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 (HSRRO) 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 reviewed by the Program, Office, or Region’s Human Subjects Officer (HSO) prior to submission to the HSRRO for their review. HSRRO. Controlled human exposure studies conducted at EPA's Office or Research and Development (ORD) undergo multiple 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 human subjects research conducted or supported by EPA are in compliance with EPA regulations for protection of human subjects in research. All human subject research conducted or funded by 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 their 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. The HSRRO 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 subjects 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. Human subject research involving intentional exposure of pregnant women, nursing women, or children is prohibited pursuant to 40 CFR 26.203, "Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support research involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child." 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. If the substance in question is not regulated by the EPA, then it will not constitute intentional exposure research as defined at 40 CFR 26. 202.
In addition to complying with the applicable federal 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.
To obtain approval or a concurrence of exemption by the HSRRO, researchers must submit the IRB-approved research package (including evidence of IRB approval) or documentation of exemption, and all correspondence between the IRB and the researcher(s).
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.