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It is clear that doH modification is more frequent (see Figure 1). However, it must be recognized that only two of the revisions (1975 and 2000) are more than minor. This means that the period between major revisions is 11 (1964-1975) and 25 years (1975-2000). Therefore, the DoH, essentially in its 1975 form, has had a quarter of a century to become part of the medical research community, which can contribute significantly to the position it has taken. On the other hand, it is recognized that the document needs to be updated to recognize the evolution of the world of biomedical research [15]. It will be important to strike the right balance between the need to modernize the document and the need to make the text known within the medical research community in order to obtain DoH status. The document was extensively revised by the 1964 version. Perhaps the most important addition to the future implementation of medical research was the requirement that independent committees be required to review research protocols. Another important development has been the development of informed consent requirements. These requirements have also been transferred to the “Basic Principles” section (see Appendix 2; Points I.9-I.11). For more thought on informed consent, see “Medical Research Associated with Clinical Care.” These amendments coincided with a simplification of consent requirements for “non-therapeutic” research, simply stating that “subjects should be voluntary” (point III.2).

Because the principles established in the “Basic Principles” section apply to both the “clinical” and “non-therapeutic” research categories, there was no net loss of protection for subjects. The final act of Helsinki was an agreement signed by 35 nations that closed the conference on security and cooperation in Europe in Helsinki (Finland). The multifaceted law addressed a number of important global issues and had a significant impact on the Cold War and US-Soviet relations. This study was conducted in accordance with the ethical standards of the Institutional Ethics Committee and the Helsinki Declaration of 1964 and its subsequent modifications or comparable ethical standards. The declaration was originally adopted in Helsinki (Finland) in June 1964 and has since been revised (the last at the General Assembly in October 2013) and two clarifications from 11 paragraphs in 1964 to 37 in 2013. [7] The explanation is an important document in the history of research ethics, as it is the first major effort of the medical community to regulate research itself and forms the basis of most subsequent documents. Adopted by the General Assembly of 18 . WMA in Helsinki, Finland, in June 1964, 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 point WMA General Assembly, Washington DC , UNITED States , 55 October 2002 (precision to be added) General Assembly 55.WMA, Tokyo, Japan, October 2004 (precision to add) 59.WMA, Seoul, Republic of Korea, October 2008 64.WMA General Assembly, Fortaleza, Brazil, October 2013 The DoH was first adopted at the WMA General Assembly in Helsinki in 1964.