The Helsinki Declaration and the Law: An International and Comparative Analysis

Abstract

The Declaration of Helsinki constitutes one of the cornerstones of medical research ethics, providing the scientific and medical communities with a set of fundamental rules for conducting research with humans for over 40 years. This chapter presents an international and comparative analysis of different ways in which the Declaration of Helsinki is explicitly referred to or integrated in legislation or in regulatory documents. It provides an analysis of the extent to which the Declaration of Helsinki can be considered to create legal norms within various legal systems. The paper discusses how the Declaration of Helsinki is referred to in the European Union, the United States, Switzerland, Germany, France, the United Kingdom and Canada. The chapter identifies how and to what extent the Declaration is embedded in those regulatory regimes and what impacts this may have on its legal nature in these countries. More important than the reference to the Declaration itself is the fact that the regulatory systems analysed in this chapter contain in some way references to the fundamental and universal principles laid down in the Declaration.

Keywords: Declaration of Helsinki, Medical Research Ethics, Drug Regulation, Human Subjects research, Research Governance