Which statement best describes the role of the IRB in emergency situations involving informed consent?

Prepare for the CITI Good Clinical Practice (GCP) Exam with comprehensive questions, hints, and explanations. Master the essential concepts to excel in your exam!

The role of the Institutional Review Board (IRB) in emergency situations involving informed consent is primarily focused on the ethical oversight of research involving human subjects. In situations where informed consent cannot be obtained due to an emergency, as per federal regulations and ethical guidelines, it falls upon the investigator to proceed with the emergency treatment without prior IRB approval, as long as the reasons are justified.

After such an emergency intervention, the investigator is indeed required to notify the IRB about the circumstances surrounding the situation. This is crucial for ensuring that the IRB can review the event, assess compliance with ethical standards, and determine if any follow-up actions are necessary regarding the study protocol or participant welfare. Furthermore, this notification helps maintain transparency and accountability in the research process.

The other options do not accurately represent the IRB's role. The IRB does not have to authorize emergency treatment beforehand; its function is more about oversight rather than direct intervention. Additionally, the IRB is not responsible for providing medical care during emergencies, and confidentiality regarding emergency information is not the primary concern in this context. Instead, the IRB's focus is on the ethical implications of research conduct and the protection of participants' rights.

Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy