What do I do if a subject understands English but cannot read or write?

A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document, when consistent with applicable state law.

A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means. If:

• the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and
• is able to indicate approval or disapproval to study entry, they may be entered into the study.

The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consent interview is recommended.  From FDA IRB Information Sheets

Legally blind or illiterate subjects

If subjects who cannot read the consent materials due to illiteracy, blindness, or the subject’s surrogate is legally blind, the following consent process is recommended:

• Have an impartial witness observe the consent process, such as a subject advocate or someone not affiliated with the research team.  Family members are not recommended to serve as witnesses.
• The consent forms should be presented to potential subjects orally and the potential subject.  You may wish to provide the subject with an audiotape of the discussion for their reference. 
• If potential subjects have access to equipment that can read the consent document for them, provide them sufficient time to review the consent document independently of the research team.
• As would be expected for any consent process, ensure sufficient time is allowed for questions to be asked by the potential subject, subject’s surrogate to ensure that the consent process was clear and effective.
• Add a statement to the consent form that the subject was unable to read the consent form and that they were read to the subject by a member of the research team designated to obtain informed consent.
• The subject signs and dates the consent form, if capable of doing so.  In the case that informed consent is being obtained from the subject’s surrogate the surrogate will instead sign and date the form.
• The witness signs and dates the consent form. A statement should precede the witness’ signature that attests that the consent information was explained and that the subject apparently understood the information, and informed consent was given freely.