Richard H Nicholson, Bioethics Publications Limited, London, UK
Published online: July 2006
DOI: 10.1038/npg.els.0005178
The Helsinki Declaration is the most widely accepted set of ethical principles for the protection of the human subjects of medical research. Subsequent revisions have made it clear that the interests of the subject must always take precedence over the interests of science and society, but this has met considerable resistance from those involved in drug trials for licensing purposes.
Keywords: research; regulation; ethics; human subjects protection
| References | |
| Angell M (1997) The ethics of clinical research in the third world. New England Journal of Medicine 337: 847–849. | |
| book Department of Health (2001a) Research Governance Framework for Health and Social Care. London, UK: UK Department of Health. | |
| book Department of Health (2001b) Governance Arrangements for NHS Research Ethics Committees. [Available at http://www.doh.gov.uk/research/documents/gafrec.doc.] | |
| Editorial (1931) Reichsgesundheitsblatt 10: 174–175. [1980 English translation, International Digest of Health Legislation 31: 408–411.] | |
| book National Research Act (1974) US Public Law 93-348. [Reprinted in Maloney DM (ed.)(1984) Protection of Human Research Subjects, pp. 23–30. New York, NY: Plenum.] | |
| book Reverby SM (ed.) (2000) Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study. Chapel Hill, NC: University of North Carolina Press. | |
| Temple R and Ellenberg SS (2000) Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part I: ethical and scientific issues. Annals of Internal Medicine 133: 455–463. | |
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| book World Medical Association (1964) Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Adopted Helsinki, 1964; amended 1975, 1983, 1989, 1996, and 2000. Ferney-Voltaire, France: WMA. [Available at http://www.wma.net.] | |
| Further Reading | |
| book Annas GJ and Grodin MA (eds.) (1992) The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York, NY: Oxford University Press. | |
| book Doyal L and Tobias JS (eds.) (2001) Informed Consent in Medical Research. London, UK: BMJ Books. | |
| book Katz J (1972) Experimentation with Human Beings. New York, NY: Russell Sage Foundation. | |
| book Levine RJ (1986) Ethics and Regulation of Clinical Research, 2nd edn. Baltimore, MD: Urban & Schwarzenberg. | |
| book McNeill PM (1993) The Ethics and Politics of Human Experimentation. Cambridge, UK: Cambridge University Press. | |
| World Medical Association (2000) Revising the Declaration of Helsinki. Bulletin of Medical Ethics 150: 9–11. | |
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