UNIVERSITY OF MINNESOTA Twin Cites Campus Sponsored Projects Administration 450 MeNamara Alumni Center 200 Oak Sireet SE Minneopots, MN 55485 Office: 612-624-5599 Fax: 612-624-4843 January 27, 2016 Professor Carl Elliott Center for Bioethics 'NS04 Boynton 410 Church Street Minneapolis, MN 55455 SUBJECT: Your Complaint of November 3, 2015 (RCO File No. RC16-002-FCI-H) Dear Dr. Eliott, ''m writing to provide you with the outcome of your complaint dated November 3, 2015 (received by my office on “November 4, 2015). You expressed three matters of concern, and | am responding to each in turn below: a) 2) Your first matter was the public statement issued by the University about a former participant in a bifeprunox study. Your complaint said that you felt that the statement was an intentional violation of the participant's medical privacy aimed solely at discrediting him and his testimony. You indicated that you hhave been unable to get university administrators to take any action to prevent this from happening ‘again, and that you feel that the Academic Health Center needs to abandon tactics designed to intimidate potential whistleblowers and deter complaints by subjects who have been injured or mistreated. You acknowledged and provided a copy of a letter from the University’s Privacy Officer, who had previously reviewed this matter and determined that the University did not violate the participant's legal privacy rights. | did not find any new information in your complaint that would warrant my re-opening the question of violation of legal rights. | reviewed the patient information release document and the written statement issued by the University to the news reporter, and determined that the information provided to the reporter was consistent with what the participant authorized for release, and to whom he hhad asked that it be released. My office is not, however, in a position to interpret intent or suggest inclusion or exclusion of specific information for release. It is important for the University to characterize patient information carefully, even with a patient release, and | have shared your concerns with Sr. Vice President Jackson's Communication staff so that they can take your perspective into consideration for the future. Your second concern related to the subjects in the bifeprunox study, and the timing and existence of notifications to them about the FDA declining to approve bifeprunox for marketing. You indicated that under FDA regulation 21 CFR 50.25(b), study participants should have been notified when FDA declined to approve bifeprunox and that the notification should have included reference to the death of a European patient in the study witha later independent pathology report concluding that the death was ‘most lkely due to bifeprunox. My analysis determined that the consent form signed by the participant before he entered into the study already included the information about the patient death that occurred, including the possibility that the death was study-related. You indicate in your complaint that the University has previously agreed that study subjects should have ‘been informed in 2007 thatthe FDA declined to approve bifeprunox. That position has been confirmed by the IR. You provided me with the copy ofthe letter the former participant recived from the University acknowledging this fact. The Principal Investigator has since also attempted to inform the other study subjects to provide them with this same information (not all could be located), and the IRB has reviewed his communication procedure and deemed it acceptable to this icumstance, Ihave also personally verified evidence of such communication attempts. Driven to Discover”3) You indicate that your third (and most pressing) concern is the University’s conclusion that the participant was “not pressured or coerced to participate in this study.” You said you find that response “baffling,” You cite a 2009 Minnesota state law that subsequently limited the recruitment of patients under a stay of commitment into psychiatric drug studies. As you know, the enrollment of the participant in the trial took place in 2007, before the passing of the 2008 legislation by the State of Minnesota relative to the practice of recruiting patients undergoing a stay of commitment. There also was not (and still is not) a national regulation in 2007 relative to this practice. This practice, therefore, was considered acceptable at the time of the participant's enrollment inthis trial and appears to remain allowable under Minnesota law with respect to 72 hour holds, which are not the same as a stay of commitment. A detailed review both by a University investigative panel of human subjects experts, and by an independent investigative group outside of the University each confirmed that the participant was neither pressured nor coerced to participate in the study. Strategies that are in the present day and time considered important tools for determining whether a participant is capable of consent were in fact deployed back in 2007 to help ensure that the participant's consent was provided in an informed and knowledgeable way, including the deployment of a patient advocate during the consenting process, and the use of “teach-back” methodology to verify that the participant adequately understood the core elements of consent. 4) There is no new information contained in your complaint that would lead me to a conclusion that this matter should now be re-opened. You acknowledge in your letter that the University has itself chosen to discontinue the practice of recruiting 72-hour hold patients into psychiatric drug studies. ‘Thank you for sharing your concern with the University. Arrnsta Q. whet Pamela A. Webb ‘Associate Vice President for Research Enclosure: Original complaint letter of November 3, 2015 Ce: Or. Brian Herman Dr. Frances Lawrenz Ms. Debbie Dykhuis