Towards Principles-Based Approaches to Governance of Health-related Research using Personal Data

Eur J Risk Regul. 2013 Jan 1;4(1):43-57. doi: 10.1017/s1867299x00002786.


Technological advances in the quality, availability and linkage potential of health data for research make the need to develop robust and effective information governance mechanisms more pressing than ever before; they also lead us to question the utility of governance devices used hitherto such as consent and anonymisation. This article assesses and advocates a principles-based approach, contrasting this with traditional rule-based approaches, and proposes a model of principled proportionate governance. It is suggested that the approach not only serves as the basis for good governance in contemporary data linkage but also that it provides a platform to assess legal reforms such as the draft Data Protection Regulation.

Keywords: Principles; data; information; principled proportionate governance; regulation; research; rules.