'Draft work plan' for U of Minn. human research conduct

The University of Minnesota is trying to clean up what's been described as "a culture of fear" within the Department of Psychiatry.

An advisory panel has come up with a list of reforms to answer ongoing questions about ethical misconduct by some researchers in the department. Among the proposed changes is beefing up oversight of how research studies are approved and monitored and more ethics training for staff.

"I think we will have a process that can restore trust and we will be able to move ahead to everyone's satisfaction," Dr. Brooks Jackson with the U of M medical school said.

This comes in response to strong criticism surrounding the case of Dan Markingson, a mentally ill man who killed himself while in a drug study at the university. Researchers have been accused of ignoring his mother's warnings that he was in danger of hurting himself.

Critics say the plan can't be taken seriously until the university takes some kind of disciplinary action against the researchers involved in the Markingson case and admits to covering up their misconduct.

"It just appears that there are no consequences for behaviors that have led to this whole problem in the first place," clinical psychiatric nurse Nicki Gjere said.

Members of the advisory panel say the changes will give human research subjects, especially ones who are mentally ill or vulnerable, the strongest protections anywhere in the country.

So far, these items all remain recommendations. Until June 1, the public can weigh in and offer feedback, then, a final plan will be presented to the Board of Regents.

Recommendations of the External Review of the U of M Human Research Protection Program: [PDF]

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