By Ezekiel J. Emanuel
The Lancet, Volume 381, Issue 9877,
Pages 1532 - 1533, 4 May 2013
doi:10.1016/S0140-6736(13)60970-8
Next year will mark the 50th anniversary of the Declaration of Helsinki. Consequently, the World Medical Association (WMA) is developing its eighth version of the Declaration. This anniversary presents an excellent opportunity to reconsider the problems of the Declaration and how they can be remedied to ensure the document retains its prominent status.
In 1964 when the Declaration of Helsinki was initially enacted, it contained 11 articles and 713 words. At that time, the Declaration was unique. Over the years, ethical guidance on research involving human participants has proliferated substantially to encompass the Belmont Report by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; the International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences; multiple laws and regulations, such as the US Federal Policy for the Protection of Human Subjects (known as the “Common Rule”, 45 CFR part 46) and the European Union's Clinical Trials Directive; and the eight principles of What Makes Research Ethical?. Simultaneously, the Declaration of Helsinki has been revised six times and tripled in size with its 35 articles and 2045 words. The revisions have often been extensive. For instance, the distinction between “clinical research combined with professional care” and “non-therapeutic clinical research” was eliminated after much withering criticism. The article that relates to use of placebos was revised and scaled back multiple times between 2000 and 2008.
Over the years problems with, and objections to, the document have accumulated. I propose that there are nine distinct problems with the current version of the Declaration of Helsinki: it has an incoherent structure; it confuses medical care and research; it addresses the wrong audience; it makes extraneous ethical provisions; it includes contradictions; it contains unnecessary repetitions; it uses multiple and poor phrasings; it includes excessive details; and it makes unjustified, unethical recommendations. For instance, the Declaration reads like a haphazard list of articles without an overall logical framework. The topics of articles 21 to 24 are literally a jumble: they cover the importance of the research outweighing research risks, the requirement for voluntary consent, the need to protect participants' privacy, and informed consent requirements for competent individuals, respectively.
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