MSU HRPP Manual Section 2-2-B

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.

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. This subpart applies to all research initiated on or after April 15, 2013 involving intentional exposure of a human subjects to specific criteria defined in 40 CFR 26.1101(a)(1) and (2), unless the exemption defined in 40 CFR 26.1101(c) is applicable. 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 and prohibits third party research involving intentional exposure to a pesticide of human subjects who are children or pregnant or nursing women. 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.

Related HRPP Manual Sections

None

Approved PDF Version

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