Navigating tissue banking regulation: conceptual frameworks for researchers, administrators, regulators and policy-makers

Wendy Lipworth

Research output: Contribution to journalArticlepeer-review

8 Citations (Scopus)

Abstract

In the "post-genomic" age of biomedical research, researchers often wish to utilise collections of human tissue. This type of research raises many ethical and legal issues and anyone wishing to use such collections is faced with an enormously complex set of regulatory requirements, many of which are still ambiguous, reflecting ongoing ethical and legal debate. Whilst there is no way of entirely avoiding such regulatory complexity and ambiguity, conceptual frameworks can assist those who wish to use, administer, authorise and generate policy on tissue banking research. Two conceptual frameworks are described here: a taxonomy of tissue banking practices, aimed at assisting those who need to ensure that tissue banks meet ethical and legal requirements; and a "syncretic" approach to policy-making, for those who wish to generate new policy, or streamline existing policy relating to tissue banking research.

Original languageEnglish
Pages (from-to)245-55
Number of pages11
JournalJournal of Law and Medicine
Volume13
Issue number2
Publication statusPublished - Nov 2005
Externally publishedYes

Keywords

  • Australia
  • Biomedical Research
  • Confidentiality
  • Ethics, Research
  • Genetic Research
  • Government Regulation
  • Humans
  • Living Donors
  • Policy Making
  • Public Policy
  • Tissue Banks
  • Journal Article

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