Approved by the: Faculty Senate - December 5, 2013
Administration - Faculty 2014*
Board of Regents - no action required
*The Administration recognizes the Faculty Senate resolution requesting an external review of clinical research on human subjects at the University of Minnesota and is moving forward with this review. The review will be managed by an independent, external firm who is expected to call upon national experts in the field of clinical research on human subjects research and who are widely recognized for their expertise, knowledge and achievement in this field. This review will include a review of relevant standard operating procedures and an assessment of University compliance with regulations and applicable law. It will result in a detailed report outlining strengths and weaknesses of current policies, practices, and oversight and any recommendations for any deficiencies identified. This process will include consultation with faculty and the final report will be public.

Issues Arising from the CAFE Study and the Suicide of Dan Markingson

PREAMBLE:

In May 2004, Dan Markingson, while enrolled in a clinical trial of an antipsychotic drug (the CAFE study) at the University of Minnesota, committed suicide. Since then individuals and groups within and outside the University have raised questions about the study, how Markingson was recruited into it, his treatment during the study, and the circumstances of his suicide.

On October 21, 2013, a letter co-authored by six bioethicists from outside the University, with 175 co-signatories, was addressed to President Eric Kaler and Professor Eva von Dassow, as chair and vice-chair (respectively) of the Faculty Senate, and to members of the University of Minnesota Senate. The letter asked the Senate to endorse and request an independent investigation of the issues arising from the Markingson case and the CAFE study. That letter is available at: http://www1.umn.edu/usenate/fsenate/docs/131205toronto_letter.pdf. The list of additional co-signatories is available at: http://www1.umn.edu/usenate/fsenate/docs/131205toronoto_signatures.pdf.

On November 20, 2013, fourteen faculty senators co-signed a request to the Faculty Consultative Committee to place this matter on the agenda of the December 5 Faculty Senate meeting for discussion, and further requesting that a resolution calling for an independent investigation be presented for discussion and action. That letter is available at: http://www1.umn.edu/usenate/fsenate/docs/131205letter_to_fcc.pdf.

The FCC discussed the letter and the issues it raises at its meetings on Oct. 24, Nov. 14, and Nov. 21. While these discussions have not reached a conclusion, and members of the FCC have varying views, a consensus emerged that it is appropriate to bring the matter before the Faculty Senate at this time. The FCC wishes to emphasize the following points.

First, it is important that those participating in decisions about this matter familiarize themselves, with the history of the case and investigations conducted to date.

Second, as the FCC studied this issue, two things became clear: that the Markingson tragedy specifically had been investigated several times from different perspectives, and that those investigations did not address the broader question of whether the University's current policies, procedures and practices, some of them changed since the Markingson case, reflect both best practices in clinical research on human subjects and the faculty's high ambitions for ethical behavior. Members of the FCC also recognize that external evaluations can have the advantage of fresh perspectives not biased by familiarity with current practice, and are a way for the public to have the utmost confidence in the integrity of the research conducted at the University of Minnesota.

For this reason, the FCC feels that the way forward is to recommend that an independent and transparent examination be undertaken to evaluate the University's procedures, practices, and policies governing clinical research on human subjects, and in particular clinical research involving adult participants with diminished functional abilities. While the specific charge for such an examination requires further work, FCC believes issues to address may include investigator conflict of interest, institutional conflict of interest, consent policies and procedures, case management of enrolled participants, mechanisms for overseeing such research and mechanisms for addressing adverse events.

Therefore, the FCC suggests to the Faculty Senate the following resolution:

Resolution on the matter of the Markingson case

WHEREAS the faculty of the University of Minnesota are committed to upholding high ethical standards in the conduct of research;

WHEREAS questions continue to be raised about the policies and procedures followed in the case of Dan Markingson, a 26-year-old participant in a clinical trial who committed suicide in 2004;

WHEREAS the University has suffered reputational harm in consequence of this tragic case and its aftermath;

WHEREAS the faculty seek to ensure through independent evaluation that the University's ethical standards for clinical research on human subjects meet or surpass the norm,

BE IT RESOLVED that a panel external to and independent from the University of Minnesota be constituted for the purpose of conducting an inquiry examining current policies, practices, and oversight of clinical research on human subjects at the University, in particular clinical research involving adult participants with diminished functional abilities. The administration, in collaboration with appropriate faculty governance committees, shall initiate the constitution of such an independent panel and shall support its inquiry. The panel shall have authority to obtain any records it deems necessary for a thorough inquiry, to the extent consistent with applicable law. At the conclusion of the inquiry, the panel shall issue a report that will be made publicly available, within the limitations of regulations governing the protection and privacy of individuals, including research participants, and the results will be reported back to the Faculty Senate so that senators have an opportunity to ask questions and discuss the report.


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