Critical external review of U of M’s human-research protections program going to faculty Senate

Review of U of M's program going to faculty Senate
The review said it found “inadequate and inconsistent attention to the process of consent, capacity to consent, the use of surrogate decision‐makers, and general efforts to address vulnerability of potential research subjects to coercion and undue influence.”

An independent review of the University of Minnesota’s efforts to protect people involved in research studies found fault with the program and says leaders should have done more to address deficiencies.

The review, which Science Magazine called a “damning report,” will be formally submitted to the university’s faculty Senate on Friday.

The 97-page review (PDF) said that the issues have led to “persistent concern and ongoing distrust of the clinical trials activities within the Department of Psychiatry.”

It said:

Many weaknesses in policy and practice were evident and require attention. Indeed, in the context of persistent internal and external criticism of University research involving populations of patients in which the likelihood of impaired consent capacity is high, the external review team believes the University has not taken an appropriately aggressive and informed approach to protecting subjects and regaining lost trust.

The review noted some good things in the program and found that some improvements have been implemented.

The review looks at issues like those involved in the 2004 suicide death of Dan Markingson while he was involved in a university drug study.

Much criticism of the program has ensued, including an open letter to legislators last month from former Gov. Arne Carlson, who castigated the university’s Board of Regents for failing to investigate.

The review’s conclusions include:

  • There are significant problems with core functions of the human research protections program, including Institutional Review Board (IRB) review, investigator education, practices related to consent to research, and the effective coordination of administrative oversight, clinical care and research.
  • Given the history of concern and scrutiny of its programs, the university’s leadership should have taken more informed and affirmative steps to identify and address deficiencies, particularly within the Department of Psychiatry.
  • The university and Medical School’s failure to develop an institutional culture that demands excellence, compliance, and accountability has resulted in persistent concern and ongoing distrust of the clinical trials activities within the Department of Psychiatry.
  • The review team did observe much strength in the university’s human subjects program and the value of newly implemented enhancements in policy and practice. The vast majority of faculty and staff demonstrated pride in their work, obvious dedication to the ethical conduct of research, and a desire to improve performance.  

The review also said it found “inadequate and inconsistent attention to the process of consent, capacity to consent, the use of surrogate decision‐makers, and general efforts to address vulnerability of potential research subjects to coercion and undue influence.”

And: “It was clear to the external review team that the membership of the Medical IRBs did not include sufficient members with the scientific expertise necessary to adequately address the research being reviewed at corresponding meetings.”

In conducting the review, investigators found that: “Faculty and staff in Psychiatry repeatedly characterized the climate of work as a ‘culture of fear.’  They provided stories of intimidation by researchers and fear of retaliation should staff voice opposition to practices that were of concern.”

The university’s response from President Eric Kaler and Vice President for Research Brian Herman [PDF] said action will be taken “on several of the panel’s recommendations, such as increasing staff and resources for enhanced training and monitoring, and adding members with relevant expertise to the Institutional Review Board.”

Also in the response: “Measuring the difference between our current research program and our commitment to becoming beyond reproach was the charge given to the independent review panel. Now, we will be accountable for taking action.”

(The university paid for the review, which was conducted by a team assembled by the Association for the Accreditation of Human Research Protection Programs.)

Kaler also said initially: “I am particularly gratified—but not surprised—that the panel found no legal or compliance violations, affirming numerous previous reviews and accreditations of our program. The strength of our program is a testament to our outstanding faculty and committed staff.”

Dr. Carl Elliott, a bioethics professor at the University of Minnesota who has long sought an independent investigation into the Markingson case and related research-ethics issues, was displeased, and said Monday:

The reaction of the administration so far is, quite frankly, offensive to any research subject who has been harmed in a study at the U. This reports lists failure after failure, and President Kaler reacts as if the university has been given a prize.

The review panel said they were startled by the widespread perception on campus that the administration does not care about protecting research subjects. Well, this reaction just reinforces that perception. You can’t fix a problem until you admit you have a problem.

The review now goes to the Faculty Senate, which commissioned it more than a year ago in response to renewed questions about Markingson’s death. In addition to the concerns about the young man’s death, many worried that the issues are affecting the university’s reputation and recruitment.

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