In November 2012, after a lengthy investigation, the Minnesta Board of Social Work issued a corrective action against Jean Kenney, the study coordinator for the CAFE study. Although the corrective action was limited to Kenney's conduct with regard to a single study subject, Dan Markingson, the report raised troubling questions about the care provided to all research subjects under her supervision.
For example, the Board concluded that Kenney had practiced beyond her competence and scope of practice as a clinical social worker; failed to modify informed consent documents and resubmit them to the University of Minnesota IRB after new risks associated with participating in the CAFÉ study were identified by the study sponsor (AstraZeneca); invalidated the informed consent of a study subject—and possibly the informed consent of all CAFÉ trial participants—by failing to disclose new risks associated with participating in the study; forged paperwork by initialing clinical documents with a physician’s initials; and dispensed legend prescription drugs without authorization and in violation of University policy.
Despite these extraordinary violations, there is no public record of the University of Minnesota IRB ever investigating Kenney's conduct with regard to other research subjects. Leigh Turner and I have asked Dr. Susan Berry, the Chair of the IRB Executive Committee, if such an investigation has taken place, and if not, we have asked that the IRB initiate such an investigation immediately.
You can read the letter here.