University of Minnesota
Office of the Vice President for Research
http://www.researchumn.edu
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Office of the Vice President for Research : University of MinnesotaOffice of the Vice President for Research : University of Minnesota


Key documents

Below are 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.

January 2017
December 2016
November 2016
November 2016
October 2016
September 2016
August 2016
July 2016
June 2016
May 2016
April 2016
March 2016
February 2016
January 2016
December 2015
November 2015
October 2015
September 2015
August 2015
July 2015

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 and Compliance Consulting

UMN Department of Psychiatry Assessment Report and CTSI Management Plan (12/31/15)

Compass Point Research

Human Research Protection Program Independent Review of Investigator Compliance and Recommendations for Post Approval Review Program (3/9/16)

External Panel Review

An External Review of the Protection of Human Research Participants at the University of Minnesota; appendices (2/23/15)

Food and Drug Administration

Establishment Inspection Report (FDA) (11/10/14)

FTI Consulting

Independent Assessment of a University of Minnesota IRB Non-Compliance Determination (FTI Consulting) (3/11/15)

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)