title: Ethics and medical research in children.
abstract: The ethics of clinical research is based on several well-known guidelines and documents. The guidelines vary between countries, but the principles of respect for persons, beneficence, and justice are constant. These principles are reflected in requirements to obtain free and informed consent, to minimize risk or harm, and to not overly burden or disadvantage particular populations. For research to be ethical, it must also be of such a standard, and be conducted in such a manner that it will generate knew and useful knowledge. Children have limited capacity for understanding and may be more open to coercion. Therefore, they are regarded as a particularly vulnerable population, and specific clauses regarding children are incorporated into many guidelines. A key concept in these clauses is the degree of risk acceptable for children involved in research. While it is generally agreed that children require particular attention because of their vulnerability, there is also increasing concern that children in general should not be disadvantaged by lack of knowledge due to reduced research activity. Finally, an increasingly active area of research in children involves genetics and biobanking. Research in these areas raises new and challenging ethical issues.
authors.affiliation: Department of Anesthesia and Pain Management, The Royal Children's Hospital, Murdoch Children's Research Institute, Parkville, Victoria, Australia. andrew.davidson@rch.org.au
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Davidson
authors.forename: Mike
authors.initials: M
authors.lastname: O'Brien
mesh_terms: D000328:Adult; D000758:Anesthesia; D035843:Biomedical Research / Q000941:ethics* / Q000592:standards; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics; D003219:Confidentiality; D028744:Ethics Committees, Research; D004992:Ethics, Medical / Q000266:history*; D005823:Genetics; D049672:History, 19th Century; D049673:History, 20th Century; D006801:Humans; D007258:Informed Consent; D007348:Insurance, Health; D028683:National Socialism; D009965:Orphan Drug Production; D010372:Pediatrics / Q000941:ethics* / Q000592:standards; D018907:Privacy; D011785:Quality Assurance, Health Care; D018570:Risk Assessment; D012935:Social Justice