What must the IRB/IEC do regarding changes that increase risk to participants?

• A. Changes that increase risk require no action.
• B. They must be notified only of changes that reduce risk.
• C. Only changes that decrease risk require IRB notification.
• D. The IRB/IEC must be notified of any changes that increase risk to participants or significantly affect the trial conduct.

Answer: (D)

The key point is that participant safety drives oversight. If a change to the study protocol, procedures, or informed consent could increase the risk to participants or substantially affect how the trial is conducted, it must be reviewed and approved by the IRB/IEC before that change is implemented. This review ensures that any new risks are identified, weighed against potential benefits, and communicated to participants (often via an updated consent). The IRB/IEC’s role is to protect participants, so increases in risk trigger mandatory oversight and prior approval, rather than being implemented unreviewed. Minor administrative changes that do not affect risk or trial conduct generally do not require IRB approval, but anything that raises risk or significantly alters how the trial is run does.