How relevant will the U’s review of clinical research practices be?

Academic Matt Lamkin writes in the Star Tribune on behalf of about a dozen University of Minnesota scholarly alumni about concerns they have with a coming outside review of the U's clinical research practices.

In essence, they fear the review will never really get to the heart of what practices or policies may have caused the 2004 suicide of U patient Dan Markingson during a drug trial:

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Kaler (UMN)

Minnesota President Eric Kaler appears intent on continuing the university’s efforts to avoid scrutiny. In a recent interview with the Minnesota Daily, Kaler said that the inquiry will not look at Markingson’s death at all, but rather will focus solely on “what we are doing now and what we’re going to do moving forward.”

Such a limited inquiry would defeat the purposes of the [Faculty] Senate’s [call for the investigation]. Although the resolution does call for an inquiry into the university’s current practices, the Senate left no doubt that the aims of that investigation included resolving “questions [that] continue to be raised about the policies and procedures followed in the Markingson case” and addressing the harm to the university’s reputation “in consequence of this tragic case and its aftermath.”

Any inquiry that merely considers the university’s forms and policies without examining the experiences of actual research subjects would only further erode confidence in the institution and compound the harm to its reputation.

Lamkin also writes that his group is concerned that Kaler, who was not around during the Markingson case, may intend to handpick the investigators:

Any involvement by the administration in selecting the members of the investigative panel would destroy the body’s credibility. The offices of the president, the general counsel and the Academic Health Center are all important players in the Markingson controversy whose roles must be examined by the investigative panel. It would be a clear conflict of interest for the targets of this inquiry to select their own investigators.

You can read the full letter here.

Also, a recent letter from a University of Toronto professor in health law and policy also asks the U to be sure the investigation "covers the problems in the Markingson case" and that "the selection of committee members not be controlled by those who have been the target of criticism."

(I'll post the letter as soon as I can.)


And here's an account of the matter by