The FDA and the Declaration of Helsinki: A New Rule Seems to Be More About Imperialism than Harmonisation

Abstract

This paper critically discusses the Food and Drug Administration (FDA)'s decision to remove respect of the Declaration of Helsinki as a crucial requirement for clinical research and to affirm the need to respect the requirements of the International Conference on Harmonisation Good Clinical Practice (GCP). The paper discusses the symbolic meaning of this decision. It suggests that the FDA's decision sends the message that the US FDA standards are distinct from globally accepted norms of research ethics. It creates the impression that the FDA it is more interested in facilitating research than respecting the rights of people who are the subjects of research.

Keywords: Clinical Research, Declaration of Helsinki, Human Subjects