History and Focus of the Human Studies Review Board
The Human Studies Review Board (HSRB) provides advice and recommendations on third-party research involving exposure to pesticides, where the results are intended to be submitted or relied upon in connection with any regulatory action that EPA takes or involving intentional exposure to any substance (not only pesticides) when the results are intended to be submitted in support of or relied upon in connection with decisions under the pesticide laws (FIFRA and FFDCA).
- Third-party research proposals and protocols
- Third-party reports of completed research with human subjects
The HSRB must review proposals (or protocols) for third-party 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 third-party 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 third-party 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 Science Advisor. 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
A charter for the Human Studies Review Board dated February 21, 2006, was issued in accordance with the provisions of FACA, 5 U.S.C. App.2 § 9. The Board's charter was reauthorized March 25, 2014. A link to information for HSRB members is also provided below.