If non-English speaking participants are to be routinely included in a study, the approved English consent form must be translated into the appropriate language by an IRB-approved translator, and approved by the IRB. A member of the study team who is fluent in both English and the second language must obtain consent from these individuals, and must be available to communicate with them during the course of their participation.
If an investigator needs to consent a single person who is unable to read or understand written English, per 45CFR46.117(b)(2) , a short form written consent document and an oral presentation of the elements of consent may be used to consent these individuals. The short form essentially states that the elements of informed consent required by the Federal regulations at 45.CFR46.116 have been presented orally to the subject or the subject’s legally authorized representative. Any use of this procedure, as well as the written summary of what will be presented to the subject or the subject’s representative, must be approved by the IRB. The summary is usually the study consent form, which must be explained to the subject so that you can be sure that he or she understands.
- There must be a witness to the oral presentation, who can attest to the subject’s understanding of the presentation.
- The witness must sign both the short form and a copy of the summary.
- The subject or the subject’s representative, signs only the short form.
- The person obtaining consent must sign a copy of the summary.
- A copy of the summary, and a copy of the short form are given to the subject or the subject’s representative.