http://repub.eur.nl/res/aut/18076/ List of Publications en http://repub.eur.nl/static-eur/img/logo.png http://repub.eur.nl http://repub.eur.nl/res/pub/38121/ 2012-11-21T00:00:00Z In recent years, developments in genomics technologies have led to the rise of commercial personal genome testing (PGT): broad genome-wide testing for multiple diseases simultaneously. While some commercial providers require physicians to order a personal genome test, others can be accessed directly. All providers advertise directly to consumers and offer genetic risk information about dozens of diseases in one single purchase. The quantity and the complexity of risk information pose challenges to adequate pre-test and post-test information provision and informed consent. There are currently no guidelines for what should constitute informed consent in PGT or how adequate informed consent can be achieved. In this paper, we propose a tiered-layered-staged model for informed consent. First, the proposed model is tiered as it offers choices between categories of diseases that are associated with distinct ethical, personal or societal issues. Second, the model distinguishes layers of information with a first layer offering minimal, indispensable information that is material to all consumers, and additional layers offering more detailed information made available upon request. Finally, the model stages informed consent as a process by feeding information to consumers in each subsequent stage of the process of undergoing a test, and by accommodating renewed consent for test result updates, resulting from the ongoing development of the science underlying PGT. A tiered-layered-staged model for informed consent with a focus on the consumer perspective can help overcome the ethical problems of information provision and informed consent in direct-to-consumer PGT.European Journal of Human Genetics advance online publication, 21 November 2012; doi:10.1038/ejhg.2012.237. http://repub.eur.nl/res/pub/38120/ 2012-11-13T00:00:00Z Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place - and a need - for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. http://repub.eur.nl/res/pub/32524/ 2012-04-27T00:00:00Z Al eeuwen dromen mensen van een maakbare wereld, een wereld die beter is dan de wereld die we kennen. Een wereld waar ziekte, dood en lijden zijn uitgebannen. Lange tijd bevond die betere wereld zich in het hiernamaals. Maar sinds de Verlichting is het dromen overgegaan in actief handelen; en in een geloof dat wij mensen door gebruik van de rede, van wetenschap en van technologie de wereld en onszelf daadwerkelijk, hier en nu, kunnen verbeteren. http://repub.eur.nl/res/pub/38124/ 2012-01-20T00:00:00Z Background: Companies are currently marketing personal genome tests directly-to-consumer that provide genetic susceptibility testing for a range of multifactorial diseases simultaneously. As these tests comprise multiple risk analyses for multiple diseases, they may be difficult to evaluate. Insight into morally relevant differences between diseases will assist researchers, healthcare professionals, policy-makers and other stakeholders in the ethical evaluation of personal genome tests. Discussion. In this paper, we identify and discuss four disease characteristics - severity, actionability, age of onset, and the somatic/psychiatric nature of disease - and show how these lead to specific ethical issues. By way of illustration, we apply this framework to genetic susceptibility testing for three diseases: type 2 diabetes, age-related macular degeneration and clinical depression. For these three diseases, we point out the ethical issues that are relevant to the question whether it is morally justifiable to offer genetic susceptibility testing to adults or to children or minors, and on what conditions. Summary. We conclude that the ethical evaluation of personal genome tests is challenging, for the ethical issues differ with the diseases tested for. An understanding of the ethical significance of disease characteristics will improve the ethical, legal and societal debate on personal genome testing. http://repub.eur.nl/res/pub/24052/ 2011-06-14T00:00:00Z Background: As genetics technology proceeds, practices of genetic testing have become more heterogeneous: many different types of tests are finding their way to the public in different settings and for a variety of purposes. This diversification is relevant to the discourse on ethical, legal and societal issues (ELSI) surrounding genetic testing, which must evolve to encompass these differences. One important development is the rise of personal genome testing on the basis of genetic profiling: the testing of multiple genetic variants simultaneously for the prediction of common multifactorial diseases. Currently, an increasing number of companies are offering personal genome tests directly to consumers and are spurring ELSI-discussions, which stand in need of clarification. This paper presents a systematic approach to the ELSI-evaluation of personal genome testing for multifactorial diseases along the lines of its test characteristics. Discussion: This paper addresses four test characteristics of personal genome testing: its being a non-targeted type of testing, its high analytical validity, low clinical validity and problematic clinical utility. These characteristics raise their own specific ELSI, for example: non-targeted genetic profiling poses serious problems for information provision and informed consent. Questions about the quantity and quality of the necessary information, as well as about moral responsibilities with regard to the provision of information are therefore becoming central themes within ELSI-discussions of personal genome testing. Further, the current low level of clinical validity of genetic profiles raises questions concerning societal risks and regulatory requirements, whereas simultaneously it causes traditional ELSI-issues of clinical genetics, such as psychological and health risks, discrimination, and stigmatization, to lose part of their relevance. Also, classic notions of clinical utility are challenged by the newer notion of 'personal utility.' Summary: Consideration of test characteristics is essential to any valuable discourse on the ELSI of personal genome testing for multifactorial diseases. Four key characteristics of the test - targeted/non-targeted testing, analytical validity, clinical validity and clinical utility - together determine the applicability and the relevance of ELSI to specific tests. The paper identifies and discusses four areas of interest for the ELSI-debate on personal genome testing: informational problems, risks, regulatory issues, and the notion of personal utility. http://repub.eur.nl/res/pub/34489/ 2011-06-01T00:00:00Z http://repub.eur.nl/res/pub/24901/ 2009-11-01T00:00:00Z Telecare, the provision of care through remote interaction enabled by information and communication technology, is quickly developing. Integration with other technological developments is to be expected and will create systems that enable more intense, continuous and unobtrusive monitoring of health, and more personalised feedback and instructions. One of the goals of telecare is enhancing the independence and self-management of patients. In this article three degrees of self-management are described and a distinction is made between compliant and concordant forms of self-management. It is argued that telecare merely promotes forms of self-management in which compliance to medical instructions is central. Technological developments and normative policy con- siderations may enforce this trend to implement an interpretation of self-management in which compliance to a strict medical regime is prominent. Against this, a plea is made for developing telecare systems that incorporate concordant and collaborative forms of self-management, in which the patient's own perspective is empowered. Copyright http://repub.eur.nl/res/pub/24900/ 2009-08-01T00:00:00Z Introduction: In The Netherlands, physicians have to be convinced that the patient suffers unbearably and hopelessly before granting a request for euthanasia. The extent to which general practitioners (GPs), consulted physicians and members of the euthanasia review committees judge this criterion similarly was evaluated. Methods: 300 GPs, 150 consultants and 27 members of review committees were sent a questionnaire with patient descriptions. Besides a "standard case" of a patient with physical suffering and limited life expectancy, the descriptions included cases in which the request was mainly rooted in psychosocial or existential suffering, such as fear of future suffering or dependency. For each case, respondents were asked whether they recognised the case from their own practice and whether they considered the suffering to be unbearable. Results: The cases were recognisable for almost all respondents. For the "standard case" nearly all respondents were convinced that the patient suffered unbearably. For the other cases, GPs thought the suffering was unbearable less often (2-49%) than consultants (25-79%) and members of the euthanasia review committees (24-88%). In each group, the suffering of patients with early dementia and patients who were "tired of living" was least often considered to be unbearable. Conclusions: When non-physical aspects of suffering are central in a euthanasia request, there is variance between and within GPs, consultants and members of the euthanasia committees in their judgement of the patient's suffering. Possible explanations could be differences in their roles in the decision-making process, differences in experience with evaluating a euthanasia request, or differences in views regarding the permissibility of euthanasia. Copyright http://repub.eur.nl/res/pub/15741/ 2009-07-01T00:00:00Z The hopes and fears expressed in the debate on human enhancement are not always based on a realistic assessment of the expected possibilities. Discussions about extreme scenarios may at times obscure the ethical and policy issues that are relevant today. This paper aims to contribute to an adequate and ethically sound societal response to actual current developments. After a brief outline of the ethical debate concerning neuro-enhancement, it describes the current state of the art in psychopharmacological science and current uses of psychopharmacological enhancement, as well as the prospects for the near future. It then identifies ethical issues regarding psychopharmacological enhancements that require attention from policymakers, both on the professional and on the governmental level. These concern enhancement research, the gradual expansion of medical categories, off-label prescription and responsibility of doctors, and accessibility of enhancers on the Internet. It is concluded that further discussion on the advantages and drawbacks of enhancers on a collective social level is still needed. http://repub.eur.nl/res/pub/26970/ 2009-07-01T00:00:00Z The use of psychopharmaceuticals to enhance human mental functioning such as cognition and mood has raised a debate on questions regarding identity and authenticity. While some hold that psychopharmaceutical substances can help users to 'become who they really are' and thus strengthen their identity and authenticity, others believe that the substances will lead to inauthenticity, normalization, and socially-enforced adaptation of behaviour and personality. In light of this debate, we studied how persons who actually have experience with the use of psychopharmaceutical medication would view their 'self' or their authentic personal identity in relation to the use of medication. We have interviewed a number of adults diagnosed with ADHD and discussed their experiences with medication use in relation to their conceptions of self and identity. In the first part of this paper we illustrate that the concepts of identity and authenticity play an important and sometimes problematic role in experiences of ADHD adults. This shows that the question about identity and psychopharmacology is not merely an 'academic' issue, but one that influences everyday lives of real people. In order to answer the question whether psychopharmaceuticals threaten personal identity and authenticity, more than empirical research is needed. We also need to analyse the concepts of personal identity, authenticity and self: what do we mean when we are using statements as 'a way of living that is uniquely our own', 'our true self', or 'who we really are'? In the second part of this paper we discuss two important philosophical views on personal identity, authenticity and self: the self-control view as elaborated by Frankfurt, and the self-expression view as proposed by Schechtman. We compare these with the experiences of our respondents to see which view can help us to understand the diverse and often conflicting experiences that people have with medication for ADHD. This will contribute to a better understanding of whether and in which cases personal identity and authenticity are threatened by psychopharmacology. http://repub.eur.nl/res/pub/25202/ 2009-05-01T00:00:00Z http://repub.eur.nl/res/pub/15249/ 2008-09-01T00:00:00Z One argument that is frequently invoked against the technological enhancement of human functioning is that it is morally suspect, or even wrong, to take an easy shortcut. Some things that usually take effort, endurance or struggle can come easily with the use of an enhancer. This paper analyses the various arguments that circle round the idea that enhancement of human functioning is problematic because of the 'easy shortcut' that it offers. It discusses the concern that quick fixes lead to corrosion of character and the idea that suffering, pain, hard work and effort are essential for real and worthy achievements, and argues that these views are largely mistaken. Next, the paper argues that the core worry about taking an easy shortcut is that it makes us lose sight of the complexities of our means and ends; in other words, the argument warns against reducing the richness of human activities. A vocabulary of 'practices', 'internal goods' and 'focal engagement' will be used to articulate this argument further. The conclusion is that the easy shortcut argument has no general validity as an argument against enhancement 'as such'. The paper urges us, however, to evaluate enhancement technologies not only in terms of their efficiency in reaching certain goals but also in terms of their contribution to intrinsically worthwhile human activities. It can point out some of the caveats, as well as the opportunities, of the use of enhancement technologies. http://repub.eur.nl/res/pub/29341/ 2008-02-25T00:00:00Z It has been suggested that the recent rapid developments in the fields of neuroscience and psychopharmacology have increased the possibilities for pharmacological enhancement of mental functioning. Here, evidence is reviewed which shows that drugs acting on a variety of neurotransmitter systems can indeed enhance cognition, and to a lesser extent mood and pro-social behavior. Moreover, it seems possible to interfere with the (re)consolidation of traumatic memories. There are, however, a number of caveats: first, as cognition-enhancing drugs can simultaneously exert both linear and quadratic (U-shaped) effects, doses most effective in facilitating one behavior could at the same time exert null or even detrimental effects on other cognitive domains. Second, individuals with a 'low memory span' might benefit from cognition-enhancing drugs, whereas 'high span subjects' are 'overdosed'. And finally, evidence suggests that a number of trade-offs could occur. For example, increases of cognitive stability might come at the cost of a decreased capacity to flexibly alter behavior. A short overview of ethical issues raised by the use of cognition and mood enhancing drugs demonstrates the tremendous variety in views and opinions regarding the subject. http://repub.eur.nl/res/pub/29610/ 2008-02-01T00:00:00Z One frequently used argument in the discussion on human enhancement is that enhancement is a form of cheating. This argument is well-known in relation to doping in sports, but recently it has also been used with regard to cognitive enhancement in the context of education and exams. This paper analyses the enhancement-is-cheating argument by comparing sports and education, and by evaluating how the argument can be interpreted in both contexts. If cheating is understood as breaking the rules in order to gain an unfair advantage over others, it can be argued that some enhancements are a form of cheating. This problem of cheating is, however, relatively easy to remedy by either changing the rules, or by instituting controls and sanctions. This does not, therefore, constitute a categorical objection to enhancement. A further analysis of the intuitions behind the enhancement-is-cheating argument, however, shows that if sports and education are understood as "practices", with their own internal goods and standards of excellence, some potential problems of enhancement can be articulated. These concern the internal goods and standards of excellence that are characteristic of specific practices. Seen from this perspective, the important question is how enhancement technologies might be embedded in specific practices - or how they might corrode them. http://repub.eur.nl/res/pub/36796/ 2007-06-01T00:00:00Z Aldous Huxley's Brave New World is a famous dystopia, frequently called upon in public discussions about new biotechnology. It is less well known that 30 years later Huxley also wrote a utopian novel, called Island. This paper will discuss both novels focussing especially on the role of psychopharmacological substances. If we see fiction as a way of imagining what the world could look like, then what can we learn from Huxley's novels about psychopharmacology and how does that relate to the discussion in the ethical and philosophical literature on this subject? The paper argues that in the current ethical discussion the dystopian vision on psychopharmacology is dominant, but that a comparison between Brave New World and Island shows that a more utopian view is possible as well. This is illustrated by a discussion of the issue of psychopharmacology and authenticity. The second part of the paper draws some further conclusions for the ethical debate on psychopharmacology and human enhancement, by comparing the novels not only with each other, but also with our present reality. It is claimed that the debate should not get stuck in an opposition of dystopian and utopian views, but should address important issues that demand attention in our real world: those of evaluation and governance of enhancing psychopharmacological substances in democratic, pluralistic societies.