The University of Minnesota has released what it calls a "final work plan" to tighten oversight on research involving human subjects, following a two-week public comment period.
U releases plan to tighten human research protections
Public has commented, so now regents to consider final version.
June 18, 2015 at 3:44PM
The 75-page plan released Tuesday calls for "a more stringent structure for managing conflicts of interest," according to a university announcement. It also would strengthen the panel, known as an Institutional Review Board, that is charged with protecting patients in research studies.
The proposed changes, which will be submitted to the Board of Regents later this week, would cost an estimated $7.8 million over the next two years, the university said.
The plan, first released for public comment on May 18, was designed to respond to mounting criticism of the U's research practices in the wake of the 2004 death of Dan Markingson, who killed himself while in a controversial study of schizophrenic drugs. The final version released Tuesday includes "minor changes" reflecting public comments, the university said.
"This plan is a testament to our commitment to move forward and learn," said President Eric Kaler in a written statement Tuesday. "Our faculty are on the front lines 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."
In March, the university suspended its recruitment of subjects for psychiatric studies and promised to overhaul its research protections after a scathing report by Legislative Auditor James Nobles.
Nobles, who investigated complaints about the research, accused the university of shoddy oversight and said that it had "lost perspective about what is a conflict of interest."
Critics had accused university researchers of coercing 27-year-old Markingson, who was schizophrenic, into an industry-funded drug study over his mother's objections. He took his life while in the study.
The final work plan can be found at http://tinyurl.com/UMNworkplan.
Maura Lerner • 612-673-7384
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