Newspaper article MinnPost.com

Critical External Review of U of M's Human-Research Protections Program Going to Faculty Senate

Newspaper article MinnPost.com

Critical External Review of U of M's Human-Research Protections Program Going to Faculty Senate

Article excerpt

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? …

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