In a life-threatening situation requiring immediate action, what must an investigator do regarding informed consent?

In life-threatening situations requiring immediate action, the investigator can proceed with the test article and notify later is appropriate under certain circumstances. This option is based on the understanding that the urgency of the situation may prevent the investigator from obtaining informed consent in the traditional manner.

The rationale behind this approach is grounded in the ethical principles that prioritize the well-being and safety of the patient when a delay in treatment could lead to serious harm or death. In emergency contexts, obtaining informed consent may not be feasible due to the predefined criteria that dictate how consent should be granted, such as time constraints or a patient's inability to communicate effectively.

In these cases, many institutional review boards (IRBs) allow for a waiver of informed consent under specific regulatory conditions, allowing researchers to use investigational drugs or interventions that may be lifesaving, provided that the study meets the necessary ethical standards and regulations designed to protect patients within emergent medical scenarios.

This practice aligns with ethical standards in research while still safeguarding participants' rights, as there are typically established protocols to gather informed consent as soon as possible after the immediate medical situation has been addressed.