Conflict of Interest: Yesterday, Today and Tomorrow

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Conflict of InterestYesterday, Today and
Tomorrow
Sherrie Settle Assistant Director
Institutional Research Compliance
Program Conflict of Interest Officer
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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 employees objectivity in meeting
  University duties or responsibilities, including
  research activities. 
• - UNC Policy
  Manual

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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
  

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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

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Who Cares?

• University and UNC System
• Sponsors
• Federal Government
• Public

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Key Elements

• Federal requirements
• UNC-CH policies
• Internal Processing Forms
• RAMSeS/eCOI

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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.

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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

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Assumptions

• PI knows the entire research teams circumstances
• PI knows whats on the IPF

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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 dont prompt next step
• Screening is electronic, but disclosures are not

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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

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Good News and Bad News

• COI questions removed from IPF
• All investigators must reply to screening
  questions before proposal can be submitted

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How Does it Work?

• Log-in with UserID and ONYEN
• Select IPF or IRB record
• Select Yes/No for screening questions

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If All Replies are No
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If One or More Yes Replies
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What Will Research Administrators See?

• Investigator certification status in RAMSeS
• Review/approval status under Compliance tab

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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)

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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

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Other Changes FYI

• Disclose financial interest of any value
• 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

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Tomorrow Brought to You By

• Provosts Task Force
• University Counsel
• Office of Research Information Systems

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Questions??coi_at_unc.edu