In an emergency situation requiring a test article without consent, what is the best course of action for the investigator?

In emergency situations where a test article is necessary but obtaining consent is not possible, seeking an exception for informed consent with a physician's agreement is the best approach. This option acknowledges the critical nature of emergencies, where waiting for consent could delay necessary treatment and potentially result in harm to the patient.

By obtaining the agreement of a physician, the investigator ensures that there is professional accountability and oversight in the decision-making process. The physician's role is essential as they can assess the medical necessity and urgency of using the test article. This collaboration also aligns with ethical standards that prioritize patient welfare while navigating the constraints of informed consent requirements under extraordinary circumstances.

In contrast, delaying the use of the test article until consent is obtained could prevent timely interventions in life-threatening situations. Moreover, using a test article without consent and subsequently notifying the IRB may not provide the requisite ethical safeguards, as it can lead to potential violations of regulatory guidelines. Finally, while consulting the institution's legal team is important for overall compliance and ethical considerations, the immediate priority in emergencies is to secure the necessary medical approval to act swiftly.