IRBs continue to have the responsibility to review and approve informed consent
documents. 21 CFR § 56.109(b). The waivers to documentation of informed consent
regarding certain studies still apply. 21 CFR § 56.109(c)(1). Even if documentation is
waived under 21 CFR § 56.109(c)(1), the trial participant still provides consent and the
statement is required during the oral presentation of the research and/or in the written
statement regarding the research, if required by the IRB under 21 CFR § 56.109(d).
Under 21 CFR §§ 50.23 and 50.24 regarding exceptions to informed consent, the
statement is also required in the informed consent documents if these trials are applicable
clinical trials.
