Ethical issues are constantly changing as clinical research and practice push out the boundaries of what we know and do
The beginnings of ethical and regulatory oversight of the human research enterprise are customarily traced to the Nuremberg Code, a set of principles and standards for medical experiments outlined by the Nuremberg war crimes tribunal in 1947 following revelations of the infamous Nazi experiments conducted during World War II.1 Ironically, Germany was the first Western country to officially require informed consent for non-therapeutic research. In 1900, the Prussian minister for religious, educational and medical affairs issued a directive after it came to light that Albert Neisser had injected syphilitic serum into prostitutes without their knowledge or consent;2 and in 1931, the Reich Minister of the Interior introduced Guidelines on innovative therapy and scientific experimentation following an inquiry into the Lübeck disaster, in which 75 infants died and 168 others developed tuberculosis after receiving a contaminated batch of oral BCG vaccine.3,4
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- Royal Prince Alfred Hospital, Sydney, NSW.
- 1. Weindling P. The origins of informed consent: the International Scientific Commission on medical war crimes, and the Nuremberg Code. Bull Hist Med 2001; 75: 37-71.
- 2. Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg Code. BMJ 1996; 313: 1445-1447.
- 3. Berlin correspondent. The Lübeck trial. Lancet 1931; 218: 927-928, 986, 1038, 1098-1099, 1160, 1214, 1319-1320, 1428-1429; Lancet 1932; 219: 102, 154, 259-260, 365.
- 4. Bonah C, Menut P. BCG vaccination around 1930: dangerous experiment or established prevention? Debates in France and Germany. In: Roelcke V, Maio G, editors. Twentieth century ethics of human subjects research. Historical perspectives on values, practices, and regulations. Stuttgart: Franz Steiner Verlag, 2004. http://books.google.com.au/books?id=NgvQHQqA1HkC&printsec=frontcover#PPA111,M1 (accessed Apr 2008).
- 5. World Medical Association. World Medical Association declaration of Helsinki. Ethical principles for medical research involving human subjects. http://www.wma.net/e/policy/b3.htm (accessed May 2008).
- 6. National Health and Medical Research Council. History of ethics and ethical review of human research in Australia. Canberra: NHMRC, 2007. http://www.nhmrc.gov.au/ethics/human/ahec/history/index.htm (accessed May 2008).
- 7. Loblay RH, Chalmers DRC. Ethics committees: is reform in order [editorial]? Med J Aust 1999; 170: 9-10. <MJA full text>
- 8. National Health and Medical Research Council. National statement on ethical conduct in research involving humans. 1999. http://www.nhmrc.gov.au/publications/synopses/_files/e35.pdf (accessed May 2008).
- 9. United Kingdom Department of Health. Research governance framework for health and social care: second edition. 24 Apr 2005. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962 (accessed Apr 2008).
- 10. Walsh MK, McNeil JJ, Breen KJ. Improving the governance of health research. Med J Aust 2005; 182: 468-471. <MJA full text>
- 11. George AJT, Gale R, Winston R, Korn D. Research governance at the crossroads. Nature Med 2002; 8: 99-101.
- 12. Frew D, Martlew A. Research governance: new hope for ethics committees? Monash Bioeth Rev 2007; 26: 17-23.
- 13. National Health and Medical Research Council; Australian Research Council; and Australian Vice-Chancellors’ Committee. National statement on ethical conduct in human research. 2007. http://www.nhmrc.gov.au/publications/synopses/e72syn.htm (accessed May 2008).
- 14. Babl FE, Sharwood LN. Research governance: current knowledge among clinical researchers. Med J Aust 2008; 188: 649-652. <MJA full text>
- 15. National Health and Medical Research Council; Australian Research Council; and Universities Australia. Australian code for the responsible conduct of research. 2007. http://www.nhmrc.gov.au/publications/synopses/_files/r39.pdf (accessed May 2008).
- 16. Commonwealth Department of Health and Aged Care. Therapeutic Goods Administration. DSEB adopts two pivotal European guidelines. TGA News 2000; (33): 5. http://www.tga.health.gov.au/docs/pdf/tganws/tganews33.pdf (accessed May 2008).
- 17. Therapeutic Goods Administration, Commonwealth Department of Health and Aged Care. Note for guidance on good clinical practice (CPMP/ICH/135/95), annotated with TGA comments. Canberra: TGA, July 2000. http://www.tga.gov.au/docs/pdf/euguide/ich/ich13595.pdf (accessed May 2008).
- 18. Therapeutic Goods Administration. Note for guidance on clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95), annotated with TGA comments. Canberra: TGA, July 2000. http://www.tga.gov.au/docs/pdf/euguide/ich/ich37795.pdf (accessed May 2008).
- 19. De Roy PG. Helsinki and the Declaration of Helsinki. World Med J 2004; 50: 9-11.
- 20. Ballantyne AJ, Rogers WA. Fair inclusion of men and women in Australian clinical research: views from ethics committee chairs. Med J Aust 2008; 188: 653-656. <MJA full text>
- 21. Wachter RM. AIDs, activism, and the politics of health. N Engl J Med 1992; 326:128-133.
- 22. United States Department of Health and Human Services. National Institutes of Health guideline on the inclusion of women and minorities as subjects in clinical research — updated 1 August 2000. http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm (accessed Apr 2008).
- 23. National Health and Medical Research Council. Report of the review of the role and functioning of institutional ethics committees. Report to the Minister for Health and Family Services, March 1996. http://www.nhmrc.gov.au/publications/synopses/withdrawn/e34.pdf (accessed May 2008).
- 24. National Health and Medical Research Council. NHMRC human research ethics handbook: commentary on the National statement on ethical conduct in research involving humans. Canberra: NHMRC, 2001: E165-E169. http://www.nhmrc.gov.au/publications/hrecbook/_files/hrechand.pdf (accessed May 2008).