What should an investigator do in a life-threatening situation requiring a test article, if the subject cannot provide consent?

In urgent and life-threatening situations where a test article is necessary, and the subject is unable to provide consent, it is crucial to act rapidly to prevent harm. The correct approach involves the collaboration of medical professionals to determine the immediate need for intervention, which can justify the use of the test article without prior informed consent from the subject.

When another physician agrees to use the test article, it facilitates immediate medical intervention based on ethical considerations. This is often aligned with provisions in regulatory guidelines that allow for exceptions to the informed consent requirement in emergency scenarios, emphasizing the need to prioritize the subject's health and safety.

The urgent nature of the situation makes it imperative to act swiftly, rendering waiting for consent from a legal representative or submitting an expedited protocol to the Institutional Review Board impractical. Likewise, signing consent on behalf of the subject is not a legitimate practice unless explicitly allowed under specific regulations, which typically do not apply in emergency cases where timely intervention is required. Thus, the agreement with another physician to proceed with the test article is grounded in both ethical and medical urgency, making it the appropriate response in such circumstances.