U Commits to Improve Human Subjects Research Program

Today University of Minnesota President Eric Kaler outlined specific and decisive steps the University will take to improve its human subjects research practices so they meet the highest standards of ethics and science. The actions come in response to two recent external reviews of the University’s programs and practices, particularly related to individuals with limited decision making capacity.

Kaler appeared before the Minnesota Senate Higher Education and Workforce Development Committee this afternoon regarding the Minnesota Legislative Auditor’s special review of Dan Markingson’s participation in, and 2004 death during, a clinical drug study at the U. Kaler was joined by Dr. Patricia Simmons, M.D., a member of the University’s Board of Regents; Dr. Brian Herman, vice president for Research at the University; and Dr. Brooks Jackson, M.D., dean of the U’s Medical School and vice president of Health Sciences.

"Before all else, I want to express our deepest sympathy to Dan Markingson’s mother, Mary Weiss, and apologize to her for his death while he was under our care. The loss of Dan Markingson’s life was a terrible tragedy," Kaler said.

"Our doctors, nurses, researchers and leaders at the University of Minnesota are dedicated to finding cures and treatments for diseases that affect Minnesotans, including mental illness, which takes an incredible human toll," he said. "While we strive to be the very best, it is clear that we can do better. Today we reaffirm our commitment to protect patients, and we are taking immediate action to improve Minnesota’s research university."

Kaler announced a number of steps developed in consultation with, and with oversight from, the University’s Board of Regents. The steps include:

o Suspending enrollment in all Department of Psychiatry interventional drug studies - those both active and awaiting approval - until they are reviewed by an independent Institutional Review Board;
o Developing a plan of action by May 15 - in fewer than 60 days from today - to review and implement recommendations from an external review panel report on the U’s human subjects research practices, which was issued earlier this month;
o Examining other clinical studies that target vulnerable populations, using an independent Institutional Review Board and the U’s post-approval monitoring process; the studies will be reviewed to ensure researchers are meeting best practices;
o Appointing a Community Oversight Board of external experts in human subjects research and research ethics to ensure we are using best practices.

"These actions, among others we’re already taking, will provide the level of oversight recommended by the Legislative Auditor and an external review panel that recently reviewed the University’s human subjects research practices," Kaler said. "Most importantly, we hold ourselves responsible and accountable to improve, and will work tirelessly to restore confidence in our work."

According to Board of Regents Chair Richard Beeson, "The University’s Board of Regents has closely followed this issue and has worked with President Kaler and his administration to shape the University’s plans. The Board will provide robust oversight to the implementation of those plans through its Audit Committee. And we will ensure transparency and accountability as the University takes steps to become a national model in human subjects research."

Beeson has appointed Regent Simmons as the Board’s liaison during the process. Simmons, who is beginning her third term on the Board and is a former Board chair, also brings three decades of medical experience. She recently retired from Mayo Clinic.

"As an academic physician and clinical researcher, I understand first-hand the complexity, as well as the importance, of medical research to truly help people with illnesses," Simmons said. "But we must also ensure the University’s clinical trials are ethically sound and always place the patient first. Our actions moving forward reflect our deep commitment to an ethical human subjects research program that is exemplary. We will hold ourselves accountable. And we will closely monitor the University’s research program as it improves."

The Board will review the Legislative Auditor and the external panel reports at its next public meeting on Friday, March 27. The Board is also expected to act on a resolution that endorses Kaler’s actions and requires additional input and oversight.

The Legislative Auditor’s report focused on the events surrounding the 2004 death of Dan Markingson while he was enrolled in a clinical trial at the University. The report can be found at http://www.auditor.leg.state.mn.us/sreview/markingson.pdf and the University’s management response is at: http://z.umn.edu/umnresponse.

The report follows an external, independent panel report released earlier in March, which was requested by the U’s Faculty Senate and charged by the administration. The panel’s review focused on current University human subjects research practices, particularly as they relate to working with people with diminished decision making capabilities. Information about the review and the U’s response is available at http://z.umn.edu/externalreview

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