When new safety information becomes available during a trial, who must be informed of this information?

• A. Sponsor only
• B. Regulatory Authority only
• C. Study Participants only
• D. Investigators and Ethics Committees/IRBs

Answer: (D)

When new safety information emerges, the immediate obligation is to keep those directly overseeing and conducting the trial informed. The sponsor must promptly inform the investigators and the Ethics Committees/IRBs so they can reassess the risk-benefit, consider protocol or monitoring changes, and update the consent form if needed. Investigators then relay appropriate information to participants and implement any required actions. While regulatory authorities may also need notification in many jurisdictions, the essential recipients who must be informed to protect participants and maintain ethical oversight are the investigators and the ethics committees/IRBs.