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Corresponding author. Ilvie Otto, B.A. Institute of Ethics, History and Philosophy of Medicine, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
In health technology assessment (HTA), the demarcation of ethical and social aspects in two separate domains is a given fact. While an overlapping of ethical and social aspects is possible, this also raises theoretical and methodological questions, such as why overlaps happen (on the basis of which understanding of ethical and social aspects), or whether they are legitimate from a methodological point of view.
Methods
We analyzed, on a basis of purposive sampling, a) two well-known HTA frameworks (HTA Core Model, INTEGRATE-HTA), b) methodological literature about ethical and/or social aspects in HTA, and c) published HTA reports from the German DAHTA database and the international CRD database regarding statements on the understanding (definition/characterization) and relationship between ethical and social aspects.
Results
The frameworks use identical definitions for ethical aspects but deviate when it comes to social aspects. Methodological papers do not always provide a definition of social and ethical aspects. In the context of ethical aspects, they often refer back to ethics as a base discipline that deals with the motives and consequences of good and bad actions for ethical aspects, while for social aspects, there is orientation towards already existing checklists and methods, without reference to a base discipline such as sociology. The analyzed HTA reports barely offered details on their understanding of ethical or social aspects (7% of n = 33).
Discussion
The problem of defining/characterizing and differentiating ethical and social aspects exists in both theory and practice. The impression is that little attention is paid to demarcations and overlaps, and that also the methodological literature has not yet thoroughly addressed the issue. While there are also pragmatic reasons for the possible ambiguity between the ethical and the social domains, deeper epistemological issues related to the multi-/interdisciplinarity nature of HTA will have to be considered, too, such as the danger of “disciplinary capture” (pressure on some domains and their basic disciplines, e.g., ethics, to adopt the concepts and standards of other domains that are more dominant in HTA, e.g., efficacy assessment/evidenced-based medicine).
Conclusion
The domains in HTA reports should be better described epistemologically and brought into a coherent relationship with each other. This is important to avoid unreasonable overlapping and possible problematic redundancy. Further, this could help with questions of adequate expertise and methods for the processing of all relevant information for solid technology assessment.
Zusammenfassung
Einleitung
Bei der Durchführung eines Health Technology Assessments (HTA) ist die Abgrenzung von ethischen und sozialen Aspekten in zwei getrennten Domänen vorgesehen. Eine Überschneidung von ethischen und sozialen Aspekten ist zwar möglich, wirft aber auch theoretische und methodische Fragen auf, z. B. warum es zu Überschneidungen kommt (welches Verständnis von ethischen und sozialen Aspekten liegt dem zugrunde?), oder ob diese aus methodischer Sicht legitim sind.
Methoden
Wir haben in einer zweckdienlichen Stichprobe a) zwei bekannte HTA-Rahmengerüste (HTA Core Model, INTEGRATE-HTA), b) methodische Literatur zu ethischen und/oder sozialen Aspekten in HTA sowie c) publizierte HTA-Berichte aus der deutschen DAHTA-Datenbank und der internationalen CRD-Datenbank hinsichtlich Aussagen zum Verständnis (Definition/Charakterisierung) und Verhältnis von ethischen und sozialen Aspekten analysiert.
Ergebnisse
Die Rahmengerüste verwendeten identische Definitionen für ethische Aspekte, wichen aber bei den sozialen Aspekten voneinander ab. In der Methodenliteratur fanden wir nicht immer Definitionen für soziale und ethische Aspekte. Während im Zusammenhang mit ethischen Aspekten häufig auf die philosophische Ethik als Basisdisziplin zurückgegriffen wurde, ist die Soziologie nicht gleichbedeutend für soziale Aspekte. Im Zusammenhang mit ethischen Aspekten griffen sie häufig auf die philosophische Ethik als Basisdisziplin zurück, die sich mit den Motiven und Konsequenzen von guten und schlechten Handlungen für ethische Aspekte beschäftigt. Hingegen erfolgt für soziale Aspekte eine Orientierung an bereits existierenden Checklisten und Methoden, ohne Bezug auf eine Basisdisziplin wie die Soziologie. Schließlich fanden sich in den analysierten HTA-Berichten kaum (7% von n = 33) Angaben zum jeweiligen Verständnis von ethischen oder sozialen Aspekten.
Diskussion
Das Problem der Definition/Charakterisierung und Abgrenzung von ethischen und sozialen Aspekten existiert sowohl in der Theorie als auch in der Praxis. Es entsteht der Eindruck, dass diesem Problem wenig Aufmerksamkeit geschenkt wird und auch die methodische Literatur das Thema nicht vertieft behandelt. Obwohl es auch pragmatische Gründe für fließende Übergange und uneinheitliche Zuordnung von Aspekten zur ethischen oder der sozialen Domäne gibt, müssen auch erkenntnistheoretische Fragen berücksichtigt werden. Bedeutend ist hierbei der multi-/interdisziplinäre Charakter von HTA, woraus u.a. Gefahren entstehen wie die sog. “disziplinäre Vereinnahmung” (Druck auf einige Domänen und ihre Basisdisziplinen, z.B. Ethik, die Konzepte und Standards anderer Domänen zu übernehmen, die in HTA dominanter sind, z.B. Wirksamkeitsbewertung/Evidenzbasierte Medizin).
Schlussfolgerung
Die Domänen in HTA-Berichten sollten epistemologisch besser beschrieben und in ein kohärentes Verhältnis zueinander gebracht werden. Dies ist wichtig, um unangemessene Überschneidungen und mögliche problematische Redundanzen zu vermeiden. Weiterhin könnte dies bei Fragen der adäquaten Expertise und Methoden zur Aufbereitung aller relevanten Informationen für eine solide Technologiebewertung helfen.
Ethical and social aspects in health technology assessment
Health technology assessment (HTA) is a policy-advising tool for the decision-making process employed when deciding whether the costs and use of a particular health care technology should be covered and e.g. reimbursed by health insurance companies. An international joint task group co-led by the International Network of Agencies for Health Technology Assessment (INAHTA) and Health Technology Assessment International (HTAi) has developed the internationally accepted definition of HTA as “a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making to promote an equitable, efficient, and high-quality health system” (see [
Health Technology Assessment and Health Policy-making in Europe: Current Status, Challenges and Potential, European Observatory on Health Systems and Policies.
]. While the handling of the benefit, risks and cost-benefit analysis follows a standardized procedure that is nowadays also vastly informed by methods and tools developed in evidence-based medicine (EBM) [
Kritische Bewertung von Health Technology Assessment-Berichten.
in: Kunz R. Ollenschläger G. Raspe H. Jonitz G. Donner-Banzhoff N. Lehrbuch Evidenbasierte Medizin in Klinik und Praxis. Deutscher Ärzte-Verlag, Köln,
2007: 191-202
], we see a different situation in the ELSI (ethical, legal and social issues) domain. The authors nevertheless assume in the following that HTA as scientific policy advice should entail some degree of methodological transparency and traceability across its various domains, even though the rigor and the exact operationalization of scientific/academic
We are using a German meaning of “science” in the sense of “Wissenschaft”, which is a broad understanding that includes natural sciences, social sciences and humanities as well.
requirements vary depending on the individual domain (e.g. efficacy vs. ethics).
For some years now, there has been ongoing international discussion as to why ethical aspects, but also the processing of social aspects, are rarely part of HTA [
]). These problems with the ethics and social domains stand in contrast to the much-invoked importance of ethical and social aspects, which is emphasized in all major HTA programs
Eunet H.T.A. Work Package 8, HTA Core Model Version 3.0. https://eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf, 2016.(accessed 21 August 2019).
]. These questions concerning the significance of the ethical and social domains should be distinguished from these domains’ present quality and quantity in actual assessments. Just because something is valued in theory does not mean it enjoys frequent and comprehensible implementation.
The demarcation of ethical and social aspects in two separate domains is a given fact at the present time. Both methodological frameworks mentioned and the national agencies that publish HTAs often stipulate such a separation. Although the reality of implementation might sometimes look different, a categorical abandonment of ethical and social aspects as separate domains cannot be easily demanded and put into practice. Therefore, it is reasonable to assume that a distinction between ethical and social aspects is in principle defendable.
The general importance of ethical and social aspects becomes clear in the case of health technologies whose efficacy/risk profile turns out to be very positive, but which nevertheless have an important impact on society and turn values and norms upside down. Often this cannot be addressed by efficacy and cost-benefit analysis alone. If we consider cochlear implants, as just one example among others, given significant improvements in hearing performance, the question arises as to whether this brings advantages for those affected or whether the resulting risk of suppressing the communication culture of the deaf outweighs the benefits. The cochlear implant (CI) raises the question of whether deafness is considered a disability. Advocates of the deaf community, who believe that deafness is first and foremost a culture, may feel discriminated against and stigmatized by the CI-technology. There are certainly several other examples of clearly ethically relevant technologies as in case of expensive technologies such as Zolgensma, or in topics such as antidepressants for children.
We thank an anonymous reviewer for bringing these additional examples up.
Problem description
The consideration of ethical and social aspects comes (at least) from two different disciplines. Let us suppose the technology under investigation is described in the literature as a burden for families and their economic situation due to long journeys to a specialized hospital. There are good reasons to consider this situation as ethical, since principles such as justice are affected. Likewise, these access barriers have a social dimension, because parents are involved for a longer (driving) time. While overlapping of ethical and social aspects (i.e., the same “fact” is considered an ethical as well as a social aspect) is possible – and may also be accepted –, it also raises theoretical and methodological questions: Why are a) overlaps happening (because of which understanding of ethical and social aspects)? And when they are happening, b) why, or under which circumstances, are they methodologically legitimate (e.g., do not lead to inexplicable redundancy for readers, and to the production of unnecessary text in the HTA report)?
If there are no (meaningful) answers to such questions, it may give the reader the impression of arbitrariness when it comes to classifying aspects as “ethical” or “social”. This could weaken the standing of ELSI domains, as it could convey the further impression that these domains are “not to be taken very seriously” due to – so perceived – unclear methodology, lack of common understanding of their very own domains. (= definition/characterization of ethical and social aspects), and thus dependency on individual authors (one classifying aspects in one way, the other in a different way, without reasonable explanations why they classified the aspects as they did). Arbitrariness and redundancy are furthermore not compatible with the already often scarce resources of HTA (e.g. because of duplications, which can occur when topics are not – or cannot be – clearly assigned to one or the other HTA author). Since HTA is also not only performed for its own sake, its instrumental character as a policy advisory tool should be taken into account. Finally, HTA reports as “knowledge syntheses” are particularly valuable if it is clear also for non-experts what they cover and where it can be found. This further allows a better (methodological) comparison between different HTA reports (e.g., what to expect from an ethics domain in any HTA report). Thereby, redundancy, especially when its benefits are not clear, not only costs valuable, already scarce resources, but may also reduce the value as an advisory tool for non-experts. So, more conceptual clarity about what “makes” an aspect an “ethical aspect” or a “social aspect”, how they are to be separated, or when overlapping is unproblematic (or even fruitful), could thus help to avoid these problems, and can give additional orientation to HTA practice when processing ethical and social aspects.
However, finding such conceptual clarification in current theory and practice of HTA proves difficult. Examples such as the aforementioned cochlear implants are often used to clarify the definition of ethical or social aspects (e.g. [
(Eds.), Health Technology Assessment: Konzepte, Methoden, Praxis für Wissenschaft und Entscheidungsfindung, Medizinisch Wissenschaftliche Verlagsgesellschaft.
]). In fact, they do not tell us what an aspect is on a conceptual level. As we will argue later, it is precisely extensional definitions (i.e. definitions that use examples) that show how unclear the definition of an ethical or social aspect actually often is, seldom accounting for possible overlapping or relevant demarcation of these aspects on the basis of the definitions given. While the concrete ethical or social aspects identified and described in HTA reports may still naturally differ between the different technologies, conceptual general definitions are preferable, as they can also explain meaningful overlaps (or may help avoid unreasonable ones).
Therefore, if increased work on these ELSI domains is to be strengthened, it must be clear what the object of investigation is, and a clear idea of what we understand as ethical and social aspects is needed. One may discuss the diversity of methods in these domains at length (e.g. [
]), but the fruitfulness of this debate is at least doubtful if it is not even clear what the target of application is.
Aim
The aims of this article are the following: We want to demonstrate the hypothesis that there actually is a certain ambiguity regarding the definition or characterization (and its subsequent demarcation or overlapping) of ethical and social aspects in the context of HTA is plausibly justifiable, and that the relation between the two aspects is often not systematically clarified. In this empirical part of the article, we thus analyze, on a basis of purposive sampling, a) two well-known HTA frameworks (HTA Core Model, INTEGRATE-HTA), b) methodological literature about ethical and/or social aspects in HTA, and c) published HTA reports. This analysis should answer the following research questions: Is the definition or characterization of ethical and social aspects in HTA in theory (= HTA frameworks, methodological literature) or in practice (= HTA reports) clear/unambiguous? And is the relationship or interaction between ethical and social aspects described, and if yes, in which respect?
Further, we provide explanations for the ambiguities found and analyze the status quo. This theoretical analysis, which is part of our discussion, is based on the empirical findings, but also on the experiences of several years in which we ourselves have been involved in processing ethical and social aspects in HTA. The analysis extensively uses theoretical approaches of philosophy of science to answer the following research question: Assuming that there are ambiguities in defining or characterizing ethical and social aspects in the theory and/or practice of HTA, what might be relevant epistemological, methodological or practical causes that may explain the existence of these ambiguities?
The article will not yet develop a defendable definition of ethical and social aspects. This would be up to another paper. We want to show that these definitional problems exist and to discuss potential reasons that are rooted in the epistemological structure of current HTA.
Method
Definitions and concepts of ethical and social aspects in HTA literature and frameworks
A useful first step for finding a definition of ethical aspects and social aspects is to examine common HTA frameworks. The HTA Core Model and INTEGRATE HTA have already been mentioned as widespread frameworks for handling HTA. Additionally, research literature on the design and delimitation of the domains was screened. The subsequent qualitative text analysis focused on definitions and demarcation approaches, i.e., criteria that were used.
A definition should define the meaning of a term and explain how it is applied. Criteria should help one to recognize what kind of object is present, i.e. they are identification features.
The specific methodological approaches for identifying and analyzing ethical and social aspects will not be discussed in detail here. Nonetheless, it should be noted that the use of a method that is itself usually embedded in a theory with corresponding background assumptions can also lead to a different (implicit) understanding of how ethical and social aspects are defined/understood. For analyses, the categories of interest were ”definition”, ”object of investigation” and the ”diversity of methods”. The methodological approaches are descriptively included in our overview of the frameworks (see Table 1).
Table 1Empirical results of analyzed HTA frameworks
“considers prevalent social and moral norms and values relevant to the technology in question” (p. 254)
“understanding of the consequences of implementing or not implementing a healthcare technology in two respects: with regard to the prevailing societal values and with regard to the norms and values that the technology itself constructs when it is put to use” (p. 254)
• Benefit–harm balance, autonomy, respect for people, justice & equity, legislation and ethical consequences of the HTA.
• Derived from the general values of the population, aims of the healthcare system and values arising from the use of a technology.
1) Casuistry, 2) coherence analysis (CA), 3) interactive, participatory HTA approach (iHTA), 4) principlism, 5) social shaping of technology, 6) wide reflective equilibrium (WRE), 7) the ’triangular model’ based on the human person-centred approach, 8) axiological (Socratic) approach
“Patient aspects relate to issues relevant to patients, individuals and caregivers.” (p. 346)
“Social aspects are related to social groups, that is, specific groupings of patients or individuals that may be of specific interest in an HTA, such as older people, people living in remote communities, people with learning disabilities, ethnic minorities, immigrants etc.” (p. 346)
• Unique perspectives about experiences, attitudes, preferences, values and expectations concerning health, illness, service delivery and treatments • The burden of living with the condition being studied • Experiences of current health technologies • Experiences with and expectations of the health technology being studied (in particular which aspects of the technolgoy would be valued most and issues regarding managing technology administration and side-effects) • ”Patients’ perspectives on ethical and/or political topics could also be discussed in the Ethical Analysis (ETH) domain or Legal Aspects (LEG) domain […].” (p. 349)
1) advanced skills in social science are required, coming from any of the following fields: Medical Anthropology, Medical Decision-Making, Medical Sociology, Science and Technology Studies, Governance of Innovation Studies, Medical Ethics, Social Psychology, Communication Science, Health Services Research, Health Sociology, 2) qualitative research should provide in-depth (thick) descriptions of analyzed themes, 3) quantitative studies (such as surveys, PROs etc.) also provide important insights into patients and social aspects, 4) primary studies, 5) qualitative synthesis: the framework approach, the Cochrane Qualitative Review Methods Group, JBI system for qualitative synthesis, synthesizing qualitative research in HTAs
“Ethics or moral philosophy is the part of philosophy that deals with questions about moral values and norms, i.e., what is good or bad (what is a good life for humans?) and what is right and wrong (what is the right way for a human to act in a given situation?).” (p. 60)
In HTA, ethical aspects deal with “moral norms and values relevant for the technology in question”, including prevailing norms and values and the norms and values constructed by putting the technology into use (p. 257).
1) Principlism, 2) casuistry, 3) coherence analysis (CA), 4) wide reflective equilibrium (WRE), 5) social shaping of technology, 6) interactive, participatory HTA approach (iHTA), 7) the “triangular model” based on the human person-centred approach, 8) the HTA Core Model, 9) axiological (Socratic) approach
• Refers to socio-cultural aspects by focusing on social and cultural aspects and their mutual interactions. • Socio-cultural aspects of a health technology, a disease, or a health care system comprise: knowledge, beliefs, symbols, conceptions, rules (such as morals), regulations (such as laws), customs, goals (values), institutions and any other capabilities and habits acquired by a group which is specifically related to the health technology, disease, or healthcare system, and explicit and implicit behaviorial patterns, including their embodiment in symbols and artefacts. • The essential core of culture consists of historically derived and selected ideas and values that are shared by members of a group.
Social construction/understanding of health issues: • Social image of technology and use: 1. perceived usefulness and the idea of benefit, 2. knowledge about and understanding of technology, 3. attitudes to and acceptance of technology and use, 4. risk perception and handling • Socio-cultural aspects of implementation of technology /organization of technology use: 1. socio-cultural characterization of target group, 2. social inequalities and technology use, 3. user-professional relationships and decision-making, 4. relationships between professionals providing the technology
1) Theory-based approaches (Pierre Bourdieu's habitus concept and Cultural Theory), 2) methodological approaches: seeking expert advice, primary research using methods of qualitative and quantitative empirical research, and secondary research based on published literature on social and ethical issues, 3) checklists, 4) participatory approaches.
Characterizations and concepts of ethical and social aspects in HTA reports
Based on the analysis of the literature, the question arises whether the distinction of ethical and social aspects is only a theoretical problem that does not occur in practice. To describe these implications, we reviewed a purposive sample of existing HTA reports.
Searches were conducted in April 2019 in the German DAHTA database and the international CRD database. Search terms used included variations of “ethics” and “social” (e.g. “ethical”, “bioethics”, or “socio”), but also related terms such as “moral”, “human rights”, or “beneficence”. Reports were included if they had recognizably different chapters, of which at least one included ethics or social aspects.
The search was explorative and does not claim to fulfill criteria of a full-sample survey. An acceptable number of HTA reports were included in the purposive sample, so that the analysis could result in an adequate picture of the status quo in the field. We performed a cursory empirical document analysis of the reports found. We examined whether the ethics and social domains are intermixed and how they characterized ethical and/or social aspects.
We did not expect the HTA reports to give theoretical definitions or in-depth conceptual discussions of possible definitions, but at least short characterizations of what they understood by “ethical” or “social” aspects.
Results
Definition and concepts of ethical and social aspects in HTA literature
HTA frameworks
While the HTA Core Model tries to give a definition or characterization of what ethical aspects can be (e.g. prevalent social and moral norms and values relevant to the disease, the technology, and its consequences), as well as social aspects, INTEGRATE-HTA does not provide a definition or explanation of the subject's “ethical aspect” on its own (see Table 1). They claim to follow the definition of the Core Model. INTEGRATE-HTA includes a paragraph titled “Definition of ethical aspects in HTA” in which the philosophical background is presented and the elements (i.e. values) that the domain considers. The content of this chapter could not be clearly assigned to our analysis categories.
Regarding ethical aspects, methodologically, the Core Model of EUnetHTA suggests an unsystematic eclectic approach. At least six different methods from different theoretical areas are explicitly described, which may be combined as desired [
Eunet H.T.A. Work Package 8, HTA Core Model Version 3.0. https://eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf, 2016.(accessed 21 August 2019).
]. The ethics chapter from INTEGRATE-HTA also primarily discusses different methodological approaches in the ethical domain (e.g. principlism, casuistry, the Socratic Method etc.; see Table 1) and how to find the appropriate one for different forms and aspects of technologies [
]. There is no specification of the definition of “ethical aspects” depending on different methods.
While there seems to be agreement regarding the definition of ethical aspects, the definition of social aspects differs in scope of application. The HTA Core Model identifies the social aspects as social and patient aspects which should deal primarily with the perspective of affected individuals (i.e. patients and caregivers). A general view on citizens (i.e. citizens who use health services but do not suffer from the disease under study) is not included in the patients and social aspects section, but should be dealt with in the ethics and law section according to the core model [
Eunet H.T.A. Work Package 8, HTA Core Model Version 3.0. https://eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf, 2016.(accessed 21 August 2019).
]. INTEGRATE HTA, on the other hand, describes social aspects as socio-cultural aspects and differs in this respect to the HTA Core Model. The authors state that established glossaries such as the International Network of Agencies for Health Technology Assessment (INAHTA) HTA Glossary, the EUnetHTA Adaptation Glossary, or the Cochrane Collaboration Glossary do not provide definitions for social, cultural, or socio-cultural aspects. An unclear concept of social aspects is also mentioned as a possible reason for the infrequent work on the domain [
]. For that reason, INTEGRATE HTA develops its own definition and states that “socio-cultural aspects of a health technology, a disease, or a health care system comprise knowledge, beliefs, symbols, conceptions, rules (such as morals), regulations (such as laws), customs, goals (values) institutions and any other capabilities and habits acquired by a group which is specifically related to the health technology, disease, or health care system. (p. 78)” [
]. The socio-cultural norms and values of a technology should be considered in terms of their impact on different levels of social organization (macro-, meso-, and micro-level and their interrelations).
In the HTA Core Model, social aspects are called social and patient aspects. To deal with these aspects, it is recommended to rely on the expertise of the social sciences. This expertise could come from different fields such as health sociology, science and technology studies, social psychology, or even medical ethics [
Eunet H.T.A. Work Package 8, HTA Core Model Version 3.0. https://eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf, 2016.(accessed 21 August 2019).
]. The focus should be on qualitative studies to be used for explorative mapping of the topics: “Examples of subthemes are: how illness or risk perceptions change family relations, roles, people's interaction with technology, unforeseen and unintended social consequences, risk management” [
Eunet H.T.A. Work Package 8, HTA Core Model Version 3.0. https://eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf, 2016.(accessed 21 August 2019).
]. Synthesis of qualitative studies should be performed according to different methods, such as metaethnography, meta-synthesis, or narrative analyzes, as described in the framework approach, the Cochrane Qualitative Review Methods Group and other sources [
Eunet H.T.A. Work Package 8, HTA Core Model Version 3.0. https://eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf, 2016.(accessed 21 August 2019).
(Eds.), Health Technology Assessment: Konzepte, Methoden, Praxis für Wissenschaft und Entscheidungsfindung, Medizinisch Wissenschaftliche Verlagsgesellschaft.
]. Especially the four approaches mentioned by Gerhardus and Stich, namely checklists, literature reviews, participatory approaches and primary empirical research, are discussed in the INTEGRATE HTA with regard to their suitability, pros and cons [
]. Examples of common issues are access to and availability of a technology, the patient–professional relationship and shared decision-making. Responsibility and autonomy are also typically common issues for ethical, social and legal aspects. Nevertheless, INTEGRATE sees a risk of losing information in joint processing. Still, they mention that it may be labor-saving to investigate these issues (partly) jointly and that the outcome of the HTA may also be enriched by assessing these them in an integrative manner [
Even though papers discussing methods do not always provide a definition of social and ethical aspects, some interesting observations can be made in the literature. A commonly used succinct general definition of ethics describes it as a branch of philosophy that deals with the motives and consequences of good and bad actions.
Interestingly, one tends not to see an explicitly mentioned situatedness of the social aspects in the social sciences. This could, however, also be due to the lower number of literature on social aspects compared to literature on ethical aspects.
Also, morality is usually defined as existing moral norms, values, rules and attitudes in a given society. These are also considered the subject of the ethical analysis [
] consider the existing moral values in medicine to be largely consensual and rather see the weighting of these values in the context of the technology or intervention as the object of interest of ethical inquiry. As decisive values, they name the four principles according to Beauchamp and Childress [
] (beneficence, non-maleficence, respect for autonomy and justice). These are supplemented by relevant principles for supra-individual decisions such as the principle of human dignity, solidarity and cost-effectiveness [
]. However, to a certain extent, these are already methodical approaches to analysis and cannot themselves provide a definition of what is conceptually meant by an ethical or social aspect.
The existing concepts and definitions of social aspects are seldom developed out of a basic academic discipline such as sociology, or by referring explicitly to a sociological theory. They are rather oriented towards already existing checklists and methods for use in HTA [
Soziale und kulturelle Aspekte im Health Technology Assessment – Eine Methodenübersicht und Methodenanwendung am Beispiel der medikamentösen Behandlung mit Methylphenidat von Kindern und Jugendlichen mit Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung.
]. The working definition of social aspects given by influential authors focuses on the interaction of technology with the different areas of society (values, attitudes, meanings, power relations, behavior and allocation of resources) [
In addition, there are also methodological papers that deal with the collection of ethical and social values or issues without making clear to which of the domains these are to be linked back, and whether the term “value” or “issue” is synonymous with “aspect” [
]. Lehoux and Williams-Jones (2007) consider the ”what-question” or a conceptual framework for ethical and social issues to be fundamental to the choice of method. In order to clarify this question, they point out that the answer depends on the responding discipline and will differ between social scientists and ethicists [
Characterizations and concepts of ethical and social aspects in HTA reports
33 HTA reports featuring the domains “Social” and “Ethics” (or comparable domains/chapters) from the period 2008–2018 were examined. These HTAs were mainly written in German (88%, n = 29), with some in English (12%, n = 4). The German HTAs were published by the Deutsches Institut für Medizinische Dokumentation und Information (DIMDI) in Germany and the Ludwig Boltzmann Institute in Austria. Reports written in English were published by the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), the Ludwig Boltzmann Institute in Austria and the HTA-centrum in Götaland in Sweden.
In the context of dealing with ethical and social aspects, 7% offer details on their understanding of one or the other (characterization). This means that 93% of the HTA reports lacked any kind of characterization of ethical and/or social aspects, especially with regard to the technology under investigation. However, 17 (52%) reports addressed both ethical and social aspects, 14 (82%) of them in a shared domain (no demarcation) and only 3 (18%) dealt with ethical and social aspects in two distinct domains (see Figure 1). Out of those 14 with a shared domain, 8 (57%) reports stated a shared research question. These questions are often characterized by a very general wording like “which ethical and social aspects are to be considered?”.
Figure 1Empirical results of analyzed HTA reports.
Definition and concepts of ethical and social aspects in HTA literature
In the frameworks and especially the literature, it seems to be common to explain ethical and especially social aspects by means of extensional definitions, i.e., by means of providing examples, instead of providing an intensional (substantial) definition that seeks to capture the core characteristics of what is to be defined. It is particularly common in the definition of social aspects. Such examples used for extensional definitions of social aspects include “medicalization of the menopause through hormone replacement therapies”, the “definition of brain death in transplant medicine”, “prenatal diagnostics”, but also the “rejection of the cochlear implant by the deaf community” [
(Eds.), Health Technology Assessment: Konzepte, Methoden, Praxis für Wissenschaft und Entscheidungsfindung, Medizinisch Wissenschaftliche Verlagsgesellschaft.
]. It is somewhat perplexing, however, that the examples chosen to demonstrate social or ethical aspects are probably seldom derived from more ”ordinary” HTA topics such as “Mistletoe therapy as a concomitant treatment to reduce the toxicity of chemotherapy for malignant diseases” [
], but were rather chosen for their suitability as a particularly clear illustration and normative polarizing technology. Normativity of a technology differs gradually [
], and “ordinary” should not be understood here in the sense of complete absence of normativity. Still, it is striking that technologies in which ethical and/or social implications are obviously relevant tend to be used for clarification via extensional definition. As the greater amount of HTA topics will be more of the “ordinary” kind, there seems to be a certain discrepancy between the reality of processing ethical and social aspects in HTA, and the HTA topics “cherrypicked” for illustrating ethical and social aspects: for most HTA topics, then, these extensional definitions will probably not be applicable or transferable, and thus will in many cases not be helpful in conceptual clarification or methodological orientation. But for the more “ordinary” HTA topics, one also should have an idea of what an ethical or social aspect is, without a (problematic) comparison to the strongly normatively charged topics.
Furthermore, although possible overlaps of the ELSI domains are addressed in the methodological literature (e.g. [
]), little effort is made to further clarify and especially justify these overlaps. While a separation of ethical and social aspects is required as standard in practice by most agencies, some authors consider a separation to be neither possible nor necessary since the disciplinary assignment plays no role in the actual praxis of assessing aspects in a HTA report [
]. In her work on the definition of socio-cultural aspects, Stich, for example, concedes that aspects that overlap with other ELSI domains have been assigned to the socio-cultural aspects as long as they have a “social character” [
Soziale und kulturelle Aspekte im Health Technology Assessment – Eine Methodenübersicht und Methodenanwendung am Beispiel der medikamentösen Behandlung mit Methylphenidat von Kindern und Jugendlichen mit Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung.
]. “Social character”, however, is also defined in a rather exemplary way and ultimately remains unclear. Furthermore, such criteria for demarcation and overlapping quickly become arbitrary, since almost every ethical aspect is, it could be argued, at least reflected in the social world (and thus has a “social character”). While there can be examples where social aspects (understood this way) can be sufficiently differentiated from ethical aspects, there will also be good examples where this might prove difficult (e.g., “telemonitoring” with direct influence on the doctor–patient relationship (p. 77) [
], which could also be classified as an ethical topic, for example by referring to a principle of respecting patient autonomy).
Lack of distinctiveness between ethics and social domains in HTA practice
The lack of distinctiveness between ethical and social aspects in theory is also evident in many published HTA reports. The approach chosen in each case was never discussed or justified, neither in the methods sections of the reports nor in the content elaboration of the respective domains (0%) (see Figure 1). Additionally, the results of our document analysis are compatible with those of Polus et al. [
], who came to similar conclusions in their study on the characteristics and comparison of methods in HTA reports of public health interventions. First, they also observed a frequent combination of the ELSI domains. Second, they observed heterogeneity in what is discussed under the label of “ethics”: for example, some reports only refer to empirical data such as risk factors as the “ethics domain”, while other reports discuss the implications of relevant legal cases. Finally, a few deal with duties and moral conflicts arising from certain ethical principles [
]. Thus, regarding our questions about definitions or demarcation criteria, the exploratory examination of the actual practice could not provide satisfying answers.
However, it has to be considered that a) our sample was only purposive and small, so that probably a larger and more recent sample would have given (better) answers (though, based on the examples found ourselves, and also compared with those of Polus et al., one may reasonably doubt it). Also, limited resources and time, or social pressure from the “hard” domains, may have in some HTA reports resulted in ethics and social domains being kept small, or even having been “rationalized away”. This, in turn, could also negatively impact how questions of demarcation and overlapping etc. of these domains were addressed (or even acknowledged); it is expectable that with increasingly more “full HTAs” being financed, also the awareness about and the quality of dealing with the demarcation or overlapping etc. of the ethics and social domain will increase.
On the basis of the analyzed literature and HTA reports, it can be argued that the problem of defining/characterizing and differentiating ethical and social aspects can probably be found often in the theory as well as in the practice of HTA. The impression is that in the processing of the two domains, little attention is paid to demarcations and overlaps, and that also the methodological literature does not address the issue in-depth. It is seldom clarified (a) in which questions or concrete aspects there can be overlaps (clarification of content), (b) why and where such overlaps exist or should exist or do not and should not (theoretical clarification), and (c) which approaches are appropriate for the processing of the domains (given a specific understanding of ethical/social aspects), including the answer to the question concerning which information (“evidence”) is relevant for which domain (methodological clarification) [
]. Such lack of clarification may undermine the understandability (why is this “ethical”, and would it be different if it would be “social”?), relevance (why should e.g. “ethical aspects” be read and considered in decision-making?) and scientific validity (why are these ethical and social aspects reliable information?) of the respective domains in HTA reports, and is thus contrary to scientific requirements of transparency. If this is sufficiently acknowledged, at least as a plausible hypothesis, the question arises as to what causes this problem, and what can help to reduce it.
Theoretical Discussion
Pragmatic causes
First, there are of course pragmatic reasons for the underrepresentation and ambiguity between the ethical and social domain. Particularly at the beginning and during the first implementation of HTAs, specialized expertise was hardly available, and hence these domains were dealt with by clinicians and economists without much previous training in ethics (and presumably also social science) [
]. It was quite common to simply check the literature already found for the cost-benefit analysis of content for the ethical aspects (and more rarely the social aspects too).
This procedure was at least reported frequently in the HTA reports that we screened.
It seems plausible to assume that this primarily clinical or economic research literature could not provide a lot of insights that could be utilized for the ethical and social domains. At least the insights were not already framed in a way that their ethical and/or social content would be apparent to the clinician or economist.
Even though ethical and social aspects are in the last decade (at least in Germany) more established domains, our analysis shows that the conceptual questions remain still open.
Multi-/interdisciplinarity and “disciplinary capture” as a cause
HTA regularly involves several disciplines. The demand for disciplinary integration seems to vary from country to country, from report to report, which is why HTA cannot be clearly assigned to multi- or interdisciplinary research [
Disciplinarity, multidisciplinarity, interdisciplinarity–Concepts and indicators.
in: Davis M. Wilson C.S. Proceedings of the 8th international conference on scientometrics and informetric, ISSI. University of New South-Wales,
Sydney2001: 705-716
]. Especially in the ELSI domains, disciplinary mixtures are conceivable. For example, lawyers may also work on ethics in addition to the legal aspects. The exchange between the authors of the different domains may also vary and have an influence on the disciplinary exchange.
Due to the involvement of numerous disciplines, which may also be involved in different domains, it is worth looking at the structures of inter-/or multidisciplinary work. In the following, interdisciplinary work is defined as a process of answering a question, solving a problem, or treating a topic that is too extensive or complex to be adequately addressed by a single discipline [
]. Interdisciplinary efforts require a more or less strong integration and even modification of the disciplinary contributions during the investigation. Different participants must take into account the contributions of their colleagues in order to make their own contribution. Multidisciplinary projects, on the other hand, do not involve close cooperation and the participants do not necessarily have to be aware of the work of another participant [
]. While cooperation between related disciplines usually runs quite smoothly, cooperation between natural scientists and researchers in the humanities and social scientists frequently displays problems [
]. These problems are usually characterized as communication problems or misunderstandings. More precisely, they are the consequence of the collision of different deeply rooted epistemological beliefs [
There are a few common factors resulting from divergent or even disjunctive expertise in multi- and especially interdisciplinary research in general: disagreement over facts, causes, standards of evidence or “rigor” and research objectives. These factors are interrelated and mutually supportive, so that obligations of one type may entail obligations of another type. For example, disagreement regarding the nature of causal claims being made may determine the standards of evidence used. This decision may in turn cause researchers in one discipline to question the appropriateness of empirical data considered appropriate by another [
]. When epistemological disputes cannot be resolved on the basis of considerations arising from a shared starting point of scientific work (like common disciplinary standards or an example of prior research) a form of conflict known as disciplinary capture may appear.
The concept of disciplinary capture is based on the approach of Evelyn Brister [
], who defines it as a situation in which decisive conceptual decisions are strongly oriented towards the standards of one discipline, but not towards the others involved. This usually leads to further decisions that follow on from the previous decision and support it in such a way that team members of the neglected disciplines become increasingly alienated from the project. It is important to note that the disciplinary capture does not presuppose any bad intention on the part of researchers whose disciplinary standards take precedence. It can result from decisions that at the time the decision was made seem harmless, uncontroversial, or only appropriate [
]. The logic of a disciplinary framework is so rigid in some cases that epistemological decisions made early in the research process can promote other epistemological decisions that also follow that disciplinary framework. At no point in a series of decisions is it necessary for members of one discipline to impose their perspective on others because any single epistemological decision may appear sufficiently well supported because it is consistent with–or constrained by–earlier decisions. For example, a decision to limit research methods to quantitative and objective measurements may preclude the consideration of specific research questions or the use of normatively loaded metrics.
Although natural scientists, social scientists and scholars in the humanities are equally convinced that cooperation makes sense for certain research questions (especially if they are connected to policy, as is the case in HTA), it often turns out that the standard of the methods is more oriented towards the natural sciences. Moreover, social scientists and humanities scholars often find their natural science colleagues rather unresponsive to their impulses [
]. This problem is particularly discussed in the context of sustainability and environmental research.
Similar patterns can also be observed in the HTA process. A disciplinary capture here could be described as pressure on some domains and their basic disciplines, e.g. ethics, to adopt the concepts and standards of other domains that are more dominant in HTA, e.g. efficacy assessment/evidenced-based medicine. As Bjørn Hofmann already discussed in 2014, the question can be raised whether ethicists and social scientists are strangers to HTA, viewed from the perspective of other scientific cultures [
]. The methods, models and rationality of HTA and, for example, ethics are categorically different. HTA draws its approach from evidence-based medicine with e.g. “evidence hierarchies”, while ethics and the social sciences are anchored in the “humanities” [
]. Hofmann, who is particularly concerned with the problem of implementing ethical assessments in HTA, rejects the argument of a foreign scientific culture, arguing that disciplines such as epidemiology, economics and statistics, but also health professions such as midwifery and physiotherapy are well integrated [
]. However, the majority of these disciplines are closely related to biomedical, scientific disciplines or have at least methodological (and cultural) overlaps. Scientific, empirical studies in general place great emphasis on experiment and observation and are characterized by formal hypotheses, careful measurement, and the drawing of conclusions about a phenomenon by projecting results from a sample for a specific population. The cornerstones of quality are in particular the controlled experiment, the randomized study, and “standardized” and “validated” questionnaires.
Although scientists do not conduct their own experiments as part of HTA reports, their disciplinary methods inform their notions of scientificity.
Even though economists and statisticians are not natural scientists, dealing with calculations and figures quickly gives the impression of objective and comprehensible empiricism – especially since the goal of weighing up economic costs and benefits is naturally close to the medical practice of weighing up of effects and side effects.
The structure of an HTA report, as an objective, fact-based systematic review, is adapted to the epistemological ideas and methods of natural science-based disciplines and especially evidence-based medicine [
Kritische Bewertung von Health Technology Assessment-Berichten.
in: Kunz R. Ollenschläger G. Raspe H. Jonitz G. Donner-Banzhoff N. Lehrbuch Evidenbasierte Medizin in Klinik und Praxis. Deutscher Ärzte-Verlag, Köln,
2007: 191-202
]. HTA and EBM use comparable cognitive tools, have a common quality ranking scale for evidence, agree in part with regard to elements or criteria, but differ fundamentally in terms of the aims of their recommendations [
]. The epistemological standards are not clearly distinguishable. For example, in safety assessment, the results of the literature studied are usually based on observation or experiment, which allows the collection of “objective information” [
]. More often, evidence hierarchies are understood and used as a conceptual map depicting “objectivity” and ”rationality” (and by implication, “science”) as alternatives to thinking that is “subjective” and “personal”: these categories are treated as oppositions, mutually exclusive, on either side of an absolute dividing line [
]. Since HTA as a tool is oriented towards or informed by EBM standards (especially the efficacy domain, which can be seen as central, since a technology that fulfills all “requirements” except efficacy is probably rather useless), one could assume that these standards are projected onto the ELSI domains within the framework of disciplinary capture. In addition, some of the HTA agencies also perform other evidence-based procedures, such as assessments for drugs, and postulate a general orientation towards the standards of evidence-based medicine. Since ethical and social aspects do not appear at all in the EBM ranking, ethics, for example, can only fail due to the requirements of verifiability and strictness if such standards are (erroneously) applied [
Ethics and qualitative research in the social sciences thus remain to a certain extent separate from this evidence hierarchy, as they are more “subjective” and “personal”. Case studies, which are the studies most likely to appear in the search for ethical literature and which could be placed in an evidence hierarchy, are prone to being categorized as less objective and lower in the evidential hierarchy. Often, one does not even find these studies; rather, searches tend to list reflective, theoretical texts. Since the descriptive methodology of the social sciences still has more empirical potential, it is also understandable that a methodological leaning in this direction makes it even more difficult to distinguish between ethical and social aspects, because it excludes the reflective level which a philosophically shaped ethics could claim as a unique characteristic.
Although ethics is mentioned in some HTA definitions (see notes in [
]. Epistemological differences of the disciplines or domains involved are not well emphasized in the definition of HTA. All domains seem to be seen on the same level. Therefore, some – especially non-ethics experts – may think that the ethics domain is capable of providing “empirical evidence” and that it can therefore be treated in the same way as, for example, benefit assessment. Now, however, there are some approaches such as the socratic or axiological approach to the systematic processing of ethical aspects that are intended to provide more factual information [
Eunet H.T.A. Work Package 8, HTA Core Model Version 3.0. https://eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf, 2016.(accessed 21 August 2019).
EBM's concepts of scientificness might therefore be a factor in the expectations placed on the ELSI domain and is thus a possible example of disciplinary capture. From it, conceptions follow of what constitutes adequate evidence and with what means such evidence can be methodically recorded. Methods may determine what an aspect of an HTA domain actually “is”. If the provision of the “demanded” type of evidence fails, ethical analyses are ultimately seen as ineffective, inconclusive or unnecessary. The combination of already quite firm ideas about how evidence in HTA should be processed (according to EBM) and the vague results arising from this may promote skepticism towards these domains [
]. Such skepticism can also lead to ethical and social aspects being seen as “the other thing in HTA that cannot be clearly grasped and remains intangible”. This supports the use of an approach probably based more on common sense and one's everyday experiences as a moral and social subject than on theory and methodological reflection, thus without clear criteria regarding what constitutes a particular aspect and how one should differentiate between ethical and social aspects.
Conclusion
“Full HTA” that includes ELSI domains is most likely only possible as a multi- or interdisciplinary enterprise, as knowledge and methods that stem from different disciplines are needed. However, the danger of disciplinary capture, for example, exemplified by a superimposition of EBM standards on the ethics and social domains of HTA, may not only lead to unreasonable and unfulfillable requirements for these domains but may also blur their very ontological, epistemological and methodological distinctiveness. This could be – in part – a reason why the definition and demarcation (or possible overlapping) of ethical and social aspects is sometimes in theory as well as in practice not sufficiently addressed. Therefore, the epistemological differences of the ethics and social analysis and the rest of the HTA should be made more explicit. This includes acknowledging the peculiarities of the ethics and social domains and allowing them to explore and establish their own way of processing – and also structuring – HTA reports. This freedom of a somehow pre-conceived notion of what kind of methods or results an HTA domain should deliver could be a basis for developing (better) definitions of ethical and social aspects in (HTA) theory. Such definitions could be more general (intended to clarify ethical aspects and social aspects for all HTA purposes) or within “consistent” HTA methodologies (e.g. based on particular HTA frameworks). At the very least, being more explicit about how ethical and social aspects are a) characterized as aspects on their own (e.g. on the basis of which theoretical approach are they defined?), and b) characterized as aspects with (possible) overlaps (e.g. what criteria can identify and separate such aspects?) should be required for specific HTA reports, even if they are not (yet) backed up by an elaborate theoretical account.
The same might be true for further ambiguities of demarcation regarding other ELSI domains, such as between ethics and law. The demarcation could also be questioned for non-ELSI domains and ethics. For example, how can aspects that are related to benefit and risks or costs and reimbursement by insurance companies be delineated from ethical (or social) aspects?
A possible way of especially clarifying the relationship between ethical and social aspects (but probably also other aspects) could be to interpret ethical aspects as supervening based on social (or other) aspects. Supervenience implies that the supervening part (ethical aspects) cannot change without the other part (social aspects) changing. Therefore, this approach would describe ethical aspects as depending on social (or other) aspects, and not so much as “aspects on their own”; in fact, the ethics domain would rather be conceptualized as a “meta-domain” that ethically classifies and discusses findings of the other domains (besides probably also discussing further aspects that are not processed by the other domains). For defining ethical aspects, an explicit reference to an ethical approach is needed, e.g. a specific principlism framework. In this example, an ethical aspect could be defined as being a (mere hypothetical or empirically evidenced) situation where the ethical principles of the used framework are actually violated, or are at least at danger of being violated. Social aspects, on the other hand, could be defined as describing social facts (in a specific sociological meaning), social cognitions (incl. opinions, preferences etc.), social values (as they are embraced by a certain group) and (probable) consequences of the technology on the aforementioned social facts, cognitions or values; important is that they are part of a theoretically consistent framework that delineates social aspects clearly from other aspects, esp. ethical aspects.
Such a sharpening of the demarcation issues would also help with questions of expertise for the processing of domains, i.e. who should use which method, which in turn can be a quality criterion for the assessment by the HTA user. Referring back to a theory and method – perhaps yet to be developed – would help ensure verifiability and traceability and may prevent a problematic impression that the ethics and social domains are not sufficiently relevant due to unclear boundaries, “evidence standards” or methodological approaches.
Acknowledgement
We thank Hai Thi Hong Trinh for assisting us in the search and subsequent empirical analysis of HTA reports.
Conflict of interest
The authors declare that there is no conflict of interest.
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Kritische Bewertung von Health Technology Assessment-Berichten.
in: Kunz R. Ollenschläger G. Raspe H. Jonitz G. Donner-Banzhoff N. Lehrbuch Evidenbasierte Medizin in Klinik und Praxis. Deutscher Ärzte-Verlag, Köln,
2007: 191-202
Eunet H.T.A. Work Package 8, HTA Core Model Version 3.0. https://eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf, 2016.(accessed 21 August 2019).
(Eds.), Health Technology Assessment: Konzepte, Methoden, Praxis für Wissenschaft und Entscheidungsfindung, Medizinisch Wissenschaftliche Verlagsgesellschaft.
Soziale und kulturelle Aspekte im Health Technology Assessment – Eine Methodenübersicht und Methodenanwendung am Beispiel der medikamentösen Behandlung mit Methylphenidat von Kindern und Jugendlichen mit Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung.
Disciplinarity, multidisciplinarity, interdisciplinarity–Concepts and indicators.
in: Davis M. Wilson C.S. Proceedings of the 8th international conference on scientometrics and informetric, ISSI. University of New South-Wales,
Sydney2001: 705-716
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