Emergency Research

Planned Emergency Research

FDA regulations allow certain planned emergency research to be undertaken when the intervention or interaction will be used on subjects unable to provide consent because of the emergency situation. A novel mechanism called “community consultation” must be utilized to alert the relevant community of this planned research before the IRB can give final approval. The regulations require consultation with representatives of (and public disclosure to) the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation. The conditions required to conduct this type of research with exception from informed consent are described in 21 CFR 50.24. and detailed in USC Human Subjects Protection Program Policies and Procedures – Section 18.

FDA Guidance on Exceptions from Informed Consent

Emergency Use of a Test Article (Investigational Drug, Biologic or Device)

FDA regulations provide for use of a test article in a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval (21 CFR 56.104(c)).  Refer to USC HSPP Section 18

Individual Emergency Use of an Investigational Drug, Biologic

The emergency use of an unapproved investigational drug or biologic requires an IND. The need for an investigational drug or biologic may arise in an emergency situation that does not allow time for submission of an IND. In such a case, FDA may authorize shipment of the test article for treatment of an individual in advance of the IND submission. (21 CFR part 312, subpart I)

Individual Expanded Access Involving Investigational New Drug