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Surrogate Decision Making for Severely Cognitively Impaired Research Subjects: The Continuing Debate

Published online by Cambridge University Press:  29 July 2009

Evan DeRenzo
Evan DeRenzo
Affiliation:
Bioethics Officer at the National Institutes of Health Clinical Center, Bethesda, Maryland
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Extract

As research into Alzheimer's disease and other dementing disorders becomes more complex, risky, invasive, and commonplace, the need intensifies for discussion of the ethics of involving persons with dementia in research, specifically research of greater than minimal risk and of no expected direct benefit to the subject. (It is beyond the scope of this paper to consider the ethical issues related to research involvement of cognitively impaired children or children or adults with intermittent and/or reversible cognitive or psychiatric impairments. For such discussions, refer to the references in notes 1–6.) Reviewing such studies pushes our traditional analysis tools to their limits. Simply balancing and prioritizing the basic ethical principles of respect for persons, beneficence, and justice that serves us well in reviewing the vast majority of studies is inadequate when reviewing research of such ethical complexities as studies with marked risks and no expectation of direct benefit to subjects unable to consent or withdraw. Moving up to the level of theory, placing these principles within the commonly applied frameworks of consequentialism, deontology, or virtue ethics bring us no closer to reducing the tensions such research creates between upholding individual autonomy and advancing society's need to learn how to treat and cure these devastating diseases. What is needed is the introduction of more contemporary moral analyses. Specifically, we need to become more inclusive of the diversity of values perspectives of our general citizenry. In more theoretical terms, we ought to elevate to a more central role a communitarian perspective and a feminist ethics emphasis on relationships and context as we rush to keep in step, ethically, with this rapidly expanding area of medical inquiry.

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. 539 - 548
Copyright
Copyright © Cambridge University Press 1994

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References

Notes

1. Koren, G, ed. Textbook of Ethics in Pediatric Research. Malabar, Florida: Krieger, 1993.Google Scholar

2. Stanley, B, Sieber, JE, eds. Social Research on Children and Adolescents: Ethical Issues. Newbury Park, California: Sage, 1992.Google Scholar

3. Levine, RJ. Deferred consent. Controlled Clinical Trials 1991; 12: 546–50.CrossRefGoogle ScholarPubMed

4. Spivey, WH, Abramson, NS, Iserson, KV, MacKay, CR, Cohen, MP. Informed consent for biomedical research in acute care medicine. Annals of Emergency Medicine 1991; 20: 1251–65.CrossRefGoogle ScholarPubMed

5. Fulford, KWM, Howse, K. Ethics of research with psychiatric patients: principles, problems and the primary responsibilities of researchers. Journal of Medical Ethics 1993; 19: 85–91.CrossRefGoogle ScholarPubMed

6. DeRenzo, EG. It is time to reopen the discussion on the ethics of involving psychiatrically impaired persons in biomedical research. IRB: A Review of Human Subjects Research. In press.Google Scholar

7. Beecher, HK. Ethics and clinical research. New England Journal of Medicine 1966; 274: 1354–60.CrossRefGoogle ScholarPubMed

8. Tuskegee Syphilis Study Ad Hoc Advisory Panel. Final Report. Washington, D.C.: U.S. Department of Health, Education, and Welfare, Public Health Service, 1973.Google Scholar

9. Katz, J. Ethics and clinical research: revisited. Hastings Center Report 1993; 23(5): 31–9.CrossRefGoogle ScholarPubMed

10. Daly, CB. MIT president “sorry” for radioactive tests. The Washington Post 1994 01. 8: A2.Google Scholar

11. Frank, JA. Radioactive days: B-movies and human guinea pigs: didn't we always sense the creepy truth about the ‘50’s? The Washington Post 1994 01. 9: C1, C5.Google Scholar

12. See note 9. Katz, . 1993; 23(5): 31–9.Google Scholar

13. Katz, J. The consent principle of the Nuremberg Code: its significance then and now. In: Annas, GJ, Grodin, MA, eds. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press, 1992: 227–39.Google Scholar

14. Levine, RJ. Ethics and Regulation of Clinical Research. Baltimore, Maryland: Urban & Schwarzenberg, 1986.Google Scholar

15. High, D. Research with Alzheimer's Disease subjects: informed consent and proxy decision making. Journal of the American Geriatrics Society 1992; 40: 950–7.CrossRefGoogle ScholarPubMed

16. Melnick, VL, Dubler, NN, Weisbard, A, Butler, R. Clinical research in senile dementia of the Alzheimer type. Journal of the American Geriatrics Society 1984; 32: 531–6.CrossRefGoogle ScholarPubMed

17. Fletcher, JC, Dommel, FW, Cowell, DD. Consent to research with impaired human subjects. IRB: A Review of Human Subjects Research 1985; 7: 1–6.CrossRefGoogle ScholarPubMed

18. Fletcher, JC, Wichman, A. A new consent policy for research with impaired human subjects. Psychopharmacology Bulletin 1987; 23(3): 382–5.Google ScholarPubMed

19. See note 16. Melnick, et al. 1984;32: 531–6.Google Scholar

20. See note 17. Fletcher, et al. 1985;7: 1–6.Google Scholar

21. See note 18. Fletcher, , Wichman, . 1987; 23 (3): 382–5.Google Scholar

22. DC Code Ann, Section 21–2047 (C). (1993).

23. DC Code Ann, Section 21–2211 (1993).

24. Neb. Rev. Stat. Section 31–3420 (S) (1992).

25. OR. Laws 767, Section 8, 1993.

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

27. See note 14. Levine, . 1986.Google Scholar

28. See note 17. Fletcher, et al. 1985;7: 1–6Google Scholar. See note 18. Fletcher, , Wichman, . 1987; 23 (3): 382–5.Google Scholar

29. Melnick, VL, Dubler, NN. Alzheimer's Dementia: Dilemmas in Clinical Research. Totowa, NJ: Humana, 1985.CrossRefGoogle Scholar

30. Trent, B. Alzheimer's research: physicians begin to tread in an ethical minefield. Canadian Medical Association Journal 1989; 140: 726–8.Google Scholar

31. Helmchen, H. The problem of informed consent in dementia research. Medicine and Law 1990; 9: 1206–13.Google ScholarPubMed

32. Lane, LW, Cassel, CK, Bennett, W. Ethical aspects of research involving elderly subjects: are we doing more than we say? Journal of Clinical Ethics 1990; 1: 278–85.Google ScholarPubMed

33. Brazier, M, Lobjoit, M. Protecting the Vulnerable: Autonomy and Consent in Health Care. New York: Routledge, 1991.Google Scholar

34. Ackerman, TF. Balancing moral principles in federal regulations on human research. IKB: A Review of Human Subjects Research 1992; 14(1): 1–6.Google ScholarPubMed

35. Jecker, NS. Aging & Ethics. New Jersey: Humana, 1992.CrossRefGoogle Scholar

36. Wicclair, MR. Ethics and the Elderly. New York: Oxford University Press, 1993.Google Scholar

37. U.S. Congress, Office of Technology Assessment. Biomedical Ethics in U.S. Public Policy: Background Paper. Washington, D.C.: U.S. Government Printing Office, 1993.Google Scholar

38. See note 16. Melnick, et al. 1984; 32:531–6.Google Scholar

39. See note 26. American College of Physicians. 1989; 111: 843–8.Google Scholar

40. See note 9. Katz, . 1993; 23 (5): 31–9.Google Scholar

41. See note 8. Tuskegee Syphilis Study Ad Hoc Advisory Panel. 1973.Google Scholar

42. High, D. Advancing research with Alzheimer disease subjects: investigators' perceptions and ethical issues. Alzheimer Disease and Associated Disorders 1993; 7(3): 165–78.CrossRefGoogle ScholarPubMed

43. Capron, AM. It's Time for a New President's Commission. Statement of Alexander Morgan Capron, Henry, W. Bruce University Professor of Law and Medicine, Co-Director, Pacific Center for Health Policy and Ethics, University of Southern California, Los Angeles, for the Hearing on “Biomedical Ethics and U.S. Public Policy” before the Committees on Labor and Human Resources, United States Senate, 14 10 1993.Google Scholar

44. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. OPRR Reports. Washington, D.C.: U.S. Government Printing Office, 1979.Google Scholar

45. Emanuel, EJ. The Ends of Human Life: Medical Ethics in a Liberal Polity. Cambridge, Massachusetts: Harvard University Press, 1991Google Scholar. Gilligan, C. In a Different Voice. Cambridge, Massachusetts: Harvard University Press, 1982Google Scholar. Cortese, A. Ethnic Ethics. Albany: State University of New York Press, 1990Google Scholar. Secundy, M. Trials, Tribulations and Celebrations: African-American Perspectives on Health, Illness, Aging and Loss. Yarmouth, Maine: Intercultural Press, 1992.Google Scholar