Advertisement

The Articulation of the Principle of Free and Informed Consent in Human-Rights Documents

  • Grzegorz Mazur
Chapter
Part of the Philosophy and Medicine book series (PHME, volume 112)

Abstract

After World War II it became evident that scientific research needed international oversight in order to eliminate or at least to curtail abuses of human subjects. Here I will briefly examine several documents that seek to achieve this goal. The principle of informed consent occupies an essential position in each of them. Yet, given the rapid development of medical science as well as its close connection to law, politics, and demographics in diverse cultural and economical milieus, the position of informed consent may vary from one document to another. What is more, it might be argued that the principle itself, so clearly and sharply articulated in the Nuremberg Code, has been gradually devalued with the passing of time. Regardless of its articulation in human-rights documents and its strong legal status in the United States and in many countries of Western Europe, the principle has also been compromised even to the point of open violation in the post-World War II era.

Keywords

National Commission World Medical Association Legal Capacity Belmont Report Hippocratic Oath 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. Alexander, L. 1976. “Ethics of Human Experimentation.” Psychiatric Journal of the University of Ottawa 1:40–46.Google Scholar
  2. Angell, M. 2000. “Investigators’ Responsibilities for Human Subjects in Developing Countries.” The New England Journal of Medicine 342(13):967–69.PubMedCrossRefGoogle Scholar
  3. Annas, G. J. 1992. “The Nuremberg Code in U.S. Courts: Ethics Versus Expediency.” In The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation, edited by G. J. Annas and M. A. Grodin, 201–22. New York, NY: Oxford University Press.Google Scholar
  4. Annas, G. J., L. H. Glantz, and B. F. Katz. 1977. Informed Consent to Human Experimentation: The Subject's Dilemma. Cambridge, MA: Ballinger.Google Scholar
  5. Annas, G. J., and M. A. Grodin. 1998. “Human Rights and Maternal-Fetal HIV Transmission Prevention Trials in Africa.” American Journal of Public Health 88(4):560–63.PubMedCrossRefGoogle Scholar
  6. Beauchamp, T. L. 2005. “The Origins and Evolution of the Belmont Report.” In Belmont Revisited: Ethical Principles for Research with Human Subjects, edited by J. F. Childress, E. M. Meslin, and H. T. Shapiro, 12–25. Washington, DC: Georgetown University Press.Google Scholar
  7. Beauchamp, T. L., and J. F. Childress. 2001. Principles of Biomedical Ethics (5th ed.). New York, NY: Oxford University Press.Google Scholar
  8. Beecher, H. 1960. “Human Experimentations – A World Problem from the Standpoint of a Medical Investigator.” World Medical Journal 8:79–80.Google Scholar
  9. Beecher, H. 1966. “Ethics and Clinical Research.” The New England Journal of Medicine 274(24):1351–60.CrossRefGoogle Scholar
  10. Bernard, C. 1927. Introduction to the Study of Experimental Medicine. Eng. trans. H. Copley. New York, NY: Macmillan.Google Scholar
  11. Bhutta, Z. A. 2004. “Beyond Informed Consent.” Bulletin of the World Health Organization 82(10):771–77.PubMedGoogle Scholar
  12. Brannigan, M. C., and J. A. Boss. 2001. Healthcare Ethics in a Diverse Society. Mountain View, CA: Mayfield Pub. Co.Google Scholar
  13. Churchill, L. R. 2005. “Toward a More Robust Autonomy. Revisiting the Belmont Report.” In Belmont Revisited: Ethical Principles for Research with Human Subjects, edited by J. F. Childress, E. M. Meslin, and H. T. Shapiro, 111–25. Washington, DC: Georgetown University Press.Google Scholar
  14. Drinan, R. F. 1992. “The Nuremberg Principles in International Law.” In The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation, edited by G. J. Annas and M. A. Grodin, 174–82. New York, NY: Oxford University Press.Google Scholar
  15. Faden, R. R., T. L. Beauchamp, and N. M. P. King. 1986. A History and Theory of Informed Consent. New York, NY: Oxford University Press.Google Scholar
  16. Fitzgerald, D. W., C. Marotte, R. I. Verdier, W. Johnson, and J. W. Pape. 2002. “Comprehension During Informed Consent in a Less-Developed Country.” The Lancet 360:1301–302.CrossRefGoogle Scholar
  17. Frankena, W. K. 1973. Ethics (2nd ed.). Englewood Cliffs, NJ: Prentice-Hall.Google Scholar
  18. Glantz, L. H. 1992. “The Influence of the Nuremberg Code on U.S. Statutes and Regulations.” In The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation, edited by G. J. Annas and M. Grodin, 183–200. New York, NY: Oxford University Press.Google Scholar
  19. Grodin, M. A. 1992. “Historical Origins of the Nuremberg Code.” In The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation, edited by G. J. Annas and M. Grodin, 121–44. New York, NY: Oxford University Press.Google Scholar
  20. Herranz, G. 1998. “The Inclusion of the Ten Principles of Nuremberg in Professional Codes of Ethics: An International Comparison.” In Ethics Codes in Medicine: Foundations and Achievements of Codification Since 1947, edited by U. Tröhler, S. Reiter-Theil, and E. Herych, 127–39. Aldershot and Brookfield, VT: Ashgate.Google Scholar
  21. Howard-Jones, N. 1982. “Human Experimentation in Historical and Ethical Perspectives.” Social Science and Medicine 16:1429–48.PubMedCrossRefGoogle Scholar
  22. Jonsen, A. R. 2005. “On the Origins and Future of the Belmont Report.” In Belmont Revisited: Ethical Principles for Research with Human Subjects, edited by J. F. Childress, E. M. Meslin, and H. T. Shapiro, 3–11. Washington, DC: Georgetown University Press.Google Scholar
  23. Jonsen, A. R., R. M. Veatch, and L. R. Walters, eds. 1998. Source Book in Bioethics. Washington, DC: Georgetown University Press.Google Scholar
  24. King, P. A. 2005. “Justice Beyond Belmont.” In Belmont Revisited: Ethical Principles for Research with Human Subjects, edited by J. F. Childress, E. M. Meslin, and H. T. Shapiro, 136–47. Washington, DC: Georgetown University Press.Google Scholar
  25. Lebacqz, K. 2005. “We Sure Are Older but Are We Wiser?.” In Belmont Revisited: Ethical Principles for Research with Human Subjects, edited by J. F. Childress, E. M. Meslin, and H. T. Shapiro, 99–110. Washington, DC: Georgetown University Press.Google Scholar
  26. Levine, R. J. 1996. “International Codes and Guidelines for Research Ethics: A Critical Appraisal.” In The Ethics of Research Involving Human Subjects: Facing the 21st Century, edited by H. Y. Vanderpool, 235–59. Frederick, MD: University Pub. Group.Google Scholar
  27. Levine, R. J. 1999. “The Need to Revise the Declaration of Helsinki.” The New England Journal of Medicine 341(7):531–34.PubMedCrossRefGoogle Scholar
  28. Levine, R. J. 2005. “The National Commission’s Ethical Principles, with Special Attention to Beneficence.” In Belmont Revisited: Ethical Principles for Research with Human Subjects, edited by J. F. Childress, E. M. Meslin, and H. T. Shapiro, 126–35. Washington, DC: Georgetown University Press.Google Scholar
  29. Pence, G. E. 2004, Classic Cases in Medical Ethics: Accounts of Cases That Have Shaped Medical Ethics, with Philosophical, Legal, and Historical Backgrounds. Boston, MA: McGraw-Hill.Google Scholar
  30. Percival, T. 1985. Medical Ethics; or a Code of Institutes and Precepts Adapted to the Professional Conduct of Physicians and Surgeons. Birmingham, AL: Division of Gryphon Editions, Ltd.Google Scholar
  31. Perley, S., S. S. Fluss, Z. Bankowski, and F. Simon. 1992. “The Nuremberg Code: An International Overview.” In The Nazi Doctors and the Nuremberg Code, edited by G. J. Annas and M. A. Grodin, 149–73. New York, NY: Oxford University Press.Google Scholar
  32. Ross, W. D. 1988. The Right and the Good. Indianapolis, IN: Hackett Pub. Co.Google Scholar
  33. Sass, H.-M. 1988. “Comparative Models and Goals for the Regulation of Human Research.” In The Use of Human Beings in Research: With Special Reference to Clinical Trials, edited by S. F. Spicker, 47–85. Dordrecht and Boston, MA: Kluwer Academic Publishers.Google Scholar
  34. Shapiro, H. T., and E. M. Meslin. 2005. “Relating to History: The Influence of the National Commission and Its Belmont Report on the National Bioethics Advisory Commission.” In Belmont Revisited: Ethical Principles for Research with Human Subjects, edited by J. F. Childress, E. M. Meslin, and H. T. Shapiro, 55–73. Washington, DC: Georgetown University Press.Google Scholar
  35. Sherwin, S. 2005. “Belmont Revisited Through a Feminist Lens.” In Belmont Revisited: Ethical Principles for Research with Human Subjects, edited by J. F. Childress, E. M. Meslin, and H. T. Shapiro, 148–64. Washington, DC: Georgetown University Press.Google Scholar
  36. Tollman, S. M. 2001. “Fair Partnerships Support Ethical Research.” British Medical Journal 323:1417–19.PubMedCrossRefGoogle Scholar
  37. Vanderpool, H. Y. 1996. “Introduction and Overview: Ethics, Historical Case Studies, and the Research Enterprise.” In The Ethics of Research Involving Human Subjects: Facing the 21st Century, edited by H. Y. Vanderpool, 1–30. Frederick, MD: University Pub. Group.Google Scholar
  38. Varmus, H., and D. Satcher. 1997. “Ethical Complexities of Conducting Research in Developing Countries.” The New England Journal of Medicine 337(14):1003–1005.PubMedCrossRefGoogle Scholar
  39. Veatch, R. 2005. “Ranking, Balancing, or Simultaneity. Resolving Conflicts Among the Belmont Principles.” In Belmont Revisited: Ethical Principles for Research with Human Subjects, edited by J. F. Childress, E. M. Meslin, and H. T. Shapiro, 184–204. Washington, DC: Georgetown University Press.Google Scholar
  40. Winslade, W. J., and T. L. Krause. 1998. “The Nuremberg Code Turns Fifty.” In Ethics Codes in Medicine: Foundations and Achievements of Codification Since 1947, edited by U. Tröhler, S. Reiter-Theil, and E. Herych, 140–62. Aldershot and Brookfield, VT: Ashgate Pub.Google Scholar
  41. “Beaumont, William”. 2008. In Encyclopaedia Britannica Ultimate Reference Suite Edition. Google Scholar
  42. “Department of Defense Request for Exemption from Informed Consent Requirements for Operation Desert Shield and Food and Drug Administration Response.” 1990. Federal Register 55:52813–17.Google Scholar
  43. European Agency for the Evaluation of Medical Products. 2001. EMEA/CPMP Position Statement on the Use of Placebo in Clinical Trials with Regard to the Revised Declaration of Helsinki [On-line] Accessed August 10, 2008. http://www.emea.europa.eu/pdfs/human/press/pos/1742401en.pdf
  44. Heller, J. 1972. “Syphilis Victims in U.S. Study Went Untreated for 40 Years.” New York Times July 26, 1, 8.Google Scholar
  45. Human, D., and S. S. Fluss. 2001. The World Medical Association's Declaration of Helsinki: Historical and Contemporary Perspectives. Fifth Draft: 24/07/01 [On-line] Accessed August 11–12, 2008. http://www.wma.net/e/ethicsunit/pdf/draft_historical_contemporary_perspectives.pdf
  46. “Medicine”. 2008. Encyclopaedia Britannica Ultimate Reference Suite Edition. Google Scholar
  47. Military Tribunal 1. 1950. “Case1. United States v. Karl Brandt et al.” In Trials of War Criminals Before the Nuremberg Tribunals under Control Council Law 10. Washington, DC: U.S. Government Printing Office.Google Scholar
  48. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report [On-line] Accessed August 11, 2008. http://ohsr.od.nih.gov/guidelines/belmont.html
  49. National Research Act. 1974. Title II, Public Law, 93–348.Google Scholar
  50. “Nürnberg Trials”. 2008. Encyclopaedia Britannica Ultimate Reference Suite Edition.Google Scholar
  51. World Medical Association. 1964. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects [On-line] Accessed August 11, 2008. http://www.wma.net/e/policy/b3.htm
  52. Pharmaceutical Research and Manufacturers of America. 2001. PhRMA Discussion Paper on the Declaration of Helsinki as Revised in October 2000. Washington, DC: Pharmaceutical Research and Manufacturers of America.Google Scholar
  53. Council for International Organizations of Medical Sciences. 1974. Protection of Human Rights in Light of Scientific and Technological Progress in Biology and Medicine. Geneva: World Health Organization.Google Scholar

Copyright information

© Springer Science+Business Media B.V. 2012

Authors and Affiliations

  1. 1.Dominican College of Philosophy and TheologyKrakówPoland

Personalised recommendations