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

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): 695–713; 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): 315–325; 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): 141–148;

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): 1449–1453; Macklin R. , “After Helsinki: Unresolved Issues in International Research,” Kennedy Institute of Ethics Journal 11, no. 1 (March 2001): 17–36; 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): 190–193; Schuklenk U. , “The Standard of Care Debate: Against the Myth of an ‘International Consensus opinion,’” Journal of Medical Ethics 30, no. 2 (2004): 194–197; 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): 670–672.

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.

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): 22800–22816.

See Ashcroft , supra note 1.

World Medical Association (WMA), World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, Ferney-Voltaire, 2008.

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.

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.

Macklin R. , Double Standards in Medical Research in Developing Countries (Cambridge, UK and New York, NY: Cambridge University Press, 2004).

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): 379–397; 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): 923–928; 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).

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.