New FDA Guidance on Exception from Informed Consent

April 5, 2011

The FDA issued an updated Guidance for Institutional Review Boards and Investigators about Exception from Informed Consent.  The new Guidance is a question and answer format that describes the current interpretations of the federal regulations (50.24 (21 CFR 50.24)). The federal regulations were written in 1996 and have not changed.  This Guidance represents the ongoing, cooperative effort between the community, investigators and regulators to understand how best to accomplish research in emergency settings, while respecting the autonomy and rights of individuals.