What is one requirement for using a test article without consent in life-threatening situations?

In life-threatening situations, one key requirement for using a test article without consent is that the investigator believes it is necessary. This stipulation is grounded in ethical considerations and regulatory guidelines that prioritize the well-being of the patient in emergency situations. The investigator must assess that the potential benefits of administering the test article outweigh the risks, even in the absence of informed consent, which may not be feasible in a scenario where immediate action is critical.

In such circumstances, the urgency to provide a therapeutic intervention may justify bypassing the normal informed consent process, provided that the investigator acts in good faith and with the patient's best interests in mind. This requirement ensures that even in high-pressure scenarios, there is a semblance of oversight and ethical conduct guiding medical decisions. It reflects the intent to uphold patient welfare while allowing for flexibility in emergency medical care.

The other potential requirements, such as obtaining verbal agreement from the subject or ensuring written consent is obtained later, typically do not align with the immediacy and urgency found in life-threatening situations. Similarly, having only one physician's concurrence may not be sufficient to provide the necessary ethical and clinical justification for proceeding without consent.