Multiple recent NIH interactions have raised compliance concerns over two NIH policies that require your immediate attention.

  1. Foreign Component (Involvement):  Foreign collaborations involving NIH funding have always required prior approval. Recent congressional concern over the U.S. losing IP to foreign countries has led to a reminder announcement in May, recent close review of RPPR cited publications to confirm compliance and a special announcement by NIH Director Collins. While most PIs understand that the policy applies to sub-awards of federal $s for foreign performance of part of the work scope, the latest announcement has clarified that the policy also applies to foreign conduct of any of the work scope regardless of the source of funding. Based on program officer reviews recently received, such involvement also includes unfunded collaborations with a foreign entity or a foreign person, including visiting scholars, graduate students and fellows funded by their home country, exchanging material and/or data, or other use of foreign resources. The announcement in May stated:

NIH Policy: Foreign Components Added to a Grant to a Domestic or Foreign Organization

Adding a foreign component under a grant to a domestic or foreign organization requires NIH prior approval. For purposes of this policy, a foreign component is defined as 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 include the following:

  • The involvement of human subjects or vertebrate animals at a foreign site.
  • Extensive foreign travel by grantee project staff for the purpose of data collection, surveying, sampling, and similar activities.
  • Any activity of the grantee that may involve the population, environment, resources, or affairs of a foreign country.

Examples of other grant-related activities that may be significant are:

  • collaborations with investigators at a foreign site anticipated to result in co-authorship;
  • use of facilities or instrumentation at a foreign site; or
  • receipt of financial support or resources from a foreign entity.

A change in the performance site within a foreign country or the addition of a performance site in a country other than that specified in the approved application requires NIH awarding IC prior approval. The transfer of work by a domestic grantee to a foreign component also requires awarding IC prior approval.

  1. If you have such a foreign involvement with a current NIH or other federal award, prepare a letter explaining the relationship, you recent awareness of the clarified policy, and request approval from your program officer for the foreign involvement. Your ORA Grants Associate must countersign the letter before it is submitted.
  2. If you are proposing a new foreign component, mid-project, propose the new foreign involvement in your RPPR.
  3. If you are applying for a new or competitive renewal with foreign involvement, the applicable application instructions are located in part 6, posted at: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/research-forms-e.pdf

Prohibited Mention of Prior Review for New Replacement Applications:

If you are submitting a revised application that does not qualify as an A1 resubmission, you are prohibited from referring to the prior review and must present the application as a new application.  Recently a limited RFA application, submitted because the revised application was also unfunded, was rejected because the PI included reference to the prior review and priority score of the prior resubmitted application.

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