Ethical Research with Vulnerable Populations: The Mentally Disordered By J. Arboleda-Flórez & D.N. Weisstub In Weisstub DN (ed.) (1998) Research on Human Subjects : Ethics, Law, and Social Policy. Oxford : Pergamon, pp. 433-450.

A. The Mentally Disordered As A Vulnerable Population

The mentally disordered stand at the intersection of several social systems, particularly health and justice. Health care systems claim the mentally disordered on the premise that they suffer from an illness that deprives them of the ability to make proper decisions, entitling them to specialized care, treatment, and protection. The justice system, on the other hand, claims that the mentally disordered are in need of protection from themselves and even from those persons whose job it is in the other systems to protect them. Even when the mentally disordered commit offences, the justice system considers that they should not be punished with the full force of the law. Health and justice are both geared to protect the mentally disordered; their aims are the same. Their methods, however, differ; for while health care can be understood as trying to protect the mentally disordered at the expense of their rights, justice can be seen as protecting their rights at the expense of their autonomy. In the quest to develop protections for mentally disordered persons, the legal system has introduced a variety of structures, including guardianship laws, regulation and liability of caregivers, and exemptions from criminal liability. However, these regimes are designed not only to protect the mentally disordered, but also, in certain cases, to protect society. Unfortunately, and as might be expected, these two antithetical objectives can lead to extremely difficult decisions. As a consequence of institutionalization, whether for short or long periods, the mentally disordered become highly vulnerable to exploitation and abuse. Both their dependency upon others and their general lack of freedom to use independent judgement raise doubts about the voluntariness of their decisions. Moreover, owing to the inherent nature of mental disorders, the cognitive capacity of affected individuals is frequently compromised, which affects their competence to make decisions in their best interests. These two factors place the mentally

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disordered among special populations who present specific problems in the context of human experimentation.

A.1. Defining “Mental Disorder”

Before elaborating upon the legal and ethical issues raised by the conduct of non-therapeutic research with the mentally disordered, it is important first to identify what is meant by the term “mental disorder”.

Mental disorders are not homogeneous. Indeed, many questions

have been raised about the ways in which they could be diagnosed.1 While the definition of this term has been an evolutionary process that has depended upon medical, social and legal developments,2 it is also a contextual definition, varying according to the given circumstances. Traditionally, there has been a difference between legal and clinical definitions of the term.3 While clinical definitions emphasize symptoms, disability or distress, and tend to consist of ambiguous generalities,4 legal definitions tend to emphasize constructs such as incapacity and incompetence. Finally, although the presence of a ‘mental disorder’ is the threshold requirement for any further legal decisions, it lacks a precise operational definition.5

1 T. Szasz, The Myth of Mental Illness: Foundations of a Theory of Personal Conduct

(New York: Hoeber-Harper, 1961). 2 For more on this subject, refer to the English Court of Appeal decision W. v. L.,

[1973] 3 All E.R. 884, and Winterwerp v. The Netherlands (1979), 2 E.H.R.R. 387; and X. v. The United Kingdom (1981), 4 E.H.R.R. 188; Luberti v. Italy (1984), 6 E.H.R.R. 440.

3 J. Arboleda-Florez & M. Copithorne, Mental Health Law and Practice (Toronto: Carswell, 1994) at 1-42.

4 J.M. Livermore, C.P. Malmquist & P.E. Meehl, “On the Justification for Civil Commitment” (1968) 117 University of Pennsylvania Law Review 75 at 80.

5 For example, the Diagnostic and Statistical Manual of Mental Disorders defines “mental disorder” as:

…a clinically significant behavioral or psychological syndrome or pattern that occurs in a person and that is associated with present distress (e.g., a painful symptom) or disability (i.e., impairment in one or more important areas of functioning) or with a significantly increased risk of suffering death, pain, disability, or an important loss of freedom. In addition, this syndrome or pattern must not be merely an expectable and culturally sanctioned response to a particular event, for example, the death of a loved one. Whatever its psychological cause, it must currently be considered a manifestation of a behavioral, psychological, or biological dysfunction in the individual. Neither deviant behavior (e.g., political, religious, or sexual) nor conflicts that are primarily between the individual and society are mental disorders unless the deviance or conflict is a symptom of a dysfunction in the individual, as described above.

See American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (Washington, D.C.: A.P.A., 1994) [hereinafter DSM IV] at xxi-xxii.

This definition clearly covers the broad range of “developmental disorders,” “organic mental disorders” (e.g. intoxications, “primary degenerative dementia of

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Clinical definitions of ‘mental disorder’ suffer from ambiguities. Because of overlapping categories and the absence of defined borders among conditions that affect different systems simultaneously, these definitions are useful for clinical purposes, but they lack legal functionality. On the other hand, legal definitions tend to differ according to whether they are for purposes of criminal proceedings or civil commitment. For example, a leading Canadian legal text uses the term “mental disability” in a generic sense to include “any mental disorder or developmental disability, including mental illness, mental retardation and related developmental disabilities.”6 In Canadian mental health legislation, the definition of “mental disorder” is varied. The Criminal Code, while providing a circuitous definition of “mental disorder” as a “disease of the mind,”7 uses the term in s. 16 (the “not-criminally responsible” clause) not as a definition but as a way to describe a person who may not be criminally responsible.8 Otherwise, under the Uniform Mental Health Act9 (adopted by Uniform Law Conference representatives in 1987, but never implemented provincially as such), the term is defined as “a substantial disorder of thought, mood, perception, orientation or memory that grossly impairs judgment, behaviour, or capacity to recognize reality or ability to meet the ordinary demands of life.”10 This

the Alzheimer type”), disorders resulting from injury (e.g. in children, for example, receiving a severe injury), “functional” mental conditions (e.g. schizophrenia, affective disorders), “neurosis” (e.g. anxiety, panic disorders, obsessive compulsive disorders), and personality disorders of every kind. The heterogeneity of individuals included in this definition translates into an array of management options including ambulatory care, short term acute admission, or long term institutionalization, voluntarily or otherwise. While for some chronically mentally disordered persons, permanent institutionalization may be an option, for others, suffering from seriously acute and severe conditions such as irreversible coma, permanent hospitalization is the only option.

6 See G.B. Robertson, Mental Disability and the Law in Canada, 2d ed. (Toronto: Carswell, 1994) at 2.

7 See the Criminal Code, R.S.C. 1985, c. C-46, s. 2. It may be argued, however, that the definition of “disease of the mind” is included in R. v. Cooper, [1980] 1 S.C.R. 1149: “[a disease of the mind includes] any illness, disorder or abnormal condition which impairs the human mind and its functioning, excluding, however self-induced states of alcohol or drugs; as well as transitory mental states such as hysteria or concussion.”

8 Ibid., s. 16(1): “No person is criminally responsible for an act committed or an omission made while suffering from a mental disorder that rendered the person incapable of appreciating the nature and quality of the act or omission or of knowing that it was wrong.”

9 See M.A. Gaudet, Overview of Mental Health Legislation in Canada 1994 (Ottawa: Supply and Services Canada, 1994) at 19-20.

10 The definition contained in the Uniform Mental Health Act (1987) has been adopted in several provinces, in toto, as in Alberta, or with modifications, as in Manitoba, Saskatchewan, New Brunswick, P.E.I., the Yukon and the Northwest Territories. In Ontario and Newfoundland, however, mental disorder is defined as “any disease or disability of the mind,” while in British Columbia a “mentally ill person” is defined as “[a] person who is suffering from a disorder of the mind that seriously impairs

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definition, apart from being more functional, and possibly broader than the DSM IV definition, is also more helpful to conceive legal standards that could be later used to establish legal parameters for research involving the mentally disordered.

A.2. Capacity And The Mentally Disordered Person

The key component of a functional definition of “mental disorder” is the presence of a mental or physical impairment which often seriously reduces the subject’s capacity to provide consent.11 In this sense, capacity refers to whether a person possesses the psychological and physiological foundations that constitute the wherewithal required to make decisions.12 A determination of capacity is a medical act.13 However, the factor taken into account most often when considering the mentally disordered is competency, which involves the ability to understand and appreciate the nature and consequences of one’s decisions.14 Competence is a legal categorization.15

his ability to react appropriately to his environment or to associate with others; and that requires medical treatment or makes care, supervision and control of the person necessary for his protection or for the protection of others.” In Nova Scotia, a person suffering from a mental disorder is not referred to as having a mental disorder, but is rather defined as “‘an adult in need of protection’ who is not receiving adequate care and attention in the premises where he resides and ‘is incapable of caring adequately for himself by reason of…mental infirmity, and refuses, delays or is unable to make provision for his adequate care and attention.”’ Finally, the legislation in Québec does not provide a definition of “mental disorder.” Ibid.

11 “In a wide spectrum of disorders and conditions, mental or physical impairment seriously reduces the subject’s capacity to give informed consent. Among these conditions are Alzheimer’s disease, schizophrenia, manias with depression and suicidal behavior, types of aphasia, and states of partial or total coma.” See J.C. Fletcher, F.W. Dommel Jr. & D.D. Cowell, “Consent to Research with Impaired Human Subjects” (1985) 7:6 IRB 1 at 1.

12 “In contrast to competency, decision making capacity is defined as the ability to make an acceptable choice with respect to a specific decision.” See D.N. Weisstub (Chair), Enquiry on Mental Competency: Final Report (Toronto: Queen’s Printer, 1990) at 31.

13 “Medical” is understood as covering all medicine related professions. 14 “A person is capable with respect to a treatment if the person is able to understand

the information that is relevant to making a decision concerning the treatment and able to appreciate the reasonable foreseeable consequences of a decision or lack of decision.” See Consent to Treatment Act, 1992, S.O. 1992, c.31, s. 6(1).

15 “Competency” has been defined as “the capacity to function in a particular way, the ability to process and understand information and to make relevant, well-circumscribed decisions based on that understanding…[but] in plain language, however, individuals are ‘competent’ if they are recognized as having achieved a certain level of expertise or ability in a particular area.” See Weisstub (1990), supra note 12 at 26.

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Cognitive impairment, in the context of experimentation, “…renders persons incompetent to make their own decisions to participate in research if it eliminates the person’s ability to understand, make choices about, or communicate a decision regarding particular research.”16 Such a characterization, although often convenient, is overly broad, including the mentally ill, mentally handicapped, the demented, and even the unconscious. The mentally disordered, when cognitively impaired, may be considered incompetent and unable to act autonomously. Along these lines, the Medical Research Council of the United Kingdom provides a useful definition of “mental incapacity” as it relates to the mentally disordered:

We agreed that for our purposes mental incapacity should be defined as incompetence to give consent. Various categories of person are included in this definition; we are primarily concerned with the mentally ill, the mentally handicapped, the demented and the unconscious. Some of these persons will never have the capacity to give consent, some will lose it irrevocably and in some it will be present at times but not at others.17

While it may often be convenient to use a broad all-inclusive description of ‘mental disorder,’ it is preferable to use a more restrictive term that would only include, for example, dementias and psychotic disorders, distinguishing those persons afflicted with mental disorders from individuals with developmental disabilities. This distinction is made primarily on the basis that the latter have never possessed, nor are they ever likely to possess, to varying degrees, sufficient competence to make decisions regarding their own welfare. As a result, the developmentally disabled will be discussed separately.18

16 American College of Physicians, “Position Paper on Cognitively Impaired

Subjects” (1989) 111 Annals of Internal Medicine 842 at 843. 17 Working Party on Research on the Mentally Incapacitated, The Ethical Conduct of

Research on the Mentally Incapacitated (London: Medical Research Council, 1991) at para. 3.1.1.

18 See J. Arboleda-Florez & D.N. Weisstub, “Ethical Research with Vulnerable Populations: The Developmentally Disabled” (1996) [In this Volume].

In addition to the basic definitional problem associated with the mentally disordered, there is also the problem of overlap with other vulnerable groups. For example, mental disorders can be found among children, the elderly, prisoners, and the developmentally disabled. In such cases, the protective principles applicable to each population must be observed.

There is also the practical problem of identifying an individual as “mentally disordered,” especially in the case of the developmentally disabled because “[i]ndividuals with Mental Retardation have a prevalence of comorbid mental disorders that is estimated to be three to four times greater than in the general population.” See DSM-IV, supra note 5 at 42. Owing to an individual’s inability to communicate effectively, mental disorders may go undiagnosed in such persons, or they may be misdiagnosed.

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A.3. Fluctuating Capacities

It is possible that mentally disordered persons may exhibit increasing or decreasing levels of competence, and so, they could best be characterized as having fluctuating periods of lucidity, during which times they may be competent to a certain degree.19 The frequency of such periods and the corresponding quality of decision-making capacity may vary depending upon the type and severity of the mental disorder. Specific delusions could affect the decision at hand, even though “pacific,” seriously depressed patients, may waive their rights. Under such circumstances, it would be unwise for a researcher to assume that the patient had the proper capacity to make a decision.20 Fluctuating degrees of competence will therefore have special consequences on the means by which the mental competency of such individuals is assessed and on the question of how consent to participation in research should be obtained.

The powers given to guardians are also relevant in this context.

Traditionally, although no longer the case in many provinces, a guardian appointed over a mentally disordered adult’s physical person had plenary powers.21 In other words, a guardian would have total control and authority over the incapable adult. Such an appointment is made when there is a finding of ‘mental incompetency,’ where the individual is completely unable to make decisions or otherwise act in his or her best interests. However, this position is based upon the assumption that a person is either ‘incompetent’ or not. Such an approach fails to 19 The problem of fluctuating periods of lucidity, accompanied by a general decline in

decision-making capacity as a whole can be found in patients suffering from, for example, Alzheimer’s disease. This can be a serious problem in lengthy research proposals where a patient may be competent at the commencement of the experiment, only to be incompetent by its conclusion. See 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 320, 326.

20 J. Arboleda-Florez, “Reibl v. Hughes: The Consent Issue” (1987) 32 Canadian Journal of Psychiatry 66 at 69.

21 Based on 19th century English lunacy laws, this basis of Canadian guardianship law has been criticized as being archaic. However, Alberta, Saskatchewan, Québec and Ontario (with British Columbia soon to follow) no longer automatically award plenary guardian powers. Until recently, only Saskatchewan, Alberta and Québec were among the jurisdictions which endorsed and enacted the concept of limited guardianship. These provinces, in their legislation, recognize that individuals may be incapable of making decisions in some areas of their lives, while being completely competent in others. See R.M. Gordon & S.N. Verdun-Jones, Adult Guardianship Law in Canada, Rel. 2 (Scarborough: Carswell, 1994) at 4-5ff. In Ontario, for example, complete guardianship is granted only if an individual is completely incapable of personal care. “A person is incapable 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.” Otherwise, a person is granted only partial guardianship. See Substitute Decisions Act, 1992, S.O. 1992, c. 30, ss. 45, 55-77.

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acknowledge the possibility that, apart from acute and serious conditions such as strokes, a person does not become totally incapacitated overnight; incapacities tend to develop gradually. A person may be incapable of making decisions in certain situations. In this regard, it is important to acknowledge that incapacity, and hence incompetency, (a) fluctuates and may vary according to the area under investigation in the patient’s life, (b) “can vary over time for a variety of physiological and psychological reasons and also as a result of learning and increased familiarity with the subject matter of the decision,”22 and (c) “is not to be understood in any global sense, but rather as reflecting incapacities with respect to specific decisions or areas of decision.”23

Therefore, although mentally disordered persons are, in general,

capable of making decisions on their own behalf, because of a potentially fluctuating capacity that may affect them from time to time, their capacity to act autonomously may be questionable. These concerns raise the important question of whether, because of their restricted autonomy, the participation of the mentally disordered in non-therapeutic research should be circumscribed. The dilemma is complicated further by the potential problem of voluntariness.

A.4. Voluntariness

From time to time, mentally disordered persons may be placed in institutions, and consequently present themselves as a convenient group for research purposes.24 Moreover, it has been observed that “…institutionalization can contribute to a person’s vulnerability, increase dependency, foster peer pressure and a desire to please caregivers, and put in doubt the voluntariness of a resident’s consent.”25 In light of these

22 See D.N. Weisstub (1990), supra note 14 at 46. 23 Robertson, supra note 6 at 3. 24 While cases of flagrant abuse and exploitation of the mentally disordered have

occurred in the experimental context, known cases are fortunately uncommon. However, since cognitively impaired individuals may not be in the best position to vocalize their objections, it is possible that abuses of the mentally disordered may be far more common than believed. Unlike the case of prisoners, where experimental abuses were more frequent, part of the reason for a decreased number of incidents of abuse of the mentally disordered in the experimental context may be due to the population’s general unsuitability for experimentation. There are many problems with aspects of the standard experimental design (such as randomisation, the use of control groups and blinding) that arise when conducting research on the mentally disordered. For a discussion of such problems, see R.J. Dworkin, Researching Persons with Mental Illness (Newbury Park, N.Y.: Sage Publications, 1992) at 50-55. Consequently, research utilizing the mentally disordered as subjects will tend to be limited to the study of mental disorders, rather than general disorders which can be tested on the general population.

25 For example, in the case of Alzheimer’s disease and other dementias, there is an “..increased sense of dependence upon caregivers (including families), investigators

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circumstances, the mentally disordered may be particularly vulnerable to exploitation and abuse. More specifically, these considerations raise concerns regarding the voluntariness of their consent to participate in biomedical research.

Voluntariness invokes the question of whether a decision is made

freely and whether it is truly representative of the individual’s will. This issue is especially of concern where the subject has been civilly committed. Like prisoners, civilly committed individuals may be highly susceptible to inducements in exchange for participation in research.26 It has been observed that “…institutionalization can contribute to a person’s vulnerability, increase dependency, foster peer pressure and a desire to please caregivers, and put in doubt the voluntariness of a resident’s consent.”27 More generally, the Medical Research Council of Canada stated:

Mentally-incompetent adults with whom research may legally be conducted present special problems as well as when they are institutionalized. As such, they are similar to patients, prisoners, or, for example, members of military forces. Their will may be conditioned by their surroundings and by the influence of personnel having control of their comforts and environments. They may also be induced by the promise of advantages to which those in free circumstances would not respond.28

Therefore, threats against the voluntariness of decision-making among the institutionalized mentally ill increase the importance of the question of whether civilly committed patients should be excluded automatically from participation in non-therapeutic research protocols. Further, an individual may meet the criteria for commitment and yet may still be competent to make decisions about treatment and participation in research.

The concern for voluntariness relates to the notion that the legal

requirement of informed consent may not be an adequate safeguard to ensure voluntariness when applied to institutionalized populations. Even if the criteria for providing informed consent are met and a seemingly valid consent is obtained, mild inducements (from an ‘outside’ perspective) may

who are health care professionals, and institutions. These factors may in some cases reduce the voluntariness necessary in order to provide a legally valid informed consent.” See Keyserlingk et al., supra note 19 at 320, 322.

26 J.L. Hill, “Exploitation” (1994) 79 Cornell Law Review 631 at 697. 27 See Keyserlingk et al., supra note 19 at 322. 28 Medical Research Council of Canada, Guidelines on Research Involving Human

Subjects (Ottawa: Supply and Services Canada, 1987) at 31.

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seem significant, almost coercive, in an institutional setting.29 Consent, therefore, while it may appear informed, may not be voluntary.

It is not only the physician who may affect voluntariness; close

family members may have an influence as well,30 placing on the patient additional pressures to participate in research. The effects of family members on decision making was pointedly described by Lord Donaldson as “subtle, insidious, pervasive and where especially powerful religious beliefs may be involved.”31 His Lordship concluded that two factors were of crucial importance in assessing the effect of outside influence: the strength of the will of the patient (“one who is very tired, in pain or depressed will be much less able to resist having his or her will overborne than one who is rested, free from pain and cheerful”); and the relationship of the “persuader” to the patient.

Therefore, factors affecting voluntariness contribute to the overall

vulnerability of the mentally disordered. Among other precautions, institutional review committees must take care to ensure that individuals (and substitute decision-makers) do not have the impression that refusal to participate in a research protocol would result in substandard care. However, one should not exaggerate the impact of institutionalization. Institutions differ widely in quality of care and degree of independence, and may have been chosen by the patient before a serious mental condition, such as dementia, sets in. Institutionalization, in and of itself, should not be a limiting factor.32 “People do not automatically become incapable of competent and voluntary consent the moment they enter a mental institution.”33 Rather, institutionalization should be viewed as a factor in assessing the legitimacy of a potential subject’s consent to participate in an experiment.

29 For example, an unspoken promise of better treatment in exchange for participation

in research may serve as an unbalancing factor in the decision-making process of an institutionalized person.

30 See Arboleda-Florez & Copithorne, supra note 3 at 5-18. 31 In Re T., [1992] 4 All E.R. 649 (C.A.) at 667. 32 Also, by entirely banning research on institutionalized populations, one may

preclude the study of phenomena which are particular to institutionalized settings, for example, the study of the effects of institutionalization, or the spread of contagious diseases in a mental health facility.

33 Office for Protection from Research Risks, National Institutes of Health, Protecting Human Subjects: Institutional Review Board Guidebook (Washington, D.C.: U.S. Government Printing Office, 1993) at 6-28.

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B. Approaching The Problem Of Protection Versus Autonomy

The conflicting aims of society and those of the subject, that is, promoting research versus the desire not to be exposed to risks of harm, go to the heart of the dilemma of human experimentation. As expressed by Melnick et al.:

… [invasive research that poses greater than minimal risk with no direct therapeutic benefit to a subject] poses in the most dramatic form the conflict between the societal interest in the conduct of important and promising research and the interests of the potential subject; these interests are protected both by the doctrine of informed consent and by the laws of many states which limit the ability of family members or legal guardians to authorize such interventions.34

Indeed, various jurisdictions have addressed this conflict in different ways. For example, the primary goals of the New York State Office of Mental Health regulations (1990) in relation to medical research on the mentally disordered have been described as follows:

1. maximization of patient autonomy & control over participation in research;

2. protection of the rights and welfare of this potentially vulnerable population; and,

3. creation of an environment in which appropriate research may be conducted.35

These statements recognize the need to balance two major ethical considerations: protecting individuals while respecting their autonomy. Enabling the mentally disordered to make decisions on their own behalf is but one consideration. Adequate safeguards designed to protect them from exploitation and abuse must also be enforced. Therefore, in addressing issues of competence and voluntariness as they relate to the problem of consent to participation of the mentally disordered in non-therapeutic research, any ethical, moral and legal discussion must also engage the conflicting ethical objectives of protecting individuals through interventions while respecting their autonomous rights.36

34 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.

35 See S.J. Delano & J.L. Zucker, “Protecting Mental Health Research Subjects Without Prohibiting Progress” (1994) 45 Hospital & Community Psychiatry 601 at 602. The Regulations referred to are: New York State Office of Mental Health Regulations Governing Research, 14 N.Y.C.R.R. (1990) § 527.10.

36 For example, when speaking of enabling the mentally disordered to make personal decisions, the fact that such individuals may be lucid at some times but not others should not be overlooked. The right to consent to participate in research would be meaningless when individuals are incompetent to express it.

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B.1. Fluctuating Capacities And The Presumption Of Competency

The common law presumption of competency extends to the

mentally ill.37 Further, Fleming v. Reid38 held that informed consent was a liberty interest protected by s. 7 of the Charter, and consequently one that could only be infringed by procedures in accordance with the principles of fundamental justice.39 This decision places a responsibility on physicians to test the competency of a mentally disordered person prior to treatment.40 The same considerations would apply, mutatis mutandis, to researchers, especially if it is assumed that the competency of mentally disordered persons may be compromised according to the fluctuating characteristics of their mental condition.

Given the fluctuating capacities of the mentally disordered, that is,

periods of lucidity at various points during their lives, such persons may be competent to make decisions regarding their involvement in biomedical research at such times. This is assumed to be the case even if the quality of lucidity fluctuates periodically and is generally unpredictable. In this context, it is important to consider Fleming v. Reid and Malette v. Shulman,41 in which advanced directives were declared valid for refusing treatment, even though in both cases the patients were presently incompetent. Any system of enabling the mentally disordered must therefore be geared toward capitalizing on those moments when they are lucid, and toward maximizing their decision-making capacity when not fully competent. They should be empowered to make decisions on their own behalf insofar as they are able to do so, as determined by a mental competency assessment, and they should be able to exercise their right to self-determination through the use of research directives and durable powers of attorney while competent. Indeed, direct consent by an individual while competent, including through the use of research directives, may provide the most suitable means by which mentally disordered persons would be allowed to participate in biomedical research, and should be sought whenever possible.

37 For the sake of the present discussion, it is presumed that those individuals who are

affected by mental disorders that are so severe as to render them entirely incompetent are in the minority.

38 Fleming v. Reid (1991), 4 O.R. (3d) 74 (C.A.). 39 Section 1 of the Charter. 40 See Arboleda-Florez & Copithorne, supra note 3 at 5-15. 41 (1990), 72 O.R. (2d) 417 (C.A.).

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B.2. Specific Capacities, Incapacities And The Presumption Of Capacity

Conducting non-therapeutic experimentation on the mentally disordered is complicated by the difficulty (or impossibility) of obtaining the subject’s informed consent coupled with the ethical dilemmas associated with the use of proxy or substitute decision-makers. Any response to these problems must first address the following question:

…society must first ask itself whether or not it should be at all acceptable to use human subjects that cannot participate directly in decisions involving their own physical integrity, when the procedure used on them is of no personal benefit to them. A strong and coherent argument can thus be built for total prohibition on a philosophical and ethical level.42

Pursuing such an argument would lead to a protectionist solution whereby experimentation of a non-therapeutic nature on the mentally disordered would be banned completely. This position relies upon the assumption that all mentally disordered persons possess diminished or impaired competence sufficient to justify maximum protection. Indeed, a generalization of this kind relies upon a global presumption of incompetence. Yet, while a dichotomy between competence and incompetence remains, the modern tendency is to separate incapacity for specific circumstances from declarations of total incapacity.43 In other words, “[o]ne’s mental competency or capacity must be considered in relation to particular tasks.”44

To further emphasize this point, mental incapacity occurs along a

gradient. A declaration of incapacity for a particular legal event does not necessarily imply that the person cannot have capacity for other events. Weisstub, for example, indicates:

The more complicated cases with regard to assessing capacity are those in which the individual appears capable of making some decisions but not others…. [thus] [b]earing in mind that in all other cases individuals’ capacities are marginal, the desirability of allowing individuals to exercise the greatest possible measure of control of their

42 J.-L. Baudouin, “Biomedical Experimentation on the Mentally Handicapped:

Ethical and Legal Dilemmas” (1990) 9 Medicine & the Law 1052 at 1058. 43 In Ontario, for example, guardians are granted plenary powers only if a 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, … [and] … is not able to appreciate the reasonably foreseeable consequences of a decision or lack of decision.” See Substitute Decisions Act, 1992, supra note 21, ss. 59(1), 45

44 “Historically, psychiatric patients were deemed mentally incompetent in all areas of their lives on admission to psychiatric hospitals. In most areas of their lives, this view has undergone a complete change.” See G. Sharpe, The Law and Medicine in Canada, 2d. ed. (Toronto: Butterworths, 1987) at 394, 395.

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bodies and their lives demands that tests of decisional capacity accurately reflect the requirements of a particular decision.45

The importance of avoiding false presumptions regarding the mentally disordered was also noted by Delano and Zucker:

It is commonly assumed that persons who are mentally ill have a significantly impaired ability to provide meaningful informed consent and, in the case of those who are institutionalized, that they are further restricted in their ability to consent by the inherently coercive nature of their setting … neither of these propositions is necessarily true.46

The purpose of a presumption a capacity, rather than an incapacity, to consent, is to stop perpetuating the fallacy that persons with mental illness are automatically incapable of making life decisions, which in Canada, could amount to discrimination under the Charter.47 Therefore, mentally disordered persons should be presumed competent to consent to participate in biomedical experimentation unless proven otherwise. By enabling the mentally disordered to make decisions on their own behalf, the effect of stigmatization on a population, already distinguished as “vulnerable”, can be offset. The impetus behind enabling individuals is also grounded in the fundamental ethical principle of respect for persons. This includes avoiding presumptions of incompetence merely because an individual is afflicted with a mental condition.

In addition to the right to be informed, the most important aspect

of the principle of respect for persons is the respect for autonomy. This requires “…that those who are capable of deliberation about their personal choices should be treated with respect for their capacity for self-determination.”48 Naturally, enabling the mentally disordered to make their own decisions can only extend so far as those persons who are capable of making those decisions. Limitations should be determined on a case-by-case basis, grounded in the assessment of an individual’s capacity (or competence) to make decisions.

Enabling an individual requires the presumption that a person is

both capable and competent to make decisions. Where these assumptions fail, as in the case of an assessment resulting in a declaration of incompetence, the person would be precluded from making the decision of whether or not to participate in an experiment. In such a situation, he or 45 See Weisstub (1990), supra note 12 at 47. 46 See Delano & Zucker, supra note 35 at 601. 47 Section 15(1) of the Charter stipulates that “Every individual is equal before and

under the law and has the right to equal protection and equal benefit of the law…in particular, without discrimination based on…mental or physical disability.”

48 Council for International Organizations of Medical Sciences, in collaboration with the World Health Organization, International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993) at 10.

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she may be requested to identify a substitute decision-maker or to produce a research directive. It is important, therefore, in anticipation of future mental incapacity, to prepare advanced directives for research, and if the law permits, to appoint in advance a substitute decision-maker.49 In addition, the guarantees extended to competent research subjects, including the rights to refuse to participate or to withdraw from a research protocol without jeopardizing their treatment or care, should also apply to incompetent subjects. Thus, while mentally disordered persons may be inducted into a research protocol through the consent of guardians or substitute decision-makers, the power of the surrogate should not be extended to override the incompetent patient’s decision to refuse, or to withdraw at a later date.

In conclusion, there are two ethical considerations encapsulated in

the fundamental principle of respect for persons: a respect for autonomy in competent individuals, and the protection of persons with diminished autonomy.50 A protectionist solution, such as completely banning experimentation on the mentally disordered would be incompatible with the primary consideration that individuals should be treated as autonomous agents. Rather, a flexible position that protects the incapacitated persons while at the same time permitting and promoting participation in research should be pursued. Such an approach is supported in the recent recommendations of the Law Commission of the United Kingdom,51 and indeed should be adopted as the course for reform of the law on experimentation in Canada.

C. Ethical And Legal Principles: International And Canadian Sources

Developing a set of guidelines for the conduct of ethical research involving the mentally disordered requires a consideration of the various international and national declarations, codes, guidelines, and laws that address this issue. Upon completing such a survey, it becomes evident that a modern consensus exists which states that experimentation on the mentally disordered should not be banned, but that adequate safeguards are essential.52

49 For a detailed discussion of the ethical and legal considerations raised by advance

directives for research and durable powers of attorney. See D.N. Weisstub & A. Moorhouse, “Advance Dircectives for Research: Ethical Problems and Responses” (1996) [In this Volume].

50 See CIOMS Guidelines, supra note 48 at 10. 51 The Law Commission, Mental Incapacity (London: HMSO, 1995) at 100. 52 See D.N. Weisstub, “Regulation of Biomedical Experimentation with Special

Populations: International Trends and Canadian Options” (1996) 16 Health Law in Canada [in press]

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With the Nuremberg Code,53 the International Covenant on Civil and Political Rights54 and the first incarnation of the Declaration of Helsinki,55 there was a ban on research with individuals unable to provide consent. Over the years, however, this restrictive stance was relaxed, as can be observed in the evolution of the Declaration of Helsinki into its present form, and is supported by the World Psychiatric Association’s Declaration of Hawaii,56 the United Nations General Assembly’s Resolution on Principles for the Protection of Persons with Mental Illness and the Improvement of Health Care,57 the Draft Bioethics Convention presently being considered by the Council of Europe,58 and the International Ethical Guidelines for Biomedical Research Involving Human Subjects, promulgated in 1993 by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization.59 However, despite the elaboration of ethical principles on an international level, surprisingly few jurisdictions, with France being a notable exception,60 have legislation or regulations addressing the problem of non-therapeutic research involving the mentally disordered.

In the United States, the Belmont Commission examined the

problem of experimentation on vulnerable populations between 1974 and 1978. These studies led to the publication of recommendations for

53 The Nuremberg Code constituted part of the judgement 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).

54 International Covenant on Civil and Political Rights, 19 December 1966, Can T.S. 1976 No. 47, 999 U.N.T.S. 171, 6 I.L.M. 368, art. 7.

55 World Medical Association, Declaration of Helsinki. Adopted at the 18th World Medical Assembly in Helsinki in June 1964. Amended at the 29th 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.) [Reprinted in (1991) 19 Law, Medicine & Health Care 264.]

56 World Psychiatric Association, Declaration of Hawaii (1977), s. 4. The full text of the Declaration of Hawaii appears in D. Clarence & D. Blomquist, “From the Oath of Hippocrates to the Declaration of Hawaii” (1977) 4 Ethics in Science & Medicine 139. The Declaration is currently undergoing revision to be ratified at the Congress of the World Psychiatric Association in Madrid, on August 21, 1996.

57 GA Res. 46/119 (1991). 58 Steering Committee on Bioethics, Draft Convention for the Protection of Human

Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Bioethics Convention and Explanatory Memorandum (Strasbourg: Directorate of Legal Affairs, 1994); Council of Europe, Committee of Ministers, Recommendation No. R. 90 (3) (1990); and Parliamentary Assembly, Council of Europe, Opinion No. 184 of the Parliamentary Assembly of the Council of Europe on the Draft Bioethics Convention (Strasbourg: Steering Committee on Bioethics, 1995).

59 See CIOMS, supra note 48 at 22. 60 Arts. L.209-1 to L.209-18 Code de la santé publique. An Experimentation Bill was

also recently under consideration in the Netherlands.

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research involving the mentally disordered,61 but were criticized as failing to “specifically address research involving persons with mental illness,” and thus “were never successfully incorporated in federal regulations, despite attempts to do so by the Department of Health and Human Services (DHHS).”62 The DHHS regulations only allude to research involving persons with mental illness, and fail to provide specific guidelines.63 Consequently, the American College of Physicians developed its own guidelines by analogy, based on the federal stance on research with children.64 Nevertheless, although federal regulations do not address research with the mentally disordered explicitly, various states have enacted legislation or issued regulations to supplement those promulgated by the DHHS.65

In Canada, with the exception of Québec,66 there is a complete

absence of statutory regimes regulating research with the mentally disordered. Rules for ethical conduct exist only in guidelines promulgated by such bodies as the Medical Research Council of Canada.67 Although

61 This report stated that experimentation should be performed on the mentally infirm

only upon satisfying two conditions: that there is minimal risk; and that the subject’s approval, if at all possible, should be obtained, but the approval of a legal representative should be necessary in all cases.

See National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Those Institutionalized as Mentally Infirm: Report and Recommendations (Bethesda, Md.: The Commission, 1977) at 44.

62 See Delano & Zucker, supra note 35 at 601. 63 See 45 C.F.R. 46 (1991) § 46.111 (7)(b). 64 See American College of Physicians (1989), supra note 16 at 846. 65 For example, in 1990, the New York State Office of Mental Health issued

regulations to govern research involving patients in psychiatric facilities operated or licensed by the State. See New York State Office of Mental Health Regulations Governing Research, 14 N.Y.C.R.R. (1990) §527.10. However, it is important to note that, at the time of writing, these regulations do not have the force of law. On February 28, 1995, Judge Edward J. Greenfield of the Supreme Court of New York, New York County, held that the “OMH regulations for the conduct of human subject research were promulgated by the Commissioner of OMH beyond his authority and are thus invalid. Accordingly,…the regulations codified at 14 NYCRR 527.10 [are] invalid and unenforceable.” See T.D. v. New York State Office of Mental Health 626 N.Y.S. (2d) 1015 (S.C. 1995). While the judgment was stayed upon the application by the OMH for appeal, the Court of Appeal, on August 3, 1995, vacated the stay. See T.D. v. New York State Office of Mental Health, M-3213, Index No. 5136/91 (N.Y. Ct. App. 1995) [unreported].

66 Arts. 20-25 C.c.Q. 67 See Medical Research Council, supra note 28 at 30-32. This document is currently

under revision by the Tri-Council Working Group, which released its Draft of the Code of Conduct for Research Involving Humans in March, 1996.

See Tri-Council Working Group, Code of Conduct for Research Involving Humans (Draft Document) (Ottawa: Minister of Supply and Services Canada, 1996) at 128-129. The Code emphasizes the need to designate an appropriate substitute decision-maker, but, like its predecessor, fails to provide a legal solution for the problems

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professional guidelines play a significant role in education and encouraging ethical behaviour, the mere availability of ethical codes, from a legal point of view, is of limited worth as a regulatory authority.68 Such sources, even if adhered to, probably fall short of establishing a standard of professional conduct that would absolve researchers and their affiliated institutions from liability in the event of an injury or death resulting from research activity.69

Indeed, the legality of research conducted with mentally

incapacitated persons in the absence of court approval has been seriously questioned in common law jurisdictions.70 In Canada, case law suggests that the parens patriae jurisdiction of the superior courts, a power derived from the common law, would be unlikely to authorize non-therapeutic experimentation with cognitively impaired adults.71 Therefore, in Canada, there exists a legal necessity to clarify the obligations of researchers and the rights of subjects in non-therapeutic experimentation, especially in cases involving vulnerable populations such as the mentally disordered.

It is proposed that the solution lies in the establishment of a

statutory regime in Canada’s common law provinces, and in the expansion of the existing regime in Québec. Indeed, there is a trend favouring external regulation, characterized by the enactment of statutes or regulations, rather than internal controls, such as through professional codes.72 Advocates for legislation include the Law Reform Commissions of Canada,73 the United Kingdom74 and Queensland, Australia,75 and

raised by such an alternative form of consent. Thus, the revised Code provides little more than a restatement of ethical principles, failing to provide any impetus toward much needed legal reform.

68 See e.g. P.R. Benson, “The Social Control of Human Biomedical Research: An Overview and Review of the Literature” (1989) 29 Social Science & Medicine 1.

69 This observation is illustrated by the holding of Weiss v. Solomon, [1989] R.J.Q. 731 (S.C.). See 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.

70 In the United Kingdom, see The Law Commission, supra note 51 at para. 6.33, and Working Party on Research on the Mentally Incapacitated, supra note 17. In Australia, see Queensland Law Reform Commission, Assisted and Substituted Decisions: Decision-making by and for People with a Decision-Making Disability (Draft Report) (Brisbane: Q.L.R.C., 1995).

71 See E. (Mrs.) v. Eve., [1986] 2 S.C.R. 388. 72 See Weisstub (1996), supra note 52. 73 See Law Reform Commission of Canada, Working Paper No. 61: Biomedical

Experimentation Involving Human Subjects (Ottawa: Law Reform Commission, 1989). at 45

74 See The Law Commission, supra note 51 at para. 6.3.2 75 See Queensland Law Reform Commission, supra note 70.

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most recently, the Enquiry on Research Ethics submitted to the Government of Ontario.76

D. Establishing Safeguards For Research On The Mentally Disordered

All experiments involving human subjects should be required to undergo review by an independent body, such as a Research Ethics Committee (REC).77 The REC must ensure that the research itself is of significant value and scientifically valid, that is, conducted by scientifically qualified persons, conforms to generally accepted scientific principles, has been preceded by experimentation on animal or other models, and is accompanied by a thorough knowledge of the scientific literature. Members of vulnerable populations should not be employed as subjects where other, more competent, persons could be available. Hence, research with the mentally disordered must be restricted to that which furthers the understanding, prevention or alleviation of a problem directly related to a condition or circumstance affecting the subject, or the class to which the subject belongs.

Researchers have a positive duty to minimize risks of harm to

subjects. This duty exists before an experiment, through a careful risk assessment and preparations to prevent injury; during an experiment, with ongoing support and monitoring, including the immediate termination of the protocol if there is probable cause to believe that injury, disability or death of the subject might arise; and after an experiment, by providing follow-up support for those subjects who require it. Generally, research involving the mentally disordered should not raise more than minimal risks. Wherever possible, non-therapeutic research should be conducted by researchers who are not the primary providers of health care to the subject.78

In addition to such general requirements, ethical research with the mentally disordered requires the elaboration of further safeguards taking into consideration the special characteristics of the population, specifically with regard to questions of voluntariness and competence, and the philosophical approach described above.

76 Enquiry on Research Ethics: Final Report (Chairman: David N. Weisstub,

Submitted to the Hon. Jim Wilson, Minister of Health of Ontario, Aug 28, 1995) 77 P.M. McNeill, The Ethics and Politics of Human Experimentation (Cambridge:

Cambridge University Press, 1993) at 138. 78 For a detailed discussion of general safeguards for research involving vulnerable

populations, including the notions of risk and risk assessment, see D.N. Weisstub, J. Arboleda-Florez & G.F. Tomossy, “Establishing the Boundaries of Ethically Permissible Research with Special Populations” (1996) [In this Volume]

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Research ethics committees must conduct a careful assessment of both the level of risk inherent in a research protocol, and also the level of mental competency possessed by a prospective subject. These two factors will interact to suggest what sort of experiments may be permitted on a particular mentally disordered person. A non-therapeutic experiment with minimal risk raises minor concerns regarding the consent of a subject, and only demands general protective measures. A procedure with no foreseeable risk is even less problematic. However, once an experiment exposes the subject to more than a minimal level of risk, additional protections become important, especially where the subject is a vulnerable person.

If primacy is given to the principle of autonomy, a mentally

competent person should be allowed to assume a high level of risk even without a direct personal benefit. However, by virtue of the principle of personal inviolability, this right is often circumscribed by law.79 As such, the determination of the level of risk of a research proposal must be conducted prior to any assessment of the mental competency of prospective subjects. “The criteria for determining competence might vary according to the degree of risk or discomfort presented by research procedures.”80 Consequently, competency assessments can serve to determine whether an experiment, classified according to level of risk, is permissible on a particular subject or class of subjects.

As a general rule, protection should be proportionate to the level of

risk involved. As stated by Melnick et al.:

The greater the risks posed by the research, the lesser the direct benefits likely to accrue to the subject from participation in the research, and the more complex the procedures involved in the research, the greater the need for careful scrutiny of the potential subject’s capacity to provide consent.81

In order to properly determine the validity of an individual’s decision to participate in a research experiment, it is necessary to assess that individual’s level of mental competence. The topic of mental competency assessment has been discussed at length by the Enquiry on 79 S.N. Verdun-Jones & D.N. Weisstub, “Consent to Human Experimentation in

Quebec: The Application of the Civil Law Principle of Personal Inviolability to Protect Special Populations” (1995) 18 International Journal of Law & Psychiatry 163 at 168.

80 See Office for the 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. [hereinafter OPRR Guidebook]

81 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 533

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Mental Competency.82 Various factors are taken into account in any such process, and a variety of techniques and preferred methods exist.83 Unfortunately, assessment protocols tend to be concerned mainly with the issue of consent to treatment, rather than with research. The objectives behind consent to treatment and consent to participation in biomedical research are very different. Therefore, when assessing mental competency for research purposes, assessors must modify their approach.

It is important to acknowledge the fact that among the mentally

disordered, a wide spectrum of capacities to provide consent can be found. Competence can vary in terms of degree and in duration. The following classification scheme, for mentally disordered patients suffering from dementia, demonstrates the fluctuating nature of a mental disorder’s effect on the individual’s competence, and consequently on his or her capacity to provide consent:

(i) Patients at a pre-dementia or early dementia stage who are presently competent and who have no diminishment or fluctuation in cognitive and reasoning skills, short-term memory, or expressive capacities.

(ii) Patients at an early dementia stage, who are presently competent despite a minor diminishment or fluctuation in cognitive and reasoning skills, short-term memory, or expressive capacities.

(iii) Patients of uncertain competence and those who are clearly incompetent in view of a more serious diminishment or fluctuation in cognitive or reasoning skills, short-term memory, or expressive capacities…84

This classification also illustrates the importance of competence as a factor used to assign a patient to a category that will have consequences for determining the type of experiment in which such a person may participate. “Competence” generally refers to an individual’s decision-making capacity, and an assessment of this ability might be justified by a

82 See Weisstub, supra note 12. 83 For example, among the various sorts of information used when assessing

competence, B. Quarrington, “Approaches to the Assessment of Mental Competency” (1994) 15:2 Health Law in Canada 35, states his preference for information provided by a person familiar with the person. That is, a person who,

has had the opportunity to observe the person spontaneously engaging in the activities of everyday life in which incompetence is alleged or suspected. If this familiar individual is governed by what is in the best interests of the person, and if the observations are recent and reasonably extensive, we accept his/her judgements of competency since they have an obvious validity. No additional data or information is needed. Given the good will of the familiar, no special qualifications are needed beyond those of understanding the life situation of the person, and being able to recognize success and failure in the coping behaviour of that person.

84 See Keyserlingk et al., supra note 19 at 322. Note that similar concerns can be raised about the competence of individuals with psychotic disorders, who would similarly have fluctuating cognitive capacities.

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mere doubt on the part of the clinician or researcher. Fletcher, et al., citing a 1984 NIH working committee report, stated three key assumptions for the assessment of decision-making capacity:

(a) In determining capacity, the assessment of a patient’s actual functioning in decision-making situations is given precedence over the outcome of a patient’s decision…

(b) Except as noted, individuals should be assumed to possess decisional capacity unless otherwise demonstrated; incapacity should be found to exist only when the individual lacks the ability to make decisions that promote his/her well-being in conformity with his/her previously expressed values and preferences. Rarely should incapacity be considered to be absolute; even when ultimate decisional authority is not left with the individual, a reasonable effort should be made to provide to the subject relevant information about the protocol and the available options and to accommodate his/her preferences.

(c) At least three criteria are relevant to determining level of impairment:

(1) how independently the subject has been functioning in making choices in daily life;

(2) evaluations of mental status requested from … consultants in psychiatry or neurology; and

(3) results of the physician’s initial efforts to inform the subject in the presence of a family member or significant other about the protocol and the available options.85

The criteria suggested as relevant to determining the level of impairment of decision-making capacity no doubt form the basis of many methods for competency assessment. However, in addition to the stigmatizing nature of mental incompetency, many deficiencies in relation to current practices in assessment procedures have been pointed out. These criticisms include: a failure in many evaluations to proceed with the fundamental assumption that an adult is competent rather than incompetent; the futility of attempting to establish a single criterion of incompetency; the fact that a medical diagnosis of mental disorder does not immediately imply incompetency; and the fact that incompetency will often fluctuate and vary in relation with different areas of an adult’s life.

As an assessment of competency is important to any consent

process, several useful guiding principles should be recognized. A mental disorder should not be presumed to diminish a person’s capacity to consent to participation in research. Even where a court has declared a person to be incompetent, unless the court specifically states that this declaration includes the capacity to consent to participation in research, such incapacity should not be presumed, especially since certain mental disorders may result in fluctuating levels and periods of incompetence. A competency assessment should never be influenced by the outcome of a 85 See Fletcher, Dommel Jr. & Cowell, supra note 11 at 4.

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patient’s decision, should not be prejudged, and should only occur where justified by the circumstances.

D.2. The Doctrine Of Informed Consent

Although the expectation has been that subjects have a responsibility to avoid abuse by withholding consent, this is not always possible for the mentally disordered. A mental competency assessment is therefore important to determine whether an individual has the capacity to decide to participate at all. Whether a mentally disordered person is competent (and decides personally) or is found to be incompetent (and a substitute decides), the first and most important safeguards are to ensure that the consent to participate in research is both free and informed. This goal can be difficult to achieve with the mentally disordered owing to difficulties in establishing competence and voluntariness.

To obtain an informed consent, the researcher must provide proper

disclosure of all information relevant to the subject’s decision,86 and the prospective subject must be capable of fully understanding the information presented. In no case should research ethics committees and investigators assume that mentally disordered subjects “are unable to grasp any element of a protocol. While they may not be legally capable of making a valid choice to participate, appropriate respect for these prospective subjects requires that they be given the fullest possible explanations consistent with their abilities and in terms most easily understandable to them.”87

The Medical Research Council (UK) emphasized both the need to

seek consent and the elements of such consent:

…[s]eeking the consent of an individual to participation in research reflects the right of that individual to self-determination and also his fundamental right to be free from bodily interference whether physical or psychological. These are ethical principles recognized by English law as legal rights. We identified three elements to consent in its broadest sense — the information given, the capacity to understand it and the voluntariness of any decision taken.88

“Understanding,” or “comprehension,” is certainly the most important element, and depends on a number of factors. The Medical Research Council (UK) stated that understanding consists of 86 Deception can only be justified in rare instances. See D.N. Weisstub & G. Sharpe,

“White Lies and Grey Truths: Duplicity in Biomedical Research” (1996) [In this Volume].

87 See Keyserlingk et al., supra note 19 at 339. 88 See Working Party on Research on the Mentally Incapacitated, supra note 17 at

para. 3.2.1. This appears to be a standard categorization of the three required elements of consent. The Belmont Report, supra note 61 at 4, specified the same three elements to consent.

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comprehension of the nature and purpose of a course of action, and the long-term risks and benefits.89 The definition of “cognitive incapacity” provided by the Law Commission (UK) demonstrates this point:

A person should be considered unable to take the decision in question (or decisions of the type in question) if he or she is unable to understand an explanation in broad terms and simple language of the basic information relevant to taking it, including information about the reasonably foreseeable consequences of taking or failing to take it, or to retain the information for long enough to take an effective decision.90

Nevertheless, too much reliance on the doctrine of informed consent as a safeguard is not advisable. A test for informed consent can often serve as a test of comprehension, not of consent. For example, Irwin et al. noted in their study on psychotic patients’ understanding of informed consent that “most patients stated they had understood the informed consent information. Objective assessments of their understanding did not confirm this.”91 Therefore, the doctrine of informed consent only serves as a useful safeguard for valid consent with mentally disordered persons when they are competent (assuming that competence is not confused with comprehension). In fact, a patient may comprehend (cognitively) the elements of the information presented, and yet not appreciate the impact of the same information at an emotional level. Although the information may be comprehended, the patient may not be able to apply it. Finally, it should also be noted that the scope of consent that a subject provides may be different in length and complexity than what the researcher has in mind, or that the subject may have doubts about continuous participation as the project goes on. Therefore, it is essential that the researcher questions the subject on this issue from time to time throughout the duration of the project.

D.3. Voluntary Consent

As with prisoners, other institutionalized individuals may have a different set of values and a different notion of self-worth than the general public.92 As such, an institutionalized individual may consent to a far greater level of risk for a relatively minor reward (which may seem

89 See Working Party on Research on the Mentally Incapacitated, ibid. at para. 3.2.3. 90 See the Law Commission (1992), supra note 51 at 28 91 M. Irwin et al., “Psychotic Patients’ Understanding of Informed Consent” (1985)

142 American Journal of Psychiatry 1351 at 1352. The authors went further to say that, “The patients, all of whom were acutely psychotic were able to read the informed consent information, and most reported that their understanding of the information about antipsychotic medication was good. Objective measures, however, did not confirm their self-reports. Many simply affirmed understanding to mask confusion while reading the information about antipsychotic medication.”

92 See e.g. J.L. Hill, “Exploitation” (1994) 79 Cornell Law Review 631 at 697.

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significant to the subject) than would a person whose liberty is not restricted. Civilly committed individuals would be prone to similar exploitation and other forms of coercion possible in an institutional setting. As such, there should be a cap on the level of risk to which institutionalized mentally disordered persons may be subjected.

Therefore, in addition to an assessment of mental competence,

ethics review committees should include special safeguards to ensure that consent is truly voluntary. These safeguards might include:

• ensuring that representatives of the mentally disordered are granted meaningful roles as members of ethics review committees;

• ensuring the presence of an independent third party throughout the consent process. (a role that might best be served by a family member); and

• reducing incentives that might cause a prospective subject to become involved in research where others would not. This is especially relevant in the case of civilly committed patients.

D.4. Advance Directives For Research

Where a person is either unable to provide direct consent to participation in biomedical research or anticipates future mental incapacity, that individual’s autonomy and right to self-determination can be preserved in two ways.93 A competent individual may prepare a research directive, in the form of an instructional directive, which may include specific or general instructions detailing future participation in research protocols. Such a course of action is likely to occur as a consequence of a diagnosis of a disorder which predicts a future loss of competence. In the alternative, a person may create a durable power of attorney which specifies the individual’s substitute decision-maker of choice. The latter may be invoked in advance, as a directive; or it may be invoked where an individual is incapable of providing direct consent, but is capable of selecting a person who will consent on his or her behalf. Ideally a research directive should consist of both an instructional directive and a durable power of attorney.

As the mentally disordered represent a population that can have

fluctuating periods of lucidity or have been competent at some time in the past, the use of research directives is clearly relevant to their situation. Research directives should not be considered to be an exception to the general rule that research should only be conducted with the subject’s consent, but rather as an alternative means of indicating and ensuring

93 See Fletcher, Dommel Jr. & Cowell, supra note 11 at 2.

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consent. A research directive would provide a specific direction in place of future consent.

As discussed elsewhere, research directives are different from

advance directives concerning therapy or cessation of treatment. In the case of a directive consenting to participation in non-therapeutic research, the directive must be constructed restrictively and must not be open to interpretation. Consequently, a research directive must be specific in its terms, limiting the scope of future participation, including the level of pain and discomfort which will be tolerated. An individual should generally be restricted to consenting, in advance, to no more than a negligible or less than substantial risk. Exceeding this level of risk should be allowed only with judicial or quasi-judicial approval. It is also recommended that Ulysses Contracts consenting to substantial risks should be prohibited.94

D.5. Substituted Consent

As a general rule, the consent of participants is preferable to that of surrogates. However, in the absence of a competent contemporaneous or advance decision to participate in an experiment, experimenters must rely on substitute decision-makers.

There is an important distinction between a decision made by a

competent individual and that of an incapable person’s guardian. The former can be characterized as a direct expression of an individual’s will; the latter represents a subjective evaluation of what the incapable individual would have decided if competent to do so, or a decision made in the incapable person’s best interests.95 One can safely say that all modern legal systems have made provisions for guardianship of incapable adults.96 For example, the Law Commission (UK) report Mental Incapacity recommends that local social service authorities be named as guardians.97 Similar dispositions for the protection of research subjects could be made. However, in common law Canada, there are considerable doubts regarding the validity of third-party consent to non-therapeutic research.98 As discussed above, the courts, in exercising their parens

94 For a detailed discussion of advance directives for research, see Moorhouse &

Weisstub, supra note 49. 95 That is, it is important to distinguish between a decision made “in the shoes of” or

“in the best interests of” an incapable person. See e.g S.A. Kline, “Substitute Decision-making and the Substitute Decision-maker” (1992) 13 Health Law in Canada 125 at 127.

96 In the United States, the DHHS regulations clearly allow for the use of substitute consent by stating that “Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.” 45 C.F.R. 46 (1991) § 46.111 (a)(4)

97 See Law Commission (1995), supra note 51. 98 See G.B. Robertson (1994), supra note 6 at 164.

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patriae powers, are unlikely to authorize non-therapeutic experimentation. Therefore, there is a need for legislation to fill this gap in the law.

As described by Robertson,99 there are two major approaches to

substitute consent. The first is based on a “best interests” approach. Consent to non-therapeutic experimentation could not, by definition, be in the best interests of the subject. Therefore, a “best interests” approach would prevent a guardian from providing consent, even when there is no risk of harm. The decision reached in Re Eve, in which the Supreme Court of Canada refused to permit parents to authorize the non-therapeutic sterilization of their mentally handicapped child, might be applied by analogy to the issue of non-therapeutic experimentation on incapable subjects. The MRC seems to concur with this interpretation, providing additional justifications based on the Charter of Rights and Freedoms.100

The second approach involves a substituted judgment test, which

would permit consent to non-therapeutic research by a substitute decision-maker. The test entails determining whether or not the guardian believes that the person under his or her care would have agreed to participate in the experiment. If so, the guardian could provide consent on behalf of the incompetent subject.101

In Ontario, under the Substitute Decisions Act, 1992, with respect

to duties of guardians of the person and attorneys for personal care, competently expressed wishes supersede both the best-interest and the substitute judgment models. “If a 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.”102 Otherwise, the guardian is to make a decision based on the person’s best interests. However, even then, the person’s values and beliefs should be taken into consideration.103 Therefore, substitute decisions regarding personal health care in Ontario seem to be a hybrid between the best interests and substitute judgment models.

In addition, certain authors have expressed the need for judicial

authorization over and above that of the legal representative.104 Indeed,

99 Ibid. at 163-164. 100 See Medical Research Council, supra note 28 at 31. 101 B.M. Dickens, “Substitute Consent to Participation of Persons with Alzheimer’s

Disease in Medical Research: Legal Issues” in J.M. Berg, H. Karlinsky & F.H. Lowy, eds. Alzheimer’s Disease Research (Toronto: Thomson Professional Publishing, 1991) 60.

102 Substitute Decisions Act, 1992, supra note 21, s. 66(3)(1). 103 Ibid., s. 66(3)(4)(a). 104 See Baudouin (1990), supra note 42 at 1059.

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Québec requires that the Minister of Health and Social Services approve experimentation conducted on a group of incapable subjects of full age.105 Certainly, as the level of risk of a given protocol increases, and the justification for pursuing the research becomes correspondingly harder to demonstrate, judicial authorization could be a wise safeguard.

Regardless of which approach is used, the most fundamental

problem with relying upon substitute consent is that the decision to consent to research (and to any associated risk) is not that of the prospective subject. It is impossible for a third party to make a decision which would perfectly reflect the wishes of the person on whose behalf the decision is being made.106 Substitute consent is easier to justify in the context of medical treatment than in the context of non-therapeutic biomedical research which provides no benefit to the subject. Therefore, the simplest solution would be to prohibit the participation of mentally disordered subjects except in a very limited number of circumstances. These might include the following situations:

(i) the individual has verbally consented to an experiment while lucid;

(ii) the individual has prepared an advance directive in which he or she specifically consents to participate in the experiment or has named a substitute decision-maker in a durable power of attorney specifically for the purpose of consent to participation in research; or

(iii) a valid and informed consent has been obtained by the legal guardian of the individual.

Even if an individual has consented in one of the ways listed, the level of risk to which a substitute decision-maker could consent must be limited. Various authors have stated that, absent a research directive to the contrary, a substitute decision-maker must not be allowed to consent to research involving more than a low risk.107 Substitute consent to a procedure involving a substantial risk must be approved by a judicial or quasi-judicial authority, and should only be approved in exceptional cases.

Another consideration is the selection of the surrogate, a role that

can only be fulfilled by those with sufficient knowledge about both the patient and the research in question. Precedence should be given for the surrogate chosen by the patient. Lacking such an indication, a spouse, or

105 Art. 21 C.c.Q. 106 In fact, Veatch pushes this reasoning one step further by suggesting that even

clinicians “cannot obtain valid consent to treatment because they cannot guess which treatment option will serve a particular patient’s best interests.” [Emphasis added] See R.N. Veatch, “Abandoning Informed Consent” 25:2 Hastings Center Report 5 at 5.

107 See the American College of Physicians, “Position Paper on Cognitively Impaired Subjects (1989) 111 Annals of Internal Medicine 843 at 845; and Keyserlingk et al., supra note 19 at 348, both of whom also place the limit at minimal risk.

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parent or guardian (if a child), should be preferred unless a patient objects. Any such objection should be overruled only by a court order. The court may then appoint a close friend who must not be connected to the facility conducting the study.108

Regardless of who is chosen as the surrogate decision-maker,

decisions continue to be in the mentally disordered person’s best interests. Attention should be paid to any bias which the surrogate may possess. Family members may normally be in the best position to interpret an incompetent person’s cognitive status and anxieties; however, because of concerns for the inheritability of a disease, family members may have a vested interest in the results of the research, and may place undue pressure on the patient to participate.

E. Conclusion

The preferred method for enrolling mentally disordered persons in research protocols should be by obtaining contemporaneous, or in the alternative, advance consent, including by way of a research directive. In the case where it is impossible to obtain either, substituted consent by a legal guardian should be permitted, but only in cases of negligible to minimal risk. Exceeding this level should require judicial or quasi-judicial approval. It is recommended further that those jurisdictions lacking regulatory regimes enact legislation to regulate non-therapeutic research involving the mentally disordered, including provision for substituted and advance decisions. Such legislation must serve to protect this population, while at the same time strive to maximize and facilitate individual autonomy. All protocols must receive approval from established RECs, with particular care being given to ensuring voluntary and informed consent to participation. Sanctions should be imposed on researchers who do not adhere to the suggested guidelines. Serious deviations are either the result of extreme naiveté on the part of the researcher, or conscious attempts at misleading that may include preliminary steps at falsifying data. Naiveté amounts to negligence, whereas misleading and falsification of data is fraud, given that a researcher obtains approval of a protocol under strict conditions of adherence. The second problem is more difficult to recognize and to eradicate, but requires vigilance of the research community and RECs in a particular institution or jurisdiction. Both lack of adherence and unapproved research from outside the jurisdiction present threats to special populations, including the mentally disordered, who would not have the sophistication or the mechanisms to prevent their being abused.

108 See Kline, supra note 95 at 126.

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