Institutional Compliance & Ethics Council: COI Workgroup

1. Institutional Compliance & Ethics Council:COI Workgroup October 24, 2007 Chair: Camille A. McWhirter, J.D. USF Health Office of Research Office of Research Compliance

2. Institutional Objective To provide an infrastructure that facilitates compliance with internal and external laws, regulations, policies, and procedures and targets industry standards and best practices in the review and management of conflicts of interest in all areas of University operations.

3. COI Workgroup Objectives Level I. Organization and Accountability of Individual COI Units/Programs • Identify individual COI “units” or “programs” • Recommend assignments of individual responsibility for COI oversight in various areas (i.e., shared responsibility is no responsibility) • Evaluate each existing unit or program in relation to COI requirements, industry standards and best practices • Make recommendations to address specific concerns arising from the program evaluation

4. COI Workgroup Objectives (con’t) Level II. Integration and Coordination of COI Activities • Implement a comprehensive website for University employees to describe the diverse areas of COI and the policies, processes, training opportunities and contact info applicable to each COI Unit/Program. • Develop and coordinate consistent messages at employee orientation, end user, and other training programs as appropriate across the various classification levels. • Integrate COI disclosure, review and management processes where possible to reduce institutional and employee and institution “paperwork” and to avoid duplication of effort

5. Membership • Camille McWhirter-Chair (Institutional Conflicts of Interest/USF & Health) • Dwayne Smith-Vice-Chair (Outside Activity & Nepotism-Faculty/USF & Vendor Interactions--Main Campus) • Michael Stephens (OA & Nepotism-Staff/USF & Health) • Tom DiBella (Employees as Vendors & Purchasing Agents/USF) • Olga Joanow (OA & Nepotism-Faculty/Health) • Patsy Bickel (Vendor Interactions--Medical Center/Health) • Liz O’Connell (COI in Research-Disclosure & Reporting/USF) • Vinita Witanachchi (COI in Research-Review & Monitoring/USF & Health)) • Joan Bailey (Financial Aid & Lender Relationships/USF) • Valerie McDevitt (Tech Transfer Issues/USF) • Theresa Chisolm (Faculty Rep/USF) • Bill Marshall (Faculty Rep/Health)

6. Individual COI Units • Financial Interests in Research/Disclosure & Reporting • Responsible Person: Liz O’Connell • Financial Interests in Research/Review & Management • Responsible Person: Vinita Witanachchi • Vendor Interactions at the Medical Center • Responsible Person: Patsy Bickel

7. Individual COI Units (con’t) • Employee as Purchasing Agent or Vendor • Responsible Party: Tom DiBella • Financial or Business Relationships in Technology Transfer • Responsible Party: Valerie McDevitt • Outside Activity & Nepotism: USF Faculty • Responsible Party: Dwayne Smith • Vendor Interactions on Main Campus • Responsible Party: Dwayne Smith

8. Individual COI Units (con’t) • Outside Activity & Nepotism: Health Faculty • Responsible Party: Olga Joanow • Outside Activity & Nepotism: USF & Health Staff • Responsible Party: Michael Stephens • Institutional Conflicts of Interest • Responsible Party: Camille McWhirter • Financial AidLender Relationships • Responsible Party: Joan Bailey

9. Faculty Representatives • Faculty Representative: Health • Bill Marshall • Faculty Representative: USF • Theresa Chisolm

10. COI Workgroup Objectives Level I. Organization and Accountability of Individual COI Units/Programs • Identify individual COI “units” or “programs” • Recommend assignments of individual responsibility for COI oversight in various areas (i.e., shared responsibility is no responsibility) • Evaluate each existing unit or program in relation to COI requirements, industry standards and best practices • Make recommendations to address specific concerns arising from the program evaluation

11. Level 1 Objective : Organization and Accountability of Individual COI Units Part I. Describe the Program Part II. Identify Program Effectiveness Targets: Regulatory/Standards/Best Practices Part III. [For later] Evaluate Effectiveness Of Existing COI Processes & Identify Gaps

12. Part I: Describe the Program • Need: A statement of need describes the problem or opportunity that the program addresses and implies how the program will respond. • Expected effects: Descriptions of expected effects convey what the program must accomplish to be considered successful. • Primary Risks: Identify the primary risks associated with an ineffective program. • Activities: Describe specific steps, strategies, or actions in a logical sequence. This demonstrates how each program activity relates to another.

13. Part I: Describe the Program (con’t) • Resources: Resources include the time, talent, technology, information, money, and other assets available to conduct program activities. • Stage of development: • Planning. During planning, program activities are untested, and the goal of evaluation is to refine plans. • Implementation. During implementation, program activities are being field-tested and modified; the goal of evaluation is to characterize real, as opposed to ideal, program activities and to improve operations, perhaps by revising plans. • Effects. The goal of evaluation is to identify and account for both intended and unintended effects.

14. Part I: Describe the Program (con’t) • Context: Descriptions of the program’s context (e.g., history, geography, politics, social and economic conditions, and efforts of related departments) within which the program operates. Understanding these environmental influences is required to design a context-sensitive evaluation. • (Optional) Visual description: Demonstrate visually how issues are brought to the program and resolved (or not resolved as the case may be In other words, use a flow chart, map, or table to portray the sequence of steps leading to program results.

15. Part II: Identify Program Effectiveness Targets • Regulatory requirements targets • What rules apply (laws, regulations, agency policies, University policies) • To whom (staff, faculty, students, researchers, sub grantees, etc.) • To what functions (procurement, research, employment, etc.) • Industry standard targets • Best practices targets

16. Part III: Evaluate Program Effectiveness A. Compare University policies/practices to • regulatory requirements • industry standards/guidance • best practices at other institutions B. Identify “gaps” or deficiencies in existing policies, processes or programs that inhibit program effectiveness

17. Sample Program Evaluation: Parts I &II COI Program: Financial Interests in Research/Review & Management Responsible Party: Vinita Witanachchi

18. Need: This program operates a system for the review and management of disclosures of financial interests relating to research. Expected Effects: To be successful the program must provide for Knowledgeable review of disclosures Process for development of appropriate management plan Process for communicating results of review to investigator, DSR, IRB Process for monitoring compliance with approved management plan Sample Program Description

19. Sample Program Description (con’t) • Primary Risks • Loss of federal funding from NIH and NSF • IRB accreditation at risk • Loss of public trust in research, loss of donors • Sponsors want assurance that institutions are managing COI of investigators; otherwise could be very costly to sponsors; won’t work with institutions whose COI review and management program is deficient

20. Sample Program Description (con’t) • Activities • Receive disclosure • Review of disclosure by administrative official • Determination of necessity for Committee review/management plan • (If required) Develop management plan with investigator • (If required) Committee review • Action on disclosure • Notification of action on disclosure to: • Investigator • DSR (if sponsored) • IRB (if human subjects involved) • Monitoring

21. Sample Program Description (con’t) • Resources • Knowledgeable Administrative Official • Committee (5-9 members) • Interactive Database • Standard office resources (computer, copier, etc.) • Stage of development • Effects. The goal of this program evaluation is to identify and account for both intended and unintended effects.

22. Sample Program Description (con’t) • Context: This program originated in the mid 1990’s as a result of a DHHS/NIH and NSF policy on objectivity in research. The program was further refined in 2003 as a result of attention to this issue and guidance issued for academic medical centers. The outcome was the formation of a policy committee at USF Health and ultimately the development of a USF Health specific policy and Committee.

23. Sample Program Description (con’t) • Context (con’t): The original USF Committee then elected to refer medical issues to the USF Health Committee based on its expertise in medical research issues. Finally, a decision was made in association with application of our IRB for accreditation (2004) to refer all human subjects research through the USF Health program. There is currently an agenda within the USF Office of Research to consolidate the two programs under the USF Division of Research Integrity & Compliance.

24. Sample Program Description (con’t) V. Visual Description

26. Sample Program Effectiveness Targets • Regulatory Requirements • NIH/NSF Objectivity in Research • To Whom Requirements Apply • Institution • Written enforced policies on COI • Designated institutional official to review COI • Require that each investigator submits a disclosure form for PHS and NSF research annually • Provide guidelines to review and manage COI • Maintain records for 3 years • Establish enforcement mechanisms and sanctions • Report failures to comply to awarding agency

27. Sample Program Effectiveness Targets (con’t) • Investigator • Must disclose any “significant financial interests” (including those of spouse and dependent children) that would reasonably appear to be affected by the research to a designated institutional official by the time the application is submitted to PHS/NSF. • In what activities? • Research

28. Sample Program Effectiveness Targets (con’t) • Industry Standards • IRB AAHRPP Accreditation Standards • AAMC Guidance, “Individual Financial Conflicts in Research” (2001, 2004) • [Name other relevant industry guidance documents] • Peer Institution Benchmarks • [name specific institutions]

29. Sample Program Effectiveness Targets (con’t) • Best Practices Targets • User friendly, effective policies • Not text heavy, minimum verbiage-- “Just tell me what I need to do”. • Define scope, audience and other parameters • Identify “the rule” • Contact info • Step by step instructions • Generous white space • Flexible, modular outline

30. Sample Program Effectiveness Targets (con’t) • User friendly access to information • Info is accessible via easily navigable webpage • Effective disclosure monitoring • Effective education and training on procedures • Existing employees • New employees • Monitoring compliance • Consistency of treatment

31. HOMEWORK • Use the Sample Program Evaluation as a model to describe your own COI Unit and the regulatory/standards/best practices that apply to your program • Send me the completed template by Monday, January 7, 2008. • Call on me for help with any aspect of the Program Evaluation—I am here to assist you cmcwhirt@health.usf.edu or 974-6676