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Changes to NIH Foreign Collaborations

If you run into an eRA Commons validation error around human subject study records, see instructions here.

Download a template Letter of Support for a foreign entity.

Overview of Changes for NIH Foreign Collaborations

The NIH will no longer allow award recipients to issue subawards to foreign entities under any prime award. Instead, activities by a foreign entity that performs a ‘significant scientific element’ to the project will be considered a ‘foreign component.’

Each foreign component proposed will be individually evaluated and, if awarded, will be direct funded via a linked RF2 award. This creates several major changes in the structure, application, and management of projects with foreign components. This does not affect domestic subawards on NIH awards, which JHU will continue to assess for risk, issue, and monitor.  This also does not affect other foreign activity that is not a ‘significant scientific element,’ such as foreign travel, consultants, or vendors.

Projects with a foreign entity performing a justifiable “significant scientific element” will require:

  • Proposals using the new PF5 (or UF5) mechanism, which will separate the project into domestic (research) and foreign components.
  • Submission as a “multi-component” project, following all M-MultiProject instructions
  • Individual Just-In-Time responses after the domestic and foreign components have been disaggregated and separately evaluated.
  • Each awarded component will be direct funded, via a PF5 to the domestic institution for the research component, and a linked RF2 to the foreign institution for the international component

The first Parent Announcement for a multi-component PF5/RF2 application has been released: PA-26-002. This opportunity opens for submission on April 25, 2026, with the first due date on May 25, 2026.

Considerations Prior to Proposal

All proposed foreign activities will require increased justification.

  • Why the foreign component cannot be led by a domestic entity
  • Why the foreign component scope of work is not considered a contractor or vendor (see Subrecipient vs Contractor Guide)
  • How the foreign component is beneficial to US public health
  • Any other foreign involvement, such as travel, contractors, or vendors

Foreign partners must complete additional registrations, some of which may take several months to complete.  All foreign organizations should begin these registrations now:

  • At time of submission: foreign organization must have (or have requested) a Unique Entity Identifier and provide an AO letter attesting to their willingness to complete further registrations.
  • At Just-In-Time: foreign organization must have completed their organizational registration in eRA Commons** (several weeks) and SAM.gov (several months).
  • At time of award: foreign organization must also have completed registration in grants.gov

The overall PD/PI must be from the domestic entity. Each foreign organization should identify a ‘Project Lead,’ who will become the PD/PI of their direct RF2 award. Because these personnel do not become a PD/PI until the components are disaggregated, they do not need to comply with PD/PI requirements until that time. If a Multi-PD/PI structure is used, and a foreign personnel is a PD/PI at the time of the PF5 submission, then substantial changes are required:

  • Both the Multi-Project and Multi-PD/PI instruction call outs must be followed
  • A Multi-PD/PI leadership plan will be required on the overall component (in addition to the dispute resolution plan that is required in the overall component research plan on all projects).
  • **While all foreign collaborators must have an organizational eRA account with an AO assigned and personnel affiliated by Just-In-Time, this requirement changes to time of submission if they are a co-PD/PI on the entire PF5 project.

If planning to submit an NIH proposal with a foreign component, coordinate early with your representatives from the Research Development Team or RASP (JHURA & ORA).

Submitting a PF5 Multi-Component Proposal

Submissions must use the Multi-Component instructions. The requirements for attachments, area of focus, and page limits change between the required and optional components.

Components of the PF5 Multi-Component Proposal

wdt_ID wdt_created_by wdt_created_at wdt_last_edited_by wdt_last_edited_at Overall Component Research Component Foreign Component(s)
1 aschaff6 02/03/2026 08:05 PM aschaff6 02/03/2026 08:05 PM Focus on collaboration and integration. Identify PD/PI for whole project. Budget total only. Research strategy is 12 pg, include dispute resolution Focus on domestic entity, identify project leads and resources. Include R&R budget. Research strategy is 12 pgs, TECHNICAL MERIT Focus on foreign entity, identify project leads and resources. Include R&R budget. Research strategy is 6 pgs, limit to foreign scope.
2 aschaff6 02/03/2026 08:05 PM aschaff6 02/03/2026 08:05 PM

Both the research and international components will have their own R&R budgets. These funds should remain entirely independent and only be reported jointly on the Overall Component SF-424. For direct costs on the research component, continue to use the JHU negotiated rates, and continue to include the first $25,000 of each domestic subaward in the indirect base. This budget also includes any other foreign activities, such as foreign travel, consultants, or vendors, with standard IDC rates applied.

For direct costs on each foreign component, add 8% indirect costs for compliance. Do not claim any JHU indirect costs on any amount of any foreign component budget.

Considerations for Evaluation and Just-In-Time Requests

The submitted PF5 will be disaggregated. Any component may or may not be funded. When evaluation of individual foreign components, researchers will focus on the use of unique resources and the advancement of US public health.

Individual Just-In-Time requests will be made to each institution. For domestic organizations, there are no changes to the types of JIT requests expected. For foreign organizations, the full organizational registrations in SAM.gov and eRA Commons must be complete to be issued a direct NIIH award. Additionally, all personnel who are listed as project lead in the international component must have their eRA Commons account affiliated with the foreign organization, to be assigned the PD/PI role of the linked RF2 award.

Considerations for Awards and Award Management

Upon award, each institution will be responsible for complying with the terms of their NOA, with may differ from other components within the overall project. Each institutions will also be responsible for their own financial management and reporting.

We are waiting on guidance regarding RPPRs in particular; some information has been released in NOT-OD-25-155

 

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Email: jhura@jhu.eduSend an email to jhura@jhu.edu

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