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Conflict of Interest: Yesterday, Today and Tomorrow

Conflict of Interest: Yesterday, Today and Tomorrow. Sherrie Settle Assistant Director Institutional Research Compliance Program Conflict of Interest Officer. What Is It?.

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Conflict of Interest: Yesterday, Today and Tomorrow

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  1. Conflict of Interest:Yesterday, Today and Tomorrow Sherrie Settle Assistant Director Institutional Research Compliance Program Conflict of Interest Officer

  2. What Is It? Conflict of interest relates to situations in which financial or other personal considerations may compromise, may involve the potential for compromising, or may have the appearance of compromising an employee’s objectivity in meeting University duties or responsibilities, including research activities.  - UNC Policy Manual

  3. Conflict is Inherent to Research Enterprise COI is a situation, a confluence of potentially competing factors Careers, lives, institutions with multiple facets will have these conflicts COI is not a reflection of character or integrity

  4. COI in the Media • Student Loan Programs • Study Abroad Programs • ‘De-Duking’ of the NIEHS • Congressional scrutiny of pharmaceutical company influence on physicians and biomedical researchers • Boston Legal episode questions perceived influence of “unrestricted” gifts

  5. Who Cares? • University and UNC System • Sponsors • Federal Government • Public

  6. Key Elements • Federal requirements • UNC-CH policies • Internal Processing Forms • RAMSeS/eCOI

  7. Code of Federal Regulations CFR Title 42 Each Institution must: Require that by the time an application is submitted to PHS each Investigator who is planning to participate in the PHS-funded research has submitted to the designated official(s) a listing of his/ her known Significant Financial Interests (and those of his/her spouse and dependent children): (i) That would reasonably appear to be affected by the research for which PHS funding is sought; and (ii) In entities whose financial interests would reasonably appear to be affected by the research.

  8. UNC-CH Approach • Yesterday: Annual disclosure of everything • Today: Project-specific, event-based • Screening questions determine if detailed report is needed • Screening through IPF and IRB Application • PI answers for research team

  9. Assumptions • PI knows the entire research team’s circumstances • PI knows what’s on the IPF

  10. Is it Working? • Good start • Weak correlation between electronic IPF and paper IRB answers for same project • Missed positives in IPF screening from: • Inadequate information provided to Research Administrator • Project team information not known to PI • Positive IPF answers don’t prompt next step • Screening is electronic, but disclosures are not

  11. Introducing eCOI • Each investigator answers screening questions for himself/herself • If positive, investigator can continue to disclosure or complete later • Connects to RAMSeS and IRBIS

  12. Good News and Bad News • COI questions removed from IPF • All investigators must reply to screening questions before proposal can be submitted

  13. How Does it Work? • Log-in with UserID and ONYEN • Select IPF or IRB record • Select Yes/No for screening questions

  14. If All Replies are “No”

  15. If One or More “Yes” Replies

  16. What Will Research Administrators See? • Investigator certification status in RAMSeS • Review/approval status under “Compliance” tab

  17. Fit with Federal Reg? CFR Title 42 Each Institution must: Require that by the time an application is submitted to PHS each Investigator who is planning to participate in the PHS-funded research has submitted to the designated official(s) a listing of his/ her known Significant Financial Interests (and those of his/her spouse and dependent children)

  18. Does the NIH Mean It? FY2006 Targeted Site Review Report • Grant applications submitted prior to collecting significant financial interests from investigators • Grant funds expended prior to reporting identified financial conflicts of interest to NIH

  19. Other Changes FYI • Disclose financial interest of anyvalue • Disclosure may be sufficient to manage many conflicts in basic research • Presumption that interest of any value precludes engagement in human studies research • New modules for technology transfer, management roles

  20. Tomorrow Brought to You By: • Provost’s Task Force • University Counsel • Office of Research Information Systems

  21. Questions??coi@unc.edu

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