In a life-threatening situation requiring the use of a test article without informed consent, what should the investigator do?

In life-threatening situations where obtaining informed consent is not feasible, it is crucial for investigators to operate within ethical and regulatory frameworks. The correct approach involves collaboration with an independent physician who can evaluate the urgency of the situation and the appropriateness of waiving informed consent for the use of the test article. This process helps to ensure that the patient's welfare and rights are prioritized while still allowing for urgent medical intervention.

The agreement with an independent physician adds an essential layer of oversight. This physician assesses the patient's condition and the potential benefits versus risks of using the test article without prior consent. Such collaboration ensures that ethical considerations are maintained and that there is a valid justification for acting without informed consent in a critical scenario.

Submitting a protocol for expedited review may be necessary in different contexts but does not address the immediate need for action in life-threatening situations. Using the test article without consent and notifying the IRB afterward does not provide the necessary preemptive ethical evaluation required in these cases. Lastly, opting not to use the test article under any circumstance could prevent a potentially beneficial intervention for the patient in dire need.