DefinitionA financial conflict of interest exists when the recipient's designated official(s) reasonably determines that an investigator's significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
Summary of Current RegulationNIH requires recipient institutions and investigators (except Phase I SBIR/STTR applicants and recipients) to comply with the requirements of 42 CFR 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought" (FCOI Regulation), as implemented in the 2011 Final Rule for grants and cooperative agreements.
The requirements promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from any conflicting financial interest of an investigator. An "investigator" is someone:
- defined as the PD/PI and any other person, regardless of title or position
- who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding
- which may include, for example, collaborators or consultants.
These FCOI requirements do not apply to Federal employees or Federal agencies. Federal agencies have their own set of rules governing financial conflicts of interest for employees.
When submitting a grant application, the signature of the Authorized Organization Representative (AOR) certifies the applicant institution's compliance with the requirements of 42 CFR 50, Subpart F, including that:
- There is in effect at the Institution an up-to-date, written and enforced administrative process to identify and manage Financial Conflicts of Interest (FCOI) with respect to all research projects for which NIH funding is sought or received;
- The Institution shall promote and enforce Investigator compliance with the regulation's requirements including those pertaining to disclosure of Significant Financial Interests;
- The Institution shall identify and manage FCOIs and provide initial and ongoing FCOI reports to the NIH consistent with this subpart;
- When requested, the Institution will promptly make information available to the NIH/HHS relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of an FCOI;
- The Institution shall fully comply with the requirements of the regulation.
For full FCOI requirements, see the NIH Grants Policy Statement and the Final Rule.
Elements of an FCOI Report
The FCOI regulation requires institutions to submit the following information when reporting an FCOI:
Submitting an FCOI ReportReport FCOIs for grants and cooperative agreements through the eRA Commons FCOI Module. For contracts, contact the NIH Contracting Officer identified on the contract.
Learn how to submit a grant-related FCOI report through eRA Commons:
- About the FCOI module
- Who Can Access the FCOI Module?
- Initiating an FCOI Report
- Submitting FCOI Report to Agency
- Searching Existing FCOI Reports (Notifications)
- Revising a Submitted FCOI Report (Following a Retrospective Review Only)
- Agency Requests for Additional Information
- FCOI History
- Submitting FCOI Annual Reports
- When Will I Receive a Notification?
- eRA Commons FCOI module information page
- Types of FCOI Reports Summary Chart – (8/21/2012) – (MS Word) - Summary of different FCOI reports that can be submitted in the eRA Commons FCOI Module
- Instructions for submitting an FCOI Policy into eRA Commons IPF Module (10/1/2020) – (PDF) – This document provides the instructions for submitting the institution’s financial conflict of interest (FCOI) policy in the eRA Commons IPF Module per NIH Guide Notice NOT-OD-21-002 “Required Submission of Financial Conflict of Interest Policy into the eRA Commons Institution Profile (IPF) Module” dated 9/30/2020.
- FCOI Policy Development Checklist (4/24/2020) – (PDF) - An overview of the FCOI regulation to serve as a resource when developing, revising or reviewing an Institution’s FCOI policy to determine compliance with all regulatory requirements. [MS Word version - 37 KB]. Initially posted on 4/12/2012.
- FCOI Noncompliance Reporting Requirements Summary Chart – (8/21/2012) - (MS Word) - Summary of the reporting requirements when there is an instance of noncompliance with the FCOI regulation
- Financial Conflict of Interest Presentation with Case Studies (06/26/2012) - (PowerPoint - 13.4 MB) - These slides provide an overview of the Federal FCOI regulation provided at 42 CFR Part 50, Subpart F on Promoting Objectivity in Research that was presented at the NIH Regional Seminar in Washington, DC on June 22, 2012.
What NIH Grantees Need to Know About the 2011 Revised Financial Conflict of Interest Regulation:
Webinar, November 30, 2011, 2-3:30pm EST.
- NIH Guide Notices Related to Financial Conflict of Interest