Each clinical trial has a protocol or road map that explains how it will work. All clinical trials are run in an ethical manner and regulated by federal rules.
Your rights and safety are protected through informed consent in which the research team, made up of physicians and nurses explain the purpose, risks, and benefits of a clinical trial. The team will also explain that you have a right to make a decision about participating and that you may leave the study at any time.
A scientific review panel and an institutional review board (IRB) must carefully review and approve of the clinical trial protocol before proceeding with the clinical trial. The IRB reviews a clinical trial protocol before it even starts accepting patients and monitors the ongoing clinical trial from beginning to end. This board of consumers, clergy, and health professionals reviews the protocol to assure that the research will not expose patients to excessive or unethical risks.
Data and Safety Monitoring Boards (DSMBs) monitor certain phase I and II clinical trials, but mostly only phase III trials. A DSMB is an independent committee compiled of statisticians, physicians, and other experts.