External Review

On December 5, 2013, the University of Minnesota’s Faculty Senate passed a resolution calling for an external review to examine the current policies, practices, and oversight of clinical research on human research participants at the University; in particular, clinical research involving adult participants with diminished functional abilities.

The external review was logistically managed by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the industry’s foremost accreditation body, which assembled a panel of independent subject matter experts.

On March 6, 2015, the final report (including appendices) was formally presented to the Faculty Senate, where members of the independent review panel participated in a public dialogue regarding the report and its recommendations for the University.

The University is now taking action to implement the report’s recommendations, specifically in the areas of:

  • Institutional Review Board (IRB) membership and review process
  • Education and training
  • Scientific review
  • Monitoring
  • Engagement: research subjects and community
  • Consent
  • Culture and leadership

Documents related to the External Review:
Faculty Senate resolution
Charge Letter from President Kaler
External Review of Clinical Research on Human Subjects RFP
AAHRPP proposal