Monday, October 21, 2013

Declaration of Helsinki 10.0

A revised, 50-year anniversary edition of the Declaration of Helsinki was released this week. The Declaration is often described -- especially in your standard ethics training sessions -- as the most influential research ethics guidance document on our planet. Its reputation may even have gone to its own head, considering that it states (Paragraph 10) that "No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration." More authoritative than international requirements? That sounds downright awesome. Or maybe a bit too awesome. It was not too long ago that the FDA abandoned the Declaration of Helsinki as the ethical standard for evaluating data from clinical trials conducted abroad. Which suggests you don't have ultimate authority just by stating that you do.

The Declaration has been revised 10 times over the last 50 years, and more frequently as time has gone on. The latest revision is more like a tweaking, without too much in the way of novelty and excitement. The document's structure has been spruced up, making it less burdensome to read. The emphasis on compensation for research-related harm is relatively new and welcome, though the Declaration provides little concrete guidance on what fair compensation would look like. The Declaration reiterates that, in order to fulfill the most basic ethical requirement of research, research results must be disseminated, including negative results. The section about the use of placebos in clinical trials, which usually is good for a firestorm of dispute, seems to be unchanged this time around.

The Declaration of Helsinki has increasingly become a contested document. Not everyone is happy with the Declaration in its present form. The Journal of the American Medical Association has published, with open access, both the new Declaration and a critical commentary, here and here. Despite its aspiration to super-international authority, perhaps the real power of the Declaration lies in the translation of its precepts into more concrete national regulations, particularly when they are backed by the force of law. That means, of course, if there are problems with the Declaration itself, they will be reproduced around the world. That is why this modest, 4 page document has to be kept under close scrutiny.  

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