Turning Ethics into Institutions: The Techno-politics of Human Research Regulation in Taiwan

Abstract

This article provides a critical assessment of the development of Taiwan’s ethical framework for regulating medical and biopharmaceutical innovations. Advancing science, technology and society scholarship that treats ethics as subject to modification, adjustment and negotiation rather than as an abstract set of principles, this article examines the dominant role of East Asian states in the development of the life sciences. It also looks at the logic these states utilise to legitimise their therapeutic standards and to support the biopharmaceutical infrastructure in order to increase their economic competitiveness. In particular, this article traces the establishment of legal regulations in different social settings where innovations in clinical practice and medicine are introduced. It argues that, instead of a comprehensive, coherent ethical framework based on the adoption of international conventions, Taiwan’s 2011 Human Subjects Research Act is a techno-political assemblage, an inconsistent legal product involving not only policy makers but also physicians, the pharmaceutical industry and the state. This article also takes a critical stance towards institutional review boards (IRBs), which resolve jurisprudential conflicts within this legal framework of human research. It argues that, rather than being passive organisations that protect research from unethical fraud, IRBs in Taiwan have been institutions in which negotiations among investigators, research sponsors and the government are conducted in the name of health governance.