Reminders About Financial Conflicts of Interest and Other Support

A recent study from the HHS Office of Inspector General (OIG) affirmed that NIH  grant recipients play a key role in protecting the integrity and security of U.S. biomedical research, in part through requiring Investigators to disclose all of their significant financial interests and all sources of their other support. As noted by the OIG, failures by some recipients to disclose substantial contributions of resources from foreign entities (including foreign governments) have raised concerns about threats to the integrity of NIH-supported research. In response to the OIG recommendations, we are reminding grant applicants and recipients again today of NIH’s Financial Conflict of Interest (FCOI) and Other Support grant requirements.

Today we released NOT-OD-22-210 that provides important reminders about the FCOI regulation and Other Support policy requirements. We encourage all those involved in the NIH grants process to review this information carefully to ensure compliance.

Financial Conflict of Interest (FCOI) 

The FCOI regulation (42 CFR Part 50 Subpart F) applies to all foreign and domestic NIH grants and cooperative agreements (applications and awards), excluding Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR). The FCOI regulation also applies to subrecipient institutions and their investigators.

Investigator Disclosure

Investigators, as defined by regulation, are required to completely and accurately disclose all foreign and domestic significant financial interests (SFIs)  (and those of the investigator’s spouse and dependent children) that are related to the investigator’s institutional responsibilities (professional responsibilities the investigator performs on behalf of the organization such as research, research consultation, teaching, clinical) and that are received from or held in an entity outside the institution.  Investigators must disclose their SFIs to their institution by the time an application is submitted to the NIH for funding, within thirty days of discovering or acquiring a new SFI, and on an annual basis.

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 received from any foreign entity, including Institutions of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country).  Required disclosures include income from seminars, lectures, or teaching engagements, and income from service on advisory committees or review panels. However, investigators are not required to disclose these same interests when they are domestic.

Institutional Responsibilities

• Maintain an up-to-date, written, and enforced policy on FCOI that complies with the FCOI regulation that is posted on a publicly accessible Web site.
• Upload and submit a PDF copy of the FCOI policy to the NIH via the eRA Commons Institution Profile Module (see the NIH Grants Policy Statement, Section 4.1.10, Financial Conflicts of Interest).
• Train investigators on the requirements of the FCOI regulation, the institution’s FCOI policy, and their disclosure responsibilities . The NIH FCOI webpage includes a training module that satisfies the portion of the training requirement related to the Federal regulation.
• Designate at least one  official to review each investigator SFI disclosure to determine if it  is (1) related to the NIH-funded research and (2) an FCOI.  When FCOIs are identified, institutions are required to develop a management plan, monitor investigator compliance, and report the identified FCOI to the NIH via the eRA Commons FCOI Module. FCOI reports are due prior to the expenditure of funds under a new award or within 60 days of identifying an FCOI during the period of an award.

Other Support

Other Support is required for all individuals designated in an application as senior/key personnel and includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes but is not limited to:

• Resources and/or financial support from all foreign and domestic entities, that are available to the researcher. This includes but is not limited to, financial support for laboratory personnel, and provision of high-value materials that are not freely available (e.g., biologics, chemical, model systems, technology, etc.).
• Consulting agreements, when the PD/PI or other senior/key personnel will be conducting research as part of the consulting activities. Non-research consulting activities are not Other Support.
• In-kind contributions, e.g. office/laboratory space, equipment, supplies, or employees or students supported by an outside source. If the time commitment or dollar value of the in-kind contribution is not readily ascertainable, the recipient must provide reasonable estimates.
• For Other Support submissions that include foreign activities and resources, recipients are required to submit copies of contracts, grants, or any other agreement specific to senior/key personnel foreign appointments and/or employment with a foreign institution as supporting documentation. If they are not in English, recipients must provide translated copies.

In light of the OIG’s findings and recommendations, we hope you find these reminders helpful.

Additional Resources of Interest:

• Sections 4.1.10 and 2.5.1 of the NIH Grants Policy Statement
• FAQs (which are updated regularly)
• NIH Disclosures Table
• NIH All About Grants podcast on FCOI