UNIVERSITY OF MINNESOTA The Honorable Clyde E- Allen, Jr 600 MeNamara Alumni Comer 1200 Oak Siret SE. ‘Chair, Board of Regents ‘Minneapolis, MN $5455-2020 fice: 61225-6300 Poe 616243318 February 7, 2011 Carl Elliott, Professor Dianne Bartels, Assistant Professor Joan Liaschenko, Professor Mary Faith Marshall, Professor John Song, Associate Professor Leigh Turner, Associate Professor Susan Craddock, Associate Professor Joan Tronto, Professor Center for Bioethics N504 Boynton 410 Church Street SE Minneapolis, MN 55455-0346 Dear Professors Elliott, Bartels, Liaschenko, Marshall, Song, Turner, Craddock, and ‘Tronto: Thank you for your correspondence of November 29, 2010, in which you raise significant questions related to the suicide of Dan Markingson, who was enrolled in a psychiatric research study at the University of Minnesota in 2003-04. On behalf of the entire Board, I take this opportunity to express again the University community's heartfelt sympathy to Markingson’s family and friends for this tragic loss. At the Board’s request, our General Counsel has provided us with the extensive reviews of this case that were performed over the years by a number of independent experts and governmental units. They include careful examinations by the US, Food and Drug Administration, the Hennepin County District Court, and the Minnesota Board of Medical Practice, assisted by the Minnesota Attorney General's office. In addition to these independent reviews, the University’s IRB and a number of nationally recognized psychiatrists not affiliated with the University reviewed the course of treatment provided to Mr. Markingson. Each and every one of these reviews resulted in the same conclusion: there was no improper or inappropriate care provided to Mr. Markingson, nor is there evidence of misconduct or violation of applicable laws or regulations. Driven to Discover”Page Two February 7, 2011 Thave asked our General Counsel to provide you with a more detailed response to the allegations you raised in your letter. At this time, however, we do not believe further University resources should be expended re-reviewing a matter such as this, which has already received such exhaustive analysis by independent authoritative bodies. More generally, we note that the University maintains a human subjects protection program that is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the gold standard, to ensure the protection of subjects participating in University research. We do not intend to suggest that the broader concerns you raise related to protection of subjects involved in clinical research are unimportant, To the contrary, we encourage the University community to engage in further discussion about these wider issues. In an era when public funding of our University and its research is limited, we must recognize that critically important medical and health research requires substantial private investment, both from donors and from corporate sponsors. Those funding sources provide great opportunities -- and pose significant challenges -- for the University. We believe our faculty is ideally suited to engage in a rigorous, open, and honest exploration of these opportunities and challenges, and the impact they may have for the integrity of our research mission. We ask the administration to work with interested faculty to create an appropriate forum where these issues can be fully examined. ‘Thank you again for sharing these important and serious concerns with the Board. Best regards, fe“ ae Clyde E. Allen, JrfChair Board of Regents