The Declaration of Helsinki and the ongoing debate

Abstract

The Declaration of Helsinki refers to the ethical principles required for medical research on human beings. It was adopted by the 18th Assembly of the World Medical Association in 1964 in Finland and is the best known of all the documents that entity has approved. The original version of the document has been modified five times since its approval (1975, 1983, 1989 , 1996 and 2000). In addition, other Assemblies have incorporated clarifying notes to the text (2002 and 2004). In any case, since 2004 the medical profession continues to debate adjustments and changes. Particular attention and controversy have aroused the proposals to modify articles 29 and 30. Article 29 establishes: "The possible benefits, risks, costs and efficacy of any new procedure must be evaluated by comparing them with the best preventive, diagnostic and therapeutic methods This does not exclude that a placebo, or no treatment, may be used in studies for which there are no proven preventive, diagnostic or therapeutic procedures. "The draft amendment establishes exceptions to this principle:" The possible benefits, risks, costs and Efficacy of any new procedure should be evaluated by checking with the best existing proven method, except in the following circumstances: –The use of a placebo, or no treatment, is acceptable in studies for which there is no existing proven procedure.-When For methodological, scientific, and compelling reasons, the use of a placebo is necessary to determine the efficacy acia and the safety of a method that does not involve additional risk, serious adverse effects or irreversible harm for patients receiving placebo or no treatment. "Article 30 states:" At the end of the investigation, all patients participating in The study must be certain that they will have the best proven and existing preventive, diagnostic and therapeutic methods identified by the study. " The modification proposal entails a considerable modification, by replacing the current text with this other: "At the end of the research, all patients participating in the study have the right to be informed about its results." And in relation to the subject adds at the end of article 14 that "the protocol must describe the arrangements for access after the trial to methods identified as beneficial in the study or access to other appropriate care or benefits." The World Medical Association is in the process of debating to carry out these and other modifications to the Declaration of Helsinki in force, and it is expected that this year, on the occasion of the October 2008 Assembly to be held in Seoul, decisions will be taken. For biomedical publications, it is a transcendent debate that involves divergent views and interests. The Uruguayan Medical Journal hopes to contribute to a frank and enriching debate on problems that involve both the advancement of Medicine and respect for Human Rights.