Statement from U of M president following New York Times story

The following is from University of Minnesota President Eric Kaler.

The New York Times’ April 17 story raises important questions about medical research issues that we have been addressing since before this story and the recent Legislative Auditor’s report. We fully acknowledge that we must do better and I am committed to leading that change.

When I testified to the Minnesota Legislature last month, I promised that improvements to our human subjects research program would be thorough, quick and transparent. We are strengthening our program to meet the highest standards of ethics and science, and to be a national leader. We are responding to the findings and recommendations of the independent, external review that was initiated in December 2013 by the Faculty Senate, which I accepted. The Legislative Auditor’s primary recommendation for improvement was to implement those recommendations.

We are a few weeks into the implementation planning process and progress has been made:

  • The Implementation Team comprised primarily of faculty and chaired by Mayo Clinic’s Dr. William Tremaine, M.D., is meeting weekly and will have a plan to me by May 15. Last week Professor Naomi Scheman was asked and agreed to join that team. I am confident this broad-based team will act first and foremost in the interest of our patients and is well constituted to meet its charge to advance the University’s human subjects research program to become a national model.
  • The Board of Regents held a public meeting on the external reports, has created an additional oversight mechanism and passed a resolution endorsing our immediate action steps. The Board will hold a public hearing from 4:30-5:30 p.m. on Thursday, May 7. Regent Patricia Simmons, a retired Mayo Clinic doctor, is acting as the Board’s liaison to the administration and will lead the Board’s oversight.
  • To ensure that all of our human subjects research activities are ethical and protect patients at the highest standards, I directed that enrollment in all Department of Psychiatry interventional drug studies – both active and awaiting approval – be suspended until they are reviewed by an external and independent institutional review board. Those reviews are underway. This is a serious decision that I did not take lightly.

Suspending psychiatry interventional drug studies was necessary to ensure they were being conducted appropriately. But we also need to remember that the important medical research conducted at the University of Minnesota provides hope for patients who are suffering from serious and sometimes life-threatening illnesses. Patients and their families are depending on us to re-start these trials, and implement the review panel’s recommendations, as quickly as possible.

The core issues raised in the borderline personality disorder treatment study reported on by The New York Times, namely issues related to consent, conflict of interest, communications and recordkeeping, are all ones central to the external panel’s recommendations. As we implement changes I expect our processes in these areas to be more robust.

The independent external review, which formed the basis for the Auditor's recommendations, said this about medical research at the U: "In the course of our work, we encountered considerable strength in both programs and people dedicated to advancing clinical research...We were left with no questions about the sincerity of University leadership in their desire to address the problems of the past by building a program in human subjects research protections that is of the highest quality."

This is a challenging time, and I want to thank you for your patience and commitment. Ultimately, this will make us stronger. Minnesotans can have confidence that we will change our culture, and establish new processes and structures as needed to become world class.

For progress updates about the University’s work, visit Implementation Progress Alerts.

Click here for additional information that addresses specific issues raised by The New York Times.

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