Regulatory AffairsPat Ward

November 1, 2011

Purpose

• Regulatory Good-Standing…

Purpose

• Protect…

• 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

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

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

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 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)

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

Current Tactical Initiatives

Current Tactical Initiatives

Current Tactical Initiatives

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