|Navigating the EPA human studies review board|
|Proposals to collect insect repellent efficacy data for registration purposes must first be reviewed by the US Environmental Protection Agency.|
The purpose of this review is to ensure the rights and safety of human research subjects in repellent efficacy tests. Scientific merit and potential societal benefit are also evaluated, as balanced against risks. The agency is supported in the review by the Human Studies Review Board (HSRB), a Blue Ribbon Panel of academic Bioethicists and Biomedical Researchers. This 16 member Board convenes quarterly in the Washington DC area to review our protocols and study reports.
Since the advent of this augmented regulation in early 2006, Carroll-Loye has worked intensively with EPA staff to further refine our state-of-the-art protocols. The EPA has recommended our protocols and study reports to the HSRB, and the Board has reviewed them favorably. Under the EPA review system, Carroll-Loye is the only repellent science company to deliver successful results to sponsors for both field and laboratory efficacy studies.
More information about the HSRB may be found on the US EPA web site at www.epa.gov/OSA/hsrb/index.htm. For answers to specific questions, and additional insight into meeting EPA and HSRB requirements, please contact us.