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 Order 1000.17 Change A1 (now archived) further codifies EPA requirements for the protection of human research subjects in 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 only if the IRB finds and documents that the research is consistent with 45 CFR 46 Subpart D and that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians (see IRB policy for research involving children for information about permission and assent requirements).
- 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 that the research is consistent with 45 CFR 46 Subpart D, including adequate provisions to obtain parent permission and child assent,
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, and
o risk-to-benefit ratio of the research is at least as favorable to the subjects as that of available alternative approaches.
Additional Requirement for EPA Review and Approval Following IRB Approval
EPA Prohibitions for Human Subject Research
Research conducted or supported by EPA, or intended for submission to the EPA, the University IRBs recognize that research involving the intentional exposure of pregnant women or children is prohibited and will not approve such research. This prohibition extends to intentional exposure by third-parties on behalf of the University and to research not conducted or supported a federal agency.
Additional Requirements for Human Research Involving Intentional Exposure to Pesticides*
NOTE: The following applies to intentional exposure by third-parties on behalf of the University and to research not conducted or supported a federal agency.
Unless the research is exempt under DHHS regulations (45 CFR 46.101 item (4), EPA requirements a §26.1101 (i.e., Subpart K) apply to research involving intentional exposure of non-pregnant, non-nursing adults that was initiated on or after April 15, 2013 to
- any substance* if the person who conducted or supported the research intended either to submit results to EPA or hold the results for later EPA inspection by EPA for consideration of an EPA action under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136-136y) or section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a); or
- a pesticide if the person who conducted or supported the research intended either to submit results to EPA or hold the results for later EPA inspection by EPA for consideration in connection with any EPA-regulated action other than FIFRA or section 408 of FFDCA.
The IRB and EPA may consider any available and relevant information to assess a person's intent as described above. The existence of intent will be presumed if the person conducting or supporting the research, or her/his agent:
- has submitted or made available for inspection the results of such research to EPA; or
- is a member of a class of people who, or whose products or activities, are regulated by EPA and the results of the research would be relevant to EPA's regulatory authority.
University and Affiliate investigators must also comply with applicable foreign laws/regulations providing additional protections to human subjects and the Nevada Pesticide Act (NRS Chapter 586). The Act includes requirements for registration of brands of pesticides which are or will be distributed, sold or offered for sale within Nevada, or delivered for transportation or transported in intrastate commerce or between points within Nevada through any point outside Nevada.
Additional EPA Requirements for Submission of Information to EPA for Completed Research
After completing research subject to EPA regulations for human research, Investigators must comply with EPA regulations at §26.1303 by providing the EPA with the following information (when not previously provided to the EPA):
- Copies of all of all records relevant to the research (e.g., IRB applications; scientific evaluations, if any; approved sample consent documents; progress and problem reports, and IRB approvals.
- Copies of all of records relevant to the requirement for EPA approval following IRB approval (at §26.1125).
For three years following the closure of the research project, Investigators and the IRB will maintain the records as specified in §26.1115, item (a).
NOTE: If any of this information is not provided, the PI must describe the efforts made to obtain the information.