Q – If, for any reason, an English-speaking research participant is physically unable to sign a consent form (i.e., bandaged hands, loss of limbs, contact isolation, etc.), how should this individual’s consent to participate be documented?
A - The IRB will accept consent obtained in the following way as valid consent: The participant should be presented with a copy of the IRB-approved written consent document, the text should be read aloud by the person obtaining consent and the participant should be encouraged to ask questions and allowed to have questions answered, as is usual during a normal consent process. The participant would give consent verbally. The person obtaining consent and one other person (not associated with the study) would then sign and date the document. A complete and explicit description of why the participant was not able to sign the document should be included in the chart to provide a clear record of the event and the surrounding circumstances.
