title: An empirical study of tissue banking in Australia: navigating regulatory and ethical challenges.
abstract: Collections of tumour samples can be an invaluable resource for medical research. There are, however, numerous ethical and legal challenges associated with tumour banking. While there has been extensive discussion of these issues in the legal and ethical literature, there are few available empirical data in relation to the activities of tumour banks in Australia, their practices around ethically charged issues, and their success in implementing complex regulatory guidelines. The aim of this study was to gain more information about the activities of tumour banks in New South Wales, Australia, with a particular focus on their management of, and attitudes towards, ethical and regulatory issues. A survey of 27 tumour collection and research facilities was conducted using a 55-item questionnaire. There is significant heterogeneity of research methodologies as well as of methods for gaining consent and ensuring donor privacy, and there is general concern among the research community about ethical and regulatory issues related to tumour banking. Heterogeneity of practice and uncertainty about ethical and regulatory requirements is problematic in its potential to hinder research and its potential to generate the space for unethical practice, whether intentional or unintentional. There is a pressing need to address these issues so that tumour banks can be used in the most ethical and efficient way possible.
authors.affiliation: Centre for Values Ethics and the Law in Medicine, Blackburn Building DO6, University of Sydney, NSW 2006, Australia.
authors.forename: Georgina
authors.initials: G
authors.lastname: Clark
authors.forename: Wendy
authors.initials: W
authors.lastname: Lipworth
authors.forename: Bokey
authors.initials: B
authors.lastname: Les
authors.forename: J M
authors.initials: JM
authors.lastname: Little
authors.forename: Ian H
authors.initials: IH
authors.lastname: Kerridge
mesh_terms: D000047:Academies and Institutes; D001315:Australia; D003625:Data Collection; D004992:Ethics, Medical; D032984:Ethics, Research; D033161:Government Regulation; D006801:Humans; D011795:Surveys and Questionnaires; D014015:Tissue Banks / Q000941:ethics / Q000331:legislation & jurisprudence*