Emergency Use of Test Articles and of Humanitarian Use Devices Policy

1. The UW-Madison Health Sciences IRB complies with the FDA regulations related to emergency use of test articles and emergency use of HUDs.

2. Definitions.

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

2.2. Life-threatening includes both life-threatening and severely debilitating diseases or conditions.

2.2.1. Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival. The condition does not have to be immediately life-threatening or to immediately result in death. Rather, the patient must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.

2.2.2. Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.

3. Emergency use is the use of a test article or HUD 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.

3.1. The emergency use provision in the FDA regulations is an exemption from prior review and approval by the IRB and can only occur if all of the conditions described in 21 CFR 56.102(d) exist:

3.1.1. the patient is experiencing a life-threatening situation;

3.1.2. no standard acceptable treatment is effective or available;

3.1.3. there is no known available IRB-approved protocol using the same test article or the patient cannot be enrolled into an existing IRB-approved protocol; and

3.1.4. there is not sufficient time to obtain IRB approval.

3.2. In the case of an unapproved medical device or a HUD, the treating physician must obtain an independent assessment by an uninvolved physician that the use is warranted and that no other reasonable alternatives are available.

4. The need for a test article may arise in an emergency situation that does not allow time for submission of an IND or IDE.

4.1. Emergency use of an unapproved investigational drug or biologic generally requires an IND. If the intended subject does not meet the criteria of an existing study protocol, or if an approved study protocol does not exist, the treating physician should contact the manufacturer to determine if the drug or biologic can be made available for the emergency use under the company’s IND.

4.1.1. If the need for an investigational drug or biologic arises in a an emergency situation that does not allow time to submission of an IND, the FDA may authorization shipment of the test article in advance of an IND submission. Requests for such authorization may be made by telephone or other rapid communication means.

4.2. The FDA allows the emergency use of an unapproved medical device prior to submission of an IDE if the need arises that does not allow time for submission of an IDE in the usual manner. While prior approval for shipment or emergency use of the investigational device is not required, the use must be reported to the FDA by the IDE sponsor within 5 working days. If no IDE exists, the physician must report the use to the FDA.

4.3. If the need to use a test article arises in an emergency situation that does not allow time for submission of an IDE or IND in the usual manner, the treating physician (or the physician’s designee) is required to ensure that all FDA requirements are satisfied.

5. Informed consent from the patient or the patient’s legally authorized representative is required unless the conditions for an exception are met.

5.1. The informed consent document should include a statement that the FDA may require data from the emergency use to be reported to the sponsor and/or the FDA in support of a marketing application.

5.2. For an exception to the informed consent requirement to occur, all of the following conditions must be met and both the treating physician (or designee) and a physician who is not otherwise involved in the emergency use of must certify in writing that:

5.2.1. The patient is confronted by a life-threatening situation necessitating the use of the test article.

5.2.2. Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the patient.

5.2.3. No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the patient's life.

5.2.4. Time is not sufficient to obtain consent from the patient's legal representative.

5.3. If, in the opinion of the treating physician (or designee), there is not sufficient time to obtain an independent written certification of the criteria for an exception from the informed consent requirement prior to the use of the test article, the treating physician (or designee) should make the determination and, within 5 business days after the use of the article, have the determination reviewed and evaluated in writing by a physician who is not participating in the use of the test article.

5.4. The treating physician (or designee) must submit to the IRB the written documentation supporting the exception to the informed consent requirement within 5 business days after the use of the test article.

6. If the emergency use occurs involving a VA patient being treated at the Madison VA Hospital, VA policies and procedures apply.

6.1. VA regulations state that the use of test article under FDA emergency use regulations is not considered research and thus the patient receiving the test article is not considered a research subject and the emergency care cannot be claimed as research.

7. The FDA limits an emergency use of a test article to one emergency use per institution and any subsequent use of the test article must have prospective IRB review and approval.

7.1. Under FDA regulations, however, an emergency treatment of a second individual will not be denied if the only obstacle is that the IRB has not had sufficient time to convene a meeting to review the use.

8. The IRB should be notified, if at all possible, before the emergency use of a test article.

9. The emergency use must be reported to the Health Sciences IRB within 5 business days following its use.

10. The treating physician must provide outcomes and/or safety information to the test article sponsor/manufacturer and the FDA as required by FDA regulations.

11. If the treating physician (or designee) expects to use the test article in a subsequent patient, he or she must submit to the IRB a protocol requesting multiple use of the test article.

12. When the IRB reviews an emergency use of a test article, it determines whether the conditions for emergency use or informed consent requirements were satisfied.

12.1. If the use did not meet the FDA criteria for the emergency use of a test article, the IRB must follow the Noncompliance Policy.

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Scope

• This policy applies to the emergency use of a test article at the University of Wisconsin - Madison.

Applicable HRPP Policy

• Review of FDA-Regulated Research Policy

Attachments and Other References

• Emergency, Expanded Access for an Investigational Medical Product (One Patient)
• Emergency/One-Time Use Consent Template (Word Doc)
• Emergency Use of an Investigational Drug or Biologic - Information Sheet
• Guidance on IDE Policies and Procedures: Expanded Access to Unapproved Devices
• Using HUDs in Emergency Situations