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Conducting Human Subjects Research (HSR) at EPA

Program in Human
Research Ethics

PHRE Online Tutorial

This page provides information for EPA investigators and other EPA personnel who participate in projects that may meet the regulatory definition of HSR.

What Kinds of Projects May Be HSR?

Any project that collects data from or about humans may meet the regulatory definition of research with human subjects and thereby be subject to the requirements of EPA Regulation 40 CFR 26 and EPA Order 1000.17 Change A1. This includes projects conducted under programs that are not considered research for other purposes. For example, some demonstration programs and some public health practice programs may include research activities. Any EPA personnel who participate in any project that collects data from or about humans should therefore be sure that an accurate HSR/non-HSR determination has been made before proceeding with the project.

Who Makes the HSR/non-HSR Determination?

The EPA component conducting the project is responsible for the HSR/non-HSR determination. Some EPA components have an HSR Officer who is trained to make this determination accurately and to process those projects that meet the regulatory definition of HSR according to the requirements of 40 CFR 26 and Order 1000.17 Change A1. Personnel from EPA components where an HSR Officer is not available may contact the EPA Human Subjects Research Review Official (HSRRO) directly to obtain these services.

If the Project is HSR, What Does It Mean for EPA to be Engaged in It?

If EPA personnel interact or intervene in any way with human research subjects, or if they have access to identifiable private information about them, EPA is considered to be “engaged” in the HSR under the regulations. This means, among other things, that EPA must hold an assurance of compliance and that the research must be reviewed and approved by an institutional review board (IRB) listed on that assurance before it can be conducted, unless the research meets the regulatory criteria for exemption.

Federalwide Assurance (FWA):

EPA holds an FWA, which is an assurance of compliance that covers the engagement of the Agency in any HSR conducted or supported by any Common Rule agency, including EPA. EPA's FWA Number is FWA00012755. 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.

Institutional Review Board (IRB) Coverage:

EPA has a contract with the University of North Carolina at Chapel Hill (UNC) for IRB services that meet regulatory requirements. Options also exist for obtaining IRB review through other mechanisms, which can be arranged by the HSRRO when appropriate.

Research Conducted by the Office of Research and Development (ORD):

The Human Research Protocol Office (HRPO), located in the Environmental Public Health Division of the National Health and Environmental Effects Research Laboratory, processes and oversees all HSR conducted by ORD. The HRPO Director works directly with the HSRRO to obtain any needed input, as well as HSRRO review and approval of projects as required. The HRPO also serves as the interface with the UNC IRB. To contact the HRPO, call 919-966-6217.

Research Conducted by Other EPA Components:

EPA personnel outside of ORD should contact their local HSR Officer or the HSRRO directly for instructions about how to proceed. If the research is non-exempt and submission to the UNC IRB is planned, the HRPO will assume its interface function and facilitate the submission. In cases in which alternate IRB review arrangements are made, however, the HRPO's role will be more limited.

Project Review by the EPA Human Subjects Research Review Official (HSRRO):

EPA Order 1000.17 Change A1 requires that all HSR conducted by EPA be reviewed and approved by the 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. More detail about HSRRO review can be found on the Project Review page.


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