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

HISTORY AND THEORY OF HUMAN EXPERIMENTAION – THE DECLARATION OF HELSINKI AND MODERN MEDICAL ETHICS, pp. 223-252, Andreas Frewer, Ulf Schmidt, eds., Franz Steiner Verlag, 2007

30 Pages Posted: 14 Nov 2010 Last revised: 26 Aug 2011

See all articles by Dominique Sprumont

Dominique Sprumont

University of Neuchatel

Sara Girardin

affiliation not provided to SSRN

Trudo Lemmens

University of Toronto - Faculty of Law

Date Written: 2007

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

Suggested Citation

Sprumont, Dominique and Girardin, Sara and Lemmens, Trudo, The Helsinki Declaration and the Law: An International and Comparative Analysis (2007). HISTORY AND THEORY OF HUMAN EXPERIMENTAION – THE DECLARATION OF HELSINKI AND MODERN MEDICAL ETHICS, pp. 223-252, Andreas Frewer, Ulf Schmidt, eds., Franz Steiner Verlag, 2007, Available at SSRN: https://ssrn.com/abstract=1707947

Dominique Sprumont (Contact Author)

University of Neuchatel ( email )

1, A.-L. Breguet
Neuchatel, CH-2000
Switzerland

Sara Girardin

affiliation not provided to SSRN

Trudo Lemmens

University of Toronto - Faculty of Law ( email )

78 and 84 Queen's Park
Toronto, Ontario M5S 2C5
Canada

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