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.

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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