October

5, 2015

Senator Terri Bonoff, Senate Higher Education and Workforce Development Chair

Re: Your Refusal to Investigate Clinical Trial Recruitment of Patients Involuntarily Held
on a Locked Psychiatric Unit at the University of Minnesota Medical Center, Fairview

Dear Senator Bonoff:

Thank you for your September 30 email response to my letter to you of September 29, 2015. In
your email you express your satisfaction with the monthly reports the University of Minnesota
is providing you concerning changes to its human research protection program. On September
18, 2015, the Association for the Accreditation of Human Research Protection Programs
informed the University of Minnesota that the Universitys Human Research Protection
Program failed to meet the standard for full accreditation. On October 1, 2015, the University of
Minnesota provided you with its mandated monthly report concerning Human Subject
Research Standards. That report should have informed you of the Universitys failure to obtain
full accreditation. Instead, it neglected to mention this important development. In your own
words, the reports meet our requirements. If the reports you are receiving meet your
requirements and expectations, your standards for disclosure are so low that senior university
officials are free to withhold important information from you when producing these reports.

In my letter to you, I urged you to investigate various questions related to clinical trial
recruitment of mentally ill patients involuntarily held on a locked psychiatric unit. The
questions I listed for you identify key issues that need to be addressed by university officials
now that we know university faculty members recruited at least one patient involuntarily
confined to a locked psychiatric unit. It does not require a PhD or expertise in research ethics
to ask such questions. Senior university officials such as President Kaler, Vice President
Herman, and Vice President Jackson should have long ago demanded answers to these very
questions. However, they have made no effort to investigate whether additional research
subjects were recruited while being involuntarily confined to a locked psychiatric unit. Since
senior university administrators have failed to conduct investigation of this grave matter, I
turned to you given your role as Chair of the Senate Higher Education and Workforce
Development Committee. I am disappointed though not surprised by your response.

As a matter of public record, I want our exchange to document that you were asked to make
reasonable inquiries concerning possible research misconduct at the University of Minnesota
and you refused to take even the most elementary steps to determine whether vulnerable,

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mentally ill individuals were coerced into participating in clinical trials while they were
involuntarily confined to a locked psychiatric unit. I cannot understand why a state legislator
would act in such a manner but unlike individuals involuntarily confined to a locked
psychiatric unit you are at liberty to proceed as you see fit. It saddens me to know that this
decision is now part of your record as a state senator.

Yours sincerely,

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

cc: Representative Bud Nornes, House Higher Education Policy & Finance Chair
Senator Jeremy Miller, Senate Higher Education & Workforce Development Ranking
Minority Member
Representative Gene Pelowski, House Higher Education Policy & Finance Ranking Minority
Member
Dean Johnson, Chair of the University of Minnesota Board of Regents
Laura Brod, Chair, University of Minnesota Board of Regents Audit Committee
Arne H. Carlson, Former Governor of Minnesota
Eric Kaler, PhD, President, University of Minnesota
Brian Herman, PhD, Vice President for Research, University of Minnesota
Brooks Jackson, MD, MBA, Dean and Vice President for Health Sciences, University of
Minnesota
Gail Klatt, Associate Vice President, University of Minnesota Office of Internal Audit
Debbie Dykhuis, Executive Director, University of Minnesota Human Research Protection
Program
Michelle H. Biros, MD, Vice Chair, University of Minnesota Executive Committee IRB
Joanne Billings, MD, Chair, University of Minnesota Executive Committee IRB
David Murphy, Fairview Board Chair and Interim Chief Executive Officer
Carolyn Wilson, RN, Executive Vice President and Chief Operating Officer of Fairview
M.J. Swanson, Executive Consultant, Research Administration, Fairview Health Services
Jill Cordes, Director, Research Administration, Fairview Health Services