September 16, 2022
NOT-OD-21-073 - Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021
NOT-OD-21-110 - Implementation of Changes to the Biographical Sketch and Other Support Format Page
NOT-OD-21-002 - Required Submission of Financial Conflict of Interest Policy into the eRA Commons Institution Profile (IPF) Module
NOT-OD-18-160 - Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests
NATIONAL INSTITUTES OF HEALTH (NIH)
Purpose:
The purpose of this Guide Notice is two fold: (1) to remind the NIH extramural research community about the longstanding requirements provided in the financial conflict of interest (FCOI) regulation at 42 CFR Part 50 Subpart F, Promoting Objectivity in Research (FCOI regulation for grants and cooperative agreements). This requirement also is included in the NIH Grants Policy Statement (NIH GPS), Section 4.1.10, Financial Conflict of Interest, and serves as a term and condition of NIH grant awards. This Notice reminds the extramural applicants and recipient institutions of the requirements to develop a FCOI policy, to post it on their website and submit it to NIH, to ensure Investigator disclosure of both foreign and domestic Significant Financial Interests(SFI), to review Investigator SFIs, to determine if there is a FCOI that must be reported to NIH, and to train Investigators on FCOI requirements; and (2) to remind the NIH extramural research community of the requirement to submit complete and accurate Other Support information (NOT-OD-21-073) (NOT-OD-21-110).
REMINDERS
FCOI REQUIREMENTS: NIH-funded institutions are required to understand, implement, and comply with the FCOI requirements; furthermore, recipients must recognize that there are different Investigator disclosure requirements for foreign financial interests (see details below). All FCOI requirements serve as a term and condition of all NIH awards which means that compliance with the requirements is a condition of funding. An institution’s failure to comply with FCOI requirements may cause NIH to do one or more of the following: delay the issuance of awards, impose specific award conditions, or take enforcement actions to remedy non-compliance.
Throughout this Guide Notice, the term Investigator is used as defined by the FCOI regulation. The regulation defines Investigator as the project director or principal Investigator 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, which may include, for example, collaborators or consultants.
The information in this Guide Notice is representative of FCOI regulatory requirements as noted but is not meant to be comprehensive. Institutions should consult the regulation referenced above to identify all requirements to ensure compliance.
APPLICABILITY OF THE FCOI REGULATION: The FCOI regulation applies to institutions of all types, including domestic and foreign, that apply for or receive NIH research funding in the form of NIH grants or cooperative agreements. The regulation also applies to individuals who plan to participate in or that participate in NIH-funded research that meet the regulatory definition of Investigator and to subrecipient institutions and Investigators as defined above. (See: FCOI NIH FAQs).
The FCOI regulation applies to all NIH grant and cooperative agreement awards, including Phase II Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) applications or awards, conference grants (i.e., H13, R13, T14, and U13), resource grants, and training grants, among others. The FCOI regulation, however, does not apply to Phase I SBIR/STTR applications and awards. (See: FCOI NIH FAQs).
We would like to emphasize that NIH-funded conference grants are subject to FCOI requirements. In accordance with the NIH GPS, Section 14.6, Public Policy Requirements and Objectives, Support of Scientific Meetings (Conference Grants), conference grants are subject to public policy requirements, which includes FCOI (See 4.1.10, Financial Conflict of Interest, Public Policy Requirements and Objectives).
OVERVIEW OF FCOI REQUIREMENTS: Investigators must disclose their SFIs (See FCOI NIH FAQs), and those of their spouse and dependent children, that reasonably appear to be related to the Investigator’s institutional responsibilities. Institutions are required to review each disclosed SFI to determine (1) if the SFI is related to the 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) if the SFI could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. If the institution finds that an SFI meets both criteria, the SFI is an FCOI that must be managed and reported to NIH. FCOI reports, including FCOI reports of subrecipient Investigators, must be submitted to NIH prior to the expenditure of funds and within 60 days of any subsequently identified FCOI. FCOI reports are submitted by the recipient’s FCOI Signing Official via the eRA Commons FCOI Module.
INVESTIGATOR TRAINING ON FCOI: At times, institutions need to be reminded that they, and subrecipients, must provide FCOI training to each Investigator. The regulation requires Investigators to be trained prior to engaging in NIH-funded research and at least every four years, and immediately under the designated circumstances:
- Institutional FCOI policies change in a manner that affects Investigator requirements
- An Investigator is new to an Institution
- An Institution finds that an Investigator is not in compliance with the Institution’s FCOI policy or management plan
Institutions are encouraged to utilize resources available on NIH’s Grants and Funding FCOI Web page found at Financial Conflict of Interest | grants.nih.gov to satisfy those training requirements related to the Federal regulation. However, Institutions must also provide additional training regarding the Institution’s FCOI policy and the Investigator’s responsibilities for disclosure of SFIs per the institution’s FCOI policy. (See NIH FCOI FAQs for more information).
DISCLOSURE OF FOREIGN AND DOMESTIC SIGNIFICANT FINANCIAL INTERESTS PER FCOI REGULATION AND NIH GUIDANCE: Investigators are required to disclose all foreign and domestic SFIs that are related to the Investigator’s institutional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on FCOI, which may include for example activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
NIH reminded the community of long-standing guidance in NIH Guide Notice NOT-OD-18-160 that 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). Therefore, Institutions are strongly encouraged to review their FCOI policy and make any necessary changes to ensure Investigators fully understand their disclosure responsibility. See NIH FCOI FAQs.
As with all Investigator SFI disclosures, the institution’s designated official(s) must review each disclosure to determine if an Investigator’s SFI(s) is an FCOI, as discussed above.
FCOI POLICY REQUIREMENTS AND SUBMISSION OF FCOI POLICY TO NIH: Each institution that is subject to the FCOI regulation is also required to maintain an updated, written, enforced policy on FCOI that complies with the regulation. Institutions must make the policy available via their respective publicly accessible website.
On September 30, 2020, NIH issued a Guide Notice NOT-OD-21-002, Required Submission of Financial Conflict of Interest Policy into the eRA Commons Institution Profile (IPF) Module (IPF Module). NIH funded institutions are required to submit their publicly accessible FCOI policy to NIH via the eRA Commons IPF Module . A PDF of the FCOI policy must be submitted by the institutional signing official (SO). The information is provided on an institutional level as part of an institution’s IPF, rather than on a grant-specific level, so it is not necessary to submit the FCOI policy with each grant application.
Institutions may utilize the FCOI Policy Development Checklist to develop, revise, or review an Institution’s FCOI policy to determine compliance with the FCOI regulation. The checklist, FAQs, presentations, and many other resources, are posted on NIH’s Grants and Funding FCOI webpage at https://grants.nih.gov/grants/policy/coi/index.htm.
OTHER SUPPORT DISCLOSURE REQUIREMENTS: Institutions are reminded that information submitted to the NIH on other support for identified senior/key personnel under NIH’s Just-in-Time Procedures or in Progress Reports must include all resources made available to senior/key personnel in support of and/or related to all 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, which includes resources and/or financial support from all foreign and domestic entities. As noted in NOT-OD-21-073 NIH requires supporting documentation, which includes copies of contracts, grants or any other agreement specific to senior/key personnel foreign appointments and/or employment with a foreign institution for all foreign activities and resources that are reported in Other Support. If the contracts, grants, or other agreements are not in English, recipients must provide translated copies.
In an effort to remind the community of where to disclose and report on other support and FCOI requirements, NIH has provided a NIH Disclosures Table to outline, by activity, what is andwhat is not required to be disclosed.
FCOI inquiries may be submitted to:
Division of Grants Compliance and Oversight
Office of Policy for Extramural Research Administration, OER
Email: FCOICompliance@mail.nih.gov
Other Support disclosure policy inquiries may be submitted to:
Division of Grants Policy
Office of Policy for Extramural Research Administration, OER
Email: GrantsPolicy@od.nih.gov
and Human Services (HHS)
