Participant safety and welfare is always the most important aspect of any research study. As a result, studies are highly regulated with safeguards in place by both the study sponsor and by the Institutional Review Board (IRB) or Ethics Committee (EC). Research studies are also overseen by governmental agencies, such as the Food and Drug Administration in the United States, to protect the rights and welfare of volunteers. Once a research study begins, the IRB/EC watches over it in case there are any problems. If you are in a research study, you can contact the IRB/EC with any questions or concerns. Study centers will follow recommended local and federal clinical guidelines.