Exemption for Emergency Use

The National Jewish IRB grants exemption from prospective IRB review for emergency use according to federal regulations. Per OHRP regulations, this data cannot be used for research purposes.

PROCEDURE:

The principal investigator must generate a letter to the IRB Chair describing the emergency-use situation. The letter must document compliance with specific FDA requirements for emergency use, indicating (a) a life-threatening situation exists in which no standard acceptable treatment is available, and (b) the test article must be used expeditiously, meaning insufficient time is available to convene a quorum for full-board IRB approval. The notification to the IRB must occur prior to or within five days of use of the use of the test article.

The IRB Chair will review the investigator's letter and confirm that (a) an emergency situation exists, and (b) there is not sufficient time to convene a full-board IRB meeting.

The IRB Office will generate a letter, signed by the IRB Chair, acknowledging notification of emergency use of the test article. The IRB letter will indicate only knowledge of, acknowledgement of, or appropriate notification of the use of the test article. The IRB letter will not indicate IRB review or approval.

All subsequent uses of the test article will be required to be reviewed using the full board IRB review process. If an investigator believes another request for the use of this test article is forthcoming, the full IRB review process should be initiated.

NOTE: The procedures described above pertain only to FDA-regulated research. The FDA elected to make some changes in the DHHS federal policy (Common Rule). DHHS does not provide for an emergency exception to IRB review. However, DHHS allows physicians to provide emergency medical treatment to their patient. The difference between research conducted through the DHHS and research regulated through the FDA is that in an emergency-use situation, the DHHS does not consider the patient a research participant. Thus, the data are not allowed as part of a research study. The FDA does allow the data from an emergency-use situation to be used as part of a research study.

For more assistance in a emergency-use situation, please contact the IRB Manager at (303) 398-1855.