FDA Takes Close Look at Experience Gained from Regulations Allowing Emergency Research With An Exception from Informed Consent Requirements
This federal regulation allows the conduct of research studies to test emergency treatments on patients with specific life-threatening medical conditions (head trauma, cardiac arrest, stroke) when patients cannot give informed consent because of their conditions, and family is not available to give provide consent either. Such emergency research has been allowed under very restricted circumstances since 1996 when FDA regulations went into effect providing for a narrow exception to the informed consent research requirements.