To describe the type and level of ethical integration in published health technology assessment (HTA) reports and systematically identify the ethical approaches utilized.

A literature search was conducted with the Google™ search engine using the keyword “ethic” between 1 January 2015 and 20 August 2019. Only HTA assessment reports with a section on ethics were retained and classified according to their level of ethical integration: no ethical analysis, ethical issues highlighted, assessments according to legal or social norms, and assessments from a moral or axiological perspective—using a qualitative methodology to distinguish such integration.

This review yielded 188 reports with a section identified as being on ethics, produced by seventeen HTA agencies in eleven countries. One hundred and thirty-six reports did not develop an ethical analysis, thirty-one highlighted ethical issues, seventeen conducted a norm-based ethical assessment using a descriptive approach grounded in social norms, and four developed an assessment grounded in a moral or axiological perspective. The bioethical “four-principles” framework was used, but mainly for presenting ethical issues and not as a moral framework.

The majority of reports featuring a section on ethics mention ethical considerations without ethical analysis. Ethical issues are grouped with legal, social, and organizational issues and treated as contextual considerations that decision makers should be aware of. When reports present systematic norm-based ethical assessments from a descriptive perspective or ethical assessment based on a moral or axiological perspective, there is a tendency to ground these analyses in frameworks created for the purpose and reliant on a concept of ethics supporting them.

The fact that HTA is a value-laden process is recognized in the literature. This is one of the reasons for promoting a better integration of ethics in HTA processes. Although what is meant by value-judgment (VJ) and how it can be used in HTA is not clear for some authors; others have proposed the elicitation of implicit VJs, to make them more explicit, as one way for clarifying the role ethics may play in HTA. In order to clarify what a VJ is, a conceptual analysis is needed to distinguish it from a factual-judgment and see how they diverge on certain aspects and converge on others.

The distinction between VJs and factual-judgments was debated in the fifties. At the core of the philosophy of language was a distinction between factual-scientific assertions about facts, considered objective, and VJs on what is right/wrong-good/bad, considered subjective. In speech-act theory these distinctions were treated as two different operations: assertive and evaluative. A conceptual analysis of VJs, considering them as specific speech-acts, was used for clarifying/deciphering the role of VJs in HTA.

VJs are intrinsically embedded in decision-making since they are the reasons justifying decisions. This is why implicit VJs can be identified at every decision-step in the HTA process. Assessment is usually considered objective while appraisal seems subjective. Since VJs are entrenched in the decisions taken throughout the assessment process, the results are not completely objective. Ethical analysis also distinguishes two types of VJs, those based on normative criteria and those based on various degrees of value actualization. Furthermore, since evaluation requires criteria based on a rational process, VJs are not totally subjective.

Elicitation of VJs in HTA is one way of integrating ethics in HTA and offers decision-makers a more thorough picture of the ethical issues involved in their decision.

Eliciting implicit value-judgments (VJs) in the HTA process is one way of integrating ethics in HTA since the latter is recognized as a value-laden process. An analysis of the diversity of opinions on implicit VJs in HTA and of their role, highlights the connection there exists between VJs and the different decisions involved in the whole HTA process. Such a link is corroborated by a conceptual analysis of VJ using a speech-act philosophical approach grounded in the philosophy of language, since VJs are linked with normative speech-acts such as commands, recommendations and advices.

We propose an analysis of the published citations mentioning VJs, extracted from our systematic review on the challenges of integrating ethics in HTA. In order to do so, those quotes were categorized in a chart, the latter of which presents: (i) the different steps of decision-making in the HTA process, (ii) the description of the implicit VJ(s) and (iii) the criteria involved. This chart was elaborated with the participation of the HTA local evaluators involved as co-investigators in our research group. The final version was discussed, debated and validated by the entire research group.

The chart shows 18 decision-making steps in the HTA process in which twenty-three implicit VJs can be observed. The range of such VJs encompasses the whole HTA process from the initial mandate to the agency presenting the decisional issues, to the dissemination of the final report. The published citations gathered for each category compile different expectations on the elicitation of the implicit VJs, thus making the latter VJs more explicit.

This chart allows a better understanding of the expectations that are at the core of the appeal for more transparency in the HTA process, since stakeholders need to understand which value-judgments the final conclusion of a report is relying on.

One of the barriers of integrating ethics in Health Technology Assessment (HTA) relates to the social role of HTA (1). The aim of this study is to provide a better understanding of the way by which law circumscribes the social role of HTA. Our hypothesis: HTA's social role is embedded within a mixed governance based on hard law and soft law.

Three HTA agencies were conveniently selected for our study: Haute Autorité de santé (HAS) (France), National Institute for Health and Care Excellence (NICE) (United Kingdom) and Institut national d'excellence en santé et en services sociaux (INESSS) (Québec, Canada). Our analysis of the legal, administrative and procedural documents relating to the existence and assessment processes of these three agencies is guided by the following criteria:

1. 1. The normative strength of the documents (categories of hard law or soft law) (2)

2. 2. The definition of the agencies’ social role (1)

3. 3. The integration of ethics in the agencies’ mandate.

Hard law contributes to establish a general mandate and some legal legitimacy for these agencies. Soft law, grounded in the HTA producers' practices, plays a major role in the legal governance of HTA. Our results demonstrate that these agencies existing practices seem to circumscribe their social role further than their constitutive laws. In this context, social actors become responsible to define, structure and operationalize the implementation of HTA.

In addition, the legal framework (hard law) through which HTA unfolds does not clearly support its structural and social role. Despite existing legal frameworks, the normative legitimacy of HTA is not entirely established, as it depends on soft law. Taken altogether, this maintains a persisting conceptual vagueness in HTA governance.

The social role of HTA should be defined either through modifying existing legislations (hard law) or through harmonization of the agencies internal policies and regulations (soft law). Such legal initiatives would help clarify the aims of HTA evaluations: assessments (scientific) or appraisal (value-laden), and therefore give a clearer indication on how best to integrate ethics in HTA.

The main difficulties encountered in the integration of ethics in Health Technology Assessment (HTA) were identified in our systematic review. In the process of analyzing these difficulties we then addressed the question of the diversity of ethical approaches (1) and the difficulties in their operationalization (2,3).

Nine ethical approaches were identified: principlism, casuistry, coherence analysis, wide reflexive equilibrium, axiology, socratic approach, triangular method, constructive technology assessment and social shaping of technology. Three criteria were used to clarify the nature of each of these approaches:

1. 1. The characteristics of the ethical evaluation

2. 2. The disciplinary foundation of the ethical evaluation

3. 3. The operational process of the ethical evaluation in HTA analysis.

In HTA, both norm-based ethics and value-based ethics are mobilized. This duality is fundamental since it proposes two different ethical evaluations: the first is based on the conformity to a norm, whereas the second rests on the actualization of values. The disciplinary foundation generates diversity as philosophy, sociology and theology propose different justifications for ethical evaluation. At the operational level, ethical evaluation's characteristics are applied to the case at stake by specific practical reasoning. In a norm-based practical reasoning, one must substantiate the facts that will be correlated to a moral norm for clearly identifying conformity or non-conformity. In value-based practical reasoning, one must identify the impacts of the object of assessment that will be subject to ethical evaluation. Two difficulties arise: how to apply values to facts and prioritize amongst conflicting ethical evaluations of the impacts?

Applying these three criteria to ethical approaches in HTA helps understanding their complexity and the difficulty of operationalizing them in HTA tools. The choice of any ethical evaluations is never neutral; it must be justified by a moral point of view. Developing tools for ethics in HTA is operationalizing a specific practical reasoning in ethics.

The objective was to identify the conceptual and methodological issues surrounding integration of ethics in Health Technology Assessment (HTA). We conducted a systematic review examining: (i) social needs, (ii) methodological and procedural barriers, (iii) concepts or processes of ethics assessment used and (iv) results of experimentations for integrating ethics in HTA.

Search criteria included ‘ethic’, ‘technology assessment’ and ‘HTA’. The literature search was done up to 21 November 2016 in Medline/Ovid, SCOPUS, CINAHL, PsycINFO and international HTA Database. Screening of citations, screening of full-text and data extraction were performed by two subgroups of two independent reviewers. The first group was constituted of HTA experts, and the second of ethics and philosophy experts. Data extracted from articles were regrouped in categories for each objective.

A list of 2,420 citations was obtained while 1,646 remained after the removal of duplicates. Of these, 132 were fully reviewed, yielding 67 eligible articles for analysis. Eight categories were identified within the social needs. The mostly evoked were ‘Informed policy decision making’ (n = 16) and 'Informed public/patient decision making’ (n = 12). Ten categories of methodological and procedural barriers were identified. The most mentioned were 'Lack of standardized and recognized proceedings for ethical analysis’ (n = 28) and ‘Lack of shared consensus on the role of ethical theory and ethical expertise’ (n = 17). Within the concepts or processes of ethics assessment, thirteen categories were identified. The most mentioned were ‘Fairness and Equity’ (n = 12), ‘Beneficence and Non-maleficence’ (n = 10) and, ‘Autonomy’ (n = 10). Within results of experimentations, five categories were identified. The most mentioned was ‘Usefulness of ethics for identifying relevant problems’ (n = 3). While few experimentations were identified, no clear operational method was found in our research.

This study confirms the necessity to design an operational method integrating ethics and addressing social needs of HTA. Our results constitute the basis for developing a new theoretical and practical method.