Since 1996, when new US federal regulations required researchers and institutional review boards (IRBs) to obtain exceptions from standard informed consent for studies involving patients with emergency or life-threatening conditions, IRBs have been reluctant to approve such research, causing a limited number of such studies to be conducted. But new recommendations that offer a template to help IRBs and researchers designing trials meet these regulations may help remedy this situation.
Mitka M. Aiding Emergency Research Aim of Report on Exceptions to Informed Consent. JAMA. 2007;298(22):2608-2609. doi:10.1001/jama.298.22.2608