Should the FDA trump the Declaration of Helsinki?
A BMJ editorial discusses the recent FDA ruling that clinical trials performed outside the US no longerhave to conform to the Declaration of Helsinki if used to supportapplications for registration of products in the US but that the regulatory standard expected is that of the International Conference on Harmonisation Good ClinicalPractice. The article, by Michael Goodyear and colleagues, argues that "The FDA is at best acting as if its standards are distinct fromglobally accepted norms by pressuring the declaration to agreeto its demands. At worst, it is creating an impression thatit is more interested in facilitating research than respectingthe rights of people who are the subjects of research." The editorial concludes that "Ultimately, ethicallyresponsible research remains a collective responsibility".