U of M releases final plan to strengthen human research protections

Following a 2-week public comment period, an Implementation Team at the University of Minnesota charged with drafting a plan for improving human research protections released its final work plan.

The final plan outlines action steps, a timeline and resources needed to address recommendations from an independent external panel to enhance culture, education and training, and reaffirm the University’s commitment to ethics. The final plan takes into account comments received during a 15-day public comment period that ended June 1. More than 70 individual and group comments were submitted and all were carefully considered.

"This plan provides strong, comprehensive direction to strengthen our research enterprise, better consider the needs of patients and their families, and ensure we conduct research at the highest standards of science and ethics," said President Eric Kaler. "Now the real and important work begins, and we are committed to complete it fully."

The comments informed a number of minor changes, as well as broader revisions in the final work plan. Many comments focused on questions about:

  • Proposed policy changes regarding Conflict of Interest
  • Suggestions for community engagement
  • Concerns about changes to scientific review
  • Applicability to the Social and Behavioral IRB
  • Additional administrative burden on research

In addition, the plan includes steps to strengthen the Institutional Review Board, establishes new ways of engaging with research subjects, their families and community members, and improves University processes for continuously monitoring capacity to consent. The plan also includes recommendations for strengthening the U’s relationship with Fairview Health Services and a more stringent structure for managing conflicts of interest.

"We asked independent experts to take a hard, critical look at what we were doing and we agree we can and must do some things better," said Kaler. "This plan is a testament to our commitment to move forward and learn. 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.

Kaler’s commitment to implementing the plan will be reflected in the FY16 and FY17 budgets, including $7.8 million to fund the improvements - $5.5 million in one-time costs and $2.3 million in recurring costs, primarily for increased staffing and Institutional Review Board support. As well, the University will report monthly to the Legislature on its progress and those reports will be posted publicly at Advancing Human Subjects Research.

The Board of Regents has been fully engaged in this process and will consider a resolution endorsing the final work plan and directing the president to implement its action steps during meetings on Thursday, June 11 and Friday, June 12. The board has committed to providing ongoing oversight of the implementation through its Audit Committee.

The full work plan and all public comments received are available on the Advancing Human Subjects Research website.

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