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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
06-1045 Protections for Subjects in Human Research Rule With this final rule, EPA bans research for pesticides involving intentional exposure of human subjects, when the subjects are pregnant women or children. The rule further strengthens existing protections for subjects in research conducted or supported by EPA, by prohibiting such research if it would involve intentional exposure of human subjects who are pregnant women or children. The rule also extends new protections to adult subjects in research for pesticides conducted by others who intend to submit the research to EPA, when it involves intentional exposure of human subjects who are non-pregnant adults, and creates a new, independent Human Studies Review Board to advise the Agency on the ethical and scientific issues arising in such research. This final rule focuses on third-party intentional dosing human studies for pesticides and sets the stage for further Agency actions. In addition, in order to display the OMB control number for the information collection requirements contained in this final rule, EPA is amending the table of OMB approval numbers for EPA regulations that appears in 40 CFR part 9. 2006-02-06 2006 2 https://www.federalregister.gov/documents/2006/02/06/06-1045/protections-for-subjects-in-human-research https://www.govinfo.gov/content/pkg/FR-2006-02-06/pdf/06-1045.pdf Environmental Protection Agency 145 With this final rule, EPA bans research for pesticides involving intentional exposure of human subjects, when the subjects are pregnant women or children. The rule further strengthens existing protections for subjects in research conducted or supported...

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