Impact of Human Studies Review Board on Agricultural Worker Exposure Studies

摘要

In February, 2006, the Final Rule strengthening existing protections for human volunteers in research studies was enacted. Along with extending new protections to subjects involved in pesticide research, the law created a new, independent Human Studies Review Board (HSRB) to advise the EPA on the ethical and scientific issues arising in such research. The process for gaining approval to conduct studies involving human volunteers has changed radically. Standard protocols that have been used for decades to conduct occupational exposure monitoring studies have been transformed as a result of input from HSRB. Many changes provide additional protections and rights for the volunteers. Additionally, the HSRB has had an impact on the science aspects of study protocols, including enhancement of the study objective, review and discussion of existing exposure data, statistical considerations, and fundamental changes in test subject identification and recruitment.