This proposal follows bioethics and community engagement research conducted at the NUS Centre for Biomedical Ethics (CBmE) in collaboration with the Ministry of Health for Phase 1 of the National Precision Medicine strategy (NPM). Outcomes of that research conducted from 2018-2021 were summarised in a Policy Brief and presented to the Board Oversight Committee of Precision Health Research, Singapore (PRECISE) in July 2021.

Key findings from Phase 1 demonstrated conditional support for sharing health-related data for PM that was contingent upon certain assumptions and expectations being met .Assumptions included a consent-in regiment with options to withdraw at any time, and privacy protections with state-of-the-art data security protocols (encryption, de-identification etc). Participants also recognised that some trade-offs would be needed to achieve the benefits of PM with individuals having less control over data access than conventional research protocols. Governance systems with independent oversight from trusted authorities who can ensure PM initiatives were accountable, operated transparently and in the public interest, would be critical. Taken together, these findings support the notion of earning and maintaining a social licence to operate the NPM with broad consent under certain conditions.

The Social License to Operate (SLO) is a concept developed in the natural resource extraction and development sectors to achieve broad-based and ongoing community support for conducting operations. The SLO goes beyond legal and regulatory compliance to meeting the expectations of stakeholders and broader civil society in reciprocal arrangements of benefit sharing. It is attained through the co-creation of meaningful partnerships and mutual trust between an operator, profession or industry, and the communities that grant the social license. The SLO is also being employed for the ethical governance of data-intensive health research programmes where large amounts of information about individuals are captured, collated, used, shared and/or linked from wide ranging sources. 8 It relates closely to trust and is granted on societal expectations that the research is legitimate and in the public interest.

Demonstrating an institution, government or industry has attained social license is extremely difficult as the SLO is an intangible asset granted, often implicitly, where operations are accepted as morally and socially permissible, and occur within the boundaries of community expectations. Falling short of those expectations can undermine public trust and cause irreparable damage to the SLO. The SLO is also impermanent and subject to continual renewal and evaluation of how well the activities and practices of the operator are perceived as meeting the terms and conditions of the social license. Ongoing community engagement and dialogue is thus critical in monitoring expectations for the NPM and responding pro-actively where norms and values fall out of alignment with current practices and policies.