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Program in Human Research Ethics (PHRE)

Program in Human
Research Ethics

PHRE Online Tutorial

The mission of the Program in Human Research Ethics (PHRE) is to support the ethical conduct and regulatory compliance of human subjects research (HSR) conducted, supported, or regulated by EPA. PHRE provides direct regulatory oversight of HSR conducted or supported by the Agency, and it also supports the Office of Pesticide Programs (OPP) in its regulatory oversight of HSR done by third parties involving substances meeting the regulatory definition of pesticides over which EPA has statutory authority. PHRE executes its mission through the coordinated activities of its two components, the Human Subjects Research Review Official (HSRRO) and the Human Studies Review Board (HSRB).

History leading to the establishment of PHRE:

1977: EPA issues Order 1000.17 requiring that certain human research conducted or supported by the Agency be conducted according the requirements of 45 CFR 46, the regulation for the protection of human subjects promulgated by the Department of Health, Education, and Welfare and the predecessor regulation to the Common Rule.

1991: EPA joins multiple other Federal agencies in adopting the newly promulgated Common Rule for the protection of human subjects in all research conducted, supported, or otherwise subject to regulation by any agency adopting the rule. EPA codifies the Common Rule at 40 CFR 26.

1999: EPA designates a part-time HSRRO in the Office of Research and Development (ORD) and issues Order 1000.17 Change A1 to replace Order 1000.17 for all human research conducted or supported by the Agency. Under the new policy, the HSRRO must approve all research covered by the policy as compliant with 40 CFR 26 or determine it to be exempt research before the research can begin.

2006: EPA promulgates an expanded version of 40 CFR 26 containing additional protections for children, pregnant women, and nursing women in research conducted or supported by the Agency, as well as specific regulations for third-party human research for pesticides submitted to EPA under the pesticide laws. The expanded rule establishes the HSRB, which EPA places in OSA to help assure its independence. At the same time, a dedicated program is established by the Agency in OPP to provide regulatory oversight of the newly regulated third-party pesticide research, and the HSRB supports the OPP program by reviewing and providing advice on particular studies as mandated by the rule. Later in the year, the HSRRO position is converted from part-time to full-time and moved from ORD to OSA.

2008: The HSRRO and the HSRB are together designated the Program in Human Research Ethics in OSA under the direction of the HSRRO.

Special Note on Human Subjects Research at the EPA

The EPA has a ban on conducting intentional exposure research that involves pregnant women, nursing women, or children. This means that the EPA cannot conduct, fund, or sponsor any research that introduces a new exposure to a group, or modifies subjects’ exposure in any way -- *including by decreasing their exposure* – if the research involves any of these protected groups. For more information about this, please see the “Project Review” page or contact the Human Subjects Research Review Official at 202-564-2550 or schonfeld.toby@epa.gov.

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