If English is not the potential subject’s primary language, the consent form should be translated into the appropriate language. The oral explanation accompanying the form must also be in the potential subject’s native language. The investigator or the member of the research team responsible for negotiating the consent must be present to answer questions. The policy in most medical centers is that the oral translation of the oral presentation of information should be done by an individual who is impartial to the subject (e.g., family members are not acceptable) and the research, so as to avoid the filtering of information. Most hospitals have an approved list of translators for various languages.
However, if it is not possible to translate the consent form, then a translated short-form consent document including the elements of informed consent (as approved by the IRB) should be presented to the subject by a translator. The subject will then sign the short-form consent document. The signature must be witnessed (the translator may be the witness). A copy of the summary (in the subject’s native language) and the short-form consent are then provided to the subject. More information is available in the Third Party as Witnesses section of this module.