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Additional Requirements When Conducting Human Subjects Research with Environmental Protection Agency (EPA) Support
When working with certain governmental entities, there are additional steps and protections that PIs and IRBs must be aware of and execute, or risk complications with their funding.
EPA Research applies to research conducted, supported or otherwise subject to regulation by the EPA. NOTE: The EPA prohibits reliance on human research conducted before April 7, 2006 if there is clear and convincing evidence that the conduct of the research was fundamentally unethical (e.g., the research was intended to seriously harm participants or failed to obtain informed consent), or was significantly deficient relative to the ethical standards prevailing at the time the research was conducted.
Human subjects research (HSR) is any research that collects data or information from or about humans (individuals) in a systematic investigation.
Examples of such investigation include:
- Analysis of biological specimens
- Epidemiological and behavioral studies
- Environmental studies
Examples of research oriented investigation include:
- Focus groups
Differences between EPA (40 CFR Part 26) and DHHS (45 CFR Part 46) Human Subjects Regulations
EPA's regulations differ from the Department of Health & Human Services human subjects regulations in the following respects:
- For research intended for submission to the EPA, any and all intentional exposure to any substance involving children, nursing women, and pregnant women and fetuses is prohibited. THERE ARE NO EXCEPTIONS TO THIS RULE.
- EPA extends the protections found in 40 CFR Part 26 to non-pregnant, non-nursing adults as well.
- For research supported by the EPA, research involving intentional exposure of pregnant women or children to any substance is prohibited and not approved by the IRB.
- NOTE: These prohibitions apply in all circumstances, including (but not limited to): studies involving controlled exposures to neutral substances (such as clean, filtered air), foods, or therapeutic drugs.
- Studies that involve naturally occurring environmental exposures may meet the regulatory definition of observational research (if the participant’s exposure is not artificially manipulated or controlled). Additional protections for observational research can be found in 40 CFR 26, Subparts C and D.
- EPA defines a child as someone less than 18 years of age (whereas DHHS regulations defer to state or local law).
- EPA does not recognize a category of research on children involving "a minor increase over minimal risk."
- EPA has no provisions for "research not otherwise approvable" for children, nursing infants, or fetuses.
- EPA has not adopted DHHS 45 CFR 46, Subpart D.
Order 1000.17 Change A1 requires that all human participants research funded by an EPA component be reviewed and approved by the Project Review by the EPA Human Subjects Research Review Official (HSRRO) as compliant with 40 CFR 26, or be determined to be exempt research, before the research begins. This requirement is in addition to IRB review and approval, and it occurs subsequent to it as the final step before the research commences. Initial IRB review of EPA-funded studies should determine that it complies with the requirements laid out in this Order and CFR before submission to the HSRRO.
IRBs must review observational research involving pregnant women and fetuses using 40 CFR 26 and 45 CFR 46 Subpart B.
IRBs may review and approve observational research involving children that does not involve greater than minimal risk only if the IRBs find that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 40 CFR 26.406.
IRBs may review and approve observational research involving children that involves greater than minimal risk but presenting the prospect of direct benefit to the individual participants if the IRBs find and documents that:
- The intervention or procedure holds out the prospect of direct benefit to the individual participant or is likely to contribute to the participant's well-being.
- The risk is justified by the anticipated benefit to the participants.
- The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by available alternative approaches.
- Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in 40 CFR 26.406.
There are no additional funding requirements for EPA studies. Refer to the UW department of Research and Sponsored Programs website for guidance: https://www.rsp.wisc.edu/
Per UW policy, researchers are expected to complete a financial conflict of interest report on an annual basis while the study is active. Researchers may be required to submit a COI management plan if a conflict is identified. Refer to the UW COI website for guidance: https://research.wisc.edu/respolcomp/coioar/
There is no additional training required for EPA studies. Researchers and their study staff are expected to take human participants research training as required by the UW, and maintain this certification while participating on an EPA trial. The UW uses the CITI program for this training. The NIH has a FAQ that discusses who on the researcher’s study team is required to have human participants training, and what programs satisfy this requirement.
There is no additional reporting required for EPA studies.
Researchers and their study staff are expected to follow UW policy on reporting adverse events, continuing reviews, etc.
There are no additional requirements for retention of EPA study materials. Refer to UW IRB for recordkeeping guidance here:
- 40 CFR 26.1201, 26 (Third-Party Human Research for Pesticides Involving Intentional Exposure)
- 40 CFR 26.1704 (Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults conducted before April 7, 2006)
- 40 CFR 26 Subpart C (Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA)
- 40 CFR 26 Subpart D (Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA)