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U of M sets out plan to revamp heavily-criticized human research trials

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The University of Minnesota released a final draft of plans to tighten up protections for those taking part in its human testing trials.

The U suspended enrollment in trials in March, after two scathing studies into its Department of Psychiatry highlighted serious issues with the way it handled the case of Dan Markingson, who had been diagnosed with schizophrenia. He took his own life in 2004 while taking part in a drug trial.

It launched a review in the wake of the reports with the aim of tightening up procedures so that human research subjects across all its departments are better protected, while conflicts of interest are minimized and ethical standards are upheld.

Following a two-week public comment period, it released its final draft on Tuesday, which will be put before its Board of Regents later this week. In the plan, the U will spend almost $8 million over two years (plus additional costs in the following years) to implement key features, including:

  • A new system to determine whether a potential medical trial patient has a mental impairment that affects their ability to give consent. In the Markingson case, he was told he either took part or would be committed, while his mother objected to his participation in the project.
  • Restructuring its Institutional Review Board (IRB) – designed to protect patients on the trials – by increasing the number of review panels which evaluate research, increasing the number of people on the panels, and paying members for their involvement.
  • Investigations into misconduct or ethical violations to be taken out of the hands of the U's Human Research Protection Program, and given to the Office of the Vice President for Research.
  • Implementing a "more stringent reporting structure" for managing conflicts of interests, so that any financial interest including equity, consulting income, speaker fees and/or royalties must be disclosed from the first dollar. An investigator can also not receive any cash from a company that is funding the research project they are working on.

"This plan is a testament to our commitment to move forward and learn," U President Eric Kaler said in a news release. "Our faculty are on the front line of the battle against cancer, diabetes, neurological conditions and other illness and disease and these improvements can give everyone confidence that we are doing that work ethically, humanely and appropriately."

The plan will set the U back $5.5 million in one-off costs and $2.3 million in ongoing costs as it creates new oversight and administrative positions, as well as compensating IRB board members.

More independent oversight

The proposals also include additional input from people independent of the university, such as the creation of a 12-member Community Oversight Board filled with external academics, professionals and community experts.

An "international expert" will also be brought on as an adviser to the vice president of research.

The U's failure to investigate possible ethical issues and conflicts of interest was one of the main criticisms leveled at it over the Dan Markingson case, with a state auditor saying the U had misled people over past reviews of the case as well as dismissing the need for further investigation.

Last month, a bioethics professor at the U wrote an op-ed for the New York Times in which he accused the university of being more interested in "covering-up" its drug trial scandals than dealing with them.

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