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Regulation & Compliance

Knowing and understanding the impact of research compliance and regulation.

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Frequently Asked Questions

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.

Do all federal agencies have defined foreign components?

No, the concept of “Foreign Component” is specific to NIH.

What is the NIH definition of a foreign institution?

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 Program Director/Principal Investigator.

What is a foreign component?

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.

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.

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