Regulation & Compliance
Knowing and understanding the impact of research compliance and regulation.
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Frequently Asked Questions
What are some examples of a ‘significant element of a project’ when making determinations regarding a foreign component?
When making determinations about significance, the element of the project that is being conducted outside of the United States should be evaluated within the context of the project as a whole. 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
Does work being conducted in the United States ever count as a foreign component?
Generally, no.
I have a collaborator from another country who will work in my NIH-funded laboratory on my NIH project but receive no salary from my NIH grant. Is this considered a foreign component?
No, a “Foreign Component” exists only if the research activities occur outside of the United States.
I am the PI on an NIH grant to a domestic university. I have a visiting post-doctoral fellow in my lab, who works on my NIH grant and does all of his/her work in the United States. The fellow’s salary is paid by a foreign government. Is this a foreign component?
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, since all of the work is being conducted in the US, there would be no foreign component. However, this must be reported as Other Support. All in-kind resources, which includes visitors or employees who are paid directly by outside resources, should be disclosed as Other Support.
I am a PI on an NIH award to a domestic university. I will have a visiting fellow joining my lab whose salary will be supported by a foreign university. Do I need NIH prior approval before the fellow can work on my NIH funded research?
Since specific circumstances may vary, it would be best to discuss with NIH Program Officer.
What is an example of an activity that is not a foreign component, but would meet the definition of other support? What is the difference?
This is unique to each situation and depends upon specific details surrounding a particular 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.
A researcher at my institution has a 9-month appointment. S/he spends two months at a University outside of the United States during the summer conducting research under a foreign award. Does this count as Other Support?
Yes, this would be considered Other Support. 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.
What should I do if I’m not sure if something needs to be included as Other Support?
Err on the side of disclosure. Federal agencies require complete and accurate reporting of all sources of research support, financial interests and affiliations, both foreign and domestic. If you have any questions about whether something should be reported, please contact the Program Officer.
My research involves human subjects, how do I get approval?
Begin the process by reviewing the information on the Human Research Protections Programs’ website about how to submit a proposal through the online platform HS-ERA.
My research involves the use of animals, how do I get approval?
The Institutional Animal Care & Use Committee and the Office of Animal Welfare answer frequently asked questions, including the requirements for submitting a protocol to conduct animal research.