Informed consent process are to be conducted in “language understandable to the subject.” How should this requirement be addressed for research that will, or unexpectedly might, include subjects who don’t speak English well?
Investigators who expect their studies to enroll non-English speakers should develop a consent process for this population. This would include describing in the protocol and new submission form whether an interpreter will be used during the consent process and throughout the rest of the study. Investigators should also provide translated copies of the full consent form and any other materials the subjects will see during the consent process. (Note: Please wait until the English versions are approved before getting them translated.) When submitting the translated version, please include a description of the translator’s qualifications and a certification that the document is an accurate translation.
The Arkansas patient population also means investigators may also unexpectedly encounter a non-English-speaking potential subject. In these cases, the study team must get IRB approval to enroll that subject. Because a translated consent form typically won’t be available, the “short form” of consent documentation may be approved. The study team must submit to the IRB a description of the entire consent process, including a description of how they will ensure the consent process and any continuing communication are in a language understandable to the subject. Please also provide a copy of the short form consent document you will use. A Spanish version is available on the IRB’s website. Any short form must have a signature and date lines for the subject or legally authorized representative and for a witness. The witness must be conversant in both English and the language of the subject or LAR, and must be present for the entire oral presentation of the consent. The study team must also have a written document summarizing what was presented orally — the approved English-language consent form can serve this function. The summary must have signature and date lines for the person obtaining consent and the witness (note the subject/LAR is NOT required to sign the summary.) The subject must be given a copy of the signed short form and the signed summary.
Note that IRB approval must be obtained before a short form consent process is used. If you have a subject sitting there in front of you and want to start the consent process as soon as possible, please submit a modification form and then call the IRB office to let someone there know you need quick approval. We can help you get the required approval if we know about the pending modification.
While regulations do not currently require reconsent of a “short form” subject on a translated consent form, such a practice should be undertaken whenever practicable, i.e. the study involves multiple subject contacts over a relatively long period of time, long enough for you to get the consent form translated. An added bonus is that the next time a non-English-speaking subject comes in, you’ll already have a translated consent form ready to go (assuming subsequent subjects speak the same foreign language your first one did). Please remember to get that translated version approved by the IRB before using it to consent subjects.
IRB policy 15.4 pertaining to consenting non-English speakers is available on the IRB’s website. Other information from the federal Office for Human Research Protections can be found here (yes, it’s really from 1995, but it’s what we’ve got). And here’s the FDA guidance that includes information about non-English-speaking subjects (from 1998). Last but not least is a draft FDA guidance that updates language about non-English-speaking subjects. Keep in mind that this is only a draft guidance and has not yet been finalized. But we note that it greatly expands the discussion of non-English-speaking subjects, and includes mention of having the English consent form translated and using it to reconsent subjects.