Genomic Data Custodianship Practices in Australia: An Interview Study

Background. Sharing human genomic data has become a key part of healthcare systems and a linkage between scientific advancement and clinical practice. To realise the benefits of genomic data sharing and use, the project aims to assist the LINEAGE Study in developing an ethical framework for genomic data governance by exploring the roles and practices of genomic data custodians. In the field of genomics custodians are generally those individuals and groups considered as being responsible for managing genomic data. To date, few studies explore how data custodians make decisions and organise custodial duties (see Section 1). Method. This study addresses a gap in research through interviewing 14 individuals with data custodian duties, from across research, clinical, Indigenous genomics, bioinformatic service provider, and translational research settings. Semi-structured interviews were conducted, questioning the decision-making practices that custodians used across the areas of data use, data sharing, and data management, as well as participants' understandings of data ownership and stakeholdership (see Section 2). Findings. We found that, while data custodianship roles largely reflected those described in academic literature, the decision-making processes of data custodians were more complicated. Most decision-making could be categorised as either ethical practices, legal practices, technical practices, or socio-political practices. However, a number of decision-making practices included discretionary, deferred, or negotiated decisions, presenting a more nuanced picture of how custodianship duties are arranged in practice. While most agreed that data donors were the most important stakeholders in data custodianship, there was less certainty about who owns genomic data. Both genomic data experts and sponsors were acknowledged as having interests in patient and donor data (see Section 3). Implications. We conclude that while there are core custodianship practices that can be identified, uncertainties around custodial roles present ethical challenges for fostering trustworthy data custodianship. Furthermore, five data custodianship scenarios identified in this study highlight a need for inclusion of the practical experiences of data custodians in the design of an ethical framework for data custodianship (see Section 4). Recommendations. We present three recommendations for an ethical governance framework that is informed by the experiences of data custodians (see Section 5): 1. Clarify the roles of data stakeholders, including custodians; 2. Develop a mechanism for including data experts in governance design; and 3. Use examples of custodial scenarios and duties in an ethical framework.