The LINEAGE approach
Our project will develop a governance framework for genomic data. Our framework will be applicable to genomic data in a variety of use settings and across the data life cycle. The framework will be developed to reflect the findings of interdisciplinary research, including the views of multiple stakeholders.
LINEAGE Project Phases
Our project comprises four Phases, geared to meet its 4 Aims[AN1] .
The first year of LINEAGE comprised Phase 1. During this period, Investigators scoped out the current landscape in genomic data governance. 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.
Based on our work so far, we are developing a good idea of what ELSI issues arise in current governance of genomic data in Australia. We are also close to agreeing terminology for genomic data, to ensure we discuss our subject matter consistently across the project, and beyond.
LINEAGE Phase 2 was initiated in early 2024 and will last for around two years. During this time, we will undertake in-depth work on important ELSI in genomic data governance. This will include several small projects, commissioned from within our consortium after a competitive internal call. We will also meet with international stakeholders to ensure that LINEAGE is responsive to global developments. We are also starting to consider what our governance framework – the key deliverable for our project – will look like.
By the end of this phase, we will have developed a position on various ELSI issues in the governance of Australian genomic data, to inform the design of our Governance framework.
Phase 3 will commence in mid-2025. Here we will begin 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.
By the end of this phase, we will have identified a range of governance solutions for genomic datasets and will have developed a draft 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 this Phase – and 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.