An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual’s LAR and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:
Do not use the test article until either the subject or the subject’s LAR can give consent.
Use the test article without obtaining consent from the subject or the LAR then notify the IRB.
Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately.
The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.
The correct answer and explanation is :
The correct answer is:
The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.
Explanation:
Under FDA regulations (21 CFR 50.23(a)), an exception from informed consent requirements is allowed in life-threatening situations where:
- The subject faces a life-threatening condition requiring immediate intervention.
- No standard acceptable treatment is available that could be used instead.
- There is no time to obtain consent from the subject or their legally authorized representative (LAR).
- A second, independent physician agrees that the situation necessitates the use of the test article.
In these cases, the investigator is permitted to use the test article without informed consent but must notify the Institutional Review Board (IRB) as soon as possible after its use. The rationale behind this provision is to allow potentially life-saving interventions in emergency situations without unnecessary delays.
Other answer choices are incorrect because:
- “Do not use the test article until either the subject or the subject’s LAR can give consent” – This is incorrect because waiting for consent could result in serious harm or death when immediate treatment is required.
- “Use the test article without obtaining consent from the subject or the LAR then notify the IRB” – This is partly correct but lacks the requirement for independent physician concurrence.
- “Submit a research protocol to the IRB and justify an expedited review approval of the consent document” – This is not practical in emergencies, as waiting for IRB review would take too much time.
Thus, the best course of action aligns with FDA guidelines allowing an informed consent waiver when an independent physician agrees and the IRB is notified later.