked a federal court to determine who owns the repository. Catalona contended that research participants always have the right to withdraw from research protocols and this should include the right to withdraw their donated samples. The court determined the university is the rightful owner and granted authority for it to continue to use the tissue and share it with other researchers in pursuit of a cancer cure.

As the dean of Washington University School of Medicine and a longtime genetics researcher, I believe the April 2006 court ruling in Washington University's favor is both vital to scientific research and protective of research participants' rights.

I was not surprised by the court's decision, but I was gratified. I believe that the decision resolves several important matters, including the ability of Washington University scientists and other investigators to use these tissues and blood samples in an effort to find better treatments or a cure for prostate cancer. Also, it establishes an important principle regarding ownership of tissue repositories and upholds the paramount importance of the covenant we make as researchers to comply with the federal regulations that govern our work.

There have been several other legal cases in which the issue of ownership of donated tissue samples has been raised. In each instance, the courts have found that research subjects relinquish the right to their tissues when they donate them to research institutions that have followed proper federal guidelines for informed consent and the use of such materials.

I am intensely concerned about the rights of patients who volunteer to participate in human research endeavors. Without the trust and confidence of such individuals, we could never make progress in our efforts to learn more about the causes and cures of human disease.

When volunteers agree to participate in research at Washington University and at most other places, there are an extensive series of rules that are in place to ensure their safety and protect their interests.

A duly constituted institutional review board considers and approves all research protocols and consent forms before volunteers can be approached about enrolling. Such IRBs contain laypersons as well as those knowledgeable about science, medicine, the law, and ethics. Both the individual interests of donors and the greater public interest are best served by adhering to the federal laws and institutional guidelines put in place to protect research participants.

When those laws are skirted, even for what might be deemed good reason, the outcome is exactly as Judge Stephen Limbaugh described in his ruling — it allows bias or a researcher's private agenda to supersede donors' interests, and that should never happen.

If donors were able to retain ownership rights to their tissues indefinitely and could redirect them at any time to another institution or person, imagine the consequences. Someone who once donated a kidney might demand to have it given to another individual; blood donors might restrict their blood for use only by a particular ethnic group.

Tissue repositories work because of the large number of samples they maintain, samples obtained across a broad spectrum of patient cases. It is important to protect the breadth of the samples, and losing large parts of the repository can damage its research value.

Washington University is dedicated to making progress in treating many diseases, including cancer, and this tissue repository and others are essential resources for these efforts. Establishing and maintaining such collections is costly in time, effort, and money. So if they could be disassembled easily, few places would make the investments necessary to create them.

We make this resource available to others who have good ideas about how to use these samples to serve the purposes for which they were intended, and we are always open to new ideas about how to use this resource to create new knowledge.

Editor's note: The AAMC filed an amicus brief supporting Washington University's position in the litigation.

Detailed information about the case is available at http://prostatecure.wustl.edu.

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