NIH Collaborative International Research Project (Parent PF5 Clinical Trial Optional)

The National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services, has issued the "NIH Collaborative International Research Project (Parent PF5 Clinical Trial Optional)" funding opportunity (PA-26-002) to support formal research collaborations between U.S.-based institutions and foreign organizations. The NIH comprises numerous Institutes and Centers (ICs), all of which are participating in this opportunity and whose individual missions span the biomedical, behavioral, and social sciences. The overarching purpose of this opportunity is to strengthen international scientific partnerships while enhancing the rigor, relevance, and innovation of NIH-funded research through coordinated global collaboration. This opportunity offers a unique funding mechanism, the PF5 grant type, which allows a domestic organization to serve as the prime awardee, with separate, linked awards (RF2) issued to foreign organizations. This structure enables NIH to track international funding and enhance its oversight capacity. The funding is explicitly intended for international research partnerships that include at least one foreign subproject—projects that merely involve foreign consultants or vendors are ineligible. The international component must leverage talent, data, or environmental conditions that are otherwise unavailable or limited in the U.S., thereby contributing significantly to the NIH mission of improving human health. Applications under this opportunity must follow a multi-component structure, including: (1) an Overall component outlining the global coordination strategy and goals of the collaborative research; (2) at least one domestic Research Project component; and (3) at least one International Project component, with its own defined scope of work and budget. Optional components include shared cores and Institutional Career Development and Training elements for more complex programs. Clinical trials are permitted but not required. The NIH requires each application to follow strict formatting and submission requirements. Applications must be submitted electronically through either NIH's ASSIST system or a system-to-system solution integrated with Grants.gov. Key documents include a Data Management and Sharing Plan (DMS), detailed budget justifications, performance site location forms, and biosketches for key personnel. Letters of support from foreign collaborators' authorized officials are mandatory and must confirm readiness to act as award recipients if selected. The NIH will evaluate applications based on significance, innovation, approach, investigator qualifications, and the added value of international collaboration. Key dates include the initial open date of April 25, 2026. Thereafter, applications follow NIH standard due dates (e.g., May 25, September 25, January 25 annually through 2029), with awards typically announced 9–10 months after the submission deadline. The opportunity supports both new and resubmission applications, with budgets tailored to project needs (no cap, but must be justified). Project periods may extend up to five years for non-clinical trials and seven years for clinical trials. Foreign organizations involved must complete all required federal registrations, including UEI, SAM.gov, and eRA Commons, prior to award issuance. The evaluation and award process involves peer review by NIH study sections and advisory councils. Each application will be assessed as a whole, but international components will also be reviewed independently for merit and feasibility. If an application is funded, the international component(s) will be disaggregated and assigned unique NIH grant numbers, managed as standalone awards to the foreign institutions. NIH reserves the right to fund all, some, or none of the components of a PF5 application.

Include a clearly defined international scope of work and dispute resolution plan; confirm foreign entity registration early; follow NIH application formatting exactly to avoid delays.