Seventh revision of Declaration of Helsinki published

Michael Cook
7 Dec 2013
Reproduced with Permission

Next year marks the 50th anniversary of the Declaration of Helsinki, the benchmark for ethical medical research on subjects. To mark the occasion, the World Medical Association, which is responsible for updating the document, has issued a seventh revision. The WMA president, Margaret Mungherera, President of the WMA, explains the scope of the changes:

"We have spent two years consulting our national medical association members, outside experts and the public and we are satisfied that today we have a Declaration that requires greater transparency about medical research, greater accountability and increased patient safety. The changes also place more obligations on the sponsors of research, on the researchers themselves and on host governments to protect research subjects."

The origins of the Helsinki Declaration lie in the atrocities by Nazi doctors during World War II. In the wake of the war crimes trials, the 1947 Nuremberg Code set down ten conditions for research to be ethical. This was the first standard of human research ethics. However, this needed to be refined to cover the ever-expanding need to test medical advances on human subjects.

The result was the 1964 Declaration of Helsinki. The first edition contained 11 articles and 713 words. With constant revision, it has grown to 37 articles and 2,240 words which are read and glossed like a Biblical text.

One of the leading US experts on research ethics, Dr Ezechiel Emanuel, of the University of Pennsylvania, has been highly critical of the new draft in articles in JAMA and The Lancet. He claims 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."

In addition, he says, constant revision "undermine the legitimacy of the Declaration". A statement of ethical principles should be unchanging; otherwise it makes researchers think that they are not truly authoritative."