U hires panel to review research practices

The University of Minnesota has hired an outside organization to conduct a six-month review of its clinical research practices.

The Association for the Accreditation of Human Research Protection Programs, a nonprofit accrediting body, will run the inquiry on a proposed budget of $142,000.

University officials say it will manage a team of independent investigators that includes experts from Harvard Medical School and Johns Hopkins University.

The announcement today comes after a December resolution by the U’s faculty senate calling for a review of how the U treats its human patients in clinical trials. The resolution came amid lingering questions over the 2004 suicide of a patient, Dan Markingson, who was involved in a university drug trial.

Vice President for Research Brian Herman called the organization “the Good Housekeeping Seal of Approval,” and said the reviewers were among the world’s leading experts in the appropriate use of humans in clinical research.

“I think they’re an outstanding group to look at the questions we’ve asked them to look at,” he said.

But U of M bioethicist Leigh Turner said the questions are the heart of the problem for critics such as him.

He said the U doesn’t need a bland review of current practices, but a genuine investigation into cases such as Markingson’s. He and other academic critics from other universities have said previous inquiries have been weak.

Turner said an investigation “needs to look at particular allegations of research misconduct.”

Trudo Lemmens, a University of Toronto professor of health law and policy — who has been critical of the U’s handling of the Markingson case — echoed Turner’s concern in an email.

“People familiar with accreditation programs will agree that these are focused on paper work and procedures, not on what is happening on the ground,” he wrote. “What I find particularly troubling for an organization that states it aims to protect research subjects, is that it accepts in these circumstances to conduct an inquiry which excludes any reference to serious concerns that have been raised in specific cases. A credible organization should put its conditions on the table, and explicitly request a wider mandate that includes the elephant in the room.”

Lemmens also questioned the association’s independence, saying it already accredits the U and so has a “client-provider relationship.”

“It is clearly not in the organization’s interest to admit that its accreditation has done little to prevent serious problems, or that its accreditation procedures may have overlooked serious problems,” he wrote.

Hermann said that to his knowledge no one involved in the review has a conflict of interest.

The U says the panel will issue a public report, and it will recommend any necessary improvements to university practices. A university spokeswoman could not say when it will issue the report.

  • R. De Vries

    Let’s say General Motors hired an outside agency to accredit its quality control process, and let’s say that agency approved of all the processes GM put in place to make sure that no cars would leave the factory with flaws that may be fatal to GM car owners. It is then discovered that GM was knowingly shipping cars with problems that resulted in deaths causing GM car owners (or the government) to demand an inquiry.

    Are you with me?

    Would you hire that same agency, the one that certified the process — the one whose reputation is tied to its ability to find and correct flaws in the process — to examine if there were problems with the process?

  • Alice Dreger

    The UMN administration seems determined to draw more and more attention to the Markingson case with its unwillingness to support an independent, transparent, complete investigation of what happened in the CAFE study. It’s as if they’re trying to up the ante with this obviously self-serving move.

    To shift Ray DeVries’ question just a touch: *Why* would you hire that same agency, the one that certified the process —
    the one whose reputation is tied to its ability to find and correct
    flaws in the process — to examine if there were problems with the

    Only one reason you would go with this approach: because you don’t really want to know what happened and you don’t really want to take responsibility for the past and the future.

  • Trudo Lemmens

    Dr. Herman suggests no person involved in the review has a COI. I raised with Alex Friedrich another COI concern: the company Quintiles played a central management role in the CAFE study, precisely the study in which Dan Markingson participated and committed suicide. One of the members of the newly established AAHRPP committee is Dr. Jeremy Sugarman, who is also on a “Comprehension of Informed Consent Advisory Board” of Quintiles. Problems of informed consent are precisely front and center in the Markingson case, and are also mentioned in the context of other alleged controversies surrounding psychiatric clinical trials at the University of Minnesota. Are members of this AAHRPP committee not aware at all of the context of this ‘review’, i.e. allegations about various concerns (many consent-related) in the context of the Markingson case and other alleged cases? Could they reasonably exclude, before even starting the review, that they will be able to avoid issues related to informed consent, including in Quintiles coordinated studies? And if they would try to argue they can do so, what does that tell us about this review? Same conclusions as my two other colleague-commentators before.

    Another troubling issue: I have written to AAHRPP in the past, asking if they are aware of allegations of research ethics concerns in the context of the University of Minnesota (which they have accredited), and if–as an accrediting body–they will investigate these concerns. The response by AAHRPP’s CEO was that “AAHRPP is not an investigative body” and that “our role is limited to evaluating whether an applicant or accredited organization complies with our Standards and Procedures”. Why even have an extra accreditation review by the same agency that did this kind of standards and procedures review before? This is not what people have been asking for. It adds insult to injury.

  • thomas hussman

    When JFK was shot multiple times from separate trajectories in Dallas, the news accounts spread around the world that 3 shots rang out. The number of shots was critical to the disinformation scheme that had been well planned.

    When Dr. Frank Olson was murdered in New York City, a future Watergate participant arrived at the scene to represent the “Agency” shortly after the crime occurred.

    When Father Bruce Wollmering died, after he “fell” several times at St. Johns College subsequent to being privately accused for his involvement in two missing person cases, Giumond and Wetterling, the lawyers who represent the college had already notified a criminal defense lawyer to be prepared, in the event “anyone” was charged with murder.

    For any complex crime to succeed, many things must be in place prior to the act. Cover stories, judges and prosecutors must be paid off, disinformation via media contacts must be arranged. Money must be available. Motive, means and opportunity must be concealed before, during and after the crime.

    The case (s) coming out of the UMN are being perpetrated by people who have all the same credentials, as those who pulled off the above murders. At this point nothing will they spare. They may even invite a former president to town, and give him an innocuous award, so he can participate in the disinformation process by telling his audience to look toward solving the problems of the future, with a subliminal message to forget about Dan Markingson, et al.

    For any complex crime to succeed, several things must be in place prior to the act to avoid detection. Professional killers must be paid. A cover story must be arranged, with contingencies. Disinformation is naturally part of the process.
    Several things must be present for any well

    planned murder to succeed. All the necessary

    traits which permitted