CONFLICTS OF INTEREST: RECOGNITION AND MANAGEMENT
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CONFLICTS OF INTEREST: CONFLICTS OF INTEREST: RECOGNITION AND RECOGNITION AND
MANAGEMENTMANAGEMENT
Judith L. CurryAssociate General Counsel
NC State University
January 20, 2011
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Introduction Introduction What are Conflicts of Interest and
Conflicts of Commitment?
Why should you be concerned?
Consequences if not handled properly?
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Overview Overview Conflicts of Interest in the academic
community may arise in:– Conduct of Research– Economic Development – Consulting and Other External Activities for
Pay http://www.ncsu.edu/general_counsel/legal_topics/consulting-faqs.php
– Student Supervision– Contract Management
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Conflict of Commitment Conflict of Commitment DefinedDefinedWhen pursuit of outside activities involves
an inordinate investment of time that interferes with one’s obligations to University responsibilities
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Managing Conflicts of Managing Conflicts of CommitmentCommitment
External Activity for Pay (Consulting) Review http://www.ncsu.edu/sparcs/coi/
“Time” related
Generally more easily dealt with
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Conflict of Interest DefinedConflict 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
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Federal RequirementsFederal RequirementsPublic Health Service
National Science Foundation
Both require recipients of federal research funding to have policies and require reporting of financial conflicts of interest
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Public Health ServicePublic Health ServiceAll 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
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ComplianceCompliance
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
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Significant Financial InterestSignificant Financial InterestSFI: Anything of monetary value, including
consulting fees, stock, stock options, 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
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Disclosable Financial InterestDisclosable Financial InterestIf SFI would reasonably appear to be
affected by the research for which funding is sought
it is a
Disclosable Financial Interest http://www.ncsu.edu/sparcs/coi/index.php
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Managing Conflicts of InterestManaging Conflicts of InterestInstitutional 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
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Managing Conflict (cont.)Managing Conflict (cont.)Public DisclosureMonitoring by Independent ReviewersModification of Research PlanPublication OversightStrict Adherence to Data Retention Alternate Supervision of StudentsFull Disclosure to Students
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NC Gen. Stat. NC Gen. Stat. §§14-234 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
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NC Gen. Stat. NC Gen. Stat. §§14-234 (cont.)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
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OTHER CONSEQUENCESOTHER CONSEQUENCESFalse 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
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More InformationMore 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 Policieshttp://grants.nih.gov/grants/policy/coi/nih_review.htm