Bureaucratic Ethics: IRBs and the Legal Regulation of Human Subjects Research

Abstract

Much of the literature on human subject regulation asserts that Institutional Review Boards (IRBs) have failed at the task of regulating human subjects research. These critiques of IRB law can be grouped into three loose categories: critiques of IRB law as law, critiques of IRBs as regulation, and critiques of IRBs as a system of norm creation. Moving beyond critique, we rethink the literature on IRBs drawing on the tools and scholarship of the social sciences. In particular, we examine human subjects regulation as an insufficient remedy to inequalities between weak and powerful actors, as a site of professional claims- and career-making, and as an occasion for institutionalization. Finally, distinguishing between the regulation of science and the regulation of ethics, we observe that the latter is far more difficult because ethics are contextual and subject to social construction. For these reasons, IRBs often substitute bureaucratic ethics for professional ethics.