Office for Human Research Protections (OHRP)

Special Protections for Children as Research Participants

When a proposed research study involves children and is supported or conducted by HHS funding, the local research institution's Institutional Review Board (IRB) must take into consideration the special regulatory requirements that ensure the greatest protection for the children who would be involved in the research. If the proposed research involves FDA-regulated products, then FDA's parallel regulations apply.

By regulatory definition, children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under applicable law of the jurisdiction in which the research will be conducted. Generally the law considers any person under 18 years old to be a child.

In addition to the general regulatory requirements the IRB must consider, a research study involving children must also consider the benefits, risks and discomforts of the research and assess their justification for children's participation in light of the benefits to the child-subject or to society as a whole. In calculating the risks and benefits, the IRB should consider the circumstances of the children under study, the magnitude of risks or discomforts that may result from participating in the research, and the potential benefits the research may provide to the child or to other children with the same disease or condition.

For any protocol involving children, the IRB, in consultation with the principal investigator of the research study, must determine which of the four categories of research apply to that study and must document the rationale for this choice.

The categories of research which may be approved by IRBs are:

45 CFR 46.404 - Research that does not involve greater than minimal risk to the children;

45 CFR 46.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child involved in the study. To approve research in this category, the IRB must determine that

• the risk is justified by the anticipated benefits, and
• the risk represented by the study is at least as favorable for the child as other currently available treatments or procedures;

45 CFR 46.406 - Research involving greater than minimal risk and no prospect of benefit to the individual child in the study. In order to approve research in this category, an IRB must determine

• that the risk of the research represents no more than a minor increase over minimal risk;
• that the intervention or procedure presents experiences to the child that are reasonably commensurate with those inherent in their actual, or expected medical, dental, psychological, social or educational situations; and
• that the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition which is of vital importance for the understanding or amelioration of the disorder or condition.

45 CFR 46.407 - Research not otherwise approvable under one of the above categories but the IRB determines that the study presents a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children. In these cases the IRB will forward the research to the HHS Secretary [contact info] who may approve the research after consultation with a panel of experts and after requesting public comments on the proposed research. The Secretary must then determine

• that the research presents a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children,
• that the research will be carried out according to sound ethical principles, and
• that the research will be conducted in accordance with sound ethical principles.
  Materials to send to HHS for 46.407 review
  Research proposals previously reviewed under this category

In all cases, the IRB must ensure that adequate provisions have been made for soliciting permission of the parents or legal guardians and the assent of the children, to the degree possible.

Related Documents

Protections for Children in Research: A Report to Congress
http://www.hhs.gov/ohrp/reports/ohrp502.pdf

• Effects of Single Dose of Dextroamphetamine in Attention Deficit Hyperactivity Disorder: A Functional Magnetic Resonance Study

Research proposals previously reviewed under 45 CFR 46.407

• HIV replication and thymopoiesis in adolescents
• Characterization of mucus and mucins in bronchoalveolar lavage fluids from infants with cystic fibrosis
• Sleep mechanisms in children: role of metabolism
• Alcohol, sleep and circadian rhythms in young humans, study 2 - effects of evening ingestion of alcohol on sleep, circadian phase, and performance as a function of parental history of alcohol abuse/dependence
• Precursors to diabetes in Japanese-American youth
• A multi-center, randomized dose-response study of the safety, clinical and immune responses of Dryvax administered to children 2 to 5 years of age

HHS Home | Questions? | Contact HHS | Site Map | Accessibility | Privacy Policy | Freedom of Information Act | Disclaimers

The White House | FirstGov

U.S. Department of Health & Human Services · 200 Independence Avenue, S.W. · Washington, D.C. 20201