Implementation

From 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	See webpage	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 (Front) (Back) 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)	Meeting Summaries: Meeting Summary 06-26-17 Meeting Summary 04-24-17 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