In an earlier blog of October 15, 2013, I reported on the controversy surrounding the death of Dan Markingson, a patient who participated in a controversial clinical trial of anti-psychotic medication, in a University of Minnesota hospital. (To get a sense of the wider concerns the case raises about clinical trial practices and human research protection, see the earlier blog, various links there, and recent blogs by Bill Gardner, Dale Hammerschmidt and Kirstin Borgerson). I was happy to report in a follow-up blog in December that a request for an independent inquiry, supported by more than 170 scholars in health law, research ethics, medicine and other relevant disciplines, and directed at the University of Minnesota Senate, appeared at first sight successful. Unfortunately, recent developments have compelled the drafters of the letter (Raymond Devries, Alice Dreger, Jerome Kassirer, Susan Reverby, Lois Shepherd, and myself) to write on April 23, 2014 another letter to the University of Minnesota Senate, explicitly distancing ourselves from how this review process is now unfolding. Silence could all too easily have been interpreted as a sign of support for what appears to have done in response.
The developments are disappointing, but not entirely surprising. The somewhat vague language of the Senate’s motion in support of an inquiry, and particularly statements by University of Minnesota President Kaler following the vote, motivated many commentators, including University of Minnesota alumni, to re-emphasize the need for a fully independent and thorough investigation. We also stressed in a follow-up letter what we saw as some core requirements for an independent inquiry: 1. A committee of inquiry should receive a wide mandate to look at specific past and present research practices, procedures and guidelines, and at the reaction of the University when things go wrong. This had to include a review of the Markingson case; and 2. The committee selection process should ensure the independence of the committee and its members, particularly avoiding that those who have been the target of criticism in the context of the Markingson case would be in control of the process.
Unfortunately, the skeptics were right. Some of the essential elements of an independent inquiry appear to be missing in the procedure that the University has set up. Without giving much publicity to its initiative, the administration posted a Request for Proposal on its contracting website, asking for contractors to submit a proposal to conduct a review of “current practices, policies, and oversight of clinical research on human subjects at the University of Minnesota” which has to be finalized in or around July 1 of this year, a short timeframe. The RFP procedure is the type of procedure that is used for regular contracts offered by the administration to a contractor – akin to a request to supply light bulbs or stationery. (For critical comments on the RFP process and recent developments, see here and here). The procedure followed, and the terms of contract proposed, are not in line with we and others asked for, and also ignore what the University of Minnesota Senate itself emphasized as being the specific reason for setting up this inquiry, i.e. the ongoing controversy surrounding the Markingson case.
The administration could easily have consulted with different stakeholders from inside and outside the university to help identify the most appropriate members for an inquiry committee, and could have obtained widespread support for the selection of the committee and for the terms of reference. It opted not to go that route. With the RFP procedure, the administration selects the contractor and the contractor has to report directly to the administration, which creates a serious conflict of interest, since the administration’s dealing with the Markingson case should be part of the inquiry. It will be difficult for the contractor to critique the administration’s handling of research controversies.
The language of the RFP confirms not only that the administration is in control but also that the inquiry is limited to a narrow focus on current procedures and practices, with no reference to past problems. The RFP precludes a thorough investigation of past practices and the influence of those practices on the current treatment of research subjects, even though the Senate explicitly mentioned the ongoing controversy surrounding the Markingson case as a key factor for setting up the inquiry. The RFP asks the review to be “forward looking, productive, transparent and independent review of current practice” with a focus on "best practices and norms." And although this may be standard language for an RFP, references to the fact that the "selected Respondent will be the Respondent whose Proposal is the most advantageous to the University" and that the University has “sole discretion” to select the contractor do not help to create public confidence in the process. In our letter, we argue that the procedure is so flawed as to preclude any chance the resulting report will be seen as legitimate, except perhaps by those vindicated by it.
As discussed earlier (see the earlier blog; and my commentary in Bioethical Inquiry), one of the disturbing aspects of the Markingson case is how seemingly reliable bureaucracies, set up to protect research subjects and patients, can be conveniently used to shield institutions from further scrutiny. How the letter writing action and the Senate vote is now being steered away from its original intent shows how well intended actions may simply end up providing additional procedural protection. This is why it appeared important to register our disapproval. We will be looking at other ways in which we can support the efforts to see a transparent, independent investigation of the type so many have been demanding.
In Minnesota, those who have been asking for a public inquiry are now undertaking other actions, including increasing their efforts to obtain an external inquiry through State Governor Mark Dayton and the University Board of Regents (for details of various actions, see here).
Update April 29: Minnesota's VP Research and the Chair of the Senate's Faculty Consultative Committee responded to our last letter. In their letter, they indicate that the University is moving ahead with an inquiry along the lines of the Senate motion (but again not mentioning the Markingson case) and they invoke among other things its accreditation by the Association of the Accreditation of Human Research Protection as a sign of its committment to the highest ethical research standards. This raises the question whether the AAHRP is going to pay attention to the concerns that have been raised in the wake of the Markingson case when it is evaluating the request for re-accreditation of the University.
Update May 8, 2014: On behalf of my colleagues Raymond Devries, Alice Dreger, Lois Shepherd, Susan Reverby and Jerome Kassirer, I sent an e-mail to Mr. Beeson, Chair of the Board of Regents of the University of Minnesota, to express our dissaproval of how the University administration is responding to the University of Senate's motion supporting an inquiry into the Markingson case (see here for a copy of the e-mail).