What must the IRB/IEC specify regarding protocol deviations?

• A. Deviations can be initiated at any time without approval.
• B. No deviations or changes should be initiated without prior documented IRB/IEC approval, except when necessary to eliminate immediate hazards to participants.
• C. Deviations require sponsor approval but not IRB.
• D. Deviations may be reported after trial ends.

Answer: (B)

Any change to the study plan can alter participant risk, consent, and data integrity, so ethics oversight must review and approve deviations before they’re carried out. The IRB/IEC is responsible for safeguarding participants, and their prior approval ensures the risk-benefit balance remains acceptable. The only exception is when an immediate hazard to participants must be eliminated; in that urgent case, actions can be taken to remove the hazard, but the deviation must be documented and reported to the IRB/IEC as soon as possible and the protocol amended accordingly. Relying on sponsor approval alone or waiting until after the trial ends would bypass necessary independent ethical review and could jeopardize participant safety and integrity of the study.