Tissue donation: ethical guidance and legal enforceability.

The legal and ethical framework regulating the use of tissue donated for medical research in Australia provides clear direction on the appropriate use of donated tissue in many instances. However, this article argues that the current framework may be inadequate to address some of the problems that may arise from misuse of such tissue. It argues that the Human Tissue Acts do not provide a sufficiently broad system of regulation and require updating. It also notes that as much of Australian research practice is regulated through ethics guidelines, which do not have the status of law, in some cases this approach may fail to provide remedies for those whose tissue is used inappropriately.