Human Studies Review Board
Client: Office of the Science Advisor, U.S. Environmental Protection Agency
Background
The Department of Interior, Environment, and Related Agencies Appropriations Act directed the U.S. Environmental Protection Agency to establish an independent Human Studies Review Board to review studies to be used for regulatory purposes under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Process
The Human Studies Review Board (HSRB) is a Federal advisory committee that was constituted to provide advice, information and recommendations on issues related to scientific and ethical aspects of human subjects research through provision of recommendations to the U.S. Environmental Agency (EPA) based on review of: (a) research proposals and protocols; (b) reports of completed research with human subjects; and (c) ways to strengthen EPA’s programs for protection of human subjects.
Based on a situational assessment related to difficult meeting and leadership dynamics, PPM suggested a range of process options to the HSRB. PPM provided the HSRB leadership with facilitation support, consulted extensively with the EPA’s Office of the Science Advisor and Office of Pesticide Programs (OPP) on issues related to membership, leadership, and meeting dynamics, and helped prepare orientation materials for new HSRB members.
The HSRB includes representatives of environmental scientific/technical fields, human health care professionals, academia, industry, public and private research institutes and organizations, other governmental agencies, and experts in disciplines such as bioethics, biostatistics, human health risk assessment, and human toxicology.
Result
Ultimately, the HSRB moved beyond its initial leadership challenges and became an effective body for providing scientific and ethical reviews of proposed studies and protocols for third party research conducted with human subjects.
