Office of research compliance progress report
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OFFICE OF RESEARCH COMPLIANCE: Progress Report. Camille A. McWhirter, J.D. Director May 11, 2007 Office of Research, Graduate and Postdoctoral Affairs Staff Meeting. COI/Compliance Committee Management Grid. COI Committee: Committee Membership.

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Camille A. McWhirter, J.D.


May 11, 2007

Office of Research, Graduate and Postdoctoral Affairs

Staff Meeting

COI/Compliance Committee Management Grid

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

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

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

COI Committee: Accessibility

If someone is looking for your program, will they be able to find it?

  • Website :

  • Specific program information (policies, processes, forms, Committee roster & schedule, deadlines)

  • Procedures

    Goal Achieved: November 2006

COI Committee: Record-Keeping

  • Records should be accessible and searchable

  • Database for financial interest disclosures and management plans

    Goal: June 2007

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

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

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.


    • Fall 2006

    • Winter 2007

ORC: Contracting Function

  • Website content for sponsor education

  • Assist with pending contracts

  • Review contract language

ORC: Ombudsman Function

  • IRB

  • Outside Activity Process

  • Public Records Requests

  • Contracting Process

  • Research Misconduct Investigations

  • “We don’t have a policy for this.”

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

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