Adjusting the focus: A public health ethics approach to data research

Abstract

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population-level research and big data because it results in a primary focus on consent (meta-, broad, dynamic and/or specific consent). Two recent guidelines - the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health-related research involving humans - both focus on the growing reliance on health data for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision-making capacity? I propose that a public health ethics framework - based on public benefit, proportionality, equity, trust and accountability - provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest.

Keywords: CIOMS; data; health information; informed consent; public health ethics; research ethics; social value.