What is the approval process for human subjects research at the EPA?
Every project involving human subjects research conducted or supported by the EPA goes through multiple levels of approval. The specific path for review differs slightly depending on the origin of the research, but all human subjects research projects must be approved by the Human Subjects Research Review Official before any work involving human subjects can begin.
EPA's approval process guidelines exceed what is generally accepted and required by universities, industry, and other government agencies. In those organizations, human subjects research is often proposed by an investigator, reviewed by a supervisor, and finally, reviewed by an Institutional Review Board (IRB). Research conducted or supported by EPA, on the other hand, has additional levels of oversight. For example, projects that are conducted or funded by the EPA are required to gain approval from the Human Subjects Officer (HSO) and the Human Subjects Research Review Official (HSRRO). Controlled human exposure studies conducted at EPA's Office or Research and Development (ORD) often undergo up to 13 levels of both internal and external review.
What is required for Human Subjects Research Review Official (HSRRO) Approval?
The HSRRO's responsibility is to ensure that all research studies supported by EPA are in compliance with EPA regulations concerning research with human subjects. All human research studies at the EPA must be approved by the HSSRO before work can begin.
The HSRRO makes certain that a variety of components are in place before giving his/her approval. For example, the HSRRO must review proof of external oversight of the study, specifically IRB approval and documentation. The HSRRO also reviews the research plan to ensure that researchers are using best practices in study design and methodology. He/she pays close attention to the description of subject selection to ensure that it is equitable and reviews the informed consent process to confirm that subjects are respected. The HSRRO is interested in ensuring that subjects will learn the goals of the project and expectations of participation before providing their voluntary consent to participate. Finally, the HSRRO confirms that the value of the research to society justifies the risk to research participants and that researchers take precautions to minimize risks to subjects.
Please note that if pregnant women, nursing women, or children are likely to be included as subjects of a study, the HSRRO will closely review the study to determine whether it involves intentional exposure. Research involving intentional exposure of pregnant women, nursing women, or children is prohibited pursuant to 40 CFR 26.203. "Research involving intentional exposure of 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." Studies in which researchers intervene to reduce or mitigate the level of exposure to a substance that participants would otherwise experience, and do not administer a dose of a substance or deliberately cause or bring about participants' exposure to a substance, generally would not fall into the category of intentional exposure research.
In determining whether studies involving pregnant women, nursing women, or children could be considered intentional exposure research, the HSRRO will look for a change in the pre-existing source or delivery mechanism of a pollutant regulated by the EPA as part of the research plan. Interventions that do not involve the administration of a dose of a substance and which reduce participants' exposure from the pre-existing source of that exposure will generally not be categorized as instances of intentional exposure research. Additionally, if the substance in question is not regulated by the EPA, then that also will not constitute intentional exposure research as defined at 40 CFR 26. 202.
In addition to complying with the applicable regulations, EPA conducted or supported studies must also comply with EPA Oder 1000.17A, Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research. This document was updated in 2016 to ensure that it is consistent with contemporary research practice and applicable regulations.
To obtain approval or a concurrence of exemption by the HSRRO, researchers must submit the IRB-approved research package or documentation of exemption, including evidence of IRB approval and any correspondence between the IRB and the researchers.
If you are an EPA researcher, you can find more information about required documentation for each project type and instructions on how to submit your project for HSRRO review on the Program in Human Research Ethics and Oversight's (PHREO) intranet site.
If you are applying for a human subjects research grant you can find specific information on the request for agreement.
For other parties interested in requirements for human subjects review at EPA, please contact the HSRRO.