Inez de Beaufort

Predictive Genetic Testing for Cardiovascular Diseases: Impact on Carrier Children

We studied the experiences of children identified by family screening who were found to be a mutation carrier for a genetic cardiovascular disease (Long QT Syndrome (LQTS), Hypertrophic Cardiomyopathy (HCM), Familial Hypercholesterolemia (FH)). We addressed the (a) manner in which they perceive their carrier status, (b) impact on their daily lives, and (c) strategy used to cope with these consequences. Children (aged 8–18) who tested positive for LQTS (n = 11), HCM (n = 6) or FH (n = 16), and their parents participated in semi‐structured audiotaped interviews. Interview topics included illness perception, use of medication, lifestyle modifications, worries, and coping. Each interview was coded by two researchers. The qualitative analysis was guided by Leventhals model of self‐regulation. The children were overall quite articulate about the disease they were tested for, including its mode of inheritance. They expressed positive future health perceptions, but feelings of controllability varied. Adherence and side‐effects were significant themes with regard to medication‐use. Refraining from activities and maintaining a non‐fat diet were themes concerning lifestyle modifications. Some children spontaneously reported worries about the possibility of dying and frustration about being different from peers. Children coped with these worries by expressing faith in the effectiveness of medication, trying to be similar to peers or, in contrast, emphasizing their “being different.” Children generally appeared effective in the way they coped with their carrier status and its implications. Nevertheless, dealing with the daily implications of their condition remains difficult in some situations, warranting continued availability of psychosocial support.

An ethical framework for the prevention of overweight and obesity: a tool for thinking through a programme’s ethical aspects

INTRODUCTION It is important to be aware of the ethical pitfalls in programmes to prevent overweight and obesity, such as stigmatization, blaming the victim and reinforcement of health inequalities. In this article, we present an ethical framework for facilitating a structured analysis to the extent to which a programme prevents overweight or obesity is ethically acceptable. METHODS First, we made an inventory of ethical issues in programmes to prevent overweight and obesity. Secondly, we studied the available ethical frameworks that address the area of public health. Finally, we designed an ethical framework for the prevention of overweight and obesity, which was tested in two international workshops. RESULTS At the heart of the framework is a list of eight questions on the morally relevant features of a programme: its effects on physical health, psychosocial well-being, informed choice, cultural values, equality, privacy, responsibility and liberty. Answering these questions provides a map of the potential ethical pitfalls of a specific programme. This mapping should be followed by a structured discussion of the arguments and their importance, and the decision whether, and if so under what conditions, the programme should be implemented. CONCLUSION Considering the ethical aspects of the programmes to prevent obesity or overweight is extremely important in the face of the urgent and extensive health problem of overweight and obesity. Our framework is a practical tool for systematic ethical evaluation. It is applicable to a broad range of programmes in different stages of development and implementation.

Scientific and ethical issues related to stem cell research and interventions in neurodegenerative disorders of the brain

Should patients with Parkinsons disease participate in research involving stem cell treatments? Are induced pluripotent stem cells (iPSC) the ethical solution to the moral issues regarding embryonic stem cells? How can we adapt trial designs to best assess small numbers of patients in receipt of invasive experimental therapies? Over the last 20 years there has been a revolution in our ability to make stem cells from different sources and use them for therapeutic gain in disorders of the brain. These cells, which are defined by their capacity to proliferate indefinitely as well as differentiate into selective phenotypic cell types, are viewed as being especially attractive for studying disease processes and for grafting in patients with chronic incurable neurodegenerative disorders of the CNS such as Parkinsons disease (PD). In this review we briefly discuss and summarise where our understanding of stem cell biology has taken us relative to the clinic and patients, before dealing with some of the major ethical issues that work of this nature generates. This includes issues to do with the source of the cells, their ownership and exploitation along with questions about patient recruitment, consent and trial design when they translate to the clinic for therapeutic use.

Preconception care: an essential preventive strategy to improve children's and women's health.

Reproductive health has improved little in the last few decades. The Netherlands, particularly in large cities, has relatively high perinatal death rates compared with other European countries. Lack of improvement in reproductive outcomes despite improved quality of and better access to prenatal care strongly suggests that prenatal care alone is insufficient. We discuss how preconception care offers new strategies for improving reproductive health, how it usefully connects the life course of the affected individual and many health-care disciplines, and the benefits of combining a top-down policy structure and bottom-up organisation around caregivers. Given the likely benefits and cost savings calculated for the Netherlands, we conclude that failing to facilitate preconception care would reflect a breakdown of both professional and governmental responsibilities.

An overview of ethical frameworks in public health: can they be supportive in the evaluation of programs to prevent overweight?

BackgroundThe prevention of overweight sometimes raises complex ethical questions. Ethical public health frameworks may be helpful in evaluating programs or policy for overweight prevention. We give an overview of the purpose, form and contents of such public health frameworks and investigate to which extent they are useful for evaluating programs to prevent overweight and/or obesity.MethodsOur search for frameworks consisted of three steps. Firstly, we asked experts in the field of ethics and public health for the frameworks they were aware of. Secondly, we performed a search in Pubmed. Thirdly, we checked literature references in the articles on frameworks we found. In total, we thus found six ethical frameworks. We assessed the area on which the available ethical frameworks focus, the users they target at, the type of policy or intervention they propose to address, and their aim. Further, we looked at their structure and content, that is, tools for guiding the analytic process, the main ethical principles or values, possible criteria for dealing with ethical conflicts, and the concrete policy issues they are applied to.ResultsAll frameworks aim to support public health professionals or policymakers. Most of them provide a set of values or principles that serve as a standard for evaluating policy. Most frameworks articulate both the positive ethical foundations for public health and ethical constraints or concerns. Some frameworks offer analytic tools for guiding the evaluative process. Procedural guidelines and concrete criteria for solving important ethical conflicts in the particular area of the prevention of overweight or obesity are mostly lacking.ConclusionsPublic health ethical frameworks may be supportive in the evaluation of overweight prevention programs or policy, but seem to lack practical guidance to address ethical conflicts in this particular area.

How Best to Define the Concept of Minimal Risk

Some studies necessary for improving pediatric care cannot directly benefit the children involved. For example, pharmacokinetic studies and studies into pathophysiological mechanisms often do not directly benefit their subjects. From an ethical point of view, involving children in such studies is complex: when considering the assumption that children cannot give informed consent, it is not easy to justify research risks that are faced solely for research purposes. Yet a total ban on such studies would seriously harm future sick children. As a compromise, the drafters of the US Federal Regulations and those of many other rules and regulations have chosen to allow review boards to approve research that does not directly benefit the children involved only when the risks are minimal or, under certain conditions, constitute a minor increase over minimal risk. 1 The concept of ‘‘minimal risk’’ was not drawn from common language. Thus, it is not clear how pediatric researchers, when designing studies, and review boards, when reviewing them, should understand and use this concept. How should one judge whether, for instance, a lumbar puncture, an anorectal manometry, or a bronchial provocation test can be considered minimal risk? An adequate definition of the concept seems vital, not only to support those involved in designing and reviewing pediatric studies but also to appropriately protect children from research risks and to let research that involves acceptable risk levels be approved. The approach in the United States was to define minimal risk in relation to other situations with risks that one may regard as minimal. The definition reads as follows: ‘‘the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.’’ 2 Thus, to determine whether certain research risks are minimal, researchers and review boards are supposed to comparethemwiththerisksofdailylifeandofroutineexaminations.

Informing on prenatal screening for Down syndrome prior to conception. An empirical and ethical perspective

In most Western countries, information on prenatal screening for Down syndrome is provided in the first‐trimester of pregnancy. The purpose of this study was to examine whether this information should additionally be provided before pregnancy to improve the informed decision‐making process. In an empirical study, we obtained data from pregnant women with respect to their preferences regarding information on prenatal screening preconceptionally. Questionnaire data (n = 510) showed that 55.7% of responding women considered participating in prenatal screening for Down syndrome before pregnancy. 28.0% of women possessed information on prenatal screening preconceptionally. 84.6% preferred not to receive information preconceptionally in retrospect. In an ethical analysis, we elaborated on these preferences by weighing pros and cons. We considered two arguments against the provision of information on prenatal screening preconceptionally: womens preference to receive information in a step‐by‐step manner, and the risk of providing a directive message. We identified three reasons supporting its provision preconceptionally: the likelihood of making an informed decision could, firstly, be increased by “unchaining” the initial information from possible subsequent decisions, and, secondly, by providing women sufficient time to deliberate. Thirdly, the probability of equal access to prenatal screening may increase. To conclude with, we propose to incorporate an information offer on prenatal screening for Down syndrome in preconception care consultations. By offering information, instead of providing information, prospective parents are enabled to either accept or decline the information, which respects both their right to know and their right not‐to‐know.

‘Please, sir, can I have some more?’ Food, lifestyle, diets: Respect and moral responsibility

This article is about respect for food, responsibility for lifestyle and diet and responsibility for those who suffer from lack of food. After some general reflections on food, feasts, flatulence, taboos and waste, I argue that we have a responsibility to live a healthy lifestyle, but that there are also morally good reasons for taking risks with our health as we cherish other goals and values. Then I discuss situations, using the example of obesity, in which people are not free to choose their lifestyle. Governments and doctors have responsibilities in enabling people to chose healthy eating habits, e.g. by facilitating access to healthy foods and by criticizing scientifically unfounded weight loss diets. I continue to defend that we need to respect food and those who prepare it, and that we have a moral responsibility to contribute to the solution of the food gap in the world.

Regulating “Higher Risk, No Direct Benefit” Studies in Minors

(Goodyear-Smith et al. 2002). Significant difference across the judgment of ERCs without good reasons may itself be unfair and cause further confusion. The concept of minimal risk and its purposes may require further discussion. Providing a clear definition of minimal risk or its optimal and consistent interpretation may certainly be desirable. Nevertheless, it may not necessarily solve all the difficulties related to risk assessment. In practice, ERCs must grapple with a variety of research protocols to ensure that the ethical requirements including risk determination are fulfilled. What is important in the future may be more comprehensive and specific guidance on the ethics review process so that the participant’s well-being and social justice will be secured not only in terms of the level of risk involved but also with respect to other requirements for research to be ethically conducted. Much is left to be solved.

The camel syndrome

AimDescription and analysis from an ethical point of view of the habit of young people nowadays to carry around a bottle of water at all times.QuintessenceThis paper describes the habit and discusses its possible origin as well as some rituals and rules attached to the drinking of the water. Ethical questions are raised, such as a possible ‘aqua gap’ related to socio-economic circumstances within affluent Western societies and the problem of global justice in a world where the availability of clean drinking water is so unequally divided. It is strange that the notion of a ‘healthy addiction’ does not seem to attract the attention of ethicists.ConclusionsThe first conclusion is that the habit, because it is a healthy habit, influences views on what is considered to be polite or socially acceptable, such as the right to drink from a water bottle during theatre performances. The second conclusion is that there are lessons to be learned: that bottled water drinking is considered ‘cool’ can make many adapt to a healthy habit in a relatively short time. This could be useful for health education purposes.