FDA's Information Sheets state that "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. 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 witness signature is also required when using the "short form" written consent document. [21 CFR 50.27 and 45 CFR 46.117]
So, what exactly is the role of the witness? "The witness is required to attest to the adequacy of the informed consent process and to the subject's voluntary consent. Therefore, the witness must be present during the entire consent interview, not just for signing the documents."
GCP Guidance (ICH E6 4.6.9) also provides guidance regarding requirements for a witness' signature:
- By signing the consent form, 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 authorized representative.
- The witness must be impartial.
- The witness dates his/her signature.
NOTE: In addition to federal regulations for obtaining witness signatures for consent forms, it is imporatnt to also check with state and local laws prior to obtaining consent from witnesses for prospective participants.