Children and Viable Neonates
The human subject research regulations define “children” as:
Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted [See 45 CFR 46.402(a) of the U.S. Department of Health and Human Services (HHS)].
In the United States the legal age of adulthood is a matter of state and local law. This means that who is legally considered a child may vary from state to state; in a large majority of states 18 years old is the legal age of adulthood. But this is not true in every state, locality, or territory.
Also, there may be exceptions to who is considered a child and additional laws in places that define emancipated minors. The definition of “children” also takes into account the particular treatments or procedures involved in the proposed research. For example, in some places individuals who are 16 may legally consent to certain medical treatments, and so if the involvement of human subjects in a proposed research activity consists of these treatments, then they may be considered as adults for that purpose. If a proposed activity includes something for which the subject has not yet reached the legal age of consent, however, that person must be considered a child.
When required, permission for the participation of children or viable neonates in research may only be obtained from the parent(s) or legally authorized representative. The Institutional Review Board (IRB) will determine if one or both parents’ permission is required based on risks and benefits of the research in accordance with 45 CFR 46 subpart D.
In addition to parental permission, federal regulations require that the Institutional Review Board (IRB) must determine whether adequate provisions are made for soliciting the Assent of a child to participate in research when the child is capable of providing assent [45 CFR 46.408]. Assent is defined as “a child’s affirmative agreement to participate in research.” However, the mere absence of an objection by the child should not be construed as Assent.
Children who are wards of the state or any other agency, institution, or entity require the appointment of an advocate, in addition to the child’s legally authorized representative, when the research is greater than minimal risk, and has no prospect of direct benefit to the child.
References and Additional Guidance
- U.S. Food and Drug Administration (FDA): section 21 CFR 50, subpart D
- U.S. Office of Human Research Protections (OHRP): section 45 CFR 46, subpart D
- U.S. Office of Human Research Protections (OHRP): “Research with Children – FAQs”