2014 年 45 巻 2 号 p. 41-51
The latest revision of the Declaration of Helsinki was adopted by the World Medical Association (WMA) in October 2013. The year 2014 is the 50th anniversary since the first adoption of the Declaration in 1964, which was based on strong reflection over the unethical human experimentation conducted by doctors during World War II. Subsequently, the WMA has continuously elaborated the Declaration with the goal to prevent abuse of human dignity, and to guide physicians worldwide toward the conduct of ethically and scientifically sound research involving human subjects, to adhere to their duty of working for the patients' best interest.
The most remarkable points discussed toward this 2013 revision are: (1) adding subheadings; (2) creating a provision to assure compensation and treatment for subjects harmed as a result of research; (3) clarifying the provisions of comparators e.g., placebo; (4) clarifying the provisions of protecting vulnerable populations and post-study arrangement; (5) adding the concept of biobank in the provision of research using human material and/or data; (6) strengthening the function of research ethics committees; (7) expanding the range of research to be registered in public database; and (8) clarifying the provision of the use of unproven intervention.
There remain pros and cons of the principles in the revised Declaration; however, it is important to understand the historical background and continuing debates regarding the Declaration as a "living document". In this paper, the author describes such discussions that are believed to promote profound understanding of this document, which are necessary for the research communities in the world to conduct ethically and scientifically sound research involving human subjects.
