Is the Red Queen Sitting on the Throne?

Abstract

Human health research is a vast enterprise; worldwide, hundreds of billions of dollars are spent annually on health research involving millions of research participants. 1 This research is guided by multiple regulations and guidance documents that commonly reflect several core principles: the protection of the rights and welfare of individual research participants; the promotion of justice in the practice and outcomes of research; and that human health research should be socially valuable (see van Delden and van der Graff , Chapter 4, in this volume). In addition, oftcited goals of health research regulation include the development of a culture of ethical concern among researchers and institutions, and the maintenance of public trust in the research enterprise. 2 However, these generally accepted principles belie an ongoing tension between the protection of individual participants through appropriate regulation, and the facilitation of health research. 3 Authors have, for example, written regarding the amount of waste in research, including inefficient research regulation and management. 4 Others have pointed to the variation in decisions 5 and time takenwith associated costs 6of obtaining ethics