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Children: Regulations

IRB MEMBER FACT SHEET 

Summary

Federal regulations require that IRBs give special consideration to protecting the welfare of vulnerable subjects, such as children. Title 45 CFR Part 46, Subpart D provides for "Additional Protections for Children Involved as Subjects of Research."

IRB Member's Role

When reviewing protocols that propose to enroll children, IRB members must pay particular attention to the additional regulatory requirements outlined in Subpart D. In order to approve the enrollment of children, each IRB member must assess the proposed project to determine whether it fits into one of the categories described below. Enrollment of children cannot be approved if the proposed project does not fit into one of the allowable categories.

46.404:

The research is NOT greater than minimal risk. The IRB must ensure that adequate provisions for soliciting the assent of the child and permission of the parents or guardian are in place;

46.405:

The research poses more than minimal risk to the child where the intervention or procedure holds out the prospect of direct benefit for the child, or is likely to contribute to the subjects well-being. The IRB must determine:

  • the risk is justified by the anticipated benefit to the child;
  • the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
  • adequate provisions are made for soliciting the assent of the child and the permission of the parent or guardian.

46.406:

The research poses greater than minimal risk with no prospect of direct benefit to the child, but is likely to yield generalizable knowledge about the child disorder or condition. The IRB must determine:

  • the risk represents a minor increase over minimal risk;
  • the intervention or procedure presents experiences to subjects that are reasonably commensurate with those with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;
  • the intervention/procedure is likely to yield generalizable knowledge about the child's disorder or condition; and
  • adequate provisions are made for soliciting assent of the child and permission of the parent or guardian.

In addition to making the appropriate regulatory finding, the IRB is responsible for ensuring that adequate provisions are made for obtaining the child's assent and the permission of each child's parents or guardians. The IRB may find the permission of one parent is sufficient for research approved under 46.404 or 46.405. Under 46.406, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when one parent has legal responsibility for the care and custody of the child.

A waiver of parental permission is possible under 46.408(c).

Definitions

Assent:

A child's affirmative agreement to participate in research [45 CFR 46.402(b)].

Children:

Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of jurisdiction in which the research will be conducted [45 CFR 46.402(a)]. Under Wisconsin law, the legal age for consent to treatment or research procedures is, in most cases, 18.

Guardian:

An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care [45 CFR 46.402(3)].

Minimal Risk:

That the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102(i)].

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