Clinical Research Involving Children

Type: Consensus Study
Topics: Biomedical and Health Research, Children and Families, Public Health
Board: Board on Health Sciences Policy

Activity Description

An IOM committee reviewed and considered federal regulations, federally prepared or supported reports, federally supported evidence-based research, and other sources of available information related to research involving children. Based on this review the IOM prepared a report that includes recommendations relating to clinical research involving children.

In conducting the review the IOM considered:

  1. The written and oral process of obtaining and defining "assent", "permission" and "informed consent" with respect to child clinical research participants and the parents, guardians, and the individuals who may serve as the legally authorized representatives of such children (as defined in subpart A of part 46 of title 45, Code of Federal Regulations).
  2. The expectations and comprehension of child research participants and the parents, guardians, or legally authorized representatives of such children, for the direct benefits and risks of the child's research involvement, particularly in terms of research versus therapeutic treatment.
  3. The definition of "minimal risk" with respect to a healthy child or a child with an illness.
  4. The appropriateness of the regulations applicable to children of differing ages and maturity levels, including regulations relating to legal status.
  5. Whether payment (financial or otherwise) may be provided to a child or his or her parent, guardian, or legally authorized representative for the participation of the child in research, and if so, the amount and type of payment that may be made.
  6. Compliance with the regulations referred to in subsection (a)(1)(A), the monitoring of such compliance (including the role of institutional review boards), and the enforcement actions taken for violations of such regulations.
  7. The unique roles and responsibilities of institutional review boards in reviewing research involving children, including composition of membership on institutional review boards.

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