An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is
unable to provide informed consent and there is no time to obtain consent for the individual's legal representative. Under the FDA regulations, describes the best course of action for the investigator.
The Institutional Review Board will be notified later.
Explanation:
The objective of informed consent provides sufficient information to a potential subject and enables that individual to make an informed choice about involvement in research. When both the investigator and an independent practitioner confirm the condition entails the application of the test article. In such circumstances, an exception can be made for informed consent under the Food and Drug Administration regulations.
