![]() Opponents of the paragraph argue that it is the responsibility of local health care systems, not the study sponsors, to provide access to ongoing health care and that, in any case, the infrastructure does not always exist to enable study sponsors to ensure this access. Some argued that the research could be justified by the devastation caused by the epidemic, and the fact that these patients could not otherwise obtain medication others have argued that ethical standards are universal and that all research subjects deserve a certain standard of protection regardless of their geographic location. This occurred after some of the trials of HIV/AIDS drug therapy conducted in some African nations in the 1990s. 5 The primary intention of the paragraph is to prevent trial sponsors from performing studies in populations that would not normally have access to the study treatment, only to remove access to the intervention once the trial has been completed. This addition to the Declaration has given rise to significant debate and discussion, including in the pages of the journal. This paragraph reads as follows:Īt the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study. 4 Our concern here, however, is with paragraph 30, which addresses the issue of post-study access to treatment. Many feel that this note has not served to clarify conditions in which placebos can ethically be used but, rather, may have weakened the intent of the existing paragraph. The first of these, added in 2002, pertains to paragraph 29, which deals with the use of placebos. ![]() The addition of paragraphs 29 and 30 in the amendment of 2000 has been among the more significant and controversial changes made to the document, and subsequently prompted the addition of 2 notes of clarification. The Declaration of Helsinki has been amended 5 times, most recently in 2000. This document evolved from the Nuremberg Code, which was put in place to protect human research subjects in response to atrocities committed by Nazi physicians in the name of medical science. Internationally, there is little argument that the pre-eminent document addressing research ethics is the Declaration of Helsinki, 3 adopted by the World Medical Association (WMA) in 1964. ![]() However, Health Canada and many private funding sources generally use the World Health Organization's guidelines, 2 which differ slightly from the Tri-Council statement. In Canada, the Tri-Council Policy Statement 1 must be adhered to by individuals and institutions who receive public funding for research. Research on human subjects is governed by a large number and wide variety of codes and policies worldwide.
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