Human Research Program Reaccredited

From Minnesota Alumni Magazine Spring 2017

By Cynthia Scott

On December 19 the University of Minnesota regained full accreditation with special distinction from the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP), an independent organization that ensures research institutions meet rigorous standards for quality and protection. AAHRPP had assigned the U the status of “reaccreditation pending” after a site visit in July 2015 found that the human research program did not meet the criteria for full accreditation.

This reaccreditation followed a period of significant reforms and improvements to the U’s human research program prompted by complaints about past cases of research participant recruitment and treatment. This included questions raised about Dan Markingson, a patient who died by suicide in 2004 while enrolled in a clinical drug trial at the U. An independent review of the U’s human research participants protections and a report from the Office of the Legislative Auditor recommended significant reforms, which were implemented by the U in 2016.

AAHRPP’s special distinction commends the U for its new policy on adults with limited or diminished capacity to consent to participating in research. The policy establishes a high level of protection for such potential participants and clearly conveys these expectations to the research community. It is one of more than 60 changes.

Another significant change has involved how the department of psychiatry engages community members. Sophia Vinogradov, M.D., who succeeded Charles Schulz, M.D., as head of psychiatry last year, established a Community Advisory Council to provide regular feedback about department practices. One of the first members is Mike Howard, a friend of Markingson’s family and longtime advocate for University reforms.

“I wanted this council because I want to get the perspective of people not in the department,” Vinogradov says. “People who have the lived experience of mental illness, their family members, people from the nonprofit or legislative worlds. . . .Their points of view are so important to the work we do.” Vinogradov also developed a Chair’s Advisory Group within the department focused on the well-being of research volunteers.

In addition, with the blessing of Markingson’s family, Vinogradov instituted the annual Dan Markingson Lecture on the role of the family in mental health treatment, with the first lecture scheduled for this spring. The event will also include a panel discussion with family members and people with lived experience related to medical decision-making.


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