The FDA works to protect participants in clinical trials by ensuring that volunteers have reliable information before deciding whether or not to join a clinical trial.
The Federal government has regulations and guidelines for the management of clinical research to protect participants from unreasonable risks. They require researchers to give prospective participants complete and accurate information on the precise nature of each step of a trial.
Therefore, before joining a study, participants are given an informed consent document that outlines their rights as a participant. They are also provided with, details on the nature of the study, including any potential risks.
