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Protections for Subjects in Human Research

pesticide · Rule · Published 2006-02-06 · Effective 2006-04-07 · 71 FR 6138

Document

Document number
06-1045
Federal Register citation
71 FR 6138
CFR reference
40 CFR 9
Type
Rule
Action
Final rule.
Category
pesticide
Publication date
2006-02-06
Effective date
2006-04-07
EPA docket
EPA-HQ-OPP-2003-0132

Abstract

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.

Source

Authoritative
Federal Register document
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