title: Children in medical research: Australian ethical standards.
abstract: This paper examines standards for the use of children as research participants in medical research which are relevant to Australia and relates the standards to pivotal ethical issues. The standards include the National Health and Medical Research Council's NHMRC Statement and Supplementary Notes, professional codes of ethics, international human rights conventions, United Kingdom and United States codes of ethics, and statute and case law. The key ethical issues of potential risk and benefit to the child, and consent to research participation are discussed. Suggestions for the improvement of the NHMRC Statement are made.
authors.affiliation: Department of Science and Technology Studies, University of Wollongong, New South Wales, Australia.
authors.forename: C A
authors.initials: CA
authors.lastname: Berglund
mesh_terms: D001315:Australia; D002648:Child; D002651:Child Advocacy / Q000331:legislation & jurisprudence*; D002669:Child Welfare / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D030881:Disclosure; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D038622:Internationality; D007872:Legal Guardians; D033242:Minors; D033281:Nontherapeutic Human Experimentation; D033282:Parental Consent; D010353:Patient Education as Topic / Q000331:legislation & jurisprudence; D026684:Personal Autonomy; D035842:Research Subjects; D018570:Risk Assessment; D012307:Risk Factors; D036302:Therapeutic Human Experimentation