Financial Conflict of Interest 1. Financial Conflict of Interest (FCOI) Regulations 42 CFR Part 50 Subpart F (grants and cooperative agreements) 42 CFR.

Financial Conflict of Financial Conflict of InterestInterest

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Financial Conflict of InterestFinancial Conflict of Interest(FCOI) Regulations(FCOI) Regulations

42 CFR Part 50 Subpart F (grants and 42 CFR Part 50 Subpart F (grants and cooperative agreements)cooperative agreements)

45 CFR Part 94 (contracts)45 CFR Part 94 (contracts)

These regulations went into effect on October 1, These regulations went into effect on October 1, 19951995

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What is the Purpose of the What is the Purpose of the Regulation?Regulation?

This regulation is aimed at ensuring This regulation is aimed at ensuring that the design, conduct, or reporting that the design, conduct, or reporting of research funded under NIH grants of research funded under NIH grants and cooperative agreements will not and cooperative agreements will not be biased by any conflicting financial be biased by any conflicting financial interest of the Investigators interest of the Investigators responsible for the research. responsible for the research.

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Objectivity in ResearchObjectivity in Research

• Maintaining objectivity in researchMaintaining objectivity in research• Preserves the public trustPreserves the public trust• Integrity Integrity

InstitutionInstitution InvestigatorInvestigator DataData NIHNIH

• TransparencyTransparency44

The Regulation The Regulation

ComplianceCompliance(including accurate(including accurate& timely reporting)& timely reporting)

Institutional PolicyInstitutional PolicyImplementationImplementation

ManagementManagementOversightOversight

InstitutionInstitution

DisclosureDisclosureComplianceCompliance

InvestigatorInvestigator

OversightOversightEducation & OutreachEducation & Outreach

NIHNIH

Who is Covered?Who is Covered?

Each Institution that applies for NIH Each Institution that applies for NIH grants or cooperative agreements for grants or cooperative agreements for researchresearch• Domestic, foreign, public, private (not Domestic, foreign, public, private (not

Federal)Federal) Any Investigator, as defined by the Any Investigator, as defined by the

regulation, participating in the regulation, participating in the researchresearch

SBIR/STTR Phase I applications are SBIR/STTR Phase I applications are exemptexempt

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What is an FCOI?What is an FCOI?

A significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH funded research

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Institutional ResponsibilitiesInstitutional Responsibilities

Institutions must establish standards to ensure there is no reasonable expectation that the design, conduct, or reporting of NIH funded research is biased by a conflicting financial interest of an Investigator

Institutional ResponsibilitiesInstitutional Responsibilities

• Maintain a written, enforced policy that Maintain a written, enforced policy that complies with the regulation andcomplies with the regulation and

inform Investigators of the policy, the inform Investigators of the policy, the regulation, and their reporting regulation, and their reporting responsibilitiesresponsibilities

• Establish enforcement mechanisms and Establish enforcement mechanisms and provide for sanctions where appropriateprovide for sanctions where appropriate

• Maintain records for at least three years Maintain records for at least three years from date of submission of final from date of submission of final expenditures reportexpenditures report

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Institutional Responsibilities Institutional Responsibilities Designate an Institutional Official to

• solicit & review disclosure statement from each Investigator planning to participate in NIH-funded research

• Provide guidelines to identify conflicting interests

• Take action to ensure they are managed, reduced, or eliminated

By the time an application is submitted, assure that the Institutional Official has received a financial disclosure statement from each Investigator who is planning to participate in the NIH-funded research.

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Institutional ResponsibilitiesInstitutional Responsibilities If NIH-funded research is performed through If NIH-funded research is performed through

“subgrantees, contractors, or collaborators,” “subgrantees, contractors, or collaborators,” [aka subrecipients] the grantee Institution [aka subrecipients] the grantee Institution must take reasonable steps to ensure must take reasonable steps to ensure compliance by either requiring:compliance by either requiring: • Subrecipient Investigators to comply with the Subrecipient Investigators to comply with the

Institution’s policy ORInstitution’s policy OR• Subrecipient Institutions to provide assurances to Subrecipient Institutions to provide assurances to

the grantee Institution that will enable it to the grantee Institution that will enable it to complycomply

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Subrecipients should report identified FCOIs to the grantee Institution. Grantee Institution reports to NIH.

Institutional ResponsibilitiesInstitutional Responsibilities Certify in each application for funding:Certify in each application for funding:

• There is in effect a written and enforced There is in effect a written and enforced administrative process to identify and manage, administrative process to identify and manage, reduce or eliminate conflicting interests reduce or eliminate conflicting interests

• Report existence of an FCOI prior to Report existence of an FCOI prior to expenditure of funds under an award and expenditure of funds under an award and within 60 days of identification of a new within 60 days of identification of a new conflicting interestconflicting interest

• Agree to make information available upon Agree to make information available upon request regarding all conflicting interests request regarding all conflicting interests identified by the Institution and how those identified by the Institution and how those interests have been managed, reduced, or interests have been managed, reduced, or eliminated. eliminated.

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Institutional ResponsibilitiesInstitutional Responsibilities Reports of an identified Financial Conflict of

Interest include: • grant and/or contract number, • PD/PI or contact PD/PI, • name of Investigator with the FCOI, and • an indication whether the conflict has been

managed, reduced or eliminated.

For grants, all FCOI reports must be submitted through the eRA Commons FCOI Module.

For contracts, reports should be sent to the appropriate Director, Office of Acquisitions.

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Institutional ResponsibilitiesInstitutional Responsibilities

eRA Commons – FCOI ModuleeRA Commons – FCOI Module• Enables grantees to report identified Enables grantees to report identified

FCOIs to NIH through the eRA CommonsFCOIs to NIH through the eRA Commons• Mandatory use began 7/1/09Mandatory use began 7/1/09

NIH Guide Notice: NOT-OD-09-072 NIH Guide Notice: NOT-OD-09-072 http://grants.nih.gov/grants/guide/notice-http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-072.html files/NOT-OD-09-072.html

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eRA Commons FCOI eRA Commons FCOI Module/reporting toolModule/reporting tool

System allows institutions to:System allows institutions to:• Initiate and send a new FCOI report electronically Initiate and send a new FCOI report electronically

through the eRA Commonsthrough the eRA Commons• Search previously created recordsSearch previously created records• Edit a previously submitted recordEdit a previously submitted record• Respond to a request for additional information Respond to a request for additional information • Rescind a previously submitted recordRescind a previously submitted record• View history of actionsView history of actions

To prepare, institutional Signing Officials must assign To prepare, institutional Signing Officials must assign FCOI roles to users in eRA Commons.FCOI roles to users in eRA Commons.

More information on the FCOI Module can be found at More information on the FCOI Module can be found at http://era.nih.gov/services_for_applicants/other/fcoi.cfmhttp://era.nih.gov/services_for_applicants/other/fcoi.cfm

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Summary of FCOI Summary of FCOI Reporting RequirementsReporting Requirements

1. At the time of application: Investigators must submit known significant financial interests to the Institution.

2. Prior to the expenditure of funds: The Institution must report an identified financial conflict of interest to the NIH and assure that it has been managed, reduced, or eliminated.

3. FCOI identified after the initial report: The Institution must report to the NIH within 60 days of identification and assure that it has been managed, reduced, or eliminated.

Definition of InvestigatorDefinition of Investigator

The Principal Investigator (PI) AND The Principal Investigator (PI) AND any other person who is responsible any other person who is responsible for the design, conduct, or reporting for the design, conduct, or reporting of NIH-funded research, or proposed of NIH-funded research, or proposed for such fundingfor such funding

Includes Investigator’s spouse and Includes Investigator’s spouse and dependent childrendependent children

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Investigator ResponsibilitiesInvestigator Responsibilities

Submit financial disclosure statements which is a listing of Significant Financial Interests • that would reasonably appear to be affected by

the research for which you are seeking funding, and

• in entities whose financial interests would reasonably appear to be affected by the research

Comply with all Institutional requirements

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Significant Financial InterestSignificant Financial Interest

Anything of monetary value, Anything of monetary value, including but not limited to:including but not limited to:• Salary or other payments for services Salary or other payments for services

(e.g., consulting fees or honoraria)(e.g., consulting fees or honoraria)• Equity interests (e.g., stocks, stock Equity interests (e.g., stocks, stock

options or other ownership interests)options or other ownership interests)• Intellectual property rights (e.g., Intellectual property rights (e.g.,

patents, copyrights and royalties from patents, copyrights and royalties from such rights)such rights)

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Significant Financial InterestSignificant Financial InterestExclusionsExclusions

Salary, royalties, or other remuneration from the applicant Institution

Ownership interests in the Institution, if the Institution is an applicant under the SBIR program

Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities

Income from service on advisory committees or review panels for public or non-profits entities

Salary, royalties, or other payments that when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next 12 months are not expected to exceed $10,000

Significant Financial InterestSignificant Financial InterestExclusionsExclusions

An equity interest that when aggregated An equity interest that when aggregated for the Investigator and the Investigator’s for the Investigator and the Investigator’s spouse and dependent children meets spouse and dependent children meets both of the following tests:both of the following tests:• Does not exceed $10,000 in value as Does not exceed $10,000 in value as

determined through reference to public prices determined through reference to public prices or other reasonable measures of fair market or other reasonable measures of fair market value ANDvalue AND

• Does not represent more than a 5% ownership Does not represent more than a 5% ownership interest in any single entityinterest in any single entity

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SFI vs. FCOISFI vs. FCOI

A Significant Financial Interest (SFI) is not always an FCOI

An FCOI exists when a designated Institutional official reasonably determines that an SFI could directly and significantly affect the design, conduct, or reporting of the NIH-funded research

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NIH Responsibilities• NIH may request information regarding all

conflicting interests identified by the Institutions and how those interests have been managed, reduced, or eliminated to protect research from bias.

• If the failure of an Investigator to comply with the Institution’s conflict of interest policy has biased the design, conduct, or reporting of the NIH-funded research, the Institution must promptly notify NIH of the corrective action taken or to be taken. NIH will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the funded project.

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NIH Responsibilities NIH may at any time inquire into the

Institutional procedures and actions regarding conflicting financial interests in NIH-funded research, including a requirement for submission of, or review on site, all records pertinent to compliance. NIH may decide that further corrective action is needed or that the Institution has not managed, reduced, or eliminated the conflict in accordance with requirements. If necessary, NIH may suspend funding until the matter is resolved.

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NIH ResponsibilitiesNIH Responsibilities In any case in which an NIH-funded clinical

research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not disclosed or managed in accordance with the regulation, the Institution must require the Investigator(s) involved to disclose the conflicting interest in each public presentation of the results of the research

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Policy TipsPolicy Tips

Ensure that your Institution’s FCOI policy is Ensure that your Institution’s FCOI policy is compliant with all aspects of the FCOI compliant with all aspects of the FCOI regulation regulation

Clearly state to whom the policy applies Clearly state to whom the policy applies Include definition of termsInclude definition of terms Delineate roles and assign responsibilitiesDelineate roles and assign responsibilities

• InvestigatorsInvestigators• Designated Official(s)Designated Official(s)• OversightOversight• ReportingReporting

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Policy TipsPolicy Tips

Ensure that the definition of Ensure that the definition of Investigator is consistent with the Investigator is consistent with the FCOI regulationFCOI regulation• Broad definitionBroad definition• Consider roles rather than titlesConsider roles rather than titles• Consider degree of independence with Consider degree of independence with

which individuals workwhich individuals work

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Policy TipsPolicy Tips Develop a process to identify all Develop a process to identify all

Investigators Investigators • The PI and any other person who is responsible The PI and any other person who is responsible

for the design, conduct, or reporting of NIH-for the design, conduct, or reporting of NIH-funded researchfunded research

Ensure that Investigators understand their Ensure that Investigators understand their responsibility to discloseresponsibility to disclose

Conduct a meaningful and consistent Conduct a meaningful and consistent review of financial disclosures review of financial disclosures

Develop and execute appropriate Develop and execute appropriate management plans and ensure management plans and ensure compliance with themcompliance with them

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Policy TipsPolicy Tips

Comply with all reporting requirementsComply with all reporting requirements• Prior to the expenditure of funds under a Prior to the expenditure of funds under a

grant awardgrant award• Within 60 days of identifying new FCOI Within 60 days of identifying new FCOI

Ensure that all identified FCOIs are Ensure that all identified FCOIs are reported to the NIH for each awardreported to the NIH for each award

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Policy TipsPolicy Tips

Ensure that subrecipients are in Ensure that subrecipients are in compliance by compliance by • Complying with your Institution’s policy Complying with your Institution’s policy

OROR• Providing assurances to your Institution Providing assurances to your Institution

to enable it to complyto enable it to comply Are subrecipients reporting identified FCOIs Are subrecipients reporting identified FCOIs

to your Institution?to your Institution? Are you reporting them to NIH?Are you reporting them to NIH?

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Policy TipsPolicy Tips

Maintain proper documentationMaintain proper documentation• All Financial disclosuresAll Financial disclosures• All actions taken by the institution with respect All actions taken by the institution with respect

to each conflicting interestto each conflicting interest

Retain records for at least 3 years Retain records for at least 3 years following submission of final Financial following submission of final Financial Status report or, where applicable, from Status report or, where applicable, from other dates specified in 45 CFR 74.53(b) other dates specified in 45 CFR 74.53(b) for different situations.for different situations.

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Things to ConsiderThings to Consider

How effectively do you communicate FCOI How effectively do you communicate FCOI policy requirements to Investigators?policy requirements to Investigators?

Are forms clear and do they collect the Are forms clear and do they collect the correct information? correct information?

Are your policies and other documents Are your policies and other documents related to FCOI readily accessible? related to FCOI readily accessible?

Do you periodically review your policies Do you periodically review your policies and procedures to ensure that they are and procedures to ensure that they are current and operating as intended?current and operating as intended?

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ResourcesResources OER FCOI Web SiteOER FCOI Web Site

• http://grants.nih.gov/grants/policy/coi/http://grants.nih.gov/grants/policy/coi/

Frequently Asked QuestionsFrequently Asked Questions• http://grants.nih.gov/grants/policy/coifaq.htmhttp://grants.nih.gov/grants/policy/coifaq.htm

Web-based tutorialWeb-based tutorial• http://grants.nih.gov/grants/policy/coi/tutorial/fcoi.htm http://grants.nih.gov/grants/policy/coi/tutorial/fcoi.htm

Mailbox for inquiriesMailbox for inquiries• [email protected] [email protected]

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