41st Meeting, Hong Kong, 1996: Fourth revision. Later that year the American Medical Association proposed a further note of clarification that was incorporated. The declaration's strength lies in its core principles, which are a moral compass transcending procedural rules and revisions. The Declaration of Helsinki was adopted in 1964 by the 18th WMA General Assembly, at Helsinki. 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. The issue of the use of placebo in turn raised questions about the standard of care in developing counties and whether, as Marcia Angell wrote "Human subjects in any part of the world should be protected by an irreducible set of ethical standards" (1988). 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). World Medical Journal 2008; 54(4): 120-25, International response to Helsinki VI (2000). Article 30 was debated further at the 2003 meeting, with another proposed clarification but did not result in any convergence of thought, and so decisions were postponed for another year, but again a commitment was made to protecting the vulnerable. , 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. 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. 'Legal guardian' was replaced with 'responsible relative'. 2013 Nov 27;310(20):2143-4. doi: 10.1001/jama.2013.281632.  Article 19 first introduces the concept of social justice, and extends the scope from individuals to the community as a whole by stating that 'research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research'. The controversies and national divisions over the text have continued. 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. The most controversial revisions . 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).  Article 29 restates the use of placebo where 'no proven' intervention exists. 1 It was developed from 10 principles first stated in 1947 in the Nuremberg Code and further incorporated elements from the Declaration of Geneva (made in 1948), a … Shah S. FDA Puts Medical Test Subjects in Danger. 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.”. The Declaration of Helsinki largely echoed the Nuremberg Code, but helped to define distinctions between therapeutic and nontherapeutic clinical research. 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). Recommendations included limiting the document to basic guiding principles. In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. History and theory of human experimentation: the Declaration of Helsinki and modern medical ethics. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2013. These trials appeared to be in direct conflict with recently published guidelines 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. Social Medicine Portal June 1st 2008. Please select which sections you would like to print: Corrections? 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. Center for Genetics and Society May 15th 2008, FDA abandons Declaration of Helsinki for international clinical trials. It clearly stated that "concern for the interests of the subject must always prevail over the interests of science and society. 1-1,1-2 The declaration and its revision have greatly increased the global research community's sensitivity to research ethics.. In paragraph 30 the WMA called for detailing “post-trial access arrangements” for ethical review committees, which would presumably comment on their feasibility. The Basic Principles establish a guide for judging to what extent proposed research meets the expected ethical standards. 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. 18th Meeting, Helsinki, 1975: First revision. The third revision (1989) dealt further with the function and structure of the independent committee. These arguments are intimately tied to the concept of distributive justice, the equitable distribution of the burdens of research. 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. 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, and even the question of the future of the Declaration became a matter for conjecture. In fact a schism between ethical universalism and ethical pluralism was already apparent before the 1993 revision of the CIOMS guidelines. 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. Address to Scientific Session, World Medical Association General Assembly, September 2003, Helsinki Global Bioethics Blog May 6 2008. As WMA states in the note, there appeared to be 'diverse interpretations and possibly confusion'. 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 European Commission, however, does refer to the 2000 revision. Let us know if you have suggestions to improve this article (requires login).  The Declaration of Helsinki (DoH) is the World Medical Association’s (WMA) best-known policy statement.  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. 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. The initial declaration, which was less than 2,000 words long, focused on clinical research trials. 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. Declaration of Helsinki. Both documents influenced the development of the Declaration of Helsinki. It augmented the oversight powers of ethical review committees and adjusted the language related to placebos in medical studies. 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. 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. There are a number of available tools which compare these. Other countries have guides with similar roles, such as the Tri-Council Policy Statement in Canada. 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 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. This consisted of a call for submissions, completed in August 2007. 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. 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. See also changes related to Declaration of Helsinki, or pages that link to Declaration of Helsinki or to this page or whose text contains "Declaration of Helsinki". The fundamental distinction of the Declaration is between clinical research combined with professional care and non-clinical scientific research. Public debate was relatively slight compared to previous cycles, and in general supportive. Information regarding the study should be publicly available (Article 16).  Attempts to amend the Declaration for a fifth time have rumbled on for 2 acrimonious years.  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). 'Best current' has been variously held to refer to either global or local contexts..  In this sense the Declaration endorsed ethical universalism. 35th Meeting, Venice, 1989: Third revision. Indian Journal of Medical Ethics.  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". Ethical Principles for Medical Research Involving Human Subjects. 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. It has continually grown and faced more frequent revisions. A final text was then developed by the Working Group for consideration by the Ethics Committee and finally the General Assembly, which approved it on October 18. 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. 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. 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.  Those comments were then incorporated into a second draft in May. As Macklin points out, both sides may be right, since justice "is not an unambiguous concept". 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 entire process was carried out based on the latest version of the Declaration of Helsinki (Human, 2001). 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. Challenges include the apparent conflict between guides, such as the CIOMS and Nuffield Council documents.  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". Declaration of Helsinki The Declaration of Helsinki was created by the World Medical Association to set a standard for the way human subjects are to be treated in experimentation. 2005", "Schuklenk U. Helsinki Declaration revisions.  In the United States regulations governing IRBs came into effect in 1981 and are now encapsulated in the Common Rule. Effectively this shifted the WMA position to what has been considered a 'middle ground'. The discussions 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. Access to society journal content varies across our titles. 2, Stuttgart, Franz Steiner, 2007, pp. Determining the optimal relationship between public health and individual health is a major ethical challenge for health systems and providers. Get exclusive access to content from our 1768 First Edition with your subscription. The revised Declaration of Helsinki represents a significant improvement over previous versions. 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. Surprisingly, although the wording was virtually unchanged, this created far more protest in this revision. Declaration of Helsinki WorldMedicalAssociationDeclarationofHelsinki. JAMA 2000 Dec 20 284:2983-2985 (password required), Singer P, Benatar S. Beyond Helsinki: a vision for global health ethics. Creating an international document to guide research around the world is an enormously difficult and complicated task.  The debate over these and related issues also revealed differences in perspectives between developed and developing countries. The Ethics of Research Involving Human Subjects: Facing the 21st Century. Rennie S. The FDA ditches the Declaration of Helsinki. This has raised a number of concerns regarding the apparent weakening of protections for research subjects outside the United States. 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? Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964. and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975.  Given the previous lack of consensus, this merely shifted the ground of debate, 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. The protocol should address the ethical issues and indicate that it is in compliance with the Declaration (Article 14). The justification for this was partly to take account of expanded scope of biomedical research since 1975. Although not without its controversies, it has served as the standard in medical research ethics. The Declaration of Helsinki is a statement outlining the ethical principles for medical research involving human subjects that was initially adopted by the 18th Assembly of the World Medical Association in Helsinki, Finland in June 1964. General Assembly WMA Hamburg, Germany 1997, Nancy Dickey, Kati Myllymäki, Judith Kazimirsky, Williams JR. 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.  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. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 29th Meeting, Tokyo, 1983: Second revision. (1996). The influence of the declaration is far-reaching. The European Union similarly only cites the 1996 version in the EU Clinical Trials Directive published in 2001. The distinction between therapeutic and non-therapeutic research introduced in the original document, criticised by Levine 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 Declaration of Helsinki and public health John R Williams a. 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. Given the lack of consensus on many issues prior to the fifth revision it is no surprise that the debates continued unabated. Parent topics. 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. 35th WMA General Assembly, Venice, Italy, October 1983. The 1975 revision was almost twice the length of the original.  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), and an entire issue of the Bulletin of Medical Ethics was devoted to the debate.  Article 27 expanded the concept of publication ethics, adding the necessity to disclose conflict of interest (echoed in Articles 13 and 22), and to include publication bias amongst ethically problematic behavior. Stuttgart: Franz Steiner Verlag, 2007. 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.  In 1997 Lurie and Wolfe published their seminal paper on HIV trials, raising awareness of a number of central issues.  The later revision in 2000 would go on to require monitoring of scientific research on human subjects to assure ethical standards were being met. 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? Jan-Mar 2001 9(1)", "WMA - The World Medical Association-Hello world! After consultation, which included expressions of concern,  In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. a final rule was issued on April 28, 2008 replacing the Declaration of Helsinki with Good Clinical Practice effective October 2008.  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 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. 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). Biopolitical Times. The 2002 clarification to Article 29 was in response to many concerns about WMA's apparent position on placebos. 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 It is widely regarded as the cornerstone document on human research ethics. Our editors will review what you’ve submitted and determine whether to revise the article.  Studies should be discontinued if the available information indicates that the original considerations are no longer satisfied (Article 17). Investigators still have to abide by local legislation but will be held to the higher standard. The promise and limits of international bioethics: Lessons from the recent revision of the Declaration of Helsinki. 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. Ethical publications extend to publication of the results and consideration of any potential conflict of interest (Article 27). Code of Ethics of the World Medical Association. This viewpoint argues that where no standards of care exist, as for instance in developing countries, then placebo-controlled trials are appropriate. The most recent iteration of Helsinki (2013) was reflective of the controversy regarding the standard of care that arose from the vertical transmission trials. 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 World Medical Association's Declaration of Helsinki offers guidelines to doctors engaged in biomedical research with human subjects. It was first announced on July 18, 1964 in the British Medical Journal, and just had its 54 th birthday this month. 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. For other uses, see, document outlining the ethics of human medical experimentation, Clarifications of Articles 29, 30 (2002–2004). Updates?  Others include CIOMS and the US Government..  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.  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. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. 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 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. 5th draft", "Comparison of Common Rule with the Declaration of Helsinki and Good Clinical Practice", "Declaration of Helsinki History Website", "Letter from...Denmark.  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). A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. This article is about the human medical experimentation ethics document. 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. The circulation of a draft revised version in April last year caused most controversy of all. Omissions?   Further workshops were held in Cairo and São Paulo and the comments collated in August 2008. 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.". 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