The reform of adult guardianship laws: The case of non-therapeutic experimentation

International Journal of Law and Psychiatry

Volumn 20, Issue 1, 1997, Pages 113-139

  Tomossy, George F ^a   Weisstub, David N ^a  

^a UNIVERSITÉ DE MONTRÉAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

COGNITIVE DEFECT; DECISION MAKING; INFORMED CONSENT; LAW; MEDICAL RESEARCH; REVIEW;

EID: 0030903986     PISSN: 01602527     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0160-2527(96)00026-X     Document Type: Article

References (138)

1. Enqiury on Research Ethics: Final Report (Chairman: David N. Weisstub, Submitted to the Hon. Jim Wilson, Minister of Health of Ontario, Aug. 28, 1995). [hereinafter Enquiry on Research Ethics]
2. Enqiury on Research Ethics: Final Report (Chairman: David N. Weisstub, Submitted to the Hon. Jim Wilson, Minister of Health of Ontario, Aug. 28, 1995). [hereinafter Enquiry on Research Ethics]
3. The presence or absence of a benefit to the subject forms the core of this categorization and should be assessed on the basis of "immediacy of application" as substantiated by acceptable scientific data. A high standard should be applied, with "possible," "hypothetical" or "speculative" therapeutic results being deemed insufficient to assign a therapeutic label; rather, the proffered benefit should be "likely," "probable," or even "reasonably foreseeable." Otherwise, the research should be classified as non-therapeutic. See ibid. at 54.
4. See e.g. C. Fried. Medical Experimentation: Personal Integrity and Social Policy (New York: American Elsevier Publishing, 1974) at 25-26. Annas, although acknowledging the continuum from experiment to treatment, assumes a more rigid stance, stating that "few interventions are in the gray zone and [that] an objective distinction can almost always be made between an experimental intervention and a treatment," See G. J. Annas, "Questing for Grails: Duplicity, Betrayal and Self-Deception in Postmodern Medical Research" (1996) 12 Journal of Contemporary Health Law and Policy 297 at 321.
5. See e.g. C. Fried. Medical Experimentation: Personal Integrity and Social Policy (New York: American Elsevier Publishing, 1974) at 25-26. Annas, although acknowledging the continuum from experiment to treatment, assumes a more rigid stance, stating that "few interventions are in the gray zone and [that] an objective distinction can almost always be made between an experimental intervention and a treatment," See G. J. Annas, "Questing for Grails: Duplicity, Betrayal and Self-Deception in Postmodern Medical Research" (1996) 12 Journal of Contemporary Health Law and Policy 297 at 321.
6. The term therapeutic research has been described as a tool used to facilitate self-deception in the research process, allowing a researcher to assume the mantle of a physician, thereby confusing subjects who may, as patients, submit to research with the expectation of a benefit that in fact does not exist. Hence, therapeutic research constitutes a doublethink "used to disguise the true nature of experimental protocols and to obscure the ideology of science (which follows a protocol to test a hypothesis) with the ideology of medicine (which uses treatments in the best interests of individual patients)." [footnotes omitted] See Annas, ibid. at 314. The Law Reform Commission of Canada recommended that this term be dropped from the medical lexicon. See Law Reform Commission of Canada, Working Paper No. 61: Biomedical Experimentation Involving Human Subjects (Ottawa: Law Reform Commission, 1989) at 5.
7. The term therapeutic research has been described as a tool used to facilitate self-deception in the research process, allowing a researcher to assume the mantle of a physician, thereby confusing subjects who may, as patients, submit to research with the expectation of a benefit that in fact does not exist. Hence, therapeutic research constitutes a doublethink "used to disguise the true nature of experimental protocols and to obscure the ideology of science (which follows a protocol to test a hypothesis) with the ideology of medicine (which uses treatments in the best interests of individual patients)." [footnotes omitted] See Annas, ibid. at 314. The Law Reform Commission of Canada recommended that this term be dropped from the medical lexicon. See Law Reform Commission of Canada, Working Paper No. 61: Biomedical Experimentation Involving Human Subjects (Ottawa: Law Reform Commission, 1989) at 5.
8. The discussion will also generally be confined to clinical research, although some aspects will certainly bear relevance to research in the social sciences.
9. It is important to consider an experiment as the sum of its component parts, which may individually have therapeutic or non-therapeutic applications. For example, in the administration of a known treatment, repeated incidental and diagnostic procedures may preclude the classification of the protocol as a whole as therapeutic. Also, the researcher/physician has an inherent conflict of interest between his loyalty to the therapeutic needs of the subject/patient and the scientific integrity of the experiment. As such, it is important that an objective assessment be conducted, independent of the stated intent of the researcher. See also J. Katz, "Human Experimentation and Human Rights" (1993) 38 Saint Louis University Law Journal 7: and more generally, Enquiry on Research Ethics, supra note 1 at 51-55, 57-59. A clear-cut classification is difficult when considering randomized clinical trials (RCTs), where claims of a therapeutic objective may be confounded by the element of randomization and the use of placebos. The literature on this specific topic is extensive and will not be addressed here. Although such trials should generally be classified as non-therapeutic, this may not always be the case, such as where non-therapeutic elements are minimized and treatment options of participants are not compromised. See generally Enquiry on Research Ethics, supra note 1 at 55-57. The Law Commission (UK) stated that RCTs should be labeled as therapeutic only where it is genuinely impossible to identify whether an old treatment, no treatment, or new treatment is preferable, and therefore all three may equally be in the best interests of a patient. See The Law Commission, Mental Incapacity (London: HMSO, 1995) at para. 6.28.
10. It is important to consider an experiment as the sum of its component parts, which may individually have therapeutic or non-therapeutic applications. For example, in the administration of a known treatment, repeated incidental and diagnostic procedures may preclude the classification of the protocol as a whole as therapeutic. Also, the researcher/physician has an inherent conflict of interest between his loyalty to the therapeutic needs of the subject/patient and the scientific integrity of the experiment. As such, it is important that an objective assessment be conducted, independent of the stated intent of the researcher. See also J. Katz, "Human Experimentation and Human Rights" (1993) 38 Saint Louis University Law Journal 7: and more generally, Enquiry on Research Ethics, supra note 1 at 51-55, 57-59. A clear-cut classification is difficult when considering randomized clinical trials (RCTs), where claims of a therapeutic objective may be confounded by the element of randomization and the use of placebos. The literature on this specific topic is extensive and will not be addressed here. Although such trials should generally be classified as non-therapeutic, this may not always be the case, such as where non-therapeutic elements are minimized and treatment options of participants are not compromised. See generally Enquiry on Research Ethics, supra note 1 at 55-57. The Law Commission (UK) stated that RCTs should be labeled as therapeutic only where it is genuinely impossible to identify whether an old treatment, no treatment, or new treatment is preferable, and therefore all three may equally be in the best interests of a patient. See The Law Commission, Mental Incapacity (London: HMSO, 1995) at para. 6.28.
11. It is important to consider an experiment as the sum of its component parts, which may individually have therapeutic or non-therapeutic applications. For example, in the administration of a known treatment, repeated incidental and diagnostic procedures may preclude the classification of the protocol as a whole as therapeutic. Also, the researcher/physician has an inherent conflict of interest between his loyalty to the therapeutic needs of the subject/patient and the scientific integrity of the experiment. As such, it is important that an objective assessment be conducted, independent of the stated intent of the researcher. See also J. Katz, "Human Experimentation and Human Rights" (1993) 38 Saint Louis University Law Journal 7: and more generally, Enquiry on Research Ethics, supra note 1 at 51-55, 57-59. A clear-cut classification is difficult when considering randomized clinical trials (RCTs), where claims of a therapeutic objective may be confounded by the element of randomization and the use of placebos. The literature on this specific topic is extensive and will not be addressed here. Although such trials should generally be classified as non-therapeutic, this may not always be the case, such as where non-therapeutic elements are minimized and treatment options of participants are not compromised. See generally Enquiry on Research Ethics, supra note 1 at 55-57. The Law Commission (UK) stated that RCTs should be labeled as therapeutic only where it is genuinely impossible to identify whether an old treatment, no treatment, or new treatment is preferable, and therefore all three may equally be in the best interests of a patient. See The Law Commission, Mental Incapacity (London: HMSO, 1995) at para. 6.28.
12. It is important to consider an experiment as the sum of its component parts, which may individually have therapeutic or non-therapeutic applications. For example, in the administration of a known treatment, repeated incidental and diagnostic procedures may preclude the classification of the protocol as a whole as therapeutic. Also, the researcher/physician has an inherent conflict of interest between his loyalty to the therapeutic needs of the subject/patient and the scientific integrity of the experiment. As such, it is important that an objective assessment be conducted, independent of the stated intent of the researcher. See also J. Katz, "Human Experimentation and Human Rights" (1993) 38 Saint Louis University Law Journal 7: and more generally, Enquiry on Research Ethics, supra note 1 at 51-55, 57-59. A clear-cut classification is difficult when considering randomized clinical trials (RCTs), where claims of a therapeutic objective may be confounded by the element of randomization and the use of placebos. The literature on this specific topic is extensive and will not be addressed here. Although such trials should generally be classified as non-therapeutic, this may not always be the case, such as where non-therapeutic elements are minimized and treatment options of participants are not compromised. See generally Enquiry on Research Ethics, supra note 1 at 55-57. The Law Commission (UK) stated that RCTs should be labeled as therapeutic only where it is genuinely impossible to identify whether an old treatment, no treatment, or new treatment is preferable, and therefore all three may equally be in the best interests of a patient. See The Law Commission, Mental Incapacity (London: HMSO, 1995) at para. 6.28.
13. The definition is derived from technical definitions of mental disorder and mental retardation. See American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (Washington, D.C.: A.P.A., 1994) at xxi-xxii, 39-42.
14. American College of Physicians, "Position Paper on Cognitively Impaired Subjects" (1989) 111 Annals of Internal Medicine 843 at 843.
15. D. N. Weisstub, Enquiry on Mental Competency: Final Report (Toronto: Queen's Printer, 1990).
16. An attempt to rationalize the inclusion in research of persons whose rationality is at issue, relies upon the view that " . . . it it is morally elevating Tor persons of normal intelligence to participate in research beneficiai to others, we should elevate persons of limited capacity by taking them into this world of beneficial exchanges." The danger in promoting such a view is clear: "By such a rationale, and indeed fiction, we can decide to ask handicapped persons to give their organs to siblings in need, thereby making whole as moral beings persons who for other purposes have been given lesser evaluations with respect to their worth in the social system." It is therefore unacceptable that a presumption of implied consent, even if couched in terms of a social duty, he rooted in such moral fictions. See D. N. Weisstuh, "Roles and Fictions in Clinical and Research Ethics" (1996) 4 Health Law Journal [in press].
17. A second argument in support of a right to participate in research stems from the principle of beneficence, whereby persons should not he prevented from access to benefits of research, including certain drugs or therapies. See M. L. Elks, "The Right to Participate in Research Studies" (1999) 122 Journal of Laboratory & Clinical Medicine 130 at 131. Although arguments favouring a right to participate in research may be justified when concerning persons who are fully competent, such as in cases involving innovative treatments where no other options are available, they are difficult to apply in the context of non-therapeutic research involving cognitively impaired adults whose ability to make autonomous decisions is diminished, or perhaps even nonexistent. The notion of a right becomes relevant, however, in those cases where it is possible to express choices prior to the point at which autonomous behaviour is no longer possible.
18. In Canada, discrimination on the basis of mental disability runs contrary to s. 15(1) of the Canadian Charter of Rights and Freeedoms, Being Part of the Constitution Act, 1982, being Schedule B to the Canada Act, 1982, c. 11. However, it is doubtful that the infringement of a "right to participate in non-therapeutic research," if in fact it could be demonstrated that such a right exists, would actually attract the censure of the courts.
19. The principle of inviolability is predicated on the notion that "the State has a legitimate interest in protecting its citizens not only from external threats to their physical integrity, but also from their own choices where there is an unjustified risk of injury or death." See S. N. Verdun-Jones & D. N. Weisstub, "Consent to Human Experimentation in Québec: The Application of the Civil Law Principle of Personal Inviolability to Protect Special Populations" (1995) 18 International Journal of Law & Psychiatry 163 at 166-167.
20. See Weisstub (1996), supra note 10.
21. E.W. Keyserlingk et al., "Proposed Guidelines for the Participation of Persons with Dementia as Research Subjects" (1995) 38 Perspectives in Biology & Medicine 319 at 319.
22. See e.g. Health and Welfare Canada, Fact Book on Aging in Canada (Ottawa: Minister of Supply and Services, 1983) at 14, 25. The population aging phenomenon is one of Canada's major social issues, having as its implication an increasing demand for health care and other social services. See R. M. Gordon & S. N. Verdun-Jones, Adult Guardianship Law in Canada, Rel. 2 (Scarborough: Carswell, 1995) at 1-12-1-13.
23. See e.g. Health and Welfare Canada, Fact Book on Aging in Canada (Ottawa: Minister of Supply and Services, 1983) at 14, 25. The population aging phenomenon is one of Canada's major social issues, having as its implication an increasing demand for health care and other social services. See R. M. Gordon & S. N. Verdun-Jones, Adult Guardianship Law in Canada, Rel. 2 (Scarborough: Carswell, 1995) at 1-12-1-13.
24. See e.g. C. G. Swift, "Ethical Aspects of Clinical Research with the Elderly" (1988) 40 British Medical Journal of Hospital Medicine 370.
25. The Nuremberg Code constituted part of the judgment resulting from U.S. v. Karl Brandt et al., Trials of War Criminals Before the Nuremberg Military Tribunal Under Control Council Law No. 10. (October 1946-April 1949).
26. G. A. Res. 2200 (XXI), 999 U.N.T.S. 171 (1966), art. 7.
27. Human Rights Committee, 53rd Sess., 1413 Mtg., CCPR/G'SR. 1413, (6 April 1995), paras. 21, 35.
28. J. H. Jones, Bad Blood (New York: Free Press, 1981).
29. See H. Beecher, "Ethics and Clinical Research" (1966) 214 New England Journal of Medicine 1354; M. A. Grodin & J. J. Alpert, "Children as Participants in Medical Research" (1988) 35 Pediatric Clinics of North America 1389.
30. See H. Beecher, "Ethics and Clinical Research" (1966) 214 New England Journal of Medicine 1354; M. A. Grodin & J. J. Alpert, "Children as Participants in Medical Research" (1988) 35 Pediatric Clinics of North America 1389.
31. Advisory Committee on Human Radiation Experiments. Final Report (Washington, D.C.: U.S. Government Printing Office, 1995).
32. See Government of Canada, New Release: Background Information - Depatterning at the Allan Memorial Institute (Ottawa: Department of Justice, 17 November 1992); G. Cooper, Opinion of George Cooper, Q.,C., Regarding Canadian Government Funding of the Allan Memorial Institute in the 1950's and 1960's (Ottawa: Supply and Services Canada, 1986).
33. See Government of Canada, New Release: Background Information - Depatterning at the Allan Memorial Institute (Ottawa: Department of Justice, 17 November 1992); G. Cooper, Opinion of George Cooper, Q.,C., Regarding Canadian Government Funding of the Allan Memorial Institute in the 1950's and 1960's (Ottawa: Supply and Services Canada, 1986).
34. The need for action is heightened further by pressures to develop more efficient tools for low-cost health protection for these special populations.
35. This, in any event, is never ultimately guaranteed in any civil society, including democratic ones. In attaining these standards of surveillance, the position taken here is that self-regulation or highly discretionary decision making is unacceptable.
36. See also V. L. Melnick et al., "Clinical Research in Senile Dementia of the Alzheimer Type: Suggested Guidelines Addressing the Ethical and Legal Issues" (1984) 32 Journal of the American Geriatric Society 531 at 535.
37. The Declaration of Helsinki clearly states that "[i]n research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject." See Medical Association, Declaration of Helsinki, Adopted at the 18th World Medical Assembly in Helsinki in June 1964. Amended at the 19th World Medical Assembly in Tokyo in October 1975: the 35th World Medical Assembly in Venice in October 1983; and the 41st World Medical Assembly in Hong Kong in September 1989.
38. See Declaration of Helsinki, supra note 28.
39. Council for International Organizations of Medical Science, in collaboration with the World Health Organization, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993). [hereinafter CIOMS Guidelines]
40. C. Huriet, "La loi francaise relative à la protection des personnes qui se prêtent à des recherches biomédicales; origine et histoire" (1992) 43 Recueil International de Législation Sanitaire 414.
41. Medical Research Council of Canada, Guidelines on Research Involving Human Subjects (Ottawa: Supply & Services Canada, 1987). These guidelines are currently under revision. See Tri-Council Working Group, Code of Conduct for Research Involving Humans (Draft Document) (Ottawa: Supply & Services Canada, 1996).
42. Medical Research Council of Canada, Guidelines on Research Involving Human Subjects (Ottawa: Supply & Services Canada, 1987). These guidelines are currently under revision. See Tri-Council Working Group, Code of Conduct for Research Involving Humans (Draft Document) (Ottawa: Supply & Services Canada, 1996).
43. P. R. Benson, "The Social Control of Human Biomedical Research: An Overview and Review of the Literature" (1989) 29 Social Sciences & Medicine 1.
44. P. R. Benson & L. H. Roth, "Trends in the Social Control of Medical and Psychiatric Research" in D. N. Weisstub, ed., Law and Mental Health: International Perspectives, Volume 4 (New York: Pergamon Press, 1988) 1 at 5.
45. Weiss v. Solomon [1989] R.J.Q. 731 (S.C.).
46. Ibid, at 741.
47. B. Freedman & K. C. Glass, "Weiss v. Solomon: A Case Study in Institutional Responsibility for Clinical Research" (1990) 18 Law, Medicine & Health Care 395 at 401-402.
48. See The Law Commission, supra note 6 at paras. 6.29-6.33. This view is shared by the Queensland Law Reform Commission. See Queensland Law Reform Commission. Assisted and Substituted Decisions: Decision-making by and for People with a Decision-Making Disability, Vol. 1 (Brisbane: Queensland Law Reform Commission. 1996) at 64.
49. Medical Research Council Act, R.S.C. 1985, c. M-9.
50. Title 45 Code of Federal Regulations Part 46 (18 June 1991).
51. Loi No. 88-1138 du 20 décembre 1988 (S.O. December 22, 1988); Loi 90-86 du 23 janvier 1990, (J.O. 25 January 1990); Loi 90-549 du 2 juillet 1990, (J.O. 5 July 1990); Loi 91-73 du 18 janvier 1991, (J.O. 20 January 1991); Loi 94-630 du 25 juillet 1994, (J.O. 27 July 1994).
52. Law Reform Commission of Canada (1989), supra note 4; Law Reform Commission of Canada, Toward a Canadian Advisory Board on Biomedical Ethics (Ottawa: Law Reform Commission of Canada, 1990).
53. See The Law Commission, supra note 6.
54. See Queensland Law Reform Commission, supra note 38.
55. A "Medical Experimentation Bill" was introduced to the Second Chamber of Parliament on April 18, 1992: however, the new Minister of Health, Welfare, and Sports withdrew the bill from further discussion on March 16, 1995, because she and the Minister of Justice were planning to "formulate a definitive regulation on scientific research of human embryos and sex-cells." [Personal communication from G. Dekker, Chief Inspector of Health Care for the Netherlands (6 July 1995).]
56. Enquiry on Research Ethics, supra note 1 at 106.
57. Arts. 20-26 C.C.Q. It is worthwhile to note that, despite the existence of the Civil Code articles governing research, current regulatory models in Québec were criticised as being inconsistent and inadequate in protecting research subjects while at the same time maintaining scientific integrity. It was recommended, therefore, that a more elaborate regime be developed, one which properly takes into consideration the ethical, scientific, and financial aspects of research, and that a permanent regulatory authority be created. See Comité d'experts sur l'évaluation des mécanismes de contrôle en matière de recherche clinique. Rapport sur l'évaluation des mécanismes de contrôle en matière de recherche clinique au Québec, (Chairman: Pierre Deschamps. Submitted to the Hon. Jean Rochon. Minister of Health and Social Services, Province of Québec, June 9, 1995).
58. See e.g. R. Delago & H. Leskovac, "Informed Consent in Human Experimentation: Bridging the Gap Between Ethical Thought and Current Practice" (1986) 34 UCLA Law Review 67: K. C. Glass, "Informed Decision-Making and Vulnerable Persons: Meeting the Needs of the Competent Elderly Patient or Research Subject" (1993) 18 Queen's Law Journal 191.
59. See e.g. R. Delago & H. Leskovac, "Informed Consent in Human Experimentation: Bridging the Gap Between Ethical Thought and Current Practice" (1986) 34 UCLA Law Review 67: K. C. Glass, "Informed Decision-Making and Vulnerable Persons: Meeting the Needs of the Competent Elderly Patient or Research Subject" (1993) 18 Queen's Law Journal 191.
60. See Halushka v. University of Saskatchewan (1965), 52 W.W.R. 608 (Sask. C.A.); and Weiss v. Solomon, supra note 35.
61. It is important to reiterate that a cognitively impaired adult's inability to make meaningful decisions in the experimentation context must not be presumed, but rather, as discussed in our definition above, determined on a functional basis.
62. See Verdun-Jones & Weisstub, supra note 13 at 166-167.
63. See M. A. Somerville, "Label versus Contents: Variations Between Philosophy, Psychiatry and Law in Concepts Governing Decision-Making" (1994) 39 McGill L.J. 179 at 193, who state that ". . . there is danger in promoting the adoption of autonomy as a factor relevant to legal rights in relation to personal decision-making, because this could result in the invasion of the human rights of, a lack of interest for, and wrongful discrimination against, persons characterized as non-autonomous." An alternative view is to treat informed consent as a "gatekeeping" device, which can he used to distinguish those persons who are capable of making their own decisions from those who require additional protection. See R. R. Faden & T. L. Beauchamp. A History and Theory of Informed Consent (Oxford: Oxford University Press, 1986).
64. See M. A. Somerville, "Label versus Contents: Variations Between Philosophy, Psychiatry and Law in Concepts Governing Decision-Making" (1994) 39 McGill L.J. 179 at 193, who state that ". . . there is danger in promoting the adoption of autonomy as a factor relevant to legal rights in relation to personal decision-making, because this could result in the invasion of the human rights of, a lack of interest for, and wrongful discrimination against, persons characterized as non-autonomous." An alternative view is to treat informed consent as a "gatekeeping" device, which can he used to distinguish those persons who are capable of making their own decisions from those who require additional protection. See R. R. Faden & T. L. Beauchamp. A History and Theory of Informed Consent (Oxford: Oxford University Press, 1986).
65. Respect for persons calls not only for the promotion of self-determinative rights, but for the protection of persons with an impaired decision-making capacity. See CIOMS Guidelines, supra note 30 at 10. See also Verdun-Jones & Weisstub, supra note 13.
66. "A person of full age who is capable of giving his consent may submit to an experiment provided that the risk incurred is not disproportionate to the benefit that can reasonably be anticipated." Art. 20 C.C.O.
67. Ethical research involving vulnerable populations should fall within clearly stated boundaries of permissible behaviour, whereby the actions of both prospective subjects and persons acting on their behalf (i.e. legal guardians) are carefully circumscribed. In particular, restrictions should be placed on acceptable levels of risk, and there should he a mandatory relationship between the purpose of the research and the condition or circumstances of the subject of special population to which the subject belongs. The latter requirement necessarily implies that research not be conducted on vulnerable persons where alternative methods, treatments, or subjects are available. See D. N. Weisstub, J. Arbodeda-Florez & G. F. Tomossy. "Establishing the Boundaries of Ethically Permissible Research with Special Populations" (1996) Health Law in Canada [in press].
68. R. M. Veatch, "Abandoning Informed Consent" (1995) 25:5 Hastings Center Report 5.
69. J. Katz, "Informed Consent - Must it Remain a Fairy Tale?" (1994) 10 Journal of Contemporary Health Law & Policy 69. See also P. H. Schuck, "Rethinking Informed Consent" (1994) 103 Yale Law Journal 899.
70. J. Katz, "Informed Consent - Must it Remain a Fairy Tale?" (1994) 10 Journal of Contemporary Health Law & Policy 69. See also P. H. Schuck, "Rethinking Informed Consent" (1994) 103 Yale Law Journal 899.
71. See generally Gordon & Verdun-Jones, supra note 16.
72. For example, in Ontario it is stated specifically that "nothing in this Act affects the law relating to giving or refusing consent on another person's behalf to a procedure whose primary purpose is research." See Substitute Decisions Act, 1992, S.O. 1992, c. 30, s. 66(13). British Columbia is the only province where guardians might be able to make decisions relating to research, insofar as the definition of health care includes "participation in a medical research program approved by an ethics committee designated by regulation." See Health Care (Consent) and Care Facility (Admission) Act, S.B.C. 1993, c. 48, s. 1. [not yet in force]
73. As will be discussed below, a "substituted judgment" test is also inappropriate. Rather, a hybrid of both standards should be applied in consideration of each particular situation.
74. See e.g., Re Leeming, [1985] 1 W.W.R. 368 (B.C.S.C.).
75. G. B. Robertson, Mental Disability and the Law in Canada, 2d. ed. (Toronto: Carswell, 1994) at 118.
76. See Gordon & Verdun-Jones, supra note 16 at 1-16-1-19.
77. See Weisstub (1990), supra note 9 at 35.
78. See e.g. Substitute Decisions Act, 1992, S.O. 1992. c. 30, and also text at note 114.
79. See Robertson, supra note 62 at 119.
80. Ibid. at 170-171.
81. A critique of the common law will follow.
82. See Robertson, supra note 62 at 177-178; Gordon & Verdun-Jones, supra note 16 at 3-129. The provinces that provide for health care directives include Manitoba. Nova Scotia, Ontario, and Newfoundland, with legislation coming into force in British Columbia and in preparation in P.E.I.
83. E. (Mrs.) v. Eve, [1986] 2 S.C.R. 388 at 426,427. [hereinafter Eve]
84. Ibid. at 431.
85. See e.g., M. D. A. Freeman, "Sterilising the Mentally Handicapped" in M. D. A. Freeman, ed. Medicine, Ethics and the Law: Current Legal Problems (London: Stevens, 1988) 55.
86. M. A. Shone, "Mental Health - Sterilization of Mentally Retarded Persons - Parens Patriae Power: Re Eve" (1987) 66 Canadian Bar Review 635 at 640. See also Manitoba Law Reform Commission, Report on Sterilization and Legal Incompetence (Winnipeg: Law Reform Commission, 1992).
87. M. A. Shone, "Mental Health - Sterilization of Mentally Retarded Persons - Parens Patriae Power: Re Eve" (1987) 66 Canadian Bar Review 635 at 640. See also Manitoba Law Reform Commission, Report on Sterilization and Legal Incompetence (Winnipeg: Law Reform Commission, 1992)
88. In an earlier case involving a minor, the House of Lords decided not to authorize a non-therapeutic sterilization under the parens patrlae jurisdiction. See In Re D (A Minor) (Wardship: Sterilisation), [1976] 1 All ER 326 (H.L.). Although acknowledged by subsequent cases to have been correctly decided on its facts, this decision was not upheld. See e.g. In Re B (A Minor)(R, [1987] 2 All E.R. 206 (H.L.) [hereinafter In Re B]. In Australia, however, it was recently decided that neither the parens patriae power nor existing legislation dealing with decision making for persons with impaired capacity could authorize parents to consent to a non-therapeutic sterilization of their child. See Secretary, Department of Health and Community Services v. J.W.B. and S.M.B. (Marion's Case) (1992). 175 C.L.R. 218.
89. This English case involved a minor and is of interest as it involved the application of the parens patriae power to authorize a non-therapeutic sterilization. However, in his criticism of La Forest J in Eve, Lord Hailsham of St. Marylebone was also censured for his statement that "[t]o talk of the "basic right" to reproduce for an individual who is not capable of knowing the causal connection between intercourse and childbirth, the nature of pregnancy, what is involved in delivery, unable to form maternal instincts or to care for a child appears to me wholly to part company with reality." The unfortunate inference that can be drawn from such an assertion is that a person who is incapable of understanding or expressing a right may not be entitled to it. See In Re B, ibid. at 213. In another case, this time involving an adult, the House of Lords applied the common law concept of necessity, as the parens patriae jurisdiction could at that time no longer be applied to adults in England. See F. v. West Berkshire Health Authority (1989), 2 All E.R. 545 (H.L.). The application of this approach was criticized as tenuous, given that "necessity" should apply only in cases of genuine need, with non-therapeutic sterilization being a dubious example. For a detailed discussion of these cases and the points mentioned above, see D. Tomkin & P. Hanafin. Irish Medical Law (Dublin: Betaprint, 1995) at 192-200.
90. See Eve, supra note 70 at 423.
91. See B. M. Dickens, "Substitute Consent to Participation of Persons with Alzheimer's Disease in Medical Research: Legal Issues," in J. M. Berg, H. Karlingky & F. H. Lowy, eds., Alzheimer's Disease Research: Ethical and Legal Issues (Toronto: Thomson Professional Publishing, 1991) 60. The additional requirement added by Dickens is that there would have to be no risks associated with the research.
92. See Eve, supra note 70 at 425.
93. The view that the parens patriae jurisdiction is unlikely to permit the authorization of non-therapeutic experimentation is shared by the Queensland Law Reform Commission, supra note 38 at 64.
94. See Eve, supra note 70 at 427.
95. 81 Ibid.
96. The Queensland Law Reform Commission and The Law Commission (UK) concurred with this view, recommending that non-therapeutic research with mentally incapacitated adults be authorized only by a specialized statutory authority. The UK Commission, however, makes the additional requirement of either court approval, the consent of an attorney or manager, a certificate from a doctor not involved in the research that the participation of the person is appropriate, or designation of the research as not involving contact. See Queensland Law Reform Commission, supra note 38 at 393; The Law Commission, supra note 6 at paras. 6.33, 6.37.
97. Local research ethics committees should be formally constituted, certified, and subject to review by a central statutory authority. The composition of committees should include not only persons with scientific and legal training, but on an ad hoc basis, representatives of the subject or the class to which the subject belongs. The committee would be required to apply scientific and official guidelines, and be free of institutional and personal bias. See Enquiry on Research Ethics, supra note 1.
98. The central board would also reserve an exclusive right to make certain decisions, such as with regard to research involving substantial risks.
99. H. Sava, P. T. Mallow & M. J. Sole, "Legal Liability of Physicians in Medical Research" (1994) 17 Clinical & Investigative Medicine 148 at 165.
100. This generalization, although currently applicable to many of Canada's common law provinces, no longer applies to current Australasian models, nor indeed to many jurisdictions elsewhere in North America.
101. See Gordon & Verdun-Jones, supra note 16 at 1-28.
102. Ibid. at 1-29; See also Robertson, supra note 62 at 118-123.
103. To take a classic example, a person may lack testamentary capacity, but may be sufficiently competent to marry.
104. For an in depth discussion of mental competency and its assessments, see Weisstub (1990), supra note 9.
105. See for example Title 45 Code of Federal Regulations 46 (18 June 1991) § 46.402 (b), 46.408 (a).
106. See e.g. Queensland Law Reform Commission, supra note 38 at 391-393; The Law Commission, supra note 6 at para. 6.34.
107. This process should involve a review of the scientific and ethical merits of the proposed research.
108. In other words, no alternative (less vulnerable) pool of subjects can be available. Furthermore, non-therapeutic research involving cognitively impaired adults must be restricted to a condition or circumstance affecting the subject or the class of subjects to which the person belongs. The decision to enroll an individual in non-therapeutic experiments must not be based solely on the availability of the person nor on the inability of that person to object, but rather on the genuine social need to conduct the research in question. See Weisstub, Arboleda-Florez & Tomossy, supra note 55.
109. The list presented is by no means complete. Additional considerations include the issues of confidentiality, conflict of interest, risk assessment, and various obligations of researchers and ethics committees, prior to, during, and subsequent to the completion of an experiment, particularly with respect to minimization of risks. For further discussion, see Weisstub, Arboleda-Florez & Tomossy, supra note 55, where general safeguards are presented based on a synthesis of the various codes, guidelines, legislation, and regulations promulgated to date.
110. The Alberta Law Reform Institute and the Newfoundland Law Reform Commission each went one step further in proposing that guardians should not be permitted to enroll their dependents in non-therapeutic research unless authorized through a valid advance directive. It is our view that, at least for the present, and until the use and application of research directives becomes sufficiently widespread, this requirement would unduly inhibit research. See Alberta Law Reform Institute. Advance Directives and Subtitute Decision-Making in in Personal Health Care (Edmonton: Alberta Law Reform Institute, 1993) at 41; Newfoundland Law Reform Commission, Discussion Paper on Advance Health Care Directives and Attorneys for Health Care (St. John's: Newfoundland Law Reform Commission, 1988) at 51.
111. The Alberta Law Reform Institute and the Newfoundland Law Reform Commission each went one step further in proposing that guardians should not be permitted to enroll their dependents in non-therapeutic research unless authorized through a valid advance directive. It is our view that, at least for the present, and until the use and application of research directives becomes sufficiently widespread, this requirement would unduly inhibit research. See Alberta Law Reform Institute. Advance Directives and Subtitute Decision-Making in in Personal Health Care (Edmonton: Alberta Law Reform Institute, 1993) at 41; Newfoundland Law Reform Commission, Discussion Paper on Advance Health Care Directives and Attorneys for Health Care (St. John's: Newfoundland Law Reform Commission, 1988) at 51.
112. See A. Moorhouse & D. N. Weisstub, "Advance Directives for Research: Ethical Problems and Responses" (1996) 19 International Journal of Law & Psychiatry 107. The authors discussed the social utility of research directives, balancing their pros and cons from an ethical perspective, and outlined various recommendations with respect to their preparation, including the requisite threshold of mental capacity, their durability and execution, and fundamental restrictions on their implementation.
113. However, registration of research directives should not be onerous. In fact, the Alberta Law Reform Institute recommended against the requirement that all advance directives be registered, fearing that a complicated bureaucratic system would discourage individuals from preparing directives. See Alberta Law Reform Institute, supra note 96 at 17. The Queensland Law Reform Commission concurred with this perception, rejecting many arguments in favour of registration and reaching the conclusion that enduring powers of attorney for decisions other than financial matters should not be registrable. With respect to standard forms, the Commission recommended against the imposition by legislation of a prescribed form, owing to problems of inflexibility and potential invalidation on technical grounds, but rather that forms be developed by professional organizations in collaboration with consumer groups for use as guides. See Queensland Law Reform Commission, supra note 38 at 148-159, 355-356. The UK Law Commission, on the other hand, recommended that, in order to be valid, a continuing power of attorney should be registered after its execution. See The Law Commission, supra note 6 at para. 7.28-7.31. The position held here is that registration should be required upon the invocation of a research directive. The process should bear no cost to prospective subjects and should be streamlined to avoid administrative delays. Of course, there would be the corresponding onus of confidentiality placed on the registering authority, which could by delegation be the research ethics committee itself. See also Moorhouse & Weisstub, supra note 97 at 129-131.
114. Review committees must also ensure that guardians are free from bias and that the advance consent was not obtained in a coercive or misleading fashion, resulting from the undue influence of a family member, treating physician, or researcher. Institutionalized persons might be particularly vulnerable in this regard.
115. The concept of a threshold for capacity reflects the need to consider situational parameters affecting decisions, including increased complexity of information and the level of significance. This has been referred to as a "contextual" sliding scale and in no way interferes with a functional assessment of capacity, which requires that a determination he made on the ability to understand and appreciate both the reasons for and consequences of a specific decision while taking into account the vulnerabilities and special characteristics of the individual in the light of cultural and social factors. Sec Weisstub (1990). supra note 9.
116. See Substitute Decisions Act, 1992, supra note 65, s. 47(2).
117. See also Moorhouse & Weisstub, supra note 97 at 131-133.
118. See e.g. M. Irwin et al., "Psychotic Patients' Understanding of Informed Consent" (1985) 142 American Journal of Psychiatry 1351.
119. See Weisstub, Arboleda-Florez & Tomossy, supra note 55.
120. Art. 20 C.C.Q.
121. See Keyserlingk et al., supra note 15 at 351.
122. See the discussion on "risk" in Weisstub, Arboleda-Florez & Tomossy, supra note 55.
123. For example, the Enquiry on Research Ethics recommended that both the legal guardian and the proposed Provincial Ethics Review Board approve research directives consenting to participation in experiments with a substantial level of risk. See Enquiry on Ethics, supra note 1 at 92. See also Moorhouse & Weisstub, supra note 97 at 135-130. An onerous approval process in cases involving a substantial risk should contribute to a system that is in effect self-regulating, whereby, in order to avoid such an arduous review process, researchers would have an added incentive to minimixe potential risks of harm, pain or discomfort.
124. "Ulysses Contracts," referring to the Greek hero in the Odyssey, involve decisions made by patients in the context of treatment whereby instructions issued in advance are to be carried out despite any protest to the contrary made while incompetent. See A. Macklin, "Bound to Freedom: The Ulysses Contract and the Psychiatric Will" (1987) 45 University of Toronto Faculty Law Review 37.
125. The justification for the use of Ulysses Contracts, although valid with respect to treatment, are not commutahle to the context of research and should be permitted only when involving negligible or minimal risks. See Moorhouse & Weisstub, supra note 97 at 136. All requirements stated earlier for research directives in general should also apply to the specific cases of Ulysses Contracts, particularly the needs for specificity and a restrictive interpretation of ambiguous instructions. A guardian or research ethics committee should be able to withdraw the subject in the event where a protocol exceeds or compromises the terms specified in the Ulysses Contract.
126. Certain authorities have suggested the adoption of a "consent monitor" to ensure that consent is preserved throughout the entire research process. See Melnick et al., supra note 27 at 534; Office for Protection of Research Risks, National Institutes of Health. Protecting Human Subjects: Institutional Review Board Guidebook (Washington, D.C.: U.S. Government Printing Office. 1993) at 6-30.
127. See Weisstub, Arboleda-Florez & Tomossy, supra note 55.
128. In fact, a researcher should be required to notify immediately both the guardian and research ethics committee for any change in the conditions of the experiment, health of the subject, or indication by the subject of a desire to withdraw.
129. This approach would he consistent with a "least restrictive and intrusive" means of protection, which was supported most recently by the Law Commission of the United Kingdom, supra note 6 at para. 3.14. See also Weisstub (1990), supra note 9. A practical example can be found in Ontario, where: "A person is incapable of personal care if the person is not able to understand information that is relevant to making a decision concerning his or her own health care, nutrition, shelter, clothing, hygiene or safety, or is not able to appreciate the reasonably foreseeable consequences of a decision or lack of decision." See Substitute Decisions Act, 1992, supra note 65, s. 45. Full guardianship is awarded only if there is an incapacity in all of the areas listed above. Otherwise, partial powers will be granted (ss. 59(1), 60(1).
130. An exception to this rule includes the occasional need for a guardian to order the commitment of a dependent for the protection of others.
131. Children might have a personal stake in the outcome of research to be conducted on their elderly parents and would therefore be unsuitable guardians in this respect.
132. The guardian for research would not, therefore, be operating in a vacuum and without accountability. Moreover, as indicated earlier, research ethics committees would also be subject to review by a central statutory authority. See note 83 and accompanying text.
133. Although specifically excluded from application to the context of research, this approach is embraced by the current legislation in Ontario. See Substitute Decisions Act, 1992, supra note 65, ss. 66(3-4): (3) The guardian shall make decisions on the incapable person's behalf to which the Health Care Consent Act, 1996 does not apply in accordance with the following principles: 1. If the guardian knows of a wish or instruction applicable to the circumstances that the incapable person expressed while capable, the guardian shall make the decision in accordance with the wish or instruction. 2. The guardian shall use reasonable diligence in ascertaining whether there are such wishes or instructions. 3. A later wish or instruction expressed while capable prevails over an earlier wish or instruction. 4. If the guardian does not know of a wish or instruction applicable to the circumstances that the incapable person expressed while capable, or if it is impossible to make the decision in accordance with the wish or instruction, the guardian shall make the decision in the incapable person's best interests. (4) In deciding what the person's best interests are tor the purpose of subsection (3), the guardian shall take into consideration. (a) the values and beliefs that the guardian knows the person held when capable and believes the person would still act on if capable: (b) the person's current wishes, if they can be ascertained: and (c) the following factors: 1. Whether the guardian's decision is likely to, i. improve the quality of the person's life, ii. prevent the quality of the person's life from deteriorating, or iii. reduce the extent to which, or the rate at which, the quality of the person's life is likely to deteriorate, 2. Whether the benefit the person is expected to obtain from the decision outweighs the risk of harm to the person from an alternative decision.
134. 'We refer to the advance directive principle, the substituted judgment principle, and the best interests principle. It is important to recognize that surrogates will use a combination of these standards in their reasoning. The degree to which advance directives will influence decision making will depend upon the evidentiary weight of the person's expressed wishes: as the level increases, one approaches a substituted judgment: as the level decreases, one must rely on a calculation of best interests. See D. W. Brock, "Good Decision-making for Incompetent Patients" (1994) 24:6 Hastings Center Report Supplement S8 at S9.
135. Indeed, this observation was made in response to a series of American cases involving the application of the substituted judgment test in treatment-related decisions for cognitively impaired persons. See T. G. Gutheil & P. S. Appelbaum, "Substituted Judgment: Best Interests in Disguise" (1983) 13(3) Hastings Center Report 8 at 11.
136. See also Shone, supra note 73.
137. As a "construct of imagination,(latin letter glottal stop) the doctrine of substituted judgment in fact constitutes a dangerous legal fiction, whereby an assumption can easily lead one to forget the underlying reality of decisions made in such a manner: that one person is rational and therefore in a position of control, while the other, because of mental incapacity, is neither. See L. Harmon, "Falling Off the Vine: Legal Fictions and the Doctrine of Substituted Judgment" (1990) 100 Yale Law Journal 1 at 70-71.
138. Indeed, the Law Commission of the UK decided upon a "best interests" criterion that included an element of "substituted judgment." The exception, of course, is where it is impossible to ascertain a person's prior wishes, in which case, one must rely upon a best-interests determination. See The Law Commission, supra note 6 at para. 3.24-3.28.