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May 14, 2014

Elyse I. Summers, JD
President and Chief Executive Officer
Association for the Accreditation of Human Research Protection Programs
2301 M Street, NW
Suite 500
Washington D.C. 20037

Re: How the University of Minnesota Is Misusing AAHRPP Accreditation to Deflect Calls for
an Investigation of Psychiatric Research Misconduct

Dear Ms. Summers:

I am contacting you because I am concerned that my employer, the University of Minnesota, is
using accreditation by AAHRPP as a public relations shield to deflect calls for an independent
investigation of alleged psychiatric research misconduct.

According to your response to Professor Carl Elliott, “AAHRPP is not an investigative body but
rather, a non-governmental organization that accredits high quality human research protections. As
such, our role is limited to evaluating whether an applicant or accredited organization complies with
our Standards and Procedures.” What the University of Minnesota needs right now is a thorough
investigation by a law enforcement agency or an independent investigative body with subpoena
power. Such an investigation must examine claims that rights of mentally ill patients have been
violated. An investigation must also address functioning of institutional human research protection
programs and the conduct of senior university officials responsible for denying all calls for an
investigation of possible research misconduct. It also needs to determine how many research
subjects have died or suffered serious injury while enrolled in psychiatric clinical trials.

Among the issues requiring investigation are whether mentally ill individuals have been enrolled in
clinical trials as “consenting research subjects” despite lacking decision-making capacity; whether
threats of involuntary institutionalization have been used to coerce mentally ill research subjects
into participating in clinical trials; whether HIPAA violations have occurred in psychiatric clinical
trials; whether researchers have failed to disclose study-related risks in a timely manner; whether
financial conflicts-of-interest have resulted in aggressive recruitment tactics and inadequate
oversight by the IRB and other institutional oversight bodies; and whether the IRB and other
components of the university’s human research protection program have failed to make reasonable
inquiries in response to reports of research misconduct.


AAHRPP is not an investigative body. Your organization reviews whether or not applicants comply
with its standards and procedures. I have no doubt that my employer will provide you with
satisfactory paperwork. It is adept at promoting the appearance of compliance with regulatory
standards. Building a façade of regulatory compliance is much easier than ensuring that research
subjects are protected from harm. At the University of Minnesota the fundamental moral and legal
concern is not whether policies and procedures comply with AAHRPP’s standards and procedures.
Rather, the issue is whether institutional policies are being used to paper over harms done to
specific research subjects in particular clinical settings.

If you and your colleagues at AAHRPP are unable to look beyond paperwork and claims
concerning institutional procedures then I request that you suspend the University of Minnesota’s
current accreditation and not begin the re-accreditation review process until after an independent
investigation has determined whether psychiatric research misconduct occurred here. If you ignore
or dismiss this request I fear that the accreditation service provided by AAHRPP will be used by
university officials to claim that the University of Minnesota is “best in class” while they dismiss
calls for an investigation of possible research misconduct. I am sure you do not want your
organization and its name misused in this manner. Furthermore, it is not in your organization’s
interest to have accredited the University of Minnesota’s human research protections program if in
fact it is at some point determined that both research misconduct and a subsequent cover up have
happened here. Please do not let my employer use AAHRPP’s accreditation process as institutional

Yours sincerely,

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

cc: Governor Mark Dayton
Arne H. Carlson, Former Governor of Minnesota
Susan Berry, Chair, IRB Executive Committee, Human Research Protection Program
Debbie Dykhuis, Executive Director, Human Research Protection Program
Brian Herman, Vice President for Research, University of Minnesota
Brooks Jackson, Dean, University of Minnesota Medical School
Carl Elliott, Professor, University of Minnesota Center for Bioethics
Trudo Lemmens, Associate Professor and Scholl Chair, University of Toronto Faculty of Law