How does EPA Protect Human Subjects?
EPA follows strict safety protocols for all of its studies to protect the health and safety of volunteers, including engineering controls for the facility and protocols for the medical oversight of the exposures. In addition, all EPA research is conducted in compliance with federal regulations and best practices in ethics. The primary regulation that governs human subjects research at EPA is 40 CFR Part 26 Subpart A. It is known as the "Common Rule" because 18 federal departments and agencies have agreed to hold this regulation "in common."
All human subjects research is evaluated by an administrative body, known as an Institutional Review Board (IRB), which is designated with protecting the rights and welfare of human research subjects in research activities. IRB authority is codified at 40 CFR 26. The IRB has the authority to approve, require modifications in (to secure approval), or disapprove all research activities that fall within its jurisdiction.
In 2006, the EPA amended its regulation at 40 CFR Part 26 to include additional protections for vulnerable subjects within its subparts. Subpart B of the regulation is a ban on intentional exposure research involving pregnant women, nursing women, and children. Research involving intentional exposure of a human subject is defined in 40 CFR Part 26.202 as the “…study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study.”
Subparts C and D of 40 CFR Part 26 seek to ensure that vulnerable subjects are protected in observational research. Subpart C provides additional protections for observational research conducted with pregnant women as participants. Subpart D adds protections for observational research conducted or supported by EPA involving children as participants. Observational research is defined in 40 CFR Part 26.302 as any human research that does not meet the definition of research involving intentional exposure of a human subject.
The distinction between intentional exposure research and observational research is extremely important for EPA researchers in the development and approval process for studies involving human subjects. Since intentional exposure research involving pregnant women, nursing women, and children is banned, researchers must pay close attention to the details of their study in order to ensure that it does not meet the definition of intentional exposure if the study involves these protected populations.
EPA also added special regulations at 40 CFR Part 26, subparts K-Q, which are related to the review of third-party pesticide research involving human participants. These regulations were updated in 2013. For more information, please see the links below.
EPA holds a Federal-Wide Assurance (FWA), which is an assurance of compliance that covers the engagement of the Agency in any Human Subjects Research conducted or supported by any Common Rule agency, including EPA. This assurance covers all Agency components and therefore provides a basis for the participation of EPA personnel anywhere in the Agency in HSR under conditions that are compliant with applicable regulations.
EPA Order 1000.17 A (Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research) establishes EPA procedures and responsibilities for implementing the requirements set forth in 40 CFR Part 26. The Order requires that all human subjects research conducted or supported by EPA must either be approved or be acknowledged as exempt research by the EPA Human Subjects Research Review Official (HSRRO) before any work involving human subjects research can begin. Preliminary (or “conditional”) review by the HSRRO is not required, but can be requested, for any research project, contract, grant application, cooperative agreement, cooperative research and development agreement (CRADA), interagency agreement or any formal agreement involving EPA support of such studies. The Order describes the requirements for review, as well as the responsibilities of all parties involved in EPA research in protecting the rights and welfare of human research subjects.
EPA’s National Exposure Research Laboratory (NERL) published SEAOES as a resource document for researchers to consult as they develop and conduct observational human exposure studies. EPA Order 1000.17 A requires that all human observational exposure studies conducted or supported by EPA adhere to the principles set forth in SEAOES. SEAOES provides information on regulatory requirements, sound scientific practices, and ethical issues to consider when performing observational human exposure studies.