Emergency Use of FDA-Regulated Test Articles - Office of Research (2024)

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• Emergency Use of FDA-Regulated Test Articles

Under FDA regulations, "emergency use" is defined as the use of a test article (e.g., investigational drug, biologic, or device) on 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.’

The FDA regulations allow each institution only one exemption from the requirement for prospective IRB review in emergency cases. Multiple uses of this nature would violate FDA regulations; therefore, UAB policy requires prior review and approval in "emergency use" situations if time permits in order to prevent multiple investigators from unknowingly using the same test article in an emergency situation that is the same, or very similar, to one already performed at UAB. The following sections describe the emergency use procedures allowed at UAB and the applicable requirements.

Two categories exist for emergency use of a test article: One-Time Use for Clinical Purposes Only and Treatment Use Prior to Convened IRB Review. Both require prior review and approval by the IRB Chairman whenever time permits. When time does not permit, the UAB IRB has a procedure whereby a health care provider can apply for exemption from prior IRB review and approval after treating a patient with an FDA-unapproved test article. Notably, all these uses require that the investigator obtain the informed consent of the patient or legally authorized representative unless specific conditions apply.

Informed Consent for Emergency Use

Even for an emergency use, the investigator is required to obtain informed consent of the subject or the subject's legally authorized representative unless both the investigator and a physician who is not otherwise participating in the clinical investigation certify all of the following Before the test article is administered, the investigator and a physician unrelated to the investigation must certify in writing to the following four elements:

1. Subject is confronted with a life-threatening situation necessitating immediate use of the test article (drug or device);
2. Subject is unable to communicate or legally effective informed consent cannot be obtained;
3. Time is not sufficient to obtain informed consent from the subject’s LAR; and
4. No available alternative method or approved or generally recognized therapy exists that provides an equal or greater likelihood of saving the subject’s life.

If, in the opinion of the investigator, immediate use of the test article is required and there is not sufficient time to obtain the certification of an independent physician in advance of use of the test article, the investigator:

• Certifies in writing the four elements listed above; and
• Has an independent physician review and evaluate the decision in writing within 5 working days after the use of the test article.

One-Time Use for Clinical Purposes Only

This category of emergency use is defined as "Administration of an investigational article in an emergency use situation to one patient with no plans for subsequent use of the test article at this institution." Before administering the investigational drug/device, prior review and d approval by the IRB Chairman is required. The Chairman of the IRB will review the request and respond with an approval or request for revisions. The following information should be submitted to the OIRB:

1. Letter of explanation which specifies justification for administration of the test article (see Informed Consent and Emergency Use, above).
2. Copy of the informed consent document.
3. Any additional information from the manufacturer regarding use of the test article.

Note: If sufficient time is not available to prepare the above documents, telephone approval may be obtained by contacting the IRB Chairman, Dr. Ferdinand Urthaler, at 934-4622 or the OIRB at 934-3789. The above materials must be submitted to the OIRB within 5 days.

If the IRB, during retrospective review, finds that a given test article is used in justifiable emergency situations by several investigators, or if further justifiable emergency situations are anticipated, the IRB will request that a protocol be developed for prospective IRB review, listing all investigators who may use the article in the institution in the future. By reviewing and approving this protocol prospectively, subsequent use of the test article would not be subject to the emergency use provision for those investigators.

Treatment Use Prior to Convened IRB Review

This category of emergency use is defined as "Administration of an investigational drug/device

• to one patient in an “emergency use” situation that was unforeseeable and
• in which there are plans to subsequently submit an application for convened IRB review so that patients may be entered into a research protocol."

Review by the IRB Chair is required before the test article is administered to the patient. The Chair will review the request and respond in writing. The following information should be submitted to the Chair for this review:

1. Letter of explanation which specifies justification for administration of the test article (see Informed Consent and Emergency Use, above) and which clearly indicates that a full IRB review application will be submitted at a later date;
2. Copy of the informed consent document; and
3. Copy of the sponsor's protocol and/or information concerning the test article.

Exemption from Prior Review and Approval by the UAB IRB

In an emergent situation, there may be circ*mstances under which a health care provider may wish to use an unapproved device to save the life of a patient or to prevent irreversible morbidity when there exists no other alternative therapy. In such a case, within 5 working days of the emergency use, the investigator submits information to the IRB to qualify for exemption from prior IRB review and approval. The submission must include the following information:

• The date the information is being submitted to the IRB
• A description of the life-threatening situation that required immediate intervention with the use of the test article;
• The known or foreseeable risks of the intervention and the anticipated benefits of the intervention;
• A copy of the signed informed consent document if consent was obtained or, if obtaining consent was not feasible, copies of the certifications addressing the items noted above;
• The name of the investigational drug, agent, biologic, or device used;
• A description of the treatment plan in sufficient detail for IRB review;
• Any reportable problems described under POL006 UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB;
• The outcome of the emergency-use intervention, if known.
• An assessment of the likelihood of a similar need for the investigational or unlicensed test article and, if likely, immediately initiates the process to obtain an IND or IDE and convened IRB approval;
  • Note that data obtained about a recipient of emergency medical care with an FDA-unapproved test article cannot be used for a prospectively conducted research activity.
• A copy of the notification to be sent to designated officials at performance sites, as applicable.

Treatment IND and Emergency Use IND Protocols

Under the FDA regulations, an IND sponsor may apply for a Treatment IND. If the FDA grants the Treatment IND, the investigational drug may be used to treat patients with serious or immediately life-threatening diseases for whom no comparable or satisfactory alternative drug or therapy is available.

FDA policy specifies that "the provision for emergency use would almost never apply to a treatment protocol or a Treatment IND because these are planned uses of the test article and sufficient time is available to obtain prospective convened IRB review and approval." However, in the rare cases in which emergency use does apply, the procedures outlined above for "One Time Use for Clinical Purposes Only" or "Treatment Use Prior to Convened IRB Review" should be followed.

Although the FDA may waive the requirement for IRB review, the UAB IRB policy specifies that prior review and approval by the Chairman is required. Procedures described above under "Prior Treatment Use" must be followed with two additions:

1. The phrase "Treatment IND" must be included in the title.
2. The letter of explanation must include the Treatment IND number assigned by FDA.