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 identi. The declaration of helsinki, 50 years later global. Prospective registration and reporting of trial number in. At a time when there was great attention and intense public controversy surrounding clinical especially multinational research, the 52nd general assembly of the world medical association wma adopted the 5th revision of the declaration of helsinki in october, 2000available at. Read the nuremberg code nuremberg code read the declaration of helsinki declaration of helsinki read the geneva declaration geneva declaration. The structure of the 2000 text was substantially reworked from 1996. It is the duty of the physician to promote and safeguard the health of the people. Next year will mark the 50th anniversary of the declaration of helsinki. Pdf the declaration of helsinki in relation to medical. Prior to the 1947 nuremberg code declaration of geneva 1948, a statement of physicians ethical duties. The first version was adopted in 1964 and has been amended seven times since, most recently at the general assembly in october 20. World medical association declaration of helsinki recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th world medical assembly helsinki, finland, june 1964 and amended by the 29th world medical assembly, tokyo, japan, october 1975 35th world medical assembly, venice, italy, october 1983.
Nuremberg code, belmont report, and the declaration of helsinki. In 1964 when the declaration of helsinki was initially enacted, it contained 11. Dec 15, 2001 the world medical associations fifth revision of the declaration of helsinki strives to strike a balance between ensuring high ethical standards and retaining sufficient sensitivity to local circumstances, especially in developing world research, to avoid thwarting research with bureaucracy. The declaration of helsinki does not address this type of exploitation. The declaration of geneva of the world medical assembly binds the physician with the words, the health of my patient will be my first consideration, and the international code of medical ethics declares that, a physician shall act only in the patients interest when providing medical care, which might have. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. The declaration of helsinki doh is the world medical associations wma bestknown policy statement. The doh has been revised five times, the last time by the 52nd wma general assembly in edinburg, scotland october, 2000. Its current form contains 3 sections in 32 separate paragraphseach on a specific topic. In this lesson, we will learn about the declaration of helsinki, its purpose. At a time when there was great attention and intense public controversy surrounding clinical especially multinational research, the 52nd general assembly of the world medical association wma adopted the 5th revision of the declaration of helsinki in october, 2000 available at these revisions are the most substantial adaptations since those adopted by the 29th wma assembly.
The world medical association adopted a new set of ethical rules and regulations regarding human experimentation in 1964. Fda will not accept clinical data that is in conformance with declaration 2000. As such it has been incorporated into a number of guidance documents for research u. The note of clarification of the world medical association to article 29 of the fifth revision of the declaration of helsinki edinburgh 2000 intensified the controversial discussion of how. The declaration of helsinki the cornerstone of research ethics.
The doh has been revised five times, the last time by the 52nd wma general assembly in edinburg, scotland. Declaration of helsinki 2000 clinical device group inc 16 16 conflict ethics committees deny approval for studies not in conformance with declaration 2000. The journal is an essential resource for all those concerned about bioethical issues in the developing world. Developing world bioethics is the only journal in the field dedicated exclusively to developing countries bioethics issues. Helsingforsdeklarationen is a set of ethical principles regarding human experimentation developed for the medical community by the world medical association wma. The declaration of geneva of the world medical assembly binds the physician with the words, the health of my patient will be my first consideration, and the international code of medical ethics declares. The declaration of helsinki doh was adopted by the world medical association wma in 1964, as a statement of ethical principles, to provide guidance to physicians and other participants in. Declaration of helsinki 1975 ethics codes collection. Declaration of helsinki in october, 2000 available at these revisions are the most substantial adaptations since those adopted by the 29th wma assembly in october, 1975. Attempts to amend the declaration for a fifth time have rumbled on for 2 acrimonious years. The world medical association has developed the declaration of helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Declaration of helsinki 2000 clinical device group inc 3 3 structure of 2000 text 32 articles.
Its guardian, the world medical association, recently invited submissions for further revision. The effect on the ethical aspects of clinical trial conduct in south africa and other developing countries four years ago, the us food and drug administration fda ceased compliance with the declaration of helsinki doh 2000 revision and all subsequent revisions for conduct of clinical trials. This anniversary presents an excellent opportunity to reconsider the problems of the declaration and how they can be remedied to ensure the document retains its prominent status. What are the effects of the fifth revision of the declaration. Comparison of common rule with the declaration of helsinki and good clinical practice toxicology excellence for risk assessment 2 august, 2002 common rule cr elements 40 cfr 26 declaration of helsinki adopted june 1964, amendments through october 2000. The declaration of helsinki is a set of ethical principles regarding human experimentation. Medical research involving human subjects includes. The fifth revision, in 2000, caused considerable controversy regarding issues such as whether the document should be revised at all, the restating of article 29. World medical association declaration of helsinki2008. The declaration of helsinki slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. The declaration of helsinki has been revised six times, in 1975, 1983, 1989, 1996, 2000, and 2008.
Wma the world medical associationdeclaration of helsinki. They argue that the consensus view now holds that it is ethically. 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. Pdf medical research aims at improving diagnostic, therapeutic and. The declaration of helsinki, 50 years later global health. Principles for medical research involving wma declaration of. The forthcoming 50th anniversary of the declaration of helsinki is a perfect moment to reassess this fundamentally important document and revise. It was upgraded in 20 and termed as a cornerstone document related to human research ethics. The declaration of helsinki is widely recognized as one of the most most influential documents in research ethics. The primary purpose of medical research involving human subjects is to.
This declaration ties together the nuremberg code and the declaration of geneva. The wma is concerned that paragraph 29 of the revised declaration of helsinki october 2000 has led to diverse interpretations and possible confusion. The problems involved are cultural and political diversity, weak thirdworld economies and infrastructures, need for consensus building, and need to prevent exploitation. In less than 2000 words, the world medical association wma spells out a set of. It is widely regarded as the cornerstone document on human re. Comparison of common rule with the declaration of helsinki. Ethical principles for medical research the nuremberg code, declaration of helsinki, and declaration of geneva provide a set of ethical principles regarding human experimentation and clinical care.
In a process that took place over several years involving some inner turmoil, yet at the same time a degree of transparency, the wma issued a significantly revised version of the declaration in 2000. Medical progress is based on research that ultimately must include studies involving human subjects. The declaration of helsinki is one of the worlds most important research ethics documents related to medical research. A fifth amendment for the declaration of helsinki the lancet. The declaration of helsinki is an influential source of guidance that assists researchers in the design and implementation of ethical research in human beings. The fifth revision, in 2000, caused considerable controversy regarding issues such as whether the document should be revised at all, the restating of article 29 which dealt with. 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. Determining the optimal relationship between public health and individual health is a major ethical challenge for health systems and providers. World medical association declaration of helsinki ethical principles. Note of clarification on paragraph 29 of the wma declaration of helsinki. Consequently, the world medical association wma is developing its eighth version of the declaration. Us fda rejected the 2000 and subsequent revisions, only recognizing the third 1989 revision, and in 2006 announced it would eliminate all reference to the declaration. The distinction between therapeutic clinical and nontherapeutic.
The declaration of helsinki, cioms and the ethics of research. Wma general assembly, edinburgh, scotland, october 2000 a. The world medical association wma has developed the declaration of helsinki. The declaration of helsinki doh is, indisputably, a remarkable document. The world medical association wma general assembly has recently revised the declaration of helsinki, the most widely accepted guideline on medical research involving human subjects. Principles for medical research involving wma declaration. Declaration of helsinki the world medical association drafted the first international agreement recommending ethical standards for clinical research. In less than 2000 words, the world medical association wma spells out a set of ethical guidelines for physicians and other participants in medical research. Yet, some of its provisions remain the topic of heated discussions. Since then, the declaration of helsinki doh was adopted in 1964 and has been revised five times.
Since 1964, the declaration of helsinki has been accepted internationally as the cornerstone for research ethics. Declaration of helsinki adopted by the 18th world medical assembly, helsinki, finland, june 1964. The declaration of helsinki, which was drawn up by the world medical association wma in 1964, has been amended four times. Oct 27, 2001 the declaration of helsinki is an influential source of guidance that assists researchers in the design and implementation of ethical research in human beings. The original text of the declaration of helsinki was presented by the royal dutch medical association and adopted by the 18th world medical assembly in helsinki, finland, in 1964 written communication, ian t. The declaration of helsinki doh, developed by the world medical association 1964, is the most widely accepted code of research ethics. General assembly, edinburgh, scotland, october 2000. It is widely regarded as the cornerstone document on. The wma has granted jama exclusive rights to publish the englishlanguage version of the declaration though december 31, 20. Unfortunately, the ethical commitment of the declaration has been eroded several times since the nuremberg code. Declaration of helsinki wikimili, the free encyclopedia. It is addressed to some extent in the commentary accompanying the council for the international organizations of medical. The most recent fifth revision of the declaration of helsinki, adopted in october 2000 by the world medical association wma, reinforces the longstanding prohibition against offering placebo. The object of this article is to evaluate the 2000 revision of the doh and discuss three problems of concern.
The declaration s strength lies in its core principles, which are a moral compass transcending procedural rules and revisions. Medical research involving human subjects includes research on identifiable human. Declaration of helsinki uc davis office of research. History the declaration was originally adopted in june 1964 in helsinki, finland and has since undergone six revisions.
The declaration of helsinki and public health john r williams a. Sep 27, 2007 the declaration of helsinki is a respected institution and one of the most influential documents in research ethics,1 w1w7 having withstood five revisions and two clarifications since its conception in 1964. Wma declaration of helsinki ethical principles for medical. This section looks back on a groundbreaking contribution to public health, reproduces an extract of the original text and adds a commentary on its significance from a modern perspective. The declaration of helsinki was born from the history of abuses of human research subjects. Us fda rejected the 2000 and subsequent revisions, only recognizing the third 1989 revision, and. A summary of important documents in the field of research. Fifty years and 7 revisions later, the 20 version of the declaration of helsinki includes several important changes. If you continue browsing the site, you agree to the use of cookies on this website.
Declaration of helsinki 2000 wma the world medical. Its role was described by a brazilian forum in 2000 in these words even though the declaration of helsinki is the responsibility of. Since october 2000, some ethics committees have denied approval for. Wma declaration of helsinki ethical principles for medical research involving human. Beginning in 1975, the declaration of helsinki has been revised several timesmost recently in 2000. Minor clarifications were also added in 2002 and 2004.
Perspectives on the fifth revision of the declaration of. To complement the theme of this months issue, john r williams looks at the declaration of helsinki. The declaration of helsinki in relation to medical research. The declaration of helsinki was adopted in 1964 by the 18th wma general assembly, at helsinki. This set of principles forms the basis for the cioms international guidelines for biomedical research involving human subjects, and the ethical components of both. Reconsidering the declaration of helsinki the lancet. The world medical association has developed the declaration of helsinki as a. 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. Changes relating to the use of placebo in the declaration of helsinki 198920. The commitment to revision of the declaration acknowledged that deficiencies and disagreements in interpretation needed to be corrected and that.
The circulation of a draft revised version in april last year caused most controversy of all. The declaration is intended to be read as a whole and each of its constituent. The most recent version of the declaration of helsinki, in addition to translations of the declaration into languages other than english, can be found on the wma web site. The world medical associations revised declaration of helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. World medical association declaration of helsinki ethical. Either the declaration of helsinki is an ethical statement or there is no reason to adhere to its provisions. 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. Declaration of helsinki worldmedicalassociationdeclarationofhelsinki ethical principles for medical research involving human subjects adopted bythe 18thwma general assembly, helsinki, finland, june1964. All intellectual property rights in the declaration of helsinki are vested in the world medical association. A final rule was issued on april 28, 2008 replacing the declaration of helsinki with good clinical practice effective october 2008. It is widely regarded as the cornerstone document on human research ethics.
Comparison of common rule with the declaration of helsinki and good clinical practice pdf. By changing the format and including several subsections, the revised declaration enhances and improves clarity regarding specific issues. The declaration of helsinki is a respected institution and one of the most influential documents in research ethics,1 w1w7 having withstood five revisions and two clarifications since its conception in 1964. Over the years, research oversight has improved but has led to the underrepresentation of certain groups in research investigations. Wma declaration of helsinki ethical principles for.
Uc davis office of research declaration of helsinki. The recent revision of the helsinki declaration, a major code of ethics governing research with human subjects, is very worrying. Evaluated in this context, i believe the fifth revision of the declaration of helsinki 4 adopted in october 2000 in edinburgh, scotland embodies both advances and problems. The world medical association describes the declaration of helsinki as a statement of ethical principles to guide physicians and other participants in medical research involving human subjects, including identifiable human tissue or data.
377 759 158 238 199 1089 57 344 1050 1157 104 211 1195 22 1086 1190 1009 459 1319 214 1289 1012 1246 190 1149 496 29 1310 234 1357 539 296 851 921 910 1155