Board acts on Kalers request

The University of Minnesota Board of Regents vowed to make the schools human research programs beyond reproach after two recent reports highlighted ethical concerns and faulted the institution for inadequately protecting its human research subjects.

Regents responded to the reports and approved resulting steps the University will take at a meeting Friday. Among other changes, the board approved suspending psychiatric drug trials and creating a Community Oversight Board to ensure the schools human research subjects are being properly protected.

The school has postponed 17 current and pending drug trials until an independent review board recommends lifting the suspension. Additionally, other clinical studies that target vulnerable populations will be reviewed to ensure human research subjects protections are adequate.

Obviously, like everyone else, we would have loved to have avoided the issue, Regent Darrin Rosha said Friday. But in this circumstance we have an opportunity to make great strides.

The University will hold a public forum in May to discuss the reports findings. Medical School Dean Brooks Jackson will hold a town hall meeting next month with Academic Health Center faculty and staff to discuss the reports findings.

The school plans to commission a task force, composed primarily of faculty members and experts, to create recommendations for the school on how to follow through with an external reports recommendations by May 15.

A legislative auditors report released earlier this month said the Universitys responses were insular and defensive when ethical concerns were raised after the 2004 death of Dan Markingson, a man who killed himself while enrolled in a University antipsychotic drug study.

The auditors report followed the release of an external review in February, which examined the Universitys human research subject protections program.

The review, managed by the Association for the Accreditation of Human Research Protection Programs, analyzed practices from 2011 to 2014 and found flaws, including a lack of employee ethics training and an insufficient institutional review board.

Though school leaders and administrators have approved plans to reform drug trial programs, some faculty members, advocates and state officials say accountability measures should come from outside the institution.

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Board acts on Kalers request

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