April 22, 2014 Debra Dykhuis, Director Human Research Protection Program University of Minnesota Human Research Protection Program D528 Mayo Memorial Building, 420 Delaware St. SE Minneapolis, MN 55455-0392 Re: Safety of Research Subjects and the IRB’s Failure to Take Prompt Action Dear Ms. Dykhuis: Thank you for your email message of April 17 regarding our request for an investigation of Jean Kenney’s conduct as a clinical trial coordinator. We are disappointed and alarmed to learn that the IRB Executive Committee has “reserved judgment” on whether to launch an investigation. We believe that the failure of the IRB to act promptly is placing research subjects in serious danger. You write that because Jean Kenney ceased employment with the University in 2005, “there is no present risk of harm to research subjects.” This is untrue. As we noted in our letter to you, Kenney operated under the direct supervision of Dr. Stephen Olson, who is still employed by the university. His co-investigator on the CAFÉ study was Dr. Charles Schulz, who is still Chair of the Department of Psychiatry. In our opinion, you should have already investigated the conduct of Dr. Olson and Dr. Schulz as clinical trial investigators in the CAFÉ study, in all additional studies involving Kenney, and indeed in all studies in which they have served or are serving as clinician-investigators. On what basis can you claim that current research subjects are not at risk of harm, given Olson and Schulz’s failure to provide adequate oversight of Kenney in the CAFÉ study and perhaps in subsequent clinical trials? As far as we can tell, the IRB has never investigated whether the violations identified by the Minnesota Board of Social Work in regard to Jean Kenney were restricted to one subject, harmed multiple study subjects, or extended to all research participants in the CAFÉ study. Nor has the IRB investigated whether Kenney’s misconduct was limited to the CAFÉ study, or if it occurred in all studies with which she was involved. Why should anyone feel confident that study participants in other clinical trials were not victimized by the same deviations from professional standard of care identified by the Board of Social Work’s investigation? After Kenney’s violations were uncovered, key element of her defense was that the study was approved by the University of Minnesota’s IRB and she was “acting in accordance with the protocols that had been approved.” Yet there remain many unanswered questions concerning the

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IRB’s approval and oversight of the CAFÉ study as well as its failure to conduct a serious investigation following Markingson’s suicide. The failure of the IRB to act promptly is even more troubling in light of the discovery that Dr. David Adson, the Chair of the IRB that approved the CAFÉ study, had significant financial and personal conflicts of interest. You write that the Institutional Review Board “is investigating current human research practices in the Department of Psychiatry.” However, you provide no insight into the nature of that investigation or whether it will address the concerns identified in our letter to you. What exactly is the investigation that the IRB claims to be conducting now? Yours sincerely,

Leigh Turner, PhD Associate Professor, University of Minnesota Center for Bioethics

Carl Elliott, MD, PhD Professor, University of Minnesota Center for Bioethics cc: Susan A. Berry, Chair, IRB Executive Committee, Human Research Protection Program Brian Herman, Vice President for Research, University of Minnesota Carolyn Wilson, President, University of Minnesota Medical Center, Fairview Kate Zacher-Pate, Executive Director, Minnesota Board of Social Work Elyse Summers, President, AAHRPP Dana Walters, Office of Scientific Investigations, FDA