Consent Process for Illiterate Research Participants
Version date: January 7, 2013
Under federal regulations, when a potential research subject cannot read a consent form an alternate consent process must be followed. When a potential research subject is illiterate the regulations allow for the presentation to the potential subject of a short form written consent document that states the required elements of informed consent have been presented orally to the subject or the subject's legally authorized representative and witness to the oral presentation is required. The witness can be a family member, friend, patient advocate, or someone independent of the research team.
When a potential subject is illiterate, the research teams have two options to meet the federal and institutional requirements for informed consent:
- If the consent form that will be used for any subject that would be enrolled is fewer than 5 pages long, the document can be read to the potential research subject who is illiterate along with any applicable HIPAA authorization form. Both the subject (or the subject's representative) and witness must sign the consent form.
- If the consent form is longer than 5 pages, the research team must prepare a written summary of the study, which includes all of the required elements of consent, that will be read to the potential research subject (or research subject's representative) along with any applicable HIPAA authorization form. Both the subject (or subject's representative) and witness must sign either the study summary or a short form to document an oral consent process should be used in these situations. An example of a study summary that contains the required elements of informed consent and a short form to document the oral consent process are available on the Health Sciences IRBs' website.
The IRB is required to approve a written summary of what is to be said to the subject or the representative to ensure all of the required elements are presented.
It is recommended for the presentation of the consent form as well as the consent process can be audiotaped and a copy of the tape or disc of this conversation can then be provided to the potential subject for review and reference. The fact that the consent form was presented orally to the subject should be documented in the research record.