Although FDA regulations require that clinical investigations of test articles (investigational drug, device, or biologic) be reviewed and approved by the IRB before they are conducted, the regulations provide for an exception of this rule in the case of an emergency. This type of exception can be made for emergency use of an investigational drug or device on a one-time, one patient basis only, per institution.
Please note that an Emergency Use exemption do NOT apply to Emergency Medicine Studies or research. Studies of this nature must be submitted to the IRB using the standard protocol submission procedure.
The following conditions must be met for the “emergency use of a test article on human subjects” 21 CFR 56.102(d):
- in a life threatening situation, and
- in which no standard acceptable treatment is available, and
- in which there is not sufficient time to obtain IRB approval.
Even for emergency use of an investigational drug, an Investigational New Drug (IND) exemption is necessary [need reference here]. The FDA requires notification for the emergency use of an unapproved investigational device.
For the emergency use of an unapproved investigational drug, device or biologic, the following procedure has been established:
The treating physician should call and advise the IRB Chair that he/she is requesting permission for the emergency use of a research therapy. The IRB Chair will ensure that the request meets the requirements of emergency use; will check whether the drug or device has already been used on an emergency basis at LLU; will advise the treating physician of any other restrictions that may apply.
Informed consent must be obtained before the use of the test article unless the fact that this is not feasible is certified in writing by both the investigator and a physician who is not otherwise participating in the clinical investigation (21 CFR 50.23).
Once the IRB Chair has been notified and it has been verified that the therapy in question has not been given an emergency use exemption in the past, the therapy may be used on an emergency basis, for one time, one patient only.
- Name, address and telephone number of dispensing physicians and department.
- Name of investigational drug or device
- Name of sponsor
- Date of request for permission
- Date of actual use of drug or device
- Name of patient
- Description of rationale for use
- Description of the patient’s response to the therapy.
The treating physician should advise the IRB Chair if documentation is needed informing the manufacturer of IRB approval. The IRB Chair will notify OSR to issue such a notice ONLY after review and approval of the full IRB.
Notifying the IRB does not equate to an IRB approval, nor does it mean that the IRB has reviewed the specific use of the test article in the emergency setting. Any subsequent use of the test article at the institution is subject to IRB review. If emergency medical care is initiated without prior IRB review and approval, the patient may not be considered a subject in research, nor may the outcome of such care be included in any report of research activity.
Once a drug, device, or biologic has been used on an emergency basis, a protocol should be developed for future use as further “Emergency Use” exemptions cannot be granted.