Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English

Department of Health and Human Services (DHHS) regulations for the protection of human subjects require that informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing (45 CFR §46.116 and §46.117).

Where informed consent is documented in accordance with §46.117(b)(1), the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent. Subjects who do not speak English should be presented with a consent document written in a language understandable to them. DHHS strongly encourages the use of this procedure whenever possible.

Alternatively, §46.117(b)(2) permits oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary.

When this procedure is used with subjects who do not speak English, (i) the oral presentation and the short form written document (see below) should be in a language understandable to the subject; (ii) the IRB-approved English language informed consent document may serve as the summary; and (iii) the witness should be fluent in both English and the language of the subject.

At the time of consent, (i) the short form document should be signed by the subject (or the subject's legally authorized representative); (ii) the summary (i.e., the English language informed consent document) should be signed by the person obtaining consent as authorized under the protocol; and (iii) the short form document and the summary should be signed by the witness. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.

The IRB must receive all foreign language versions of the short form document as a condition of approval under the provisions of §46.117(b)(2). Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.