The Independent IRB, Inc. recognizes the importance of human research of products, such as pesticides, regulated by the Environmental Protection Agency (EPA). The Independent IRB, Inc. has been a leader in EPA human subject protection since the EPA published a Final Rule in February 6, 2006. Click here for more information on submitting your research study to Independent IRB, Inc. for review. All research under EPA regulations will be reviewed in compliance with the regulations of the Environmental Protection Agency (40 CFR 26). The IRB provides documentation of approved research to all applicable parties (i.e., Sponsor, CRO, and Investigator.) It is the responsibility of the Principal Investigator to ensure that required subsequent reviews by EPA, by the EPA Human Studies Review Board (HSRB,) and if the research is to be conducted in California, by the California Department of Pesticide Regulation (CDPR) have been completed before initiation of the study. The Independent IRB, Inc., requires that the Investigator or Sponsor report Independent IRB, Inc. approval to EPA and, if applicable, to CDPR, and confirm to Independent IRB, Inc., that all required regulatory reviews have been conducted. Recommendations by EPA, HSRB, or CDPR should be incorporated into revised proposals and submitted to Independent IRB, Inc., for review and approval before enrollment of any research participants in the study. Initiation of a study conducted for submission to EPA before obtaining all required regulatory reviews or before final approval of the protocol, consent form(s), and supporting materials by the reviewing IRB is a violation of EPA regulations and will be treated as non-compliance by the Independent IRB, Inc. Special consideration and attention should be given to EPA regulated research studies that involve children, pregnant women and to determine if the study is truly an observational study.