Professor 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. Sincerely,
Debra Dykhuis
Digitally signed by Debra Dykhuis
DN: c=US, st=Minnesota, l=Minneapolis, ou=Human Research Protection Program, email=dykhu001@umn.edu, 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