Preparing Your Protocol for International Research
When research is conducted outside the United States, additional protocol information is needed to describe the international research setting, local oversight, and NIH's role. This guidance outlines the information that should be included in the protocol or, if appropriate, a protocol supplement (e.g., an NIH protocol addendum) submitted to the NIH IRB. If a protocol supplement is used, it should also be submitted to the local IRB/Research Ethics Committee (REC) for review.
When research is conducted outside the United States, additional protocol information is needed to describe the international research setting, local oversight, and NIH's role. This guidance outlines the information that should be included in the protocol or, if appropriate, a protocol supplement (e.g., an NIH protocol addendum) submitted to the NIH IRB. If a protocol supplement is used, it should also be submitted to the local IRB/Research Ethics Committee (REC) for review.
Describe NIH's Role
- Whether NIH serves as the sponsor and/or coordinating center.
- Any NIH-specific research procedures that differ from those conducted at the international research site(s).
- NIH-specific privacy and confidentiality protections.
Describe Each International Research Site
- Official site name and physical location.
- Name of the in-country Principal Investigator or Lead Site Investigator.
- Institutional affiliation or employer of the site investigator.
- Federalwide Assurance (FWA) number for each participating foreign institution, when applicable.
Describe Local IRB/Research Ethics Committee (REC) Review
The NIH IRB generally cannot issue final approval until the required local review documentation has been received.
- Name of the local IRB/REC responsible for ethical review.
- IRB registration number and IRB Organization (IORG) number, when applicable.
- Documentation of local IRB/REC approval.
- If a local IRB/REC is not available, provide a written cultural and regulatory assessment prepared by an independent expert.
Describe the Local Research Context
- Rationale for conducting the research in the host country.
- Description of the local study population, including legal age of consent, decision-making capacity standards, legally authorized representative requirements, informed consent process, languages, and vulnerable populations, as applicable.
- Applicable local laws, regulations, and cultural norms that may affect the conduct of the research.
- Any additional in-country approvals required before research activities begin.
Additional Requirements for FDA-Regulated Studies
- If investigational drugs, biologics, nutritional products, or devices will be shipped from the United States to an international research site, provide written documentation confirming that all required local approvals for use of the investigational product have been obtained.
- Consult the Clinical Center Office of Research Support and Compliance (ORSC) regarding shipment requirements.