After more than a year in court, a federal judge ruled April 14 in favor of Washington University in an important case against William J. Catalona, M.D., a former faculty member, regarding ownership of tissue samples used in research.
The comprehensive ruling by U.S. District Judge Stephen N. Limbaugh has implications for future research, the use of donated specimens and public policy.
While still at the University, Catalona collected consenting donors’ blood and tissue samples that were to be used in prostate cancer research. Catalona left the University in 2003 and wanted to take the samples, and samples collected by other University faculty members, with him. Without the approval of the University or its Human Studies Committee, he also asked the tissue donors to appeal to the University to move the samples.
In his ruling, Limbaugh determined that the University developed, paid for and maintained the repository of the samples, and that the donors signed consent forms to give the tissue to the University to use in research. The judge also granted the University the authority to continue to use the tissue and share it with other researchers, including Catalona, in pursuit of a cancer cure.
“The safety and welfare of human subject participants is protected through a variety of legal and professional standards administered by committees of persons schooled in the fields most privy to the needs of the medical/science community,” Limbaugh said in his ruling. “Medical research can only advance if access to these materials to the scientific community is not thwarted by private agendas.
“If left unregulated and to the whims of a (research participant), these highly prized biological materials would become nothing more than chattel going to the highest bidder. It would no longer be a question of the importance of the research protocol to public health, but rather who can pay the most.
“The integrity and utility of all biorepositories would be seriously threatened if (research participants) could move their samples from institution to institution any time they wanted,” Limbaugh wrote.
Faculty members here will resume using the tissue samples for their cancer research in a manner consistent with the consent forms signed by the donors. A peer-review mechanism for providing these samples to researchers at the University and elsewhere will be re-established as soon as possible.
For more information and to read Limbaugh’s complete ruling, go online to prostatecure.wustl.edu.