University of Minnesota
Office of the Vice President for Research
http://www.researchumn.edu
612-625-3394

Office of the Vice President for Research : University of MinnesotaOffice of the Vice President for Research : University of Minnesota


Implementation

June 2015 through December 2016 the University of Minnesota implemented a work plan to strengthen its human research protections and establish a program that would serve as a national model. An external review of the university’s human research protection program identified a set of 63 recommendations that would serve as a roadmap to achieve this goal.

The work plan, developed by an implementation team made up of faculty, university leaders and external experts, outlined the steps, timelines and resources needed to address these recommendations. It also included several recommendations to enhance the culture of research and ensure the protection of human research participants, including the creation of clear language about the university's commitment to research ethics and directives for the education and training requirements for investigators and staff.

Faculty and staff from across the university served as team leads to establish specific action plans to address each recommendation. Overall work plan implementation was overseen by the Research Compliance Advisory Committee.

The University has now implemented all 63 recommendations from the external review though it remains committed to ongoing enhancement, improvement and evaluation of its human research programs and policies.

See Implementation Final Report

Partners

This broad-based initiative involved many partners across the university:

Office of the President
Office of the Vice President for Research
Academic Health Center
Human Research Protection Program
Institutional Review Board
Office of Institutional Compliance
Clinical and Translational Science Institute
Center for Bioethics
Consortium on Law and Values in Health, Environment & the Life Sciences

See hierarchy of accountability

Work plan

Final work plan
Focus Area Leads

Work Plan Focus Areas

Outcomes

Leads

Accountability Metrics Final Report Sarah Waldemar
Community Oversight Board COB Roster
Purpose and Role
Research Ethics Day Slides
Paul Mattessich
Conflict of Interest Final Report Will Durfee
Cultivating a Culture of Ethics Research with Human Participants: The National Debates
Statement of Core Commitments
Research Ethics
Final Report
Ann Aronson
Susan Wolf
Lynn Zentner
Department of Psychiatry Consultant Report and CTSI Management Plan
Final Report
Mark S. Paller
Education and Training of Investigators Final Report with Appendix David Ingbar
Timothy Schacker
Engaging Research Participants Research Participant Contact Card
Research Participant Brochure
Research Participant Bill of Rights
Final Report with Appendix
Milton “Mickey” Eder
Establish Research Compliance Office Final Report Pamela Webb
External Advisor David Strauss Feedback 02-20-16
Strauss Report-Aug 2016
Strauss Report, Appendix-Aug 2016
Brian Herman
Fairview/University Research Oversight Committee (FUROC) Membership
Meeting Summary 12-21-16
Meeting Summary 10-17-16
Meeting Summary 08-31-16
Meeting Summary 04-18-16
Meeting Summary 02-03-16
Meeting Summary 09-28-15
Brooks Jackson
Beth Thomas
For Cause Investigations For-Cause Investigations Related to Research Compliance Concerns
Final Report
Sarah Waldemar
Human Research Participants Who Have Impaired or Fluctuating Capacity to Consent Lecture Series: Standards for Research with Human Participants
Capacity to Consent
IRB important changes communication
Final Report
Debra Dykhuis
Steven Miles
IRB Membership Final Report Joanne Billings
Michelle H. Biros
IRB Protocol Review Process HRPP Toolkit Overview
HRPP Toolkit Library
ETHOS
Final Report
Debra Dykhuis
Monitoring of Studies Compass Point Research Report
Final Report
Debra Dykhuis
Scientific Review of Studies Final Report Joanne Billings
Michelle H. Biros

Future updates on the work plan and progress going forward will be posted on this website.