Ron Berghmans

Inclusion of patients with severe mental illness in clinical trials: issues and recommendations surrounding informed consent.

Modern medicine would be unthinkable without the possibility of administering pharmaceuticals and other evidence-based interventions. The development of these interventions requires scientific research, ultimately with human subjects. This venture raises ethical, legal and human rights issues, which are addressed in numerous national and international declarations and regulations. In these documents, special attention is usually directed towards research involving vulnerable groups, such as children, pregnant women, unemployed persons, refugees, patients with psychiatric disorders, dementia or mental retardation, and those who are dying.In relation to patients with psychiatric disorders, two important and mutually connected ethical questions can be posed. Firstly, is research with persons who have severe psychiatric illnesses permissible? And, secondly, how can the mental capacity of prospective research subjects be assessed? We investigate these questions using the Dutch legal system as an example.Regarding the first question, the Dutch Medical-Scientific Research on Human Subjects Act (1998) presents a detailed regulation that is in line with relevant international documents, such as the Convention on Human Rights and Biomedicine (1997). In the Dutch statute, the possibilities for research involving subjects who lack mental capacity are limited, but not completely excluded. Under certain conditions, two types of research are exempted from the general prohibition of research with such subjects that is included in article 4 of the statute. These two types are (i) therapeutic research and (ii) non-therapeutic research that could not take place without the participation of subjects from the category to which the mentally incapacitated person belongs. The conditions pertain to ethical and scientific review, insurance, written proxy consent and respect for resistance by the subject. An extra condition for the permissibility of non-therapeutic research is that the risks for the prospective subject are negligible and the burdens minimal. Although the Dutch regulation obviously does not solve all problems, it is relatively clear when compared with the situation in other European countries, such as Belgium, France, Germany, and England and Wales.Regarding the second question, two basic factors need to be considered when defining ‘mental capacity’. These relate to the assumption of competence and to the task-specificity of capacity. The crucial issue in assessing mental capacity is not whether a psychiatric diagnosis is present, but whether the patient has the mental abilities required to make the decision at hand in a meaningful way. In establishing an appropriate standard for capacity assessment, several interests have to be weighed. The ethical demands of protection of subjects and stimulation of scientific research may be balanced by attempting to enhance patients’ mental capacity. The procedure of ‘experienced consent’ seems promising in this regard, although this approach entails its own ethical problems.

Editorial: Mental Capacity: In Search of Alternative Perspectives

Respecting patient autonomy is an important value in (mental) health care. In many jurisdictions, this value is translated into the concept of informed consent, which implies that before treatment or research can take place, the patient or research subject should give consent on the basis of relevant information which is provided by the health care worker or researcher. The concept of informed consent is based on the volenti non fit injuria principle, which states that a person is not harmed by acts of others to which he or she has consented (Feinberg, 1986). One of the preconditions for informed consent to be valid is that the patient or research participant has mental capacity (Faden and Beauchamp, 1986). In order to execute his or her rights, the person involved ought to have the capacity or competence to decide (decision making capacity) about treatment or research participation. In case the person lacks such decision making capacity, others may have authority to decide for the patient (proxy consent). In a number of clear-cut cases, judgments about capacity are uncontroversial, as in the case of a comatose patient or a newborn or very young infant. The issue of mental capacity generally arises (and becomes more controversial) with regard to patients who belong to ‘vulnerable’ groups: the cognitively impaired elderly, the mentally handicapped, individuals suffering from mental illness and children (Berghmans, 2001).

Advance directives in dementia care: from instructions to instruments

Advance directives are often regarded as instructions to the doctor about future care. This view is problematic, in that it obliterates that decisions about treatment and care always take place in a concrete situation, and require interpretation and communication. From a hermeneutic perspective, advance directives can be regarded as instruments which do not replace interpretation and communication, but sustain joint decision-making about treatment and care, including the patient and the family in a process of meaning-making.

Ethical issues of cost effectiveness analysis and guideline setting in mental health care

This article discusses ethical issues which are raised as a result of the introduction of economic evidence in mental health care in order to rationalise clinical practice. Cost effectiveness studies and guidelines based on such studies are often seen as impartial, neutral instruments which try to reduce the influence of non-scientific factors. However, such rationalising instruments often hide normative assumptions about the goals of treatment, the selection of treatments, the role of the patient, and the just distribution of scarce resources. These issues are dealt with in the context of increased control over clinical practice by third parties. In particular, health insurers have a great interest in economic evidence in clinical care settings in order to control access to and quality of (mental) health care. The authors conclude that guideline setting and cost effectiveness analysis may be seen as important instruments for making choices in health care, including mental health care, but that such an approach should always go hand in hand with a social and political debate about the goals of medicine and (mental) health care. This article is partly based on the results of a research project on the normative aspects of guideline setting in psychiatry and cardiology which was conducted under the guidance of the Royal Dutch Medical Association.

Coercion and pressure in psychiatry: lessons from Ulysses

Coercion and pressure in mental healthcare raise moral questions. This article focuses on moral questions raised by the everyday practice of pressure and coercion in the care for the mentally ill. In view of an example from literature—the story of Ulysses and the Sirens—several ethical issues surrounding this practice of care are discussed. Care giver and patient should be able to express feelings such as frustration, fear and powerlessness, and attention must be paid to those feelings. In order to be able to evaluate the intervention, one has to be aware of the variety of goals the intervention can aim at. One also has to be aware of the variety of methods of intervention, each with its own benefits and drawbacks. Finally, an intervention requires a context of care and responsibility, along with good communication and fair treatment before, during and after the use of coercion and pressure.

We are also normal humans, you know? Views and attitudes of juvenile delinquents on antisocial behavior, neurobiology and prevention

This paper presents and discusses the views and attitudes of juvenile delinquents regarding the implications of genomics and neurobiology research findings for the prevention and treatment of antisocial behavior. Scientific developments in these disciplines are considered to be of increasing importance for understanding the causes and the course of antisocial behavior and related mental disorders. High expectations exist with regard to the development of more effective prevention and intervention. Whether this is a desirable development does not only depend on science, but also on the ethical and social implications of potential applications of current and future research findings. As this pilot study points out, juvenile delinquents themselves have rather mixed views on the goals and means of early identification, prevention and treatment. Some welcome the potential support and help that could arise from biologically informed preventive and therapeutic measures. Others, however, reject the very goals of prevention and treatment and express worries concerning the risk of labeling and stigmatization and the possibility of false positives. Furthermore, interventions could aim at equalizing people and taking away socially disapproved capacities they themselves value. Moreover, most juvenile delinquents are hardly convinced that their crime could have been caused by some features of their brain or that a mental disorder has played a role. Instead, they provide social explanations such as living in a deprived neighborhood or having antisocial friends. We suggest that the hopes and expectations as well as the concerns and worries of juvenile delinquents are relevant not only for genomics and neurobiology of antisocial behavior, but also for prevention and intervention measures informed by social scientific and psychological research. The range of patterns of thought of juvenile delinquents is of great heuristic value and may lead to subsequent research that could further enhance our understanding of these patterns.

‘One Can Always Say No.’ Enriching the Bioethical Debate on Antisocial Behaviour, Neurobiology and Prevention: Views of Juvenile Delinquents

Genomic and neuro-scientific research into the causes and course of antisocial behaviour triggers bioethical debate. Often, these new developments are met with reservation, and possible drawbacks and negative side-effects are pointed out. This article reflects on these scientific developments and the bioethical debate by means of an exploration of the perspectives of one important stakeholder group: juveniles convicted of a serious crime who stay in a juvenile justice institution. The views of juveniles are particularly interesting, as possible applications of current and future scientific findings are considered to be most effective if applied early in life. Based on their statements we come to the following provisional conclusions. Concerns about labelling and stigmatization are recognized and widely shared. Possible effects on ones identity are acknowledged too. Yet, a possible biological underpinning of ones antisocial behaviour is not considered to result in the development of a criminal identity. Nonetheless, psychopharmacological interventions are experienced as endangering ones current self. Concerns regarding the refusal of responsibility and the blaming of ones genes or brain can be put into perspective. Instead, participants emphasize the motive of own choice as underlying their criminal behaviour. Moreover, bioethical debate should pay attention to the role of parents of children at risk and the parent-child relationship in families at-risk. We argue that the short-term and long-term interests of children at risk, as well as their interests and those of society at large, may conflict. In order to deal appropriately with newly arising dilemmas, a normative framework needs to be developed.

Sir Karl Popper, swans, and the general practitioner

At age 50 years, Ron Berghmans had back pain, which despite visits to his general practitioner increased in severity. Eventually Ron referred himself to a neurologist and realised things were more serious than anyone first thought

On the biomedicalization of alcoholism.

The shift in the prevailing view of alcoholism from a moral paradigm towards a biomedical paradigm is often characterized as a form of biomedicalization. We will examine and critique three reasons offered for the claim that viewing alcoholism as a disease is morally problematic. The first is that the new conceptualization of alcoholism as a chronic brain disease will lead to individualization, e.g., a too narrow focus on the individual person, excluding cultural and social dimensions of alcoholism. The second claim is that biomedicalization will lead to stigmatization and discrimination for both alcoholics and people who are at risk of becoming alcoholics. The third claim is that as a result of the biomedical point of view, the autonomy and responsibility of alcoholics and possibly even persons at risk may be unjustly restricted. Our conclusion is that the claims against the biomedical conceptualization of alcoholism as a chronic brain disease are neither specific nor convincing. Not only do some of these concerns also apply to the traditional moral model; above that they are not strong enough to justify the rejection of the new biomedical model altogether. The focus in the scientific and public debate should not be on some massive “biomedicalization objection” but on the various concerns underlying what is framed in terms of the biomedicalization of alcoholism.

Moral Enhancement for Antisocial Behavior? An Uneasy Relationship

John Shook (2012) discusses the meaning and possibility of moral enhancement. He is concerned that neuroethicists yield to the temptation to discuss practical questions concerning the effectiveness...