Financial Conflict of Interest

The HHS regulation 42 CFR Part 50 Subpart F, Promoting Objectivity in Research (FCOI regulation), establishes standards that provide a reasonable expectation that the design, conduct, or reporting of NIH-funded research (grants and cooperative agreements) will be free from bias resulting from any Investigator’s conflicting financial interest. NIH requires recipient institutions and their investigators (except Phase I SBIR/STTR applicants and recipients) to fully comply with all FCOI requirements. If the Institution carries out the NIH-funded research through a subrecipient (e.g., subcontractors or consortium members), the Institution must take reasonable steps to ensure that any subrecipient Investigator complies with FCOI requirements. The Final Rule, including the Preamble to the Final Rule, was published in the Federal Register, Vol. 76, No. 165 on August 25, 2011.

Key Definitions

Investigator

The PD/PI and any other person, regardless of title or position who is responsible for the design, conduct, or reporting of NIH-funded research, or proposed for such funding, and which may include for example, collaborators or consultants. Includes investigators who plan to participate in or who participate in NIH-funded research.

FCOI

A financial conflict of interest exists when the institution's designated official(s) reasonably determines that an investigator's significant financial interest (SFI) could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. The institution is required to review each Investigator SFI disclosure to determine if a SFI:

1. is related to the NIH-supported research (i.e., could the SFI be affected by the research or is the SFI in an entity whose financial interest could be affected by the research), and
2. could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.

Significant Financial Interest

See FCOI regulatory definition of SFI including NIH’s FAQs D.8., E.9. and E.20.

Highlights of the FCOI Regulation

When submitting a grant application or receiving a grant as a result of an application, the signature of the Authorized Organization Representative (AOR) certifies the applicant institution's full compliance with all of the requirements of the FCOI regulation, including:

1. Existence of institutional policy and process. There is in effect at the Institution an up-to-date, written and enforced administrative process and policy to identify and manage FCOI for all NIH-funded grants and cooperative agreements, excluding Phase I SBIR/STTR applications and awards.
2. Accessibility of institutional policy and submission to NIH. Institutions must post their FCOI policy on their publicly accessible Web site and must submit their FCOI policy to the NIH via the eRA Commons Institution Profile (IPF) Module.
3. Institutional training of investigators. The Institution must train their Investigators (and ensure subrecipient Investigators are trained) about the FCOI regulation, the Institution’s policy, and the Investigator’s responsibility to fully disclose all domestic and foreign SFIs (and those of their spouse and dependent children) that are related to their institutional responsibilities. Refer to NIH’s FCOI Training website for training resources institutions may use to train Institutional officials and Investigators about the FCOI regulation, including other FCOI-related topic areas.
4. Investigator disclosures. Investigators must disclose all domestic and foreign SFIs that are related to the Investigator’s institutional responsibilities (i.e., professional responsibilities on behalf of the institution, such as research, research consultation, teaching, professional practice, etc.) that are received from and/or held in an entity outside the institution. Note: institutional policies may provide a threshold for investigator disclosure related to certain types of SFIs (see FAQs E.9. and E.20.).
   • Disclosures of foreign financial interests. It is important to note that disclosure of foreign financial interests differs from disclosure of domestic financial interests. Investigators, including subrecipient Investigators, must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or foreign governments (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).
5. Institutions determine FCOIs. The institution’s designated official(s) is required to review each Investigator SFI disclosure to determine if a SFI (e.g., remuneration, equity interest, royalties, or reimbursed or sponsored travel) is related to NIH-funded research and, if so related, whether the SFI is a FCOI by utilizing, at a minimum, the regulatory criteria at 42 CFR 50.604(f) as noted below:
   • An Investigator’s SFI is related to NIH-funded research when the Institution’s designated official(s) determines the SFI:
     • could be affected by the research or 
     • is in an entity whose financial interest could be affected by the research.
   • An Investigator’s SFI is a FCOI when the designated official(s) reasonably determines the SFI could directly and significantly (i.e., have a material effect on the research) affect the design, conduct, or reporting of the NIH-funded research. 
6. Management and reporting of FCOIs. When the institution determines that an FCOI exits, the Institution must report to the NIH awarding Institute or Center through the submission of an initial (Original) and annual FCOI report using the eRA Commons FCOI Module. The institution must also manage the identified FCOI.
7. Maintenance of records. The Institution must maintain records of and, when requested, will promptly make information available to the NIH 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.