Recalibration of Risk in the Research Enterprise

1. Recalibration of Risk in the Research Enterprise Tim Mulcahy, Vice President for Research Sarah Waldemar, Director, Research Integrity and Oversight Pamela Webb, Associate Vice President for Research University of Minnesota Board of Regents February 10, 2012

2. Strategic Risk Management: Balance between performance and responsibility Avoidance Strategic Reckless Innovation, Optimal Pursuit of Mission Ethics, Responsibility, Accountability Positive Responsible, deliberative & accountable strategic risk management as characteristic of good governance; risk versus benefit assessments; leveraging existing strengths Boards and leadership must manage the balance.

3. Next Steps: Policies, procedures, practices Institutional policies procedures & practices Compliance obligations = Burden X As Burden increases productivity, creativity and morale decrease; frustration & costs frequently increase. These factors are often beyond the U’s control These factors are within the U’s control Institutional policies, procedures and practices reflect institutional tolerance for risk. Review and revision of policies and procedures represent excellent starting points for the process of “recalibration”

4. Strategic Risk Management Initiative in the OVPR Responsible business process owners will examine current OVPR practices, procedures and policies using a risk/benefit approach to achieve enhanced performance guided by responsibility and accountability, while providing one or more of the following benefits: • More innovative approach to research mission • Reduction of unnecessary oversight (oversight > risk) • Greater openness to opportunity • Enhanced competitiveness • Better staff engagement and empowerment • Increased efficiency; reduction of burden • Cost savings

5. OVPR Strategic Risk Management Initiative FY 11 • Developed a specific program with guidance materials, timelines and responsibilities FY12 and Beyond • Program must be incorporated into each unit’s annual work plan

6. Deliverable #1 Risks/Idea List Deliverable #4 Operationalized to FY13-14 work plans OVPR Risk Recalibration Process Deliverable #2 Initiatives Selected We are here Deliverable #3 Progress Report

7. OVPR Participation • Administration (Finance, Communications, IT) • Human Subjects Protection Program • Institutional Animal Care and Use Committee • Research Advancement • Research Integrity and Oversight • Sponsored Projects Administration • Technology Commercialization 82 = Number of projects proposed for Deliverable #1 66 = Number of projects selected for Deliverable #2 56 = Number of projects initiated/completed for Deliverable #3 34 = Number of projects completed through 12/31/11 85% of Deliverable #2 projects initiated or completed through 2011

8. Sample Initiative – Institutional Animal Care and Use Committee (IACUC)Deliverable #1: Reduce Post-Approval Monitoring (PAM) frequency for PIs with excellent history of inspection findings.Deliverable #2:

9. Deliverable #3

10. Selected Highlights of Initiatives Undertaken

11. Other Stakeholder Engagement: Certified Approvers Objective: Identify policies for which the burden exceeds the risk.Reviewed 18 research policies; rated each on 3 criteria Examples Score Criteria

12. Other Examples of Stakeholder Engagement Institutional Biosafety Committee Initiative: Streamline Institutional Biosafety application to eliminate redundancies, increase clarity and specificity, and expedite processing • Decreased number of missed renewal deadlines, reduced overall number of stipulations, expedited turnaround time/reduced review time, and improved education for new researchers Controller’s Office Initiative (in process) In concert with Office of General Counsel create simplified short-form external sales contract for high volume, low dollar, low risk activities • Reduce burden and expedite transaction process for researchers and companies wanting to do business with the U