Adults are not big children: Examining surrogate consent to research using adults with dementia

Cambridge Quarterly of Healthcare Ethics

Volumn 11, Issue 2, 2002, Pages 160-168

  Yarborough, Mark ^a  

^a Canadian Bioethics Association in Montreal   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CHILD; COGNITIVE DEFECT; COUNSELING; CUSTODY; DECISION MAKING; DEMENTIA; ETHNOLOGY; FAMILY; GERIATRICS; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; MEDICAL RESEARCH; PEDIATRICS; PRACTICE GUIDELINE; PRIVACY; RISK; SOCIAL STRUCTURE; STANDARD;

EID: 0036524602     PISSN: 09631801     EISSN: None     Source Type: Journal    
DOI: 10.1017/S0963180102112096     Document Type: Article

References (36)

1. See McCormick RA. Proxy consent in the experimentation situation. Perspectives in Biology and Medicine 1974;18:2-20; McCormick RA. A reply to Paul Ramsey: experimentation in children: sharing in sociality. Hastings Center Report 1976;6:41-6; and Ramsey P. A reply to Richard McCormick: the enforcement of morals: nontherapeutic experimentation on children. Hastings Center Report 1976;4:21-30.
2. See McCormick RA. Proxy consent in the experimentation situation. Perspectives in Biology and Medicine 1974;18:2-20; McCormick RA. A reply to Paul Ramsey: experimentation in children: sharing in sociality. Hastings Center Report 1976;6:41-6; and Ramsey P. A reply to Richard McCormick: the enforcement of morals: nontherapeutic experimentation on children. Hastings Center Report 1976;4:21-30.
3. See McCormick RA. Proxy consent in the experimentation situation. Perspectives in Biology and Medicine 1974;18:2-20; McCormick RA. A reply to Paul Ramsey: experimentation in children: sharing in sociality. Hastings Center Report 1976;6:41-6; and Ramsey P. A reply to Richard McCormick: the enforcement of morals: nontherapeutic experimentation on children. Hastings Center Report 1976;4:21-30.
4. Protection of Human Subjects. Title 45, Code of Federal Regulations Part 46, Revised June 18, 1991.
5. The most recent of these are the recommendations put forth by the National Bioethics Advisory Commission (NBAC). National Bioethics Advisory Commission. Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity. Rockville Md.: National Bioethics Advisory Commission, 1998.
6. See note 2, Protection of Human Subjects 1991:46.404.
7. See, for instance, note 3, NBAC 1998:29-33; National Institutes of Health. Consent process in research involving impaired human subjects. Clinical Center Policy and Communications Bulletin 1987;87:4, cited in NBAC report, footnote 141, p. 30; and American College of Physicians. Cognitively impaired subjects. Annals of Internal Medicine 1989;111:843-8.
8. See, for instance, note 3, NBAC 1998:29-33; National Institutes of Health. Consent process in research involving impaired human subjects. Clinical Center Policy and Communications Bulletin 1987;87:4, cited in NBAC report, footnote 141, p. 30; and American College of Physicians. Cognitively impaired subjects. Annals of Internal Medicine 1989;111:843-8.
9. See, for instance, note 3, NBAC 1998:29-33; National Institutes of Health. Consent process in research involving impaired human subjects. Clinical Center Policy and Communications Bulletin 1987;87:4, cited in NBAC report, footnote 141, p. 30; and American College of Physicians. Cognitively impaired subjects. Annals of Internal Medicine 1989;111:843-8.
10. For example, see Wolf SM, Boyle P, Callahan D, Fins JJ, Jennings B, Nelson JL. Sources of concern about the Patient Self-Determination Act. New England Journal of Medicine 1991;325:1666-71; Dresser R. Mentally disabled research subjects: the enduring policy issues. JAMA 1996;276:67-72; and The SUPPORT Principal Investigators. A controlled trial to improve care for seriously ill hospitalized patients. JAMA 1995;274:1591-8.
11. For example, see Wolf SM, Boyle P, Callahan D, Fins JJ, Jennings B, Nelson JL. Sources of concern about the Patient Self-Determination Act. New England Journal of Medicine 1991;325:1666-71; Dresser R. Mentally disabled research subjects: the enduring policy issues. JAMA 1996;276:67-72; and The SUPPORT Principal Investigators. A controlled trial to improve care for seriously ill hospitalized patients. JAMA 1995;274:1591-8.
12. For example, see Wolf SM, Boyle P, Callahan D, Fins JJ, Jennings B, Nelson JL. Sources of concern about the Patient Self-Determination Act. New England Journal of Medicine 1991;325:1666-71; Dresser R. Mentally disabled research subjects: the enduring policy issues. JAMA 1996;276:67-72; and The SUPPORT Principal Investigators. A controlled trial to improve care for seriously ill hospitalized patients. JAMA 1995;274:1591-8.
13. Dresser R. Life, death, and incompetent patients: conceptual infirmities and hidden values in the law. Arizona Law Review 1986;28:373-405.
14. The following account of the three types of surrogate consent follows the account of Meisel A. The Right to Die, Vol. 1, 2nd ed. New York: Wiley, 1995:343-52.
15. See Wicclair MR. Ethics and the Elderly. London/New York: Oxford University Press, 1993:160-200; see also note 5, American College of Physicians 1989 and National Institutes of Health 1987; and note 3, NBAC 1998.
16. See Wicclair MR. Ethics and the Elderly. London/New York: Oxford University Press, 1993:160-200; see also note 5, American College of Physicians 1989 and National Institutes of Health 1987; and note 3, NBAC 1998.
17. See Wicclair MR. Ethics and the Elderly. London/New York: Oxford University Press, 1993:160-200; see also note 5, American College of Physicians 1989 and National Institutes of Health 1987; and note 3, NBAC 1998.
18. See note 8, Meisel 1995, as well as Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 4th ed. London/New York: Oxford University Press, 1994:170-8.
19. See note 8, Meisel 1995:349-51.
20. Marsh FH. Refusal of treatment. Clinics in Geriatric Medicine 1986;2:511-20.
21. For references to numerous studies that address the quality of surrogate decisions, see: Sulmasy DP, Terry PB, Weisman CS, Miller DJ, Stallings RY, Vettese MA. The accuracy of substituted judgments in patients with terminal diagnoses. Annals of Internal Medicine 1998;128:621-9.
22. Warren JW, Sobal J, Tenney JH, et al. Informed consent by proxy: an issue in research with elderly patients. New England Journal of Medicine 1986;315:1124-8.
23. Candilis PJ, Wesley RW, Wichman A. A survey of researchers using a consent policy for cognitively impaired human research subjects. IRB: A Review of Human Subjects Research 1993; 15(6):1-4.
24. Berg JW. Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines. Journal of Law, Medicine, and Ethics 1996;24:18-35.
25. See note 16, Berg 1996:23.
26. See note 16, Berg 1996:26.
27. See note 10, Beauchamp, Childress 1994:178.
28. See note 12, Marsh 1986:519.
29. See note 9, Wicclair 1993:185.
30. Glass KC, Speyer-Ofenberg M. Incompetent persons as research subjects and the ethics of minimal risk. Cambridge Quarterly of Healthcare Ethics 1996;5:362-72.
31. See note 22, Glass, Speyer-Ofenberg 1996:368-9.
32. See note 22, Glass, Speyer-Ofenberg 1996:369.
33. Kant I. Foundations of the metaphysics of morals. In: Melden AI, ed. Ethical Theories: A Book of Readings, 2nd ed. Englewood Cliffs, N.J.: Prentice-Hall, 1967:345. I acknowledge that using Kant's notion of treating people as ends in themselves can be viewed as problematic given that Kant argued that we are worthy of such respect because we have the capacity to act out of good will rather than inclination. Such action presupposes the presence of a rational self, and neither young children nor adults with dementia fit this category. Without entering a debate about the nature of personhood, I think the use I make of Kant is warranted due to the fact that IRBs have the obligation to ensure that all research subjects are treated with respect, and, as I hope to show, you cannot treat adults with dementia with respect if you do not acknowledge salient features of who they were while they possessed full decisional capacity.
34. MacIntyre A. After Virtue, 2nd ed. Notre Dame, Ind.: University of Notre Dame Press, 1984:206-7.
35. Blustein J. Choosing for others as continuing a life story: the problem of personal identity revisited. Journal of Law, Medicine, and Ethics 1999;27:20-31; and Yarborough M. Constructed judgment and elderly adults: the role of respect in surrogate decisionmaking in the research setting. Under review.
36. Blustein J. Choosing for others as continuing a life story: the problem of personal identity revisited. Journal of Law, Medicine, and Ethics 1999;27:20-31; and Yarborough M. Constructed judgment and elderly adults: the role of respect in surrogate decisionmaking in the research setting. Under review.