Preparing Informed Consent for International Research

• NIH investigators are engaged in human subjects research conducted outside the United States.
• NIH's role determines the extent of its involvement in developing and reviewing informed consent documents.

The approach to informed consent depends on NIH's role in the research.

• If NIH interacts directly with participants: Develop consent documents that meet U.S. regulatory requirements while remaining culturally and linguistically appropriate for the local population, with input from the local institution.
• If NIH serves as the coordinating center: Local research sites should generally develop consent documents using their own templates. NIH may provide a model template when appropriate.
• If NIH receives identifiable data for analysis: Consent documents should clearly describe data sharing, confidentiality protections, and applicable U.S. regulatory requirements. Local research sites should generally develop the consent documents.

• Use the local institution's consent template whenever available.
• Do not use NIH consent templates developed for U.S.-based participants.
• Use plain language appropriate for the local population.
• Consider literacy, health literacy, and local terminology.
• Translate the consent document into the appropriate local language and obtain required certifications.
• Describe culturally appropriate consent procedures in the protocol.
• Include NIH Privacy Act language only when identifiable data will be stored in a Privacy Act system of records.
• Submit translated consent documents to the NIH IRB for review and approval.

• Include a Key Information section at the beginning.
• Include all required Common Rule elements, as applicable.
• Include FDA-required consent elements when applicable.
• For certain minimal-risk FDA-regulated studies, waiver or alteration of consent requirements may be permitted, when applicabl

• Document consent by signature or other approved method unless documentation has been waived.
• Align documentation procedures with local practices, when appropriat

• Use the local site's consent format.
• Prepare consent materials appropriate for the local population.
• The local consent process should be described in the protocol.
• Ensure all required regulatory elements are included.
• Submit translated consent documents and required certifications for NIH IRB review.

• Use the local site's consent template whenever available.
• Tailor the consent document and process to the local language, culture, and participant population.
• Ensure the consent document meets applicable U.S. regulatory requirements.
• Obtain NIH IRB review and approval before use.