History and Focus of the Human Studies Review Board
The Human Studies Review Board (HSRB) is a statutory FAC to provide advice, information, and recommendations on issues related to scientific and ethical aspects of proposed or completed human research submitted by EPA, including research involving intentional exposure of human subjects to any substance to be considered by EPA in connection with an action under FIFRA (7 U.S.C. 136–136y) or section 408 of FFDCA (21 U.S.C. 346a), and research involving intentional exposure of human subjects to pesticides to be considered by EPA in connection with an action under any statute or regulation administered by EPA.
HSRB reviews:
- Research proposals and protocols
- Reports of completed research with human subjects
The HSRB must review proposals (or protocols) for research involving intentional exposure of human subjects, initiated after April 2006, and intended for submission to EPA prior to the enrollment of subjects. Absent such a review, EPA is prohibited from relying on the resulting data. Any EPA office that intends to take an action under any regulatory statute (not only pesticide laws) administered by EPA based on third-party research of pesticides that meet the criteria of 40 CFR Part 26 involving intentional exposure of human subjects must solicit the views of the HSRB on the human research prior to EPA’s reliance on the data. For decisions under the pesticide laws (FIFRA and FFDCA), EPA must request HSRB review of any research involving intentional exposure to any substance (not only pesticides).
The HSRB meets up to 4 times a year in meetings that are open to the public.
The HSRB reports to the EPA Administrator through EPA's Human Subject Research Review Official (HSRRO). After each meeting, the HSRB produces a Final Report that summarizes the advice and recommendations for each topic reviewed.
This site contains materials that were made available to or produced by the HSRB. The meeting minutes and reports posted on this site are the products of the HSRB and represent the views and recommendations of the HSRB, not the EPA. They do not represent information approved or disseminated by the EPA and, hence, do not necessarily represent the views and policies of the EPA, nor of other agencies in the Executive Branch of the federal government, nor does mention of trade names or commercial products constitute a recommendation for use.
Charter and Bylaws
The charter provided below renews the Human Studies Review Board (HSRB) in accordance with the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. 10. This Committee was established January 20, 2006 under the authority of the “Department of Interior, Environment, and Related Agencies Appropriations Act, 2006”, Public Law 109-54 and 40 CFR 26.1605. A link to information for HSRB members is also provided below.