Products and Publications Related to Human Subjects Research
The primary regulation that governs human subjects research at EPA is 40 CFR Part 26. The regulation, codified as Subpart A, establishes a comprehensive framework for the review and conduct of proposed human research to ensure that it will be performed ethically.
EPA Order 1000.17 A (Policy and Procedures on Protection of Human Subjects) requires that all human subjects research that is conducted, sponsored, or regulated by EPA must be reviewed by the Human Subjects Research Review Official (HSRRO). The policy also describes the procedures for review, including those that the HSRRO must use in making his or her determination of approvability.
The Agency published the Scientific and Ethical Approaches for Observational Exposure Studies (SEAOES) resource document for researchers to consult as they develop and conduct observational human exposure studies. This purpose of observational human exposure studies is to understand how people come into contact with chemicals and environmental stressors in their everyday lives.