Regulatory Affairs Pat Ward November 1, 2011. Purpose Regulatory Good-Standing…
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Transcript of Regulatory Affairs Pat Ward November 1, 2011. Purpose Regulatory Good-Standing…
• 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
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
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
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!)
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