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January 27, 2015

Carl Elliott, MD, PhD
Center for Bioethics
N504 Boynton
410 Church Street
Minneapolis, MN 55455
Dear Professor Elliott:
I am writing to respond to your letter dated January 23, 2015 regarding an investigation of “An OpenLabel, Flexible-Dose, Long-Term Safety and Efficacy Study of Bifeprunox in the Treatment of
Schizophrenia, Protocol S1543002.”
While the work of the IRB investigation panel has been completed, an evaluation of the findings is in
process. An external entity has been asked to review the findings to assist the Institutional Official. The
external entity engaged to perform this work is FTI Consulting. A response date is not set but it is
expected that FTI will perform its evaluation in a thorough and timely manner.
It is my understanding that you have submitted a data practices request to University Records Manager,
Susan McKinney, for a copy of the IRB investigation report on alleged non-compliance in the
Bifeprunox studies, among other requests. This is the appropriate mechanism for requesting information
at the University.
The IRB continues to do its work to ensure that all research subjects are afforded protections defined by
research regulations and policies.


Digitally signed by Debra Dykhuis
DN: c=US, st=Minnesota, l=Minneapolis,
ou=Human Research Protection Program,, o=University
of Minnesota, cn=Debra Dykhuis
Date: 2015.01.28 08:30:51 -06'00'

Debra Dykhuis
Executive Director
c: Brian Herman, Susan Berry, Michael Oakes, Susan McKinney