Constructing Compliance: IRBs and the Rise of the Human Research Protection Field
New institutionalist scholars argue that the weak administrative capacity of the U.S. federal government can create strong adherence to particular regulatory standards. This occurs because “weak state” regulations unleash institutional forces—most especially through incubating groups of experts who interpret ambiguous regulations for risk-averse organizations (Edelman 1992; Dobbin and Sutton 1998; Dobbin 2009). I draw on a range of qualitative sources to explore the evolving role of standardization in U.S. federal regulation of research with human subjects—the regulations governing Institutional Review Boards (IRBs). I show that since the late 1990s the practices of hospital and university IRBs have converged on the norms of a flourishing new profession, in a process very much in line with new institutionalist predictions. However, I also show that that institutional standardization in IRBs has been accompanied by an equally powerful process of technical standardization—the development of hierarchical and routinized decision making driven by the need to achieve maximum efficiency with limited resources (Smith 1776; Weber 1921; Leidner 1993). Although new institutionalist scholarship has generally paid little attention to technical standardization, I argue that institutional and technical processes have played a mutually reinforcing role in constructing today’s field of human research protection.
Sarah Babb is a professor at Boston College. Her research explores the origins of economic ideas and their role in social change, the globalization of economic policy models, and the dynamics and pathologies of organizations. Her award-winning works include Behind the Development Banks: Washington Politics, World Poverty, and the Wealth of Nations (Chicago: 2009), and Managing Mexico: Economists from Nationalism to Neoliberalism (Princeton: 2001).