title: Ireland and medical research with minors: some medico-legal aspects.
abstract: The practice of medical research with minors in Ireland consist of practices pertaining to therapeutic and non-therapeutic medical research. Clinical trials (a category of therapeutic research), is governed by legislation. However, any other therapeutic research (non-clinical trials research) and non-therapeutic research, e.g. observational medical research such as a longitudinal study of children or non-therapeutic research such as blood sample collection for analysis of cause of disease, are unregulated by legislation. This, article will outline and describe some of the medico-legal issues involved in both types of research and will comment on matters such as what national law exists, how the directive on good clinical practice has been implemented, what guidelines, if any, exist.
authors.affiliation: School of Medicine and Medical Sciences, University College Dublin, Ireland.
authors.forename: Asim A
authors.initials: AA
authors.lastname: Sheikh
mesh_terms: D000293:Adolescent; D000367:Age Factors; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D002648:Child; D002669:Child Welfare; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006806:Human Rights; D006801:Humans; D007258:Informed Consent; D007494:Ireland; D033242:Minors / Q000331:legislation & jurisprudence*