About EPA Clinical Studies

EPA's mission is to protect human health and safeguard the natural environment — air, water, and land — upon which life depends. To support such a goal, EPA's research organization utilizes the practice of collecting human subjects data to help inform decision-making and assist other EPA programs with the formulation of regulatory standards for the United States.

Human subjects research (HSR) is critical for EPA’s program offices to consider when making regulatory decisions under many of the programs it administers and study data helps advance scientists’ understanding of the links between human health and the environment so that the EPA is better able to carry out its mission.

MPF Federal, LLC, in an independent contractor tasked to recruit volunteers for research on behalf of the EPA. The focus of this research is to discover how humans respond to pollution.

By understanding exactly how commonly-occurring pollutants affect various people, EPA’s research organization helps to inform decision-making, including developing regulations by other EPA programs.  These research data also help advance scientists’ understanding of the links between human health and the environment, which helps EPA to carry out its mission.

Resources

• Clinical Studies Conducted Since 2016 by EPA in the Human Studies Facility, Chapel Hill, NC (Updated July, 2022) (pdf) (105.45 KB, 10-24-2022)  The EPA Clinical Studies program provides a list of previously conducted EPA Clinical Studies.  
• Human Resources Review Board - the Human Studies Review Board (HSRB) is a federal advisory committee that operates in accordance with the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. App 2 § 9 to review and comment on all proposed and completed third-party research involving intentional human subject exposure that is subject to the coverage of EPA’s regulations
• Human Subjects Research - EPA's Program in Human Research Ethics and Oversight (PHREO) supports the ethical conduct and regulatory compliance of human subjects research, or human studies, conducted or supported by the EPA. This support is accomplished through project review, cross-agency partnership, and education and training.
• Guidelines for Human Exposure Assessment - this EPA report focus on exposures of humans to chemical substances, much of the guidance also pertains to assessing wildlife exposure to chemicals, or human exposures to biological, noise or radio-logical agents.
• NAS's Controlled Human Inhalation-Exposure Studies at EPA final report.
• Additional resources include:The following links exit the site
  • DHHS Office for Human Research Protections (OHRP)
  • DHHS Secretary's Advisory Committee on Human Research Protections (SACHRP)
  • University of North Carolina at Chapel Hill IRB and Office of Human Research Ethics
  • Public Responsibility in Medicine Research (PRIM&R)
  • Association for the Accreditation of Human Research Protection Programs (AAHRPP)