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

Abstract

A new rule seems to be more about imperialism than harmonisation

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 legislatures cannot unreservedly commit to indefinite amendments, the declaration can, and should, be considered a minimum standard that reflects core ethical principles, operationalised through instruments such as the GCP and national regulatory policy. Static referencing of specific versions has not created substantial problems to date, and no reason is given about why this should be a problem now.