Ethics Governance
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| Article - Abstract. To view full article click on the article title. | |
eMJA: Stockhausen, The Declaration of Helsinki: revising ethical research guidelines for the 21st century The Declaration of Helsinki : revising ethical research guidelines for the 21st century A recent draft proposal for revising the Declaration has provoked heated controversy MJA 2000; 172: 252-253 The World Medical Association (WMA) Declaration of Helsinki1 is regarded internationally as the pillar of ethical standards for biomedical research involving humans. In 1997, the American Medical Association presented a draft proposal to the WMA to update the Declaration to bring it more into line with contemporary ethical thinking,2-4 whereupon the WMA began the current process of revising the Declaration. Since 1964, the Declaration has evolved from a relatively broad set of ethical principles to a more defined, prescriptive set of guidelines, but it is extremely difficult to obtain global consensus on the Declaration because perceptions and ethical standards are not universal. ... we must determine just how the Declaration can remain relevant in the current biomedical research environment... Ethical standards are a product of cultural, linguistic, moral, religious, and social considerations; hence, many nations develop their own ethical guidelines for biomedical research -- for example, the National statement on ethical conduct in research involving humans,5 released recently by Australia's National Health and Medical Research Council. In June 1999, the WMA circulated a draft Proposed Revision of the Declaration of Helsinki6 to all National Medical Associations (NMAs). An international outcry ensued over the proposed amendments to issues such as informed consent, access to healthcare, placebo use, and publications (see Box).8-10 Some argued that the Proposed Revision established a model for human biomedical research ethics that encouraged utility and efficiency at the expense of patient autonomy and wellbeing.9 Those who defended the amendments said they were more in line with contemporary ethical thinking and did not impose unnecessarily stringent standards of practice.11 In this issue of the Journal, Loff and Black discuss some of the complexities associated with this debate and raise further questions.13 As a result of the lack of consensus between NMAs on the Proposed Revision, the WMA decided, at its General Assembly in October 1999, to develop a new draft revised Declaration in consultation with the public and WMA members.14 The difficulties imposed by the Declaration's prescriptive model are exemplified in the proposed amendments to placebo use (see Box). Full Article: http://www.mja.com.au/public/issues/172_06_200300/stockhausen/stockhausen.html |
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