The inherent normativity of HTA can be conceptualized as a result of normative commitments, a concept that we further specify to encompass moral, epistemological and ontological commitments at play in the practice of HTA. Based on examples from literature, and an analysis of the example of assessing Non-Invasive Prenatal Testing (NIPT), we will show that inevitable normative decisions in conducting an assessment commits the HTA practitioner to moral (regarding what makes a health technology desirable), ontological (regarding which effects of health (...) technology are conceivable), and epistemological (regarding how to obtain reliable information about health technology) norms. This highlights and supports the need for integrating normative analysis and stakeholder participation, providing guidance to HTA practitioners when making normative choices. This will foster a shared understanding between those who conduct, use, or are impacted by assessments regarding what are conceivable and desirable outcomes of using health technology, and how to collect reliable information to assess whether these outcomes are (going to be) realized. It also provides more insight into the implications of different normative choices. (shrink)

Background Scientific and technological advancements in mapping and understanding the interrelated pathways through which biological and environmental exposures affect disease development create new possibilities for detecting disease risk factors. Early detection of such risk factors may help prevent disease onset or moderate the disease course, thereby decreasing associated disease burden, morbidity, and mortality. However, the ethical implications of screening for disease risk factors are unclear and the current literature provides a fragmented and case-by-case picture. Methods To identify key ethical considerations (...) arising from the early detection of disease risk factors, we performed a systematic scoping review. The Scopus, Embase, and Philosopher’s Index databases were searched for peer-reviewed, academic records, which were included if they were written in English or Dutch and concerned the ethics of (1) early detection of (2) disease risk factors for (3) disease caused by environmental factors or gene-environment interactions. All records were reviewed independently by at least two researchers. Results After screening 2034 titles and abstracts, and 112 full papers, 55 articles were included in the thematic synthesis of the results. We identified eight common ethical themes: (1) Reliability and uncertainty in early detection, (2) autonomy, (3) privacy, (4) beneficence and non-maleficence, (5) downstream burdens on others, (6) responsibility, (7) justice, and (8) medicalization and conceptual disruption. We identified several gaps in the literature, including a relative scarcity of research on ethical considerations associated with environmental preventive health interventions, a dearth of practical suggestions on how to address expressed concerns about overestimating health capacities, and a lack of insights into preventing undue attribution of health responsibility to individuals. Conclusions The ethical concerns arising with the early detection of risk factors are often interrelated and complex. Comprehensive ethical analyses are needed that are better embedded in normative frameworks and also assess and weigh the expected benefits of early risk factor detection. Such research is necessary for developing and implementing responsible and fair preventive health policies. (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)