Yes. While the researcher is not receiving monetary compensation, the lab space, materials, and staff are resources made available to them in support of and/or related to their research efforts. Other payments, such as travel or living expenses must also be reported. As outlined in NOT-OD-19-114 this appointment must be reported as Other Support. NIH requires applicants to list all positions and scientific appointments both domestic and foreign held by senior/key personnel that are relevant to an application including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
Yes. Available resources in support of and/or related to an investigator’s research endeavors should be disclosed even if they relate to work that is performed outside of a researcher’s appointment period.
NIH takes the issue of protecting the integrity of U.S. biomedical research seriously. When issues of noncompliance are identified, NIH will take action as outlined in the NIH Grants Policy Statement, Section 8.5. This may include withdrawing approval of the Program Director/Principal Investigator or other researchers contributing to the NIH award, imposing specific award conditions, disallowing costs, withholding future awards including the possibility of suspending or terminating the award.
In the interest of full transparency, recipients should err on the side of disclosure. Researchers should consult with their institutional officials for guidance to ensure compliance with institutional and NIH policies. NIH requires complete and accurate reporting of all sources of research support, financial interests and affiliations, both foreign and domestic.
No, NIH has not changed the definition of a foreign component. NOT-OD-19-114reminds recipients that a foreign component is the performance of a significant scientific element of the NIH-supported project outside of the United States.Once a recipient determines that a portion of the project will be conducted outside of the U.S., the recipient then will need to determine if the activities are considered significant. If both criteria are met, then there is a foreign component.
The recipient institution should evaluate the element of the project that is being conducted outside of the United States within the context of the project as a whole when making determinations about significance. Some examples of activities that may be considered a significant element of the project include, but are not limited to:
- collaborations with investigators at a foreign site anticipated to result in co-authorship
- use of facilities or instrumentation at a foreign site
- receipt of financial support or resources from a foreign entity
NIH defines a foreign institution as an organization located in a country other than the United States and its territories that is subject to the laws of that country, regardless of the citizenship of the proposed PD/PI.
Generally, no. The first step in determining if an element or segment of an NIH-funded project constitutes a foreign component is to evaluate whether the work is being conducted in a foreign country. If not, then it is considered other support and must be reported. In all cases, recipients are encouraged to discuss specifics, in advance, with your Grants Management Officer regarding proper classification of Other Support and Foreign Components.
This response is dependent upon specific details that surrounding the activity. For instance, one model could be that a PI on an NIH grant may have an appointment and a lab at a foreign university. The research being done at the foreign lab is unrelated to the PI’s NIH project. This would not qualify as a foreign component of the NIH research, as the foreign work is not part of the NIH-funded project. However, it is a resource made available to the researcher in support of their research. Therefore, it must be reported as Other Support.
In general, no. The first step in determining whether research constitutes a foreign component is to evaluate whether a portion of the research is being conducted outside of the United States. In this case, all of the work is being conducted in the US, so there is no foreign component.
There has been no change to the FCOI policy. NOT-OD-19-114 serves as a reminder to the extramural community of the requirements that are outlined within 42 CFR Part 50, Subpart F, Objectivity of Research (the FCOI regulation), which specifies the requirements for investigators to disclose to their institution their significant financial interests. The requirement to disclose includes financial interests received from a foreign institution of higher education or the government of another country. This requirement is distinct from other support and foreign components.