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Incompetent Persons as Research Subjects and the Ethics of Minimal Risk

  • Kathleen Cranley Glass (a1) and Marc Speyer-Ofenberg (a2)
Extract

The voluntary and informed consent of subjects has been the central focus of concern in research reviews, overshadowing the importance of all other considerations. The Nuremberg Code, with its rights-based protection of the subject's autonomy above all else, made it difficult to justify research with no intended benefit when subjects are incompetent to make a valid informed choice to participate. Subsequent codes providing for research with incompetent subjects followed the lead of Nuremberg, substituting the informed authorization of a proxy for the informed consent of the subject.

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Notes

1. See, for example, McCormick, R. Sharing in sociality. Hastings Center Report 1970;6(6):41–6; Ramsey, P. The Patient as Person. New Haven: Yale University Press, 1970; McCormick, R. Proxy consent in the experimental situation. Perspectives in Biology and Medicine 1974; 18:220; Dworkin, G. Legality of consent to nontherapeutic medical research on infants and young children. Archives of Disease in Childhood 1978;53:443–55; Gaylin, WJ, Macklin, R, Eds. Who Speaks for the Child? New York: Plenum Press, 1982; Redmon, RB. How children can be respected as “ends” yet still be used as subjects in non-therapeutic research. Journal of Medical Ethics 1986;12:7782; Holder, AR. Constraints on experimentation: protecting children to death. Yale Law & Policy Review 1988;6:137–56; Freedman, B, Fuks, A, Weijer, C. In loco parentis: minimal risk as an ethical threshold for research upon children. Hastings Center Report 1993;23:13–9; Gidding, S, Camp, D, Managan, MH et al. , A policy regarding research in healthy children. Journal of Pediatrics 1993;123:852–55.

2. US Department of Health and Human Services. Protection of human subjects. 45 CFR 46; Civil Code of Quebec, L.Q. 1991, C. 64, Articles 20–2.

3. National Council on Bioethics in Human Research (NCBHK). Report on Research with Children. Ottawa: NCBHR, 1992.

4. Grodin, MA. Historical origins of the Nuremberg Code. In: Annas, GJ, Grodin, MA, Eds. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press, 1992; Howard-Jones, N. Human experimentation in historical and ethical perspectives. Social Science and Medicine 1982;16:1429–48.

5. The Nuremberg Code as found in United States v. Karl Brandt, Trials of War Criminals Before the Nuremberg Military Tribunals. Vols I, II. The Medical Case. Washington, DC: US Government Printing Office, 1948.

6. Annas, GJ, Glanz, LH, Katz, BH. Informed Consent to Human Experimentation: The Subject's Dilemma. Cambridge, Massachusetts: Ballinger, 1977.

7. 18th World Medical Assembly. Declaration of Helsinki. Helsinki, 1984; Revised, 29th World Medical Assembly. Tokyo, 1975; Revised, 41st World Medical Assembly. Hong Kong, 1989. Sec II.3.

8. 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, DC: US Government Printing Office, 1978.

9. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Research Involving Children. Washington, DC: US Government Printing Office, 1977; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Research Involving Prisoners. Washington, DC: US Government Printing Office, 1976; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Research Involving Those Institutionalized as Mentally Infirm. Washington, DC: US Government Printing Office, 1978.

10. Code of Federal Regulations, 45 CFR 46.401–9.

11. Code of Federal Regulations, 5 CFR 46.303(d).

12. Code of Federal Regulations, 45 CFR 46.406(a)-(b).

13. Melnick, V, Dubler, NN, Eds. Alzheimer s uementia: Dilemmas in Clinical Research. Clifton, New Jersey: Humana Press, 1985.

14. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions. Washington, DC: US Government Printing Office, 1982; Drane, JF. The many faces of competency. Hastings Center Report. 1986; 15(2): 1721; Buchanan, AE, Brock, DW. Deciding for Others. New York: Cambridge University Press, 1989.

15. Keyserlingk, EW, Glass, KC, Kogan, S, Gauthier, S. Proposed guidelines for the participation of persons with dementia as research subjects. Perspectives in Biology and Medicine 1995;32:2.

16. American College of Physicians. Cognitively impaired subjects. Annals of Internal Medicine 1989;111:843–8.

17. See note 15. Keyserlingk, et al. 1995;32:2.

18. See note 15. Keyserlingk, et al. 1995;32:2; see note 13. Melnick, Dubler. 1985; see note 3. National Council on Bioethics in Human Research, 1992.

19. Dickens, BM. Substitute consent to participation of persons with Alzheimer's disease in medical research: legal issues. In: Berg, JM, Karlinsky, H, Lowey, FH, Eds. Alzheimer's Disease Research: Ethical and Legal Issues. Toronto: Carswell, 1991; see note 15. Keyserlingk, et al. 1995;32:2.

20. See note 13. Melnick, Dubler. 1985; see note 14. 1982; 1986; 1989.

21. See note 13. Melnick, Dubler. 1985.

22. High, DM, Whitehouse, PJ, Post, SG, Berg, L. Guidelines for addressing ethical and legal issues in Alzheimer's disease research: a position paper. Alzheimer Disease and Associated Disorders 1994;8(Supp 4):6674.

23. Frank, S, Agich, GJ. Nontherapeutic research on subjects unable to grant consent. Clinical Research 1985;33:459–64.

24. See note 3. NCBHR. 1992.

25. Marston, R. Medical science, clinical trial, and society. In: Beauchamp, T, Walters, L, Eds. Contemporary Issues in Bioethics. Encino: Dickenson, 1978; Holder, A. Constraints on experimentation: protecting children to death. Yale Law & Policy Review 1988;6:137–45; See note 1. Redmon.

26. See note 16. American College of Physicians. 1989;111:843–8.Council for International Organizations of Medical Sciences (CIOMS). International guidelines for biomedical research involving human subjects (1992). In: BankowskiZ, , Levine, RJ, Eds. Ethics and Research on Human Subjects. Geneva: CIOMS, 1993; see note 15. Keyserlingk, et al. 1995;32:2.

27. For example, see note 13. Melnick, Dubler. 1985; 45 CFR 46.407.

28. See note 1. Freedman, et al. 1993;23:13–9.

29. See note 1. Freedman, et al. 1993;23:13–9.

30. See note 1. McCormick, . 1970;6(6):41–6.

31. Burgio, GR, Nespoli, L, Locatelli, F. Bone marrow transplantation in children: between “primum non nocere” (above all, do no harm) and “primum adiuvare” (above all, help). In: Burgio, GR, Lantos, ID, Eds. Primum Non Nocere Today. Amsterdam: Elsevier Science, 1994.

32. Kennedy, I, Grubb, A. Medical Law: Text and Materials. London: Butterworths, 1989.

33. See note 32. Kennedy, Grubb. 1989.

34. Ratzan, RM. Being old makes you different: the ethics of research with elderly subjects. Hastings Center Report 1980;10:3246.

35. Theobald, HS. Law Relating to Lunacy. London: Stevens and Sons Limited, 1924; Re Eve, 1986, 31 D.L.R. (4th) 1; see note 6. Annas, et al. 1977.

36. See note 19. Dickens, . 1991; see note 15. Keyserlingk, et al. 1995;32:2.

37. Re McLaughlin [1909] A.C. 343 at 347; Glass, KC. Elderly Persons and Decision-Making in a Medical Context: Challenging Law to Respond [Dissertation]. Montreal: McGill University Faculty of Law, 1992.

38. See note 6. Annas et al. 1977.

39. See note 1. Gaylin, Macklin, Eds. 1982.

40. Gutheil, TG, Appelbaum, PS. Substituted judgment: best interests in disguise. Hastings Center Report 1983;13:811.

41. See note 35. Re Eve. 1986.

42. Code of Federal Regulations, 45 CFR 46.401–9.

43. See note 1. Gaylin, Macklin, Eds. 1982.

44. See note 35. Re Eve. 1986.

45. Re S.D.; Supt. of Family and Child Services v. R.D.; Russell v. Supt. of Family and Child Services, 1983, 34 R.F.L. (2d) 34.

46. Re Goyette: Centre de Services Sociaux du Montreal Metropolitan, 1983, C.S. 429.

47. Strunk v. Strunk, 445 S.W. (2d) 145, 1969.

48. Medical Research Council of Canada. Guidelines on Research Involving Human Subjects. Ottawa: Minister of Supply & Services, 1987.

49. S. v. S., 1970, 3 All E.R. 107 at 113.

50. See note 1. Freedman, et al. 1993;23:13–9.

51. R. v. Morgentaler, 1988, 1 S.C.R. 30; Bernard, C, Knoppers, BM. Legal aspects of research involving children in Canada. In: Knoppers, B, Ed. Canadian Child Health Law. Toronto: Thompson, Inc., 1992.

52. Re Tand Catholic Children's Aid Society of Metropolitan Toronto, 1984. 46 O.R. (2d) 347; Bala, N, Redfearn, JD. Family law and the “liberty interest”: section 7 of the Canadian Charter of Rights. Ottawa Law Review 1983; 15:243.

53. Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982, Schedule B of the Canada Act 1982 (U.K.), 1982, c.ll.

54. Richard B. v. Children's Aid Society of Metropolitan Toronto, 1995, 1 S.C.R. 315439.

55. Youth Protection Act. R.S.Q. c. P–34. 1 s. 4, 1989.

56. See note 32. Kennedy, , 1989.

57. See note 3. National Council on Bioethics in Human Research. 1992; see note 15. Keyserlingk, et al. 1995;32:2; Weijer, C, Shapiro, S, Fuks, A, Glass, KC, Skrutkowska, M. Monitoring clinical research: an obligation unfulfilled. Canadian Medical Association Journal 1995; 152(12): 1973–80.

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  • EISSN: 1469-2147
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