The IRB has posted updated versions of IRB Policy 15.1, Elements of Informed Consent, and of Policy 15.3, Waivers of Signed Informed Consent Documents and Waivers of Informed Consent Elements.
Policy 15.1 has been revised to make the mandated reporter statements required only “when applicable.” The language about reporting of infectious disease results has always been an “an applicable” statement. However, now the language indicating suspected abuse must be reported to authorities is only required “when applicable.” The suggested language about reporting suspected abuse and neglect has also been revised to better reflect legal requirements.
Policy 15.3 has been updated with language clarifying that the FDA now allows waivers of informed consent in certain circumstances.