The FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial.
The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks.
Although efforts are made to control the risks to participants, some may be unavoidable since we are still learning more about the medical treatments in the study.
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial.
Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks.
The informed consent is part of the process that makes sure you understand the known risks associated with the study.
Signing it indicates that you understand that the trial is a research and that you may leave at any time.