The University Record, October 29, 2001

Investigation update

By Kara Gavin
Health System Public Relations

A three-month investigation by an independent committee has found that the U-M’s Institutional Review Board (IRB) acted appropriately in approving a research study by James Albers, professor of neurology, and Stanley Berent, professor of neurology and of psychiatry. The committee was asked to evaluate whether the IRB was correct in not requiring the researchers to obtain informed consent from railroad workers for a retrospective research study.

This is the third independent committee composed of experts internal and external to the University to reach the conclusion of no wrongdoing by the IRB, or by Albers and Berent.

The committee also concluded that Albers and Berent properly disclosed their outside interests to the Medical School Conflict of Interest Committee (COI) and were not at fault for an issue with the completion of a form used to alert the IRB to potential conflicts of interest. The committee has recommended that the form be changed, and that the linkage between the COI Committee and IRB be made more formal and public, to avoid such issues in future.