Foreign collaborations involving NIH funding have always required prior approval. But in in its Notice Regarding Policies on Other Support and FCOI (NOT-OD-19-114) – July 2019 the NIH clarified that the policy also applies to foreign conduct of any of the work scope regardless of the source of funding.

A foreign component as performance of any significant element or segment of the project outside the United States either by the grantee or by a researcher employed by a foreign institution, whether or not grant funds are expended. -   Activities that would meet this definition include the following: o   Research involving human subjects or vertebrate animals at a foreign site o   Extensive foreign travel by UMass Chan project staff for the purpose of data collection, surveying, sampling, and similar activities. o   Any activity of the grantee that may involve the population, environment, resources, or affairs of a foreign country. -   Examples of other grant‐related activities that may be significant are: o   Unfunded collaborations with a foreign entity or a foreign person, including visiting scholars, graduate students and fellows funded by their home country, o   Exchanging material and/or data developed with NIH funding with foreign collaborators o   Use of facilities or instrumentation at a foreign site; or o   Receipt of financial support or resources from a foreign entity. A change in the performance site within a foreign country or the addition of a performance site in a country other than that specified in the approved application also requires NIH prior approval, as does the transfer of work by a domestic grantee to a foreign entity.

Principal Investigators must identify and disclose all Foreign Components through progress reports and final technical reports. While we focus on NIH, sponsors have varying requirements for disclosure of Foreign Components, so it is important to understand each sponsor's proposal instructions before submission. Contact Office of Sponsored Programs with questions.

1.  Areas to Watch For

• Formal collaborations should be documented via a Memorandum of Understanding and/or a project-specific research collaboration.
• Informal collaborations with international researchers could meet the NIH definition of a Foreign Component; therefore, it will not always be apparent to the Office of Sponsored Programs when a foreign component arises.
• A joint publication with a foreign collaborator is not considered a Foreign Component if the research was performed in the US, even if the publication occurs after the international collaborator returns home.
• An activity that does not rise to the level of a Foreign Component still must be reported as Other Support.

2.  Completing a Foreign Project Registration

The PI for any project with Foreign Component must complete a Foreign Project Registration form upon indication of funding (at Just in Time or at least 60 days prior to any expenditure of funding) to ensure proper compliance and alignment of internal support. FPRs are initially reviewed by the Director of International Support Services and, as necessary, by appropriate members of the International Engagements Working Group.

During the proposal development process you are encouraged to reach out to International Support Services with questions concerning compliance and risk considerations in the locations where research activities are to be conducted.

Refer to the table entitled “Examples of What to Disclose to NIH about Senior/Key Personnel on Applications and Awards” for the most recent guidance. https://grants.nih.gov/policy/protecting-innovation.htm