Nondomestic components of rare disease organizations based in the United States and foreign organizations may serve as a partner, or stakeholder, on the application, as long as there is demonstrable benefit to the U.S. healthcare system and U.S. efforts in the area of patient-centered research can be shown clearly. However, the proposed study must demonstrate meaningful effort and involvement of U.S. organizations and investigators with pertinent expertise and experience to contribute to the project. The engagement plan for the proposed study should also adequately and sufficiently include U.S. patients and stakeholders and have clear relevance to the U.S. healthcare system.
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