Ethox and WEH Seminar - The Basic Structure Model of Research Stakeholder Obligations

ABSTRACT

Much debate about the so-called “social value requirement” for clinical research is predicated on a model of research stakeholder obligations that conceives research as primarily a private transaction between individuals. I argue that in fact clinical research is one component of an institutional structure governing the health systems in which individuals participate – an institutional structure from which they cannot opt out and which will have deep and lasting impacts on their life prospects.  As such, stakeholders in the research enterprise have obligations not only to those with whom they directly interact as sponsors, investigators, and participants, but also to all of those who are governed by the institutional structure of which clinical research is a central part and whose lives it aims to fundamentally impact.  Importantly, those obligations are grounded in obligations of justice and not in the ethics of free and fair transactions, implying that members of society have a claim to health research priority-setting motivated (primarily?) by the demands of justice.  I go on to explore some of the implications of this view.