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Title: The fifth revision of the Declaration of Helsinki and the ethical landscape of medical research
Author: Carlson, Robert V.
Awarding Body: University of Edinburgh
Current Institution: University of Edinburgh
Date of Award: 2011
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The Declaration of Helsinki (DoH) is a set of normative ethical guidelines developed by the World Medical Association (WMA) for doctors participating in medical research. Arguably the best known and most authoritative of such ethical guidelines, the DoH has roots in the Nuremberg Code (1947). First adopted in 1964, the DoH, by 2000, had been revised 5 times. The 5th (Edinburgh, 2000) revision gave rise to great controversy evidenced by the unprecedented step of the WMA issuing Notes of Clarification to the 2 most controversial paragraphs. This thesis considers in detail the text of the 5th (Edinburgh, 2000) revision. Beginning with a review of the historical evolution of the text, there follows description of the controversial issues, discussion of why controversy ensued and what may be the future of the text. Then a detailed paragraph-by-paragraph analysis details exactly what changed in the text and identifies the most significant changes. Seven major areas of change to the text were identified: use of placebos in research, postresearch duty of care to individual participants, duties to ensure reasonable likelihood of benefit to communities involved in research, ethical issues related to publication, the addition of observational research to the scope of the document, the DoH's enhanced statement of its own authority, an enhanced duty to conduct research as well as an 8th major change, a logical re-structuring of the document removing the category of "Non-Therapeutic Research". Based on observation of WMA meetings and archival research a "behind the scenes" analysis is undertaken - asking how the most controversial paragraphs came to take their form in the 5th revision and considering what lessons may be learned from the drafting process itself. Further, the DoH exists in three official languages (English, French and Spanish) and important differences were discovered. There follows a comparison of the three official language versions - investigating concerns as to how differences may lead to uneven application of the DoH but also asking how the differences may help in understanding the controversial paragraphs. This detailed analysis of the text of the 5th revision leads to the central thesis question: "Is the DoH providing adequate guidance as a set of normative ethical standards across the broad spectrum of those involved in the global medical research endeavour as evidenced by reasonable coherence of their interpretations of the DoH?" Or, on the other hand, are the interpretations so diverse that the DoH cannot be considered a source of clear guidance. Or, put another way and incorporating the symbolism inherent in the title of this thesis: "Does the DoH function adequately to map the 'landscape of medical research'"? Semi-structured interviews were constructed based on the 8 major changes identified above and 57 experts drawn from 3 major categories: the "Authors" (15 people involved in the drafting process); the "Medical Researchers" (21 interviewees directly involved in conduct or application of medical research) and the "Expert Commentators" (21 with expertise in other aspects of drafting documents such as the DoH but not directly involved in either of the above) were interviewed. The interpretation process as illustrated in the transcript of the interviews is analysed with a view to determining whether the 5th revision has been effective in achieving a workable agreement among interpretations. Analysis of the results showed the DoH to be variously successful in depicting the landscape of medical research between and amongthe above three groups of interviewees. During the course of this study a further revision of the DoH took place in 2008 and the WMA invited a submission from this author as part of the consultation process. This response is presented and some discussion of the possible influence of this ensues. Finally the summary and conclusions ask what has changed in the 2008 text in the critical parts of the DoH identified above before summing up and considering possible future trajectories for this globally important document addressing the ethical conduct of medical research.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available