Trudo Lemmens, LicJur, LLM (bioethics), DCL Scholl Chair in Health Law & Policy

Faculty of Law, University of Toronto 39 Queens park

Toronto, ON, Canada M5S 2C3 Tel: 416-978 4201

Fax: 416-946 3744 Trudo.Lemmens@utoronto.ca

President Eric Kaler, Faculty Senate Chair Professor Eva von Dassow, Faculty Senate Vice-Chair Members of the University of Minnesota Senate University of Minnesota 427 Morrill Hall 100 Church St SE Minneapolis, MN 55455 June 12, 2014,

Re: Markingson Case and Review AAHRPP

Dear President Kaler, Professor von Dassow, and Members of the Senate,

With our letter of April 23, 2014, we expressed our serious concern about the process your Universitys administration introduced to select a contractor to review current research practices and procedures. We have now read the recent announcement that the Administration signed a contract with the Association for the Accreditation of Human Research Protection Programs. We are both surprised and troubled by this contract. As recent as May 5, 2014, Ms. Elyse I. Summers, CEO of the AAHRPP, wrote in response to the question from one of us (TL), whether AAHRPP would review allegations about research practices at the University of Minnesota as part of its accreditation procedure, that "AAHRPP is not an investigative body" and that "our role is limited to evaluating whether an applicant or accredited organization complies with our Standards and Procedures". The organization either changed its approach, or sees the proposed review as being limited to a review of standards of procedures, which clearly has little to do with the thorough investigation the Senators supported. But there is more. In an interview with MPR, Vice-President for Research Brian Herman lauds the AAHRPP and suggests no person involved in the review has a COI. Unfortunately, the selection of the AAHRPP is troubling precisely because of conflict of interest concerns. The AAHRPP already has an ongoing relation with the University. It accredited the research ethics programs and will conduct again an accreditation review in the near future. While it could be valuable to review allegations about problems of research ethics as part of its new accreditation procedure, the AAHRPP cannot be seen as an independent investigative body, not even if its review would be limited to what is in place. It is clearly not in the organizations interest to conclude that its accreditation has done little to prevent serious problems or may have overlooked issues, if that would be the case. Even if AAHRPP staff is not directly involved in the review itself, the organization is in a direct contractual relation with the university with respect to an issue in which it has a direct interest. The Senators asked for an independent inquiry, not a review organized by an organization that has already provided accreditation for the existing standards of procedures and has a stake in the outcome. 1/..

A review of the curriculum of the members of this AAHRPP organized committee also makes us concerned about conflicts of interest. One of the members, Dr. Jeremy Sugarman, is a member of a Comprehension of Informed Consent Advisory Board of Quintiles. The company Quintiles played a central management role in the CAFE study in which Dan Markingson participated and committed suicide. Problems of informed consent are precisely front and center in the Markingson case, and are also mentioned in the context of other alleged controversies surrounding psychiatric clinical trials at the University of Minnesota. Quintiles may still have ongoing relations with the University. We informed Dr. Sugarman, who several us know, about the fact that we perceive this to be a conflict. He has indicated that he will alert the other committee members and AHRPP about the issue. He assured us that he would recuse himself from that portion of the review that could create a conflict. However, as we indicated before, it seems impossible to conduct a decent review without looking into what happened in the context of the Markingson case and other alleged cases of ethical transgressions. Even under the restricted mandate that you have given to the reviewers, it would be impossible to reasonably exclude, before even starting the review, that issues related to informed consent, including in Quintiles coordinated studies, will not come up, and that the relation between the University and a commercial CRO will not raise any ethical issues. Regardless of the committee members commitment to research ethics and their qualifications and integrity, this type of conflict of interest affects the credibility of the review process. The administration has not only excessively limited the mandate of the committee so as to exclude any meaningful review of ethical issues with past and ongoing research practices on the ground, it now also has appointed a committee which is affected by conflicts of interest. It is hard to understand how the administration can think it can do this and still maintain even the slightest credibility in the process.

Yours sincerely,

Trudo Lemmens, LLM, DCL Scholl Chair in Health Law and Policy Faculty of Law and Faculty of Medicine, University of Toronto Toronto, Ontario

Raymond De Vries, PhD Professor Center for Bioethics and Social Sciences in Medicine University of Michigan Medical School Ann-Arbor, Michigan 2/..

Alice Dreger, PhD Professor Medical Humanities and Bioethics Program Northwestern University Feinberg School of Medicine Chicago, Illinois

Lois Shepherd, JD Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical Ethics Professor of Public Health Sciences, Professor of Law University of Virginia, Virginia

Susan M. Reverby, PhD Marion Butler McLean Professor in the History of Ideas and Professor of Women's and Gender Studies Wellesley College Wellesley, Massachusetts

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cc. Mr. R. Beeson