In the past 50 years healthcare has undergone a myriad of. Pdf the declaration of helsinki in relation to medical. Revision of the declaration of helsinki interviewer thank you so much for accommodating this interview right after the meeting of the world medical association. The outcomes of the trials included the nuremberg codea legal document intended to stop such abusesand the establishment of the world medical. The declaration of helsinki requires revision because it is defective in two important respects. Next year will mark the 50th anniversary of the declaration of helsinki. The need to revise the declaration of helsinki nejm. Apr 21, 2009 the fourth revision of the declaration of helsinki 1996 created difficulties for the fda by restricting the use of placebos where proved interventions had become established. 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 20 and two clarifications, growing considerably in length from 11 paragraphs in 1964 to 37 in the 20 version.
The declaration of helsinki doh is the world medical associations wma bestknown policy statement. When the hiv trials were publicly criticised 4, but also strongly defended 5, calls emerged seeking a revision of the declaration of helsinki. Oct 20, 20 in 1964, the declaration of helsinki ushered in a new paradigm of thinking about medical ethics and research worldwide. Revising the declaration of helsinki journal of ethics. The world medical association wma, the organisation that issues the declaration of helsinki doh, is planning another revision of this influential ethics guidance document. Freedom and control of biomedical research the planned revision of the declaration of helsinki. Ethical principles for medical research involving human subjects. The declaration of helsinki is undergoing its seventh revision. Amended by the 29th world medical assembly, tokyo, japan, october 1975. Consequently, the world medical association wma is developing its eighth version of the declaration. Next year marks the 50th anniversary of the declaration of helsinki, the benchmark for ethical medical research on subjects. Revising the declaration of helsinki the declaration of helsinki is undergoing its seventh revision. A final rule was issued on april 28, 2008 replacing the declaration of helsinki with good clinical practice effective october 2008.
It was first announced on july 18, 1964 in the british medical journal, and just had its 54 th birthday this month. To understand the debate that continues between the defenders of the revised version of the declaration and its opponents, the conflicting motivations for instigating the revision. The process of finding common ground between the two groups will undoubtedly help meet their complementary goals of. Discussion toward the 50 anniversary of the declaration of. There are 11 completely new paragraphs, amounting to a third of the document, and modifications to others. The latest revision of the declaration of helsinki has introduced significant changes.
Its guardian, the world medical association, recently invited submissions for further revision. Therefore, article 2 of the preamble, should bear that in mind. 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. Here, we analyse the process of revision and the major changes made to the declaration. Sources of funding, institutional affiliations and conflicts of interest should be. The last revision in 2008 1 strengthened the guidelines in some respects and weakened them in others. The world medical association wma has sent out its strongest ever signal to pharmaceutical companies and research organisations around the world that rich populations should not exploit poor populations by testing on them new treatments from which they will never benefit.
It is to be known as the declaration of helsinki 6 emphasis ours. Since the djeclaration of helsinki was originally published in 1964 by the world medical association wma. This document, which was first drawn up in 1964, is essential reading for everyone doing research on human participants. The declaration of helsinki, 50 years later global health. Ethical principles for medical research involving human subjects by the world medical association wma was first adopted in 1964, and 2014 will mark its 50th anniversary. 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. The declaration of helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the world medical association. The declaration of helsinki was adopted by the world medical association in 1964 at its 18th general assembly. All scientists involved in biobanking research should understand using participants samples and data is research on human subjects. Compliance with this standard provides public assurance that the rights, safety, and. Reconsidering the declaration of helsinki the lancet. The last revision in 2008 strengthened the guidelines in some respects and weakened them in others. The council further set the seoul general assembly of october 2008 as the goal for adopting the revisions. The first version was adopted in 1964 and has been amended seven times since, most recently at the general assembly in october 20.
The declaration of helsinki was born from the history of abuses of human research subjects. 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. World medical association declaration of helsinki continued available. Request pdf revising the declaration of helsinki your chance to influence research governance in the middle of the 20th century, the nuremberg trials laid bare the abuse of medical knowledge. As is well known, the helsinki declaration grew out of physicians international initiatives which promoted general ethical standards for the medical profession after world war ii. Declaration of helsinki worldmedicalassociationdeclarationofhelsinki ethical principles for medical research involving human subjects adopted bythe 18thwma general assembly, helsinki, finland, june1964. Declaration of helsinki 1996 wma the world medical. The wma general assembly, meeting last week in edinburgh, approved a revised declaration of helsinki, which. Adopted by the 18th world medical assembly, helsinki, finland, june 1964.
Declaration of helsinki 1975 ethics codes collection. The declaration of helsinki, adopted by the world medical associations general assembly in 1964, is the most important set of guidelines about research on human participants. The nuremberg code had been formulated as a response to the judicial condemnation of the acts of nazi physicians, and did not specifically address human subject research in the context of the patientphysician relationship. Sometimes revisions ought to start closer to the original basis for the paper, considered for a revision, than to start only with linguistic reformulations and additions. They will take into account all comments submitted by all interested partiesbe they researchers, research subjects, lay groups, or healthcare practitioners. In october 2008, the 7th revision of the declaration of helsinki was adopted by the world medical associations general assembly, with increasing emphasis on prospective registration of trials and. We want to draw attention here to two important paragraphs and highlight their significance.
Uc davis office of research declaration of helsinki. The declaration of helsinki largely echoed the nuremberg code, but helped to define distinctions between therapeutic and nontherapeutic clinical research. The declarations strength lies in its core principles, which are a moral compass transcending procedural rules and revisions. The revision was the result of a huge amount of international consultation, and along with many other organisations, cope provided input into this document. 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. The declaration of helsinki was adopted in 1964 by the 18th wma general assembly, at helsinki. Wma declaration of helsinki ethical principles for. Since the revision of the helsinki declaration was proposed by the wma in chile in april 1999, it has been one of the most controversial topics in research ethics. The first initiative of the wma in that context was to update the hippocratic oath with the declaration of geneva 1948, which focused on the basic ethical.
The declaration of helsinki europe pmc article europe pmc. Revision of the world medical association helsinki declaration. This had major implications for research in resource poor nations, where placebos were being used in such situations. The full article is accessible to ama members and paid subscribers. The declaration of helsinki and research in vulnerable populations. 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. Tokyo 1975 the first revision to the doh was adopted by the wma at its 29th annual assembly in tokyo 1975. Seventh revision of declaration of helsinki published. Revising the declaration of helsinki points to consider professor dominique sprumont institute of health law, university of neuchatel switzerland trree fmh wma conference cape town, south africa december 6, 2012. Such a deeper analysis will be applied here, with a subsequent set of comments to the latest wma proposal for a new version of the declaration of helsinki. A recent draft proposal for revising the declaration has provoked heated controversy. Although not without its controversies, it has served as the standard in medical research ethics.
The declaration of helsinki its history and its future urban wiesing helsinki, 11. Overview of the 20 revision of the declaration of helsinki the declaration of helsinki. 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. Dec 15, 2001 the process of revising the helsinki declaration has had positive effects on other ethical codes. 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 emerged in the aftermath of world war ii as one of the guidelines of biomedical ethical conduct. The declaration of helsinki is one of the worlds most important research ethics documents related to medical research. Nih no longer refers to the declaration of helsinki 7. The declaration of helsinki doh is, indisputably, a remarkable document. Request pdf the revision of 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. Nevertheless, this revision process resulted in a controversial version of the declaration. What are the effects of the fifth revision of the declaration.
Declaration should not be accepted for publication. 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. 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. In this lesson, we will learn about the declaration of helsinki, its purpose. Reports of research not in accordance with the principles of this. The declaration of geneva of the wma binds the physician with the words, the health of my patient will be my first consideration, and the. The declaration of helsinki has been revised six times, in 1975, 1983, 1989, 1996, 2000, and 2008. Wma the world medical associationdeclaration of helsinki.
Last month the world association of medical editors announced the new version of the declaration of helsinki. 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. Expert conference on the revision of the declaration of. Reaction to the first draft, out for public consultation until june 15, has been polarised. Revising the declaration of helsinki points to consider. A revised version was accepted as the final draft at the meeting of the world medical association in helsinki in june 1964. Response to the revised draft of the declaration of. Since the declaration of helsinki enshrines universal ethical principles, it acts as steppingstone to clinical research and as a guiding document in legislation and regulation. Reports on the revisions have focused mainly on clinical trials that use placebos. Wma declaration of helsinki ethical principles for medical research involving human subjects. Attached to this inconspicuous announcement was the just over 700 words of the text of the original doh. 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. Does the fda have the authority to trump the declaration of. Although the declaration is addressed primarily to physicians, the wma encourages other participants in medical research involving human subjects to adopt these principles.
First, it relies on a distinction between therapeutic and nontherapeutic research. The final version of the new revision of the helsinki declaration will depend on the final analysis of the committees, council, and assembly of the wma. Adopted by the 18th wma general assembly, helsinki, finland, june 1964 and amended by the. In october 2008, the 59th world medical association wma general assembly in seoul adopted the 7th revision of the declaration of helsinki. Michael cook 7 dec 20 reproduced with permission bioedge. The declaration of helsinki in relation to medical research. It is widely regarded as the cornerstone document on human research ethics. Past, present and future the world medical associations declaration of helsinki was first adopted in 1964. The declaration of helsinki and what happened july 16, 2018. Your chance to influence research governance in the middle of the 20th century, the nuremberg trials laid bare the abuse of medical knowledge and techniques used in human experimentation, with perhaps the most famous offender being joseph mengele. They will take into account all comments submitted by all interested partiesbe they researchers, research subjects, lay. Revising the declaration of helsinki as pointed in the bmj editorial, the public consultation of the world medical association provided researchers with a unique opportunity to influence research governance, based on reallife experience.
Declaration of helsinki wikimili, the free encyclopedia. The 7th revision of the declaration continues on this path of adapting to a changed research environment and a growing awareness of newly emerging ethical issues. This structure persisted until the edinburgh 2000 revision when it was substantially revised, and we return to this issue under declaration of helsinki. On the 2008 revisions to the wma declaration of helsinki. In the wake of revelations that serious abuses of research ethics were relatively commonplace, the wma made explicit what had only been implicit in the 1964 version that in research on man, the interest of science and society should never take precedence over considerations related to the. The world medical association declaration of geneva outlines the professional duties of physicians and affirms the ethical principles of the global medical profession.
265 1433 763 619 845 496 335 1493 1538 1250 651 651 1537 86 186 762 1106 10 416 116 935 1092 392 1390 1246 1372 128 1150 289 782 493 278 1224 557 901 1461 956 488 261 477 608 340