Research bystanders, justice, and the state: Reframing the debate on third-party protections in health research.

Abstract

Research participants are afforded protections to ensure their rights and welfare are not unduly jeopardized by research activities. Yet people who do not meet the criteria for research participant status may likewise be impacted by research activities, and ethicists argue that protections should be afforded these "research bystanders." The standard rationale for extending protections to research bystanders contends that they are sufficiently like research participants that the ethical principles governing health research ought to extend to them. In this article we argue that this analogical reasoning is mistaken. Salient moral differences mean that research ethics frameworks are not fit for purpose. We defend the research bystander category by articulating a novel foundation for this new class of stakeholder. Focusing on bystanders directly impacted by publicly funded health research, we argue that bystanders are sometimes owed protections-but neither because of their similarity to research participants nor because research ethics principles should extend to them. Instead, we reframe the issue as a question of justice. Building on the work of Douglas MacKay, we argue that bystanders to publicly funded health research are owed protections as citizens of liberal states to whom the state owes duties of justice. The state has duties to protect the interests of citizens and to conduct health research. When the means by which the state fulfils the latter duty comes into conflict with the means by which it fulfils the former, the state must ensure that those impacted, including research bystanders, are afforded protections.