Human Subjects Research
Program in Human Research Ethics and Oversight Overview
EPA's Program in Human Research Ethics and Oversight supports the ethical conduct and regulatory compliance of human subjects research conducted or supported by EPA.
This support is accomplished through project review, cross-agency partnership, and education and training. Lead by the Human Subjects Research Review Official, the PHREO reviews, supports, and guides the work of EPA conducted or supported researchers involved in human subjects research to ensure that the rights and welfare of human research subjects are protected. The PHREO is in place to ensure that all EPA employees, contractors, grant recipients, and parties to other EPA agreements adhere to the highest standards of ethical conduct and are properly informed of the regulatory aspects of research involving human subjects. All research involving human subjects proposed by EPA staff or EPA supported researchers must be approved by the EPA HSRRO before human subjects work may begin.
Human subjects research at EPA allows for the collection of valuable information necessary in our mission to protect human health and the environment. Research involving human subjects informs decision-making and the formulation of regulatory standards at the Agency. HSR is critical for EPA’s program offices to consider when making regulatory decisions under many of the programs it administers, e.g., National Ambient Air Quality Standards, water quality criteria and drinking water standards, pollution mitigation techniques, and pesticide registration. Human subjects research advances scientists’ understanding of the links between human health and the environment so that EPA is better able to carry out its mission.
Human Studies Review Board
The Human Studies Review Board (HSRB) is a federal advisory committee that reviews all proposed and completed third-party research (i.e., research that is not conducted or sponsored by the Federal government) involving intentional human subject exposure. The HSRB provides advice, information, and recommendations to EPA on issues related to scientific and ethical aspects of human subjects research. Learn more about the Human Studies Review Board.
About Human Subjects Research
- Human Subjects Research defined
- About the type of research EPA conducts and funds
- Controlled exposure studies
- Currently enrolling controlled exposure studies
- How EPA protects human subjects
- Ethics of exposing humans to known toxic substances or carcinogens
- Approval process for human subjects research at EPA
- Requirements for Human Subjects Review Official (HSRRO) approval
- National Academy of Sciences (NAS) review of EPA's research studies