Safety

Participants in a research study have a right to be assured that every measure will be taken to keep them safe during the study. Participants should be encouraged to ask questions about the study and any risks they may encounter. The questions should be answered as simply and completely as possible, and the participants should be asked to describe their understanding of the answers verbally. The IC should describe the risks of participating in the study in a manner that participants can comprehend. Participants in a study should understand that the study is as safe as it can be, and that if unsafe conditions arise, the study will be stopped.