4.5.4 describes what about deviations to eliminate immediate hazards?

• A. Deviations must be approved by IRB/IEC before implementation.
• B. Deviations can be implemented without prior IRB/IEC approval; must be submitted ASAP to IRB/IEC, sponsor, and regulatory authorities.
• C. They do not require documentation.
• D. They must be reported only on annual reports.

Answer: (B)

When a participant faces an immediate hazard, actions may be taken that deviate from the protocol in order to protect safety without waiting for prior IRB/IEC approval. The priority is to prevent harm right away. After addressing the hazard, this deviation must be documented and promptly reported to the IRB/IEC, the sponsor, and the applicable regulatory authorities. This prompt reporting keeps oversight intact and allows proper review and follow-up actions. The other ideas—requiring prior approval, lacking any documentation, or restricting reporting to annual notices—do not fit because safety takes precedence and proper documentation and timely reporting are essential.