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University recommends new oversight of clinical research

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MINNEAPOLIS (AP) — The University of Minnesota is proposing a plan to improve oversight of its clinic research, 11 years after a man enrolled in a drug trial committed suicide in a case that has raised questions about research trials in the university's psychiatry department.

A panel of experts recommends reorganizing the Institutional Review Board which determines whether studies are safe. The recommendations, which were issued Monday for review by the committee, also would reassign who investigates claims of researcher misconduct and reassess how vulnerable patients are recruited to studies, the Star Tribune ( ) reported. The experts also suggest that the studies receiving board approval should be more frequently monitored.

The recommendations weren't specific to Dan Markingson, but reflect concerns raised about his death in 2004. A recent legislative audit concluded the circumstances under which Markingson enrolled in the study were potentially coercive, but did not prove a link between the drug trial and his death.

"You could call (the recommendations) Markingson's legacy in terms of taking the death seriously, regardless of causality, and saying we are going to do everything humanly possible to try and prevent similar types of concerns and issues from happening again," said Dr. Steven Miles, a bioethicist who served on the expert panel that made the recommendations over the past two months.

Public and university officials will consider the recommendations and decide whether the state can afford to make the changes.

It's expected to cost more than $2 million each year to hire staff, pay Institutional Review Board members and increase ethics training. The committee also has recommended the university spend $5 million on an electronic system to file and review research proposals.

Markingson's death prompted a critical review by the state Legislative Auditor and an external review ordered by the Faculty Senate. Both reviews found shortcomings in the university's oversight of clinical research.


Information from: Star Tribune,

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