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.
This broad-based initiative involved many partners across the University:
- Office of the President
- Research and Innovation Office
- 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
|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||Ann Aronson|
|Department of Psychiatry||Mark S. Paller|
|Education and Training of Investigators||Final Report with Appendix||David Ingbar|
|Engaging Research Participants||Milton “Mickey” Eder|
|Establish Research Compliance Office||Final Report||Pamela Webb|
|External Advisor||Brian Herman|
|Fairview/University Research Oversight Committee (FUROC)|
|For Cause Investigations||Sarah Waldemar|
|Human Research Participants Who Have Impaired or Fluctuating Capacity to Consent||Debra Dykhuis|
|IRB Membership||Final Report||Joanne Billings|
Michelle H. Biros
|IRB Protocol Review Process||Debra Dykhuis|
|Monitoring of Studies||Debra Dykhuis|
|Scientific Review of Studies||Final Report||Joanne Billings|
Michelle H. Biros