The Food and Drug Administration (FDA) has strict requirements regarding the emergency use of test articles to treat patients. Failure to follow those requirements can create big headaches for investigators and institutions. Here’s a refresher on some of the key elements of emergency use of test articles.
First, emergency use, per the FDA regulation at 21 CFR 56.102, “means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is insufficient time to obtain IRB approval.” Translated, this means you’ve got a patient in really bad shape who needs treatment; there’s no good standard treatment available, but something that is not yet approved for this particular use may be helpful; and you can’t get this on the next IRB agenda before you need to treat the patient because it’s Wednesday afternoon and the IRB won’t meet again until next Tuesday.
If possible, please let the IRB know of your intent to use the investigational product before you use it. The IRB can acknowledge that it has received your report. Note that in some cases, the investigational product’s (a drug, usually) manufacturer will require some kind of IRB acknowledgement before it will ship the drug to you or let you use it.
If it is not possible to notify the IRB before use of the test article, it is still permissible to use it for patient care if the other emergency use requirements are met, e.g., the person is facing a life-threatening situation with no available treatment options, among others. However, whether you notify the IRB pre-treatment or not, the IRB must receive a follow-up report within 5 days of the test article’s use. The report must include the following information:
- Name of test article used and date of IRB acknowledgement, if applicable
- Date, time and location of use
- Patient’s diagnosis and outcome, if known
- Any adverse events or unanticipated problems
- Copy of the signed informed consent. Note that the consent requirement can be waived in some instances, although those cases require certifications from the investigator and an independent physician.
CLARA has an Emergency Use form you can select after clicking “Create a new submission.” This form can be used for both pre-treatment and for the follow-up report; a question in the form will let you specify which one your report is.
Please see UAMS IRB Policy 18.3 for more information about the requirements related to the emergency use of test articles, and the reporting of such use to the IRB. Note that an emergency use of a test article when not all of the use requirements are met and/or without reporting the use to the IRB within 5 days can result in a noncompliance finding.