Under which circumstances may protocol deviations or changes be initiated without prior IRB/IEC approval?

• A. They may be initiated at any time without approvals
• B. They always require prior written IRB/IEC approval
• C. They may be initiated without prior written approval only to eliminate immediate hazards or when changes involve only logistical or administrative aspects
• D. They require sponsor approval only

Answer: (C)

You usually need IRB/IEC approval before making any deviation or change to a study protocol. The two allowed exceptions are narrow: you may initiate without prior written approval only to (1) eliminate an immediate hazard to a participant, implementing the change to protect safety and then informing the IRB/IEC as soon as possible; or (2) change something that is purely administrative or logistical and does not affect participants’ rights, safety, or the integrity of the data. In those cases, you still document the change and notify or seek review as appropriate after the fact. For any other alterations that could impact rights, safety, or data quality, prior IRB/IEC approval is required. Sponsor approval cannot substitute for IRB/IEC approval.