For the Record: Resolution on the matter of the #Markingson case (for Faculty Senate 5 Dec)

MEETING OF:
[University of Minnesota]

THE FACULTY SENATE 

THURSDAY, DECEMBER 5, 2013 

2:00 – 3:45 P.M.

[Important note - added Friday, Dec 6 It is my understanding that the resolution passed by the Faculty Senate was an amended version of what is below.  Added Monday, Dec 9: The final resolution, as amended and passed, may be found here.] 

Source

10. FACULTY CONSULTATIVE COMMITTEE 

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

Action by the Faculty Senate

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

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 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 Markingson case; 

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 an investigative 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. 

WILLIAM DURFEE 

CHAIR, FACULTY CONSULTATIVE COMMITTEE