Abstract

The Environmental Protection Agency (EPA) is considering the promulgation of a regulation designed to ensure the protection of human research subjects in studies used for setting environmental standards. This regulation would result in a comprehensive EPA human study review process and review board specifically designed for such studies. The process would differ from that set out in the Rule, which details acceptable ethical standards for the protection of human subjects in research conducted or sponsored by all federal agencies. The authors of this Policy Forum suggest that a far simpler and more effective approach is to require the adoption of the Common Rule or its foreign equivalents for all research used for in standard setting, regardless of the provenance of the study.

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