CHAPTER 11:
The Question Of Ethics

INTRODUCTION

“Ethics” is usually defined as the systematic, reasoned attempt to understand values and principles underlying decisions about matters of fundamental human importance.  Put simply, it is about the right and the good.

In many fields, difficult decisions usually involve consideration of numerous factors, each implicating different – and often conflicting – values, principles, viewpoints, beliefs, expectations, fears, hopes, etc.  When facing such decisions, people may reach different conclusions not only because they consider different factors, but also because they weigh them against each other in different ways.  The practical effect of the discipline of ethics is to help those who face difficult decisions to identify the inherent values and principles that apply, to weigh them against each other, and to come to the best possible decision.[519]

In the context of health and health care – either in practice, delivery or research – the ultimate goal of ethics is to improve the health and quality of life of individuals.  In a paper commissioned by the Committee, Gordon DuVal and Francis Rolleston refer to long-standing and well-established ethical values and principles underlying this goal:

·        beneficence and non-maleficence – to practice in accordance with established standards of quality care and the best interests of the patient, and not to harm him or her;

·        autonomy – to show respect for the patient as an individual and to encourage the patient’s right to self determination, choice, and the protection of sensitive information; and,

·        justice – to ensure that patients and research subjects are treated fairly and resources are allocated based on considerations of equity and fairness.[520]

Other important values mentioned by DuVal and Rolleston include the familiar elements of virtuous behaviour such as compassion, honesty, promise-keeping, moral courage, patience, tolerance, preserving dignity and accountability, as well as community and relational values.[521]  These key ethical dimensions are largely reflected in professional and institutional codes of ethics and the law.  Altogether, these principles and values guide decision-making in the programming and delivery of health services and supports, clinical care and related research.

This chapter examines various ethical issues related more specifically to mental illness and addiction.  Section 11.1 analyzes ethical issues associated with the delivery of services and supports to individuals with mental illness.  Section 11.2 discusses capacity to consent to treatment.  Section 11.3 deals with privacy and confidentiality issues.  Section 11.4 examines ethical issues with respect to specific population groups – children/youth, seniors and forensic patients.  Section 11.5 discusses the ethical implications of advances in genetics and neuroscience.  Section 11.6 reviews ethical concerns raised with respect to mental health and addiction research.  Section 11.7 provides some Committee commentary.

At the root of many of the ethical issues and concerns canvassed throughout this chapter lies the social stigma associated with individuals affected by mental illness and addiction and their families.  In itself, stigmatization contributes to a relative lack of compassion and withdrawal of the dignity and respect with which all individuals should be treated.  In the end, stigmatization is at the base of injustice, the absence of beneficence and the inequality of access to needed services and supports.

 

 

11.1       ACCESS TO SERVICES AND SUPPORTS

According to DuVal and Rolleston, the ethical issues that relate to the provision of services and supports arise from the fact that “society has not taken practical steps necessary to ensure justice and beneficence for individuals with mental illness and addiction, both within Canada’s publicly funded health care system and beyond it.”[522]  First, the complexity of mental disorders significantly increases the challenges faced by society in addressing the need for effective services and supports for individuals with mental illness relative to other categories of illness.  Second, proper diagnosis, treatment and the continuing care of mental disorders involve not only many different health care providers, but also, to an extent not found in other illnesses, other professions, such as school teachers, law enforcement officers, clergy, social workers.  Absent a well coordinated health care system, individuals suffering from mental illness and addiction and their families have greater difficulty than most in accessing adequate health care, resulting in a form of systemic discrimination.

In their paper, DuVal and Rolleston argue that the relatively poor treatment of individuals with mental illness and addiction arises not simply because people or systems want to discriminate against them, but because of the factors that derive directly from the nature of mental disorders.  Mental illness and addiction often show themselves through behavioural signs whereas almost all other illnesses present with physical signs.  Behavioural aberrations caused by mental disorders are the basis for the fear and incomprehension that they engender in many individuals.  Such behaviours often result in problems with, for example, law enforcement authorities, or in school, which then, in effect, become the first line of treatment.[523]

Although there is no justification for adopting different standards of access, quality of care or priority setting when treating individuals with mental illness and addiction as compared to individuals with physical illness, this does seem to happen.  This is particularly problematic in crisis situations, when timely and effective care is required.  Dr. James Millar, Executive Director, Mental Health and Physician Services, Nova Scotia Department of Health, told the Committee:

 

[We] must also put the same time emphasis on mental health as society does for physical health. It is unacceptable for people with chest pain to wait to determine the cause. If the cause is cardiac, people want immediate attention. Unfortunately, those with emotional pain do not get the same consideration. They will probably wait to seek help, wait further to see a professional caregiver, be treated with outdated and inappropriate methods, and continue to suffer much longer than is necessary.[524]

Carlyn Mackey, Aurise Kondziela and Dorothy Weldon, from the Christ the King Family Support Group, wrote to the Committee that ethical standards that apply to mainstream medicine are not applied consistently to the provision of mental health care:

Ethical standards for the care and treatment of the mentally ill do not appear to be consistent with normal ethical standards of mainstream medicine. One must question the ethics of tolerating dysfunctional mental health systems, or systems which can even be described as non-systems.  It follows that the ethical issues of continuing and knowingly discriminating against the mentally ill in the area of safe and adequate health care provision must be addressed at all levels of government.[525]

An additional challenge in providing services and supports to individuals with mental illness arises because many different professions and areas of expertise are involved.  DuVal and Rolleston offered the example of a school teacher who first brings to a family’s attention the possibility that their child’s difficulties in school may be due to Attention Deficit Hyperactivity Disorder (ADHD).  In cases of disruptive behaviour, the school system will give the priority to the protection of other students.  Actions such as disciplining, suspension or expulsion reinforce stigmatization of the affected child.  Retention in the school system requires special classes or special teaching support to minimize the impact on other students.  If the mental illness leads to violence, law enforcement officers may become involved.  Clergy may be an early recourse for affected individuals who feel themselves possessed by forces outside their control.  Since recognition of mental illness by the sufferer himself or herself is so important to their management of their condition, school teachers, law enforcement officers, clergy and others in parallel professions often find themselves, sometimes inadvertently, thrust into the first line of diagnosis and treatment for individuals with mental illness.[526]

There are, however, multiple barriers based on split jurisdictions between the mental health system and the social services system which inhibit proper treatment of affected individuals.  For example, Dr. Robert Quilty, a registered psychologist working with the Durham County School Board, informed the Committee about the “diagnostic halo” that inhibits the diagnosis and treatment of mental illnesses in children with developmental disorders.  With autism, for example, this “halo” phenomenon often results in failure to recognize a disorder that could have been treated successfully if caught early enough.  This problem is compounded by difficulties in entering children with developmental disability into behavioural service agencies within mental health agencies thus further clouding an already uncertain future.  Children with high functioning autism (Asperger’s Syndrome) may fare somewhat better.  However, even with partially successful treatment, on reaching adulthood, developmentally disabled individuals who need further mental health care often do not receive it because they are labelled as being in need of community support; this is the result of the lack of coordination in service provision between various provincial ministries.[527]

As a consequence, the delivery of mental health services and addiction treatment is highly fragmented, disconnected and uncoordinated.  For individuals with mental illness, the problem of navigating this complex system of services and supports is compounded by the nature of their illness.  Numerous individuals with mental illness and addiction and other experts told the Committee that this lack of cohesion and coordination has led to an increase in addiction, homelessness and incarceration.

DuVal and Rolleston pointed out that the fragmentation of the system is evident even when it is clear that institutional care is required.  A telling recent case in Ottawa, that has received extensive media attention, concerns a young woman with violent and self-destructive behaviour.  The Children’s Hospital of Eastern Ontario could not admit her because they do not have facilities for such patients; the Royal Ottawa Hospital, an adult institution which has the necessary secure facilities, could not take her because she is too young.  This illustrates the serious ethical issues that flow from fragmentation of the “system” that is supposed to provide acute and long term care for patients of different ages and with differing mental conditions.[528]

The Committee was told that it is, above all, the family that usually bears the brunt of caring for an individual with mental illness who has been entrusted to home or community care where resources are, more often than not, inadequate or insufficient to meet their needs.  Mark Miller, Ethicist, St-Paul’s Hospital (Saskatoon), wrote:

And, I would say, the biggest ethical issue beyond the health care system itself is how often resources are lacking for family members caring for loved ones at home or in the community.  Many parents, siblings and other caregivers are mostly abandoned to their own resources, which is grossly unfair and arguably creating more health problems among caregivers than necessary.  Despair is not an uncommon feeling among families with a challenging member.[529]

11.2      CONSENT AND CAPACITY ISSUES

Society preserves individual choice – the right to consent to, or to refuse treatment – based on the individual’s fundamental right of autonomy.  But for consent to mental health services or addiction treatment to be genuine, the individual must be mentally and legally capable of making that choice.

While decision-making capacity is essential for valid consent, applicable clinical tests to assess competence are controversial, especially for those with mental illness and addiction.  Decision-making capacity includes in the ability to understand the relevant information concerning treatment, to appreciate the significance of that information, and to reason so as to weigh the available options logically.

Determinations of decision-making capacity raise special issues regarding the vulnerability of those suffering from mental disorders.  Clinical assessments of decision-making capacity focus primarily on cognitive functioning.  Because mental illness and addiction can affect cognition, individuals with such disorders, particularly in severe cases, will often lack decision-making capacity.  They may do so intermittently, however, as in the case of a person suffering from addiction, or gradually, as in the case of a person who is aging, slowly succumbing to dementia or some other degenerative process affecting cognitive function.  Adapting the delivery of services, as the patient fluctuates in, or gradually loses, his/her capacity, is a challenge for the mental health and addiction treatment system.  Respect for the person requires that the changing or diminishing capacity is identified and diagnosed, and that the system adapt accordingly, in order not to infringe unduly on the autonomy of the person affected.

Non-cognitive as well as cognitive functioning can also be influenced by mental disorders in ways that affect decision-making.  For example, clinical depression and other pathological affective states may diminish an individual’s capacity to choose or reject treatment even though an understanding of the relevant information is largely unimpaired.  Accepted conceptions of capacity do not account well for non-cognitive deficits such as the pessimism about the future that may characterize depression.  The test for mental capacity is unclear in the presence of, for example, dominant but potentially transient feelings of hopelessness, worthlessness, or impulsivity.

Similarly, in patients with schizophrenia, the delusional and paranoid nature of the disease may undermine decision-making capacity in ways not clearly related to an absence or loss of cognition.   Individuals suffering from addiction may have compromised decision-making by reason of difficulties in controlling the urge to engage in addictive behaviour.  In some eating disorders, where a pathological body image distortion is experienced, the incapacity may be narrowly focused; the role of such distorted thinking in determining capacity is unclear.

Therefore, the clinical assessment of mental capacity in the presence of mental illness and addiction is a complex matter.  Mental capacity to make decisions can exist at different levels and to varying degrees and can fluctuate over time.  Yet, in law, upon expert testimony and at a given point in time the legal capacity to make decisions is decided by a judge.  It is judged either to be present or absent in respect of distinct purposes (the capacity to care for one’s property or to care for one’s person, for example).  There are no degrees of capacity or incapacity.  The process for reviewing a judicial decision to establish protective supervision and to appoint a legal representative with each fluctuation in mental state can be time-consuming and cumbersome.  In its brief to the Committee, the Canadian Catholic Bioethics Institute explained:

The legal system tends to distinguish sharply between those who are deemed “capable” of decision-making regarding their health care and those who are incapable.  Many persons with an active mental illness, such as severe depression or schizophrenia, may not meet the legal criteria for being declared “incapable”, and yet they do have significant impairment of their ability to understand their condition, appreciate their options, make prudent decisions about their mental health care and follow through on these decisions.  Since patient autonomy plays such a central role in contemporary medical ethics, it is helpful to consider the ethical challenges that arise when capacity is denied when in fact some level of capacity is retained, on the one hand, and when capacity is presumed when in fact it is significantly impaired, on the other.[530]

The Committee was told that Ontario and some other provinces have legislated community treatment orders (CTOs).  A CTO is a doctor’s order, obtained with the affected person’s consent, for an individual to receive treatment or care and supervision in the community.  To give consent, the individual must be capable of consenting to treatment under the law.  If found incapable of consenting under the law, and a substitute decision-maker has been authorized, the substitute decision-maker must consent to the CTO, even if the incapable person disagrees.  There is concern among individuals with mental illness and addiction, however, that CTO legislation is too intrusive.  Alternatively, families who in the absence of access to formal caregivers are sometimes the primary caregivers, believe that without such legislation they would at times lack the ability to help a loved one.

Witnesses explained that while family members and health care providers may wish to protect the health and well being of an individual who is vulnerable by reason of diminished capacity, it is still important to respect the individual’s autonomy.  It was suggested that families and health care givers must therefore tread a delicate balance between seeking to help an individual with mental illness/addiction and respect his/her autonomy – even partial autonomy.  The answer is never black and white, but requires a response that seeks to understand the individual and the particularities of his/her condition.

More than with other types of disease, individuals with mental illness and addiction may lack insight into the existence and nature of the illness caused by their disorder.  The result may be a high degree of mistrust of health care providers and high rates of refusal of treatment or of non-compliance.  At what point does respecting a patient’s refusal of treatment become tantamount to abandoning a vulnerable person in clear need of help or care when intervention or treatment is indicated?

There is little doubt that a person with unimpaired decision-making capacity may refuse treatment and that such refusal must be respected.  However, when a person meets the legal standard of capacity – but nevertheless has compromised decision-making abilities – and is in need of care but refuses treatment, the situation for family members may be very difficult.

A related dilemma arises when a patient who is judged to be mentally and legally incapable of decision-making in respect of his or her own person resists the intervention needed to treat a mental disorder.  Although a substitute decision-maker may legally authorize the treatment on behalf of the patient, the practical problem remains how to administer such treatment in the face of what may be stubborn resistance.  The only available options may be to administer the treatment surreptitiously (such as by mixing medicine in food or drink), or employing force, or not at all.

Administering treatment using force or deception, particularly with vulnerable individuals such as those suffering from a mental disorder, raises serious ethical issues for family members and health care professionals.  Force or deception may undermine trust, a vital ingredient in the relationship with the patient/client, making continued communication, cooperation and care even more difficult.  Yet, it may be equally inappropriate not to provide treatment to a patient, who by virtue of incapacity, is vulnerable and in critical need of protection by some trusted person.  Patients may later be grateful for treatment given against their will at a time when they were incapable of making treatment decisions or they may continue to harbour resentment and not seek treatment subsequently if their symptoms recur.

 

11.3      PRIVACY AND CONFIDENTIALITY

In its October 2002 report entitled Recommendations for Reform, the Committee explored the need to protect the privacy of electronic health records and their use in research.  Considerations of privacy are equally and perhaps of greater concern in mental health, mental illness and addiction.

In their paper, DuVal and Rolleston suggest that a central presumption in society’s preservation of privacy is that society as a whole, and each individual within it, benefits from strict preservation of the right of an individual to control the use of his or her personal information.[531]

It is always used in a crisis situation. (…)  The person is considered a danger to self or others. (…) It is not a matter of casually sharing information. There is a purpose to the action, which is to give the person the best possible and the most knowledgeable assistance. That is not sharing information widely. [Nancy Hall, Mental Health Consultant (16:27-28]

Moreover, the fiduciary relationship between health care provider and patient is built on trust and premised on the fundamental principle of confidentiality, as reflected in most professional codes of ethics.  The testimony that we have heard, however, forces the Committee to ask whether our present legal and policy frameworks on privacy and confidentiality, which generally serve the mentally competent well, can act against the best interests of those who, because of the nature and pervasiveness of mental illness and addiction, become partially or completely dependent on the multiple care providers they encounter along the continuum of care.  Mr. John Arnett, Head of the Department of Clinical Health Psychology, Faculty of Medicine, University of Manitoba, stated:

As a clinician, I cannot go down the hall to ask a colleague of mine, who has seen a patient that I am about to see, what they know that might help me to better evaluate that patient.  The intent of the law is noble, there is no question about that, but it does impose limitations that impact negatively on patient care.  A large part of patient care is having access to knowledge of history and information.  The law creates a significant limitation[532]

Concern arising from strict observation of privacy and confidentiality rules also extends to the family of individuals with mental illness and addiction.  Without the patient’s permission, which those with mental illness/addiction may not be competent to give, a physician cannot share personal information with his or her caregivers, parents, siblings or children.  Murray, whose paranoid schizophrenic son was killed by a bus after escaping from hospital, asked:

Why is it that the medical profession is not allowed to share information with family members when it has been shown that family support is beneficial to the patient?  The patient is on meds because his thinking is affected; yet the medical profession believes that sharing information with a family member must be a decision of the patient, who cannot make a reasonable or thoughtful decision.[533]

Bronwyn Shoush, Board Member, Institute of Aboriginal Peoples’ Health, Canadian Institutes of Health Research, added to this by saying:

I wish to identify one area of law that I think has had a significant, negative impact in the mental health area and stigma in particular.  Privacy legislation is seen, at least in Aboriginal communities and I believe it is true elsewhere, to be a detriment to promoting secrecy concerning health matters. It is seen as not allowing people to discuss matters and feel that they are a normal part of the human condition.  They do not allow people who might be able to offer supports to have a way to do that in a timely way.[534]

These thoughts were echoed by the brief from the Christ the King Family Support Group in Winnipeg which stated that: “confidentiality requirements are cited to justify lack of adequate information to family care-givers regarding the nature and severity of the illness”.  They further wrote that family members are excluded from information about medication, safety issues and the care and treatment plans at the time of discharge; that family concerns are arbitrarily dismissed and not documented in the patient’s files; and that families are not adequately supported in attempting to cope with the devastating consequences of severe and persistent mental illnesses.[535]  It should be noted, however, that in circumstances of clear, serious and imminent danger, a physician may have an overriding duty in law to break his/her patient’s confidence in order to warn third parties and protect public safety.

11.4      SPECIAL POPULATIONS

11.4.1    Children/Adolescents

In previous chapters, the Committee described a number of issues concerning access to mental health services and supports for children and adolescents.  In addition to these, mental health treatment for children and adolescents raises unique ethical challenges relating to vulnerability, decision-making capacity, and the use and disclosure of confidential information.

Mental health professionals must be aware of heightened vulnerability due to age when treating children and adolescents as well as the potential presence of co-occurring mental disorders and any history of social disruption.  The capacity to consent to treatment interventions, and to do so voluntarily, is already compromised by mental illness but is even more difficult for young people.  While parental and other family involvement in treatment can be extremely helpful, those providing care must be aware of the potential for mistrust, dysfunctional relationships, or undue pressure resulting from parental guilt or overprotective attitudes toward the child.  Complex issues of confidentiality may arise when having to determine whether particular circumstances warrant disclosure of patient information to parents and/or relevant governmental or social service agencies.

11.4.2   Seniors

A variety of specific ethical issues are raised in the provision of mental health services to seniors.  For example, many patients in geriatric in-patient units lack decision-making capacity and either have no close family or may be in conflict with family members.  Geriatric patients are sometimes homeless; family members may be difficult to locate, uncooperative, uninvolved or reluctant to play a significant role.  It is estimated that only 10 to 20% of such geriatric patients benefit from any active family participation, and the balance have no involved family members.  Many senior patients “fall through the cracks”, in that general hospitals may be ill equipped to manage individuals with mental illness and psychiatric hospitals may lack the resources to manage the patient’s general medical condition.  Thus, geriatric patients with mental disorders often receive inadequate care.

In psychiatric hospitals, staff may misread pain symptoms, while expressions of pain by elderly patients with mental illness are often not taken seriously in general hospitals.  Inexperience with opiate pain medication and worries about drug interactions with antipsychotic and other psychiatric medications can lead to inadequate management of pain in this population.  Anecdotal evidence indicates that care and pain control may well be inadequate; long waits for attention may be followed by discharge back to the psychiatric hospital where the care may also be inadequate.

 Stigma often makes palliative care difficult for patients and their families to access.  Staff may lack clear direction in caring for psychiatric patients who are at the end of life.  They are often uncertain when to initiate aggressive treatment as opposed to treatment oriented primarily for pain management.  Psychiatric nurses may have minimal experience using morphine and other narcotics and feel uncomfortable using them assertively.

11.4.3   Forensic Patients

In its written submission, the York University Centre for Practical Ethics stated:

Many inmates are in our prisons because of the emotional instability or mental disorder, and once there, are not given appropriate treatment unless they are threatening others or themselves.  Moreover, their condition is likely to deteriorate in such an inappropriate environment.[536]

DuVal and Rolleston identified two types of ethical dilemmas in relation to forensic psychiatry.[537]  First, mental disorders, particularly when untreated, sometimes manifest in behaviour that would otherwise be seen as criminal.  While individuals with mental disorders who are accused of offences may sometime be found unfit to stand trial or not criminally responsible, police and courts often face a choice between referring mentally disturbed individuals for treatment or to the criminal justice system.  Lack of effective training of police and other criminal justice officials may contribute to inappropriate referral of such persons away from mental health resources.  Many believe that our jail and prison system house too many individuals with mental illness and addiction and insist that they, and society at large, would benefit from treatment rather than incarceration.

The second issue is that mental health professionals practicing in forensic institutions have a “double agency” problem.  In assessing a person charged with an offence, or in giving ongoing treatment to a person under the Provincial Review Board system, or otherwise giving evidence before administrative bodies or courts, these health care professionals have two distinct and often conflicting sets of obligations.  Their obligations as medical caregivers to their patient are unquestioned duties that include acting in their patient’s best interests, and to do no harm.  But at the same time, they also have the perfectly legitimate obligation to society to offer their candid and objective judgement and advice to courts, Review Boards, and other administrative bodies with respect to the mental status, diagnosis, and prognosis of the persons under their care.  Clearly, any such testimony and advice that places the priority on the benefits to society will not always be in the best interests of their patients/clients.

These conflicting obligations can be difficult to manage and can threaten the clinical relationship in a number of ways.  Most importantly, while giving expert opinion serves a socially valuable role, the quality of care may be compromised because the forensic mental health practitioner is unable to promise the patient confidentiality.  This has clear implications for the trust between the two.  The practitioner may also be obliged to use information gathered in the clinical relationship that can be of detriment to the patient in court or administrative proceedings.

 

11.5      ETHICAL IMPLICATIONS OF ADVANCES IN GENETICS AND NEUROSCIENCE

11.5.1    Genetics and Mental Health

According to DuVal and Rolleston, the stigma associated with mental illness and addiction gives rise to particular worries about the privacy of genetic information and the traumatizing effects that disclosure may have on already vulnerable individuals.  Genetic research and diagnosis relating to behaviours may be particularly threatening.  Research thus far suggests that straightforward linkages between a given gene and specific psychiatric conditions are unlikely to be established.  It seems more likely that genetic components of particular phenotypes will involve complex interactions of genetic and environmental factors.[538]  Still, safeguards must be in place to protect sensitive personal information, particularly that which alone, or when linked with other information, reveals, or may reveal some potential mental disorder or behavioural condition.

DuVal and Rolleston explained that attempting to adequately inform patients, or their surrogates, of genetic test results using the language of susceptibility and risk will raise difficult problems for individuals with mental illness and addiction.  Affected and healthy individuals alike will have to cope with their own vulnerabilities.  Social stigma and privacy risks complicate this burden, particularly since therapeutic benefit may lag behind diagnostic reliability.   The genetic component of mental illness and addiction also raises challenging questions for families and relatives of the patient or research subject, where heritability patterns are often difficult to predict.  The individual’s right not to know must be balanced against the responsibility to inform people of a genetic predisposition.  How this balance is reached will depend in part on the likelihood of the person’s developing the condition concerned, when it might manifest itself, and the chances of their being able to take steps to prevent or reduce the effects of developing a mental illness in the future.[539]

The Committee was also informed of “genetic essentialism”, the view that persons can be defined or characterized solely in terms of their genetic makeup.  This raises special concerns for those with mental illness and addiction.  People with genetic defects may come to feel they are flawed.  Decisions about reproduction may also be affected; for some the availability of pre-natal screening may raise eugenic concerns.  Since the social stigma of mental illness remains strong, worries about discrimination in insurance, employment, education, housing and others may be particularly acute.[540]  Proper management of predictive genetic information is a challenge generally, and it is even more acute when dealing with those with mental illnesses that are already marked by social stigma.

 

11.5.2   Neuroscience and Mental Health

Recent advances in both the technological and theoretical understanding of neuroscience raise difficult ethical problems and challenge traditional notions of free will, responsibility and the self.  Society’s response to these issues will have far-reaching consequences, perhaps as much or more than those related to emerging genetic technologies.

Here we provide just a few of these issues raised by DuVal and Rolleston.  Our evolving understanding of brain function and processes, together with developing imaging technology, will increasingly permit behaviours, personality traits and other mental events to be identified, monitored and correlated with observable changes in the brain.  Employment, education, insurance, legal processes, immigration, counter-terrorism and other social activities and relationships may all be affected by the ability to identify and possibly predict both positive and negative behavioural dispositions to, for example, violence, addiction, dishonesty, stress, sympathy, cooperativeness and other behaviours.[541]

Advances in neuroscience will also make cognitive and behavioural enhancements possible.  DuVal and Rolleston contended that, aside from important questions about the ethics of enhancements involving behaviour, personality and cognitive abilities, there are real concerns for social justice if such enhancement technologies are initially expensive and available only to the wealthy and privileged.  Further, as mental events become increasingly described in terms of brain structures and mechanisms, society may be obliged to re-examine accepted notions of free will, responsibility, and accountability – the so-called neuroscience of ethics.  In the forensic context, for example, if criminal or other aberrant behaviour is found to be causally related to differences in brain structure or function, what would be the basis for appropriate criminal responsibility and punishment?[542]

 

11.6      ETHICS AND MENTAL HEALTH AND ADDICTION RESEARCH

As mentioned in the previous chapter, there has been an acceleration of clinical research into mental illness and addiction in the last two decades that has produced significant advances in treatment.  Much of this important research, however, requires the participation of research subjects who suffer from mental disorders themselves.

In their paper, DuVal and Rolleston stressed that the history of psychiatric research is littered with public and private sector studies that have exploited the vulnerability of individuals with mental disorders, the neurologically impaired and developmentally disabled research subjects.  In one particularly infamous example, the American CIA sponsored clinical trials conducted at the Allan Memorial Institute at McGill University during the 1950s and early 1960s in which psychiatric patients were given hallucinogenic drugs without their knowledge.  The history of the unacceptable treatment of these vulnerable participants has played a pivotal role in the movement toward increased scrutiny and regulation of research involving human subjects; this provides an important context for the consideration of the ethics of research into mental illness and addiction.[543]

Advances in mental health science promise great benefits for those who suffer, or will come to suffer, from mental disorders and, in some cases, for research subjects themselves.  While individuals with mental illness may be particularly vulnerable in a number of ways, research policies and regulations that focus primarily on their vulnerabilities and deficits could encourage and possibly exacerbate the stigmatization already suffered by this population.  But on the other hand, it may be unjust to exclude, by overly restrictive regulation, those individuals with mental disorders who could benefit from their participation in research.[544]

There is a particular need for special precautions in research involving individuals with mental illness and addiction.  While all subjects of clinical research are vulnerable to some degree, the vulnerability of individuals participating in clinical mental illness/addiction research warrants particular attention.  On the other hand, most individuals with mental illness function reasonably well and it may be unnecessary to put too much focus on special regulations for research involving individuals with mental illness.  Nevertheless, it is clear that ethical principles must be applied with care to the particular vulnerabilities of individuals with mental illness.[545]

An ethically appropriate framework for psychiatric research ethics balances rigorous protections for human subjects with recognition of the enormous social and individual benefits that flow from well-designed and ethically conducted scientific research.  Ethical concerns that are particularly germane to mental health research and give rise to the need for special sensitivity and insight, include decision-making capacity and research design issues.

 

11.6.1    Decision-Making Capacity

This subject has been discussed in considerable detail earlier in this chapter.  Decision-making capacity to give valid consent is an essential condition for research involving human subjects.  The vigilance that must be applied when assessing decision-making capacity and determining the appropriate decision-maker in the context of clinical care, must be applied even more vigorously in the context of research where participation in a study may not be for the direct benefit of the patient concerned.  For instance, article 21 of the Civil Code of Quebec requires that, in order for an adult who is incapable of giving consent to participate in research, substitute consent must be obtained not just by a family member (as in the context of necessary care), but by a formally appointed mandatory, tutor or curator.  As a result of this heightened protection, however, incapable adults who do not have legally appointed representatives, cannot participate in research in Québec, apart from rare emergency situations.

 

11.6.2   Research Design Issues

Some study methodologies have drawn particular ethical scrutiny when used in mental health and addiction research, both because of their inherent risks and because the subject population are individuals with mental disorders.  Three types of study design have raised particular ethical concerns.

·        Placebo-Controlled Studies:  The randomized, controlled trial is generally accepted as the “gold standard” experimental design for comparing the efficacy and safety of medications.  Comparison with placebo is regarded by regulators as providing the best evidence for the efficacy and safety of a new medication.  However, the use of a placebo control design has been strongly criticized where there is an existing established effective treatment for the disease being studied; such criticisms have been aimed prominently at research in psychiatry, where research subjects enrolled in the placebo arm of the trial might have to be deprived of their much needed existing treatment, suffer potential negative effects of withdrawal and potentially relapse into a state of mental illness for the duration of the study.

·        Washout Studies: A washout study is one in which researchers discontinue the medication of a subject patient in order to study the patient in an unmedicated state or to initiate another therapy, often an experimental one.  Accordingly, the existing medication is discontinued, usually following a gradual reduction in dosage.  The withdrawal period typically must last long enough that the drug has completely cleared from the patient’s system, so that the residual effects from the withdrawn medication do not confound the study results, or result in unwanted drug interactions.  Depending on the particular study design and the medication involved, the washout can last indefinitely, or until acute symptoms return.

·        Challenge Studies:  A “challenge” study is one in which a psychopharmaceutical agent or psychological challenge is administered to research subjects under controlled conditions to measure or observe behavioural response, a neurobiological response (using brain imaging), or both.  In psychiatry, these designs have proven to be extremely valuable in testing hypotheses and characterizing a variety of neurochemical and pathophysiological processes.  Research of this kind may lead to improved predictions of treatment response and effective new therapies.[546]

In order for placebo-controlled clinical trials to be considered ethically permissible, certain conditions must prevail.  Currently, in Canada, existing regulatory frameworks and national research ethics guidelines differ on what those conditions must be.  One major difference between the existing International Conference on Harmonization’s (ICH) Harmonized Tripartite Guideline for Good Clinical Practice (E-10) and the existing Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS) is that TCPS currently allows placebo-controlled trials only if no standard treatment is available to, appropriate for, or wanted by the individual, whereas ICH E-10 allows placebo-controlled trials to take place even if there is established effective treatment, as long as there is no risk of death or permanent ill effect to the individual.  CIHR and Health Canada have undertaken a major initiative in an attempt to review the scientific, ethical and legal principles underlying these documents with a view towards harmonizing both national policies on the appropriate use of placebos in randomized controlled trials.  The Committee highly encourages CIHR and Health Canada to pursue these collaborative efforts and to adopt and implement a harmonized national policy.

In the case of challenge studies, for practical reasons subjects must usually be deceived, or at best only partially informed about the details of the study.  Even without impaired decision-making capacity, this has clear ethical implications for informed consent.

Despite a history that has included serious abuses, mental health and addiction research is vitally important, not least to those who suffer, and those who will come to suffer, from mental disorders.  Clinical psychiatric research gives rise to challenging ethical dilemmas.  The particular vulnerabilities attending mental illness/addiction merit particularly close attention to the design, review and conduct of research.

11.7      COMMITTEE COMMENTARY

As mentioned above, the Committee believes strongly that many of the ethical issues raised with respect to mental illness and addiction originate from the stigma associated with these disorders.  Addressing stigma and discrimination through awareness campaigns designed for both mental health professionals, researchers and the general public would be an important step in responding to these ethical concerns.

The ethical principles underlying the delivery of mental health services and addiction treatment – particularly those of beneficence and justice – must be addressed carefully and in a timely manner.  It is clear that mental health and addiction lag behind other diseases and conditions covered under Canada’s health care system.  They are technologically less advanced and critically more fragmented, and the development of evidence-based guidelines to inform best practices has not reached the level of other specialties.  For these reasons, the Committee believes very strongly that the prevention and treatment of mental illness and addiction should be coordinated across the wide spectrum of potential services both within and outside health care, and should be given priority in decisions about the  allocation of scarce resources.

The Committee acknowledges that decision-making capacity may be impaired by mental illness and addiction, and also that not all mental disorders impair decision-making capacity.  Furthermore, decision-making capacity of those suffering from mental illness and addiction may be impaired to varying degrees and at different times.  Given the structure of existing laws that draw rather rigid conclusions about the presence or absence of decision-making capacity, and the relative inflexibility of changing or adapting protective supervision regimes, there should be a more fulsome debate about how to give meaningful effect to a person’s partial and/or fluctuating capacity to make decisions for himself or herself.  An appropriate balance must be struck between the respect owed to the right to individual autonomy and the need to protect vulnerable persons when their decision-making capacity is impaired by reason of mental illness or addiction.

With respect to privacy and confidentiality issues, the Committee is well aware that any erosion of privacy and confidentiality protections can have serious negative consequences on an individual’s trust in his or her caregivers.  However, as noted above, witnesses have told us that rigid adherence to privacy and confidentiality rules in certain circumstances can work against the interests of individuals whose mental health is compromised.  The unique challenges they describe must be recognized when developing, interpreting and applying privacy and confidentiality rules, so as to allow health care providers and family caregivers to provide patients with the much needed support they sometimes require.

As stated in Chapter 10, the Committee strongly supports research into mental illness and addiction; it is the foundation for future advances in treatment and prevention.  Research involving human participants must be designed and performed in accordance with the highest scientific and ethical standards and must protect the dignity of individuals and their families who make this valuable contribution to scientific progress.

The Committee acknowledges that individuals suffering from mental illness and addiction are particularly vulnerable as research subjects.  It is therefore of paramount importance to protect the rights and well-being of those research participants, while promoting ethically responsible research.  Research advances should not be pursued, however, at the expense of human rights and human dignity.  But nor should protections be so stringent so as to exacerbate existing social stigma associated with mental illness and addiction and potentially exclude this vulnerable population from vitally important research that can improve scientific knowledge about their condition and even benefit them as individuals.

It is clear that interdisciplinary research is needed to address adequately many of the challenging ethical, legal and socio-cultural issues arising from mental illness and addiction.  The Committee was told of the need to conduct this kind of research in a comprehensive and fundamental manner.  In a letter to the Committee, Dr. Julio Arboleda-Florez, Professor and Head, Department of Psychiatry, Queen’s University, suggested that there is a pressing need for further research into mental health ethics and research ethics to address effectively issues such as those discussed above:

There is not much applied ethical research in Canada or elsewhere and no oganizational or financial capacity. (…) Applied research in the sense of testing the social take and realities of ethical concepts, their transcultural reach and implications in terms of transcultural dissonances, their population acceptability, their social meaning, their ease of implementation, or even their usefulness, is sorely missing so the field is becoming a theoretical morass.[547]

We believe that Canada could play an important leadership role in this regard, both nationally and internationally.

Finally, the Committee agrees with experts that the acute and complex ethical concerns that arise in the context of neuroscience and genetic research must be addressed carefully so as to understand better the underlying values and principles associated with these and other evolving and rapidly advancing technologies in modern medicine.

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