Ethical challenges in contemporary psychiatry: an overview and an appraisal of possible strategies and research needs

Psychiatry shares most ethical issues with other branches of medicine. However, it also has to confront special ethical challenges. Psychiatrists are often called to face responsibilities that extend beyond health care stricto sensu: for instance, they may be expected to predict risky behaviors of the people they serve, and to somehow protect them and the public from these behaviors. Moreover, the power differential that exists in all medical specialties between users and physicians tends to be more pronounced in the mental health field, and this has contributed to generate, in some contexts, various forms of abuse that have raised widespread ethical concerns^1-3.

Although psychiatry faces unique ethical challenges, the profession has had no code of ethics until the 1970s. In 1977, after alarming reports of political abuse of the profession in some countries, the World Psychiatric Association (WPA) officially adopted the Declaration of Hawaii (the first of several international declarations dealing with the ethics of psychiatry), which was followed in 2020 by a Code of Ethics for Psychiatry^{4, 5}.

The WPA Code of Ethics outlines the ethical principles for clinical practice of psychiatry; psychiatric education, research and publications; and public mental health. Five principles are identified which should guide the actions of all psychiatrists: beneficence, respect for users’ autonomy, non-maleficence (i.e., avoiding harm), improving standards in practice, and applying expertise to the service of society (i.e., using psychiatric knowledge and skills to promote mental health).

However, ethical dilemmas may arise when the above principles seem to clash. Furthermore, ethical issues associated with psychiatry evolve as the professional and socio-cultural contexts change and new sensitivities emerge. Recent examples are the development of digital psychiatry, and the increasing awareness of the need to actively involve people with lived experience of mental health conditions (PWLE) and their family/informal supporters in clinical decision-making and service planning.

This paper identifies several current ethical challenges for the psychiatric profession, suggests possible strategies to address them, calls attention to risks entailed by the proposed strategies, and highlights the gaps to be narrowed by further research.

There is a focus on human rights throughout the paper. We cannot ignore that these rights, to which everyone is entitled by virtue of being human, have been sometimes denied – and continue to be denied in some contexts – to PWLE, nor the growing evidence that the quality of care, research and training in psychiatry crucially depends on respecting these rights^6-9.

The United Nations (UN) Convention on the Rights of Persons with Disabilities (CRPD)¹⁰ has been an important step forward in this respect. It has represented a paradigm shift in viewing persons with disability, including disability related to a mental health condition, no longer as just “objects” of charity, medical treatment and social protection, but rather as “subjects” with rights, capable of claiming these rights and making choices. The CRPD, as interpreted by some experts and stakeholders (though contested by others), has also raised concerns about some psychiatric practices, in particular those pertaining to treatment of persons against their will, and about conventional mental health laws. These concerns are currently a lively matter of debate.

The focus on human rights is highly relevant to the ongoing changes in mental health care provision, especially in those countries that have downscaled or are downscaling large psychiatric institutions and replacing them with community-based care. The implementation and sustainability of these changes differ significantly across countries, and even across regions within the same country. Their outcome crucially depends upon a socio-economic-political landscape that discourages discrimination and supports social inclusion and equitable access to health care, including mental health care.

The development of digital tools and interventions in psychiatry can be seen as a promising way to promote equity in the access to mental health care. However, it is also generating a wide range of ethical issues, that are being actively discussed. Similar considerations apply to the area of early intervention in psychiatry. While consistent with important ethical and health care principles, and a feasible and promising way to reduce the disability burden related to mental disorders, early intervention is raising ethical concerns due to the risk of overmedicalization of transitory conditions, and the possibility of unwanted consequences of risk/vulnerability labels.

Difficult-to-solve ethical challenges also apply to another important contemporary topic: end-of-life decisions. This issue is currently debated in general medicine, but is much more controversial in psychiatry, where certain symptoms may interfere with competent decision-making.

Psychiatrists also face ethical challenges when, in line with the principle of contributing to improved standards of care, they interact with the pharmaceutical and medical device industry; when clinical activities aiming to benefit people are influenced by intellectual allegiance to a particular school of thought^{11, 12}; or when the pursuit of people's well-being and autonomy clashes with the psychiatrist's interest in preventing perceived or actual risks related to legal responsibility.

All the above emerging ethical challenges and conundrums are addressed in the various sections of this paper. A final section focuses on the role of PWLE and family/informal supporters in shaping the agendas concerning mental health care, research and training, and in framing mental health policies that are ethically and legally sound and are at the same time tailored to their needs. No real progress of psychiatry is likely to occur without a strong collaboration among professionals, PWLE, family/informal supporters, and policy makers^{11, 12}. While this is largely acknowledged, such a collaboration is not yet implemented at a global level.

HUMAN RIGHTS AND MENTAL HEALTH CARE, RESEARCH AND TRAINING

The modern human rights framework is based on the concept of respect for the inherent dignity of all humans¹⁴. It was crystallized by the UN in the Universal Declaration of Human Rights (1948)¹⁵, which – along with the 1966 International Covenant on Civil and Political Rights¹⁶ and International Covenant on Economic, Social and Cultural Rights¹⁷ – forms the so-called International Bill of Human Rights^{14, 18}. The subject of human rights has since expanded greatly, and is now a fundamental part of our legal, political and moral landscape.

Economic, social and cultural rights (often characterized as “positive rights”) include the rights to housing, food, education, employment, health, social inclusion, and cultural participation. Civil and political rights (sometimes referred to as “negative rights”) include the rights to liberty; freedom from torture, cruel or degrading treatment, exploitation, violence and abuse; and equal recognition before the law. The above dichotomy has some conceptual basis: the former rights involve the obligation by the State to ensure that fundamental entitlements are provided; the latter refer to the duty by the State not to intrude into the lives of persons without a clear and defensible justification. However, it is well recognized that all human rights are interdependent, interrelated and indivisible^{14, 18, 19}.

Both mental health and human rights are concerned with social justice and social responsibility¹⁸, and they are inextricably related in three ways^{20, 21}: mental health policy and practice can either protect or violate human rights; conversely, human rights violations adversely impact mental health; and finally, the promotion of mental health and human rights mutually reinforce each other.

Despite the central importance of the relationship between human rights and mental health, it was more than 40 years after the Universal Declaration of Human Rights that the rights of persons with a mental health condition received international acknowledgement. This was through the Principles for the Protection of Persons with Mental Illness and the Improvement of Mental Health Care (the Mental Illness Principles or MI Principles), adopted by the UN General Assembly in 1991^{22, 23}.

The MI Principles included promotion of mental health and prevention of mental disorders; access to basic mental health care; provision of the least restrictive type of mental health care; self-determination; and automatic periodic review mechanisms. However, these Principles did not have legally binding status in terms of international law²⁴. Moreover, they were criticized on several grounds, including failing to include organizations representing PWLE in their development, and appearing to offer weaker protection than other pre-existing human rights instruments, particularly on matters of consent to treatment^{25, 26}.

Although the International Bill of Human Rights protected the rights of all persons, in practice several particularly vulnerable groups were neglected. This has led to the development, in the past four decades, of treaties concerning particular groups, with children (Convention on the Rights of the Child), women (Convention on Elimination of All Forms of Discrimination Against Women) and racial minorities (International Convention on the Elimination of All Forms of Racial Discrimination) being prominent examples. These specific conventions do not create new rights, but elaborate and expand on the realization of rights included in the International Bill, focusing on the special needs of these groups.

In the last three decades, advocacy by persons with disabilities and their representative organizations has led to the recognition that these persons were another special group and to the acknowledgement that a specific convention was required to protect their rights. The CRPD was adopted by the UN in 2006, after five years of negotiations between various stakeholders, including government delegations, UN representatives, human rights agencies and organizations working in the field, and, uniquely, PWLE and family supporter bodies¹⁰. The Convention entered into force in 2008.

The CRPD emphasizes economic, social and cultural rights, including the right to life (Article 10), and rights concerning independent living and inclusion/participation in the community (Article 19), home and family (Article 23), education (Article 24), health (Article 25), habilitation and rehabilitation (Article 26), work and employment (Article 27), adequate standard of living and social protection (Article 28), and participation in cultural life (Article 30). Civil and political rights are also stressed in the CRPD, including equal recognition before the law (Article 12); freedom from torture or cruel, inhuman or degrading treatment or punishment (Article 15); and freedom from exploitation, violence and abuse^{27, 28}.

The human rights framework adopted by the CRPD requires a renewed focus on respect for the dignity and autonomy of PWLE. The Convention states that “persons with disabilities have the right to ‘legal capacity’ – that is the right to legal standing as well as legal agency – on an equal basis with others” (Article 12); “the existence of a disability shall in no case justify a deprivation of liberty” (Article 14); and “every person with disability has a right to respect for his or her physical and mental integrity on an equal basis with others” (Article 17).

Some scholars and organizations, as well as the UN Committee set up to monitor the implementation of the Convention (CRPD Committee), interpret these articles as prohibiting involuntary psychiatric hospitalization and treatment, as well as the appointment of substitute decision makers, in any circumstances^{29, 30}. They claim that the “rights, will and preferences” of the person must always be respected, and the State is obliged to ensure that support is provided to persons to allow them to express their “will and preferences”. However, other commentators regard this interpretation as “absolutist” or “radical” and unrealistic. They have argued that, despite support, it may be sometimes difficult to determine what are the will and preferences of the individual concerned.

In such circumstances, the CRPD Committee states that the “best interpretation of the will and preferences of the individual” should be considered. In practice, this principle may be very close to “substitute decision-making”. Medical professionals contend that there are occasions when substitute decision-making is required to protect other key rights, including the right to health or the right to life^31-33. Accordingly, the WPA Code of Ethics calls for respecting the autonomy and dignity of persons with mental health conditions, but recognizes that involuntary psychiatric interventions may be required, as a last resort, when less restrictive interventions have failed, to protect safety and to restore the person's autonomy⁴.

Attention is also drawn to CRPD Article 12.4, which states that any measure affecting the exercise of “legal capacity” must apply for the shortest period, be free from conflicts of interests, and have strong safeguards in place. Coercive and restrictive interventions continue to be over-used in psychiatry. Hence, the WPA has issued a position statement and set up a task force to implement alternatives to coercion in mental health care^{34, 35}.

The age-old principles of beneficence and non-maleficence must be respected, but the human rights framework encourages the profession of psychiatry to emancipate itself from a paternalistic and institutional mentality, and shift the pendulum towards respecting the autonomy and dignity of PWLE, while also advocating for necessary supports to be available³⁶.

While it can be argued that coercive interventions may sometimes be required as a life-saving measure or to restore autonomy, the widespread over-use of these interventions in psychiatry is a function and reflection of risk aversion in society. Therefore, any attempts to shift the pendulum in clinical practice towards greater respect for people's autonomy must be accompanied by a societal level discussion on human rights promotion, stigma, media sensationalism, and risk appetite (i.e., the level of risk that can be accepted) within political circles and society at large.

Overt paternalism cannot be replaced by neglect and abandonment of PWLE. The CRPD does not advocate for such a move either. A human rights-based focus on alternatives to coercion is required, along with a recognition that risks and mistakes are part of the human endeavor, including for people with a psychosocial disability. This focus can be implemented in locally adapted ways through evidence-based, recovery-oriented, and trauma-informed practices in services that are community-based, and work within a system of collaborative care. This approach, whether implemented at national, regional or service levels, can shift the focus of psychiatric ethics towards greater respect for persons’ autonomy and dignity.

One commonly cited obstacle to the above approach is a lack of adequate resources, which then forces clinicians to rely on coercive measures. However, over-use of coercion is not restricted to scarce resource settings³⁷. In order to implement a human rights-based approach, psychiatrists and other mental health professionals must advocate for and lobby to secure the necessary resources. Continuing to use coercion where there are scarce resources generates a vicious cycle, and allows the system to keep on underfunding services³⁸.

The WPA Code of Ethics encompasses public mental health, including mental health promotion. Human rights and social justice are complementary to promotion of mental health at a population level^{39, 40}. Social justice requires equal rights through equitable access to resources and opportunities, especially for people living in poverty or with disability, or who are marginalized in various ways^{41, 42}.

We have the knowledge and means to deal with the social determinants of health, including mental health^{43, 44}. Equitable access to affordable housing, education and jobs, and social participation and inclusion in the community, are core responsibilities of governments. Political work is needed to ensure that knowledge is translated into action and mental health is the focus of policy makers in every sector of governments, including the health sector. The profession of psychiatry needs to embrace the human rights framework and champion the promotion of mental health and prevention of mental disorders⁴⁵, as well as the acceptance and application of the recovery paradigm in mental health care⁴⁶.

A pertinent ethical dilemma for many psychiatrists is the opportunity cost of dedicating time to public mental health promotion and prevention when they have heavy service commitments requiring their time. However, the example of cardiology is relevant here: just as cardiologists continue to focus on clinical work, while advising public health departments about the preventive role of healthy diet and exercise, psychiatrists should fulfil their clinical obligations, while advising public health departments – but also other departments, including social security, housing and criminal justice – about public mental health principles and strategies. Psychiatrists need to take every opportunity to ensure that public health departments see mental health promotion within their role, with input and guidance from mental health professionals, PWLE and family/informal supporters^{39, 47}.

Psychiatry training needs to embrace the human rights framework, and include macro-level skills of leadership, collaborative work with PWLE and their family/informal supporters, public advocacy, and positive use of the media⁴⁸. Psychiatric research needs to focus on social and public health aspects of mental health, as well as neuroscience and biomedicine³⁹.

NON-DISCRIMINATORY MENTAL HEALTH LAW

As previously discussed, the focus on human rights requires a shift in the pendulum of ethics in psychiatry from paternalism to a greater emphasis on respecting the autonomy and dignity of all people. This raises concerns about the principles governing the usual forms of mental health law and the treatment of persons against their will^49-52. The principles commonly governing involuntary treatment in mental health law have remained fundamentally unchanged for around two centuries. They reflect deeply rooted prejudicial stereotypes of people with mental illness, i.e., that they are necessarily incapable of making sound judgments and intrinsically dangerous to others.

The conventional criteria for compulsion are the presence of a “mental disorder”, usually vaguely defined, and a risk of harm to the person or to others. Such a “disorder + risk” schema can be seen as discriminating against people with a mental health condition, depriving them of rights enjoyed by those without a mental disorder diagnosis. In jurisdictions with well-developed laws governing non-consensual treatment in general medicine, it is only when a person lacks the decision-making capacity to consent to a treatment that the possibility of non-consensual treatment enters the frame. There is usually a further requirement: treatment must be in the person's “best interests”. It is accepted that patients with “physical” disorders, if they have decision-making capacity, can make treatment refusals even when this may carry grave consequences.

For a person with a “mental disorder” who rejects treatment, conventional mental health law does not demand that special regard be given to the person's decision-making ability, as it is usually done for people with “physical” diseases – for example, the ability to understand important information about the illness and reasons for the proposed treatment; to appreciate the relevance of that information to one's predicament; and to use or reason with that information in the light of one's values or personal life goals⁵³. Nor does the question arise of how the proposed treatment is purported to be in the person's “best interests”. The perspective is essentially the clinician's, not the service user's one. The unfair discrimination towards those with a “mental disorder” is thus clear.

There is a second form of possible discrimination: the liability to preventive detention. People with mental disorders may be detained because they are deemed to present a risk of harm to others, without – like everyone else – having committed an offence (or being strongly suspected of having committed one). The overwhelming majority of people in the population presenting a risk to others do not have a mental disorder. People with a mental disorder account for only a very low proportion of cases of serious violence^{54, 55}. Nevertheless, civil commitment law often permits detention on the basis of risk alone for those with a mental disorder. One can argue that equals are being treated unequally. If preventive detention is to be allowed for those with a mental disorder solely on account of the risk posed to others, the same criteria should apply to everyone.

To eliminate the above forms of discrimination, a single law – covering all medical settings, including psychiatry – has been proposed. This would be applicable when a person has a difficulty in making a serious treatment decision^{50, 51, 56}. In this proposal, involuntary treatment would only be permitted when the objecting person has an impairment of decision-making ability – from any cause – and if treatment is in the person's best interests.

There is no reason to believe that a mental capacity-based law cannot be applied in mental health care. Indeed, such a legislation has been drafted and enacted^{57, 58}. Measures – for example, the involvement of those who know the person well, independent advocacy, second opinions, appeals to a tribunal when there is disagreement – can be devised to ensure that PWLE are not regarded as lacking decision-making ability simply because they disagree with their doctors.

The concepts of “capacity” and “best interests” have advanced over the years, particularly in relation to the assessment of the “use” and “weigh” (or “appreciation” and “reasoning”) elements of the former, and the special regard to be given to the person's beliefs and values in the assessment of the latter.

There may also be here an avenue for engagement with the CRPD¹⁰. As previously noted, the CRPD Committee insists that involuntary treatment of people with mental health (or “psychosocial”) disabilities is prohibited²⁹. The Committee argues that Article 12 of the Convention entails that all persons, regardless of their decision-making ability, must enjoy “legal capacity” on an “equal basis with others”²⁹. Legal capacity involves the right to be recognized as a person before the law, as well as the right to legal agency, that is, to have one's decisions legally recognized. A distinction is maintained between “legal capacity” and “mental” or decision-making capacity, and it is argued that the latter cannot provide a justification for a deprivation of the former.

This interpretation has stirred much controversy⁵⁹. Actually, the understanding of the implications of an advance statement or directive becomes problematic in this Committee's interpretation, throwing up a significant inconsistency^{60, 61}.

Advance directives are a valuable tool to support persons’ autonomy in a decision-making capacity-based regime. They are also endorsed as a measure to support a person's legal capacity by the CRPD Committee: “For many persons with disabilities, the ability to plan in advance is an important form of support, whereby they can state their will and preferences which should be followed at a time when they may not be in a position to communicate their wishes to others”.

In an advance directive, a person, when having clear decision-making ability (Time 1), states that, if a future episode of illness should occur (Time 2), he/she – on the basis of past experience – will likely express a preference (e.g., refusal of treatment) that is not to be regarded as what he/she truly or “autonomously” desires, and thus should not be respected. If the illness episode occurs, which preference (Time 1 or 2) should be respected? The CRPD Committee provides no guidance on the question. Is it the Time 2 preference (refusal of treatment), disavowed at Time 1, that is to be followed, or that at Time 1? If it is the one expressed at Time 2, what is the point of such an advance statement?

Reference to the CRPD's expression “will and preferences” is now common, yet no authority, including the CRPD Committee, has provided a definition. What could these words mean? “Preference” has a relatively straightforward meaning: a greater liking for one alternative over another. The meaning of “will” is less clear. In ordinary language, “will” has a sense of strong resolve to act in a particular way. The “will” also has a long history in the philosophy of mind and action, where it has contested meanings. However, reasonably common is the concept of the “will” as a kind of higher-order motivating or self-governing mental structure that determines which desires, wishes or “preferences” should be translated into acts, and in which the person's “values” play a key role^{60, 62}.

Thus, a distinction may be drawn between “the will” and “a preference”. “The will” can be taken to be a manifestation of a person's deeply held, reasonably stable and coherent personal beliefs, values, commitments and conception of the good. In this sense, it is not the same as a desire, inclination, or “a preference”, held in the present, even a strongly expressed one. Normally, “will” and “preferences”, by and large, run together. It is when “the will” and “a preference” diverge or are contradictory, and a person needs to make a serious decision, that a problem may arise.

In this view, an advance directive is based on the difference between “the will” of a person (and its associated preferences) expressed at Time 1, and the “preferences” that the person anticipates will be expressed at Time 2 and which the person asks to be ignored as they are not what he/she “truly wills”. We generally honor the person's Time 1 “will”, when the instruction reflects the person's deeply held beliefs and values. The person might specify the psychological or behavioral indicators that his/her decision-making ability is sufficiently impaired to trigger the advance directive. This is especially important in the case of “self-binding” directives, in which the person may specify in substantial detail the conditions to be met for treatment to be given despite his/her objection, essentially giving an advance consent to that treatment.

To honor the Time 2 preference where a disjunction exists with that at Time 1 is to undermine the “will” or, in essence, the “autonomy” of the person and would not be consistent with the first General Principle of the CRPD (“respect for [the] inherent dignity, individual autonomy, including the freedom to make one's own choices, and independence of persons”).

If this analysis is accepted, it would follow that we should give similar consideration to the person's “will” and its bearing on a decision (“preference”) even if the person had not made a written advance directive, but had expressed that “will” through various statements and life choices, evidenced by people who know him/her well – for example, close relatives and friends.

This analysis of “will and preferences” adds a further dimension to the meanings of “decision-making capacity” and “best interests”, which may warrant a significant reformulation. Treatment decision-making ability is undermined when there is a serious divergence, or incoherence, between the person's “will” and a currently expressed treatment “preference”. A person's best interest is served primarily by acting to give effect, as far as possible, to the person's “will”. The stronger is the case for an involuntary intervention, the greater is the threat to the person's “will” – that is, to his/her deeply held beliefs and values, commitments and life projects – that would result from the person enacting a contradicting “preference”.

This approach has some similarity to the position taken by the German Federal Constitutional Court, based on a distinction in German Law between a person's natürlicher Wille (“natural will”) and freier Wille (“free will”)⁶³, akin to the distinction between “a preference” and “the will”, respectively. The court ruled that the State's obligation to provide protection to a person who faces serious harm, and who is unable to form a “free will”, permits the person's “natural will” – if impaired in its formation by the effects of an illness – to be overridden. The person's “original free will” – a competent “will” formed in the past – is to be given precedence. Support may be needed to enable the person to express that “free will”.

There are situations where it may be impossible to know what the person's “will” might be – for example, where no one is available who knows the person, or the person has a severe intellectual disability and has not been able to clearly express a coherent “will”. In such cases, it has been proposed that the default position would be to consider the human rights relevant to the situation as the guide for the decision to be made^{64, 65}.

ETHICS IN GLOBAL DIGITAL PSYCHIATRY

The focus on human rights is also relevant to the digital turn in psychiatry. This turn promises improved equity and accessibility of care, thus meeting some key principles of global codes of ethics. However, digital psychiatry has given rise to a wide range of ethical and, in some cases, legal issues that warrant urgent attention.

Clear potential benefits heralded by digital developments in psychiatry include web-based and other information communication technology (ICT)-based forms of support, helping to break down geographical barriers^66-68, and facilitate confidential and anonymous help-seeking. This may provide opportunities to engage hard-to-reach populations. Those in low- and middle-resource settings may especially benefit from accessible digitally facilitated support⁶⁹. Digital technology can also improve the availability of quality information to increase awareness of relevant forms of support, promote early identification and treatment, and help in monitoring and coordinating service provision.

However, there is potential for digital approaches to undermine face-to-face support; degrade trust between people and their mental health practitioners; threaten privacy, safety and security; undermine accountability and professional responsibility when things go wrong; and amplify discrimination and inequity along lines of race, language, gender, disability and poverty.

Artificial intelligence (AI) algorithms, for example, can be susceptible to biases arising from the data they are trained on, thus exacerbating existing disparities, because AI learns from humans and society. We must understand how AI makes decisions in various critical settings⁷⁰. Implicit and explicit biases that can be captured by AI algorithms have been well-documented⁷¹. In the US, which appear to have applied automated decision-making most extensively, there is even evidence that AI has been responsible for reducing access of African-American PWLE to adequate mental health care⁷².

Privacy and confidentiality can be undermined in the context of a lucrative market for people's health data, including highly sensitive data on individuals’ mental health conditions⁷³. In March 2023, for example, the US Federal Trade Commission filed a complaint against the online therapy company BetterHelp⁷⁴, which was fined US$ 7.8 million for allegedly revealing consumers’ data to Facebook, TikTok and other technology firms. The data were used for targeted advertising, despite the company promising to keep personal data confidential. In other cases, hacking of personal records from online therapy services have also brought issues of safety and security into sharp relief^75-77.

AI chatbots have also raised safety concerns, including where they have reportedly offered harmful advice to people seeking mental health support^78-80. These chatbots may also undermine service user autonomy when they are deployed in online mental health services without informed consent or traditional research approval⁸⁰.

Given the lack of any unified governance for digital mental health technologies, ethical principles offer the clearest guidance. But one problem with navigating the ethical issues is the great diversity of activities that fall under the banner of telepsychiatry. The World Health Organization (WHO) has defined telepsychiatry broadly, as “using information and communication technologies to provide mental health services”⁸¹. Accepting this broad definition poses an immediate challenge. Diverse technological practices often bring an equally diverse set of ethical and legal issues.

The range of uses for contemporary ICT in mental health is striking, including communication, information sharing (such as the sharing of electronic health records), professional decision support (including presenting data to aid professionals with decision-making), digital therapies (where technologies are used as a treatment, such as mobile apps prescribed by doctors)⁸², “personalized medicine” (involving generation and analysis of “big data” concerning a person's genes, environment and behaviors to guide treatment), patient and/or population monitoring and surveillance (involving the “tracking” of individual or population health information over time, such as identifying people or communities at risk of suicide or psychosis^{83, 84}, monitoring medication compliance by use of “digital pills”⁸⁵, or global positioning system surveillance of forensic psychiatry patients)⁸⁶, and service user informatics (e.g., supporting service users and their navigation in health systems, including personal health records, service user decision aids, and even regulatory reporting)⁸⁷.

Some of these practices appear in diverse settings, not merely in health care but also in contexts involving education (student support and monitoring tools), criminal justice (risk assessment and remote monitoring), workplaces (employment assistance programs), and the sale of direct-to-consumer products, such as the 10,000+ mental health apps on the market⁸⁸. In this latter respect, the scale of private investment is notable: in 2021, according to one market report, digital startups focusing on mental health secured more than five billion dollars in venture capital – more than double that for any other medical issue⁸⁹, and investment further increased in 2023⁹⁰.

It is often unclear whether, and to what extent, such initiatives have been subject to scientific or ethical scrutiny. Recent reports suggest that even digital health devices cleared by the US Food and Drug Administration (FDA) lack rigor. Across all approved devices, just two had been evaluated in at least one study that was randomized and blinded and that used other rigorous standards of evidence⁹¹. Another study of digital health startups found no correlation between clinical robustness and the number of clinical claims, total funding, or company age⁹².

There is also evidence that ethical scrutiny seldom forms a substantial part of applied research in the field⁹³. Regulators are also seeking clarity as they try to move from a reactive to a proactive approach, yet questions remain as to what makes for an ideal regulatory scheme, and gaps in ethical and regulatory frameworks remain⁹⁴.

Ethical schemes continue to offer value in the evolving digital mental health environment described above. Acknowledging the frequent tension between clinical practice and the consumer-driven mobile industry has generated a plethora of ethical safeguards, focused on managing risk to the therapeutic relationship, informed consent, confidentiality, and mutual alignment of treatment goals and expectations⁸⁸. Efforts have been made to identify ethical principles, themes and issues that cut across diverse practices^{87, 95-98}. Broad themes and issues include safety and security; autonomy; partnership and active involvement of PWLE impacted by new technologies; privacy; accountability; transparency; equity, non-discrimination and fairness; professional responsibility, scientific integrity, and evidence-based practice.

These general concepts may be helpful for broad discussions, but specific technological practices in specific settings will typically require closer consideration. This is occurring, for example, with the rise of digital phenotyping^99-102, electronic health records^{103, 104}, and smartphone apps¹⁰⁵. As the scientific evidence has evolved, so have the ethical concerns. For example, it is clear that digital mental health studies should include digital control groups¹⁰⁶, but ethical issues around blinding and control conditions remain largely unexplored.

Taking mental health apps as one example, they have not succeeded in “transforming care” as so many had hoped, despite billions of dollars of public and private investment¹⁰⁷. This failure can no longer be attributed to a “digital divide” concerning access to technology, although equitable access to ICTs by PWLE remains an issue^{108, 109}.

A first problem is digital self-determination, which remains “underdeveloped in populations with the greatest mental health needs”¹⁰⁷. This is partly due to inequalities in digital literacy which are rooted in deeper inequalities in educational skills. For example, a study of UK people with serious mental illness found that, while only 12% did not own a smartphone, nearly 42% lacked the fundamental digital literacy skills necessary to use a device to advance their recovery¹¹⁰.

A second problem involves concerns about efficacy and privacy. While people are interested in using mental health apps, most do not believe that these apps work and actually protect their privacy^{94, 107}. Most people report that they “don't think it will be helpful” when surveyed on reasons for non-use¹¹¹. National studies in the UK and the US suggest that less than 15% of people are willing to share anonymized personal health information with a company for the purposes of improving health care¹¹². Concerns about lack of efficacy and privacy are not isolated, and have been identified as barriers to uptake in low- and middle-income countries as well¹¹³.

The third problem relates to social connections. Low engagement has quickly emerged as a leading cause of digital mental health abandonment and non-efficacy¹¹⁴. While efforts at better design, gamification and incentives may be productive, technology alone is unlikely to solve the fundamental issue. Since isolation and loneliness are public health threats, digital mental health tools will work best “when they help people form strong social connections instead of motivating them to continue focusing inward”¹⁰⁷. This means that digital tools must be integrated into fuller care and treatment plans. Yet, only 25% of apps today have that capability¹⁰⁷. Moreover, adding more human support comes at a cost and reduces the unlimited scalability of digital health tools. It also introduces new foci for quality control, given the variation inherent to unlicensed clinical support in the form of new app coaches, or digital navigators, who will likely drive the next generation of these tools¹¹⁵.

Efforts to support digital self-determination, efficacy and privacy, and social connections can be implemented today¹¹⁶. Improving digital literacy is feasible, as demonstrated by programs such as the Digital Opportunities for Obtaining Resources and Skills (DOORS), which offers education, resources, and skills training so that participants can become comfortable and engaged using apps. App selection and verification methods have also been proposed. An example is the M-Health Index and Navigation Database (MIND), which uses the American Psychiatric Association's evaluation framework to allow clinicians to make a more informed choice between apps in a particular case¹¹⁶.

Social connection and engagement can be fueled by peer supporters, who could participate in the development of a digital health literacy curriculum, but also have a crucial role to play in leading and participating in responsible governance through regulation and oversight¹¹⁷. This latter role may be particularly important to ensure opportunities to interrogate the objectives, outcomes and potential trade-offs of introducing digital approaches to psychiatric services.

The European AI Act recognizes the potential for disparities and discrimination that AI tools present. Proposals include recognition of a principle of respect for “diversity, non-discrimination and fairness”, requiring AI systems to be “developed and used in a way that includes diverse actors and promotes equal access, gender equality and cultural diversity, while avoiding discriminatory impacts and unfair biases that are prohibited”¹¹⁸.

Despite both hype and panic, the actual development of technology will continue at a steady pace, that necessitates reasoned, not rushed, and rational, not reactive, approaches to ensure that the next generation of digital mental health tools are more “proportionate, prudent, and person-centred”¹¹⁹. Such practices should be guided by ethical principles, professional codes of conduct, and established norms of law. They should include PWLE and family/informal supporters in their development and impact monitoring.

ETHICS OF EARLY INTERVENTION IN PSYCHIATRY

Prevention has become a social and ethical imperative in psychiatry^{4, 66, 120}, especially because the onset of most mental disorders occurs at a young age, and access to appropriate care is significantly delayed. These two elements contribute to poor clinical and functional outcomes^{121, 122}. Not surprisingly, mental disorders represent the 7th cause of disability-adjusted life years (DALYs) – accounting for 4.9% of the global DALYs – and the 2nd leading cause of years lived with disability (YLDs) – being responsible for 14.6% of global YLDs¹²³. These figures may even be an underestimate¹²⁴.

In the last decades there has been an increasing investment in early intervention approaches. The focus has been on identifying subjects in the early stages of, or at risk for, developing a mental disorder, along with strategies favoring early access to care, early monitoring of clinical course, and implementation of early intervention. The aim is to delay or prevent the onset of disorder or improve its longitudinal trajectory^125-127, as is common for cardiovascular diseases, cancer and several other physical conditions.

One approach to early intervention is built on the clinical high-risk for psychosis (CHR-P) paradigm¹²⁵. This paradigm identifies individuals who are at risk of developing a psychotic disorder as they show attenuated psychotic symptoms, brief and limited intermittent psychotic symptoms, or genetic risk and functional decline^{127, 128}. More recently, following the example of the CHR-P paradigm, researchers have developed constructs identifying risk states for other mental disorders, such as bipolar, major depressive and anxiety disorders^{125, 129}.

Recent evidence, however, has shown that at-risk conditions have a low positive predictive value, as the majority of individuals identified as at risk for a mental disorder will never develop it^{130, 131}. Moreover, no tested intervention has proved effective in preventing the transition to a mental disorder^{132, 133}. Limitations of research paradigms, screening and recruitment methods^{126, 134}, and concerns about cost-effectiveness^135-138 and prognostic validity¹³⁹, have fueled the debate on the usefulness of current models of early intervention¹⁴⁰, and have cast doubts on the possibility to implement an indicated prevention in line with the ethical principles of beneficence and non-maleficence and the pursuit of people's autonomy.

PWLE suffer from stigma (including self-stigma) and discrimination. Particularly motivated by the inclusion of the attenuated psychosis syndrome among “conditions for further study” in the DSM-5^141-145, several scholars and advocacy associations have noted that risk/vulnerability labels may carry similar risks. In fact, without appropriate public education, risk/vulnerability conditions may be confounded with the full-blown mental disorders^{143, 146}.

Many studies reported that at-risk labelling may cause stigmatizing and self-stigmatizing attitudes¹⁴⁷ and called for the development of stigma-related interventions¹⁴⁸. Stigma-related stress and fear of developing a serious mental illness may lead to decreased quality of life, hopelessness, anxiety and depression, and actually increase the likelihood of psychosis onset and suicidality¹⁴⁹. In addition, scholars highlighted that stigma, including self-stigma, may be particularly harmful during adolescence and early adulthood, as it might interfere with normal identity development and the achievement of educational/occupational competences and social milestones¹⁴³.

However, before being formally labelled as “at-risk”, individuals may already suffer from stigma and discrimination due to their behaviors and symptoms, and may internalize stereotypes and feelings of shame which may lead to social isolation^{150, 151}. In this case, the identification of the at-risk condition could provide an acceptable explanation of the distressing experiences, avoiding the use of negative and untrue stereotypes¹⁵². In fact, there is evidence that the discussion with a clinician is beneficial, as it can provide understanding and recognition, and facilitate coping and hope¹⁵³.

The unwanted consequences of risk/vulnerability labels, in addition to the uncertainty about their prognostic value and the lack of treatment options, cast doubts on the opportunity of informing patients about the risk, and on the best way to do it¹⁵⁴. From an ethical point of view, the information about the presence of an at-risk condition may have a negative psychological impact, thus contradicting the principle of non-maleficence. However, choosing not to disclose the presence of an at-risk condition would violate the principle of respect for autonomy, which states that people have the right to make autonomous choices and that the duty of psychiatrists is to make them aware of the potential consequences of their choices. Being informed about one's vulnerability may help to make decisions about one's life and, in particular, clinically relevant lifestyles, such as substance use^154-156.

Surveys investigating the attitudes towards receiving information on at-risk conditions revealed a variety of perspectives and highlighted the complexity of the subject^157-160. Attitudes about risk disclosure may vary depending on individual-related factors – such as, for instance, the diagnosis, degree of certainty¹⁵⁸, or current psychological condition¹⁵⁹ – but may also depend on cultural factors¹⁶⁰. The “right not to know” has been frequently discussed as an important aspect of individual autonomy, particularly in relation to genetic diagnosis^{161, 162}, while – for those who want to know – the quality and quantity of information to provide is difficult to define^{161, 163}.

The ethical issue is further complicated by the differences across countries in regard to informed consent rules, by the complexity and uncertainty of the available knowledge, by the nosological status of risk/vulnerability conditions, and by the legal status of help-seeking individuals who, in many cases, are minors.

The best solution is likely to be a person-tailored approach^{154, 164}, which takes into account a variety of factors such as age, cognitive abilities, education, comorbidity and suicide risk, while being empathetic and acknowledging the distress that even low-risk estimates may cause^{165, 166}. Current research gaps should be accurately explained, as well as the uncertain prognostic implications of risk conditions. For instance, the use of absolute risk (e.g., ten percent risk) instead of relative risk (ten-fold increased risk) measures, and the avoidance of terms such as “early detection” and “prodromes”, in favor of a more hope-oriented terminology, have been suggested as appropriate^{167, 168}.

In the light of the above ethical concerns, current international guidelines and empirical evidence advise against the use of risk screening tools in the general population, and emphasize the need to restrict assessment and referral to help-seeking individuals^{125, 127}. Several studies document that CHR-P individuals suffer from and seek help for a variety of distressing conditions, including anxiety, depression, substance abuse, cognitive impairment, social isolation, and impaired social and vocational functioning^169-171. In addition, while only a minority of subjects develop full-blown psychosis, most non-transitioning ones have poor clinical and functional long-term outcomes^{172, 173}. On these grounds, while the use of pharmacological interventions for preventive purposes is not recommended, need-based and low-risk psychosocial interventions (psychoeducation, substance abuse reduction programs, cognitive training, social/vocational functioning) may be clinically and ethically justified, as the majority of targeted individuals may benefit from them^{167, 174}.

Early identification and intervention approaches may also raise concerns relevant to the principle of social justice^{4, 175}. In fact, resources invested in prevention services may not reach population segments with a high prevalence of risk factors but low access to mental health services, and in particular to the few services specialized in early intervention^{121, 135, 176, 177}. Indeed, early help-seeking behavior is associated with potentially beneficial social determinants, such as higher education and stronger social support^178-181, while migrants and individuals belonging to ethnic minorities are more likely to access mental health services only when the severity of their condition requires more intense and urgent care^{182, 183}.

There is evidence that minorities are under-represented in risk/vulnerable samples in comparison with clinical samples^184-187, though this has been questioned by proponents of the model, who in turn argue that ethnic minorities are still over-represented if compared to the general population¹⁵³.

Other approaches to early intervention in youth mental health care for people aged 12-25 years (or sometimes 15-30 years) have been developed and implemented in a number of countries, including Australia^188-190, Ireland^{191, 192}, Canada^{193, 194} and the US¹⁹⁵. These programs represent progress towards community engagement and stigma reduction, as well as empowerment and participation of youth and families, and service co-design^{196, 197}. They aim to allow “soft entry” (often through walk-in or self-referral options) to holistic assessment and care programs including brief psychosocial interventions and “supported transitioning” to secondary forms of care when engaging with individuals with more severe conditions^{190, 198}. They also provide digital mental health platforms as well as community awareness and prevention campaigns¹⁹⁹. Many offer integrated, “one-stop-shop” care, including general health care and vocational, educational, housing and substance abuse assistance¹⁹⁷. They characteristically take an approach tailored to the individual's needs and strengths¹⁹⁸.

Headspace in Australia is the most extensively developed of these programs to date. It has been used by youth and families across the country²⁰⁰ and has received plaudits as well as critiques in regard to efficacy^201-205, cost-effectiveness^{202, 206}, and suitability for individuals with different cultural backgrounds²⁰⁷. Evaluations of programs in other countries are underway^208-210. Important questions remain on how to best facilitate coordination and collaboration with other institutions, including school systems and pre-existing mental health services^{192, 211, 212}. Adaptation of these models to lower-resource settings needs to be explored.

Progress in early identification and intervention might provide convincing answers to the above ethical challenges. However, several of them – including stigma, discrimination, threats to the person's autonomy, and lack of social justice – are difficult to eliminate, and future scientific developments may even bring additional challenges. For instance, the implementation of biomarkers-based screening might increase the risk of stigma and discrimination²¹³, and genetic testing might require appropriate counselling to minimize the risk of misunderstanding the results²¹⁴.

The complex ethical challenges addressed above are not meant to fuel a pessimistic attitude towards the early identification of mental disorders. On the contrary, they aim to contribute to the development and dissemination of more ethically informed indicated prevention models, such as those developed for youth in the last two decades, co-designed with PWLE and characterized by a holistic and youth-friendly approach to promoting hope and resilience¹⁹⁰. These programs need to be adapted to different cultural and socio-economic contexts, and financial and human resources should be found or redirected before they can be scaled up across countries.

END-OF-LIFE DECISIONS BY PEOPLE WITH MENTAL HEALTH CONDITIONS

The ethical and legal background of decisions about the end of life is complicated by some aspects of mental disorders, including symptoms that may interfere with competent decision-making. Here we discuss the ethical issues involved in the application to PWLE of some widely debated approaches in this area.

With the development of technologies that can prolong life for people with severe impairments, such as persistent vegetative states, pressure has grown for mechanisms that would allow people to decline life-sustaining interventions in situations in which they believe that their lives have lost meaning. Appeal in these discussions is typically made to the value of personal autonomy, that is, the right of a person to determine what happens to his/her body²¹⁵. As the value of autonomy has come to predominate, countervailing considerations – such as the interests of family members in sustaining their loved ones, of the State in preserving the lives of its citizens, and of the medical profession in shaping its roles in end-of-life decisions – have been relegated to secondary concerns.

Supporting the change in attitudes regarding control over how one's life ends, the law has evolved to provide greater choice for individuals. The right of competent persons to refuse life-sustaining treatment has been widely recognized²¹⁶, along with their right in some countries to determine in advance which interventions will be applied (e.g., cardiopulmonary resuscitation, ventilators), and under what conditions²¹⁷. These advance directives can also be used to designate a proxy decision-maker who can assume responsibility for choices about medical care, should the person become incompetent to make choices for him/herself. PWLE, as long as they are considered competent to make decisions about their treatment, can formulate advance directives in the same way as any other person.

Taking the rationale for individual autonomy in decisions about one's body a step further, a growing number of jurisdictions around the world have adopted statutes or simply implemented practices that allow physician assistance in bringing about one's death²¹⁸. Initially, patients with untreatable conditions that were likely to result in death in the foreseeable future (e.g., within six months) were eligible to receive prescriptions from physicians for lethal doses of medication. Because of concern that some patients (for example, those with advanced amyotrophic lateral sclerosis) would be unable to take the medication themselves, this practice was extended in some jurisdictions to encompass physician administration of the medications, usually intravenously, a practice denoted by the term “euthanasia”²¹⁹.

However, people with disorders that were not likely to be rapidly fatal, but were associated with severe irremediable distress, soon argued that the restriction of physician-assisted death to terminal cases was irrational and discriminatory²²⁰. As a result, several countries expanded their laws to allow prescription and/ or administration of fatal doses of medication in these cases as well²²¹. It soon became evident that, once the principle was granted that an individual has the right to assistance in ending his/her life due to intolerable distress, it would be difficult to restrict this practice to cases involving physical illness. Thus, with similar arguments about discriminatory application of the law, several jurisdictions have extended physician-assisted death to include persons whose distress is the result of ostensibly untreatable mental disorders²²². And, although prevailing laws still require some diagnosis that is said to be associated with intolerable and intractable distress, media reports indicate that social isolation, financial concerns, and interpersonal difficulties appear to be the motivation behind physician-assisted death in an indeterminate number of cases²²³.

There has been considerable push-back against the extension of physician-assisted death to primary psychiatric indications. Among the concerns expressed are that a desire for death is frequently the manifestation of a mental disorder, especially but not exclusively depression²²⁴. Hence, psychiatrists who acquiesce to the desire of PWLE to end their lives, in contrast to the long-standing commitment of the profession to preventing suicide, are facilitating the worst possible outcome of a psychiatric condition.

In addition, although access to physician assistance is predicated, according to relevant national legislation, on a disorder being “unbearable and untreatable”, the assessment of these criteria in psychiatry is highly fraught. How unbearable a condition is can only be judged by a person's self-report, rendering it entirely subjective and potentially derivative of the condition itself²²⁵. Since legislation generally provides that only treatments that patients are willing to accept can be used in determining treatability, this too resides in the hands of the patient, where the known association of hopeless/helpless attitudes with depression may play a role²²⁶. Assessment of decisional competence in these cases may be extraordinarily difficult, and some data suggest that it is not being done very carefully in any case. Finally, there is concern that the offer of physician assistance in dying will be used as a substitute for the provision of adequate psychiatric and psychosocial support²²⁷, as already reported in Canada²²⁸.

All the approaches to strengthening individual autonomy over end-of-life decisions are premised on the persons making the choices being legally competent to do so. Although the terms used to define legal competence vary across jurisdictions, they generally refer to four core concepts²²⁹. Competence consists in a person's abilities to understand the relevant information, appreciate its implications for his/her own situation, reason about the choice at hand, and express his/her desires with regard to the decision.

Regardless of the presence of a mental disorder, persons who manifest these four abilities to a reasonable degree are considered competent to make their own decisions. Although severe mental disorders can impair a person's ability to use his/her decisional abilities, as can the effects of other serious illnesses, most people with psychiatric diagnoses retain the power to choose for themselves. As a matter of law, people are presumed to have decisional capacity unless shown not to.

Although psychiatrists often have training in conducting assessments of decisional capacity, most physicians have little or no exposure to these concepts or their application. Even highly consequential decisions about terminating life-sustaining treatment or requesting physician-assisted death may proceed without any careful assessment of a patient's decisional abilities. Data from the Netherlands appear to indicate that, even when physician assistance or euthanasia is being sought for a psychiatric indication, non-psychiatric physicians may do the assessment, and global judgments of competence without detailed inquiry into the elements of decisional capacity may be the norm²³⁰.

An approach to performing such assessments would take into account the importance of persons’ understanding of the nature of their illness, whether psychiatric or non-psychiatric; their likely prognosis; the pain or discomfort that may be associated with their condition in the future; and possible interventions to reduce that discomfort and/or treat the underlying condition, including the option of palliative care. In addition, people should have a realistic appreciation of their condition and its prognosis, and the consequences of death, especially its irreversibility and the consequent cut-off of future possibilities of ongoing interactions with people with whom they may have meaningful relationships. They should be able to make a clear and stable choice about their preferred option (some jurisdictions have waiting periods for physician-assisted death to ensure this). Finally, they should be able to describe how they arrived at their decision, with consideration of consequences with and without treatment and/or interventions to end their lives, and some process of weighing one set of considerations against the other and arriving at a choice consistent with those considerations.

How does a physician know whether a person has performed sufficiently well on these dimensions to be competent to make the highly consequential decision of moving in a direction that would end his/her life? As noted, all persons are presumed competent in the absence of evidence to the contrary. However, high-stakes decisions such as death generally require more capacity than lower-stakes decisions. Unfortunately, there is no precise algorithm and, though instruments have been developed to assist with the assessment of capacity to make decisions about refusal of treatment or to complete an advance directive, no such tools yet exist for decisions about physician-assisted death. Significant impairment on any dimension of competence should probably be taken to indicate incapacity for a decision as consequential as death.

Many major medical associations oppose direct physician involvement in bringing about the death of patients. The American Medical Association, for example, has held that “physician-assisted suicide is fundamentally incompatible with the physician's role as healer, would be difficult or impossible to control, and would pose serious societal risks”²³¹. In jurisdictions where physician-assisted death has been legalized, however, medical associations have tended to move toward neutral or favorable positions, perhaps in part to spare members who participate in these now-legal interventions from being labelled as unethical.

Psychiatric associations, however, have taken somewhat different stances. The American Psychiatric Association has rejected the practice holding that “a psychiatrist should not prescribe or administer any intervention to a non-terminally ill person for the purpose of causing death”²³². Perhaps because of differences of opinion between jurisdictions where physician-assisted death has been legalized for mental disorders and those where it has not, the WPA Code of Ethics has a more limited proscription: “Psychiatrists avoid endorsing patients’ requests for implementing termination of life-sustaining treatment or physician-assisted death, when they recognize that underlying psychopathology drives those requests”⁴.

How do individual physician's ethics come into play in issues relating to end-of-life decisions? In general medical settings, psychiatrists’ role will be limited to assessing patients’ competence to make decisions about refusal of life-sustaining treatment, when that is in question. Given the general acceptance of the principle of patient autonomy as it applies to such choices, few psychiatrists are likely to have qualms about conducting such evaluations, and those who do should have no difficulty finding a colleague who is willing to perform them instead. The situation may be different, however, for cases in which patients are requesting physician-assisted death, since many physicians still believe that this practice conflicts with their role in sustaining life. Controversy erupted in Ontario when the College of Physicians indicated that physicians who declined to participate in such cases had an obligation to refer people to a physician who would be willing to implement their preferences. Even that degree of facilitating the process was unacceptable to some physicians, who saw the requirement as implicating them in a practice that they considered unethical²³³.

Opposition among many psychiatrists to involvement in physician-assisted death for psychiatric indications is even stronger, given all the concerns mentioned above^{223, 234, 235}. Understandably, they believe that referring a person whom they view as suicidal to a practitioner or facility that will help him/her die would be antithetical to their primary obligation to treat mental disorders and prevent suicide. Although some psychiatrists who work in jurisdictions where the practice has been legalized have accepted the legitimacy of their participation, others remain strongly opposed. Given the split in the profession and the strongly held views, it does seem reasonable to allow psychiatrists who oppose physician-assisted death to opt out of participation, including referral.

CONFLICTS OF INTERESTS IN MENTAL HEALTH CARE, RESEARCH AND TRAINING

Conflicts of interests (CoIs) are defined as a set of circumstances that may unduly interfere with physicians’ professional obligations and primary interests in providing care, advancing research and scientific knowledge, and promoting public health. They can be financial, or related to professional achievements, or arising from allegiance to political/cultural beliefs or schools of thought^{236, 237}. The term CoI does not refer to ethical dilemmas arising from tensions between two physicians’ primary interests (e.g., a conflict between the respect for a person's autonomy and the principle of non-maleficence).

CoIs can lead to misconduct and illegal or unprofessional behavior, but far more often can influence judgment in subtle ways, and most clinicians and researchers may be unaware of an existing bias in their decision-making²³⁸. CoIs may threaten the quality of clinical care as well as the integrity of research and education, and may jeopardize public trust in science and medicine, including psychiatry^{236, 239}. The issue of public trust may be particularly relevant for psychiatry, which, more often than other medical specialties, has to face a poor public image as both a profession and a scientific discipline^240-245.

Health care professionals, including psychiatrists, may benefit from relationships with pharmaceutical and biomedical manufacturers in ways that are consistent with their primary interests, as they can acquire information on new therapeutic options, have the opportunity to give their feedback to facilitate further development of industry products, and access resources to update their knowledge and continue their education. However, while both pharmaceutical companies and professionals share the goal of improving health care, important differences cannot be ignored, as companies remain profit-driven and have their primary interest in the promotion of their brand and products. In all countries, pharmaceutical companies target health care professionals through a series of marketing strategies, which may involve gifts, free meals and travels, and provision of drug samples^{246, 247}.

Interactions between industry and professionals have raised concerns, as they can potentially influence physicians’ clinical decision-making. Several studies have addressed the relationship between financial interactions and prescription patterns²⁴⁸, and systematic reviews^{249, 250} have reported a correlation between the two, also suggesting a temporal and dose-dependent association. A study conducted in the US found that physicians were from 39% to 83% less likely to prescribe a new medication if they practiced in states with regulations against using pharmaceutical representatives to market products, in comparison with colleagues practicing in non-regulated states²⁵¹.

In the light of these concerns, attempts have been made to regulate the interactions of physicians with pharmaceutical company representatives. These have included specific restrictions on interactions or the disclosure of these interactions (either self-regulated or mandatory), especially when benefits are received by the physician. However, relevant policies and legislations show substantial heterogeneity across countries^252-255.

Both the WPA and the European Psychiatric Association (EPA) have developed sets of recommendations for psychiatrists in their relationships with the industry and in situations presenting potential CoIs^{256, 257}. The WPA warns psychiatrists to take with caution and critical review the information provided by industry representatives, and suggests that psychiatrists and health care organizations limit meetings and interactions with pharmaceutical company representatives, and forbid their access to patient care areas. Both the WPA and the EPA currently discourage psychiatrists from accepting meals and gifts, and the WPA additionally recommends accepting drug samples only to provide them to people who are otherwise unable to afford medications. In addition, both associations discourage psychiatrists from exposing items bearing companies’ logos in the presence of service users, because these may influence the users’ perceptions of the relationship between the industry and their doctors²⁵⁸.

CoI concerns have led to the development of disclosure policies mandating transparent reporting of financial interactions, such as the Physician Payments Sunshine Act²⁵⁹ in the US, and the Disclosure Code of the European Federation of Pharmaceutical Industries and Associations (EFPIA)²⁶⁰ in Europe. Disclosure may motivate clinicians to avoid circumstances and behaviors representing potential CoIs^{261, 262}, and aims to improve public trust in the health system through transparency. However, CoI disclosure may actually decrease trust, as it may make patients more aware of the relationships between their physicians and pharmaceutical companies^{263, 264}.

By significantly increasing public access to data on the financial ties of the pharmaceutical and biomedical industries with health care systems, disclosure policies have allowed systematic tracking and better understanding of this complex phenomenon. In particular, recent data shed light on the existence of a complex network involving not only prescribers and industry representatives, but multiple other parties, such as regulators, supply chains, patient advocacy groups and foundations. For instance, patient advocacy groups have been the subject of increasing reports of funding from pharmaceutical companies^265-267, and may participate in drug advisory committees, drug reviews and public reimbursement decisions²⁶⁸, thus indirectly influencing prescription patterns. Hence, a narrow focus on individual relationships, such as the direct ties between health care professionals and industry representatives, may overlook the role of the multiple pathways through which clinical decision-making may be indirectly influenced. These pathways, which may have cumulative effects, are far less documented, and may not be detected by policy makers²⁶⁹.

CoI restriction policies have been implemented to reduce the probability of prescribing a newly marketed drug as a result of marketing activities^{270, 271}, but their prevalence and strictness vary greatly, with North American medical schools having more frequent and stricter CoI policies as compared to European institutions^{272, 273}.

Non-financial CoIs are also relevant to psychiatric practice, and clinical decision-making may be influenced in case of intellectual allegiance to a school of thought or to political ideas¹², or in relation to defensive practices²⁷⁴. In the case of the latter, the pursuit of the primary interest of the PWLE's well-being and autonomy may be attenuated by the physician's personal interest in preventing a perceived or actual risk of litigation or legal responsibility. For instance, the clinician may opt for overly cautious interventions – such as overmedication, hospitalization, delayed discharge from the hospital, and even coercive measures such as involuntary hospitalization – instead of less invasive ones. Although psychiatry is at low risk of malpractice claims in comparison to other specialties²⁷⁵, surveys in different countries report that the majority of interviewed psychiatrists acknowledged having resorted to defensive practices, which, in their opinion, compromised the quality of the provided care^{274, 276, 277}.

CoIs may also be relevant to research activities, in which the pharmaceutical and medical device industries are often important partners²³⁶. Financial interactions may create secondary interests interfering with the primary goal, i.e., contributing to scientific progress through rigorous research²⁵⁷. Several studies indicate that industry funding can lead to bias in clinical trials, systematic reviews and clinical guidelines^278-281.

CoIs in research activities are currently regulated by a set of norms, policies and guidelines for researchers participating in scientific investigations, clinical trials, peer-review and publication processes, and guideline development^282-285. However, financial CoIs do not only affect individual researchers, but also academic institutions and institutional leaders^286-289, and current policies tend to regulate even small benefits to individual researchers (e.g., free meals), while often failing to address appropriately the effects of large amount of funding for institutions^{289, 290}. In addition, while current policies identify different magnitudes and types of CoIs, the lack of a shared standardized taxonomy of CoIs and the dearth of studies testing the influence of different CoIs on research and publication activities limit the efficiency of restrictions²⁹⁰.

Non-financial CoIs are less often acknowledged, although they may impact research as much as, or even more than, financial ones. Indeed, it has been stated that “the prospect of fame may be even more seductive than fortune”²⁹¹. According to this perspective, non-financial CoIs should be disclosed, or even regulated, using similar policy frameworks as for financial CoIs²⁹². In psychotherapy, for instance, an allegiance to a particular approach, due to personal training or involvement in previous research efforts, may significantly influence reported outcomes of results^293-296. A systematic review of 30 meta-analyses found that researchers’ allegiance to the tested psychotherapy inflated the reported effect sizes by almost 30%²⁹⁷.

Concerns about non-financial CoI disclosure have included privacy violation (e.g., in the case of political or religious beliefs) and irrelevance, insofar as it duplicates publicly available information, such as intellectual positions and education, training, institutional and academic affiliations²⁹⁸. It has been argued that these CoIs may be better addressed through other approaches, such as ensuring a balance of opposing perspectives^{299, 300} and diversity of professional backgrounds in the involved researchers³⁰¹.

Psychiatrists often have roles as teachers, mentors and public speakers, and participate in the education of students and residents. As such, they have a professional obligation to share up-to-date, evidence-based and ethically informed knowledge⁴. In these roles, CoIs may arise when either financial or non-financial secondary interests influence the content, quality and objectivity of the teaching and training. For instance, as pharmaceutical companies aim to promote their brands, as well as new therapeutic options, they have an interest in sponsoring educational initiatives, materials and events. Education providers may receive promotional speaking fees, which may bias – or be perceived to bias – the information they provide³⁰². Additionally, participants may receive gifts, reimbursements to participate in sponsored conferences, or scholarships^{236, 303}, and the possibility that these marketing activities influence their prescription patterns cannot be ruled out. The WPA Code of Ethics indicates that psychiatrists should be presenting in sponsored educational activities only when they have control over the educational content⁴.

Several regulators^304-308 have developed accreditation criteria limiting direct industry funding, as well as codes of conduct requiring management and transparent disclosure of CoIs. As noted, however, these regulations have limitations and may fail to address indirect financial ties and influences^{309, 310}.

Recent research and policy efforts have improved transparency and thus increased our understanding of the complexity of the issue of CoIs, as well as of the relevant health care and scientific ecosystem. In this ecosystem, not only clinicians and researchers, but each individual player may have multiple financial and non-financial interactions with multiple entities²⁶⁹, often in ways that are consistent with the primary interests of benefitting PWLE and society. However, all these interactions carry risks of undue influences, and growing evidence shows that commercial sponsors can influence these networks both at individual and institutional levels. Future policy and legislative efforts should not only aim to cut down such potential influences, but also promote a confluence of primary and secondary interests²⁹¹ and foster public trust through transparency and accountability.

THE ETHICAL DEMAND OF INVOLVING PEOPLE WITH LIVED EXPERIENCE AND FAMILY/INFORMAL SUPPORTERS IN ALL ASPECTS OF PSYCHIATRY

The ethical demand of involving PWLE and their family/informal supporters in all aspects of psychiatry – from clinical practice to policy development, research and training – is being increasingly acknowledged. The WPA endorsed these concepts in position statements in 2011³¹¹ and 2023³¹², and the WHO has developed a framework for meaningful engagement of PWLE³¹³.

A qualitative study found that PWLE often perceive the efforts of professionals to involve them in mental health care as tokenistic. They would like more information and ability to make decisions about their own care and treatment^{314, 315}. They feel that the relationship between the service user and the service deliverer is the most important factor in their care³¹⁵.

Much remains to be done to replace clinical practices based on the traditional therapeutic relationship – in which the roles are well defined and shaped by a thousand-year experience – by a new model of treatment that is still a work in progress. In fact, we need to consider the possible clash between the principles of autonomy and beneficence. By simply respecting people's autonomy and their decisions, physicians might betray their responsibilities and neglect the ethical principle of beneficence. In addition, other rights listed by the CRPD may not be enjoyed, including the right to the highest possible standard of health care.

Do all PWLE have sufficient knowledge and tools to take on the burden of the care decision responsibility? Would patient decision aids (PDA), i.e. tools designed by professionals to help PWLE understand treatment options and clarify their choices and preferences³¹⁶, represent a solution? Should all these tools be co-designed by professionals, PWLE and family/informal supporters together? May the responsibility of making decisions and choosing treatment options be distressing for some patients, and eventually worsen their mental conditions? Answers to these questions require further research – designed, conducted, analyzed and interpreted with the participation of PWLE and family/informal supporters.

Interest in peer support (i.e., involvement of PWLE in supporting other PWLE) has waxed and waned over the years, with a tremendous amount of activity at present³¹⁷. PWLE perform as well as others when they are in licensed practitioner roles³¹⁷. However, designated peer support roles are unique, with values and practices distinguishable from conventional roles³¹⁸. In general, PWLE are particularly good at getting engagement of other PWLE, reducing the use of emergency rooms and hospitals, and reducing substance misuse³¹⁹. Peer supporters increase users’ sense of hope and control, self-care, sense of belonging to a community, life satisfaction, and the ability to change their lives³¹⁷.

However, randomized controlled trials and systematic reviews reporting on the different methodologies and effectiveness of the inclusion of peer supporters in specific contexts are greatly needed, and may aid in the identification of emerging ethical issues. For instance, it is important to ascertain that placement of peer supporters in mental health services is not exclusively driven by the need to lower the costs, and that the workload does not cause them any harm (e.g., burnout).

Concerns often voiced by family/informal supporters of PWLE include lack of information about a loved one's mental health status, difficult relationships with professionals, and limited to no familial involvement in their mental health treatment³²⁰, as well as substantial personal burdens involved in providing care.

Training family/informal supporters is one of the suggested solutions to their burden^{321, 322}. With training, supporters’ morbidities, perceived burden, and negative expressed emotion have been found to decrease³²². People whose supporters received training tend to have fewer relapses than others³²³. Training supporters to identify and use their resources to make meaning from their situations, and giving them knowledge of recovery and treatment outcomes, can help them feel empowered³²⁴.

In the last decades, evidence has accumulated about the inclusion of family members in the treatment and care of their relatives with a mental health condition³²⁵. Their perspectives are valuable to foster professionals’ understanding of the problems related to those conditions, but also of the strengths associated with them. However, conflicts might arise between PWLE and relatives when they work together. In addition, the therapeutic relationship is based on respect for confidentiality, and there are instances in which PWLE oppose any involvement of their relatives in the process of care, or experience their involvement as creating high level of distress³²⁶. The psychiatrist may face pressure from both the PWLE and the family, and may need to consider the needs of both, while giving priority to the privacy and autonomy of the person for whose treatment he/she is responsible.

PWLE and caregivers have been involved as trainers of mental health professionals in the UK³²⁷. Topics covered in teaching ranged from communication to diagnostic skills, the experience of being a patient or caregiver, and involvement of PWLE in evaluation and research. Both medical students and their teachers found the experience to be valuable. Benefits to PWLE and supporters included feeling more confident and empowered, having their expertise valued, and improving their understanding of mental health professionals. Students developed increased empathy, greater awareness of stigma, and more positive views of the ability of PWLE to participate in their own care. Training of psychiatrists by PWLE often involves sharing narratives of recovery³²⁸, but PWLE should not be pressured to disclose more than they are confident with, because they may find the process of revealing their past to be distressing³²⁷.

Policy development should involve family/informal supporters and PWLE, and their inclusion is actually becoming common^329-332. One important policy win for PWLE was that they were heavily involved in negotiating and drafting the CRPD. This treaty makes involvement of service users and family supporters a legal requirement. Therefore, no policy development, review or amendment of legislation or additions to regulations should be undertaken without including PWLE. Barriers to meaningful involvement in policy formulation include that patient organizations may not really be involved in decisions, but just be performative members of groups³³³.

Most research in psychiatry is about PWLE and sometimes also about family supporters, but they are usually just the subjects of research, without direct involvement in either choosing the research directions or analyzing the results. Following from the idea of “Nothing about us without us”, it is desirable in many situations for PWLE and family supporters to be part of the team that determines the goals of the research and its applications^{312, 334, 335}.

There have been attempts to assess the practice of including PWLE in research³³⁶. It has been found that collaboration helped both academic researchers and PWLE to develop skills, and increased the credibility of research in the broader PWLE base, resulting in more legitimacy and accountability. Later studies suggested that including PWLE also helped the production of higher-quality research, better implementation chances for chosen policies, and increased empowerment and hopes for those people who contributed to the research^{333, 337}. A quantitative review also found that studies with higher patient involvement achieved higher recruitment targets, and sometimes more success in funding³³⁸.

Barriers to including PWLE in research were the challenge of an altered power structure, and the belief by some academics that psychiatric diagnoses preclude people from being able to conduct research, or concerns that they will not be objective³³⁶. Further concerns were lack of training for PWLE and, if they do have research expertise, the argument that they may not be representative of their wider community³³⁶. Also, there is not much training of researchers in how to effectively engage with PWLE³³⁹.

The WHO framework for meaningful engagement of PWLE and family/informal supporters³¹³, designed for leaders of health organizations, included the following basic principles: dignity and respect, power and equity, inclusivity and intersectionality, commitment and transparency, and institutionalization (i.e., making sure that the approaches are brought into common use in all institutions) and contextualization. Enablers of engagement include: sustainable financing, redistributing power, elimination of stigmatization, integrated approaches, capacity-building, and institutionalizing engagement.

Further research should be designed and conducted together with PWLE and family/informal supporters to clarify the best strategies and practices to foster their involvement at the different levels of mental health care, training, policies and research.

DISCUSSION

We have identified several ethical challenges in contemporary psychiatry, with the aim of raising awareness, proposing possible solutions and noting the risks entailed by these, and highlighting gaps to be narrowed by further studies and critical reflection. These challenges arise, and the potential responses are considered, in the context of major social and political changes, including health policies and the need for care, across countries.

The WPA Code of Ethics offers guidance for our profession. However, many mental health professionals are unaware of its principles. While public and professional awareness of the links between human rights and mental health care has increased significantly in the last few decades, a recent review found that only 15 out of the 143 WPA Member Societies had formal ethical documents of their own, and that these were rarely reviewed and updated³⁴⁰.

The paternalistic model, in which doctors decide and PWLE passively accept their decisions, is gradually being replaced by the shared decision-making model, in which PWLE are entitled to propose, discuss and make decisions, deserve trust and respect, and should be involved in all steps of health care provision, from service planning to care delivery²⁷. While in theory everyone agrees with this transformation, in practice there is resistance. The new models are still to be scaled up and implemented across countries and diverse cultures, and several ethical challenges need to be addressed^341-343.

The ratification of the CRPD in most countries across the world has contributed to enhancing awareness that the human rights of people with disabilities, including those due to severe mental disorders, cannot be ignored any longer. In line with the WPA Code of Ethics, the CRPD, in whose drafting PWLE were significantly involved, requires respect for dignity and autonomy of these people in psychiatric practice. In addition, it provides a detailed articulation of these principles by referring to the right to legal capacity, to liberty, and to mental and physical integrity on an equal basis with other people.

Unfortunately, while the CRPD has provided a new and important focus on human rights for PWLE, the interpretation of some of its articles has raised concerns among psychiatrists and other stakeholders. In particular, “radical” interpretations of Articles 12 and 14 as prohibiting involuntary psychiatric treatment under any circumstances are very problematic, and raise important challenges due to the clash between different ethical principles (i.e., autonomy versus beneficence, or versus right to health and life).

Anyway, the overuse of coercive and restrictive interventions in psychiatry represents an important ethical issue and requires effective action^{34, 35}. Would adequate mental health laws provide an effective solution? This is difficult to say, and even more difficult in light of the argument that a law specific for mental health care may complicate, instead of solving, the relevant ethical challenges, as it would involve an additional discrimination between PWLE and people with other medical conditions. Hence, the proposal of a law applicable across all medical specialties, in all settings, when a person has a difficulty in making decisions about treatment. Whether such a proposal provides an acceptable solution for psychiatrists and colleagues in other medical branches remains to be clarified.

Adequate legislation may contribute to addressing the above-mentioned ethical challenges, provided that the right to autonomy and freedom for PWLE does not lead to their abandonment and consequent poor mental health, social isolation and socio-economic deprivation. Advances in legislation must be complemented by adequate financial and human resources, aimed at supporting the implementation of human rights-based, recovery-oriented and trauma-informed mental health care on a large scale. The participation of PWLE and family/informal supporters should be part of this transformative project, from legislative changes to service planning, organization and delivery.

How can we reconcile the costs of this transformation with constraints in resources which seem to affect most parts of the world? Should we fear a two-level mental health care system, in which human rights-based and recovery-oriented care is provided to those who can afford paying for it, while the others will be “assisted” in lower-cost services? These are further questions requiring reflection and action.

There is hope that digital solutions may contribute to addressing the described ethical challenges by breaking down geographical barriers, enabling confidential and anonymous help-seeking, providing a quick and inexpensive answer to treatment needs for those with access to the Internet, and thus freeing up resources elsewhere in mental health services. However, we should not underestimate the risk that existing inequalities in the access to and regulation of these technologies within and between countries may exacerbate health inequalities and thus raise further ethical issues.

Relevant research and policies should contribute to improve the capacity to bring digital technologies to those most in need of access to mental health care, and support the development and adequate regulation of digital solutions for culturally diverse and resource-constrained environments. Experts, including PWLE and family/informal supporters, should implement guidelines for a gradual and cautious uptake of innovative tools through a cyclic process of testing, and a constant evaluation of sustainability with respect to the local mental health system (in which each tool should be integrated), funding and government support.

All digital solutions should be designed with the participation of end-users and long-term implementers¹¹⁷, and should be based on open standards, data and sources, to avoid the development of an unregulated and exploitive market. Unfortunately, this is not the most likely outcome currently. Joint coordinated initiatives involving policy makers and main stakeholders are urgently needed to design appropriate approval and regulatory procedures, including ethical, legal and context analyses.

The digital revolution might also have implications for another area affected by important ethical challenges, i.e. early intervention in psychiatry. At a first glance, this is an area in which the pros of intervention outweigh the cons: intuitively, the earlier we intervene to address a mental health condition, the more likely we are to spare suffering, avoid failures in achieving life's milestones, and prevent the onset or worsening of a mental disorder.

However, we still need to improve our ability to reach people in need of help, support and care at an early stage without causing stigmatization, stigma-related stress and fear of developing a serious mental illness, which are likely to lead to decreased quality of life, hopelessness, anxiety, depression, and even an increased risk of developing a serious mental disorder¹⁴³. On one side, we run the risk of breaching the principle of non-maleficence by providing information and eventually intervention; on the other, we run the risk of failing to provide relevant information and intervention to persons who might otherwise, for example, persist in clinically and socially adverse lifestyles, such as substance use, social isolation, or unhealthy sleep patterns.

Currently, guidelines emphasize the need to restrict assessment and referral to help-seeking individuals (indicated prevention), and offer low-risk psychosocial interventions (psychoeducation, substance abuse reduction programs, cognitive training, social/vocational functioning). This may be clinically and ethically appropriate, when considering that the majority of targeted individuals may benefit from them and will not need a pharmacological treatment that, in turn, is likely to raise several complex ethical concerns. However, even the adoption of the above-mentioned constraints raises ethical challenges, especially relevant to the principle of social justice⁴. Help-seeking behavior is associated with beneficial social determinants, and resources invested in prevention services – especially the few providing specialized early intervention – may not reach population segments with a high prevalence of risk factors but low access to mental health care services^{135, 196}.

There is hope that both financial and ethical issues (especially those relevant to social justice) could benefit from future implementation of biomarker-based screening, which might lead to more accurate identification of those in need of interventions, thus enabling the concentration of available resources on a limited number of people and avoiding unnecessary stigma. This apparently exciting perspective, however, also raises important ethical challenges, especially related to the potential misuse of information regarding biomarkers (including genetic variants) by insurance companies and employers who might acquire, request or use this information for their own interests. Thus, an opportunity for early mental health care could be transformed into another tool for discrimination and exclusion.

Highlighting the complex ethical challenges relevant to early intervention in psychiatry is not aimed to discourage such an important component of current models of care, but to contribute to the development and dissemination of more ethically informed prevention models, such as those co-designed with PWLE and characterized by a holistic and youth-friendly approach promoting hope and resilience¹⁹⁹.

Ethical challenges in contemporary psychiatry are also raised by the role of psychiatrists in end-of-life decisions for PWLE expressing a desire to die, which may be part of their mental condition. The WPA Code of Ethics states that “Psychiatrists avoid endorsing patients’ requests for implementing termination of life-sustaining treatment or physician-assisted death, when they recognize that underlying psychopathology drives those requests”⁴. This is familiar to clinicians, because in our practice we often meet persons who, when suffering from depression or other severe mental disorders, express a strong desire to die and, when remitted, are thankful to those who helped them overcome their difficulties and are again happy to live their life.

However, this is not necessarily obvious to policy makers. In a context in which persons’ autonomy is assigned a priority in decisions concerning health and control of their bodies, excluding PWLE from assisted life termination might be interpreted as discriminating them with respect to persons with severe physical illnesses who can freely choose to end their lives, provided that they are considered “competent to make decisions”. As a matter of fact, the extension of physician-assisted death to persons with mental disorders considered untreatable has occurred already in some countries, raising at least two ethical concerns: a) in psychiatry, more than in other medical specialties, defining a condition as untreatable is a difficult task (e.g., it is not always possible to ascertain whether the lack of treatment response is real or due to poor adherence, or whether it will generalize to treatments not yet attempted); b) the disorder itself may drive the belief that the condition is untreatable, as hopelessness is part of the disorder. In any case, given the complexity of the relevant ethical challenges, psychiatrists who are strongly opposed to physician-assisted death for PWLE should be allowed to refuse both participation and referral to another psychiatrist.

The WPA Code of Ethics might also provide further recommendations relevant to CoIs in clinical care, research and training. When illustrating the “non-maleficence” principle, the Code recommends that “Psychiatrists avoid engaging in relationships with third parties, including but not limited to the pharmaceutical industry, that may compromise their primary focus on the interests of their patients. Financial relationships should always be disclosed”⁴. Does this mean that, in addition to following the existing rules which limit interactions with industry representatives, as well as their access to care facilities, a clinician should present his/her patients a CoI declaration? While such a declaration is largely used in scientific meetings and publications, and is often adopted in educational contexts, it is not part of routine clinical practice. However, many US academic medical centers post CoI disclosures on a public website, and the US Physician Payments Sunshine Act²⁵⁹ established a federal website on which all payments by pharmaceutical companies to physicians are posted annually.

The available evidence shows a complex picture in which disclosure in clinical settings may lead to different outcomes. In fact, it might generate distrust, irrespective of the quality of the physician's advice and whether the disclosure is voluntary or mandatory. On the other hand, the disclosure might also produce increased trust, due to the enhanced perception of the physician's expertise.

Would the disclosure obligation also apply to non-financial CoIs? This appears even more complex, and would probably require different recommendations and procedures for different CoIs. Disclosing a CoI relevant to defensive practices is likely to have a negative impact on the therapeutic relationship, and to interfere with the person's willingness to accept the treatment.

As to research and publications, while there is no doubt that, when publishing the results of their research, psychiatrists must disclose the sources of their funding and other potential sources of bias, at the same time it is important to improve public understanding that the expression “CoI” refers to circumstances of factual or perceived risk of undue influence, and does not per se imply unethical behaviors. Relationships between physicians and other entities, including pharmaceutical companies, can lead to ethical problems, but it is equally true that sometimes such partnerships have led to new drug and medical device development.

Misbehaviors of some professionals should not translate into unjustified generalizations. Physicians should clearly state their relationships with all relevant individuals, companies or organizations, and in each action consider the ethical principles that should guide their behavior. However, at the same time, initiatives (e.g., debates, newspaper articles) should be implemented aimed at clarifying the correct interpretation of the term “CoI”.

Further ethical questions, which are probably more relevant to psychiatry than to other medical disciplines, are those related to the involvement of PWLE and family/informal supporters. Certainly, this involvement can contribute to improving the quality of human-rights-based mental health care, research and training. However, different ethical questions may arise depending on the kind of involvement, and the involved stakeholders, as the specific concerns often differ for PWLE and family/informal supporters.

The involvement of PWLE in their own care is generally referred to as shared decision-making, a model of care apparently endorsed by all service providers but, according to service users, too often representing a merely tokenistic approach. Of course, tokenism is not in line with the main ethical principles of our practice, and especially with respect for patients’ autonomy. However, much remains to be done to replace clinical practices based on the traditional therapeutic relationship with a new model of treatment that is still a work in progress.

PWLE in the role of caring for other PWLE could be an important resource in mental health care, given their ability to understand another's situation empathically through the shared experience of emotional distress. However, the evidence on the effectiveness of interventions provided by peer support workers is mixed. For patients with severe mental illnesses, for instance, there is some evidence of positive effects on measures of hope, recovery and empowerment, but there is no evidence of an impact on other important outcomes, such as hospitalization or overall symptoms. For patients with addiction issues, peer support can promote abstinence and result in increased involvement with Alcoholics Anonymous³¹⁹. However, further better-designed research in this area is warranted.

The role of family and informal supporters in shaping the agenda of mental health care and research should not be undervalued any longer. They represent important stakeholders, especially in the context of community-based care for people with severe mental disorders. However, PWLE may be against the involvement of relatives in their own care, or experience their involvement as creating high level of distress. This represents a significant ethical challenge.

National recommendations should be developed in all countries – based on the WPA position paper on developing partnerships with PWLE and family/informal supporters³¹², and on the WHO guidance for setting up new peer support mental health services³⁴⁴ – in order to disseminate information on the principles that should guide this partnership. In addition, further research should be designed and conducted together with PWLE and family/informal supporters to clarify the best strategies and practices to foster their involvement at the different levels of care, training, research and policies.

In conclusion, this review of ethical challenges in contemporary psychiatry aims to stimulate critical reflection on our models of care, mental health policies, training and other educational activities, as well as research methods and products. We are confronted with radical and rapid social transformations; innovations whose consequences are difficult to predict; increased awareness of and, at the same time, obvious violations of human rights; increased focus on individual needs and autonomy that are likely to clash with decreasing societal resources; and increased demand for full participation in all aspects of mental health care, education, research and policy by PWLE and their family/informal supporters.

A rethinking is needed of policies, services, training, attitudes, research methods and codes of ethics in psychiatry. This work involves engaging with major stakeholders and open-minded discussions, as well as commitment to implementation and monitoring of locally agreed solutions across health and social policy, clinical care, training and research.