Research and quality improvement activities: when is institutional review board review needed?

摘要

An IRB, also known as an independent ethics committee or ethical review board, is a committee that has been formally designated to approve, monitor, and review research involving humans with the aim to protect the safety, rights, and welfare of the research subjects (Amdur & Bankert, 2002). In the United States, the Food and Drag Administration and Department of Health and Human Services (DHHS) regulations have empowered IRBs to approve, require modifications, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.