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:

See hierarchy of accountability.

Work Plan

Final work plan
Focus Area Leads

Work Plan Focus AreasOutcomesLeads
Accountability MetricsFinal ReportSarah Waldemar
Community Oversight BoardSee webpagePaul Mattessich
Conflict of InterestFinal ReportWill Durfee
Cultivating a Culture of EthicsAnn Aronson
Susan Wolf
Lynn Zentner
Department of PsychiatryMark S. Paller
Education and Training of InvestigatorsFinal Report with AppendixDavid Ingbar
Timothy Schacker
Engaging Research ParticipantsMilton “Mickey” Eder
Establish Research Compliance OfficeFinal ReportPamela Webb
External AdvisorBrian Herman
Fairview/University Research Oversight Committee (FUROC)

Meeting Summaries:

Brooks Jackson
Beth Thomas
For Cause InvestigationsSarah Waldemar
Human Research Participants Who Have Impaired or Fluctuating Capacity to ConsentDebra Dykhuis
Steven Miles
IRB MembershipFinal ReportJoanne Billings
Michelle H. Biros
IRB Protocol Review ProcessDebra Dykhuis
Monitoring of StudiesDebra Dykhuis
Scientific Review of StudiesFinal ReportJoanne Billings
Michelle H. Biros