On the Declaration of Helsinki
These days, Stuart Rennie seems to be doing a terrific job of voicing many of my own perspectives on global ethical issues. So why not continue to link to his posts?
His latest effort assesses the FDA's decision to abandon the ethical dictates of the Declaration of Helsinki, moving instead to the weaker protections of the Good Clinical Practices of the International Conference on Harmonization. Notwithstanding my own skepticism about the utility of ethical codes, Rennie provides good reason for thinking the decision is quite important, if not substantively, at the very least as a signal as to current priorities in global research:
The Declaration of Helsinki has its own problems, not the least of which are problems of ambiguity in its language and limited enforceability. But even its most uncharitable critic can see that the document has an ethical backbone. What impact the FDA's decision will have on clinical trials around the world remains to be seen, but the decision would seem to encourage pharmaceutical companies to cut ethical corners when working abroad.
Indeed. Merrill Goozner comments here.
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