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• Investigators should be aware of additional ethical and cultural considerations when conducting international research.
• International research involving NIH investigators should be conducted under US federal laws and regulations (45 CFR 46 and, as applicable, 21 CFR) and any local laws and regulations.
• In-country approval by the local IRB (often referred to as the in-country Ethics Committee (EC)) is required before a protocol will be granted approval by the NIH IRB. (When the NIH IRB is the Reviewing IRB, and when there is no in-country IRB/EC, the NIH IRB will require a written assessment of the research for its consistency with foreign country laws and regulations, or local customs and culture, by an individual with appropriate expertise in the foreign country’s culture, who is independent of the research team.)
• The level of NIH IRB review of a study is determined by the engagement of the NIH Investigators.

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• Human subjects research conducted by NIH investigators is subject to federal law, regulation and NIH policy, regardless of whether the research is conducted domestically or internationally. Research may not be conducted by NIH investigators in any foreign country that is contrary to any U.S. Government prohibitions or restrictions on conducting research in that country.
• When conducting non-exempt human subjects research in a foreign country, NIH investigators must comply with all applicable in-country laws and regulations.
• If U.S. law, regulation, or policy (including NIH policy) differs from the foreign requirements, the most restrictive approach should be used - so long as it is not contrary to U.S. law or policy.
• For additional information, please refer to Policy 700, International Research. You can also refer to the OHSRP document, Guideline for International Research-Protocol Document,  and the OHSRP Guideline for International Research-Consent Document both of which can be found in the series 700 section of the Policy and Guidelines webpage.
• 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.
• ClinRegs is a website maintained by NIAID that is an online database of country-specific, clinical research regulatory information. ClinRegs serves as a central resource and time-saver for investigators involved in planning and implementing international clinical research.
• Research teams are also encouraged to collaborate closely with local experts to ensure local requirements are adequately addressed.

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• Non-exempt human subjects research conducted or supported by the NIH IRP in a foreign country must be consistent with NIH's Department of Health and Human Services (HHS) Federalwide Assurance (FWA).
• This means that non-exempt human subjects research conducted in a foreign country with a foreign institution must be with an institution that holds an active FWA and the research must be reviewed by an IRB/Ethics Committee (EC) registered with the HHS Office for Human Research Protections (OHRP) and that, in its review, the local IRB/EC must apply US regulations for the protection of human subjects at 45 CFR 46. Any exception to this policy statement requires a compelling justification and must be approved in advance by the NIH Institutional Official (IO).  
• You can look up the FWA and status of a local IRB or Ethic Committee in the Office for Human Research Protections Database for Registered IORGs & IRBs and Approved FWAs.

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