Notice Number: NOT-OD-18-160
Release Date: March 30, 2018
National Institutes of Health (NIH)
The purpose of this Guide Notice is to remind the NIH extramural research community that the requirements of 42 CFR Part 50, Subpart F, Objectivity of Research, apply to each institution, domestic and foreign, that applies for or receives NIH research funding in the form of grants or cooperative agreements. The regulation, also known as the Financial Conflict of Interest (FCOI) regulation, applies to both prime and subrecipient institutions, domestic or foreign, and through implementation, to each Investigator who is planning to participate in, or is participating in, such research. These regulations do not, however, apply to Phase I Small Business Innovative Research and Small Business Technology Transfer applications or awards.
The purpose of the regulation is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of NIH-funded research is free from bias resulting from Investigator financial conflicts of interest. Therefore, it is critical that there is a clear understanding of the applicability of these regulatory requirements. Equally important is that the regulation is a term and condition of all NIH grant and cooperative agreement awards, which means that compliance with the requirements is a condition of funding.
One such area of the FCOI regulation requiring clarity is Investigator disclosures with respect to foreign financial interests. The regulation refers to exclusions of Institutions of higher education as defined in 20 U.S.C. 1001(a) or a federal, state or local government agency when disclosing financial interests. However, these references refer to a U.S. Institution of higher education or a federal, state, or local government agency within the U.S. Therefore, Investigators, including subrecipient Investigators, must disclose all financial interests received from a foreign Institution of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country).
For further information about the Financial Conflict of Interest regulations, please see NIH’s Financial Conflict of Interest website, which includes links to the full regulation and extensive FAQs as well as other resources.
Please direct all inquiries to:
Division of Grants Compliance and Oversight
Office of Policy for Extramural Research Administration, OER