The second (1983) and third (1989) revisions were comparatively minor, primarily involving clarifications and updates in terminology. The revised Declaration of Helsinki represents a significant improvement over previous versions. [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. The language of the passage implied that standards of medical care in developed countries should apply to any research with human beings, including research conducted in developing countries. The investigator's duty is solely to the patient (Articles 2, 3 and 10) or volunteer (Articles 16, 18), and while there is always a need for research (Article 6), the subject's welfare must always take precedence over the interests of science and society (Article 5), and ethical considerations must always take precedence over laws and regulations (Article 9). Omissions? This has raised a number of concerns regarding the apparent weakening of protections for research subjects outside the United States. Stuttgart: Franz Steiner Verlag, 2007. ", "WMA Press Release: WMA to continue discussion on Declaration of Helsinki. [36] [26] Center for Genetics and Society May 15th 2008, FDA abandons Declaration of Helsinki for international clinical trials. The Declaration of Helsinki (DoH, Finnish: Helsingin julistus, Swedish: Helsingforsdeklarationen) is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). The most recent iteration of Helsinki (2013) was reflective of the controversy regarding the standard of care that arose from the vertical transmission trials. [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. Research should be based on a thorough knowledge of the scientific background (Article 11), a careful assessment of risks and benefits (Articles 16, 17), have a reasonable likelihood of benefit to the population studied (Article 19) and be conducted by suitably trained investigators (Article 15) using approved protocols, subject to independent ethical review and oversight by a properly convened committee (Article 13). [20] In 1997 Lurie and Wolfe published their seminal paper on HIV trials,[21] raising awareness of a number of central issues. I was dismayed that the World Medical Association was retreating from this position. Nevertheless, what had started as a controversy over a specific series of trials and their designs in Sub-Saharan Africa, now had potential implications for all research. That paragraph differed very little in meaning from a similar passage in the fourth revision: with regard to placebos, the fifth revision replaced the words “inert placebo” with “placebo, or no treatment.” That change, however, became the focal point of a debate involving the ethical use of placebo-controlled trials that had coalesced within the medical community during the 1990s. Global Bioethics Blog May 6 2008. It is recognized that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor (Articles 23, 24), then allowance should be considered for surrogate consent by an individual acting in the subject's best interest, although his consent should still be obtained if at all possible (Article 25). One of these is Good Clinical Practice (GCP), an international guide, while each country may also have local regulations such as the Common Rule in the US, in addition to the requirements of the FDA and Office for Human Research Protections (OHRP) in that country. 1-1,1-2 The declaration and its revision have greatly increased the global research community's sensitivity to research ethics.. It has continually grown and faced more frequent revisions. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2013. The Declaration of Helsinki largely echoed the Nuremberg Code, but helped to define distinctions between therapeutic and nontherapeutic clinical research. Address to the Scientific Session, World Medical Association General Assembly, September 2003. Biopolitical Times. [39][47] The debate over these and related issues also revealed differences in perspectives between developed and developing countries. Integrity in Science May 5 2008", "The FDA decision to shelve the Helsinki Declaration: Ethical considerations", "DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001", http://ec.europa.eu/research/info/conferences/edctp/edctp_ethics_en.html#fn1, U.S. National Institutes of Health (NIH) - Protecting Human Subject Research Participants, "Clinical trials in developing countries: scientific and ethical issues", "Should research ethics change at the border? The distinction between therapeutic and non-therapeutic research introduced in the original document, criticised by Levine[19][38] was removed to emphasise the more general application of ethical principles, but the application of the principles to healthy volunteers is spelt out in Articles 18-9, and they are referred to in Article 8 ('those who will not benefit personally from the research') as being especially vulnerable. Other countries have guides with similar roles, such as the Tri-Council Policy Statement in Canada. Declaration of Helsinki. In paragraph 30 the WMA called for detailing “post-trial access arrangements” for ethical review committees, which would presumably comment on their feasibility. Vanderpool, Harold Y. The utilitarian argument[44] held that the disadvantage to a few (such as denial of potentially beneficial interventions) was justifiable for the advantage of many future patients. The terms of reference included only a limited revision compared to 2000. The fifth revision reorganized the structure of the document and expanded it by creating a nine-paragraph introductory section (which broadened the scope of the declaration to include scientists as well as physicians) and sections describing various principles of medical research. 2013 Nov 27;310(20):2143-4. doi: 10.1001/jama.2013.281632. Investigators often find themselves in the position of having to follow several different codes or guidelines, and are therefore required to understand the differences between them. For other uses, see Declaration of Helsinki (disambiguation). The scope of ethical review was increased to include human tissue and data (Article 1), the necessity to challenge accepted care was added (Article 6), as well as establishing the primacy of the ethical requirements over laws and regulations (Article 9). 2005", "Schuklenk U. Helsinki Declaration revisions. The 1975 revision was almost twice the length of the original. A new working group examined article 30, and recommended not amending it in January 2004. 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. 29th Meeting, Tokyo, 1983: Second revision. 'Best current' has been variously held to refer to either global or local contexts.[46]. The influence of the declaration is far-reaching. Despite these changes, as Macklin predicted, consensus was no closer and the Declaration was considered by some to be out of touch with contemporary thinking,[57] and even the question of the future of the Declaration became a matter for conjecture. The circulation of a draft revised version in April last year caused most controversy of all. This page was last edited on 5 December 2020, at 15:08. [citation needed]. Debate ensued about revisions to the declaration, with some medical practitioners arguing for stronger language and commentary addressing clinical trials and others proposing to limit the document to basic guiding principles. 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. Public debate was relatively slight compared to previous cycles, and in general supportive. The World Medical Association's Declaration of Helsinki offers guidelines to doctors engaged in biomedical research with human subjects. In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. The fourth (1996) revision also was minor in scope but notably added a phrase that effectively precluded the use of inert placebos—drugs with no active ingredients used to test the safety and efficacy of other drugs in clinical trials or provide a patient with mental relief—when a particular standard of care existed. [62][63] Further workshops were held in Cairo and São Paulo and the comments collated in August 2008. [61] Those comments were then incorporated into a second draft in May. There are a number of available tools which compare these. Editor —The BMJ has devoted considerable coverage to the revision of the World Medical Association's Declaration of Helsinki. The 2002 clarification to Article 29 was in response to many concerns about WMA's apparent position on placebos. [81]. Attempts to amend the Declaration for a fifth time have rumbled on for 2 acrimonious years. Temple R. Impact of the Declaration of Helsinki on medical research from a regulatory perspective. Updates? Effectively this shifted the WMA position to what has been considered a 'middle ground'. The language appeared to mandate the provision of the same level of care to the patients in the study afforded to those in developing countries, which may require massive investments of staffing and capital. The Declaration of Helsinki and public health John R Williams a. It clearly stated that "concern for the interests of the subject must always prevail over the interests of science and society. It augmented the oversight powers of ethical review committees and adjusted the language related to placebos in medical studies. The entire process was carried out based on the latest version of the Declaration of Helsinki (Human, 2001). Wherever possible unproven methods should be tested in the context of research where there is reasonable belief of possible benefit (Article 32). Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964. and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975. 18th Meeting, Helsinki, 1975: First revision. This article is about the human medical experimentation ethics document. [74] The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physicians' ethical duties. (1996). Arguments over this have dealt with whether subjects derive benefit from the trial and are no worse off at the end than the status quo prior to the trial, or of not participating, versus the harm of being denied access to that which they have contributed to. Parent topics. [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. Challenges include the apparent conflict between guides, such as the CIOMS and Nuffield Council documents. Please select which sections you would like to print: Corrections? The Nation May 19, 2008, "Trials on trial: The Food and Drug Administration should rethink its rejection of the Declaration of Helsinki", "FDA scraps Helsinki Declaration on protecting human subjects. 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. For this reason the footnote indicates that the wording must be interpreted in the light of all the other principles of the Declaration. [71] Informed consent was developed further, made more prescriptive and partly moved from 'Medical Research Combined with Professional Care' into the first section (Basic Principles), with the burden of proof for not requiring consent being placed on the investigator to justify to the committee. Kennedy Inst Ethics J 2001 11(1): 17-36 (password required)", "The revision of the Declaration of Helsinki: past, present and future", "Nuffield Council on Bioethics: The ethics of research related to healthcare in developing countries. That was followed in 1948 by the WMA’s Declaration of Geneva, a document outlining every physician’s ethical duties, which included pledges to focus on the health of the patient and not to use medical knowledge to violate human rights. As Macklin[39] points out, both sides may be right, since justice "is not an unambiguous concept". Transitioning research participants to the appropriate health care when a research study ends is a global problem. Our editors will review what you’ve submitted and determine whether to revise the article. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation used in the Nuremberg Code. Jan-Mar 2001 9(1)", "WMA - The World Medical Association-Hello world! A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. [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. [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". In paragraph 29 the WMA noted that use of placebos was considered acceptable in situations where the reasons for doing so were either “scientifically compelling” or where the medical condition under study was not serious and the patient would not be placed at increased risk of serious or irreversible harm. These arguments are intimately tied to the concept of distributive justice, the equitable distribution of the burdens of research. [39] Frederick, Maryland: University Publishing Group, Inc. p. 85. [39] Macklin R. Future challenges for the Declaration of Helsinki: Maintaining credibility in the face of ethical controversies. The actual claim to authority, particularly on a global level, by the insertion of the word "international" in article 10 has been challenged. Shah S. FDA Puts Medical Test Subjects in Danger. The U.S. Food and Drug Administration rejected the fifth revision in 2007 because of its restrictions on the use of placebo conditions and eliminated all references to the declaration, replacing it with the Good Clinical Practice guidelines, an alternate internationally sanctioned ethics guide. The Declaration was originally adopted in June 1964 in Helsinki, Finland, and has since undergone seven revisions (the most recent at the General Assembly in October 2013) and two clarifications, growing considerably in length from 11 paragraphs in 1964 to 37 in the 2013 version. 2, Stuttgart, Franz Steiner, 2007, pp. Notably, it relaxed conditions for consent for participation, changing the Nuremberg requirement that consent is “absolutely essential” to instead urge consent “if at all possible” and to allow for proxy consent, such as from a legal guardian, in some instances. Editor —I was delighted by the new clause 29 in the revised Declaration of Helsinki, which forbids clinical trials comparing drugs against no treatment when an effective treatment exists. [13] The European Union similarly only cites the 1996 version in the EU Clinical Trials Directive published in 2001. The fundamental principle is respect for the individual (Article 8), his right to self-determination and the right to make informed decisions (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. The “Declaration of Helsinki” or the “Helsinki Declaration” are the short titles usually used for the World Medical Association's “Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects.”. [79] The European Commission, however, does refer to the 2000 revision. The Declaration of Helsinki is a formal statement developed by the World Medical Association that provides ethical guidelines that physicians and other medical research participants should adhere to when conducting research that uses human subjects. The first revision, conducted in 1975, expanded the declaration considerably, increasing its depth, updating its terminology, and adding concepts such as oversight by an independent committee. Amongst the many changes was an increased emphasis on the need to benefit the communities in which research is undertaken, and to draw attention to the ethical problems of experimenting on those who would not benefit from the research, such as developing countries in which innovative medications would not be available. eventually came up with a text that was endorsed by WMA's Council and passed by the General Assembly on October 7, 2000, If you have access to a journal via a society or association membership, please browse to your society journal, select an article to view, and follow the instructions in this box. Final Rule April 28 2008, effective October 27 2008", Obasogie O. Goozner on the FDA and the Declaration of Helsinki. Declaration of Helsinki The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). The opposing view held that when risk of harm is low and there are no local standards of care (as is often the case in developing countries), placebo-controlled trials are ethically acceptable, especially given their potential benefits for future patients. The declaration has been revised several times. 370, €54.00 (hardback, 978-3-515-08862-6). ", "Proposed revisions to the Declaration of Helsinki. 48th Meeting, Somerset West (South Africa), 2000: Fifth revision. S Frewer A, Schmidt U, eds. Determining the optimal relationship between public health and individual health is a major ethical challenge for health systems and providers. The Declaration of Helsinki, which was drawn up by the World Medical Association (WMA) in 1964, has been amended four times. The second revision (1983) included seeking the consent of minors where possible. [12], In retrospect, this was one of the most significant revisions because it added the phrase "This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists" to Article II.3 ("In any medical study, every patient--including those of a control group, if any—should be assured of the best proven diagnostic and therapeutic method."). The AIDS Clinical Trials Group (ACTG) Study 076 of 100 Zidovudine in maternal-infant transmission of HIV had been published in 1994. WMA 2001, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, "Human Experimentation. Investigators still have to abide by local legislation but will be held to the higher standard. See Article History. A Controversial Declaration. The NIH training in human subject research participant protection no longer refers to the Declaration of Helsinki. Declaration of Helsinki, formal statement of ethical principles published by the World Medical Association (WMA) to guide the protection of human participants in medical research. In this sense the Declaration endorsed ethical universalism. There are also operational issues that are unclear. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. [35] 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. [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. So great was the tension that the WMA issued clarifications to paragraphs 29 and 30 in 2002 and 2004, respectively. 5th draft", "Comparison of Common Rule with the Declaration of Helsinki and Good Clinical Practice", "Declaration of Helsinki History Website", "Letter from...Denmark. In developing countries, per capita health care expenditures are much lower, and some medical practitioners argued that the rule placed too great a burden on researchers and their resources after conclusion of the study. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. [72] [80], While the Declaration has been a central document guiding research practice, its future has been called into question. Creating an international document to guide research around the world is an enormously difficult and complicated task. 2005, CFR Title 45 Part 46 Protection of Human Subjects, Tri-Council Policy Statement: Ethical conduct for research involving humans (Canada), https://en.wikipedia.org/w/index.php?title=Declaration_of_Helsinki&oldid=992489245, Articles with dead external links from July 2019, Articles with permanently dead external links, Short description is different from Wikidata, Articles containing Finnish-language text, Articles containing Swedish-language text, Articles with unsourced statements from October 2009, CS1 maint: DOI inactive as of September 2020, Creative Commons Attribution-ShareAlike License, 1964: Original version. [65] Others include CIOMS and the US Government.[66]. 52nd Meeting, Edinburgh, 2008: Sixth revision, 59th Meeting, Seoul, 2013: Seventh revision, 64th Meeting, Fortaleza. General Assembly WMA Hamburg, Germany 1997, Nancy Dickey, Kati Myllymäki, Judith Kazimirsky, Williams JR. 2002 CIOMS, UNESCO: Universal declaration on bioethics and human rights. [59] In November 2007 a draft revision was issued for consultation till February 2008,[60] and led to a workshop in Helsinki in March. Although a consensus was not reached, the WMA approved the revision. and which proved to be the most far reaching and contentious revision to date. Article 30 introduced another new concept, that after the conclusion of the study patients 'should be assured of access to the best proven' intervention arising from the study, a justice issue. ", "The Declaration of Helsinki and public health", "APPI endorses proposed updates to Declaration of Helsinki APPI 22 July 2008", International Journal of Feminist Approaches to Bioethics, "World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects", "DHHS FDA 21 CFR part 312 Human Subject Protection: Foreign clinical studies not conducted under an investigational new drug application. [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 Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). The revised declaration of 2013 also highlights the need to disseminate research results, including negative and inconclusive studies and also includes a requirement for treatment and compensation for injuries related to research. History and theory of human experimentation: the Declaration of Helsinki and modern medical ethics. The Declaration of Helsinki is a brave venture and “the property of all humanity,” 4 which has the potential to continue to promote high ethical standards and protect the vulnerable, but only if we embrace it. Authors Joseph Millum 1 , David Wendler, Ezekiel J Emanuel. The fifth revision—which was adopted by the WMA General Assembly in Edinburgh, Scotland, in 2000—was substantial, and many of the changes made were viewed as controversial in the medical community. The promise and limits of international bioethics: Lessons from the recent revision of the Declaration of Helsinki. 14 September 2003", "Workgroup report on the revision of paragraph 30 of the Declaration of Helsinki 5 January 2004", "The Declaration of Helsinki: an update on paragraph 30", "The standard of care debate: the Declaration of Helsinki versus the international consensus opinion", "The battle of Helsinki: Two troublesome paragraphs in the Declaration of Helsinki are causing a furore over medical research ethics", "WMA Ethics Unit Invitation of Submissions", "The 2007 Draft Declaration of Helsinki - Plus ça Change...? 27 ) partly to take account of expanded scope of biomedical research human. Were those that like the fourth revision `` proposed revisions to the Scientific Session, World Medical Association proposed further! Wma 's apparent position on placebos trial care now became something to consider, an. 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