Guidelines for medical research in children.
Nearly everyone agrees that violations in research occur. Nobody knows how often. But if Pediatrics is to progress children must be the subjects of research carried out in an acceptable way. The following guidelines should be followed in childhood experimentation: (1) Research should not be done on children if the same investigation can be done in adults. (2) All research projects must be evaluated by ethics committees having as members lay people and investigators possessing the qualities of competence and judgement. (3) The degree of benefit from a research procedure should be assessed against the risk of disturbance, discomfort or pain. (4) Statements regarding consent are meaningless and consent is still only partially informed. Although a parental signature does not mean that consent is informed, nevertheless parental consent must still remain as a key requirement in childhood experimentation.
Papadatos
C J
CJ
Children's Hospital, Aglaia Kyriakou, GR-Athens, Greece.
D026683:Advisory Committees; D002648:Child; D032781:Codes of Ethics; D030881:Disclosure; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D005060:Europe; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D038622:Internationality; D033242:Minors; D033281:Nontherapeutic Human Experimentation; D033282:Parental Consent; D012106:Research / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends*; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation; D006113:United Kingdom; D014481:United States