Non-English Speakers and Informed Consent
For the anticipated enrollment of non-English speaking subjects:
- When an investigator anticipates enrolling non-English-speaking subjects, the protocol must reflect the methods for assuring full understanding, possibly with the assistance of an interpreter or by using translated Informed Consenting Document(s).
- If the investigator intends to use a translated version of the Informed Consent Document(s), the IRB must review and approve the translated version(s) prior to use. The credentials of the person who did the translation must be provided to the IRB.
For unanticipated enrollment (i.e. a non-English speaking subject is unexpectedly encountered):
- If a non-English speaking subject is unexpectedly encountered, investigators will not have a written translation of the consent document and must rely on oral translation.
- If investigators enroll subjects without an IRB approved written translation, a "short form" written consent document, in a language the subject understands, should be used to document that the elements of informed consent were presented orally.
- The short form states that the elements of informed consent required by the regulations have been presented orally to the subject or the subject's legally authorized representative.
- When this method is used, there must be a witness to the oral presentation. The witness should be fluent in both English and the subject’s language. The translator may serve as the witness.
- The IRB must approve a written summary of what is to be said to the subject (if the standard Informed Consent Document is presented orally, this requirement has been met).
- The subject or subject’s representative must sign and date the short form.
- The witness must sign and date both the short form and a copy of the full (English version) Informed Consent Document.
- The investigator who obtains consent must sign and date the full (English version) Informed Consent Document.
- A copy of both the short form and the full (English version) Informed Consent Document must be given to the subject or the representative.
The Human Subjects Office has developed a “short form” consent document for Spanish-speaking subjects. This form has been IRB-approved and may be used on an “as-needed” basis provided no changes are made.
If another language is needed, the investigator should use the English version, have it translated, and submit it for IRB approval prior to its use. A copy of the English version of this short form is on the next page. The Spanish version is located on our website.