Last July, the University of Minnesota Board of Regents approved a plan to reform the university's research practices, particularly research involving human participants. We made a commitment to fully implement these reforms by June 2016, and we are on track to meet that goal.
This is a top priority for the U. In health care, our commitment is to our patients. Research involving human participants plays a vital role in delivering new treatments and cures, but the most important factor in the design and implementation of any research is patient safety. Minnesotans depend on the U to be part of tackling the most difficult health issues, from cancer or Alzheimer's to infectious disease or mental health. Our promise to Minnesota is not only to conduct this important research but also to operate using best practices and at the highest ethical standards.
The external review that we commissioned last year and the report from the legislative auditor showed we were not living up to the standards we had set, so we developed a comprehensive plan to get better. That implementation plan is guiding our current efforts.
One step in the implementation plan is to transfer management of clinical trials in the Department of Psychiatry to the University's Clinical and Translational Science Institute (CTSI), which has particular expertise in clinical research. To understand the necessary staffing and steps to manage these trials, CTSI commissioned an analysis of the department's studies. That review was initiated last summer and was presented to the Board of Regents earlier this month. Not surprisingly, the report echoes many of the findings of earlier reports, and it helped clarify some of the areas that are most in need of oversight. Our critics claim the report proves our reform efforts are failing ("U research lapses show self-reform is failing," Feb. 19). In reality, the report is an important step toward our goal.
It's true that our work is not yet complete. More than 60 recommendations came out of our review process last year. The reforms we're making are urgent, but they also must be undertaken in a manner that ensures success. Today we are just more than halfway through our implementation timeline, and much important work is ahead. While some may want us to jump right from the starting gate to the finish line, true reform requires intentional steps along the way. There are no shortcuts.
The U has been transparent about progress on the implementation plan. We issue monthly reports to the Legislature (see http://advance-hsr-alerts.umn.edu). Over the last seven months significant, concrete steps have been taken:
• All interventional drug trials in psychiatry were suspended pending re-review of ethics and study design by Quorum Review IRB. New applications continue to be reviewed by Quorum pending full implementation of the recommendations.
• Compass Point Research reviewed 100 random studies, including in psychiatry, to assess compliance with institutional regulations and best practices.
