International Research

Requirements for human subjects research vary across countries. When local requirements are not clearly defined, conduct research in accordance with widely accepted ethical principles, including the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report.

What It Is:

Cultural competence in international research means understanding the social, cultural, linguistic, political, and healthcare context of the research setting. Integrating this knowledge helps ensure effective communication, appropriate recruitment, and respectful collaboration throughout the study.

Why It Matters:

Engaging with local collaborators during study planning to understand the regulatory, cultural, and practical considerations that may affect your research.

• Planning ahead can help avoid delays in IRB review and study implementation.
• Engage local collaborators and community partners early in study planning.
• Adapt recruitment, consent, and study materials to the local language, culture, and literacy level.
• Maintain communication with local partners throughout the study and, when appropriate, share study results with the community.

• If NIH investigators are engaged in non-exempt human subjects research conducted outside the United States, NIH IRB review is required.
• NIH investigators are engaged when they obtain data through intervention or interaction, identifiable private information or biospecimens, or informed consent for research purposes.

• The NIH IRB reviews international research for compliance with applicable U.S. regulations and NIH policy.
• The international institution must hold an active Federalwide Assurance (FWA) and the local IRB/REC must be registered with the Office for Human Research Protections (OHRP)
• International research typically requires review by both the NIH IRB and a local IRB/REC.
• Local IRB/REC approval is generally required before the NIH IRB can issue final approval.
• If a local IRB/REC is unavailable, provide documentation of an appropriate cultural or regulatory assessment.
• Local IRBs/RECs oversee compliance with local laws and the activities of local investigators.
• The NIH Single IRB policy does not apply to institutions located outside the United States.

• Follow applicable U.S. regulations, NIH policies, and host-country requirements.
• Obtain all required local approvals before initiating research activities.
• Follow applicable FDA requirements, when appropriate.
• If U.S. and local requirements differ, follow the more restrictive requirement unless doing so conflicts with U.S. law or NIH policy.

• Include all NIH- and site-specific information required for research conducted outside the United States.
• Address the local research context, including the research setting, participant population, and applicable local laws, regulations, and cultural considerations.
• Document the required local IRB/Research Ethics Committee approvals and institutional information for each international research site.

• Use the local site's consent template whenever available.
• Tailor the consent process and document to the local language, culture, and participant population.
• Include all required U.S. and host-country regulatory elements.

• Protocol (and protocol supplement, if applicable).
• Local IRB/Research Ethics Committee approval documentation.
• Research materials used by NIH, including translations of informed consent forms, originally prepared in a local language.
• FDA-related documentation, when applicable.

• Maintain compliance with applicable U.S. regulations, NIH policies, and host-country requirements.
• Maintain current NIH IRB and local IRB/REC approvals.
• Submit local IRB/REC continuing review approvals, modification approvals, and other required oversight documentation to the NIH IRB, as applicable.
• Report protocol changes, reportable events, and other required information in accordance with NIH IRB requirements.
• Ensure the international institution’s FWA and IRB/REC’s registration remain active.

• Additional requirements apply when investigational products or biospecimens will be shipped internationally.
• Obtain all required local approvals before shipment.
• Comply with FDA regulations, NIH requirements, and applicable local laws.
• Confirm there are no restrictions on importing or exporting biospecimens.
• Complete the NIH Biological Materials Shipping Training Course before shipping biological materials internationally.
• For questions about shipping investigational products, contact the Office of Research Support and Compliance (ORSC).

ClinRegs
ClinRegs serves as a central resource and time-saver for investigators involved in planning and implementing international clinical research. It is maintained by NIAID and is an online database of country-specific, clinical research regulatory information.

International Compilation of Human Research Standards
The DHHS Office for Human Research Protections publishes the International Compilation of Human Research Standards annually which can be used to aid research teams in identifying applicable international regulations and guidelines.