May 2008 What are requirements for including non-English speakers in a study? As required by The Department of Health and Human Services (DHHS) regulations (45 CFR 46.116 and 45 CFR 46.117) and FDA regulations (21 CFR 50.25 and 21 CFR 50.27): Unless written consent has been waived as a requirement for the study, the subjects who do not speak English must be provided with: - A written consent document in a language understandable to them AND
- A translator fluent in both English and the subject’s spoken language
Is there more than one type of written consent form for non-English speakers? Depending upon the research, the written consent document can be either: - a translation of the entire English version of the JHM IRB approved consent document OR
- a “short form” consent document stating that the elements of consent have been fully presented orally
When is a translation of the JHM IRB full English version consent form required? 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. Examples of situations that require a translated consent form: - Investigator is targeting a non-English speaking group
- Research will be done in a foreign country
- Investigator anticipates that more than a few subjects who speak the same non-English language will want to enroll in the study
Does the JHM IRB have to approve the translated version of the JHM IRB approved full English version consent form? Yes. Investigators must submit a translated version of the JHM IRB approved entire English informed consent document along with a Certificate of Translation. When should the investigator submit the translated version of the full English version consent form? The investigator may submit both the English version of the informed consent document and any translated informed consent documents needed for the study along with a Certificate of Translation. However, since any changes made by the JHM IRB to the submitted English version of the informed consent document must be included in the translation of the informed consent document, investigators are advised to have the translation completed after JHM IRB approval of the English version of the informed consent document. What are short forms? A short form is a written document stating that the elements of informed consent required by 45CFR46.116 have been presented to and are understood by the subject or the subject’s legally authorized representative. When can a short form be used? A short form may be used when the majority of study subjects are English speakers, but there may be an occasional subject who will not be able to understand the consent form written in English. A short form can be used in these instances to obtain consent ensuring equal access for potential participants. If the majority of the anticipated subjects to be enrolled do not speak English or will be unable to understand the consent form written in English, the consent form must be translated into a language understandable to the subjects. How do I use a short form? A short form may be used in conjunction with an oral presentation of the full English version consent form to the subject in his or her language (as required by 45CFR46.116). The study subject must receive a copy of the signed and dated short form consent and a copy of the signed and dated approved JHM IRB full English version consent form (signed by the witness and consent designee). The witness may be the translator. What are the required signatures with short forms? - Study subject must sign the short form consent.
- Witness must sign the short form consent and the approved JHM IRB full English version consent form.
- Consent designee must sign the approved JHM IRB full English version consent form.
HELPFUL HINT: Each person should sign the consent forms they understand. The non-English speaking subject signs the short form consent in their language. The consent designee signs the English version full consent. The witness understands both languages, so signs both. What must be approved by the IRB? - Justification of the use of short forms
- JHM IRB full version English consent form
Click here for the English version of the “short form” and the following approved translations of the “short form” (Arabic, Chinese, Haitian, Italian, Korean, Polish, Portuguese, Russian, Spanish, Vietnamese).
| 
