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CONFLICTS OF INTEREST: RECOGNITION AND MANAGEMENT

CONFLICTS OF INTEREST: RECOGNITION AND MANAGEMENT. Judith L. Curry Associate General Counsel NC State University March 5, 2007. Introduction. What are Conflicts of Interest and Conflicts of Commitment? Why is the university concerned? What is the process for identifying them?

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CONFLICTS OF INTEREST: RECOGNITION AND MANAGEMENT

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  1. CONFLICTS OF INTEREST: RECOGNITION AND MANAGEMENT Judith L. Curry Associate General Counsel NC State University March 5, 2007

  2. Introduction • What are Conflicts of Interest and Conflicts of Commitment? • Why is the university concerned? • What is the process for identifying them? • Once identified, how do you handle? • Consequences if not handled properly?

  3. Overview • Conflicts of Interest in the academic community may arise in: • Conduct of Research • Economic Development • Consulting and Other External Activities for Pay • Student Supervision • Contract Management • How these conflicts are managed determines perception of integrity

  4. Conflict of Commitment Defined • When pursuit of outside activities involves an inordinate investment of time that interferes with one’s obligations to University responsibilities

  5. Managing Conflicts of Commitment • External Activity for Pay (Consulting) Review • “Time” related • Generally more easily dealt with

  6. Conflict of Interest Defined • Financial or other considerations that may compromise (or have the appearance of compromising) one’s objectivity or independent professional judgment in meeting university duties or responsibilities

  7. Federal Requirements • Public Health Service • National Science Foundation • Both require recipients of federal research funding to have policies and require reporting of financial conflicts of interest

  8. Public Health Service • All research funded by PHS must comply with 42 C.F.R. 50.600 et seq., ensuring that the design, conduct or reporting of research will not be biased by conflicting financial interests of an investigator, or the investigator’s spouse or dependent child

  9. Compliance Compliance Requires: • Disclosure by Investigators of Significant Financial Interests (SFI); • Determination by Responsible Official as to whether SFI results in Conflict of Interest and, if so, how to manage, reduce or eliminate such Conflict of Interest; • Institution’s compliance with disclosure obligations to PHS

  10. Significant Financial Interest • SFI: Anything of monetary value, including equity and IP rights • SFI excludes: • Phase I SBIR’s • Income from certain non-profit activities • Equity interests valued at less than $10K and less than 5% ownership interest and • Salary or other payments not exceeding $10K per year

  11. Disclosable Financial Interest • If SFI “would reasonably appear to be affected by the research for which PHS funding is sought” and • Is in an entity whose financial interest would reasonably appear to be affected by the research, it is a • Disclosable Financial Interest

  12. A Word About FDA • The FDA requires disclosure of financial relationships by sponsors of the study, rather than by host institutions • FDA may consider clinical data inadequate if steps not taken to minimize bias in design, conduct and reporting of clinical study

  13. Managing Conflicts of Interest • Institutional responsibility to identify • Proposal based • Routine reports of external financial interests • Prior to expenditure of funds, notify funding agency of COI and assure that managed, reduced or eliminated • Updates annually and/or as circumstances change

  14. Managing Conflict (cont.) • Public Disclosure • Monitoring by Independent Reviewers • Modification of Research Plan • Publication Oversight • Strict Adherence to Data Retention • Alternate Supervision of Students • Full Disclosure to Students

  15. NC Gen. Stat. §14-234 • Statutory Conflict of Interest • Violation is a misdemeanor, and • A contract made in contravention of the statute is void

  16. NC Gen. Stat. §14-234 (cont.) • “No …employee who is involved in making or administering a contract on behalf of a public agency may derive a direct benefit from the contract” • “Administers” = oversees performance, or make decisions about the contract • “Direct Benefit” = >10% ownership in other party, or derives income directly

  17. NC Gen. Stat. §14-234 (cont.) • Even if not involved in “making or administering” the contract, it’s illegal for one getting direct benefit to “attempt to influence” any other person who is involved in making or administering the contract

  18. OTHER CONSEQUENCES • False Claims Act (31 U.S.C. 3729 et seq.) • Researchers who make false certifications because of failure to disclose COI’s are subject to liability • University subject to liability for failure to disclose known conflicts (See, e.g.Gelsinger v U Penn) • Loss of funding

  19. More Information • Observations on Targeted Site Reviews (NIH) http://grants.nih.gov/grants/policy/coi/index.htm • American Association of Medical Colleges http://www.aamc.org/research/dbr/coi.htm#questions • NIH Review of Institutional Conflict of Interest Policies http://grants.nih.gov/grants/policy/coi/nih_review.htm

  20. Handouts • Case Analysis • Sample Generic Management Plan

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