Environmental Protection Agency Docket EPA-HQ-ORD-2018-0280 Proposed Rule

2018-26228: Protection of Human Research Subjects

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Public comment closed .

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Summary

On January 19, 2017, the Environmental Protection Agency (EPA), acting in concert with other agencies, promulgated revisions to the "Common Rule," which is based on regulations for the protection of human research subjects originally promulgated by the Department of Health and Human Services (HHS) that were then revised and jointly adopted by multiple departments and agencies that conduct or support research involving human subjects. EPA's codification of these revisions is in 40 CFR part 26, subpart A. These revisions will go into effect on January 21, 2019. In addition to the core protections found in the Common Rule, EPA has promulgated regulations that are specific to research involving human subjects conducted or sponsored by EPA or submitted to EPA for regulatory purposes. The revisions to the Common Rule create a discrepancy within some of these EPA-specific regulations. This proposed action is to harmonize the EPA-specific regulations with revisions to the Common Rule in order to resolve those discrepancies.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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