Before any clinical trial can begin to enroll patients, its protocol and Informed Consent form must be approved by the FDA. Then, at individual hospitals or research centers, approval also must be granted by an Independent Review Board. This is a committee of doctors and lay people who make sure that the potential risks do not outweigh the potential benefits of the study.

Before you agree to participate in a study, you should:

• Clearly understand the study. The research staff must explain the goals, possible benefits, and possible risks of the study to your satisfaction.
• Check with your personal doctor, who knows your medical history and can help you decide whether you should participate in a clinical trial. Your doctor also can be a source of information about the risks and benefits of the proposed treatment(s).
• Have a good understanding about your current state of health. You will be told about the known side effects and other health risks of the treatment(s), but not all of the risks can be known when you decide to participate in a trial.