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Regulatory Affairs

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.

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Regulatory Affairs

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  1. Regulatory Affairs Pat Ward November 1, 2011

  2. Purpose • Regulatory Good-Standing…

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

  4. Products and Services • 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

  5. 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

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

  7. 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

  8. Customers Partners (making new ones every day!) • 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

  9. 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 2008 - 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)

  10. 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

  11. Current Tactical Initiatives Proposed IRB rules • Analyze and comment by October 26, 2011 • Possible benefits • Better calibrate level of review to level of risk • Eliminate most annual reviews • Harmonize disparities in various similar regulations • Possible pitfalls • Expand regulations to de-identified data/specimens • Expand regulations to non-federally funded research • Require elaborate IT security and consent even for low risk studies

  12. Current Tactical Initiatives Clinical and Educational COI • Recent policies • Industry funding of CME • Ghostwriting • Disclosure to students • Upcoming discussions • Promotional speaking • Consulting • Website for public disclosure of OIDs

  13. Current Tactical Initiatives FDA Regulatory Survival • Noncompliance • What went wrong and how to fix it • Inspections • Preparing for and responding to • Monitoring CAPA plan compliance • Faculty holding IND/IDEs • Know what they’re getting into

  14. Current Tactical Initiatives Misconduct or misbehavior • Investigations • Shorten TAT • Streamline steps and participants • Build investigative and assessment skills • Evidence chain-of-custody • Integrity of documentation

  15. Current Tactical Initiatives Dry Ice Shipping

  16. 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!)

  17. Thank You

  18. Appendix

  19. Organizational Structure

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

  21. 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

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