A Review of Legal Instruments and Codes on Medical Experimentation with Children

“A Review of Legal Instruments and Codes on Medical Experimentation with Children” (1994) 3 Cambridge Quarterly of Health Care Ethics 560-73.

Full Version (PDF)
Many governments and professional organizations have developed legal or administrative instruments that treat pediatric research differently from research with adult subjects.  This paper reviews an extensive array of legal instruments and codes to determine how they deal with four specific issues: 1) when it is permissible to conduct pediatric research, 2) who decides whether a particular child can be a research subject, 3) what kinds of research can be conducted, and 4) the composition of committees that evaluate research protocols from an ethical standpoint. There seems to be a general consensus that pediatric research is permissible but should only be conducted when research on adults cannot yield the same information. Documents differ to a great extent on how they approach children’s involvement in the decision to participate in research; some adopt a highly protectionist stance, relying solely on parental consent, while others adopt the dual requirement of parental permission and children’s consent.  herapeutic procedures are subject to a favorable risk-benefit analysis, although some documents look additionally at the magnitude of the risk or benefit; nontherapeutic research is permitted, subject to a limitation on the magnitude of the risk faced. Codes give scant attention to the composition of research ethnics committees that review proposals for pediatric research.