Language Barriers

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Researchers are responsible for ensuring that the participants understand all the elements of voluntary informed consent. All the documents used in obtaining this consent for non-English-speaking participants must be provided to the IRB in both English and the language of the participants.

 

If a non-English-speaking participant is enrolled unexpectedly, researchers may rely on an oral translation of the English language form (and other documents), but should take extra care in the informed consent process to ensure that the participant has understood the project. A statement in the study records must indicate that the translation took place, identify the translator, and document the translator's belief that the participant understands the study and the consent process.

 

Sometimes a participant understands English but does not read or write English. Here an impartial witness should document that the participant understands the study and the consent process and has consented to participate.