Statement from U of M president following New York Times story

The following is a statement from University of Minnesota President Eric Kaler following the Friday, April 17, 2015, New York Times story:

Investigators and the news media have raised questions about two psychiatric clinical studies conducted by the University of Minnesota, one done in 2004 and one in 2008. While we dispute some important claims that have been made by the media and others, we fully and unequivocally acknowledge that on some key issues, we can do better. And I am committed to leading that change.

When I testified to the Minnesota Legislature, I promised that improvements to our program would be thorough, quick and transparent. We are committed to strengthening our program to meet the highest standards of ethics and science and be a national leader. We are making significant progress in responding to the Legislative Auditor’s report and to the findings of the independent, external review that was initiated nearly 1 1/2 years ago by the Faculty Senate, the Board of Regents and me. The recommendations for improvement endorsed by the Auditor were drawn from this independent examination the University initiated in December 2013.

We are a few weeks into the process and here’s where we are in terms of progress:

  • An implementation committee chaired by Mayo Clinic’s Dr. William Tremaine has been created and is working on a plan of action. That committee’s plan to implement the external panel’s recommendations will be to me no later than May 15.
  • The Board of Regents held a public meeting about next steps, and will hold another public hearing in May. Regent Patricia Simmons, a retired Mayo Clinic doctor, 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 - those both active and awaiting approval - be suspended until they are reviewed by an external and independent institutional review board. Those reviews are underway.

We are dedicating the resources needed to complete the implementation of the recommendations thoroughly and with urgency. While suspending psychiatry interventional drug studies was a necessary step, it was not a decision I made lightly. We need always to remember that much of the medical research conducted at the University of Minnesota involves patients who are suffering from serious and sometimes life-threatening illnesses. It is important to patients and their families that we re-start these trials as quickly as possible.

Minnesotans can have confidence that we will succeed in our commitment to address and correct all issues. The independent external review - the investigation that formed the basis for the Auditor’s recommendations - said this about medical research at the University of Minnesota: "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."

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