What are WIRBs requirements for consent form signatures?
1. Subject Signatures The subject must sign and date the consent form [21 CFR 50.27(a); 45 CFR 46.117(a), ICH 4.8.8]. WIRB may waive this requirement, when appropriate, under 21 CFR 56.109(c) or 45 CFR 46.117(c)(2), or when consent is entirely waived under 21 CFR 50.23, 21 CFR 50.24, or 45 CFR 46.116(d). Please see the WIRB FAQ on the Waiver of Documentation of Consent and Waiver of Consent. 2. Signature of Person Who conducted the Informed Consent Discussion The person who conducts the informed consent discussion must sign and date the consent form (ICH 4.8.8). 3. Witness Signature WIRB does not require a witness signature on the consent form, except in rare cases or as required by state or local law. However, WIRB will include a witness signature block at the request of the investigator or the sponsor. Because WIRB does not require a witness signature, WIRB does not have written procedures identifying who may serve as a witness. The investigator or the sponsor should have written pro
