October

19, 2015

Senator Terri Bonoff
Senate Higher Education and Workforce Development Chair

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

Dear Senator Bonoff:

Thank you for your letter of October 12, 2015. In your letter you write of my request to you, You
suggest that an investigation be made to identify past incidents in which persons were recruited for
research while locked in a psychiatric facility. The proposed changes in University human subject
research practices are predicated on the principle that one incident of that recruitment is one too many.
I gather we are in full agreement that it was wrong for University of Minnesota faculty members to
recruit into psychiatric clinical trials mentally ill individuals involuntarily held on locked psychiatric
units. Where we apparently disagree is whether such wrongdoing should be investigated.

As my prior letters to you indicate, when serious wrongdoing occurs in the context of conducting clinical
research involving vulnerable individuals, it is important to investigate what happened, determine the
scale of wrongdoing, and address other unanswered questions. Right now we do not know whether Mr.
Robert Huber was the lone patient recruited into a psychiatric clinical trial in this manner or whether
other patients were recruited while they were involuntarily confined to locked psychiatric units. We do
not know whether IRB members and senior university officials were aware of this practice and
condoned recruitment of patients in this manner. We have no idea whether this recruitment practice
took place over years or decades. Indeed, had Mr. Huber not come forward to share his story about
being recruited into a clinical trial while on an emergency 72 hour hold, we would still not know that
such conduct occurred at the University of Minnesota. When wrongdoing of this kind occurs it needs to
be investigated. It is important for patients, their loved ones, the integrity of human subjects research,
and the reputation of the University of Minnesota to be transparent about such wrongdoing and provide
full account of what happened. It therefore concerns me that you are on record as refusing to make
reasonable inquiries of University of Minnesota officials and will play no part in obtaining institutional
response to these unanswered questions. It is going to be very difficult for the University of Minnesota
to move forward, to use the preferred rhetoric of university officials, until such wrongdoing is
investigated and adequately disclosed.

You suggest that perhaps an investigation will be conducted by the legislative auditor, the external
review consultants, the current group overseeing change in human subject research, the faculty senate,
or even yourself. You might as well tell me to take my concerns to the Easter Bunny or the Tooth Fairy.
The legislative auditor is overburdened with demands and understaffed relative to the number of
investigations this office is asked to conduct; the external review consultants have completed their task

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and were never asked to conduct proper investigation of psychiatric research misconduct; university
officials involved in revising clinical research practices and policies have displayed repeated failure to
investigate credible allegations of psychiatric research misconduct; the faculty senate has little
meaningful power or investigative capacity; and senior university officials will ignore, obstruct, or
dismiss whatever requests I or other faculty members make for a thorough investigation of the
recruitment of patients involuntarily confined to locked psychiatric units.

You are a state senator and the Chair of the Senate Higher Education and Workforce Development
Committee. You are the obvious person to contact when senior university officials repeatedly fail to
investigate wrongdoing that occurs in the context of clinical research. When you join them in refusing to
investigate behavior that you acknowledge is wrong it is important that there is public record of your
failure to act. No one can compel you to ask straightforward questions and make reasonable inquiries
into wrongdoing at the University of Minnesota but I am at liberty to identify where leadership is
needed and you are nowhere to be found.

In your letter you refer to an op-ed recently published in the StarTribune and make the mistaken claim
that I am the source of information that I refused to take action regarding the issue of recruiting
individuals on 72 hour mental holds for human subject research. You then write, I have not failed to
take action on the 72 hour hold issue and any statement to the contrary is false and misinformed.
Contrary to your assertions, aside from providing Professor Elliott copy of your September 30, 2015
email to me, I played no role in the writing of his op-ed. Had he asked me to provide an assessment of
your involvement I would have stated that I welcome your proposed legislation to prohibit recruitment
of individuals on 72 hour emergency holds and condemn your failure to conduct proper investigation of
the activities that now make passing such legislation necessary. My objections are not to areas where
you are providing leadership in the state legislature but to domains where your leadership is absent.

I would not have contacted you if President Kaler, Vice President Herman, Vice President Jackson, and
other senior university officials had already provided full account of the recruitment into clinical trials
of patients involuntarily confined to locked psychiatric units. They have conducted no such
investigation, there is no indication that they are going to conduct such an investigation, and even if
there was an in-house institutional inquiry by now there is good reason to question whether its findings
would be trustworthy. As a faculty member I ask myself who provides oversight when senior university
officials fail to responsibly discharge their duties and address reports of wrongdoing. Perhaps in
Minnesota the correct answer is: no one.

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

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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