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Yes, Subpart D of the HHS regulations at 45 CFR part 46 provides additional protections for children participating in human subjects research. Investigators conducting HHS-supported research must comply with the requirements of subpart D, as well as other subparts. The IRB must determine that all requirements of subparts A and D have been met. If the research involves pregnant minors, then the requirements of subpart B must be met and if the research involves incarcerated minors then the requirements of subpart C must be met.

Subpart D’s additional protections include:

1. requiring IRB review of some research activities involving children that would be exempt if the research subjects were adults;
2. use of parental permission and child assent instead of the procedures for obtaining informed consent used for research involving adults;
3. conditions for IRB approval of proposed research activities in three categories depending on the level of risk and other specified features of the proposed research activity;
4. review by the Secretary for research that an IRB finds not approvable under any of the three categories; and,
5. additional conditions for certain research activities involving children who are wards of the State or any other agency, institution, or entity

1. Altering the Exemption: Subpart D widens the range of research activities requiring IRB review by reducing the scope of the exemption in 45 CFR 46.101(b)(2) regarding research activities involving education tests, survey or interview procedures, or observation of public behavior, if the subjects are children. The exemption of research activities involving survey and interview procedures is eliminated. The exemption is also narrowed for research involving observation of public behavior, by eliminating the exemption of any research involving observation of public behavior if the investigator will participate in the activities being observed.
2. Parental Permission and Child Assent: Subpart D uses parental permission and child assent instead of the procedures for informed consent used for research involving adults. In general, one or both parents or a guardian must be provided with the information ordinarily required for informed consent, so that they may decide whether to allow the child to participate, and children capable of assent must also express their willingness to participate.Subpart D allows for various conditions and waivers of parental permission and child assent, depending on the nature of the research activity and the maturity of the child.
3. Categories of Approvable Research: Subpart D requires the reviewing IRB to identify the level of risk, the potential for direct benefits to the subjects, and other specified features of the research during the approval process. Depending on the level of risk and other specified features of the research activity, there are three categories under which the IRB can approve research involving children.
4. Secretarial Review: If the IRB does not believe that a proposed research activity fits any of the three categories, but that it does present a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children, the IRB may forward that proposed activity to the HHS Secretary for review under conditions identified in section 407 of the regulations.
5. Wards: Subpart D also sets additional conditions for research involving children who are wards of the State or any other agency, institution, or entity if the research is approved under two of the categories of approvable research: it limits the kind of research activities approved under these two categories in which children who are wards can participate, and it requires the appointment of an advocate to act in the best interests of the child.

Last Reviewed: 01/20/2011

• How do the human subject research regulations define “children”?
• What categories of research involving children can an Institutional Review Board approve?
• What research involving children may an Institutional Review Board refer to the HHS Secretary for special review under 45 CFR 46.407?
• When should an Institutional Review Board (IRB) or institution request a “407” review for research involving children as subjects?
• What materials must be submitted to the Office for Human Research Protections with a request for a 407 review for research involving children?

• Research with Children