Research Participants who have Limited Reading or English Language Skills
Potential participants who are English-speaking but unable to read should not be excluded from research on the grounds of illiteracy. Potential participants who do not speak or understand English should not be excluded from resarch on the grounds of being an English Learner. If a subject is unable to read, an impartial witness should be present during the entire informed consent discussion. The following steps are recommended for ensuring informed consent.
- All written information including the informed consent document is read and explained to the subject or the subject’s legally acceptable representative in the native language.
- Oral consent for the subject’s participation in the study is provided by the subject or the subject’s legally acceptable representative.
- The subject (if capable of doing so) signs and dates the informed consent document; OR the legally acceptable representative (if capable of doing so) signs and dates the informed consent document. The witness signs and personally dates the informed consent document.
- A copy of the consent form is given to the participant
By signing the informed consent document, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject’s legally acceptable representative. The witness signature also documents that informed consent was freely given by the subject or the subject’s legally acceptable representative.
An alternative to the sometimes lengthy Informed Consent form is available on the Request for Review Forms page of this website.
