title: Commercialisation of regenerative human tissue: regulation and reform in Australia and England, Wales and Northern Ireland.
abstract: The commercialisation of therapeutic products containing regenerative human tissue is regulated by the common law, statute and ethical guidelines in Australia and England, Wales and Northern Ireland. This article examines the regulatory regimes in these jurisdictions and considers whether reform is required to both support scientific research and ensure conformity with modern social views on medical research and the use of human tissue. The authors consider the crucial role of informed consent in striking the balance between the interests of researchers and the interests of the public.
authors.affiliation: sonjaibrown@optusnet.com.au
authors.forename: Sonja
authors.initials: S
authors.lastname: Brown
authors.forename: Shih-Ning
authors.initials: SN
authors.lastname: Then
mesh_terms: D001315:Australia; D003132:Commerce / Q000941:ethics / Q000331:legislation & jurisprudence*; D004739:England; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D009660:Northern Ireland; D010067:Ownership; D016378:Tissue Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence*; D014852:Wales