The Facebook-Cambridge Analytica data scandal in early 2018 lead to calls for more stringent regulation of tech companies’ use of data. This reliance has been highlighted by the public backlash following recent scandals in the field of data science. The success of Big Data-driven or data-intensive health research relies greatly on public acceptance.

This should ultimately contribute to a more ethical practice of governance. Greater trust can be achieved in the governance of data-intensive health research by highlighting strategic dialogue with both patients contributing the data, and the public in general. Firstly, it fits the novel scale of data-related risks secondly, it focuses attention on trustworthiness and finally, it offers co-creation as a way forward. There are several merits to using the concept of social licence as a guideline for ethical governance. Public engagement that involves patients from the start is called for to strengthen this social licence.

Incorporating such a practice paves the way towards an ethical governance, based upon trust. This is especially true for patients contributing data. Our analysis indicates that a social licence encourages us to recognise a broad range of stakeholder interests and perspectives in data-intensive health research. For these types of activities, a moral legitimation, beyond the limits of law, may need to be sought in order to preserve trust. These activities may be morally demanding. Our conceptual analysis aims to clarify how societal permission can be granted to health research projects which rely upon the reuse and/or linkage of health data. The systematic search resulted in nine publications. We used a systematic search and selection process, followed by a critical conceptual analysis. We performed a narrative review of the social licence as presented in the biomedical literature. We propose building upon the use of a social licence for achieving such ethical governance. Scandals arising out of sharing data during medical research have pointed out that going beyond the requirements of law may be necessary for sustaining trust in data-intensive health research. The rise of Big Data-driven health research challenges the assumed contribution of medical research to the public good, raising questions about whether the status of such research as a common good should be taken for granted, and how public trust can be preserved.

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