letter from debra dykhuis regarding bifeprunox investigation jan 22 2015

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January 22, 2015 Carl Elliott, MD, PhD Professor Center for Bioethics N504 Boynton 410 Church Street Minneapolis MN 55455 Dear Professor Elliott, I am writing in response to your letter dated January 18, 2015, to provide you with information regarding the status of the IRB Investigation Panel’s review of your complaint and allegations of non-compliance associated with the research conducted by Dr. Stephen Olson titled “An Open-Label, Flexible-Dose, Long-Term Safety and Efficacy Study of Bifeprunox in the Treatment of Schizophrenia, Protocol S1543002”. The IRB Investigation Panel has completed its work and the IRB has prepared an investigation report. However, this matter is not yet concluded as the University has decided to engage an outside entity to further evaluate the allegations and IRB findings. You will be informed once there is a final decision on this matter. In the meantime, I wish to thank you for your continued patience as evaluation of this important matter continues. Sincerely, Debra A. Dykhuis Executive Director c: Brian Herman Susan Berry J. Michael Oakes

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A year after a complaint is filed about misconduct in a study of bifeprunox, the University of Minnesota IRB responds

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Page 1: Letter From Debra Dykhuis Regarding Bifeprunox Investigation Jan 22 2015

January 22, 2015 Carl Elliott, MD, PhD Professor Center for Bioethics N504 Boynton 410 Church Street Minneapolis MN 55455 Dear Professor Elliott, I am writing in response to your letter dated January 18, 2015, to provide you with information regarding the status of the IRB Investigation Panel’s review of your complaint and allegations of non-compliance associated with the research conducted by Dr. Stephen Olson titled “An Open-Label, Flexible-Dose, Long-Term Safety and Efficacy Study of Bifeprunox in the Treatment of Schizophrenia, Protocol S1543002”. The IRB Investigation Panel has completed its work and the IRB has prepared an investigation report. However, this matter is not yet concluded as the University has decided to engage an outside entity to further evaluate the allegations and IRB findings. You will be informed once there is a final decision on this matter. In the meantime, I wish to thank you for your continued patience as evaluation of this important matter continues. Sincerely, Debra A. Dykhuis Executive Director c: Brian Herman Susan Berry J. Michael Oakes