Applications with Foreign Components

Applications from foreign institutions, or applications from US-based institutions involving a foreign component, require additional information to be submitted prior to award, often as part of the Just-in-Time process.  Learn more about foreign components and how they are reviewed at NIH.

What are foreign components? 

NIH defines a “foreign component” as the performance of any significant element or segment of the project outside the United States either by the grantee or by a researcher employed by a foreign institution, whether or not grant funds are expended. Activities that would meet this definition could include: 

  • 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 
  • The involvement of human subjects/or animals. 
  • Extensive foreign travel by grantee project staff for the purpose of data collection, surveying, sampling, and similar activities (Note: Foreign travel for consultation is not considered a "foreign component"). 
  • Any activity that may impact on U.S. foreign policy through the involvement of grantee project staff in the affairs or environment of the foreign country. 

While awards directly to foreign/non-US-based institutions may not require additional explanation, NIH determines foreign components on a case by case basis.

Who determines what constitutes a foreign component? 

Your NINDS Program Officer and Grants Management Specialist review applications fully, including letters of support, to identify any otherwise undisclosed foreign components. Program staff then consider whether this work would meet the threshold for being considered an NIH-defined foreign component.  

What to submit if my application includes a foreign component? 

If your work is identified as including a foreign component, a NINDS staff member will reach out and request the following information: 

  • Foreign collaborators' name and email 
  • Foreign institution's name and full address
  • Estimated total cost, if any, of foreign collaboration or resources 
  • A description, in lay terms, of the scope and objectives of the research to be performed in the foreign country, or a description of the materials to be acquired (1-3 sentences)
  • A description of the activities that will be carried out at the foreign site (1-2 paragraphs) 

If the collaboration involves the use of human subjects, expect to submit: 

  • Demographics, such as age range or gender 
  • Number of subjects and how they will be recruited if known 
  • What participation will entail, (e.g., clinic visits, questionnaires, blood samples)
  • How long subjects will participate (e.g. one clinic visit a month for a year) 
  • Statement on protection of welfare of human subjects. This should describe informed consent and confidentiality procedures to be used. Applicants may use a general statement if suitable (e.g., “Informed consent for participation will be obtained from all human subjects and confidentiality of subjects will be protected, in compliance with NIH and in-country guidelines under the assurance number provided.”)

If the collaboration involves human subjects data or samples are pre-collected, expect to confirm: 

  • If data/samples were collected under another project 
  • If data/samples are not anonymous, state how confidentiality will be ensured 
  • If data/samples are anonymous, state that the study is not considered "human subjects research" because data/samples were previously collected and anonymous 

If animal subjects are involved, expect to submit: 

  • The species and how many will be used 
  • What will they be used for
  • An explanation of what will happen to the animals after the study ends

 

Budget Format Requirements 

All applications from non-US (foreign) institutions must use the detailed budget format, even when the modular format is available. 

NIH funds facilities and administrative (F&A) costs for grants to foreign organizations, as well as foreign consortiums of domestic grants, at a fixed rate of 8 percent of modified total direct costs (exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000). 

F&A costs are paid to support the costs of compliance with federal requirements. Some examples of NIH compliance requirements are included below.  

  • The protection of human subjects (including the required education in the protection of human research participants) 
  • Animal welfare 
  • Invention reporting 
  • Other post-award reporting requirements 
  • Financial conflict of interest  
  • Research misconduct investigations 

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