Review of Human Tissue Laws

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’s Review of Human Tissue Laws is a timely opportunity to ensure that there is greater uniformity across Australia in the content and application of all relevant laws and other regulatory instruments.

Using human tissue for research requires informed consent. Broader, more dynamic consent models could reduce the burden sometimes placed on donors and researchers in settings such as biobanks. In our February 2026 submission, the Academy outlines how offering specific, broad and dynamic consent options could enhance donor confidence while providing the flexibility needed to enable a wide range of lifesaving research.

The Academy advocates for the need for careful consideration of consent for future uses and strong data stewardship. Our submissions recommend that:

• Human Research Ethics Committee-approved waivers of consent be available for archived tissue collections where ethically appropriate.
• A national regulatory framework for biobanks be established to ensure consistent standards, ethical oversight and protection of donor rights.
• Legacy collections be governed under flexible guidelines that bring them into alignment with contemporary ethical and regulatory requirements.

A national oversight body, similar to the UK Human Tissue Authority, would improve overall coordination and overarching governance in complex situations such as the closure of institutions or biobanks. The Academy suggests that a national oversight body for research uses of human tissue be established and appropriately resourced, either 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 is a clear example of national harmonisation through a single licensing framework, which could streamline regulation, ensure consistent ethical standards and reduce duplication while preserving state and territory autonomy.

Inconsistencies between domestic and international rules around human cell lines are too often complicating or even undermining the governance of human tissue used for research. To overcome this, the Academy recommends standardising provenance and consent requirements for both domestic and international human-derived materials, ensuring comparable oversight regardless of origin. Complimentary mechanisms such as sunset clauses, exemptions or special review processes for low-risk, long-standing historical materials also have a role to play.