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Stricter rules for conducting human trials approved at U of M

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An action plan to improve the safety of patients involved in University of Minnesota human trials was approved by the Board of Regents.

The U has been under fire after a series of scathing reports about the way its Department of Psychiatry recruited patients into its drug trials, following investigations into the death of Dan Markingson in 2004.

Earlier this week, the university released a plan to tighten up procedures concerning its human testing trials. The new guidelines are designed to better protect patients while reducing conflicts of interest and upholding ethical standards.

This plan will cost $7.8 million to implement over the next year – $2.3 million of which are ongoing costs. It was approved unanimously by the Board of Regents Friday.

"With our actions today, the Board of Regents has directed implementation of a bold and comprehensive plan that protects patients, and creates a strong culture of accountability and transparency," said Board Chairman Richard Beeson in a news release. "It charts the right course for the future of medical research at this University, and we will oversee its full implementation."

More information about what changes the action plan will bring can be found here, and they include the implementation of a new system to determine whether a prospective patient is of sound enough mind to agree to be enrolled on a program.

In 2004, it was found that Dan Markingson – who was a diagnosed schizophrenic – was given a choice of either enrolling in a U of M drug trial funded by AstraZeneca, or face being committed. His mother also objected to his enrollment. He later took his own life while on the program.

The plan also calls for more independent oversight, after the university was accused of being misleading about its human trials failures. The Star Tribune notes it will also bring an end of researchers taking payments from companies sponsoring their work.

The newspaper reports university scientists were previously permitted to do research for drug companies while serving as paid consultants at the same time.

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