Yes, in addition to your School specific requirements, you must disclose all such affiliations in your biosketch submitted as part of a grant application.
Yes, all such affiliations must be disclosed in your biosketch submitted as part of a grant application.
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.
Yes, this appointment must be reported as Other Support. While monetary compensation is not received, the lab space, materials, and staff are resources provided in support of and/or related to the research efforts. Other payments, such as travel or living expenses must also be reported. NIH, NSF, and DoD require applicants to list all positions and scientific appointments, both domestic and foreign, that are held by senior/key personnel. This includes affiliations with foreign entities or governments, such as titled academic, professional, or institutional appointments, whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
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.
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.
NIH takes the issue of protecting the integrity of U.S. biomedical research seriously. If noncompliance is identified, potential action by NIH may include withdrawing approval of the Program Director/Principal Investigator or other researchers contributing to the NIH award, imposing specific award conditions, disallowing costs, withholding future awards including the possibility of suspending or terminating the award, per NIH Grants Policy Statement, Section 8.5.
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.
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.
It depends on the nature of the collaboration and the underlying activities. Specific authorization in the form of a license from the U.S. government may be required. It may be possible to secure a license to allow for such a collaboration in certain limited circumstances (e.g. when the reason for the individual or entity’s inclusion on the list is unrelated to the proposed collaboration). However, the license must be secured before any such collaboration is initiated and any restrictions outlined in the license must be strictly followed. Please contact the Office of Export Compliance for assistance.
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.
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.
The addition a new foreign component requires prior NIH approval.
No, the concept of “Foreign Component” is specific to NIH.
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.
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.
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
Generally, no
No, a “Foreign Component” exists only if the research activities occur outside of the United States.
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.
Since specific circumstances may vary, it would be best to discuss with NIH Program Officer.
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.
There has been no change to the FCOI policy. Investigators are still required to disclose to their significant financial interests to their institution. This includes financial interests received from a foreign institution of higher education or the government of another country. This requirement is distinct from other support and foreign components.
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.
If NIH determines that you committed a bona fide breach of confidentiality in the peer review process, they could contact you and your institution, and ask you to step down from an appointed term of service on a study section. Depending on the severity of the breach, the NIH may refer the matter to the NIH Office of Management Assessment and possibly to the Office of the Inspector General in the Department of Health and Human Services, which could result in further administrative actions such as debarment or even criminal penalties. If the matter is referred to these authorities, the NIH would be unlikely to contact you or your institution first, as it now involves possible criminal violations.
Information about possible breaches of confidentiality come to the NIH in numerous ways. Often, an applicant will report that data, figures or text from his or her grant application appears in a publication authored by a reviewer on the panel where the application was reviewed. Additionally, this may also constitute research misconduct in the form of plagiarism.
NIH sometimes learn about breaches of confidentiality from other reviewers, colleagues and students of reviewers, or even members of the media. NIH also has internal controls to monitor access to NIH computer systems
