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About PHRE

Program in Human
Research Ethics

PHRE Online Tutorial

Project Review: All human subjects research (HSR) conducted or supported by EPA must be approved by the EPA Human Subjects Research Review Official (HSRRO) as compliant with EPA Regulation 40 CFR 26 (Protection of Human Subjects) or be determined to be exempt research before the research can begin. Further information about project review by the HSRRO is available on the Project Review page. EPA personnel involved in HSR should also refer to Conducting HSR or Making Funding Awards and Other Agreements that Support HSR depending on the nature of their HSR-related activities.

Compliance: The HSRRO is responsible for compliance oversight. Observed instances of apparent non-compliance with 40 CFR 26 should be reported to the PHRE at 202-564-2677 or phre@epa.gov for evaluation by the HSRRO.

Education: The HSRRO regularly gives training talks on HSR to EPA project officers and also makes other presentations both inside and outside the Agency. Slides from the most recent talks are available on the Education and Training page. This page also contains a link to a new PHRE online tutorial for investigators and others involved in human research supported by EPA.

Guidance: Advice on the interpretation of the EPA regulations governing HSR and their application to particular protocols can be obtained by consulting directly with the HSRRO.

Human Studies Review Board (HSRB): The HSRB is an independent advisory committee that meets approximately four times per year to review and comment on the scientific and ethical aspects of HSR referred to it by the Agency. On request, the Board may also provide advice to EPA on its programs for the protection of human research subjects. Further information about the HSRB is available on the HSRB page(PDF) (1 pg, 15K, About PDF) and on the HSRB website.


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