The ethical and legal codes that govern medical practice also apply to clinical studies. In addition, most clinical research is federally regulated with built-in safeguards to protect participants.

The study follows a carefully controlled protocol—a study plan that details what researchers will do in the study. As a clinical study progresses, researchers will report any unexpected events of the study to various government agencies and ethics boards, who will in turn, decide if the study should continue or not. Individuals’ names will remain confidential and will not be mentioned in these reports.