The collection, linking and use of data in biomedical research and health care: ethical issues

Abstract

This report takes as its starting point the massive accumulation of data in biomedical research and health care, and the increasing power of data science to extract value by linking and re-using that data, for example in further health or population research. It examines the scientific, policy and economic drivers to exploit these opportunities, and the concerns and potential risks associated with doing so. The faltering ability of conventional information governance measures to keep pace with these developments is identified as a significant problem. The report therefore poses and addresses the following question: "how can we define a set of morally reasonable expectations about the use of data in any given data initiative and what conditions are required to give sufficient confidence that those expectations will be satisfied?" The report sets out a number of general recommendations, including four guiding principles for ethical design and governance of data initiatives. These help to identify specific examples of existing good practice and to make recommendations for improved practice in the use of data in the fields of health care (re-use of NHS records, clinical research, etc.) and population research (biobanks, epidemiological studies, etc.).