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Federal regulations at 45 CFR 46.116 and 117 and 21 CFR 50.20 & 27, require that the information given to the potential subject [or the subject’s legally authorized representative (LAR)] during the consent process is presented in a language understandable to the subject; and, except in specific circumstances, informed consent shall be documented by the use of a written consent form. If the study population includes non-English speaking individuals, the informed consent document must be translated into a language understandable to them. If an investigator plans to enroll primarily English speaking individuals, but encounters a potentially eligible non-English speaking individual, the regulations at 45 CFR 46.117(b)(2) permit the use of a short form consent document (Short Form) to obtain written consent. A Short Form is a consent document written in a language understandable to a non-English speaking individual (or his/her LAR). It summarizes the required elements of informed consent outlined in the federal regulations but it does not contain specific study information. Therefore, it is used in conjunction with an oral presentation of the IRB-approved English version of the Informed Consent Document (ICD), in a language understandable to the potential subject.
- The research team encounters a prospective research participant who does not speak English
- The IRB has not approved an informed consent document (ICD) translated into the potential participant’s language
- The research team does not have adequate time to have the ICD translated into the potential subject’s language, reviewed and approved by the IRB before enrolling the subject