Office of Human Research Ethics SOP 2201: Research Subject to the U.S. Environmental Protection Agency Regulations

Title

Office of Human Research Ethics SOP 2201: Research Subject to the U.S. Environmental Protection Agency Regulations

1. Purpose

The purpose of this SOP to establish written requirements to ensure compliance with U.S. Environmental Protection Agency (EPA) requirements regarding human subjects research.

This SOP applies to all research involving human subjects conducted or supported by the EPA and thus subject to the requirements set forth in 40 CFR Part 26. 40 CFR 26 includes EPA-specific additional protections and prohibitions at Subparts B-D for children, pregnant women and fetuses, and nursing women in research conducted or supported by EPA. It also contains requirements for third-party human research for pesticides and rules for data use, compliance oversight, and other matters. Additional EPA requirements are set forth in EPA Order 1000.17A: Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research.

2. Responsibility

The University of North Carolina at Chapel Hill (UNC-Chapel Hill) Institutional Review Board (IRB) and researchers conducting human subjects research supported by the EPA are responsible for ensuring compliance with this SOP.

3. Definitions

Child is defined by the EPA as a person who has not attained the age of 18 years.

Intentional exposure research means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study.

Observational research means any human research that does not meet the definition of research involving intentional exposure of a human subject. 

Observational Human Exposure Studies are studies that involve collection of environmental samples, data, and information from study participants in their everyday environments as they go about their normal activities.  They involve neither the deliberate exposure of participants nor the control of environmental conditions in a way that impacts the participants’ naturally occurring exposures. All human observational exposure studies conducted or supported by the EPA must comply with the principles set forth in the EPA document entitled Scientific and Ethical Approaches for Observational Exposure Studies (SEAOES).

Pesticide means any substance or mixture of substances meeting the definition in 7 U.S.C. 136(u) (Federal Insecticide, Fungicide, and Rodenticide Act, Section 2(u)).

4. Procedures

4.1 EPA Review of Human Subjects Research

All human subjects research conducted or supported by the EPA must be either approved or acknowledged as exempt by the EPA Human Subjects Research Review Official (HSRRO) before any research activities can begin. Preliminary review by the HSRRO can be requested for any research project, contract, grant application, cooperative agreement, cooperative research and development agreement (CRADA), interagency agreement, or any formal agreement involving EPA support. However, preliminary review is not required and if provided does not substitute for approval following IRB review.

In laboratories or regions where there is a HSRRO-approved Human Subjects Officer (HSO), projects must first be reviewed by the on-site HSO before being presented to the HSRRO. In absence of an HSO, projects must be submitted directly to the HSRRO. To obtain approval or concurrence of exemption by the HSRRO, researchers must submit the IRB-approved research package or documentation of exemption, including evidence of IRB approval and any correspondence between the IRB and the researcher(s). Researchers must also provide evidence of a Federalwide Assurance (FWA) on file with the U.S. Department of Health and Human Services (HHS).

4.2 EPA Notification Requirements

Investigators must notify the EPA HSRRO (and HSO where applicable) and EPA Project Officer of the following:

• IRB suspension or termination of research, and/or
• Unanticipated problems involving risks to subjects or others.

4.3 EPA-Specific Requirements

Subpart B of the regulations prohibits intentional exposure research, under all circumstances, in children and women who are pregnant or nursing. The ban is categorical and is not based on a risk-benefit ratio, including prospect of direct benefit.

Subpart C establishes rules for studies that involve pregnant women (and thus their fetuses) participating in observational research. Research of this nature can be conducted when there is direct benefit to the woman or the fetus. However, in the absence of direct benefit, if the risk is no greater than minimal to the fetus and the research is important for biomedical knowledge which cannot be obtained in any other manner, the research is permissible.

Subpart D applies to observational research involving children as subjects. EPA will conduct or support observational research involving children for which the IRB finds that no greater than minimal risk is presented. If the IRB finds that an intervention or procedure presents more than minimal risk to children, EPA will not conduct or support such intervention or procedure unless the IRB finds and documents that:

• 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;
• The risk is justified by the anticipated benefit to the subject;
• The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by alternative approaches; and
• Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in 40 CFR 26.406. 

Subpart K applies to all research initiated on or after September 23, 2019 involving intentional exposure of non-pregnant, non-nursing adults to:

1. Any substance, if at any time prior to initiating such research, any person who conducted or supported such research intended either to submit results of the research to EPA for consideration in connection with any action that may be performed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act or Section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), or to hold the results of the research for later inspection by EPA; or
2. A pesticide if, at any time prior to initiating such research, any person who conducted or supported such research intended either to submit results of the research to EPA for consideration in connection with any action that may be performed by EPA under any regulatory statute administered by EPA other than those statutes designated in paragraph (a)(1) of 40 CFR 26.1101, or to hold the results of the research for later inspection by the EPA under any regulatory statute administered by EPA other than those statutes designated in paragraph (a)(1) of 40 CFR 26.1101.

Subpart M establishes requirements for submission of information on the ethical conduct of completed human research. Investigators conducting EPA-regulated research must at the time of completion of such research, if not previously provided to the EPA, provide the following information to the EPA:

• Copies of all records relevant to the research specified by 40 CFR 26.1115(a) to be prepared and maintained by an IRB;
• Copies of all the records relevant to the information identified in 40 CFR 26.1125(a) through (f); and
• Copies of sample records used to document informed consent, but not identifying any subjects of the research.

If an investigator does not provide any of the above-referenced information to the EPA, the investigator must describe the efforts made to obtain the information.

Contact Information

Policy Contact

Office of Human Research Ethics
CB 7097
720 Martin Luther King Jr. Blvd.
Bldg # 385, Second Floor
Chapel Hill, NC 27599-7097

Ph: 919-966-3113
Fax: 919-966-7879