IRB, IEC, and FWA Requirements for Foreign Countries

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If you're applying from a foreign country, make sure you read Plan for Registering an IRB or IEC and Obtaining an FWA in our tutorial for information about submitting certification of institutional review board (IRB) or independent ethics committee (IEC) approval.

• The just-in-time submission policy described on the tutorial page applies to you.
• However, you should start the process as early as possible since approvals for foreign applications may take a long time.

Also, if you're applying from a country that has a national IRB or IEC, its approval process may be in addition to, or in lieu of, local IRB or IEC approval.

To prevent delays in your research, find out early on if IRB or IEC approval is required for each country associated with your proposed study, and if so, what's required for clearance. These rules and regulations are determined within each country.

Clear communication with all involved IRBs and IECs can facilitate the clearance process.

It may also benefit you to appear before each IRB or IEC in person to discuss issues and points of collaboration. If there are multiple levels of IRB or IEC review, you must send NIAID the full documentation from all the IRBs or IECs. Check with your program officer for advice.

If you have a domestic or foreign grant with foreign research sites, take note of the following:

• All foreign organizations engaged in clinical research funded by NIAID also need to hold a Federalwide Assurance (FWA) approved by the Office for Human Research Protections (OHRP) before NIH funds their research.
• For more information on obtaining an FWA, see the HHS Office for Human Research Protections.

On rare occasions, some collaborators may not be required to obtain their own FWA. To learn more about these special circumstances, see the following:

• Plan for Registering an IRB or IEC and Obtaining an FWA.
• OHRP's Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement.

For information about training requirements and foreign translations see Document Training in Research Conduct and Human Subjects Certifications: Training SOP.

Additional Resources

• Human Subjects Ceritifications: IRB or IEC SOP
• NIAID International Grants and Contracts section

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