Aims

Tissue banks in Australia provide critical conduits between cancer patients & researchers, improving health outcomes for all Australians.

This study will:

  • Provide empirical evidence to inform strategies towards ensuring the sustainability of tissue banks in Australia by elaborating on:
    - effective policy & practice;
    - recommendations for harmonised regulatory reform; and
    - mechanisms to stimulate public awareness, trust & support through increased community engagement
  • Address persistent & emerging threats to the utility & sustainability of tissue banks by improving our responses to: – increasing globalisation & commercialisation of biomedical research;
    - unresolved issues [data linkage & disclosure of (incidental) findings, consent, privacy];
    - emerging regulatory, ethical & scientific responses to challenges which are inconsistent, complex, lack of harmonisation or absent

Key research questions

  • What number of Australian clinical trials in haemato-oncology include tissue bank sub-studies? What research questions are they asking & to what extent are Australian human tissues being directed to ‘offshore’ tissue banks?
  • What do professionals engaged in tissue banking research identify as the major challenges confronting tissue banks in Australia?
  • What processes are employed by Australian tissue banks to address persistent & emerging ethical, legal and regulatory challenges such as:
    - consent to the collection and use of tissue  for future unspecified research;
    - data linkage;
    - disclosure of (incidental) research findings,
    - influence of industry sponsorship of research & commercial imperatives?
  • What are the current regulations relating to tissue banks in Australia & internationally? What impact do they have on the sustainability of tissue banking in Australia? Should existing regulations be reformed?
  • What are the attitudes & concerns of tissue donors, patients, members of the public & the research community towards tissue banking & related research?  Are there differences between the attitude and concerns of the respective players? Is there a mismatch between the concerns expressed & those addressed in regulations governing tissue banking in Australia?

Methods

This  National 5 Phase Study will employ an innovative mixed methods approach involving interrelated  qualitative & quantitative analysis.

Phase 1: National study of knowledge & attitudes
Tissue Bank Donors, Public & Professionals / Researchers (Year 1)

Phase 2: Audit of cancer-related tissue banks. (Years 1 & 2)

Phase 3: Case study analysis of recent challenges confronting one cancer tissue bank ( ALLG Tissue Bank) in Australia. (Year 2)

Phase 4: Regulatory audit & comparative legal analysis (Legal Expert Panel) of Australian & International regulation of tissue banks. (Years 1-3)

Phase 5: Development & dissemination of strategies to ensure the utility & sustainability of tissue banks in Australia. (Year 3)

Interrelated ethico legal challenges to be explored

  • Globalisation & Commercial Imperatives: increasing offshore biorepositories, restrictive & inconsistent regulatory responses.
  • Justice Issues: equity & access to for tissue donor collections & data, costs of high throughput technologies for DSTBs, affordability of tests & treatments,  public benefit
  • Ownership: Industry, research collectives, disconnect public – private drivers, custodianship, on-selling
  • Disclosure: obligations to inform, feedback of (incidental findings), potential therapeutic misconception
  • Consent: for future unspecified research (open-ended – largely resolved but still problematic)
  • Philosophical: genuine utility of molecular data & clinical validity of prognostic biomarkers
  • Governance: IPR, transparency, beyond cost recovery models, acquisition & distribution, biosafety & transfer, OS & multisite MTAs & insurance, quality control & risk management

A substantial portion of the material provided in the database on this website was collected for a project on personalized medicine at the Centre for Law and Genetics at the University of Tasmania. That project is funded by Australian Research Council Discovery Grant DP11010069.