Before a drug is given to people, it is first studied in the test tube and in animals to look for dangerous side effects. Before a clinical trial can begin, the drug must be approved by the Food and Drug Administration, a panel of doctors, experts and other concerned individuals. Each unit that conducts a trial is by law responsible for protecting the rights and confidentiality of people in the trial and for ensuring that the trial is ethical and as safe as possible. Individuals in a treatment trial are watched carefully, because the investigational drug may have side effects. This allows the unit staff to take steps to try to prevent or treat side effects if they do occur.
Consent is obtained before a person enrolls in a trial.
A person may choose to leave the study at any time. Clinical trials have helped to find better treatments and increase our knowledge of this disease, but extensive study must continue until a cure is found. Supported by the National Institutes of Health, the units are committed to improving the understanding of the AIDS virus and the development of effective treatment. In order to be useful, trials must be run according to a set of rules that must be understood and followed. The first responsibility of study participants is to understand what the rules are and to be honest about their ability to follow them.