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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.
Work Plan Focus Areas
|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
|Department of Psychiatry||Consultant Report and CTSI Management Plan
|Mark S. Paller|
|Education and Training of Investigators||Final Report with Appendix||David Ingbar
|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
|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
|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
|IRB Membership||Final Report||Joanne Billings
Michelle H. Biros
|IRB Protocol Review Process||Final Report
HRPP Toolkit Overview
|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.