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90. Environmental Protection Agency (EPA) Regulations for Human Subject Research (40 CFR 26)

The EPA adopted the Common Rule under 40 CFR 26 Protection of Subjects in Human Research Conducted or Supported by EPA.

EPA Subparts B, C, D, K, L, M, and Q describe prohibitions involving the intentional exposure of a pregnant or nursing woman or child in research conducted or supported by EPA; prohibitions of relying on the results of said research; and criteria and procedures for the EPA to rely on otherwise unacceptable data. See the specific subparts listed below for details.

Subpart B §26.201-203: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects Who Are Children or Pregnant or Nursing Women

Subpart C §26.301-305: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA.

Subpart D §26.401-406: Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA

Subpart K §26.1101-1125 Basic Ethical Requirements for Third-party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults

Subpart L §26.1201-1203: Prohibition of Third-party Research Involving Intentional Exposure to a Pesticide of Human Subjects Who Are Children or Pregnant or Nursing Women

Subpart M §26.1301-1303: Requirements for Submission of Information on the Ethical Conduct of Completed Human Research

Subpart Q §26.1701-1706: Standards for Assessing Whether to Rely on the Results of Human Research in EPA Actions

The University IRB requires a supplemental EPA application for investigator planning to conduct research invoking EPA regulations. Supplemental applications are necessary for the IRB to verify that investigators have addressed the IRB-relevant elements in the EPA regulations.

In presenting the protocol to the IRB, the primary reviewer will address the additional EPA regulatory requirements.

Pre-award Requirements for EPA Approval of Contracts, Grants, or Other Agreements

All human research studies supported by the EPA must either be approved or be determined to be exempt by the EPA Human Subjects Research Review Official before any contract, grant, or formal agreement involving EPA support is awarded or entered into.

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