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

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

Compliance obligations Institutional policies procedures & practices X These factors are often beyond the U’s control Next Steps: Policies, procedures, practices = Burden As Burden increases productivity, creativity and morale decrease; frustration & costs frequently increase. 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”

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

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

Deliverable #4 Operationalized to FY13-14 work plans Deliverable #3 Progress Report Deliverable #2 Initiatives Selected Deliverable #1 Risks/Idea List Identify Risks Explore opportunities for change Select initiatives and plan change VPR Approval Implement change Evaluate change Annual Work Plan OVPR Risk Recalibration Process We are here

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

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: Anticipated Benefits if Suggestion is Adopted (include quantification of improvement if possible) Perceived Risks if Suggestion is Adopted (include quantification of risk if possible) Solution/Implementation Plan (include plans to resolve any barriers. Identify any faculty/committee consultation that is needed)  Provide researchers an incentive for compliance  Decrease administrative burden on some research personnel and IACUC Committee members.  Focus for IACUC compliance staff moves to higher risk areas  May allow compliance staff to expand the scope of PAM to protocols not currently receiving PAM inspections (teaching and agricultural, primarily). Risk of not finding and correcting non- compliance in a timely manner. (Low risk, low likelihood) Risk of research personnel putting pressure on IACUC compliance staff to not report findings. (Low risk, low likelihood) IACUC Compliance Office: Will draft a proposal for IACUC review by July 1, Will request faculty input in July/August. Will revise plan if necessary in September and implement in October

Deliverable #3 Unit Description of Recommended Change Solution/Implementation Description Final Completion Date IACUC Reduce Post- Approval Monitoring (PAM) frequency for PIs with excellent history of inspection findings Anticipated to positively impact 20-25% of IACUC researchers (125 of 500 total PIs) Brief List of Major Activities Undertaken toward Achieving this Goal (including barriers overcome)  Discussed options and concerns with IACUC compliance staff.  Drafted procedure proposal for IACUC Member review  Identified potential barriers: Occupational Health & Safety (OHS) concerns over decreased Research Occupational Health Program (ROHP) compliance points, IACUC concerns over decreased compliance monitoring, general concern over implementation prior to AAALAC 2012 site visit. Results (including implementation date)  Concept approved by IACUC, OHS in September 2011  Implementation determined during November 2011 Fall Program Review. The following conditions must be met: No significant deficiencies within the last two years No concerns or complaints made of the laboratory through RAR, RAR veterinarians, outside entities, or through compliance staff concerns No repeat findings on most recent inspection No additions of a different species to be used in the laboratory (either on original protocol or through a new submission) ●Rollout December 2011 Re-do monitoring schedule Reconfigure compliance inspection database Convey change to constituents December 2011

Selected Highlights of Initiatives Undertaken UnitInitiative/Benefit Risk/ Frequency Human Subjects Accept changes to exempt protocols via notice only. Benefit: reduction of unnecessary oversight; increased efficiency, reduction of burden Low/ High Animal Subjects Provide post-procedural recordkeeping requirements that are customized to the situation, not one size fits all. Benefit: more innovative approach to research mission; better staff engagement and empowerment Low/ High Sponsored Projects Admin. Reduce frequency of effort reporting from three times per year to two times per year. Benefit: Reduction of unnecessary oversight, increased efficiency, reduction of burden Medium/ High

Other Stakeholder Engagement: Certified Approvers Objective: Identify policies for which the burden exceeds the risk. Reviewed 18 research policies; rated each on 3 criteria Severity3 University-wide impact; penalties; restrictions or suspensions 2 Sponsor reporting obligations, fix requires Central involvement 1 Limited scope, unit remedy, minimal impact after correction Frequency3 Occur frequently, involve significant costs 2 Low frequency but high cost; High frequency but low cost 1 Low cost, infrequent Impact/Burden3 Significant burden, complex, time consuming, multiple units 2 Moderate burden or large burden for limited number of units 1 Minimal or routine work required CriteriaScoreExamples

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