Deviations from or changes to the protocol should not be initiated without prior written IRB/IEC approval except in which circumstances?

Deviations from or changes to the protocol should not be initiated without prior written IRB/IEC approval except in which circumstances?

• A. Only for administrative matters when the sponsor agrees
• B. Whenever there is a change in the funding source
• C. To eliminate immediate hazards or when changes involve only logistical or administrative aspects
• D. Whenever the trial is not enrolling participants

Answer: (C)

The key rule is that changes to the protocol usually require prior IRB/IEC approval, but there are two important exceptions that allow action without waiting for that approval. One is to eliminate an immediate hazard to a participant, so you can implement a necessary safety fix right away. The other is when the changes involve only logistical or administrative aspects and do not affect participant risk or the scientific integrity of the trial. This item is the best answer because it captures both legitimate situations where you can proceed without prior approval, ensuring participant safety or keeping the study running without altering risk. After such actions, you would still report and document the change with the IRB as soon as possible.

The key rule is that changes to the protocol usually require prior IRB/IEC approval, but there are two important exceptions that allow action without waiting for that approval. One is to eliminate an immediate hazard to a participant, so you can implement a necessary safety fix right away. The other is when the changes involve only logistical or administrative aspects and do not affect participant risk or the scientific integrity of the trial. This item is the best answer because it captures both legitimate situations where you can proceed without prior approval, ensuring participant safety or keeping the study running without altering risk. After such actions, you would still report and document the change with the IRB as soon as possible.