OFFICE OF RESEARCH COMPLIANCE: Progress Report

1. OFFICE OF RESEARCH COMPLIANCE: Progress Report Camille A. McWhirter, J.D. Director May 11, 2007 Office of Research, Graduate and Postdoctoral Affairs Staff Meeting

2. COI/Compliance Committee Management Grid

3. COI Committee: Committee Membership • Include members from each college of USF Health and a college of arts & sciences member • Include both basic and clinical researchers • Include a community member • Include ex-officio representation from all compliance offices dealing with COI • Include alternates • Formalize terms of membership Goal Achieved: October 2006

4. COI Committee: Member Education • Members must be familiar with the regulations that govern COI • Members must be familiar with the industry guidance interpreting the regulations • Members must be able to apply the “rules” to the disclosures reviewed Goal Achieved: October 2006

5. COI Committee: Operating Procedures • Procedures for the operation of the Committee (scope, charge, expedited review procedures, conduct of meeting, etc.) • Distribution and intake procedures for staff to process, distribute and maintain documents • Covers all Committee and staff operations from the time a document is received to the review and distribution of the document Goal (Substantially) Achieved: April 2006

6. COI Committee: Accessibility If someone is looking for your program, will they be able to find it? • Website : http://health.usf.edu/research/compliance/index.htm • Specific program information (policies, processes, forms, Committee roster & schedule, deadlines) • Procedures Goal Achieved: November 2006

7. COI Committee: Record-Keeping • Records should be accessible and searchable • Database for financial interest disclosures and management plans Goal: June 2007

8. COI Committee: Outreach • Awareness of program by end-users • Foundation of compliance is education • Not enough that users can find you, must take the message on the road to the end user Goal: May/June 2007

9. COI Committee: Noncompliance • Every compliance committee must address the issue of how noncompliance will be handled • Need policies/procedures for identifying and managing noncompliance—both intentional and unintentional • Issues are complex enough to require subcommittee to address: first meeting was May 7, 2007 Goal: May/June 2007

10. COI Committee: Feedback & Accountability • Feedback: Website/e-mail survey to solicit feedback from users of the program to confirm customer satisfaction • Accountability: COI Office has established standards for program operations, efficiency and effectiveness • Quarterly Reports on the website to document achievement of performance standards. Weblinks: • Fall 2006 • Winter 2007

11. ORC: Contracting Function • Website content for sponsor education • Assist with pending contracts • Review contract language

12. ORC: Ombudsman Function • IRB • Outside Activity Process • Public Records Requests • Contracting Process • Research Misconduct Investigations • “We don’t have a policy for this.”

13. ORC: Education • Responsible Conduct of Research: Core Curriculum • Research Compliance Education • Newsletter: Research Compliance Matters • Live Presentations • 15 minute compliance update • Specific topics to address specific compliance needs/questions • One-on-One Counseling • Assist with OCR course in clinical research • Assist with course for research administrators Goal: Summer/Fall 2007