Objectives:Integration of ethics into health technology assessment (HTA) remains challenging for HTA practitioners. We conducted a systematic review on social and methodological issues related to ethical analysis in HTA. We examined: (1) reasons for integrating ethics (social needs); (2) obstacles to ethical integration; (3) concepts and processes deployed in ethical evaluation (more specifically value judgments) and critical analyses of formal experimentations of ethical evaluation in HTA.Methods:Search criteria included “ethic,” “technology assessment,” and “HTA”. The literature search was done in Medline/Ovid, SCOPUS, CINAHL, PsycINFO, and the international HTA Database. Screening of citations, full-text screening, and data extraction were performed by two subgroups of two independent reviewers. Data extracted from articles were grouped into categories using a general inductive method.Results:A list of 1,646 citations remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. The social need most often reported was to inform policy decision making. The absence of shared standard models for ethical analysis was the obstacle to integration most often mentioned. Fairness and Equity and values embedded in Principlism were the values most often mentioned in relation to ethical evaluation.Conclusions:Compared with the scientific experimental paradigm, there are no settled proceedings for ethics in HTA nor consensus on the role of ethical theory and ethical expertise hindering its integration. Our findings enable us to hypothesize that there exists interdependence between the three issues studied in this work and that value judgments could be their linking concept.

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

Philosophers engaged in the field of applied ethics are often challenged to revisit certain philosophical debates in order to clarify the background concepts involved in a given undertaking at stake. This is particularly evident in the field of Health Technological Assessment (HTA) where the integration of ethics has been a debate for many years. Interdisciplinary technological assessment involves a head-on discussion between the frame of reference of natural sciences and those of philosophy, which often reproduce the fact/value dichotomy debated in the field of philosophy. The challenge for a philosopher is then to explain how the fact/value dichotomy has been criticized by philosophers in such a way that the distinction between "verifiable facts" and "unverifiable values" cannot be accounted for anymore. The critiques of H. Putnam and S. E. Toulmin were the first steps towards the understanding of the dichotomy. A speech act approach, based on J. L. Austin illocutionary acts, can shed a new light on this issue by clarifying the difference between assertions, evaluations and prescriptions. By using a speech-act approach we can define the respective role of scientific evaluation

c r Researchers around the world are investigating the potential of stem cells to treat neurodegenerative diseases such as multiple sclerosis, Alzheimer's, Parkinson's, muscular dystrophy and

Objectives Integration of ethics into technology assessment in healthcare (HTA) reports is directly linked to the need of decision makers to provide rational grounds justifying their social choices. In a decision-making paradigm, facts and values are intertwined and the social role of HTA reports is to provide relevant information to decision makers. Since 2003, numerous surveys and discussions have addressed different aspects of the integration of ethics into HTA. This study aims to clarify how HTA professionals consider the integration of ethics into HTA, so an international survey was conducted in 2018 and the results are reported here. Methods A survey comprising twenty-two questions was designed and carried out from April 2018 to July 2018. Three hundred and twenty-eight HTA agencies from seventy-five countries were invited to participate in this survey. Results Eighty-nine participants completed the survey, representing a participation rate of twenty-seven percent. As to how HTA reports should fulfill their social role, over 84 percent of respondents agreed upon the necessity to address this role for decision makers, patients, and citizens. At a lower level, the same was found regarding the necessity to make value-judgments explicit in different report sections, including ethical analysis. This contrasts with the response-variability obtained on the status of ethical analysis with the exception of the expertise required. Variability in stakeholder-participation usefulness was also observed. Conclusions This study reveals the importance of a three-phase approach, including assessment, contextual data, and recommendations, and highlights the necessity to make explicit value-judgments and have a systematic ethical analysis in order to fulfill HTA's social role in guiding decision makers.