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

Federal Regulations for EPA Research Involving Human Participants

The EPA adopted the Common Rule under 40 CFR 26 A 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 investigators 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.

Additional EPA Requirements for IRB Review and Approval

In addition to the Common Rule, University IRBs will comply with the following additional requirements before approving research invoking EPA regulations.

  • The IRB will not approve research involving intentional exposure of pregnant women or children to any substance. This includes research not yet submitted to the EPA.
  • The IRB will review and approve observational research involving pregnant women and fetuses only if the IRB finds and documents that the research is consistent with 45 CFR 46 Subpart B (for details, see IRB policy for research involving pregnant women and fetuses).
  • The IRB will review and approve observational EPA research involving children that does not involve greater than minimal risk only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians (for details, see IRB policy for consent and assent requirements for research involving children).
  • The IRB will review and approve observational EPA research involving children that poses greater than minimal risk only if the IRB finds and documents that

o   the intervention or procedure holds out the prospect of direct benefit to the individual subject or is likely to contribute to the subject's well-being,
o   the risk is justified by the anticipated benefit to the subjects,
o   risk-to-benefit ratio of the research is at least as favorable to the subjects as that of available alternative approaches, and
o   adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.

Additional EPA Requirements for Submission of Human Subject Research to EPA
When the intention of research is submission to the EPA but the research is not conducted or supported by any federal agency that has regulations for protecting human research subjects, the following EPA requirements apply:

  • the prohibition against the intentional exposure of pregnant women, nursing women, or children to any substance; and
  • the extension of the provisions of 40 CFR 26 to human research involving the intentional exposure of non-pregnant, non-nursing adults to any substance.

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