Hostname: page-component-78c5997874-ndw9j Total loading time: 0 Render date: 2024-11-06T11:54:52.073Z Has data issue: false hasContentIssue false
  • English
  • Français

Issues in Preparing Ethical Guidelines for Epidemiological Studies

Published online by Cambridge University Press:  29 April 2021

Bernard M. Dickens
Get access Rights & Permissions [Opens in a new window]

Extract

The Nuremberg Code of 1947 is often taken to mark the beginning of the modern age of ethical codes for medical and health-related research with human subjects. The 1947 Code was fashioned in response to inhumane medical experimentation revealed at the Nuremberg War Crimes Tribunal. The fact that, prior to 1939, Germany had an ethical code for human research in medicine that appears sensitive and sophisticated even by current standards indicates that codes in themselves do not assure ethical conduct. Nevertheless, calls continue for the preparation of codes of conduct to guide the exercise of ethical judgment in health-related research.

Medical research concerned with individual subjects as such now possesses codes or guidelines at many levels, including funding agency, research institutional, national and international levels. The World Medical Association's Helsinki Code is now in its fourth version, and the Guidelines proposed in 1982 by the World Health Organization affiliate, the Council for International Organizations of Medical Sciences (CIOMS) is about to be revised to take account of a decade of significant developments.

Type
Article
Information
Law, Medicine and Healthcare , Volume 19 , Issue 3-4 , Fall Winter 1991 , pp. 175 - 183
Copyright
Copyright © American Society of Law, Medicine and Ethics 1991

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Conveniently accessible in Levine, R.J., Ethics and Regulation of Clinical Research (Baltimore, Munich: Urban & Schwarzenberg, 2nd ed. 1986) 425–6.Google Scholar
Republished in News and Views. “1931 German Guidelines in Human Experimentation,” Int'l Digest Health Legislation, 31 (1980):408–411.Google Scholar
Council for International Organizations of Medical Sciences, Proposed International Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1982).Google Scholar
See e.g. Skrabanek, P., “Why Is Preventive Medicine Exempted from Ethical Constraints?” J. Medical Ethics 16 (1990): 187–190.Google Scholar
The author was a principal CIOMS consultant in this project.Google Scholar
Last, J.M. (ed.) Dictionary of Epidemiology (New York: Oxford Univ. Press, 2nd ed. 1988) 42.Google Scholar
See generally Annas, G.J. Glantz, L.H. and Katz, B.F., Informed Consent to Human Experimentation: The Subject's Dilemma (Cambridge, Mass: Ballinger, 1977).Google Scholar
A recent measles epidemic in the U.S., resulting in more than 60 deaths of children, was associated with the failure of the vaccination system due to a decline in the level of public health services; see New York Times, Jan. 9, 1991.Google Scholar
Vaccination programs often accommodate religiously-based objection by parents, however, in limited recognition of conscientious objection.Google Scholar
See the Canadian Federal Centre for AIDS Guidelines on ethical and legal considerations in anonymous unlinked HIV seroprevalence research Can. Med. Assoc. J. 143 (1990):625–27.Google Scholar
See Gillon, R., “Testing for HIV without Permission,” Brit. Med. J. 294 (28 March 1987):821–23.CrossRefGoogle Scholar
See note 10, above.Google Scholar
See Capron, A.M., “Protection of Research Subjects: Do Special Rules Apply in Epidemiology? J. Clinical Epidemiology 44 (1991), reprinted in this issue of Law, Medicine & Health Care.Google Scholar
See Beauchamp, T.L. and Childress, J.F., Principles of Biomedical Ethics (New York: Oxford Univ. Press, 3rd ed. 1989).Google Scholar
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington D.C.: DHEW Publications, 1978).Google Scholar
See Levine, R.J., note 1 above at 218–20.Google Scholar
See Id. at 178–181.Google Scholar
See Sabatier, R., Blaming Others: Prejudice, Race and Worldwide AIDS (London: The Panos Institute, 1988)Google Scholar
See e.g. Hankins, C.A. Laberge, C. et al, “HIV Infection Among Quebec Women Giving Birth to Live Infants”, Can. Med. Assoc. J. 143 (1990):885–893.Google Scholar
For instance, Falashas are Jews who lived in Ethiopia since Biblical times, but in the local language “falasha” means “stranger.”Google Scholar
See Drane, J.F., Becoming a Good Doctor: The Place of Virtue and Character in Medical Ethics (Kansas City: Sheed & Ward, 1988).Google Scholar
See American Medical Association, Council on Ethical and Judicial Affairs, Conflicts of Interest: Report A (I-86) (Chicago: A.M.A., 1986).Google Scholar
Moore v. Regents of the University of California, 793 P.2d 479 (1990).Google Scholar
See Report of The [Ontario] Commission of Inquiry into the Confidentiality of Health Information, 3 vols. (Toronto: Ontario Government Publications Office, 1980).Google Scholar
See note 23, above.Google Scholar
See Angell, M., “Ethical Imperialism? Ethics in International Collaborative Research”, New Eng. J. Med. 319(16) (Oct. 20 , 1988):1081–83.Google Scholar
See e.g. Fosmire v. Nicoleau, 551 N.E.2d 77 (N.Y.C.A., 1990); Malette v. Shulman, 67 D.L.R.(4th) 321 (Ont.C.A., 1990).Google Scholar