Nicole Nelson: Reproducibility reforms in American biomedicine and the diffusion of the “regulatory ethos”

Recent scholarship has described the “reproducibility crisis” and its associated reform movement as a social movement or a scientific-intellectual movement. This talk will argue for an alternative framing of these events which de-emphasizes high-status intellectual actors and their agendas for change, and emphasizes instead structural aspects and how they shape which reforms come to be seen as possible and desirable. Taking this alternative lens, we could see the reproducibility movement not as a successful network of methodologists stitched together by Twitter and investment from private foundations, but as one instantiation of a broader diffusion of a “regulatory ethos” from highly regulated contexts into academic settings. Together with Lara Keuck, we describe the regulatory ethos as a specific type of scientific ethos (following Merton) that relies on documentation practices and favors plans over situated actions, uniformity over heterogeneity, and validation over external validity. Through a detailed history of the emergence of the reproducibility crisis in American biomedicine, I will show how pharmaceutical drug development and clinical medicine – two highly regulated spheres of practice – were key to providing the evidence and solutions that first generated support from key figures at the National Institutes of Health for reproducibility reform. From this I argue that this reform movement should be understood analytically as not merely an expression of the open science ideals of its most charismatic leaders, but as part of ongoing efforts to ensure the interoperability of experimental systems across distributed research spaces.