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What is required from the IRB after using an investigational product without informed consent?
The patient must be informed within 30 days
The IRB must be notified within five working days
Consent must be obtained afterwards
Additional testing must be conducted
The correct answer is: The IRB must be notified within five working days
The correct answer emphasizes the requirement for timely communication with the Institutional Review Board (IRB) following the use of an investigational product without informed consent. When such a situation occurs, regulatory guidelines mandate that the IRB must be notified within five working days to ensure proper oversight and evaluation of the circumstances surrounding the incident. This notification helps the IRB assess any risks to the patient and determine whether further action is needed to protect participant welfare and maintain ethical standards in research. While informing the patient within 30 days or obtaining consent afterwards may be important aspects of clinical research practices, the direct requirement for notifying the IRB within a specified timeframe is a crucial regulatory step to ensure that an ethical review is conducted promptly. Additional testing might be necessary in some cases, but it is not specifically mandated in the scenario described regarding the lack of informed consent.