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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 February 27, 2014. Conflict of Interest Defined.

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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 February 27, 2014

  2. Conflict of Interest Defined • Financial or personal interests that may compromise (or have the appearance of compromising) one’s objectivity in meeting university duties or responsibilities • NC State REG 01.25.01(Conflict of Interest and Conflict of Commitment) • UNC Policy Manual 300.2.2

  3. Significant Financial Interest • SFI: Any monetary interest, including consulting fees, stock, stock options, and IP rights • Appears to be related to institutional responsibilities • Publicly Traded Entity • >$10,000* or >5% Equity • Non-Publicly Traded Entity • >$10,000 or Any Equity Interest • SFI excludes: • Phase I SBIR’s • Income rom 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

  4. Conflicts of Interest in the academic community may arise in: • Conduct of Research • Entrepreneurial Activity • Consulting and Other External Activities for Pay • Personal Relationships • Student Supervision • Contract Management

  5. NC Gen. Stat. §14-234 • “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

  6. Compliance • RECOGNIZE • DISCLOSE • Annually • Prior to engaging in EPAP • Within 30 days of new SFI (New Rule) • MANAGE, reduce or eliminate

  7. Managing Conflict • Develop Plan • Modification of Research Plan • Fully disclose COI in any Publication • Strict Adherence to Data Retention • Alternate Supervision of Students • Full Disclosure to Students

  8. Why Should you Care? • Loss of funding • Researchers who fail to disclose may be subject to liability under the False Claims Act (31 U.S.C. 3729 et seq.) (Treble damages plus up to $11,000 for each false claim) • University may also be subject to liability for failure to disclose known conflicts (See, e.g.Gelsinger v U Penn)

  9. Public Perception • “The public trust in what we do is just essential, and we cannot afford to take any chances with the integrity of the research process.” • Dr. Francis Collins, Director, NIH

  10. Additional Resources • OGC Consulting FAQ’s http://www.ncsu.edu/general_counsel/legal_topics/consulting-faqs.php • PHS Regulations 42 CFR Part 50, Subpart F • SPARCS http://research.ncsu.edu/sparcs/systems-portal/coi/coi-plan-help/

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