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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Acknowledgements
- Michael DE Goodyear, Karmela Krleza-Jeric and Trudo Lemmens (28 September 2007)
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The Delaration of Helsinki is DEAD
- John H Noble Jr (29 September 2007)
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Re: The Delaration of Helsinki is DEAD
- udo schuklenk (8 October 2007)
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The Declaration of Helsinki and The Ottawa Statement on trial registration
- Michael DE Goodyear, Karmela Krleza-Jeric, Trudo Lemmens (18 December 2007)
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Michael DE Goodyear, Assistant Professor Department of Medicine, Dalhousie University, Halifax, Nova Scotia Canada B3H 2Y9, Karmela Krleza-Jeric and Trudo Lemmens
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We would like to thank the following for agreeing to read and offer constructive criticism of early drafts, however any faults lie not in our stars, but in ourselves; Richard Ashcroft, Jeff Blackmer, Robert Carlson, Jocelyn Downie, Lisa Eckenwiler, Janice Graham, Chris MacDonald, John Noble, Tamara O’Doherty, Teela Sanders Competing interests: None declared |
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John H Noble Jr, Retired 508 Rio Grande Loop, Georgetown, Texas, USA 78633
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Michael Goodyear and his coauthors are owed a debt of thanks for laying out the history and failings of repeated revisions of the Declaration of Helsinki. Unfortunately, the United States in service to the overarching interests of the pharmaceutical and medical device industry has apparently successfuly intervened in the past (and continues to try) with provisions that weaken the protection of human subjects, taking the document for what it is worth farther and farther from the principles and intent of the Nuremburg Code. The World Medical Association (WMA), it appears, has been party to medical malpractice in its most wanton manifestation. Fortunately, unlike the Nuremberg Code, most courts of law in the United States and elsewhere do not rely on the Declaration of Helsinki for guidance. Unfortunately, the answer to the authors' question, "Declaring Helsinki -- Alive or Dead?," seems to this non-physician observer to be that the Declaration of Helsinki is DEAD on the basis of no brain waves, no heart beat, and a rapidly bloating, blow fly infested, stinking cadaver. Cynically, one must ask "what is the purpose of current efforts to "harmonize" the ethics and legalities of clinical trials in countries with no device regulatory system in the upcoming conference of the Global Harmonization Task Force (GHTF)?" How can one "harmonize" the practice of numerous unethical experiments conducted by researchers with no "internalized ethical values?" How can one "harmonize" wholesale failure to internalize ethical values?" As aptly put by Arthur Caplan, ethicist at the University of Pennsylvania in the New York Times article cited below, "In many ways, rats and mice get greater protection as research subjects in the United States than do humans." Efforts to change the Declaration of Helsinki that come from sources in the United States by now should be recognized for what they represent. The United States and the US Federal Drug Administration (FDA) have essentially abdicated oversight of human subjects research, as indicated by the most recent report of the US Department of Health and Human Services (HHS) Inspector General, ". . . federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed." See: Gardiner Harris (September 28, 2007), "Report Assails F.D.A. Oversight of Clinical Trials, THE NEW YORK TIMES. http://www.nytimes.com/2004/11/19/business/19fda.html Sadly, on the basis of available evidence, I must conclude that it is time for the rest of the world to look away from the United States for moral leadership. Perhaps it is time for the world to turn to the Canadian Ottawa Statement to which the authors approvingly refer. Competing interests: I read and commented on the authors' original draft. |
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udo schuklenk, Professor and Ontario Research Chair in Bioethics Queen's University, Watson Hall 308, Kingston, ON, Canada
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One observation and one comment: The observation - Just a few years ago an Editorial such as this would have led to a true avalanche of letters and comments. The absence of pretty much any response suggests that Dr Noble might be right. One wonders whether professionals have decided to move on from the Declaration of Helsinki. The comment - Perhaps the difficulties in terms of quality, transparency of the deliberative process and other such crucial issues are not only a problem with regard to the Declaration of Helsinki. Other 'ethical' guideline producers such as CIOMS, or UNESCO with its utterly inapt Declaration on Bioethics and Human Rights, have to confront the question of whether halfway intelligible ethics documents can reasonably result from committee based drafting processes. The evidence suggests that that probably is not a good idea to begin with. Perhaps the time has come to discard most 'ethics' guidelines and request their owners label them correctly. Virtually all 'ethical' guidance documents and declarations are barely disguised policy documents hiding under the cloak of 'ethics'. No wonder that the arguments over Helsinki have been as bitter as they were, given that many of those involved were not in the business of drafting an ethics document but a policy document aimed at changing real world practices (preferably in other countries). Competing interests: None declared |
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Michael DE Goodyear, Assistant Professor Department of Medicine, Dalhousie University, 1278 Tower Road, Halifax, Nova Scotia, Canada B3H 2Y9, Karmela Krleza-Jeric, Trudo Lemmens
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John Noble and Udo Schuklenk raise some important concerns about the evolution of the Declaration of Helsinki. While we share some of their concerns, we do not go as far as to state that Helsinki is dead. We still think that a document like the Declaration has a place in the ethical lexicon, can learn from commentary and has the capacity to adapt over time. However we wanted to point out the necessity of focusing on core ethical norms as opposed to the more detailed implementation of such norms which reflect the capacity of the research environment at any point in time. It is therefore these details that are more likely to be the subject of ongoing revision. The current revision process provides an opportunity to address one of the most serious challenges in the medical research environment today: the erosion of trust in clinical research due to lack of transparency. More specifically it offers the opportunity to embed the principles of prospective public disclosure of research information and results through trial registration. There is a compelling ethical reason why trial registration must become an inherent attribute of research on human beings. A host of controversies have confirmed claims that hiding research and obscuring details is occurring frequently in the context of an increasingly commercialized research environment, corroding the integrity of the foundation of evidence based health care. At the same time advances in communications technology has made the accessibility of large amounts of information practically feasible. At the time of the last revision of the Declaration (2004) trial registration was in its infancy but is evolving rapidly. Several initiatives from groups such as the International Committee of Medical Journal Editors (ICMJE), the World Health Organization (WHO), the Ottawa Group (1) as well as a number of registers have advocated both the principles and practice of trial registration, compensating for the increasing complexity of research, and the resultant concentration of power. (2) By placing transparency and accountability at the centre of any initiative to re-establish trust in health research, the Ottawa Statement establishes a new research paradigm of information sharing and collaboration. Trial registration is a critical tool to fulfill our ethical and scientific obligation to both those people who enroll in research and to society at large by making the design, structure and results of all research publicly available and accessible through disclosure and deposition. These principles are congruent with the over-arching aims of the Declaration, namely to ensure that research is conducted in a scientifically and ethically responsible and transparent manner to maximise benefit, minimize risk and empower those who take part in such research. The joint efforts of the ICMJE, WHO and Ottawa Group provide a practical framework for advancing science and protecting people. While the initial proposals and implementation have concentrated on clinical trials, there are compelling ethical reasons to now extend these principles to all human research. (3) We commend the World Medical Association for having addressed these issues in its most recent proposed revisions (November 2007) (4). References (1) Ottawa Statement on trial registration http://ottawagroup.ohri.ca/index.html (2) Saul, J R. The Collapse of Globalism and the Reinvention of the World. Viking Canada, 2005. (2) Choi B. et al. Vision for a Global Registry of Anticipated Public Health Studies. Am J Public Health.2007; 97: S82-S87 (4) World Medical Association. Draft revision proposals to the Declaration of Helsinki. November 2007 http://myweb.dal.ca/mgoodyea/files/ethics/DoH%20Review%20Consultation%20Draft -Nov2007 Competing interests: None declared |
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