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The 2008 Declaration of Helsinki — First among Equals in Research Ethics?

Published online by Cambridge University Press:  01 January 2021

Extract

The World Medical Association's (WMA) Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort to maintain its influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration (FDA) recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States.

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Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

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References

Carlson, R. V., Boyd, K. M., and Webb, D. J., “The Revision of the Declaration of Helsinki: Past, Present and Future,” British Journal of Clinical Pharmacology 57, no. 6 (2004): 695713; Williams, J., “The Declaration of Helsinki: The Importance of Context,” in Frewer, A., Schmidt, U., eds., History and Theory of Human Experimentation: The Declaration of Helsinki and Modern Medical Ethics (Stuttgart, Germany: Franz Steiner Verlag, 2007): 315325; Ashcroft, R., “The Declaration of Helsinki,” in Emanuel, E. J., Grady, C., Crouch, R. A., Lie, R. K., Miller, F. G., and Wendler, D., eds., The Oxford Textbook of Clinical Research Ethics (New York: Oxford University Press, 2008): 141148;Google Scholar
Forster, H. P., Emanuel, E., and Grady, C., “The 2000 Revision of the Declaration of Helsinki: A Step Forward or More Confusion?” The Lancet 358, no. 9291 (2001): 14491453; Macklin, R., “After Helsinki: Unresolved Issues in International Research,” Kennedy Institute of Ethics Journal 11, no. 1 (March 2001): 1736; Lie, R. K., Emanuel, E., Grady, C., and Wendler, D., “The Standard of Care Debate: The Declaration of Helsinki Versus the International Consensus Opinion,” Journal of Medical Ethics 30, no. 2 (2004): 190193; Schuklenk, U., “The Standard of Care Debate: Against the Myth of an ‘International Consensus opinion,’” Journal of Medical Ethics 30, no. 2 (2004): 194197; Wolinsky, H., “The Battle of Helsinki: Two Troublesome Paragraphs in the Declaration of Helsinki Are Causing a Furore over Medical Research Ethics,” EMBO Reports 7, no. 7 (July 2006): 670672.CrossRefGoogle Scholar
Department of Health and Human Services, Food and Drug Administration, Guidance for Industry: Acceptance of Foreign Clinical Studies, Rockville, MD, 2001; European Parliament, Council of the European Union, Directive 2001/20/EC; Commission of the European Communities, Directive 2005/28/EC.Google Scholar
Department of Health and Human Services, Food and Drug Administration, “Human Subject Protection; Foreign Clinical Studies Not Conducted under an Investigational New Drug Application: Final Rule,” Federal Register 73, no. 82 (April 28, 2008): 2280022816.Google Scholar
See Ashcroft, , supra note 1.Google Scholar
World Medical Association (WMA), World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, Ferney-Voltaire, 2008.CrossRefGoogle Scholar
Confusingly, the Declaration uses the term “participants” for non-physician investigators and the term “subjects” for patients or healthy volunteers who participate in research. We adopt this terminology here exclusively for reasons of clarity.Google Scholar
Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 2002; United Nations Educational Scientific and Cultural Organization (UNESCO), Universal Declaration on Bioethics and Human Rights, Geneva, 2005.Google Scholar
Macklin, R., Double Standards in Medical Research in Developing Countries (Cambridge, UK and New York, NY: Cambridge University Press, 2004).CrossRefGoogle Scholar
London, A. J., “The Ambiguity and the Exigency: Clarifying ‘Standard of Care’ Arguments in International Research,” Journal of Medicine and Philosophy 25, no. 4 (2000): 379397; Wendler, D., Emanuel, E. J., and Lie, R. K., “The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive to Those Countries' Health Needs?” American Journal of Public Health 94, no. 6 (2004): 923928; Nuffield Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries, London, 2002; Emanuel, E. J., Finding New Ethical Conceptions through Practical Ethics: Global Justice and the ‘Standard of Care’ Debates, 2006, available at <http://www.ethics.utoronto.ca/pdf/events/Paper-EzekielEmanuel.pdf> (last visited January 29, 2010).Google Scholar
See CIOMS, supra note 8; Joint United Nations Programme on HIV/AIDS (UNAIDS), Ethical Considerations in HIV Preventive Vaccine Research, UNAIDS Guidance Document, Geneva, 2000.Google Scholar

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