March 4, 2014 Susan A.

Berry, MD Chair, IRB Executive Committee University of Minnesota Human Research Protection Program D528 Mayo Memorial Building, 420 Delaware St. SE Minneapolis, MN 55455-0392 Re: Open Letter Requesting An Investigation of Jean Kenneys Conduct as a Clinical Trial Coordinator Employed by the University of Minnesota Department of Psychiatry Dear Dr. Berry: We are contacting you with regard to Jean M. Kenney. Ms. Kenney used to be employed as a clinical trial coordinator by the University of Minnesotas Department of Psychiatry. She was based at the University of Minnesota Medical Center, Fairview. We would like to know whether you or any other members of the University of Minnesota IRB Executive Committee have investigated Ms. Kenneys conduct in all clinical trials for which she was employed as a study coordinator. If such an investigation has already been completed we request copy of your findings. If no such investigation has taken placeand there is no public record of such an inquirywe urge you to initiate such an investigation and review all studies with which she was involved. As you know, the Minnesota Board of Social Work investigated Jean Kenneys conduct in the Comparison of Atypicals for First-Episode Psychosis (CAF) study. Focusing upon record of single study participant but raising many questions about care provided all research subjects in the CAF study, that investigation concluded Kenney: 1) Practiced beyond her competence and scope of practice as a clinical social worker; 2) Failed to modify informed consent documents and resubmit them to the University of Minnesota IRB after new risks associated with participating in the CAF study were identified by the study sponsor (AstraZeneca) and communicated to researchers; 3) Invalidated the informed consent of a study subjectand possibly the informed consent of all CAF trial participantsby failing to disclose new risks associated with participating in the study; 4) Forged paperwork by initialing clinical documents with a physicians initials; 5) Dispensed legend prescription drugs without authorization and in violation of University policy;

2 6) Failed to consistently document correct diagnosis and prescription doses; 7) Failed to address family concerns in a prompt and effective manner; 8) Prepared documentation that was below minimum practice standards for a clinical social worker; 9) Failed to document critical information concerning interventions and plans; 10) Failed to maintain clearly articulated and consistent set of treatment goals; 11) Failed to add to the medical record in a timely manner; 12) Failed to document information relevant to suicide prevention; 13) Inappropriately delegated tasks to a social work intern. In addition to professional misconduct identified by the Minnesota Board of Social Work, subsequent investigative work indicates that the HIPAA authorization to release private health information to the study sponsor was signed after the study subject identified in the Boards report was already enrolled in the CAF study. In addition, there are unanswered and profoundly troubling questions concerning the Evaluation to consent forms used in the CAF study. Given the findings of the Minnesota Board of Social Work, if you have not already done so we urge you to investigate Jean Kenneys conduct in all studies for which she was employed as a clinical trial coordinator. Such an investigation is required to determine whether the misconduct identified by the Board of Social Work was limited to one clinical study or occurred in additional clinical trials. In addition, noting that Ms. Kenney acted under the direct supervision of faculty members and points to these individuals when attempting to justify her behavior, we urge you to examine not only Ms. Kenneys conduct but also the conduct of the psychiatrists who supervised her. 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: Debbie Dykhuis, Executive Director, 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