title: Ethical issues of clinical trials in children: a European perspective.
abstract: Children should not be harmed by their participation in clinical trials, therefore should no clinical trials be performed? This is a view that needs to be balanced as clinical trials provide the evidence we need to allow children safe and effective prescribing of medicines. Therefore, is it unethical not to involve this population in research? This review looks at new ethical guidance released to support the recently introduced European legislation for the licensing of medicines.
authors.affiliation: Academic Division of Child Health, University of Nottingham, The Medical School, Clinical Sciences, Derbyshire Children's Hospital, Derby, UK. helen.sammons@nottingham.ac.u
authors.forename: H
authors.initials: H
authors.lastname: Sammons
mesh_terms: D000293:Adolescent; D000367:Age Factors; D035843:Biomedical Research / Q000941:ethics*; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence; D038622:Internationality; D008297:Male; D010372:Pediatrics / Q000941:ethics; D017410:Practice Guidelines as Topic; D018570:Risk Assessment