Ethical Considerations

  • T. Hope
  • J. Savulescu


Clinical trials have had enormous impact in several areas of medical practice. Some examples are the trials assessing the value of aspirin and thrombolytic therapy following acute stroke [1–3]. Millions of patients benefit from the knowledge gained from trials. There is, however, a dark side to medical experiments carried out on people.


Acute Ischaemic Stroke Local Research Ethic Committee Competent Adult Valid Consent Normal Clinical Practice 
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  1. 1.
    Donnan GA, Davis SM, Chambers BR, Gates PC, Hankey GJ, McNeil JJ, et al. Trials of streptokinase in severe acute ischaemic stroke. Lancet 1995; 345: 578–579.PubMedCrossRefGoogle Scholar
  2. 2.
    Italy (MAST-I) Group. Multicentre Acute Stroke Trial: randomised controlled trial of streptokinase, aspirin, and combination of both in treatment of acute ischaemic stroke. Lancet 1995; 346: 1509–1514.Google Scholar
  3. 3.
    Europe Study Group. The Multicentre Acute Stroke Trial. Thrombolytic therapy with streptokinase in acute ischaemic stroke. N Engl J Med 1996; 335: 145–150.Google Scholar
  4. 4.
    Pappworth MH. Human guinea pigs: experimentation on man. London: Routledge and Kegan Paul, 1967.Google Scholar
  5. 5.
    Beecher HK. Ethics and clinical research. N Engl J Med 1966; 274: 1354–1360.PubMedCrossRefGoogle Scholar
  6. 6.
    Annas GJ, Grodin MA, editors. The Nazi doctors and the Nuremberg Code: human rights in human experimentation. Oxford: Oxford University Press, 1992: 343–345.Google Scholar
  7. 7.
    World Medical Association. The Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. Adopted by the 18th World Medical Assembly Helsinki, 1964 and amended by the 29th World Medical Assembly Tokyo, 1975; 35th World Medical Assembly Venice, 1983; and 41st World Medical Assembly Hong Kong, 1989.Google Scholar
  8. 8.
    Department of Health Circular. Local Research Ethics Committees (HSG(91)5) London: Department of Health, 1991.Google Scholar
  9. 9.
    Department of Health. Health Service Guidelines (HSG (97) 23 ). Ethics Committee Review of Multi-Centre Research. London: Department of Health, 1997.Google Scholar
  10. 10.
    Botros S. Ethics in medical research: uncovering the conflicting approaches. In: Foster C, editor. Manual for research ethics committees. 4th ed. King’s College, London: The Centre of Medical Law and Ethics, 1996.Google Scholar
  11. 11.
    Grotta J. Should thrombolytic therapy be the first-line treatment for acute ischaemic stroke? t-PA: the best current option for most patients. N Engl J Med 1997; 337: 1310.PubMedGoogle Scholar
  12. 12.
    Royal College of Physicians. Guidelines on the practice of ethics committees in medical research involving human subjects. London: The Royal College of Physicians, 1990.Google Scholar
  13. 13.
    Royal College of Physicians. Research involving patients. Summary and recommendations of a report of the Royal College of Physicians. J R Coll Physicians 1990; 24: 10–14.Google Scholar
  14. 14.
    Medical Research Council. MRC guidelines for good clinical practice in clinical trials. London: MRC, 1998.Google Scholar
  15. 15.
    Hirsch SR, Harris J, editors. Consent and the incompetent patient. Ethics, law and medicine. London: Royal College of Psychiatrists, 1988.Google Scholar
  16. 16.
    British Paediatric Association. Guidelines for the ethical conduct of medical research involving children. V.27. 1. London: British Paediatric Association, 1992.Google Scholar
  17. 17.
    Babcock M, de Silva D, Oaks R, Davis-Kaplan S, Jiralerspong S, Montermini L, et al. Regulation of mitochondrial iron accumulation by Yfhlp, a putative homolog of frataxin. Science 1997; 276: 1709–1712.PubMedCrossRefGoogle Scholar
  18. 18.
    Koenig M, Mandel J-L. Deciphering the cause of Friedreich’s Ataxia. Curr Opin Neurol 1997; 7: 689–694.CrossRefGoogle Scholar
  19. 19.
    Chalmers I. Evaluating the effects of care during pregnancy and childbirth. In: Chalmers I, Enkin M, Keirse M, editors. Effective care in pregnancy and childbirth. 1989: 3–38Google Scholar
  20. 20.
    Hope T. Evidence-based patient choice. London: The King’s Fund, 1996.Google Scholar
  21. 21.
    Moser HW. Adrenoleukodystrophy: phenotype, genetic, pathogenesis and therapy. Brain 1997; 120: 1485–1508.PubMedCrossRefGoogle Scholar
  22. 22.
    Edwards SJL, Lilford RJ, Braunholtz D, Jackson J. Why “underpowered” trials are not necessarily unethical. Lancet 1997; 350: 804–807.PubMedCrossRefGoogle Scholar
  23. 23.
    Lilford RJ, Thornton JG, Braunholtz D. Clinical trials and rare diseases: a way out of a conundrum. BMJ 1995; 311: 1621–1625.PubMedCrossRefGoogle Scholar
  24. 24.
    Piantadosi S. Clinical trials: a methodologic perspective. New York: Wiley, 1997.Google Scholar
  25. 25.
    Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987; 317: 141–145.PubMedCrossRefGoogle Scholar
  26. 26.
    Collins R, Doll R, Peto R. Ethics of clinical trials. In: Williams CJ, editor. Introducing new treatments for cancer: practical, ethical and legal problems. Wiley, 1992: 50.Google Scholar
  27. 27.
    Doll R. Summation of the conference. In: Warren KS, Mosteller F, editors. Doing more good than harm: the evaluation of health care interventions. Ann N Y Acad Sci. 1993; 703: 310–313.Google Scholar
  28. 28.
    Chalmers I, Silverman WA. Professional and public double standards on clinical experimentation [commentary]. Control Clin Trials 1987; 8: 388–391.PubMedCrossRefGoogle Scholar
  29. 29.
    Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ 1996; 313: 1390–1393.PubMedCrossRefGoogle Scholar

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© Springer-Verlag London 2001

Authors and Affiliations

  • T. Hope
  • J. Savulescu

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