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Review of Legal Instruments and Codes on Medical Experimentation with Children

Published online by Cambridge University Press:  29 July 2009

Sujit Choudhry
Sujit Choudhry
Affiliation:
Associate Member of the Centre for Bioethics, University of Toronto, where he is also a student in the Faculty of Law.
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Extract

Medical research with children has been the subject of ongoing debate. The reason for controversy is clear. As with research on adults, one must strike a balance between two goals – promoting the health of children through advances in scientific knowledge and protecting child research subjects from exploitation and harm. However, because of their age and relative immaturity, children cannot protect their own interests as well as adult subjects can. Yet as they progress toward adulthood, increasing care must be taken to involve children in decisions that affect them, even to the extent of allowing them to make choices that may have serious and long-term consequences.

Type
Special Section: Research Ethics: Ethics at the Borders of Medical Research
Information
Cambridge Quarterly of Healthcare Ethics , Volume 3 , Issue 4 , Fall 1994 , pp. 560 - 573
Copyright
Copyright © Cambridge University Press 1994

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References

Notes

1. See generally Grodin, MA, Glantz, L, eds. Children as Research Subjects: Science, Ethics, and Law. New York: Oxford University Press. 1994.Google ScholarNicholson, RH, ed. Medical Research with Children: Ethics, Law, and Practice. New York: Oxford University Press. 1986.Google ScholarKoren, G, ed. Textbook of Ethics in Pediatric Research. Malabar, Florida: Kreiger Publishing. 1993.Google Scholar

2. This study is based on source materials available in the Health Legislation Unit, WHO. Although codes and laws from a variety of jurisdictions and national organizations and those promulgated by many international bodies have been examined, this paper does not purport to be a comprehensive review of all laws and codes governing medical experimentation with children.

3. Tunisia, . Decree No. 90–1401 of 3 September 1990 on Medical/Scientific Experimentation on Drugs for Human Use. 1990:Section 2. Reprinted in International Digest of Health Legislation 1991;42:489.Google Scholar

4. British Paediatric Association. Guidelines for the Ethical Conduct of Medical Research Involving Children. 1992:3.Google Scholar

5. American Medical Association. Current Opinions of the Council of Ethical and Judicial Affairs on Clinical Investigation. 1992:5.Google Scholar

6. See, e.g., Medical Research Council of Canada. Guidelines on Research Involving Human Subjects. 1987:28.Google ScholarMedical Research Council (UK). The Ethical Conduct of Research on Children. 1991:13.Google ScholarDepartment of Health (UK). Local Research Ethics Committees. 1991:16.Google ScholarRoyal College of Psychiatrists (UK). Guidelines for Research Ethics Committees on Psychiatric Research Involving Human Subjects. 1990:4.Google ScholarCouncil for International Organizations of Medical Sciences [CIOMS]. International Ethical Guidelines for Biomedical Research Involving Human Subjects. 1993:20.Google ScholarAustralian Health and Medical Research Council. Statement on Human Experimentation and Supplementary Notes. 1987:7.Google Scholar

7. Hungary, . Ordinance No. 11 of 19 August 1987 of the Minister of Health on Biomedical Research. 1987: Section 7(3). Reprinted in International Digest of Health Legislation 1988;39:97–8.Google Scholar

8. National Council on Bioethics in Human Research [NCBHR] (Canada). Report on Research Involving Children. 1992:7.Google Scholar

9. U. S. v. Karl Brandt et al. Trials of War Criminals before the Nuremberg Military Tribunals Under Control Council Law No. 10. Vol. I, Vol. II: 181–5, principle 2. 1949.Google Scholar

10. See note 4. British Paediatric Association. 1992:6.Google Scholar See note 6. CIOMS, . 1993:20.Google Scholar

11. See note 5. American Medical Association. 1989:5.Google Scholar

12. Commission of the European Communities. Good Clinical Practice for Trials on Medicinal Products in the European Community. 1990:16.Google Scholar

13. European Parliament. Resolution on a European Charter of Rights of the Child. 1992:Paragraph 8.30. 1992Google Scholar. Reprinted in International Digest of Health Legislation 1993; 44:139.Google Scholar See also note 7. Hungary, . 1988;7(1)Google Scholar. World Psychiatric Association. Declaration of Hawaii II. 1983:Art. 10.Google Scholar

14. See note 8. NCBHR (Canada). 1992:11.Google Scholar

15. United States. 45 Code of Federal Regulations [CFR]. Part 46, sec. 408(a). 1991.Google Scholar

16. Council of Europe. Preliminary Draft Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Bioethics Convention. 1993: Article 6. 6 July 1993.Google Scholar

17. World Medical Association. Declaration of Helsinki. IV 1989: principle 11.Google Scholar See note 6. CIOMS. 1993:20.Google Scholar See note 6. Australian Health and Medical Research Council. 1987:8.Google ScholarCouncil of Europe. Recommendation No. R (90) 3 of the Committee of Ministers to Member States Concerning Medical Research on Human Beings. 1990: Principle 4Google Scholar. Reprinted in International Digest of Health Legislation 1990;41:461, 463.Google Scholar

18. See note 8. NCBHR (Canada). 1992:3.Google Scholar

19. France, . Law No. 88–1138 of 20 December 1988 on the Protection of Persons Participating in Biomedical Research. 1988:Article 209–10.Google ScholarReprinted in International Digest of Health Legislation 1989;40:111–112.Google Scholar

20. See note 15. United States. 1991:sec. 408.Google Scholar

21. See note 17. World Medical Association. 1989:principle 11.Google Scholar

22. See note 15. United States. 1991:sec. 408.Google Scholar

23. See note 15. United States. 1991:sec. 408.Google Scholar

24. See note 6. CIOMS. 1993:20.Google Scholar

25. See note 15. United States. 1991:sec. 408(a), 116(d).Google Scholar

26. See note 6. Medical Research Council of Canada. 1987:29.Google Scholar

27. See note 6. Royal College of Psychiatrists (UK). 1990:4.Google Scholar

28. See note 6. Medical Research Council (UK). 1991:13.Google Scholar

29. See note 19. France. 1990.Google Scholar

30. See note 6. CIOMS. 1993:20–1.Google Scholar

31. See note 6. Medical Research Council (UK). 1991:13–6.Google Scholar

32. Royal College of Physicians (UK). Research Involving Patients. 1990:20.Google Scholar

33. See note 6. Department of Health (UK). 1991:16.Google ScholarBritish Medical Association. Medical Ethics Today: Its Practice and Philosophy. Plymouth: Latimer Trend & Co., 1993:92.Google Scholar

34. See note 4. British Paediatric Association. 1992:12.Google Scholar

35. [1992] 3 W.L.R. 758 (CA). Noted in Medical Law Review 1993;87:1.Google Scholar

36. See note 3. Tunisia, . 1991;42:489.Google Scholar

37. See note 15. United States. 1991:sec. 111.Google Scholar

38. See note 17. World Medical Association. 1989:principle 5.Google Scholar

39. Levine, RJ. Ethics and Regulation of Clinical Research. 2nd ed.Baltimore-Munich: Urban & Schwarzenburg, 1986:38.Google Scholar

40. See, e.g., note 6. CIOMS. 1993;21.Google Scholar

41. See note 15. United States. 1991:sec. 405.Google Scholar

42. See note 4. British Paediatric Association. 1992:5.Google Scholar

43. See note 8. NCBHR (Canada). 1992:27–8.Google Scholar

44. See note 6. CIOMS. 1993:21.Google Scholar See also note 6. Australian Health and Medical Research Council. 1987:8.Google Scholar

45. See note 6. Medical Research Council (UK). 1991:14.Google Scholar

46. See note 17. Council of Europe. 1990:principle 5.Google Scholar

47. See note 8. NCBHR (Canada). 1992:36.Google Scholar

48. See note 3. Tunisia, . 1991;42:489.Google Scholar

49. See note 33. British Medical Association. 1993:94.Google Scholar

50. Prussian Minister of Religious, Educational and Medical Affairs. Directive of 29 December 1900. Complete text in Grodin, M. Historical Origins of the Nuremberg Code. In: Annas, GJ, Grodin, M, eds. The Nazi Doctors and the Nuremberg Code. New York: Oxford University Press, 1992:121, 127.Google Scholar Translation from German prepared by Health Legislation Unit, WHO.

51. See note 9. U.S. v. Karl Brandt et al. 1949:principle 1.Google Scholar

52. International Covenant on Civil and Political Rights. 999 U.N.T.S. 107, Article 7, 1976.Google Scholar

53. Perley, S, Fluss, SS, Bankowski, Z, Simon, F. The Nuremberg Code: an international overview. In: Annas, GJ, Grodin, MA, eds. The Nazi Doctors and the Nuremberg Code. 1992:153.Google Scholar

54. Pakistan. Drugs Research Rules. 1978.Google Scholar Rule 7. Reprinted in Janjua, Z., ed. The Manual of Drug Laws and Rules Framed Thereunder. Lahore: Lahore Times Publications, 1987:94.Google Scholar

55. See note 6. Department of Health (UK). 1991:16.Google Scholar See note 6. Australian Health and Medical Research Council. 1987:8.Google ScholarCouncil of Europe. 1990: principles 2, 5Google Scholar (for this interpretation, see Council of Europe. Explanatory Memorandum, p. 7Google Scholar). See note 16. Council of Europe. 1993:article 6.Google Scholar See note 15. United States. 1991:sec. 404.Google Scholar See note 32. Royal College of Physicians (UK). 1990:19.Google Scholar See note 4. British Paediatric Association. 1992:9.Google Scholar See note 33. British Medical Association. 1993:93.Google Scholar

56. For a philosophical discussion of minimal risk, see Freedman, B, Fuks, A, Weijer, C. In loco parentis: minimal risk as an ethical threshold for research upon children. Hastings Center Report 1993;2:23:13.Google Scholar

57. See note 6. Medical Research Council (UK). 1991:14.Google Scholar

58. See note 6. CIOMS. 1993:20.Google Scholar

59. Law Reform Commission of Canada. Biomedical Experimentation Involving Human Subjects. 1989:42.Google Scholar

60. See note 6. Department of Health (UK). 1991:16.Google Scholar

61. See note 6. Medical Research Council of Canada. 1987:29.Google Scholar See also note 6. Australian Health and Medical Research Council. 1987:8.Google Scholar

62. See note 6. CIOMS. 1993:21.Google Scholar

63. See note 6. Medical Research Council (UK). 1991:14.Google Scholar See note 15. United States. 1991:sec. 102(i).Google Scholar

64. See note 6. Medical Research Council (UK). 1991:15.Google Scholar

65. See note 4. British Paediatric Association. 1992:9.Google Scholar

66. See note 6. CIOMS. 1993:21.Google Scholar

67. See note 17. Council of Europe. 1990:principle 2.Google Scholar

68. See note 15. United States. 1991:sec. 406.Google Scholar

69. See note 8. NCBHR. 1991:36.Google Scholar

70. See note 6. Medical Research Council of Canada. 1987:29.Google Scholar

71. See note 8. NCBHR (Canada). 1992:11.Google Scholar

72. See note 8. NCBHR (Canada). 1992:29–31.Google Scholar

73. British Paediatric Association. Commentary on the Guidelines for the Ethical Conduct of Medical Research Involving Children. 10 December 1992.Google Scholar

74. See note 60. Law Reform Commission of Canada. 1989:42.Google Scholar

75. See note 1. Nicholson, . 1986:163–4.Google Scholar

76. See note 1. Nicholson, . 1986:164.Google Scholar

77. See note 4. British Paediatric Association. 1992:11.Google Scholar

78. Royal College of Physicians (UK). Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects. 1990:2.Google Scholar

79. See note 15. United States. 1991:sec. 107(a).Google Scholar

80. See note 8. NCBHR (Canada). 1992:53.Google Scholar