According to recent news reports, the U.S. FDA recently decided to abandon its endorsement of the Declaration of Helsinki when sponsors submit clinical trial data obtained overseas.
The Declaration of Helsinki (DoH)- which was first adopted in 1964- is the World Medical Association’s statement on ethical requirements for human experimentation. According to an editorial in Nature (22 May 2008), 85 countries have endorsed the DoH.
The FDA had long ago began distancing itself from the DoH when it refused to endorse revisions to the statement that followed controversies over the use of placebos in HIV mother-to-child transmission studies. But the FDA has now opted to slam shut a door it had, for years, left ajar.
Helsinki is an imperfect document. Certain paragraphs– particularly those involving international research– have continued to provoke heated debate. But it is arguably the most influential, multilateral statement on ethical human experimentation, and it speaks clearly to considerations of justice when high income countries pursue trials in resource-poor settings.
Shame on FDA, and the U.S. government, for favoring parochial interests over international policy and, indeed, human rights. (photo credit: sobergeorge 2007)