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.