This paper proposes a framework for an ethical impact assessment which can be performed in regard to any policy, service, project or programme involving information technology. The framework is structured on the four principles posited by Beauchamp and Childress together with a separate section on privacy and data protection. The framework identifies key social values and ethical issues, provides some brief explanatory contextual information which is then followed by a set of questions aimed at the technology developer or policy-maker to (...) facilitate consideration of ethical issues, in consultation with stakeholders, which may arise in their undertaking. In addition, the framework includes a set of ethical tools and procedural practices which can be employed as part of the ethical impact assessment. Although the framework has been developed within a European context, it could be applied equally well beyond European borders. (shrink)

Bariatric surgery is effective on short- and medium-term weight loss, reduction of comorbidities, and overall mortality. A large and increasing portion of the population is eligible for bariatric surgery, which increases instant health care costs. A review of the literature identifies a series of ethical challenges: unjust distribution of bariatric surgery, autonomy and informed consent, classification of obesity and selecting assessment endpoints, prejudice among health professionals, intervention in people's life-world, and medicalization of appearance. Bariatric surgery is particularly interesting because it (...) uses surgical methods to modify healthy organs, is not curative, but offers symptoms relief for a condition that it is considered to result from lack of self-control and is subject to significant prejudice. Taking the reviewed ethical issues into account is important when meeting persons eligible for bariatric surgery, as well as in the assessment of and decision making on surgery for obesity. (shrink)

It can be assumed that value judgements, which are needed to judge what is ‘good’ or ‘better’ and what is ‘bad’ or ‘worse’, are involved in every decision-making process. The theoretical understanding and analysis of value judgements is, therefore, important in the context of bioethics, for example, to be able to ethically assess real decision-making processes in biomedical practice and make recommendations for improvements. However, real decision-making processes and the value judgements inherent in them must first be investigated empirically (‘empirical (...) bioethics’). For this to succeed, what exactly a ‘value judgement’ is and of what components it might consist must initially be theoretically clarified. A corresponding conceptual model can then support or even enable empirical data collection and analysis and, above all, subsequent ethical analysis and evaluation. This paper, therefore, presents a value judgement model with its theoretical derivation. It also illustrates its application in an interview study of decision-making between animal experimentation and alternative methods in the context of biomedical research. Though the model itself can be theoretically deepened and extended, the application of the model works in general and helps to uncover what value judgements can enter into decision-making. However, the empirical methods, for example, qualitative interviews, can also be better oriented towards eliciting value judgements (as understood according to the model). Further applications of the model to other topics or by means of other empirical methods are conceivable. (shrink)

BackgroundWhile evaluation of ethical aspects in health technology assessment has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response to the increasing demand for expansion of health technology assessment methodology to include ethical issues more systematically, this article reports on a multi-stage study that aimed at construction of a framework for improving the integration of ethics in HTA.MethodsThe framework was developed through the following phases: 1) a systematic review and (...) content analysis of guidance documents for ethics in HTA; 2) identification of factors influencing the integration of ethical considerations in HTA; 3) preparation of an action-oriented framework based on the key elements of the existing guidance documents and identified barriers to and facilitators of their implementation; and 4) expert consultation and revision of the framework.ResultsThe proposed framework consists of three main components: an algorithmic flowchart, which exhibits the different steps of an ethical inquiry throughout the HTA process, including: defining the objectives and scope of the evaluation, stakeholder analysis, assessing organizational capacity, framing ethical evaluation questions, ethical analysis, deliberation, and knowledge translation; a stepwise guide, which focuses on the task objectives and potential questions that are required to be addressed at each step; and a list of some commonly recommended or used tools to help facilitate the evaluation process.ConclusionsThe proposed framework can be used to support and promote good practice in integration of ethics into HTA. However, further validation of the framework through case studies and expert consultation is required to establish its utility for HTA practice. (shrink)

The integration of ethical analysis in Health Technology Assessment (HTA) has proven difficult to implement even though it is explicitly recognized as an important component of such assessments in HTA literature. When compared to the standardized scientific method for systematic reviews in HTA, the diversity of ethical analysis has been characterized as a fundamental barrier to the integration of ethics. The present paper aims to identify the theoretical and practical differences between the approaches underpinning ethical analysis in HTA and clarify (...) the reasons for such diversity. Our systematic review of HTA literature pertaining to the barriers to the integration of ethics in HTA identified nine ethical approaches: Principlism, Casuistry, Coherence Analysis, Wide Reflective Equilibrium, Axiology, the Socratic approach, the Triangular model, Constructive Technology Assessment and Social Shaping of Technology. Citations pertaining to each approach were extracted and categorized according to three constitutive components of ethical argumentation established in a previous research evaluating nanotechnologies: i) the disciplinary foundation that grounds the validity of the ethical evaluation, ii) the characteristics of such evaluation, iii) the operational process involved in applying it to a particular case (i.e., its practical reasoning). This comparison shows that, 1) the difference between these approaches rests primarily on their disciplinary foundation (rooted in philosophy, philosophy/theology, or sociology), 2) their complexity can be observed in the distinct characteristics of ethical evaluation deriving from their differing disciplinary foundation, and 3) although four different types of operationalization procedure were identified, little information was available in regards to the practical reasoning associated with these approaches. (shrink)

Nous voulons mieux comprendre les lois circonscrivant le rôle social de l’Évaluation des technologies en santé (ETS) et les raisons empêchant l’inclusion de l’éthique en ETS. Nous avons ciblé un débat qui est au coeur du rôle perçu du droit réglementaire dans le développement de technologies en santé : l’opposition entre les enjeux environnementaux, sécuritaires et sanitaires (EHSI) et les enjeux éthiques, légaux et sociaux (ELSI), issus de la gouvernance technologique. La collecte de données est basée sur une revue de (...) la littérature issue de travaux antérieurs, et sur une analyse de cas où trois agences d’ETS ont été sélectionnées en utilisant différentes catégories d’obligation légale selon leur degré de force contraignante. La revue de littérature a révélé cinq thèmes relatifs au rôle social de l’ETS et une distinction entre le rôle/utilisation du droit dur et du droit souple dans le droit réglementaire, permettant ainsi de comprendre comment les agences ont utilisé le droit pour intégrer (ou non) l’éthique en ETS. Les deux approches ont démontré que le débat, EHSI/ELSI observé initialement dans la gouvernance et l’évaluation de technologies est reproduit en ETS. La principale tendance confirmée par ces analyses est la présence d’un pacte entre la science et le droit réglementaire. La demande sociale d’intégrer les ELSI, particulièrement l’évaluation éthique en ETS, n’est pas prise en compte par le droit réglementaire traditionnel régissant l’ETS et doit plutôt être considérée par le droit souple. Les difficultés d’intégration de l’éthique en ETS démontrent la nécessité de repenser la gouvernance juridique de l’ETS. (shrink)

Endeavors have been made to found and incorporate ethical values in most aspects of healthcare, including health technology assessment. Health technologies and their assessment are value-laden and could trigger problems with dissemination if they contradict societal norms. Per WHO definition, preconception expanded carrier screening is a new health technology that warrants assessment. It is a genetic test offered to couples who have no known risk of recessive genetic diseases and are interested pregnancy. A test may screen for carrier status of (...) several autosomal recessive diseases and X-linked at one go. The technique has been piloted in the Netherlands and is discussed in other countries. The aim of the study was to examine values and value conflicts that healthcare experts recounted in relation to the discussion of implementation and use of preconception ECS in Sweden. We interviewed ten experts, who were associated with influencing health policymaking in Sweden. We employed systematizing expert interviews, which endeavor to access experts’ specialist knowledge. There were four female and six male informants, of which four were physicians, three bioethicists, one a legal expert, one a theologian and one a political party representative in the parliament. The participants functioned as members of two non-governmental bodies and three governmental organizations. We employed thematic analysis to identify themes, categories and subcategories. Two main themes surfaced: values and value conflicts. The main categories of Respect for persons, Solidarity, Human dignity, Do no harm, Health and Love formed the first theme, while values conflicting with autonomy and integrity respectively, constituted the second theme. Concepts relating to respect for persons were the most commonly mentioned among the participants, followed by notions alluding to solidarity. Furthermore, respondents discussed values conflicting with Swedish healthcare ones such as equality and solidarity. The experts highlighted values and concepts that are distinctive of welfare states such as Sweden and delineated how preconception ECS could challenge such values. Moreover, the analysis revealed that certain values were deemed more substantive than others, judging by the extent and detail of inference; for example, respect for persons and solidarity were on top of the list. (shrink)

The approach to innovations known as Responsible research and innovation aims to move the innovation system towards creating products that strive to realize social values along with economic benefits. This paper discusses the systematic assessment of assistive technologies in order for them to meet the aims expressed in RRI. A central issue in the discussion is how to facilitate an integration of insights from the discourse on RRI with more established assessment approaches such as Health Technology Assessment. Based on the (...) literature on existing socio-ethical assessment tools, I investigate how these tools can be combined with HTA and how they can add perspectives from RRI that might increase the socio-ethical value of assistive technologies. Through a discussion on how to understand RRI, HTA, assessment and integration, I suggest a list of four possible approaches that have the potential to be applied as assessment approaches that integrate insights from RRI and HTA. These are then evaluated on their ability to address issues that have emerged from a literature review on RRI and assistive technologies, on empirical studies in this technology field and on their product focus. In conclusion, I argue that the Ethical Impact Assessment, the Socratic approach, the Ethical Matrix, and the HTA Core Model seem to be the most promising methodologies, but that these need adjustments to cover substantive themes from RRI. _Keywords:_ energy scenarios, justice, future generations, capabilities approach. (shrink)

Demographical changes in high income counties will increase the need of health care services but reduce the number of people to provide them. Welfare technology is launched as an important measure to meet this challenge. As with all types of technologies we must explore its ethical challenges. A literature review reveals that welfare technology is a generic term for a heterogeneous group of technologies and there are few studies documenting their efficacy, effectiveness and efficiency. Many kinds of welfare technology break (...) with the traditional organization of health care. It introduces technology in new areas, such as in private homes, and it provides new functions, e.g. offering social stimuli and entertainment. At the same time welfare technology is developed for groups that traditionally have not been extensive technology users. This raises a series of ethical questions with regard to the development and use of welfare technologies, which are presented in this review. The main challenges identified are: (1) Alienation when advanced technology is used at home, (2) conflicting goals, as welfare technologies have many stakeholders with several ends, (3) respecting confidentiality and privacy when third-party actors are involved, (4) guaranteeing equal access and just distribution, and (5) handling conflicts between instrumental rationality and care in terms of respecting dignity and vulnerability. Addressing these issues is important for developing and implementing welfare technologies in a morally acceptable manner. (shrink)

The Scandinavian welfare states have public health care systems which have universal coverage and traditionally low influence of private insurance and private provision. Due to raises in costs, elaborate public control of health care, and a significant technological development in health care, priority setting came on the public agenda comparatively early in the Scandinavian countries. The development of health care priority setting has been partly homogeneous and appears to follow certain phases. This can be of broader interest as it may (...) shed light on alternative models and strategies in health care priority setting. Some general trends have been identified: from principles to procedures, from closed to open processes, and from experts to participation. Five general approaches have been recognized: The moral principles and values based approach, the moral principles and economic assessment approach, the procedural approach, the expert based practice defining approach, and the participatory practice defining approach. There are pros and cons with all of these approaches. For the time being the fifth approach appears attractive, but its lack of true participation and the lack of clear success criteria may pose significant challenges in the future. (shrink)

BackgroundBariatric surgery for children and adolescents is becoming widespread. However, the evidence is still scarce and of poor quality, and many of the patients are too young to consent. This poses a series of moral challenges, which have to be addressed both when considering bariatric surgery introduced as a health care service and when deciding for treatment for young individuals. A question based (Socratic) approach is applied to reveal underlying moral issues that can be relevant to an open and transparent (...) decision making process.DiscussionA wide range of moral issues with bariatric surgery for children and adolescents is identified in the literature. There is a moral imperative to help obese minors avoiding serious health problems, but there is little high quality evidence on safety, outcomes, and cost-effectiveness for bariatric surgery in this group. Lack of maturity and family relations poses a series of challenges with autonomy, informed consent, assent, and assessing the best interest of children and adolescents. Social aspects of obesity, such as medicalization, prejudice, and discrimination, raise problems with justice and trust in health professionals. Conceptual issues, such as definition of obesity and treatment end-points, present moral problems. Hidden interests of patients, parents, professionals, industry, and society need to be revealed.SummaryPerforming bariatric surgery for obese children and adolescents in order to discipline their behavior warrants reflection and caution. More evidence on outcomes is needed to be able to balance benefits and risks, to provide information for a valid consent or assent, and to advise minors and parents. (shrink)