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

• Published in: The Hastings Center report Vol. 48; no. 6; pp. 25 - 32
• Main Author: WENNER, DANIELLE M.
• Format: Journal Article
• Language: English
• Published: United States Wiley 01.11.2018; Blackwell Publishing Ltd
• Subjects: Biomedical Research - ethics; Ethics; Ethics, Research; Humans; Public Opinion; Research Personnel - ethics; Research Subjects; Resource Allocation - organization & administration; Social Norms; Social Values; Trust
• ISSN: 0093-0334; 1552-146X; 1552-146X
• DOI: 10.1002/hast.934

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.