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UNIVERSITY OF MINNESOTA

Office of the Vice President for Research

420 Johnston Hall
101Pleasant Street S.E
Minneapolis, MN
55455-0421
612-625-3394
Fax: 612-626-7431

January 16, 2015
Leigh Turner, PhD
Associate Professor, University of Minnesota Center for Bioethics
Carl Elliott, MD, PhD
Professor, University of Minnesota Center for Bioethics

Dear Professors Turner and Elliott:
I am writing in response to the four questions raised in your letter of January 14, 2015.
The FDA conducted a clinical investigator inspection involving Dr. Stephen Olson in November
2014. To the extent FDA investigators find deviations from statutes or regulations during an
inspection, they issue a Form 483 (Inspectional Observations) at the conclusion of the
inspection. The FDA investigators did not issue a Form 483 to Dr. Olson. To the University’s
knowledge, the FDA has not yet issued its written inspection report.
There currently are no internal or external findings against Dr. Olson that would warrant the
University restricting his privilege to conduct human subjects research.
The FDA periodically conducts inspections of University clinical investigators and the
University has no practice of issuing press releases when these inspections occur.
The University is cooperating fully with all entities conducting reviews or audits related to
psychiatric research at the University.

Sincerely,

Brian Herman, PhD
Vice President for Research
Cc:

Stephen Olson, MD, Department of Psychiatry
Debra Dykhuis, Human Research Protection Program