Regulatory Affairs Pat Ward November 1, 2011

Purpose Regulatory Good-Standing…

Purpose Protect… Employees Students Patients Research subjects Neighbors Research Education Training Environment Fiscal steward- ship Integrity Reputation

In general… –Maintain awareness –Regulations and other standards –Stakeholder interests (faculty, staff, students) –Connect the dots between requirements and stakeholder interests –Fact-finding, advice, problem resolution –Remediation of misconduct, misbehavior, non-compliance –Faculty disputes over research resources –Chaperone interactions with regulatory authorities Products and Services

OID and COI, in particular… –Operate Outside Interest Disclosure (OID) system (M-Inform) –Monitor external listings and resolve discrepancies –Review IRB and grant applications for Conflicts of Interest (COIs) –Negotiate, document, and monitor COI management plans (CMPs) –Support COI committees –MEDCOI, CECOIC, ICOI, OCs

Products and Services Answer questions! (or help find answers to them)

Customers Internal –UMMS faculty, staff, students –Administrations at the UMMS division/department, center/institute, and school levels –UMHS Compliance, OVPR, and other central UM units External –Oversight agencies –Government, accreditation, review boards

Customers BTS/BEU CC-CTO CECOIC Compliance Office Compliance Committee DRDA eRRM eRPM Facilities Finance FGP FOIA GTMLP HAL HIM HR IBC ICOI IDS IRB Council IRBMED MCRU MEDCOI MICHR MSIS OAA OCA OFA OGC OHRCR OoR OSEH OTT OVPR PR&M QA Risk Management RPC/RDRC/SHUR TPS U-Audits UCUCA ULAM Partners (making new ones every day!)

Staffing Trends 2008 – present 2 FTE from OoR (General) + 3 FTE from Dean’s Office (OID/COI) 5 FTE in new RA office - 1 FTE attrition 4 FTE (late early 2011) + 3 FTE (increase in requests for general assistance, 7 FTE expansion of COI to clinical and educational areas, political/media attention to OIDs)

Current Tactical Initiatives New COI Rules Develop and implement plan by August 2012… –Review OIDs of every investigator on every PHS grant at submission –Not just PI, not just when COI “checked”, not just if awarded –Investigator OID must be current (within 30 days) –Not just annual –COIs must be managed and details reported to NIH (60 days) –Not just yes-or-no –Additional training, reporting, public release/posting of COIs, elaborate investigation and documentation of minor non- compliance

Current Tactical Initiatives

Opportunities for Collaboration & Synergy RA improvement initiatives –Information management and tracking systems –Website renovation and high-priority messages –Outreach to internal stakeholders –Regulatory analysis Synergies with UMMS units –Departmental liaisons –Work together to cover all angles (HR/FA, MICHR) –Sharing lessons learned (even painful ones!)

Thank You

Appendix

Organizational Structure

Key Performance Indicators OID/COI –% OID compliance –# CMPs produced/monitored –eResearch review TAT General –# Regulatory interactions facilitated –# Noncompliance cases facilitated –# Repeat violations avoided

Benchmarked Data and Performance Comparing notes with peers at other institutions  University of Miami – FDA inspections  University of Minnesota – IND/IDE programs  MD Anderson – IND/IDE programs  Vanderbilt – Clinical data de-identification  Case Western – Clinical COI  Duke – International human research  Johns Hopkins – Human subject protection  Ohio State University – Animal management programs, new COI rule implementation  University of Pittsburgh – IND/IDE programs, COI systems, honest broker system  University of Wisconsin – Clinical trial registration  CTSA RKSP Leaders – IRB systems  University of California – Various regulatory concerns  University of Iowa – OID disclosure websites