If a Data Safety Monitoring Board indicates a higher than expected adverse event rate, what must be revised?

When a Data Safety Monitoring Board (DSMB) indicates a higher than expected adverse event rate, it is crucial to ensure that participants in the study are clearly aware of any new risks that may have emerged. The informed consent form is a key document that communicates the risks and benefits of participation in a study. If the DSMB identifies an increased rate of adverse events, it necessitates a revision of the informed consent form to reflect this new information accurately.

Updating the informed consent ensures that potential and current participants can make an informed decision about their participation based on the most current data regarding the risks involved. This action is a fundamental part of ethical research practice, as it respects the autonomy of the participants and adheres to regulatory requirements for transparency and informed decision-making in the context of clinical trials.

The other options do not address the immediate need for participants to be informed about new risks. While revisions to funding sources, research site personnel, or eligibility criteria may also be important in the context of overall study management, they do not directly pertain to how informed consent is communicated to participants regarding changing safety information.