Regulation & Compliance
Knowing and understanding the impact of research compliance and regulation.
Top Resources for Regulation & Compliance
Frequently Asked Questions
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.
How do I know who has been officially designated, since I am not allowed to share applications with someone who has not been officially designated to participate in the peer review meeting?
Officially-designated members include appointed members, temporary ad hoc members, the Scientific Review Officer, and NIH staff with a need to know. Applications, proposals, and confidential meeting materials cannot be shared with anyone who is not a member of the study section where those documents and information are being reviewed
I have been invited to present at an international conference in a country that is on the U.S. sanctions list. Can I do this?
Presenting at an international conference in a U.S. sanctioned country may be viewed as providing a prohibited “service” under U.S. sanctions regulations. You should consult with the Office of Export Compliance prior to presenting to determine if a license is required (please note a license is required even when giving a virtual presentation).
Generally, any presentation to an international audience should be limited to the following:
• information that is already published;
• information already in the public domain; and/or
• information consistent with that conveyed by instruction in catalog courses and associated teaching laboratories at U.S. institutions of higher education.
Please visit Engaging with Sanctioned and Embargoed Countries for more information.
I am collaborating with a colleague abroad and would like to send some data to my collaborator. What should I do?
Depending on the nature of the data and the related technology, exchange of data with foreign collaborators may require a license. Please contact the Office of Export Compliance who can review the data and the country of the collaborator to determine whether there are any restrictions, or if a license is required.
A Data Use Agreement may also be needed to facilitate the transfer of data to a collaborator. Please reach out to the Office of Research Services for additional assistance with Data Use Agreements.
I plan to host a webinar/web conference on my research to be shared internationally. What do I need to know?
Information released at an open conference, meeting or webinar is considered published and excluded from certain controls. “Open” means that all technically qualified members of the public are eligible to attend, and attendees are permitted to take notes or otherwise make a personal record (not necessarily a recording) of the proceedings and presentations. An “open” conference can charge a registration fee reasonably related to cost, and can limit actual attendance, as long as attendees either are the first who have applied or are selected on the basis of relevant scientific or technical competence, experience, or responsibility. However, certain sensitive information cannot be shared via open conference or webinar. Evaluation is case-specific. Thus, it is recommended that you contact the Office of Export Compliance to review your circumstances.
How do I transfer equipment out of the United States?
An export license may be required to ship or hand-carry items or equipment out of the U.S. The need for a license is dependent upon the nature of the equipment, as well as the end-use, recipient, and destination of the equipment. Additionally, even temporary export of equipment to some locations may incur customs tax obligations. Due to complexities of the requirements you should consult the Office of Export Compliance for assistance regarding shipping or traveling with equipment internationally.