Who oversees health research and clinical studies to make sure they are safe and fair?

All health research and clinical studies that involve human volunteers are reviewed by an Institutional Review Board (IRB), primarily the one at Indiana University Purdue University of Indianapolis (IUPUI) located on the IU School of Medicine campus. The IRB’s primary concern is to make sure that volunteers are safe and that the study is fair and ethical. The IRB actively monitors each research study until the study is complete. The IRB must approve any changes to the study before they can take effect, and any new information about the risks of the study are required to be reported to the IRB by the researchers.