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In a life-threatening situation without the possibility of obtaining informed consent, what should an investigator do?

  1. Proceed without any form of consent

  2. Only document the decision in study records

  3. The investigator and another physician agree to use the test article and notify the IRB later

  4. Wait until consent can be obtained from a legal representative

The correct answer is: The investigator and another physician agree to use the test article and notify the IRB later

In a life-threatening situation where obtaining informed consent is not possible, the investigator and another physician may agree to use the test article and notify the IRB later. This is the most ethical course of action in this situation because it allows for the potential benefit of the test article to be used in emergency situations while still adhering to ethical guidelines. Choosing option A would violate ethical principles and potentially harm the subject. Option B may be insufficient and not fulfill the necessary requirements for proper documentation. Option D may not be feasible in a time-sensitive and life-threatening situation.