Environmental Protection Agency

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Purpose and Applicability

This webpage provides guidance for researchers, the UW IRBs, and HSD staff for research supported by the Environmental Protection Agency (EPA).

Research that is subject to EPA regulations includes research that is: (1) funded by the EPA, (2) conducted in EPA facilities by any person, or (3) conducted in any facility by EPA employees.

Regulations

The EPA has signed onto the Common Rule with its interpretation of 45 CFR 46, Subpart A described in 40 CFR 26.

The EPA has not signed onto the other subparts in 45 CFR 46. The EPA has additional protections for human subjects, including pregnant women and children, described in subparts of 40 CFR 26. Subpart B describes a ban on intentional exposure research involving pregnant women, nursing women, and children. Subparts C and D describe additional protections for observational research with pregnant women and children as participants.

The EPA has additional protections described in subparts K-Q for human participants in third-party pesticide research.

Definitions

Intentional exposure research. Research where the exposure experienced by the subjects would not have occurred if the subject had not participated in the study. This includes any research in which the subject s exposure is artificially manipulated or controlled (i.e., the researcher controls some aspect of the exposure under study). It may involve intentional dosing where the study substance is administered directly. It also includes controlling the subject s behavior so as to bring him or her into contact with a study substance already in the environment. This type of research is also referred to as controlled exposure research.

Observational research. Any research that does not involve intentional exposure. Studies that involve naturally occurring environmental exposures may meet the regulatory definition of observational research (if the subject s exposure is not artificially manipulated or controlled).

Observational Human Exposure studies. As defined in Scientific and Ethical Approaches for Observational Exposure Studies (SEAOES), observational human exposure studies are studies that involve the collection of environmental samples, data, and information from study participants in their everyday environments as they go about their normal activities. They involve neither the deliberate exposure of participants nor the control of environmental conditions in a way that impacts the participants naturally occurring exposures.

Child. A person who has not attained the age of 18 years (40 CFR 26.202). There is no provision in EPA regulations for deferral to state or local law in defining child and adult .

Procedures

Researchers conducting research that is subject to EPA regulations must seek multiple approvals before the research project can start.

HSD and the UW IRB do not have a separate application supplement to capture information specific to the additional EPA regulations. Researchers should review the WORKSHEET Environmental Protection Agency to identify additional information that may be needed to demonstrate compliance with the EPA regulations. That information should be incorporated into the appropriate application form to the UW IRB.

As part of the standard pre-review process of a new application or modification, HSD staff use the WORKSHEET: Environmental Protection Agency to confirm that the materials provided by the investigator address the EPA requirements. The IRB ensures that the EPA requirements are met prior to granting IRB approval. The IRB uses the EPA definitions provided in the Definitions section to determine whether the research involves intentional and/or observational exposure research. The IRB follows EPA policy that the risk level of the research (including zero or minimal risk) is irrelevant to the determination of whether the research involves intentional exposure or is observational.

Additionally, researchers will need to obtain approval or exempt status from the EPA Human Subjects Research Review Official (HSRRO) before beginning the research. This is required for any activities that will meet the regulatory definition of research with human subjects during the period of EPA support.

Researchers should be prepared to send HSRRO:

• All materials submitted to the UW IRB
• IRB approval or exemption letter
• IRB-approved consent form(s)
• Subject-facing materials, e.g., surveys, questionnaires, and recruitment materials
• Copies of correspondence between the IRB or HSD staff and the researcher and
• Documentation of the UW Federalwide Assurance (FWA).

Researchers are responsible for communicating with their EPA Program Officer to ensure that all EPA requirements are met prior to starting an IRB-approved study.

Related Materials

WORKSHEET Environmental Protection Agency
EPA Human Subjects Research Page

Regulatory References

EPA Human Subjects Protection Regulations 40 CFR 26
EPA website: Conducting Human Subjects Research at EPA https://www.epa.gov/osa/basic-information-about-human-subjects-research
EPA Order 1000.17 A1, approval date 06/15/2016, updated 09/29/2022, Policy and Procedures on Protection of Human Research Subjects in EPA Conducted or Supported Research .

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