[1][2][3][4] It is not a legally binding instrument under international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations.
[5] Its role was described by a Brazilian forum in 2000 in these words: "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity.
The interests of the participant after the study is completed should be part of the overall ethical assessment, including assuring their access to the best proven care (Article 30).
The Declaration was originally adopted in June 1964 in Helsinki, Finland, and has since undergone eight revisions (the most recent at the General Assembly in October 2024) and two clarifications, growing considerably in length from 11 paragraphs in 1964 to 37 in the 2024 version.
The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code.
However, from 1993 onwards, the Declaration was not alone as a universal guide since CIOMS and the World Health Organization (WHO) had also developed their International Ethical Guidelines for Biomedical Research Involving Human Subjects.
[10] This was a placebo controlled trial which showed a reduction of nearly 70% in the risk of transmission, and Zidovudine became a de facto standard of care.
The subsequent initiation of further placebo controlled trials carried out in developing countries and funded by the United States Centers for Disease Control or National Institutes of Health raised considerable concern when it was learned that patients in trials in the US had essentially unrestricted access to the drug, while those in developing countries did not.
Justification was provided by a 1994 WHO group in Geneva which concluded "Placebo-controlled trials offer the best option for a rapid and scientifically valid assessment of alternative antiretroviral drug regimens to prevent transmission of HIV".
[20] In 1997 Lurie and Wolfe published their seminal paper on HIV trials,[21] raising awareness of a number of central issues.
These included the claims that the continuing trials in developing countries were unethical, and pointing out a fundamental discrepancy in decisions to change the study design in Thailand but not Africa.
[27][28] Many editorials and commentaries were published reflecting a variety of views including concerns that the Declaration was being weakened by a shift towards efficiency-based and utilitarian standards (Rothman, Michaels and Baum 2000),[29][30][31][32] and an entire issue of the Bulletin of Medical Ethics was devoted to the debate.
Others saw it as an example of Angell's 'Ethical Imperialism', an imposition of US needs on the developing world,[33] and resisted any but the most minor changes, or even a partitioned document with firm principles and commentaries, as used by CIOMS.
The idea of ethical imperialism was brought into high attention with HIV testing, as it was strongly debated from 1996 to 2000 because of its centrality to the issue of regimens to prevent its vertical transmission.
[20] Brennan summarises this by stating "The principles exemplified by the current Declaration of Helsinki represent a delicate compromise that we should modify only after careful deliberation".
These implications further came into public view since the Helsinki declaration had stated, "In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement, it offers hope of saving life, reestablishing health or alleviating suffering.
[37] This involved a restructuring of the document, including renumbering and re-ordering of all the articles, the changes in which are outlined in this Table Archived 2010-06-05 at the Wayback Machine.
The Basic Principles establish a guide for judging to what extent proposed research meets the expected ethical standards.
Address to Scientific Session, World Medical Association General Assembly, September 2003, Helsinki and even considered for a clarification footnote.
The discussions[36] indicate that there was felt a need to send a strong signal that exploitation of poor populations as a means to an end, by research from which they would not benefit, was unacceptable.
This revision implies that in choosing a study design, developed-world standards of care should apply to any research conducted on human subjects, including those in developing countries.
The opposing view, as expressed by Levine[19] and by Temple and Ellenberg[43] is referred to as 'placebo orthodoxy', insisting that placebo controls are more scientifically efficient and are justifiable where the risk of harm is low.
[48][49][50] Zion and colleagues (Zion 2000)[30][48] have attempted to frame the debate more carefully, exploring the broader social and ethical issues and the lived realities of potential subjects' lives as well as acknowledging the limitations of absolute universality in a diverse world, particularly those framed in a context that might be considered elitist and structured by gender and geographic identity.
Article 30 was debated further at the 2003 meeting, with another proposed clarification[50] but did not result in any convergence of thought, and so decisions were postponed for another year,[53][54] but again a commitment was made to protecting the vulnerable.
At a gathering of the WMA Council in France in May 2004, the American Medical Association presented the subsequent clarifying statement: The WMA reaffirms its stance that it is imperative, within the study planning phase, to identify provisions for post-trial access by research participants to prophylactic, diagnostic, and therapeutic procedures deemed beneficial in the study or to access to other appropriate healthcare.
The specifics of post-trial access arrangements or alternative care should be outlined in the study protocol, enabling the ethical review committee to evaluate these provisions during its assessment.
[67] In addition, the updated version is felt to be more relevant to limited resource settings—specifically addressing the need to ensure access to an intervention if it is proven effective.
After consultation, which included expressions of concern, [68] a final rule was issued on April 28, 2008, replacing the Declaration of Helsinki with Good Clinical Practice effective October 2008.
Consequently, the DoH, essentially in its 1975 version, had a quarter-century to establish itself within the medical research community, and this has significantly contributed to its current status.
This organization represents the largest global assembly of physicians, and consequently, it could be argued that the WMA is a credible and authoritative entity for issuing statements on behalf of the medical profession as a whole.