21.5(a) General Principles
Individual subjects and sometimes significant portions of the subject population, may not comprehend the spoken English language or read and comprehend documents, such as those for informed consent, that are written in English. If possible, such individuals should not be excluded from research that may have potential benefits. If they are to be included, their ability to engage in the consent process and make informed decisions about participation in research and its risks and benefits must be protected. To accomplish this, informed consent documents should be presented to prospective subjects in a manner and language that they can understand. The same is true for other research related documents such as interviews or surveys.
NOTE – The IRB may, at its discretion, approve translated versions of documents, questionnaires or other materials published in peer reviewed journals or materials previously approved by the UM IRB.
To determine what consent documents should be used for individuals considered by investigators to be potential subject, the following policies apply:
1) If, in the view of the investigator, a potential subject can read and comprehend English at what may reasonably be considered to be at a sixth grade level or higher, the written consent form may be in English
2) If a potential subject cannot read English but can read another language, any written consent that is obtained should be in that alternative language. Any amendments or addenda to the consent form must also be in that language
3) If a potential subject cannot read English but he/she fully comprehends spoken English, the consent form may be read to the subject in English. The subject's ability to understand English should be noted in writing, and signatures of the subject, the person who obtains consent, and a witness should be obtained
4) If a potential subject cannot read either English or the available alternative language, and does not fully comprehend spoken English but does fully comprehend the alternative language when spoken, the consent form that has been translated into the alternative language should be read to the subject. The subject's ability to understand the alternative language should be noted in writing, and the signatures of the subject, the person who obtains consent, and a witness should be obtained
Exceptions to the above policies may be made in situations when:
1) A subject requires rapid entry into a study for his/her well-being but the study does not have a consent form fully translated in writing to the subject's language
2) Investigators are uncertain whether non-English speaking subjects might be enrolled in a study, or believe that the majority of subjects are English speakers and that there might be only a small number of subjects (less than five) who will not understand English.
3) A waiver of written consent has been approved by the IRB In this case, consent must be obtained verbally from all participants in whichever language was understood
4) A waiver of consent (written and verbal) has been approved by the IRB
In situation 1 and 2 (above), regulations [45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2)] permit the use of a short form in the subject's language together with a summary document in English. The "short form" consent document may be generic but it must affirm that the required elements of informed consent have been presented orally to the subject or the subject's legally authorized representative and that a witness fluent in both English and the subject's language was present to observe the process. When the person obtaining informed consent is assisted by a translator, the translator may serve as the witness.
The research subject or the legally authorized representative must sign only the short form. The witness must sign the short form and the IRB-approved written summary; and the person obtaining consent must sign the summary. A sample short form written document is provided on the OHRP website (NOTE –To access, click on http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm).
All foreign language versions of the complete form or the short form must be approved by the IRB in advance of their use. IRB approval of the "short form" may be by expedited review of the IRB Chair or designee, if the study and the full English language informed consent document and the English version of the short form document have already been approved by the IRB. The IRB Chair or designee may, if appropriate, defer review of the "short form" to the convened IRB.
Investigators obtaining consent within the short form process must orally present all elements of informed consent outlined in the IRB approved consent form to the subject. This presentation may be directly to the subject if the investigator speaks the same language as the subject or may be presented through an interpreter who shall convey the information to the subject. Subjects shall be given a copy of the full English consent (or summary) along with the short form in the subject's own language.