Implementation team formed to advance University of Minnesota human subjects research protection program

The University of Minnesota has established the team charged with overseeing plans to advance the University’s human subjects protection program. The team will focus on how to implement a set of independent review panel recommendations for strengthening the University’s human subjects research practices, especially those involving people with limited decision making capacity.

University President Eric Kaler has asked the team to advance the program to become a national model, meeting the highest standards of ethics and science. At its March 27 meeting, the Board of Regents approved immediate and longer term action plans to implement the recommendations. It also committed to an open and collaborative action planning process and continued monitoring and oversight of the University’s efforts.

The implementation team, made up of both internal and external members, is chaired by Dr. William Tremaine, M.D., a member of the Gastroenterology and Hepatology Departments at the Mayo Clinic and director of the Mayo Clinic Institutional Review Board.  Dr. Brooks Jackson, M.D., dean of the U’s Medical School and vice president for health sciences, and Dr. Brian Herman, vice president for research, will serve as co-vice chairs of the committee. Other members include:

• Joanne Billings, M.D., MPH, Assistant Professor, Department of Medicine
• William Durfee, Ph.D., Morse Alumni Distinguished Teaching Professor, Mechanical Engineering
• Debra Dykhuis, Executive Director, Human Research Protection Program
• Paul F. Goering, M.D., Vice President, Allina Mental Health
• Gail Klatt, Associate Vice President, Office of Internal Audit
• Steven Miles, M.D., Professor and Maas Family Endowed Chair in Bioethics, Center for Bioethics; Professor, Department of Medicine
• Timothy Schacker, M.D., Professor, Department of Medicine
• Daniel Weisdorf, M.D., Professor, Department of Medicine
• Carolyn S. Wilson, RN, Executive Vice President and Chief Operating Officer of Fairview; Co-President, University of Minnesota Health
• Jean Wyman, Ph.D, RN, GNP-BC, FAAN, FGSA Professor and Cora Meidl Siehl Endowed Chair in Nursing Research Director

The implementation team will meet weekly, with its first full meeting occurring this week. The team will widely engage stakeholders in developing the plan, and will conduct an open and transparent process in sharing progress. The team’s primary tasks will be to:

• Complete a work plan that includes accountability metrics
• Provide an analysis of the resources necessary to implement the plan
• Review best practices on managing conflicts of interest and organizational or structural changes that would improve the University’s processes
• Form a committee of external experts and community members to provide input into the University’s human subjects protection program

The implementation team will deliver a final action plan to Kaler on May 15, which will include both short-term and long-term action items across multiple University units and departments.

For more information about the team’s progress and implementation plan, visit Advancing Human Subjects Research. Questions or comments regarding the planning process and implementation can be sent to [email protected].