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

British Medical Journal, Vol. 338, pp. 1157-1158, 2009

6 Pages Posted: 20 Aug 2011

See all articles by Michael Goodyear

Michael Goodyear

Dalhousie University

Trudo Lemmens

University of Toronto - Faculty of Law

Dominique Sprumont

University of Neuchatel

Godfrey B. Tangwa

University of Yaounde 1

Date Written: 2009

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

Suggested Citation

Goodyear, Michael and Lemmens, Trudo and Sprumont, Dominique and Tangwa, Godfrey B., The FDA and the Declaration of Helsinki: A New Rule Seems to Be More About Imperialism than Harmonisation (2009). British Medical Journal, Vol. 338, pp. 1157-1158, 2009, Available at SSRN: https://ssrn.com/abstract=1912226

Michael Goodyear

Dalhousie University ( email )

6225 University Avenue
Halifax, Nova Scotia B3H 4H7
Canada

Trudo Lemmens (Contact Author)

University of Toronto - Faculty of Law ( email )

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

Dominique Sprumont

University of Neuchatel ( email )

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

Godfrey B. Tangwa

University of Yaounde 1 ( email )

P.O. Box 13597
Yaounde
Cameroon
237-31 89 97 (Phone)
237-23 21 04 (Fax)

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