Regulation & Compliance
Knowing and understanding the impact of research compliance and regulation.
Top Resources for Regulation & Compliance
Frequently Asked Questions
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.
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.
I received an honorary Membership at a foreign Academy of Sciences. Do I have to disclose it?
Yes, all such affiliations must be disclosed in your biosketch submitted as part of a grant application.
As part of a collaboration effort with a colleague at a foreign institution, we are submitting a joint application for funding to a foreign entity. Does this need to be disclosed in my federal grant applications?
Please consult with the Office of Research Services regarding the internal approval process. In addition, you must disclose all such applications in your “Current and Pending” or “Other Support” page.