RESEARCH

The US Supreme Court has been asked to hear the widely-publicized case of renouned prostate cancer researcher William Catalona's attempt to take the biorepository of tissue samples he helped create at Washington University in St. Louis to his new institution, Northwestern University.

The case has been followed closely by research institutions, since it addresses the ownership of samples gathered by investigators under specific IRB protocols at research universities. At the time he chose to leave Washington University, Catalona wrote to 50,000 to 60,000 individuals who had donated their samples, asking them to sign a permission releasing the samples to him. Catalona did not have IRB approval to send the letters and release forms to the research participants. About 6,000 individuals returned the signed forms. The University has claimed ownership of the samples in the biorepository, some of which were collected by Catalona, as well as by other physicians and even other institutions.

According to the appeals court ruling, the informed consent documents signed by the research participants only permitted the participants to request that their sample be destroyed, not transferred or returned to them. The ruling has been supported by the Association of American Medical Colleges, the American Cancer Society, and several research universities including Cornell, Duke and Johns Hopkins.

The US Supreme Court has not yet decided whether it will review the case.

Link to Washington University's coverage: http://prostatecure.wustl.edu/.

The Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies passed a bill to increase the FDA’s budget by more than $185 million over fiscal 2007 to strengthen drug safety. The additional resources will help the FDA “stay ahead of events” such as safety issues with prescription drugs, the subcommittee added.

The bill provides an increase of $16.2 million to fund the FDA’s adverse events reporting system, including hiring more scientists and drug safety experts. Among other areas receiving increased funding are the Offices of Generic Drugs and Women's Health and the agency’s Critical Path Initiative.

Copies of the bill will not be available to the public until after July 19.

The Northeast Ohio Chapter of the Association of Clinical Research Porfessionals (ACRP) will be holding its third annual conference titled, "Promoting Excellence in Clinical Research", on Friday, September 21, 2007.

The conference will feature local and national speakers discussing the Evolution of Responsible Conduct of Research, Informed Consent, Maintaining Compliance within Institutions, and FDA Bioresearch Monitoring Inspections.

For further information and to register, go to: http://www.acrpnet.org/chapters/neoh/index.html.