Clinical trials must meet rigorous safety standards, which are mandated by the federal government. The U.S. Food & Drug Administration (FDA) must approve the study design (also known as the protocol). These are detailed guidelines that describe the objectives and length of the trial, the type of patients who may participate, the schedule of tests and procedures, the medications and dosages to be studied, and so on.
In addition, every medical center has an Institutional Review Board (IRB), which is a panel of scientists and non-scientists that oversees clinical research and is responsible for approving the studies conducted at that institution. The IRB makes sure that the study meets the institution’s standards, that participants have given consent to participate and are fully informed of their risks, and that researchers take appropriate steps to protect participants from harm. If the study is a multi-center trial – one that involves several medical centers – each institution’s IRB must give its approval.
