Key Documents
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.
Legislative Updates
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
- Fairview/University Research Oversight Committee (FUROC)
- 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
Work Plan
The final work plan outlines the steps, timelines, and resources needed to address recommendations from the external review.
- Final work plan (6/11/15)
- Public comments (6/1/15)
- Draft work plan (3/15/15)
Reports
The following reports provide reviews of and recommendations for the University’s Human Research Protection Program and practices.
Clinical Research & Compliance Consulting
UMN Department of Psychiatry Assessment Report and CTSI Management Plan (12/31/15)
Compass Point Research
External Panel Review
An External Review of the Protection of Human Research Participants at the University of Minnesota and appendices (2/23/15)
Food & Drug Administration
Establishment Inspection Report (FDA) (11/10/14)
FTI Consulting
Institutional Review Board
IRB Investigation Report into Fairview Concerns Regarding Psychiatry Research Studies (5/5/15)
IRB Investigation Report: Alleged Non-Compliance in Bifeprunox Studies (10/13/14)
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)