The Role of Social Value in Data-Intensive Health Research.

Abstract

Data-intensive health research complicates traditional requirements for informed consent, due to the amount of data contributors and data points, the open-ended nature of research questions, and repeated or secondary data use. To still enable data-intensive health research, there is a move towards other-generally lower-standards for consent such as opt-out systems, in current developments such as the European Health Data Space (EHDS). This is premised on the social value that data-intensive health research is assumed to provide through advancing research and innovation. Traditionally, social value functions both as a fundamental requirement for research, as well as a ground to justify individual risk in research ethics. However, ongoing debates surrounding data-intensive health research suggest that social value can also be used to justify lower standards of consent. Here, social value seems to obtain an additional and distinct function. This raises questions on the role of social value in research ethics and evaluations of the acceptability of research. In this paper, we examine three possible roles of social value: (i) to prevent research waste and set research priorities; (ii) to justify exposing research participants to risk; and (iii) to lower standards for consent. We discuss the presuppositions underlying these various roles. When social value is invoked to justify lower consent standards, this specifically impacts data contributors' ability to have control over when and how their data are used. Therefore, we propose that this use of social value requires arranging alternative forms of meaningful involvement and control for data contributors.