Published 21 April 2009, doi:10.1136/bmj.b1559
Cite this as: BMJ 2009;338:b1559

Editorials

Does the FDA have the authority to trump the Declaration of Helsinki?

A new rule seems to be more about imperialism than harmonisation

The first 150 words of the full text of this article appear below.

The Food and Drug Administration (FDA) of the United States has ruled that clinical trials performed outside the US no longer have to conform to the Declaration of Helsinki if used to support applications for registration of products in the US.¹ Instead, the International Conference on Harmonisation Good Clinical Practice (GCP) has been designated as the new regulatory standard. This suggestion met considerable opposition from scientists, ethicists, and consumer groups before and during the consultations.^{1 2 3} The FDA’s justifications included the arguments that it was merely harmonising its regulations with a global standard, and that legal instruments, such as the US Code of Federal Regulations, cannot embed external documents subject to change beyond the agency’s control (dynamic referencing).^{1 4}

This justification failed to explain why GCP was any different in this respect, or why the declaration and the GCP were considered mutually exclusive.² Although such dynamic referencing can create legal problems,^{5 6} because . . . [Full text of this article]

¹ Dalhousie University, Halifax, Nova Scotia, Canada B3H 2Y9, ² University of Toronto, Toronto, Ontario, Canada M5S 2C5, ³ Institute of Health Law, University of Neuchâtel, 2000 Neuchâtel, Switzerland, ⁴ University of Yaoundé 1, PO Box 13597, Yaoundé, Cameroon

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