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 Committee Representation Broaden, Diversify, FormalizeAccessibility Website, Guidance Noncompliance Subcommittee, Policy Development Member/StaffEducation Disclosure Review, Application of Federal Regulations & Industry Guidance Record-KeepingDatabase, Filing System Feedback/Accountability How are we doing? Efficiency, Effectiveness Operating Procedures Operations, Intake/ Distribution, Records Outreach Education, Research Compliance Matters Improvement Incorporate feedback, establish standards and goals

3. COI Committee: Committee Membership Include members from each college of USF Health and a college of arts & sciences member Include members from each college of USF Health and a college of arts & sciences member Include both basic and clinical researchers Include both basic and clinical researchers Include a community member Include a community member Include ex-officio representation from all compliance offices dealing with COI Include ex-officio representation from all compliance offices dealing with COI Include alternates Include alternates Formalize terms of membership 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 regulations that govern COI Members must be familiar with the industry guidance interpreting the regulations Members must be familiar with the industry guidance interpreting the regulations Members must be able to apply the “rules” to the disclosures reviewed 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.) 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 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 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 : Website : http://health.usf.edu/research/compliance/index.htm Specific program information (policies, processes, forms, Committee roster & schedule, deadlines) Specific program information (policies, processes, forms, Committee roster & schedule, deadlines) Procedures Procedures Goal Achieved: November 2006

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

8. COI Committee: Outreach Awareness of program by end-users Awareness of program by end-users Foundation of compliance is education Foundation of compliance is education Not enough that users can find you, must take the message on the road to the end user 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 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 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 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 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 Accountability: COI Office has established standards for program operations, efficiency and effectiveness Quarterly Reports on the website to document achievement of performance standards. Quarterly Reports on the website to document achievement of performance standards.Weblinks: Fall 2006 Fall 2006 Fall 2006 Fall 2006 Winter 2007 Winter 2007 Winter 2007 Winter 2007

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

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

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