On the interconnected nature of risk and responsibility in the research and development of new and emerging technologies.

Risk analysis of new and emerging technologies requires innovative approaches that are agile, exploratory, and can accommodate broad stakeholder engagement and perspectives. Existing theories of risk governance and responsible innovation suggest that operationalizing guiding principles for engagement such as inclusion and reflection may provide a useful approach to the risk analysis of these technologies. Yet, methodologies to systematically assess how we might operationalize such guiding principles in risk analysis are limited in existing risk research. We contribute to filling this gap by demonstrating a practical methodology for examining and documenting how research and development (R&D) professionals operationalize inclusion and reflection in risk analysis and what value this provides to risk analysis in the R&D context. We use the Australian nanotechnology R&D sector as our case study, interviewing 28 experts to examine how R&D professionals have operationalized inclusion and reflection into their risk analysis practices, generating three findings. First, we describe how our research design enables the successful translation of theory into a methodology that supports an empirical assessment of the integration of these guiding principles into risk analysis practice. Second, we argue that successfully and systematically integrating inclusion and reflection in risk analysis fosters a wider understanding and identification of risk through the activation of multi-actor and multi-institutional stakeholder engagement processes. Third, we outline how this research depicts the outward-facing and introspective nature of risk analysis.

Future-proofing genomic data and consent management: a comprehensive review of technology innovations.

Genomic information is increasingly used to inform medical treatments and manage future disease risks. However, any personal and societal gains must be carefully balanced against the risk to individuals contributing their genomic data. Expanding our understanding of actionable genomic insights requires researchers to access large global datasets to capture the complexity of genomic contribution to diseases. Similarly, clinicians need efficient access to a patient's genome as well as population-representative historical records for evidence-based decisions. Both researchers and clinicians hence rely on participants to consent to the use of their genomic data, which in turn requires trust in the professional and ethical handling of this information. Here, we review existing and emerging solutions for secure and effective genomic information management, including storage, encryption, consent, and authorization that are needed to build participant trust. We discuss recent innovations in cloud computing, quantum-computing-proof encryption, and self-sovereign identity. These innovations can augment key developments from within the genomics community, notably GA4GH Passports and the Crypt4GH file container standard. We also explore how decentralized storage as well as the digital consenting process can offer culturally acceptable processes to encourage data contributions from ethnic minorities. We conclude that the individual and their right for self-determination needs to be put at the center of any genomics framework, because only on an individual level can the received benefits be accurately balanced against the risk of exposing private information.

Balancing the safeguarding of privacy and data sharing: perceptions of genomic professionals on patient genomic data ownership in Australia.

There are inherent complexities and tensions in achieving a responsible balance between safeguarding patients' privacy and sharing genomic data for advancing health and medical science. A growing body of literature suggests establishing patient genomic data ownership, enabled by blockchain technology, as one approach for managing these priorities. We conducted an online survey, applying a mixed methods approach to collect quantitative (using scale questions) and qualitative data (using open-ended questions). We explored the views of 117 genomic professionals (clinical geneticists, genetic counsellors, bioinformaticians, and researchers) towards patient data ownership in Australia. Data analysis revealed most professionals agreed that patients have rights to data ownership. However, there is a need for a clearer understanding of the nature and implications of data ownership in this context as genomic data often is subject to collective ownership (e.g., with family members and laboratories). This research finds that while the majority of genomic professionals acknowledge the desire for patient data ownership, bioinformaticians and researchers expressed more favourable views than clinical geneticists and genetic counsellors, suggesting that their views on this issue may be shaped by how closely they interact with patients as part of their professional duties. This research also confirms that stronger health system infrastructure is a prerequisite for enabling patient data ownership, which needs to be underpinned by appropriate digital infrastructure (e.g., central vs. decentralised data storage), patient identity ownership (e.g., limited vs. self-sovereign identity), and policy at both federal and state levels.