(Articles 29, 30) were placed in this new category. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation used in the Nuremberg Code. See Article History. Critics claimed that the Zidovudine trials in developing countries were in breach of this because Zidovudine was now the best proven treatment and the placebo group should have been given it. Citing Literature. The idea of ethical imperialism was brought into high attention with HIV testing, as it was strongly debated from 1996-2000 because of its centrality to the issue of regimens to prevent its vertical transmission. 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). 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. 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. The 1975 revision was almost twice the length of the original. [69] This document lays out the requirements for ethical treatment of human subjects, and was drawn up … Creating an international document to guide research around the world is an enormously difficult and complicated task. Eventually Notes of Clarification (footnotes) to articles 29 and 30 were added in 2002 and 2004 respectively, predominantly under pressure from the US (CMAJ 2003, Blackmer 2005). The entire process was carried out based on the latest version of the Declaration of Helsinki (Human, 2001). 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. Indian Journal of Medical Ethics. 41st Meeting, Hong Kong, 1996: Fourth revision. [9] In the United States regulations governing IRBs came into effect in 1981 and are now encapsulated in the Common Rule. Similarly, the Declaration of Helsinki argues that physicians' primary consideration must be to promote the health of patients in article 3. 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? It clearly stated that "concern for the interests of the subject must always prevail over the interests of science and society. After consultation, which included expressions of concern, 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. I was dismayed that the World Medical Association was retreating from this position. For this reason the footnote indicates that the wording must be interpreted in the light of all the other principles of the Declaration. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available (Article II.1). 48th Meeting, Somerset West (South Africa), 2000: Fifth revision. 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. World Medical Journal 2008; 54(4): 120-25, International response to Helsinki VI (2000). Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964. and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975. 52nd Meeting, Edinburgh, 2008: Sixth revision, 59th Meeting, Seoul, 2013: Seventh revision, 64th Meeting, Fortaleza. 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. [56] In this clarification the issue of post trial care now became something to consider, not an absolute assurance. 'Legal guardian' was replaced with 'responsible relative'. It then outlined circumstances in which a placebo might be 'ethically acceptable', namely 'compelling... methodological reasons', or 'minor conditions' where the 'risk of serious or irreversible harm' was considered low. BMJ 2001 March 31 322:747-748, "Declaration of Helsinki should be strengthened : Equipoise is essential principle of human experimentation", "The standard of care debate: against the myth of an "international consensus opinion, "The three official language versions of the Declaration of Helsinki: what's lost in translation? [78] 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. Both documents influenced the development of the Declaration of Helsinki. [39] Macklin R. Future challenges for the Declaration of Helsinki: Maintaining credibility in the face of ethical controversies. [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. "[8] It also introduced the concept of oversight by an 'independent committee' (Article I.2) which became a system of Institutional Review Boards (IRB) in the US, and research ethics committees or ethical review boards in other countries. 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). The protocol should address the ethical issues and indicate that it is in compliance with the Declaration (Article 14). The American Medical Association put forward a proposed revision in November that year,[22][23] and a proposed revision (17.C/Rev1/99) was circulated the following year,[24][25] causing considerable debate and resulting in a number of symposia and conferences. The influence of the declaration is far-reaching. 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. Subsequent revisions between 1975 and 2000 were relatively minor, so the 1975 version was effectively that which governed research over a quarter of a century of relative stability. The controversies and national divisions over the text have continued. 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. Stuttgart: Franz Steiner Verlag, 2007. The second revision (1983) included seeking the consent of minors where possible. One of the more controversial aspects of the fifth revision was the addition of paragraph 29, which called for weighing various aspects of a new treatment against currently known best medical practices. 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...? JAMA 2000 Dec 20 284(23): 3045-6, "Macklin R. After Helsinki: Unresolved issues in international research. The placebo question was already an active debate prior to the fourth revision but had intensified, while at the same time the placebo question was still causing controversy in the international setting. 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. Authors Joseph Millum 1 , David Wendler, Ezekiel J Emanuel. 35th Meeting, Venice, 1989: Third revision. The Declaration of Helsinki (DoH) is the World Medical Association’s (WMA) best-known policy statement. [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. 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. The AIDS Clinical Trials Group (ACTG) Study 076 of 100 Zidovudine in maternal-infant transmission of HIV had been published in 1994. 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. 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. 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. [64] Input was received from a wide number of sources, some of which have been published, such as Feminist Approaches to Bioethics. 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. 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 Declaration of Helsinki was adopted in 1964 by the 18th WMA General Assembly, at Helsinki. and which proved to be the most far reaching and contentious revision to date. 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."[34]. [7] The Declaration is an important document in the history of research ethics as it is the first significant effort of the medical community to regulate research itself, and forms the basis of most subsequent documents. In the article The 50 th Universally of The Declaration of Helsinki “Progress but many remaining the challenges,” Milium, Wendel And Emanuel argue that though there have been improvement in ethical principles guiding medical research, more so , those that include human participants ,much more needs to be done. [11] Address to the Scientific Session, World Medical Association General Assembly, September 2003. [65] Others include CIOMS and the US Government.[66]. 2, Stuttgart, Franz Steiner, 2007, pp. [61] Those comments were then incorporated into a second draft in May. JAMA 2000 Dec 20 284:2983-2985 (password required), Singer P, Benatar S. Beyond Helsinki: a vision for global health ethics. [72] Int J Bioethics 2004 15(1): 31-42, CS1 maint: DOI inactive as of September 2020 (, International Ethical Guidelines for Biomedical Research Involving Human Subjects, NIH training in human subject research participant protection, Human experimentation in the United States, "Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects", WMA Press Release: WMA revises the Declaration of Helsinki. Nevertheless, important problems and some confusion remain in this 50th-anniversary declaration. The declaration has been revised several times. [1][2][3][4], It is not a legally binding instrument under the 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. Any experimental manoeuvre was to be compared to the best available care as a comparator (Article II.2), and access to such care was assured (Article I.3). 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. Experimental investigations should always be compared against the best methods, but under certain circumstances a placebo or no treatment group may be utilised (Article 29). The declaration's strength lies in its core principles, which are a moral compass transcending procedural rules and revisions. ", "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. ", Riis P. Perspectives on the fifth revision of the Declaration of Helsinki. The revised Declaration of Helsinki represents a significant improvement over previous versions. Editor —The BMJ has devoted considerable coverage to the revision of the World Medical Association's Declaration of Helsinki. For other uses, see, document outlining the ethics of human medical experimentation, Clarifications of Articles 29, 30 (2002–2004). The duty to the individual was given primacy over that to society (Article I.5), and concepts of publication ethics were introduced (Article I.8). Although not a legally binding document, it has been codified into the laws that govern medical research in countries across the world and has served as a basis for the development of other international guidelines. The Declaration of Helsinki and public health John R Williams a. One of the major causes stoking that debate occurred in 1997, with the publication of a paper by American physicians Peter Lurie and Sidney Wolfe. [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". Some practitioners maintained that achieving equivalent levels of care would not be practical and would keep sponsoring organizations from funding placebo-related research in developing countries, whereas others argued that it would be unfair to keep the benefits of a medical treatment from the very patients whose participation helped develop them. 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. They argued that providing sick patients with placebos instead of available proven-effective medical treatment could cause harm, especially in cases involving disease transmission, such as the transmission of HIV between a mother and child. Please select which sections you would like to print: Corrections? [citation needed]. [26] and praised, Planning of scientific-ethical committees", "Recommendations from the Meeting on Prevention of Mother-to-Infant Transmission of HIV by Use of Antiretrovirals", Council for International Organizations of Medical Sciences, "Guideline 11: Selection of pregnant or nursing (breastfeeding) women as research subjects", "Search for FDA Guidance Documents - Acceptance of Foreign Clinical Studies", "The 2000 Revision of the Declaration of Helsinki: A Step Forward or More Confusion? WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. The seventh revision added new rules designed to protect patients in research studies, including provisions to compensate people who have been harmed by their participation in medical research and to expand their access to beneficial treatments that result from the study. [74] eventually came up with a text that was endorsed by WMA's Council and passed by the General Assembly on October 7, 2000, [80], While the Declaration has been a central document guiding research practice, its future has been called into question. Ethical publications extend to publication of the results and consideration of any potential conflict of interest (Article 27). 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. General Assembly WMA Hamburg, Germany 1997, Nancy Dickey, Kati Myllymäki, Judith Kazimirsky, Williams JR. [39][47] The debate over these and related issues also revealed differences in perspectives between developed and developing countries. It augmented the oversight powers of ethical review committees and adjusted the language related to placebos in medical studies. Information regarding the study should be publicly available (Article 16). The implication being that placebos are not permitted where proven interventions are available. 2013 Nov 27;310(20):2143-4. doi: 10.1001/jama.2013.281632. 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. By signing up for this email, you are agreeing to news, offers, and information from Encyclopaedia Britannica. [40] The recent controversies undermine the authority of the document, as does the apparent desertion by major bodies, and any rewording must embrace deeply and widely held values, since continual shifts in the text do not imply authority. 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 “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.”. 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. Access to society journal content varies across our titles. [36] Updates? The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. 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. and even considered for a clarification footnote. These trials appeared to be in direct conflict with recently published guidelines[12] for international research by CIOMS, which stated "The ethical standards applied should be no less exacting than they would be in the case of research carried out in country", referring to the sponsoring or initiating country. Even though most meetings about the proposed revisions failed to achieve consensus, and many argued that the declaration should remain unchanged or only minimally altered, after extensive consultation the Workgroup Get exclusive access to content from our 1768 First Edition with your subscription. [32][45] As with much of the Declaration, there is room for interpretation of words. This article is about the human medical experimentation ethics document. [6] A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. [79] The European Commission, however, does refer to the 2000 revision. Let us know if you have suggestions to improve this article (requires login). [81]. In addition, the National Institutes of Health training in research with human participants no longer refers to the declaration, and the European Commission refers only to the fourth revision. Attempts to amend the Declaration for a fifth time have rumbled on for 2 acrimonious years. After atrocities were found to have been committed by medical researchers in Germany who used involuntary unprotected participants drawn from Nazi concentration camps, the 1947 Nuremberg Code was established. [13] 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. 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. [1] It is widely regarded as the cornerstone document on human research ethics. Declaration of Helsinki Recommendations guiding medical doctors in biomedical research involving human subjects Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and As Revised by the 29th World Medical Assembly, Tokyo, Japan, 1975. Parent topics. [18] Other countries have guides with similar roles, such as the Tri-Council Policy Statement in Canada. The most controversial revisions 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. Rennie S. The FDA ditches the Declaration of Helsinki. Before World War II, no formal international statement of ethical principles to guide research with human participants existed; researchers were left to rely on organizational, regional, or national policies or their own personal ethical guidelines. Ulf Schmidt, Andreas Frewer (eds), History and theory of human experimentation: the Declaration of Helsinki and modern medical ethics, History and Philosophy of Medicine, vol. 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. Carlson raises the question as to whether the document's utility should be more formally evaluated, rather than just relying on tradition. [16] This led to the US Food and Drug Administration (FDA) ignoring this and all subsequent revisions. 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. Vanderpool, Harold Y. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The most recent iteration of Helsinki (2013) was reflective of the controversy regarding the standard of care that arose from the vertical transmission trials. The 2002 clarification to Article 29 was in response to many concerns about WMA's apparent position on placebos. These arguments are intimately tied to the concept of distributive justice, the equitable distribution of the burdens of research. [58], The sixth revision cycle commenced in May 2007. [75] The circulation of a draft revised version in April last year caused most controversy of all. In this sense the Declaration endorsed ethical universalism. The interests of the subject after the study is completed should be part of the overall ethical assessment, including assuring their access to the best proven care (Article 30). Surprisingly, although the wording was virtually unchanged, this created far more protest in this revision. 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. This viewpoint argues that where no standards of care exist, as for instance in developing countries, then placebo-controlled trials are appropriate. The Basic Principles establish a guide for judging to what extent proposed research meets the expected ethical standards. Omissions? [5], The Declaration is morally binding on physicians, and that obligation overrides any national or local laws or regulations, if the Declaration provides for a higher standard of protection of humans than the latter. It is widely regarded as the cornerstone document on human research ethics. There are a number of available tools which compare these. 'Best current' has been variously held to refer to either global or local contexts.[46]. Final Rule April 28 2008, effective October 27 2008", Obasogie O. Goozner on the FDA and the Declaration of Helsinki. 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. The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). [77] Studies should be discontinued if the available information indicates that the original considerations are no longer satisfied (Article 17). The declaration must be reinterpreted in the social, cultural, political, and economic contexts in which research occurs.1 2 Considered “dead,”10 11 the declaration’s life was further threatened when the United States Food and Drug Administration removed the requirement for trials conducted outside of the USA to comply with it. [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."). It was first announced on July 18, 1964 in the British Medical Journal, and just had its 54 th birthday this month. The World Medical Association's Declaration of Helsinki offers guidelines to doctors engaged in biomedical research with human subjects. For other uses, see Declaration of Helsinki (disambiguation). Recommendations included limiting the document to basic guiding principles. As the declaration was expanded and made more prescriptive, it became more controversial, which caused some organizations to alter some of its standards or abandon it entirely. 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