MSU HRPP Manual Section 2-2-B

U.S. Environmental Protection Agency

In addition to Basic U.S. Environmental Protection Agency (EPA) Policy for Protection of Subjects in Human Research (40 CFR 26 subpart A), the EPA has promulgated additional requirements for human subject research in subparts B – Q. This policy addresses the applicability of the EPA requirements to human subject research reviewed by the Michigan State University (MSU) Institutional Review Boards (IRB). Research conducted or supported by the EPA includes research conducted in EPA facilities by any person and research conducted in any facility by EPA employees.

EPA requires submission of IRB determinations and approval to the EPA Human Subjects Research Review Official (HSRRO) for final review and approval before research can begin. All EPA human subjects research must either be approved or be acknowledged as exempt research by the EPA HSRRO before any work involving human subjects research can begin. EPA Order 1000.17A (6/15/2016)

Subpart B

Subpart B prohibits research that is conducted or supported by the EPA from involving intentional exposure of human subjects who are children or pregnant or nursing women. See 40 CFR 26 Subpart B.

Subpart C

Subpart C provides additional protections for pregnant women and fetuses involved as subjects in observational research conducted or supported by the EPA. This subpart applies the provisions of 45 CFR 46.203, 204, and 206 and states that the exemptions at 40 CFR 46.101(b)(1) through (b)(6) are applicable to this subpart. See HRPP Manual “Pregnant Women” for requirements. See 40 CFR 26 Subpart C.

Subpart D

Subpart D provides additional protections for children involved as subjects in observational research conducted or supported by the EPA. Under this subpart, research involving children is classified into two categories. The IRB determines which category the research qualifies for and that the research meets the corresponding requirements within the category.

40 CFR 26.404 Observational research not involving greater than minimal risk. EPA will conduct or fund observational research in which the IRB finds that no greater than minimal risk to children is presented, 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, as set forth in § 26.406

40 CFR 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. If the IRB finds that an intervention or procedure presents more than minimal risk to children, EPA will not conduct or fund observational research that includes such an intervention or procedure unless the IRB finds and documents that:

(a)        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;

(b)        The risk is justified by the anticipated benefit to the subjects;

(c)        The relation of the anticipated benefit to the risk is at least as favor-able to the subjects as that presented by available alternative approaches; and

(d)        Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in § 26.406.

The requirements for permission by parents or guardians and for assent by children are similar to 45 CFR 46 Subpart D; 40 CFR 26.406(a) includes “observational” research, 40 CFR 26.406(b) provides that the IRB may find that permission of one parent is sufficient for research conducted under 40 CFR 26.404 or 405, and 40 CFR 26.406(c) adds “equivalent” regarding additional protections. See 40 CFR 26 Subpart D.

Subpart K

Subpart K provides the basic ethical requirements for third-party human research for pesticides involving intentional exposure of non-pregnant, non-nursing adults. Except as provided in 40 CFR 26.1101(c), this subpart applies to all research initiated on or after September 23, 2019 involving intentional exposure of a human subjects 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 (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 to hold the results of the research for later inspection by EPA under FIFRA or section 408 of FFDCA; 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 this section, or to hold the results of the research for later inspection by EPA under any regulatory statute administered by EPA other than those statutes designated in paragraph (a)(1) of this section. 40 CFR 26.1101(a).

Unless otherwise required by the Administrator, research is exempt from this subpart if it involves only the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens from previously conducted studies, and if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 40 CFR 26.1101(c).

Subpart K incorporates the EPA basic policy for the protection of human research subjects (40 CFR 26 subpart A) into subpart K.  See 40 CFR 26 Subpart K.

Subpart L

Subpart L applies to any research subject to subpart K (see above) and prohibits third party research involving intentional exposure to a pesticide of human subjects who are children or pregnant or nursing women. This research cannot be approved by the IRB. See 40 CFR 26 Subpart L.

Subpart M

Subpart M provides the requirements for submission of information on the ethical conduct of completed human research. See 40 CFR 26 Subpart M.

Subpart O

Subpart O applies to any human research subject to subparts A through L of this part and provides for administrative actions or disqualification. See 40 CFR 26 Subpart O.

Definitions

Assent: a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. 40 CFR 26.402(b)

Child: a person who has not attained the age of 18 years 40 CFR 26.202(b)

Guardian: an individual who is authorized under applicable State, Tribal, or local law to consent on behalf of a child to general medical care. 40 CFR 26.402(e)

Observational research: any human research that does not meet the definition of research involving intentional exposure of a human subject in 40 CFR 26.202(a). 40 CFR 46.302, 40 CFR 26.402(f)

Parent: a child’s biological or adoptive parent. 40 CFR 26.402(d)

Permission: the agreement of parent(s) or guardian to the participation of their child or ward in research. 40 CFR 26.402(c)

Research involving intentional exposure of a human subject: 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.  40 CFR 26.202 (a), 40 CFR 26.1102(i)

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 7-19-2011. Revision 1 approved by Assistant VP Regulatory Affairs on 12-9-2015. Revision 2 approved by Associate VP Research Regulatory Support on 7-24-2022.

Related HRPP Manual Sections

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