Planned emergency research is a type of research that is conducted in an emergency, life-threatening setting “where the emergency circumstances require prompt action and generally provide insufficient time and opportunity to locate and obtain consent from each participant’s legally authorized representative” FDA Guidance, 2013.
Please note that planned emergency research is not the same as a one-time emergency use of a test article. Planned emergency research involves the prospective identification and enrollment of participants into a study. Emergency use of an investigational drug or device involves treating a patient with the investigational product outside of a research setting. See SOP 502-G: Emergency Use of a FDA Regulated Product for more information about one-time emergency use.
Investigators are urged to review the FDA Regulations, FDA Guidance, and local resources linked below before initiating or preparing to submit a planned emergency research study with EFIC. Investigators should also call (405-271-2045) or email (firstname.lastname@example.org) to request a consultation meeting to discuss EFIC requirements prior to submitting an application packet to the IRB.
Additional information is available below. Links to resources are located in the left sidebar and throughout this page.