Sec. 26.401 To what do these regulations apply?

(a) This subpart applies to all research involving children as subjects, conducted or supported by EPA. This subpart also applies to all research involving children covered by Sec. 26.101(j).

(1) This includes research conducted by EPA employees, except that each head of an Office of the Agency may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint.

(2) It also includes research conducted or supported by EPA outside the United States, but in appropriate circumstances, the Administrator may, under Sec. 26.101(e), waive the applicability of some or all of the requirements of these regulations for research of this type.

(b) Exemptions at Sec. 26.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at Sec. 26.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at Sec. 26.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.

(c) The exceptions, additions, and provisions for waiver as they appear in Sec. 26.101(c) through (i) are applicable to this subpart.

Sec. 26.402 Definitions.

The definitions in Sec. 26.102 shall be applicable to this subpart as well. In addition, as used in this subpart:

(a) Children are persons who have not attained the age of 18.

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

(c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.

(d) Parent means a child’s biological or adoptive parent.

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

Sec. 26.403 IRB duties.

The provisions of 45 CFR 46.403 are applicable to this section.

Sec. 26.404 Research not involving greater than minimal risk.

EPA will conduct or fund 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 Sec. 26.408.

Sec. 26.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

EPA will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being, only if the IRB finds and documents that:

(a) The risk is justified by the anticipated benefit to the subjects. (b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches.

(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in Sec. 26.408.

Sec. 26.406 [Reserved]

Sec. 26.407 [Reserved]

Sec. 26.408 Requirements for permission by parents or guardians and
for assent by children.

(a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved.

This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with Sec. 26.116(d).

(b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by Sec. 26.116, that adequate provisions are made for soliciting the permission of each child’s parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under Sec. 26.404 or Sec. 26.405.

(c) In addition to the provisions for waiver contained in Sec. 26.116, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in subpart A of this part and paragraph

(b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, State or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

(d) Permission by parents or guardians shall be documented in accordance with and to the extent required by Sec. 26.117.

(e) When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.

Sec. Sec. 26.409-26.419 [Reserved]

Sec. 26.420 Prohibition of research involving intentional dosing of children.

Notwithstanding any other provision of this part, under no circumstances shall EPA or a person when covered by Sec. 26.101(j) conduct or support research involving intentional dosing of any child.

Sec. 26.421 Prohibition of EPA reliance on research involving intentional dosing of children.

In its regulatory decision-making under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), EPA shall not rely on any research involving intentional dosing of any child, except when such research is deemed scientifically sound and crucial to the protection of public health, under the procedure defined in Sec. 26.603.