What is a waiver of consent and what criteria must my study meet if I request one?
For FDA regulated studies, waiver of consent must meet requirements of either 21 CFR 50.23 (a) – (c) (waiver of consent for individual emergency use) or 21 CFR 50.24 (emergency research without consent). For individual emergency waivers of consent, prospective IRB approval is not always necessary if a patient’s life can be saved. Please refer to 21 CFR 50.23 (a)-(c) or call Client Services. If you are requesting a waiver of consent and the research is not an FDA regulated study, then criteria from 45 CFR 46.116(d) must be met. WIRB applies this standard to all requests for waiver of consent for non-FDA regulated research.
