The Board of Regents at the University of Minnesota unanimously voted Friday to fully implement a 75-page plan created to reform human research protections at the university.
The 14-member implementation team behind the plan was made up of faculty members at the University and led by Dr. William J. Tremaine, director of the Mayo Clinic Institutional Review Board.
Among its many actions, the plan will beef up University of Minnesota IRB staffing, create formal meeting procedures, mandate the study of IRB's at other institutions, pay faculty for IRB service, reduce workload and increase meetings to enable more thorough review of research for ethical considerations, and establish IRB work as valued activity for promotion and pay raises.
The plan would no longer allow members of one department to review their colleagues' work for compliance with ethical standards. The plan implements an extensive array of new rules and procedures for how and when to determine if a research subject has the capacity to give consent.
The report also cast the oversight of psychiatry trials in a separate light all of its own, putting the monitoring of that work in the hands of a newly created body within the university, a Clinical and Translational Research Institute.
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The report ordered the hiring of an outside consultant to help address concerns regarding the culture and climate within the department of psychiatry regarding research and ethics, and it stipulated an education plan for two unnamed psychiatry department faculty members in particular.
In a major change, the report put new limits on outside pay, requiring that an academic investigator "may not receive any personal compensation from a company during the time that investigator participates in any new research study funded by that industry sponsor."
It required the teaching of research ethics to faculty within the university, the taking of steps to notify research subjects of the outcome of research they have participated in and created a community panel to provide feedback on issues of concern.
The plan is expensive — it calls for a one-time cost of $5.5 million to initiate the changes and doubles the current budget for human research protection program, from $2.2 million to $4.4 million.
The reform was ordered following a pair of highly critical outside reports released last winter on research ethics at the university. Those reports offered a yearslong-requested independent review of the circumstances surrounding the suicide in 2004 of a psychiatry patient named Dan Markingson enrolled in a drug trial.
Critics had contended that Markingson lacked the capacity to consent to the trial and was recruited under coercive circumstances. They said he was not offered the opportunity to receive other treatments despite his worsening condition, and that the university misrepresented the nature of investigations into the matter.
Also Friday, Dr. Charles Schulz, head of the department of psychiatry at the University of Minnesota and the focus of many complaints about the Markingson case, announced he intends to retire at the end of the year. Schulz said the decision was unrelated to the report or call for reform.
Critics say more work remains to be done.
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"University of Minnesota psychiatrists remain free to recruit into clinical trials individuals who are being involuntarily held on locked psychiatric units," says bioethics professor Leigh Turner in an email. "This stance is not compatible with the University of Minnesota being 'world-class' or a national model for other universities."
Turner added that he is disappointed the university did not take action against faculty members involved in the treatment of Markingson.
