Participants and research ethics committees should be promptly and fully informed about changes in the risks or burdens of participation in clinical research if new, relevant information becomes available during the trial.

During pandemics, new information can come, for instance, from concurrent clinical studies undertaken in different countries. When new information becomes available, for instance, when a vaccine is shown to be successful, research participants in other ongoing studies and research ethics committees need to be made aware of this information. Only when they are informed can they agree to changes in the risk - benefit ratio, an essential part of the informed consent process.