In the field of health technology assessment, there are several approaches that can be used for ethical analysis. However, there is a scarcity of literature that critically evaluates and compares the strength and weaknesses of these approaches when they are applied in practice. In this paper, we analyse the applicability of some selected approaches for addressing ethical issues in HTA in the field of complex health interventions. Complex health interventions have been the focus of methodological attention in HTA. However, the (...) potential methodological challenges for ethical analysis are as yet unknown.Six of the most frequently described and applied ethical approaches in HTA were critically assessed against a set of five characteristics of complex health interventions: multiple and changing perspectives, indeterminate phenomena, uncertain causality, unpredictable outcomes, and ethical complexity. The assessments are based on literature and the authors’ experiences of developing, applying and assessing the approaches.The Interactive, participatory HTA approach is by its nature and flexibility, applicable across most complexity characteristics. Wide Reflective Equilibrium is also flexible and its openness to different perspectives makes it better suited for complex health interventions than more rigid conventional approaches, such as Principlism and Casuistry. Approaches developed for HTA purposes are fairly applicable for complex health interventions, which one could expect because they include various ethical perspectives, such as the HTA Core Model® and the Socratic approach.This study shows how the applicability for addressing ethical issues in HTA of complex health interventions differs between the selected ethical approaches. Knowledge about these differences may be helpful when choosing and applying an approach for ethical analyses in HTA. We believe that the study contributes to increasing awareness and interest of the ethical aspects of complex health interventions in general. (shrink)

Innovations permeate healthcare settings on an ever-increasing scale. Health technology innovations impact our perceptions and experiences of health, care, disease, etc. Because of the fast pace these HTIs are being introduced in different healthcare settings, there is a growing societal consensus that these HTIs need to be governed by ethical reflection. This paper reports a systematic review of argument-based literature which focused on articles reporting on ethical frameworks to screen or evaluate HTIs. To do this a four step methodology was (...) followed: Literature search conducted in five electronic literature databases; Identification of relevant articles; Development of data-extraction tool to analyze the included articles; Analysis, synthesis of data and reporting of results. Fifty-seven articles were included, each reporting on a specific ethical framework. These ethical frameworks existed out of characteristics which were grouped into five common ones: Motivations for development and use of frameworks; Objectives of using frameworks; Specific characteristics of frameworks ; Ethical approaches and concepts used in the frameworks; Methods to use the frameworks. Although this multiplicity of ethical frameworks shows an increasing importance of ethically analyzing HTIs, it remains unclear what the specific role is of these analyses. An ethics of caution, on which ethical frameworks rely, guides HTIs in their design, development, implementation, without questioning their technological paradigm. An ethics of desirability questions this paradigm, without guiding HTIs. In the end, a place needs to be found in-between, to critically assess HTIs. (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)