Reforming Human Tissue Laws to Safeguard Trust and Enable Lifesaving Research

Major advances in modern medicine rest on acts of public trust — including the decision to donate human tissue for research.

From cancer immunotherapies to regenerative medicine, Australia’s health and medical research system depends on ethical, well-governed frameworks that honour that trust and keep pace with scientific progress.

The Australian Academy of Health and Medical Sciences (AAHMS) has submitted two responses to the AUSTRALIAN LAW REFORM COMMISSION (ALRC) Review of Human Tissue Laws, focusing on the use of human tissue for research purposes:

• July 2025 – CONSIDERATIONS REGARDING RESEARCH USES OF HUMAN TISSUE
• February 2026 – RESPONSE TO DISCUSSION PAPER 90

Strengthening trust through nationally consistent reform

In its July 2025 submission, the Academy highlighted that while the Review’s Terms of Reference focus on clinical and educational uses of human tissue, the Review presents a timely opportunity to consider research uses as well.

In both submissions, the Academy emphasised that health and medical research and innovation are only possible because Australian communities are willing to donate tissue for research. That willingness will only be maintained through robust, workable consent and privacy frameworks.

Australia must develop an environment that enables the safe and secure use of human tissue for legitimate research purposes — balanced with protecting the rights and interests of individuals. Drawing on the expertise of its diverse Fellowship, the Academy has outlined targeted, actionable steps to support ethical, transparent and future-fit legislation.

Addressing regulatory gaps

The use of human tissue for research in Australia is governed by a complex, fragmented and nationally inconsistent framework of oversight, guidance and legislation.

The ALRC Review presents a timely opportunity to achieve greater uniformity across jurisdictions in the content and application of relevant laws and regulatory instruments.

Evolving consent models

Using human tissue for research requires informed consent. while maintaining adequate protections , the Academy has recommended broader, more dynamic consent models that could reduce the burden on donors and researchers, particularly in settings such as biobanks.

Offering specific, broad and dynamic consent options would enhance donor confidence while providing the flexibility needed to enable a wide range of lifesaving research.

Governance of biobanks and legacy collections

The Academy has called for careful consideration of consent for future uses and stronger data stewardship, recommending:

• Human Research Ethics Committee-approved waivers of consent for archived tissue collections where ethically appropriate
• A national regulatory framework for biobanks to ensure consistent standards and oversight
• Flexible guidelines to bring legacy collections into alignment with contemporary ethical and regulatory requirements

Establishing a national oversight body

The Academy recommends the establishment of a national oversight body for research uses of human tissue, similar to the UK Human Tissue Authority model.

Such a body would improve coordination and governance in complex situations, including institutional or biobank closures. It could be established as a new entity or incorporated into an existing structure such as the Therapeutic Goods Administration or the National Blood Authority.

The Commonwealth embryo research model demonstrates how national harmonisation through a single licensing framework can streamline regulation, ensure consistent ethical standards and reduce duplication while preserving state and territory autonomy.

Improving provenance standards

Inconsistencies between domestic and international rules governing human cell lines can complicate and undermine oversight.

The Academy recommends standardising provenance and consent requirements for both domestic and international human-derived materials, ensuring comparable oversight regardless of origin. Complementary mechanisms such as sunset clauses, exemptions or special review processes for low-risk historical materials should also be considered.

Academy media contact: Khaled Chakli: [email protected] (0423 099 568)