The primary internal and external reports, legislative updates, and other documents that have both informed and resulted from the University’s Advancing Human Research Protections initiative.
Monthly reports submitted to the Minnesota Legislature that track the University’s progress toward goals outlined in the work plan.
Focus Area Final Reports
- Accountability Metrics
- Community Oversight Board
- Conflict of Interest
- Cultivating a Culture of Ethics
- Department of Psychiatry
- Education and Training of Investigators
- Engaging Research Participants
- Establish Research Compliance Office
- External Advisor
- For Cause Investigations
- Human Research Participants Who Have Impaired or Fluctuating Capacity to Consent
- IRB Membership
- IRB Protocol Review Process
- Monitoring of Studies
- Scientific Review of Studies
The final work plan outlines the steps, timelines, and resources needed to address recommendations from the external review.
The following reports provide reviews of and recommendations for the University’s Human Research Protection Program and practices.
Clinical Research & Compliance Consulting
Compass Point Research
External Panel Review
Food & Drug Administration
Establishment Inspection Report (FDA) (11/10/14)
Institutional Review Board
Office of Legislative Auditor
A Clinical Drug Study at the University of Minnesota Department of Psychiatry (OLA) (3/19/15)
University of Minnesota Department of Psychiatry Industry-Sponsored Clinical Studies: 2004-2014, Special Review (OLA) (7/18/15)
Protections for Human Subjects in Research Studies at the University of Minnesota Department of Psychiatry: A Preliminary Assessment of Reforms (OLA) (5/19/16)