Clinical research studies in the U.S. are regulated by the Food and Drug Administration (FDA). Each study must undergo diligent reviews and follow a set of strict rules. All medications have side effects, and as a result, the participants’ health is monitored closely and frequently by the research team. All of this is put into place to ensure that the rights, safety, and well-being of participants are protected during the study. In addition to the FDA, an Institutional Review Board (IRB) is responsible for approving every clinical trial in the U.S. The IRB is a group of doctors, scientists, and lay people that are dedicated to ensuring that the health and safety of participants are put first.