title: Tackling legal challenges posed by population biobanks: reconceptualising consent requirements.
abstract: This paper examines, from an Australian and international perspective, the phenomenon of population 'biobanks' (research platforms comprising collections of human genetic samples or 'biospecimens' and relevant personal information) and the legal challenges that this development presents. In particular, the paper focuses on the legal concept of consent and the tensions on the traditional understanding of consent that large-scale, long-term population biobanks exert. The aim of the paper is to review the operation of consent principles as they apply to population biobanks and to propose a way forward for how the consent concept can be reconceptualised to meet their demands. In particular, the paper argues for a more liberal approach which allows for 'broad' (or 'enlarged' or 'open') consent in circumstances where permission is sought for future use of samples in, as yet unspecified, genetic research. In pursuing this aim, the objectives underlying this paper are to ensure that unnecessary impediments to research are removed and, at the same time, to facilitate research participation and respect for autonomous choices by research subjects.
authors.affiliation: University of Tasmania. margaret.otlowski@utas.edu.au
authors.forename: Margaret F A
authors.initials: MF
authors.lastname: Otlowski
mesh_terms: D001315:Australia; D036281:Genetic Research; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D014015:Tissue Banks / Q000331:legislation & jurisprudence*; D035502:Trust