April 1, 2015

Brian Herman, PhD

Vice President for Research
University of Minnesota
101 Pleasant Street
Minneapolis, MN 55455
Open Letter Requesting the Public Release of Three Investigative Reports That Address Alleged
Psychiatric Research Misconduct at the University of Minnesota
Dear Vice President Herman:
I am contacting you because of your failure to release reports from three investigations that addressed alleged
psychiatric research misconduct at the University of Minnesota Medical Center, Fairview. These documents
are the IRB Executive Committees Bifeprunox Investigation, the Fairview Investigation, and the
Establishment Inspection Report issued by the FDA after its November 2014 clinical investigator inspection of
Dr. Stephen Olson. Your refusal to release these reports is keeping important findings concealed from public
view and possibly putting research subjects at increased risk of harm.
Two weeks ago, you and other members of the Universitys senior management team were subjected to
scathing criticism in the Office of the Legislative Auditors report, A Clinical Drug Study at the University of
Minnesota Department of Psychiatry: The Dan Markingson Case. The report states,
We are especially troubled by the response of University leaders to the case; they have made
misleading statements about previous reviews and been consistently unwilling to discuss or even
acknowledge that serious ethical issues and conflicts are involved.
Condemning the conduct of senior university officials, the report adds,
They have repeatedly claimed that clinical research at the University meets the highest ethical
standards and dismissed the need for further consideration of the Markingson case by making
misleading statements about past reviews. This insular and inaccurate response has seriously harmed
the University of Minnesotas credibility and reputation.
Given this pattern of reprehensible behavior, senior administrators must start honoring their commitment to
transparency, make accurate claims about reviews, and ensure that investigations of alleged research
misconduct are not concealed from the public. Instead, you are stonewalling requests for these investigations.
As you know, on November 17, 2013, and May 19, 2014, Fox 9 KMSP-TV aired reports that examined the
case of Robert. In these reports Robert claimed that he was coerced into a Bifeprunox study conducted by Dr.
Stephen Olson. On January 2, 2014 and February 13, 2014, my colleague, Professor Carl Elliott, contacted the
Chair of the Universitys IRB Executive Committee and filed complaints against Dr. Olson.

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An investigation of Professor Elliotts complaint was approved by April 14, 2014. On October 13, 2014, the
IRB Executive Committee made a Recommendation for determination/action on the Bifeprunox
Investigation Report. At that point the investigation was finished and the report was completed.
Meeting minutes from December 8, 2014 indicate that the Bifeprunox Investigation Report was provided to the
six reviewers involved in the AAHRPP inquiry. According to meeting minutes from January 12, 2015, you, as
the Universitys Institutional Official, elected to engage FTI Consulting to review the process and findings of
the IRBs Bifeprunox investigation. The $25,000 contract with FTI Consulting ended March 7, 2015, and you
reportedly already have their review of the IRBs completed investigative report.
You have released the IRB investigative report to at least six outside reviewers and a private consulting
company. However, you have failed to release the completed IRB Bifeprunox Investigative Report and the
consulting firms review of that report to the Faculty Senate and other interested faculty members, the Board of
Regents, the community served by the University of Minnesota, and local reporters who are investigating
allegations of psychiatric research misconduct at the university. It is now more than fifteen months since
Professor Elliott filed his complaint against Dr. Olson. We are far beyond the date when you should have
released this investigative report.
When you provide Robert with his copy of the investigation I hope it comes with personal apologies from you,
President Kaler, Dr. Stephen Olson, Dr. Brooks Jackson, and Brian Lucas. The manner in which the
University attempted to smear Robert and destroy his credibility was unconscionable.
By April 2014, the IRB Executive Committee had also approved a broader investigation of clinical research
conducted at Fairview by faculty members in the Department of Psychiatry. According to minutes from the
June 9, 2014 meeting of the IRB Executive Committee,
This investigation is concerned with the broader issues of complaints expressed by Fairview staff
regarding the culture and recruitment practices of psychiatric trials in the Fairview clinical setting.
Records have been reviewed on multiple trials identified as enrolling subjects from the
bipolar/schizophrenia population.
This investigation was focused on the culture and practice surrounding psychiatric research within the
University of Minnesota and Fairview Health Systems. A final draft of this report was to be completed by the
February 2015 meeting of the IRB Executive Committee.
This investigative report was shared with the six AAHRPP-appointed reviewers. However, it has not been
publicly released. Findings from this investigation should have informed the resolution that was passed last
week by the Board of Regents. Instead, it is unclear whether Regents were told that this investigative report is
in your possession.
According to the AAHRPP-reviewers report, faculty and staff in Psychiatry repeatedly characterized the
climate of work as a culture of fear. They provided stories of intimidation by researchers and fear of
retaliation should staff voice opposition to practices that were of concern. Your failure to release this
investigative report risks enabling this departmental culture of fear and intimidation. There is also the
possibility that by refusing to release this report you are keeping secret allegations of research misconduct that
institutional whistleblowers expressed to investigators.

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Finally, in November 2014, the FDA conducted a clinical investigator inspection of Dr. Stephen Olson. This
investigation reportedly included an examination of the suicide of Dan Markingson while he was a research
subject in the CAF study. In total, the FDA investigation apparently examined four clinical trials conducted
by Dr. Olson.
The FDA releases Establishment Inspection Reports within 30 days of conducting site visits. Unless it
deviated from standard practice, the FDA must have released its report over three months ago. Had you
promptly released this Establishment Inspection Report, its findings could have informed the report prepared
by the AAHRPP-appointed reviewers, the Office of the Legislative Auditors report, and the resolution passed
by the Board of Regents.
To avoid a scenario in which you and other senior university officials are perceived as systematically
obstructing the public disclosure of investigations of alleged psychiatric research misconduct, I ask you to
immediately release the Bifeprunox Investigative Report, the Fairview Investigative Report, and the FDA
Establishment Inspection Report related to the FDAs November 2014 inspection of Dr. Stephen Olson.
Please publicly release these documents and provide faculty members, students, administrators, local citizens,
current and prospective research subjects, possible victims of research abuse, and journalists with the
investigative reports they need to have an informed understanding of whatever was found by inquiries initiated
following complaints of alleged psychiatric research misconduct at the University of Minnesota. It is time to
end the era of secrecy, stonewalling, and dirty tricks at the University.
Yours sincerely,

Leigh Turner, PhD

Associate Professor
University of Minnesota Center for Bioethics
cc: Jerry Menikoff, Director, Office for Human Research Protections, DHHS
Kristina Borror, Director of the Division of Compliance Oversight, Office for Human Research Protections
Sean Kassim, Director, Office of Scientific Investigations, FDA
Catherine Parker, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, FDA
Arne H. Carlson, Former Governor of Minnesota
Terri Bonoff, Minnesota Senator, Chair of the Higher Education & Workforce Development Committee
Dan Schoen, Representative, Minnesota House of Representative
Carl Elliott, Professor, University of Minnesota Center for Bioethics
Trudo Lemmens, Professor, Faculty of Law, University of Toronto
Michael Carome, Director, Public Citizen Health Research Group
James Nobles, Legislative Auditor for the State of Minnesota
Eric Kaler, President, University of Minnesota
Brooks Jackson, Vice President, Health Sciences & Medical School Dean, University of Minnesota
Bruce Blazar, Associate Vice President for Clinical & Translational Science, University of Minnesota
William Donohue, General Counsel, University of Minnesota
Keith Dunder, Legal Counsel, University of Minnesota Academic Health Center
Susan Berry, Chair, University of Minnesota IRB Executive Committee
Debra Dykhuis, Executive Director, University of Minnesota Human Research Protection Program
Richard Beeson, Chair of the Board of Regents, University of Minnesota
J. Michael Oakes, Associate Professor, School of Public Health, University of Minnesota