The Declaration of Helsinki 2000: Ethical Principles and the Dignity of Difference
Medicine and Law: The World Association for Medical Law 2006 June; 25(2): 341-354
The first detailed regulations about nontherapeutic research were promulgated by the Prussian Government in 1900. In 1947, the Nuremberg Code was decreed. Since then, the Declaration of Helsinki (DOH) was adopted in 1964 and has been revised five times. The object of this article is to evaluate the 2000 Revision of the DOH and discuss three problems of concern. These problems are: (1) If, unlike its predecessors, the DOH (2000) has recast itself as a minimum set of international standards 'binding' on physicians worldwide, from where does it derive its authority? (2) The wording of the DOH is incongruent with the underlying ethical principles. (3) The projection of the DOH into the realms of social justice raises the issue of human dignity. Finally, the feasibility or desirability of a theory of justice privileging human dignity as one of its guiding principles and the future of the DOH are examined.
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United States Regulatory Requirements for Research Involving Human Subjects Includes Appendix 1: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research; Appendix 2: World Medical Association Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects Unknown creator (1998-12)