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

FAQs

What is the emergency use of a test article? ›

Emergency use: The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available and where there is not sufficient time to obtain IRB approval. Test article: Any [investigational] drug, biological product, or medical device for human use.

What is the FDA emergency use consent? ›

The FDA can use its Emergency Use Authorization (EUA) authority under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain ...

What is an FDA regulated test article? ›

(b) Test article means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the act or under sections 351 and 354- 360F of the Public Health Service Act.

What is an emergency IND? ›

Emergency Use INDs, also called compassionate use or single-patient INDs, are filed for emergency use of an unapproved drug when the clinical situation does not allow sufficient time to submit an IND in accordance with 21 CFR §§ 312.23, 312.24.

Is emergency use considered research? ›

NOTE: Under DHHS regulations, emergency use of an investigational drug is not considered research. Patients receiving the drug are not considered research participants and the outcome of emergency use of an investigational drug cannot be included in any report of a research activity subject to DHHS regulations.

What does the term emergency use mean in the FDA IRB regulations? ›

However, the FDA's “emergency use” exemption allows 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 not sufficient time to obtain IRB approval.

What is the difference between emergency approval and FDA approval? ›

Emergency Use Authorization (EUA)

Under an EUA, the FDA authorizes uses of medical products based on a reasonable belief that the product may be effective based on the best evidence available at the time, without waiting for all the information that would be needed for an FDA approval.

Is COVID vaccine FDA approved? ›

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

What is FDA Pfizer emergency use authorization? ›

On April 18, 2023, the Food and Drug Administration amended the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccine (Original and Omicron BA. 4/BA.

How do I know if my study is FDA regulated? ›

To determine if a study is FDA-regulated, the Quality Assurance team condcuts ancillary reviews for studies using investigational drugs and devices to determine the applicability of FDA regulations. For the FDA, clinical investigation is synonomous with research, clinical research, clinical study, and study.

How do you tell if a study is FDA regulated? ›

The study is FDA Regulated if any of the following items apply and are checked on the Regulatory Page of IRB Online
  1. Approved Drug, Device, Biologic or HUD (research on)
  2. IND Exempt (Drug, Biologic)
  3. Investigational Device Evaluation.
  4. Investigational Device: Exempt.
  5. Investigational Device: NSR.
  6. Investigational Device: SR.

What does it mean to be FDA regulated? ›

The FDA approves new human drugs and biological products.

This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.

What are CDC emergency use instructions? ›

What are Emergency Use Instructions (EUI)? EUI are issued by CDC to provide information about emergency use of FDA-approved (licensed) medical products that may not be included in or differ in some way from the information provided in the FDA- approved labeling (package insert).

What is the FDA exception from informed consent? ›

In 1996, the Food and Drug Administration (FDA) created the exception from informed consent (EFIC) pathway for emergency clinical research. This pathway allows investigators to enroll patients without consent from the patient, their family, or their legally authorized representatives.

What is needed for an IND? ›

Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674).

What is a test article in research? ›

The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products.

What is emergency use of a humanitarian use device? ›

Single Patient Emergency or Compassionate Use of an HUD

If a physician in an emergency situation determines that IRB / FDA approval for the use of an HUD cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be used within the scope of its labeling or off-label without prior IRB approval.

What are emergency use instructions? ›

EUI provide information about emergency use of FDA-approved medical products that may not be included in or differ in some way from the information provided in the FDA-approved labeling (package insert).

How do you study for a test article? ›

Follow these study tips to make your best grade!
  1. Get informed. Don't walk into your test unprepared for what you will face. ...
  2. Think like your teacher. ...
  3. Make your own study aids. ...
  4. Practice for the inevitable. ...
  5. Study every day. ...
  6. Cut out the distractions. ...
  7. Divide big concepts from smaller details. ...
  8. Don't neglect the “easy” stuff.

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