U of M implementation team releases draft work plan to strengthen human subjects research

A University of Minnesota implementation team today released a draft work plan to ensure that the University’s human subjects research is conducted at the highest standards of science and ethics.

The plan outlines the steps, timeline and resources needed to address recommendations from an independent external panel. It includes several recommendations to enhance culture through education and training requirements of researchers and staff, and clear statements about the University’s commitment to ethics.

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

“This work plan recognizes the importance of culture and the responsibility of both the University and individual investigators to ensure that the well-being of research participants is paramount and at the center of all research activities,” said William Durfee, Ph.D., Morse Alumni Distinguished Teaching Professor, Mechanical Engineering, and a member of the implementation team. “It also is the result of consideration and debate by a group of committed faculty and health care experts from inside and outside the University. As a team member, I appreciate and am thankful for the thought and effort my colleagues on the team put into this plan. “

To finalize the work plan, members of the University community and general public are invited to comment on the draft between now and June 1. Comments may be submitted by emailing [email protected]. The team will consider all feedback as it finalizes the plan in early June. A final report will be presented by William Tremaine, M.D., from Mayo Clinic and chair of the implementation team, at the Board of Regents Audit Committee meeting on June 11.

“I want to thank the members of the Human Subjects Research Implementation Team for their thoughtful and thorough draft work plan,” said U President Eric Kaler. “I welcome constructive feedback from people with varying perspectives to help ensure that the final plan is as strong as possible.”

For more information, refer to the Advancing Human Subjects Research website.