The Social Value Requirement in Research: From the Transactional to the Basic Structure Model of Stakeholder Obligations.

The history of research ethics includes ethical norms that do not neatly fit into a rubric of "human subjects protections" but that are nevertheless seen as fundamental ethical dictates. Among these norms is the so-called social value requirement for clinical research. Recently, however, the ethical foundation for the social value requirement has come under criticism. I seek to clarify the terms of this foundational debate. I contend that much of this discussion-both critiques of the social value requirement as well as recent defenses-is predicated on a framework of research ethics that I refer to as the "transactional model of stakeholder obligations." I argue that this model does not fully capture the ethical considerations that ought to inform the design and conduct of clinical research, and I introduce and defend an alternative framework that I call the "basic structure model of stakeholder obligations." The basic structure model is grounded in a claim that clinical research plays a direct role in establishing the justice or injustice of our social organization and should therefore be governed more explicitly by justice-based considerations. As such, the model explicitly accounts for the fundamentally social nature of the research enterprise itself. In addition to defending the basic structure model, I show how it provides a more stable foundation for the social value requirement, and I consider some worries about whether the model may be too demanding in practice.