The LINEAGE approach

Our consortium is developing Australia’s first governance framework for genomic data. Our framework is being designed to be applicable to genomic data in a variety of use settings and across the data life cycle. It is also reflecting findings of our interdisciplinary and ongoing research, including the views of patients and Aboriginal and Torres Strait Islander peoples.

LINEAGE Project Phases

Our project comprises four Phases, geared to meet its 4 Aims.

The first year of LINEAGE, 2023, comprised Phase 1. During this period, Investigators scoped out the Australian genomic data governance landscape. This was achieved through reviewing literature about genomic data governance, speaking to key stakeholders, developing consensus definitions for key terms and identifying initial ethical, legal and social issues in genomic data governance.

LINEAGE Phase 2 was two years in duration (2024-2025). During this time, we engaged in deep  work on important ELSI in genomic data governance. This included ten targeted research projects, commissioned from within our consortium after a competitive internal call. We also met with international stakeholders to ensure that LINEAGE is responsive to global developments.

Phase 3  commenced in mid-2025. So far, we have begun to develop our initial governance solutions, including engagement with international stakeholders to critically assess their feasibility. Towards the end of this phase (around late 2026), we will draft our initial governance framework.

Phase 4 will commence in early 2027, the project’s final year. This Phase will involve taking our governance framework out to national and international stakeholders (including our project partners), to ensure it is fit for purpose and feasible for implementation. Based on the feedback received, we will refine and finalise our framework, before drafting and testing an implementation plan and roadmap.

By the end of LINEAGE,  we will have developed a framework for the ethical governance of genomic datasets. This framework will be aligned with national and international regulation and be delivered with a plan for implementation.

All project phases are underscored by cross-cutting work to involve and learn from the perspectives of First Nations Investigators and peoples, and from patients and their families and carers.

Underlying principles

We are basing our project work around a set of four overarching (but revisable) principles, which our consortium developed in the course of our application. These principles reflect major policy documents in the field of genomic data governance:

Principle 1: Governance of genomic data should be transparent, inclusive and promote trust

    • This principle reflects the fact that people (particularly underserved groups) and their interests should be the focus of governance. Governance needs to be relevant to the context of data collection, storage and use. All accountabilities and responsibilities should be defined in advance.

Principle 2: Obtain appropriate permissions across the data life cycle

    • This principle is based on respect for persons, including their wishes to know when, where and how their genomic data will be used. Permissions may be based in consent (in its various forms), or other enablers such as the public interest. Interoperability of permissions between data types and data storage entities is also important.

Principle 3: Uphold appropriate dataset creation, access and use

    • This principle recognises that dataset creation, access and use should be effective, efficient and ethical. The values, interests and wellbeing of data donors should be a paramount consideration in this. A principle of non-exceptionalism of genomic data should apply unless there are good reasons to treat it distinctly. Datasets themselves should be future-ready, including accessible, flexible and interoperable. The rationale for a datasset’s creation should be agreed in advance by diverse stakeholders.

Principle 4: Establish and use genomic datasets to promote and share benefit, improving care for all

    • This principle is based on the importance of genomic datasets being knowledge-generating and knowledge-promoting, as well as equity promoting. Benefits gained from datasets should be shared with data donors wherever possible. Datasets themselves should reflect diversity of populations. Data sovereignty is important for many data donors and should be built into governance.