![]() Critics may find it convenient to dismiss something they oppose as a revolution. First, it could be argued that this proposed revision constitutes a revolution rather than an evolution. There are four objections that might be raised to this revision. In the accompanying appendix I delineate a proposed revision of the Declaration of Helsinki that addresses the nine distinct problems I have identified, and contains fewer than 1800 words in 21 articles. In addition, the Declaration includes provisions that are ethically important, but have nothing to do with research that involves human participants, such as treating research animals with respect. And, the consensus view is that self-determination should trump promoting health. Such protection-eg, self-determination and privacy-can conflict with promoting the health of patients. However, article 11 states that physicians who take part in medical research need “to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects”. Similarly, the Declaration of Helsinki argues that physicians' primary consideration must be to promote the health of patients in article 3. For instance, in article 4 the Declaration claims that it only “binds the physician”, but then proceeds in article 30 to delineate ethical obligations of authors, editors, and publishers who are frequently not physicians. The document also contains a number of contradictory recommendations. The article that relates to use of placebos was revised and scaled back multiple times between 20. For instance, the distinction between “clinical research combined with professional care” and “non-therapeutic clinical research” was eliminated after much withering criticism. Simultaneously, the Declaration of Helsinki has been revised six times and tripled in size with its 35 articles and 2045 words. 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?. At that time, the Declaration was unique. In 1964 when the Declaration of Helsinki was initially enacted, it contained 11 articles and 713 words. The Lancet Regional Health – Western Pacific.The Lancet Regional Health – Southeast Asia.The Lancet Gastroenterology & Hepatology.
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