CONFLICTS OF INTEREST: RECOGNITION AND MANAGEMENT
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Transcript of 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
March 5, 2007
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Introduction 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?
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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– Student Supervision– Contract Management– How these conflicts are managed determines
perception of integrity
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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
“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 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
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Public Health ServicePublic 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
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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 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
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Disclosable Financial InterestDisclosable 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
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A Word About FDAA 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
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Managing Conflicts of InterestManaging 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
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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. §§14-23414-234
Statutory Conflict of Interest
Violation is a misdemeanor, and
A contract made in contravention of the statute is void
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NC Gen. Stat. NC Gen. Stat. §§14-234 (cont.)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
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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 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
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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
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HandoutsHandouts
Case Analysis
Sample Generic Management Plan