The purpose of this paper is to set out a structured meta‐methodology, named DIODE, for the ethical assessment of new and emerging technologies. DIODE has been designed by a mixture of academics, governmental people and commercial practitioners. It is designed to help diverse organisations and individuals conduct ethical assessments of new and emerging technologies. A framework discussion paper was developed for consultation to ensure that DIODE addresses fundamental ethical concerns, has appropriate and manageable scope and is comprehensive in its ethical (...) compass. The resulting DIODE meta‐methodology uses flowcharts and templates, encompassing the use of diverse tools and techniques. There are two different angles for the ethical assessment of new technologies; a strategic-abstract angle and a project-application specific angle. DIODE includes two channels to accommodate this distinction. Early stage testing yielded positive feedback and mostly favourable comment. Additional guidance materials are being developed in response to the feedback. Without training and guidance, it is difficult for technologists to take ethical concerns into account during the development and deployment of new technologies. DIODE can provide that training and guidance through a practical meta‐methodology which should help ICT professionals, policy makers and academics. There is very little structured methodology material available on the ethical assessment of new technologies. The depth and sophistication contained in DIODE is therefore believed to be unique. DIODE provides practical help while remaining rooted in the philosophical and theoretical concepts of ethics. (shrink)

The widespread application of technology in health care has imposed a broad range of challenges. The field of health technology assessment (HTA) is developed in order to face some of these challenges. However, this strategy has not been as successful as one could hope. One of the reasons for this is that social and ethical considerations have not been integrated in the HTA process. Nowadays however, such considerations have been included in many HTAs. Still, the conclusions and recommendations of the (...) HTAs are not followed. The reason for this may be that the methods for integrating ethics for HTA are not sufficiently developed, or that they are not adequate. This article presents a supplementary approach to the ethical inquiry in HTA. It is argued that a value analysis is crucial in order to address the ethical issues of health care technology in a fruitful way and to make viable decisions about such technology. (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)

The worldwide COVID-19 pandemic has shed more light on the difficulty of making health care decisions integrating scientific knowledge and values associated to life and death issues, human suffering, quality of life, economic losses, liberty of movement, etc. But the difficulties related to health care decisions and the use of innovative drugs or technologies are not new, and many countries have created agencies that have the mandate to evaluate new technologies in health care. Health Technological Assessment (HTA) reports’ aim is (...) to guide the decision makers in these difficult matters. There are two ethical components in HTA. The first is the report’s presentation of an ethical evaluation of the technology. The second is the value-ladenness of the HTA decision-making process itself. When implicit value judgments are not elicited, the justification of the final decision cannot be transparent. The present paper aims to identify and elicit the implicit value-judgments related to each step of the HTA process. This research is grounded on an applied ethics decision-making paradigm based on the role of value judgments in the decision-making process. The first part discusses two different approaches to values and value judgments in HTA. In the second part, citations mentioning value judgments extracted from a systematic review on the integration of ethics into HTA were categorized to elicit the value judgments and their criteria for each different HTA decision-making steps. The results show that there are 18 decision-making steps in the HTA process where 23 implicit value-judgments can be recognized. The range of these value judgments encompasses the whole HTA process: from the initial request, the presenting of the principal issues, to the final report’s dissemination. Since stakeholders need to understand which value judgments the conclusion of a report relies on, eliciting the implicit value judgments in the HTA decision-making process should yield more transparency. (shrink)

Health technology assessment (HTA) was developed in the 1970s and 1980s to facilitate decision making on the desirability of new biomedical technologies. Since then, many of the standard tools and methods of HTA have been criticized for their implicit normativity. At the same time research into the character of technology in practice has motivated philosophers, sociologists and anthropologists to criticize the traditional view of technology as a neutral instrument designed to perform a specific function. Such research suggests that the tools (...) and methods of more traditional forms of HTA are often inspired by an ‘instrumentalist’ conception of technology that does not fit the way technology actually works. This paper explores this hypothesis for a specific case: the assessments and deliberations leading to the introduction of breast cancer screening in the Netherlands. After reconstructing this history of HTA ‘in the making’ the stepwise model of HTA that emerged during the process is discussed. This model was rooted indeed in an instrumentalist conception of technology. However, a more detailed reconstruction of several episodes from this history reveals how the actors already experienced the inadequacy of some of the instrumentalist presuppositions. The historical case thus shows how an instrumentalist conception of technology may result in implicit normative effects. The paper concludes that an instrumentalist view of technology is not a good starting point for HTA and briefly suggests how the fit between HTA methods and the actual character of technology in practice might be improved. (shrink)

Experimental vaccines are being developed for the treatment of ‘unhealthy lifestyles’ and associated chronic illnesses. Policymakers and other stakeholders will have to deal with the ethical issues that this innovation path raises: are there morally justified reasons to integrate these innovative biotechnologies in future health policies? Should public money be invested in further research? Focusing on the case of an experimental nicotine vaccine, this article explores the ethical aspects of ‘lifestyle vaccines’ for public health. Based on findings from a qualitative (...) study into a vaccine for smoking cessation, the article articulates possible value conflicts related to nicotine vaccination as an intervention in tobacco control. The ‘vaccinization’ of lifestyle disease piggybacks on the achievements of classic vaccines. Contrary to expectations of simplicity and success, quitting smoking with a vaccine requires a complex supportive network. Social justice and public trust may become important ethical challenges when deciding whether to use further public funds for research or whether to implement these innovative vaccines in the future. (shrink)