On January 19, 2017, the Environmental Protection Agency (EPA), acting in concert with other Federal 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) and jointly adopted by multiple departments and agencies that conduct or support research involving human subjects. EPA's codification of the Common Rule is in 40 CFR part 26, subpart A. These revisions went into effect on January 21, 2019, following a one-year implementation delay. 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. The currently-proposed action is to harmonize the EPA-specific regulations with revisions to the Common Rule in order to resolve those discrepancies.
Questions and Answers
Why is this proposed rule important?
EPA has adopted, as subpart A, the Common Rule that guides participating Federal Agencies in the ethical protection of human subjects participating in research subjects. The Agency is proposing to amend subparts C, D, K, and M of its regulations relating to human research. These changes are intended to correct regulatory citation references in subparts C and D that have been rendered ineffective by the revisions to the Common Rule, 82 FR 7149 (Jan. 19, 2017), codified by EPA at 40 CFR part 26, subpart A, and to harmonize language in subpart K with those revisions, where appropriate. Finally, there is a single typographical error in subpart M that should be corrected while this action is being undertaken.
How does the agency protect human subjects participating in research?
In addition to the Common Rule (subpart A), EPA has adopted several additional subparts to the rule at 40 CFR 26 that provide enhanced protection for participants in human research conducted or supported by EPA, or certain types of third party research. Specifically, the additional protections prohibit intentional exposure studies on children and pregnant or breast-feeding women. These EPA-specific subparts were added in 2006 in response to a Congressional mandate.
Does this proposed rule change how EPA protects human subjects participating in research?
No. EPA has not changed its additional protections that prohibit intentional exposure research on children or women who are pregnant or breast-feeding. The changes correct citation references, harmonize language, or correct a typographical error in subparts C, D, K, and M.
How can I comment on the proposed rule?
The proposed rule was posted on regulations.gov at https://www.regulations.gov/document?D=EPA_FRDOC_0001-23252. The public comment period closed on February 4, 2019. A response to comments will be published, along with the final rule, which is currently underway.
Where can I read the exisiting Human Subjects Research Rules?
- This is the EPA Rule for Protection of Human Subjects Research 2/14/13Exit
- This is the Revised Common Rule 1/21/19Exit
- Protection of Human Research Subjects (Proposed) (PDF)(12 pp, 255 K, December 6, 2018, EPA_FRDOC_0001-23252)