When may the investigator implement a deviation without prior IRB/IEC approval?

• A. Never.
• B. Only to eliminate an immediate hazard to trial subjects.
• C. For administrative reasons.
• D. If the sponsor approves later.

Answer: (D)

Deviations from the approved protocol generally require ethics oversight before they’re put into action. In GCP, you normally may not implement a deviation without prior IRB/IEC approval. The one exception is when there is an immediate hazard to trial subjects—the investigator can take actions necessary to eliminate that hazard to protect safety and welfare, even without waiting for approval, but these actions must be limited to what’s necessary and must be reported to the IRB/IEC as soon as possible with a plan to obtain formal approval or amend the protocol thereafter. Relying on sponsor approval after the fact does not meet ethical oversight requirements, since IRB/IEC review is what ensures subject protections.