The Common Rule, which governs research with human subjects conducted or supported by 15 federal departments and agencies including EPA, establishes a comprehensive framework for the review and conduct of proposed human research to ensure that it will be performed ethically. The central requirements of the Common Rule are:

• That people who participate as subjects in covered research are selected equitably and give their fully informed, fully voluntary written consent; and
• That proposed research be reviewed by an independent oversight group referred to as an Institutional Review Board (IRB), and approved only if risks to subjects have been minimized and are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result.