Health expectations : an international journal of public participation in health care and health policy
Genomic Data Governance Challenges Between Research and Clinical Care: A Scoping Review
By Kim A, Merner B, Taylor M and 7 others.
Abstract
Introduction
The translational nature of genomics highlights the importance of developing a robust genomic data governance framework. To inform the development of such a framework for Australia, we conducted a scoping review to identify genomic data governance and management differences between research and clinical care.
Methods
For this scoping review, four databases were searched and 9528 relevant articles published between January 2013 and October 2024 were identified. After screening, 43 empirical, legal and theoretical/commentary articles were included. The differences reported to affect genomic data governance and management practices across clinical and research settings were extracted and synthesised.
Results
Fifteen empirical articles revealed that the 'community' and the 'workforce' reported different consent priorities and differing understandings of the expected benefits of providing genomic data for research. Three legal articles reiterated the influence of regulatory regimes on genomic data practices and rights. Lastly, all twenty-five theoretical/commentary articles were authored by researchers; none by community representatives. While 3/25 articles described the genomic data practices of rare and undiagnosed disease patient populations, 22/25 examined the ethical, legal and social implications arising from genomic data. Among the latter, 14/22 proposed 'solutions' to address identified genomic data challenges associated with consent, returning research genomic data to patients and advancing precision medicine.