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

The University of Minnesota is implementing a work plan that will strengthen its human research protections and establish a program that will serve as a national model. An external review of the university’s human research protection program identified a set of recommendations that would serve as a roadmap to achieve this goal. The work plan outlines the steps, timelines and resources needed to address recommendations from the external review. It was developed by an implementation team made up of faculty, university leaders and external experts.

The work plan recognizes that it is the responsibility of the university and the individual investigators to ensure that the well-being of research participants is at the center of all research activities. It also includes 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 ethics and directives for the education and training requirements for investigators and staff. More details on the work plan focus areas are addressed below.

Faculty and staff from across the university serve as team leads that will establish specific action plans to address each recommendation. See below for details on the team leads. Overall work plan implementation is overseen by the Research Compliance Advisory Committee.

The timeline for implementation is July 2015 – December 2016. Implementation teams are on track to deliver their final reports by June 30, 2016. Some additional activities, including implementing an electronic IRB system, educational programming and evaluation, will require the remainder of 12-18 month original timeline.

Implementation progress summary

Work plan

Final work plan
Focus Area Leads

Work Plan Focus Areas

Outcomes

Leads

Accountability Metrics Sarah Waldemar
Community Oversight Board Membership Brian Herman
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
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 09-28-15
Meeting Summary 02-03-16
Meeting Summary 04-18-16
Meeting Summary 08-31-16
Brian Herman
For Cause Investigations For-Cause Investigations Related to Research Compliance Concerns 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
Debra Dykhuis
Steven Miles
IRB Membership Final Report Joanne Billings
Michelle H. Biros
IRB Protocol Review Process Final Report
HRPP Toolkit Overview
Debra Dykhuis
Monitoring of Studies Compass Point Research 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.