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Fifty years at the forefront of ethical guidance: the world medical association declaration of Helsinki.

In June 1964, the General Assembly of the World Medical Association (WMA) approved a set of ethical principles for medical research involving human subjects. Named after the city in which it was first adopted, the Declaration of Helsinki quickly gained international significance and has since become one of the flagship documents of the WMA. This year marks the 50th anniversary of the adoption of the Declaration of Helsinki and the importance of this document is more apparent than ever before. Physicians conducting medical research face a paradox: the essential need to ensure the efficacy and safety of interventions by testing them on human subjects, with all the attendant risks, must be reconciled with their fundamental obligation to ‘‘do no harm.’’ This dilemma was recognized long before the WMA commenced drafting, notably in the 1947 Nuremberg Code, a response to the atrocities committed in the name of medical science by doctors in Nazi Germany. The Declaration of Helsinki which was drafted by physicians to provide binding ethical standards for members of their own profession, was the first truly international regulation to address this problem using a pragmatic approach that simultaneously offered real protection. Considerable change has occurred in the last 5 decades in the methods and scope of medical research, which has presented new ethical challenges. These challenges have been addressed in successive revisions of the Declaration as part of the WMA’s regular policy review, most recently in 2013. Although some have argued that the frequency of revisions has undermined its authority, the WMA always has considered the Declaration to be a ‘‘living document,’’ and it is the very fluid nature of the principles it contains that enables it to remain relevant and applicable 50 years on. Despite the emergence of numerous other regulations for medical research involving human subjects, the Declaration of Helsinki remains at the forefront of the provision of ethical guidance. Its influence is derived not from international law, although it does exert considerable authority upon national and international legislation and in some cases it has also been codified into law, but first and foremost upon the fact that it is morally binding for physicians worldwide. This primary focus upon the ethical obligations of physicians has been criticized in recent years for leading to internal contradictions in the document and not reflecting the reality of the research environment. It does, however, reflect the legal mandate of the WMA as a professional organization of physicians and does not preclude its use by members of other professions. Indeed, a key feature that sets the Declaration of Helsinki apart from other guidelines is its accessibility. Rather than being a detailed rule book, it provides researchers with a concise set of easy-to-read ethical principles. It was of major importance to the workgroup responsible for overseeing the latest revision process that this usability aspect be retained and enhanced. This led to a restructuring of the document, with paragraphs addressing the same topics being reordered under logical subheadings. Adjustments to the language also improved the consistency of the text. The current, eighth version of the Declaration of Helsinki was adopted in Fortaleza, Brazil, in October 2013. It represented the culmination of a comprehensive and systematic process of revision, which included international expert conferences on four continents, the final conference taking place in Washington, DC, and an open public consultation during which comments were solicited from the international community. Respondents to the public consultation hailed from a vast array of geographical and professional backgrounds and their input highlighted areas of particular controversy. The changes ultimately included in the revised document addressed many of the concerns raised during the revision process and succeeded in balancing the need to promote goodquality clinical research while protecting the rights and safety of research subjects. Protection for vulnerable populations was enhanced, not by including a list of groups or individuals considered particularly vulnerable, which would risk being incomplete, but by providing a general definition (paragraph 19) and setting out a stringent set of conditions for research with vulnerable Editorial