Obtaining and Documenting Informed Consent of Subjects who do not Speak English
The Belmont Principle of Justice calls for “…fair procedures and outcomes in the selection of research subjects.” Accordingly, federal regulations require the consent document to be presented in language that is understandable to the subject and in most situations, that informed consent be documented in writing.
Options for meeting these requirements when enrolling subjects who do not speak English are:
- Written translation of the IRB approved English consent document
Subjects who do not speak English should be presented with a consent document written in language understandable to them. The WFH IRB strongly encourages use of this procedure whenever possible. IRB approval is required prior to using a translated consent form.
- Short Form consent process
Alternatively, the IRB may permit an oral presentation of consent document information along with a “short form” consent document written in a language understandable to the subject when:
- The Investigator is not targeting a non-English speaking population; and
- Only a few subjects are anticipated to speak the same non-English language
If more than an occasional subject speaking the same non-English language will be enrolled in a study, then a fully translated consent form is required.
What is a short form?
A short form is a written document stating that the elements of informed consent required by 45 CFR 46.116 have been presented to and understood by the subject or the subject's legally authorized representative.
Do I need IRB approval to use a short form?
Yes. The IRB may approve use of a WFH short form as part of initial review or as an expedited amendment. The Investigator must justify use of the short form.
Where can I find the WFH short forms?
Links are provided below. Please contact the IRB Office if you need the English version translated into a different language.
How do I use the short form?
45 CFR 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.
The witness should be fluent in both English and the language of the subject. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.
At the time of consent, (i) the short form document should be signed by the subject or subject’s legally authorized representative and the witness; (ii) the summary (i.e., the IRB approved English language consent document) should be signed by the person obtaining consent as authorized under the protocol and the witness.
See OHRP guidance for additional information.