Engaging diverse social and cultural worlds: perspectives on benefits in international clinical research from South african communities.

The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South African communities on benefits in international clinical research. Twenty-four individuals with and without experience of being involved in clinical research participated in in-depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post-trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations.

'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 one's identity are acknowledged too. Yet, a possible biological underpinning of one's antisocial behaviour is not considered to result in the development of a criminal identity. Nonetheless, psychopharmacological interventions are experienced as endangering one's current self. Concerns regarding the refusal of responsibility and the blaming of one's 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.

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.

[Mental competence and elderly care]. / Wilsbekwaamheid in de ouderenzorg.

Competence or decision-making capacity are concepts, which are far from clear-cut. The normative consequences of an incapacity-judgment in elderly care require a balanced approach, which takes into consideration the risk of misuse in the context of the justification of interventions that are applied without consent of the patient. In this article a number of central issues in the debate on decision-making capacity are discussed. The different criteria, which are proposed to assess capacity, are discussed as well as the development of instruments in order to objectify capacity. It is concluded that the common approach towards decision-making capacity, which is strongly cognitive-oriented, is inadequate. A number of relevant aspects remain underexposed within this approach. A broader approach is explored, which takes into account the role of emotions, identity, and dialogue and deliberation. The different approaches are illustrated by way of a case example.

[Ethical aspects of anti-Alzheimer drugs: experiences of caregivers]. / Ethische aspecten van anti-Alzheimermiddelen: ervaringen van mantelzorgers.

The development and use of acetylcholinesterase inhibitors raise ethical issues. Ethical issues concern the consequences of an early diagnosis, the creation of unreasonable hope, possible negative effects of rivastigmine use, problems concerning stopping with rivastigmine, the patient role in decision-making and the possibility of conflicting interests. Within the ethical literature, hypotheses about the meaning of this drug for the patients have been formulated. This research aimed to investigate the experiences of caregivers of patients who used rivastigmine. The data have been collected by semi-structured interviews. The study included 12 caregivers of rivastigmine users. The--preliminary--results seem to indicate that theoretical considerations should be modified in the light of the experiences of caregivers. For example, problematic consequences of an early diagnosis and the creation of unreasonable hope did not appear in this study. Also problems concerning the rising awareness of cognitive decline were not found. In the interest of a further ethical debate concerning the development and use of antidementia drugs it is important to modify these theoretical considerations.

Ethical perspectives on decision-making capacity and consent for treatment and research.

Decision-making capacity for treatment and research raises complex conceptual issues. Given the fact that both considerations of respect for patient autonomy and beneficence/harm prevention have moral relevance in many cases, in the practice of health care the need exists to balance both in a moral responsible way. The moral concept of (mental) capacity or decisional capacity has a role to play in this balancing process. The current dominant approach towards the conceptualization and assessment of decision-making capacity, which focuses on cognition and rationality, has some serious shortcomings. In order to compensate for these shortcomings of the dominant approach, a number of alternative approaches may be promising. A first alternative focuses on issues of emotion and narrative; a second on identity and identification, and a third on dialogue and deliberation. By paying attention to the way in which people interprete their world (not only by cognition, but also by emotion), and how they shape their lives by processes of identification and communication, a broader perspective on capacity assessment in health care can be developed. Above that, these alternative approaches are less focused on the assessment of (in)capacity and more on enabling a person to become more competent through a process of empowerment, participation, and shared decision-making.

Physician-assisted suicide in psychiatry and loss of hope.

In the Netherlands, euthanasia and physician-assisted suicide (PAS) are considered acceptable medical practices in specific circumstances. The majority of cases of euthanasia and PAS involve patients suffering from cancer. However, in 1994 the Dutch Supreme Court in the so-called Chabot-case ruled that "the seriousness of the suffering of the patient does not depend on the cause of the suffering", thereby rejecting a distinction between physical (or somatic) and mental suffering. This opened the way for further debate about the acceptability of PAS in cases of serious and refractory mental illness. An important objection against offering PAS to mentally ill patients is that this might reinforce loss of hope, and demoralization. Based on an analysis of a reported case, this argument is evaluated. It is argued that offering PAS to a patient with a mental illness who suffers unbearably, enduringly and without prospect of relief does not necessarily imply taking away hope and can be ethically acceptable.

Choosing to limit choice: Self-binding directives in Dutch mental health care.

In certain cases of chronic mental illness (for example bipolar disorder) a self-binding directive or Ulysses contract may be a helpful intervention to prevent harm to the person him- or herself and/or others. By choosing such an arrangement, the patient can indicate when and how mental health professionals may intervene against his or her will and provide indicated care which may lead to an improvement of the patient's mental condition. In the Netherlands, since 2008 the Compulsory Admissions Act has been amended and now includes a paragraph on self-binding. Starting from the Dutch debate and statutory regulation of self-binding in mental health care, a number of issues with broader relevance are discussed, particularly as these pertain to the legal regulation and juridification of self-binding. It is argued that too many detailed rules are a threat to increasing patient empowerment.

"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.

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.

Informed consent and decision-making capacity in neuromodulation: ethical considerations.

In neuromodulation treatment and research, the informed consent of the patient or research subject is considered to be a moral precondition. In order to be morally valid, the consent of the person should be informed and voluntarily given, and the person should have decision-making capacity. Decision-making capacity matters from a moral point of view because it enables the patient or research subject to make a well-considered decision about treatment or research participation. Decision-making capacity is an ideal and in the practice of neuromodulation may be compromised as a result of different circumstances. These may be internal or external. Internal are factors related to illness (ie, cognitive and emotional defects; feelings of desperation and hopelessness); external are factors related to the context (ie, shortcomings in patient education and communication). In this paper, it is argued that full decision-making capacity in the context of neuromodulation is an illusion. This does not imply that we should do away with the moral ideals of decision-making capacity and valid informed consent. It is part of the responsibility of clinicians involved in neuromodulation to be aware of and sensitive to the different threats to the decision-making capacity of patients suffering from neurological and neuropsychiatric disorders, and to assist patients in making decisions that are as well considered as possible in the given circumstances.

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.

Do caregivers' experiences correspond with the concerns raised in the literature? Ethical issues relating to anti-dementia drugs.

BACKGROUND: The use of Cholinesterase inhibitors (ChE-Is) has raised debate in the literature on the ethical issues of drug treatment in dementia patients. These issues concern the quality of life of dementia patients and the process of decision-making regarding the use of ChE-Is. We interviewed caregivers of patients with dementia, focussing on issues of quality of life and the process of decision-making regarding the use of anti-dementia drugs. AIM: The aim of this article is to explore whether the ethical concerns raised in the literature are actually in line with experiences in the daily practice of dementia care. METHODS: Qualitative data that have been collected by semi-structured interviews with 12 caregivers of patients who (had) used ChE-Is. RESULTS: The results seem to indicate that theoretical considerations should be modified in the light of the reported experiences of caregivers. For example, problematic consequences of an early diagnosis and the creation of unreasonable hope did not appear in the study. Also problems concerning the rising awareness of cognitive decline were not found. CONCLUSION: In the interest of an ongoing ethical debate on the development and use of anti-dementia drugs it is important to further specify theoretical issues and to conduct empirical research into the practice of decision making and to get more insight in the perspectives of the patients using anti-dementia medicines themselves.