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Incompetent Persons as Research Subjects and the Ethics of Minimal Risk

Published online by Cambridge University Press:  29 July 2009

Kathleen Cranley Glass  and
Marc Speyer-Ofenberg
Kathleen Cranley Glass
Affiliation:
Assistant Professor in the Department of Human Genetics, McGill University, Montréal and an Associate Member at the McGill Centre for Medicine, Ethics, and Law, where she collaborates with the Clinical Trials Research Group.
Marc Speyer-Ofenberg
Affiliation:
A doctoral student in the Department of Science and Technology Studies, Cornell University, Ithaca, New York, and a Research Assistant at the Centre for Medicine, Ethics, and Law, McGill University, Montréal, Canada.
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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.

Type
Special Section: Rejuvenating Research Ethics
Information
Cambridge Quarterly of Healthcare Ethics , Volume 5 , Issue 3 , Summer 1996 , pp. 362 - 372
Copyright
Copyright © Cambridge University Press 1996

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References

Notes

1. See, for example, McCormick, R. Sharing in sociality. Hastings Center Report 1970;6(6):41–6CrossRefGoogle Scholar; Ramsey, P. The Patient as Person. New Haven: Yale University Press, 1970Google Scholar; McCormick, R. Proxy consent in the experimental situation. Perspectives in Biology and Medicine 1974; 18:2–20CrossRefGoogle Scholar; Dworkin, G. Legality of consent to nontherapeutic medical research on infants and young children. Archives of Disease in Childhood 1978;53:443–55CrossRefGoogle ScholarPubMed; Gaylin, WJ, Macklin, R, Eds. Who Speaks for the Child? New York: Plenum Press, 1982Google Scholar; Redmon, RB. How children can be respected as “ends” yet still be used as subjects in non-therapeutic research. Journal of Medical Ethics 1986;12:77–82CrossRefGoogle ScholarPubMed; Holder, AR. Constraints on experimentation: protecting children to death. Yale Law & Policy Review 1988;6:137–56Google Scholar; Freedman, B, Fuks, A, Weijer, C. In loco parentis: minimal risk as an ethical threshold for research upon children. Hastings Center Report 1993;23:13–9CrossRefGoogle ScholarPubMed; Gidding, S, Camp, D, Managan, MH et al. , A policy regarding research in healthy children. Journal of Pediatrics 1993;123:852–55.CrossRefGoogle ScholarPubMed

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.Google Scholar

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

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, 1992Google Scholar; Howard-Jones, N. Human experimentation in historical and ethical perspectives. Social Science and Medicine 1982;16:1429–48.CrossRefGoogle ScholarPubMed

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.Google Scholar

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

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.Google Scholar

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.Google Scholar

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, 1977Google Scholar; 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, 1976Google Scholar; 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.Google Scholar

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

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

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

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

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, 1982Google Scholar; Drane, JF. The many faces of competency. Hastings Center Report. 1986; 15(2): 17–21CrossRefGoogle Scholar; Buchanan, AE, Brock, DW. Deciding for Others. New York: Cambridge University Press, 1989.Google Scholar

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.Google Scholar

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

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

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

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, 1991Google Scholar; see note 15. Keyserlingk, et al. 1995;32:2.Google Scholar

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

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

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):66–74.CrossRefGoogle ScholarPubMed

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

24. See note 3. NCBHR. 1992.Google Scholar

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

26. See note 16. American College of Physicians. 1989;111:843–8.Google ScholarCouncil 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, 1993Google Scholar; see note 15. Keyserlingk, et al. 1995;32:2.Google Scholar

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

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

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

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

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.Google Scholar

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

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

34. Ratzan, RM. Being old makes you different: the ethics of research with elderly subjects. Hastings Center Report 1980;10:32–46.CrossRefGoogle ScholarPubMed

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

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

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.Google Scholar

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

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

40. Gutheil, TG, Appelbaum, PS. Substituted judgment: best interests in disguise. Hastings Center Report 1983;13:8–11.CrossRefGoogle ScholarPubMed

41. See note 35. Re Eve. 1986.

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

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

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.Google Scholar

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

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

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

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

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

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

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

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.Google Scholar

54. Richard B. v. Children's Aid Society of Metropolitan Toronto, 1995, 1 S.C.R. 315–439.Google Scholar

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

56. See note 32. Kennedy, , 1989.Google Scholar

57. See note 3. National Council on Bioethics in Human Research. 1992; see note 15. Keyserlingk, et al. 1995;32:2Google Scholar; 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.Google ScholarPubMed