International Guidelines and Ethical Context

Abstract

Clinical practice and clinical research are subject to numerous ethical principles and guidelines, both formal and informal. Protect and promote patients’ and subjects’ clinical interests. Respect autonomy. Avoid exploitation. Yet what is required to follow these principles depends on the context. Which principles and guidelines are relevant, and how they should be specified and applied, all depend to varying degrees on the context in question. This sensitivity to context influences both how individuals ought to act and how their actions ought to be evaluated. In this way, the interpretive challenge posed by empirical research—what ethical conclusions can be drawn from the data?—is heightened when the results are obtained in unfamiliar contexts. Failure to recognize the relevance of context can lead one to see appropriate behavior as involving an inappropriate ethical double standard. This happened in the evaluation of the Rotashield vaccine for rotavirus. The withdrawal of Rotashield from the U.S. market due to a risk of intussusception lead to the cancellation of trials of the vaccine in developing countries (Melton 2000; Shaw 2006). However, given the much greater risk that rotavirus disease poses in developing countries, it was incorrect to assume that conducting Rotashield trials in those contexts was unacceptable simply because it would have been unacceptable to do so in the United States. From the perspective of an outsider, evaluating three empirical studies in this volume—the ethics of Iranian surgical practice, Portuguese neonatal care, and Brazilian human subjects protection—while being sensitive to context is a daunting challenge. There is much that might be ethically relevant in the respective social/cultural/historical/political/economic settings of those practices and places. At the same time, as outsiders, our ignorance of the respective contexts is vast. How could researchers hope to provide us with the context needed to grasp the ethical significance of their data?