Abstract
A patient's informed consent is required by the Nuremberg code, and its successors, before she can be entered into a clinical trial. However, concern has been expressed by both patients and professionals about the beneficial or detrimental effect on the patient of asking for her consent. We examine advantages and drawbacks of popular variations on consent, which might reduce the stress on patients at the point of illness. Both informed and uninformed responses to particular trials, and trials in general, are discussed. The selection by doctors of patients, to whom entry to trials will be offered, is explored.
Alternative forms of consent require restrictions on patients' knowledge, personal responsibility and freedom of choice.
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Ashcroft, J.J., Leinster, S.J. and Slade, P.D. (1985) Breast Cancer - Patient Choice of Treatment: Preliminary Communication. Journal of the Royal Society of Medicine 78, 43–46.
Ashcroft, R.E., Chadwick, D.W., Clark, S.R.L., Edwards, R.H.T., Frith, L. and Hutton, J.L. (1997) Implication of socio-cultural contexts for the ethics of clinical trials. Health Technology Assessment 1(9), iv–65.
Baum, M. (1986) Do We Need Informed Consent? The Lancet, 911–912.
Baum, M. (1993) New Approach for Recruitment into Randomised Controlled Trials. The Lancet 341 812–813.
Berry, D.A. (1993) The Case for Bayesianism in Clinical Trials. In D. Ashby (Ed.), Papers from the Conference on Methodological and Ethical Issues in Clinical Trials, 27-28 June 1991, Vol. 12, Statistics in Medicine, Wiley, pp. 1377–1393.
Brazier, M. (1992) Medicine, Patients and the Law (2 edn.). Harmondsworth: Penguin.
Bursztajn, H.J., Feinbloom, R.I., Hamm, R.M. and Brodsky, A. (1990) Medical Choices, Medical Chances (2 edn.). New York and London: Routledge.
Caplan, A. (1988) Is There an Obligation to Participate in Biomedical Research? In S.F. Spicker et al. (Eds.), The Use of Human Beings in Research, with Special Reference to Clinical Trials. Dordrecht: Kluwer.
Chalmers, I. (1983) Scientific Inquiry and Authoritarianism in Perinatal Care and Education.Birth 10, 151–164.
Chalmers, I. and Silverman, W. (1987) Professional and Public Double Standards on Clinical Experimentation. Controlled Clinical Trials 8, 388–391.
Council of the International Organisation ofMedical Sciences (1993) International Guidelines for Biomedical Research Involving Human Subjects. esp. Guidelines 1-3.
Edwards, S.J.L., Lilford, R.J., Braunholtz, D.A., Jackson, J., Hewison, J. and Thornton, J. (1998) Ethical Issues in the Design and Conduct of Randomised Controlled Trials. Health Technology Assessment 2(15), vi–128.
Hanauske-Abel, H.M. (1996) Not a Slippery Slope or Sudden Subversion: German Medicine and National Socialism in 1993. British Medical Journal 313, 1453–1463.
Harrison, J. (1996) Patients Should not be Discouraged from Entering Trials. British Medical Journal 313, 1488.
Hilden, J. and Habbema, J.D.F. (1987) Prognosis in Medicine: An Analysis of Its Meaning and Roles. Theoretical Medicine 8, 349–365.
Hilden, J. and Habbema, J.D.F. (1990) The Marriage of Clinical Trials and Clinical Decision Science. Statistics in Medicine 9, 1243–1257.
Hill, A.B. (1992) Statistical Methods in Clinical and Preventive Medicine. Edinburgh and London: E & S Livingstone.
Beecher, H.K. (1970) Research and the Individual. London: J & A Churchill.
Hutton, J.L. (1995) Statistics is Essential for Professional Ethics. Journal of Applied Philosophy 12, 253–261.
Hutton, J.L. (1996) The Ethics of Randomised Controlled Trials: AMatter of Statistical Belief.Health Care Analysis 4, 95–102.
Hutton, J.L. (1998) Medical Ethics and Statistics. In D.G. Altman et al. (Eds.), Encyclopedia of Biostatistics. London: John Wiley and sons, pp. 2540–2546.
Koehn, D. (1994) The Ground of Professional Ethics. London: Routledge.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978) The Belmont Report: Ethical Guidelines and Principles for the Protection of Human Subjects of Research. Washington, DC: US government printing office. BHEW publication (OS)78-0012.
Nuremberg Code (1947); see (1996) British Medical Journal 313, 1449.
Pocock, S.J. (1992) When to Stop a Clinical Trial. British Medical Journal 305, 235–240.
Prescott, R., Gillespie, W., Counsell, C., Grant, A.M., Ross, S., Russell, I. and Kiauka, S. (1998) Factors that Limit the Number, Quality and Progress of Randomised Trials. In N. Black et al. (Eds.), Health Services Research Methods. London: BMJ Books, pp. 86–97.
Taylor, K.M., Margolese, R.G. and Soskolne, C.L. (1984) Physicians' Reasons for not Entering Eligible Patients in a Randomized Clinical Trial of Surgery for Breast Cancer. New England Journal of Medicine 310, 1363–1367.
Thornton, H. (1992) Breast Cancer Trials: A Patient's Viewpoint. The Lancet 339, 44–45.
Thornton, H. (1994) Clinical Trials - a Brave New Partnership. Journal of Medical Ethics 20, 19–22.
Toynbee, P. (1996) No One ReallyWins in This Life-and-death Lottery. The Independent May 25, 15 (cols 1-7).
Vollmann, J. and Winau, R. (1996) Informed Consent in Human Experimentation before the Nuremberg Code. British Medical Journal 313, 1445–1450.
World Medical Association (1996) Declaration of Helsinki (1964, 1975, 1983, 1989, 1996, currently under review), see (1996). British Medical Journal 313, 1449–1450.
Zelen, M. (1979) A New Design for Randomized Clinical Trials. New England Journal of Medicine 300, 1242–11245.
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Hutton, J.L., Ashcroft, R.E. Some Popular Versions of Uninformed Consent. Health Care Analysis 8, 41–53 (2000). https://doi.org/10.1023/A:1009421824028
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DOI: https://doi.org/10.1023/A:1009421824028