Informed Consent in Foreign Countries

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The requirements and customs for documenting informed consent vary widely among cultures. The IRB cannot exempt projects conducted in foreign countries from the consent requirements, but it can waive the requirement for written documentation of consent, understanding that in some settings, the process of signing the form is very intimidating and may be riskier than the research itself.

 

Researchers planning to conduct research in another country should justify their proposed method of documenting consent. The justification should include a description of local customs if they constrain the typical informed consent process. Participants in foreign sites should be given local contacts for any questions they may have about the research or about their rights.