BIDness as Usual
In yet another twist to the University of Minnesota’s longstanding refusal to support a thorough investigation of reports of research misconduct involving faculty members in the Department of Psychiatry, the University has issued a “Request for Proposals” call that solicits “bids” from prospective contractors interested in reviewing “current policies, practices, and oversight of clinical research on human subjects.” Like my colleague, Carl Elliott, I find this latest display of institutional chicanery both absurd and fully consistent with the now decade-long refusal by senior university administrators to promote anything resembling a legitimate inquiry into what appears to be a longstanding pattern of research misconduct involving vulnerable patients with mental illnesses.
If pressed, university administrators will doubtless claim that by soliciting bids for a review they are doing exactly what the Faculty Senate requested when by a vote of 67-to-23 senators approved the “Resolution on the matter of the Markingson case.” This claim is false, profoundly cynical, and effectively constitutes senior administration giving the middle finger to faculty senators and any credible notion of shared institutional governance. Before examining the Resolution I want to identify some obvious problems with University of Minnesota administrators’ attempt to promote an ersatz “review” rather than a credible investigation of whether research misconduct has occurred at the University for many years.
To begin, the call for bids was posted to the “MBID System” on the University’s Purchasing Services website. The site is password protected and it appears that prospective contractors must be registered with the site before they can find and review requests for bids. The purpose of the MBID system is to solicit bids for beverage services, waste management contracts, laboratory supplies, and related services required by the University. What this means is that instead of appointing an independent panel of experts in health law, research ethics, and regulation of human subjects research, asking Governor Dayton to establish a panel of reputable experts, or asking Minnesota’s Attorney General, the Department of Justice, or some other law enforcement body to investigate whether laws and research ethics standards were violated, university administrators want to contract this task to a private consulting firm. Unless the Presidential Commission for the Study of Bioethical Issues routinely trolls for contracts on the MBID website, it is unlikely that the kind of organization that registers with MBID is going to have the expertise, credibility, investigative powers, and forensic skills needed to conduct a thorough of investigation of numerous reports of psychiatric research misconduct. This is not a job for a local business consulting firm, contract research organization, or independent ethics consultant. Admittedly, if the University hires an organization with the stature and forensic skills of Louis Freeh and his company, as Penn State did during its investigation of child sexual abuse by former assistant coach Jerry Sandusky, there will at least be basis for thinking that the “contractor” is credible. But I do not anticipate the University awarding the bid to Freeh or anyone else with his investigative skills.
Of greater significance, even if a credible company with relevant expertise makes a successful bid for the contract, it is being given the wrong mandate. This problem can be traced to the wording of the resolution passed by the Faculty Senate. It is unsurprising that the Request for Proposals takes advantage of the poor wording of the resolution and thereby sidesteps the spirit and intent of the resolution passed by a large majority of senators. According to the RFP,
The intent of this review is to ensure that the University’s processes for clinical research on human subjects meet or surpass the established best practices and norms and to instill confidence among faculty and the public that the University of Minnesota research is beyond reproach. It is to be forward looking, productive, transparent and independent review of current practice by an external expert panel.
Setting aside the suggestion that primary mandate of the contractor is to engage in a public relations exercise for the University by “instilling confidence” that research conducted at the University of Minnesota is “beyond reproach”, the emphasis on being “forward looking” while examining only “current” policies, practices, and oversight of clinical research is profoundly disturbing. University senators gave senior administrators a loophole and as was to be expected President Kaler and his executive team went right through it.
There is, of course, much to be said in support of examining the University’s current research practices and policies and considering what should be done to better protect participants in human subjects research. Faculty members and administrators at universities should always be attentive to ways in which human subjects research can be improved. But the RFP’s focus on examining “current practice” and remaining “forward-looking” fails to address the elephant-in-the room—reported psychiatric research misconduct at the University of Minnesota. It is not enough—for a decade now it has not been enough—to look exclusively at current practices and policies. Rather, there needs to be a thorough investigation of reported psychiatric research misconduct and this can only be done by examining whether serious violations of the rights of research subjects occurred in the CAFÉ study and in other clinical studies. Calling for a review focused only on the present and future fails to confront the possibility that psychiatric research misconduct has occurred for many years at the University of Minnesota. For the sake of the University, for the sake of the faculty members alleged to have engaged in research misconduct, and—most importantly—for the sake of the alleged victims of research misconduct, it is not possible to pretend that the past can be ignored.
When they debated and passed the resolution calling for an independent panel Faculty senators were aware of the need to address past acts at the University in addition to current practices and policies. In fact, text immediately before the poorly worded resolution reveals that the resolution was brought before Senate because of “Issues Arising from the CAFÉ study and the Suicide of Dan Markingson”. Beginning with the Preamble and extending to the resolution, here is the full text of what went before Faculty Senate December 5, 2013. It is clear that longstanding allegations of research misconduct were what brought this topic before the Senate.
Issues Arising from the CAFE Study and the Suicide of Dan Markingson
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.
It is obvious that reports of research misconduct were what resulted in the senators supporting the resolution. The final resolution erred by indicting that the sole remit of an independent panel was to address “current” policies, practices, and research oversight but the remainder of the text reveals that the spirit and intent of the resolution was to address “reputational harm” suffered by the University due to unresolved questions related to the Markingson case and related concerns about “clinical research involving adult participants with diminished functional abilities.”
Prior to passage of the resolution, Naomi Scheman, a Professor of Philosophy and Gender, Women, and Sexuality Studies stood before Senate and offered a thoughtful and passionate account of why the University needed to conduct a thorough investigation that included a substantial historical component. “A significant number of highly credible, fair-minded, prominent people in the field of research ethics have raised doubts about the way some research is conducted at the University of Minnesota,” she said. “We are all of us under this cloud, and this cloud needs to be removed. Only a credible investigation of what happened in [the Markingson] case and as well as into continuing policies and procedures will remove that.”
By failing to address particular instances of reported research misconduct—some of which go back a decade and some of which are recent—senior administrators at the University of Minnesota have guaranteed that the clouds hanging over the University will remain. Of much greater significance, university officials have concocted a “review” that by design will fail to investigate whether serious research misconduct has occurred at the University for many years. Senior university administrators everywhere pride themselves on their leadership skills, professionalism, and transparency but what is being promoted as a credible institutional review looks to me like yet another example of malfeasance on the part of President Kaler and other members of his executive team.
When confronted with reports of research misconduct regents and officers of the University have a duty to make reasonable inquiries and determine whether or not wrongdoing has occurred. This “review” of current practices and policies subverts the process of reasonable inquiry and replaces a legitimate investigation with its spurious substitute. Of course, after a decade of such activity, there is no reason to be surprised.