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Children as research participants: Regulations
IRB Member Fact Sheet--Version Date: Unknown
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.
- 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.
A waiver of parental permission is possible under 46.408(c).
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)].
For further information about research involving children, please contact the Health Sciences IRBs Office at (608) 263-2362 or consult our website at http://www.medicine.wisc.edu/irb