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After scrutiny, U of M outlines plan to improve human research program

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The University of Minnesota unveiled a plan to improve the ethics and safety of human clinical trials conducted at the university.

For the past several weeks, the university has been working on a plan to improve research protocols and ensure human clinical trials are safe and ethical. The U of M announced a draft of its plan Monday that includes action steps, a timeline and necessary resources to implement the recommendations from the review.

The move comes more than a decade after Dan Markingson took his own life while enrolled in a antipsychotic drug trial at the university.

His suicide raised concerns about a person's ability to consent to research studies and prompted an external review of the psychiatry department's drug trials, which revealed ethical concerns and sub-standard safety protocols when treating human subjects.

As a result, the U of M suspended enrollment in human psychiatric studies earlier this year.

In the university's new plan, actions include reorganizing the Institutional Review Board (IRB) (which assesses proposed research studies) by adding more members, compensating them and having attendance requirements. There would also be an IRB panel tasked to evaluate the safety of studies where vulnerable patients whose "capacity to consent" to research may be limited or fluctuating.

The plan also includes strengthening how the university monitors its studies, reassigning cases so the department involved in the study isn't also reviewing the study, and improving the educational and training curriculum when it comes to ethics and research.

If the university chooses to implement this plan it comes at a cost. Hiring staff, paying board members and increasing ethics training would likely double the $2.2 million annual budget. The plan also recommends spending $5.5 million on an electronic IRB filing system for reviewing research proposals.

Public comments on the plan will be accepted through June 1, with a final version of the plan delivered to the Board of Regents for action at meetings schedule for June 11-12, a news release notes.

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