There is a clear tendency for DoH to be modified more frequently (see Figure 1). However, it must be acknowledged that only two of the revisions (1975 and 2000) were more than minor in nature. This means that the period between the in-depth revisions is 11 years (1964 to 1975) and 25 years (1975 to 2000). Therefore, the DoH, essentially in its 1975 form, had a quarter of a century to be integrated into the medical research community, which can contribute significantly to the position it has taken. On the other hand, the need to update the document to recognize the changing world of biomedical research is recognized [15]. The right balance between the need to modernize the document and the need to familiarize the text in the medical research community will be important to maintain the status of the DoH. The British Medical Journal announced the emergence of the DoH in its July 18, 1964 issue, with the following words: ”A draft code of ethics for human experimentation was published in the British Medical Journal on October 27, 1962. A revised version was adopted as a final draft at the world medical association meeting in Helsinki in June 1964. . It will be known as the Declaration of Helsinki” [6] (emphasis added). Attached to this discreet announcement were just over 700 words of the original DoH text. There seemed to be little evidence at the time of the importance of this document in the context of research ethics.

In the midst of these extremes, there are many clinical scenarios where the question of whether placebo-controlled research is acceptable or whether serious or irreversible damage is threatened must be addressed ”disease by disease”. Diseases that have recently given rise to discussions in this regard include high blood pressure [27], depression [28], schizophrenia [29] and postmenopausal osteoporosis [30]. Taking the example of osteoporosis, Brody and colleagues [31] pointed out that there are patient groups in which placebo-controlled studies clearly do not violate paragraph 29. In particular, they identify as appropriate for placebo-controlled trials: ”competent and knowledgeable patients who reject approved therapies for valid reasons, situations where ”there is a reasonable basis for significant disagreement or lack of consensus among professionals on whether approved treatments are better than placebos” or ”subjects are refractory to known effective agents”. However, it should be noted that this approach can lead to distortions. A person who agrees to participate in a blinded randomized controlled trial effectively agrees not to receive information that most people would like to receive. that is, knowing what treatment they are receiving at a certain time. This agreement not to know such information does not only apply to studies with placebo controls. Placebo controls are not considered unethical in themselves according to issue 29. What is questioned is the potential harm to research participants who may not receive proven treatments otherwise available during a placebo-controlled trial.

Adopted by the General Assembly in Helsinki, Finland, on 18.WMA and amended by the General Assembly on 29.WMA, Tokyo, Japan, October 1975. The revision, which took place in 1975, was even more extensive compared to the original document than the Edinburgh revision (2000). Almost nothing was removed from the 1964 version and much was added. This resulted in a near doubling of the length of the document. Given the relatively minor revisions of 1983, 1989, and 1996 (see below), it was indeed the 1975 version of the DoH that became the governing document of human research ethics for a quarter of a century. The Declaration was originally adopted in Helsinki, Finland, in June 1964 and has since undergone seven revisions (the last at the General Assembly in October 2013) and two clarifications, with the length increasing significantly from 11 paragraphs in 1964 to 37 in the 2013 version. [7] The Declaration is an important document in the history of research ethics, as it is the first major attempt by the medical community to self-regulate research and forms the basis of most subsequent documents. Adopted by the 18. WMA General Assembly, Helsinki, Finland, June 1964 and amended by: 29.WMA General Assembly, Tokyo, Japan, October 1975 35.WMA General Assembly, Venice, Italy, October 1983 41.WMA General Assembly, Hong Kong, September 1989 48.WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52.WMA General Assembly, Edinburgh, Scotland, October 2000 53.WMA General Assembly, Washington DC, USA, October 2002 (Clarification Note added) 55th WMA General Assembly Assembly, Tokyo, Japan, October 2004 (Clarification Note added) 59th WMA General Assembly, Seoul, Republic of Korea, October 2008 64th WMA General Assembly, Fortaleza, Brazil, October 2013 The Declaration of the World Medical Association of Helsinki was first adopted in 1964.

In its 40 years of existence, the declaration has been revised five times and has risen to a leading position as a guiding principle of ethical principles for physicians involved in medical research. However, the recent revision has sparked significant controversy, particularly in the area of ethical requirements for placebo-controlled trials and the issue of responsibilities to research participants at the end of a study. This review examines earlier versions of the Declaration of Helsinki and asks the question: how exactly did the text of the Declaration change during its lifetime? With regard to the current form of the Declaration of Helsinki, we ask ourselves what are the main changes in the recent revision and what are the controversies surrounding it? Finally, building on the detailed review of past and present versions of the Declaration of Helsinki, we examine some of the possible future paths for the Declaration in light of its history and position in the world of medical research ethics. The document was extensively revised from the 1964 version. Perhaps the most important addition to the subsequent conduct of medical research has been the requirement for independent committees to review research protocols. Another important development has been the significant development of informed consent requirements. These requirements have also been moved to the ”Basics” section (see Appendix 2; paragraphs I.9 to I.11). For more considerations on informed consent, see the section ”Medical research in combination with clinical care.” These changes coincided with a simplification of consent requirements for ”non-therapeutic” research, now simply saying that ”subjects should be volunteers” (Section III.2).

Since the principles developed in the ”Basic Principles” section apply to both the ”clinical” and ”non-therapeutic” research categories, there was no net loss of protection for the subjects. First, if the wording of the document contradicts the true underlying ethical principles, they need to be better articulated, that is, a better ”wordsmith” is the way to go. Second, there may not really be a universal consensus on the ethical issues at stake, in which case some sort of ”agreement to deviate” would be the only way to reach a consensus document. The Declaration of Helsinki is a declaration outlining the ethical principles of medical research on humans and was originally adopted by the 18th Assembly of the World Medical Association in Helsinki, Finland, in June 1964. It was developed from 10 principles, which were first established in the Nuremberg Codex in 1947, and later incorporated elements of the Geneva Declaration (1948). a statement of the ethical duties of physicians. .