title: Ethics committees and paediatric research: a personal viewpoint.
abstract: Surveillance of clinical research involving child subjects, or tissues taken from them, continues to become more formalized and sophisticated. Many doctors and most paediatricians can be expected to be offered the opportunity to serve on paediatric Institutional Ethics Committees (IEC) at some stage of their professional lives. Fearless and independent Ethics Committees have considerable influence on both the design and implementation of clinical research, and on the topics of allowable research in which infants and children will be involved. The composition of IECs generally is designed to give a balance of sexes, professional backgrounds, and institutional and non-institutional affiliations. In addition to these now well established compositional guidelines, IECs adjudicating on paediatric research have a pragmatic requirement for three extra specific roles: those of in loco parentis, in loco infanti, and the special role of nursing staff. These roles and the ethical basis for them are defined. Further, the in loco parentis role is ethnically complex, and an IEC considering this role should be clear about its implications. Paediatric research projects involve not only specific risks inherent to the project in question, but also more general risks inherent in any clinical research intervention endeavour itself. Paediatric IECs should act in a mode of encouragement, rather than purely as 'doctor watchers', and should insist ab initio on the publication of results as a condition of permission to undertake the research in question. One particularly effective form of ethical audit is the national and international peer review that follows such publication of paediatric research. This report discusses these special themes in the evolving context of greater surveillance of paediatric research.
mesh_terms: D002648:Child; D026724:Ethical Review; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D033161:Government Regulation; D006805:Human Experimentation; D006801:Humans; D033181:Information Dissemination; D033281:Nontherapeutic Human Experimentation; D010372:Pediatrics / Q000592:standards; D011367:Professional Staff Committees; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation