Ethical analysis

Last updated: 29  March 2024

What's new in this update

The authors have included additional background citations and a newly published article.

Introduction

Ethical analysis is a component of ​health technology assessment (​HTA​)​ that identifies and analyzes prevalent social and moral norms related to the technology or topic in question (1, 2). The ethical questions or issues identified may be related to the use of the technology, the context in which it is used, or the HTA process itself (1-3). Some examples taken from the EUnetHTA domain topics on ethics include benefit-harm balance, autonomy, respect for persons, justice and equity, and legislation. Different jurisdictions or societies may hold different ethical views, affected by socio-political, legal, cultural, religious, and economic differences. However, many ethical considerations are common to all cultures and societies (1). Ethical analyses may be informed by other components of the HTA and conversely, ethical analysis can itself inform the HTA project, including whether or how to conduct an HTA (4). 

There is, ​currently​, no widely accepted standard method for performing ethical analysis in HTA, and ethical analysis is not included in the majority of HTAs (1, 5-10). Reporting search and analysis methods in ethics HTAs is lacking. There is also broader debate in the ethics field about whether ethics reviews can be conducted systematically or whether ethical analysis is fundamentally non-systematic (11). When ethical analyses are included in HTAs they are performed in different ways, including: 

• Writing an expert statement (12) 

• Reviewing the literature narratively (12) 

• Reviewing the literature systematically (1, 13, 14) 

• Extrapolating ethical information from the other components of the HTA (10, 15) 

• Deliberating and seeking consensus from a group, either of experts or of the public (1, 10) 

• Soliciting and collecting responses from experts or interested parties (1)
   

Literature searching is not necessarily involved in all the above methods. Unlike in reviews of clinical evidence, authors may feel that it is not necessary to find all ethical issues that have been discussed or all papers written on a topic (16). Even if the authors do wish to identify the common ethical arguments about a health topic, they may choose to consult with experts or stakeholders instead of searching for this information in the literature. The method used to retrieve information may be influenced by the philosophical approach used, such as casuistry, the Socratic approach, or principlism (1, 13, 14, 17).  

If a literature review is conducted, the information may be taken from a search designed specifically to find ethical information, or from a general or clinical effectiveness search used for multiple components of the HTA (10, 15). The unit of information retrieved may be ethical arguments (eg. "it is unethical to fund x technology because…"), ethical principles (eg. beneficence), or ethical issues (eg. informed consent) (17). The information found may be reported as summaries of individual papers, or as a synthesis of the information found (17). The review may or may not include conclusions or recommendations about whether it is ethical to fund the technology in question (2). 

Sources 

Medical ethics is an interdisciplinary field of research (18). Searching beyond the major biomedical databases is recommended. For example, Rauprich et al. compared the search process and the results of MEDLINE and the ethics database BELIT and found in their examples only a small overlap of 3-4% between the two in terms of relevant results (19). Fangerau identified the highest quantity of medical ethics journal literature by searching a combination of databases (18). 

In a review of recent ethics reviews, Mertz et al. found that “most reviews [that they analyzed] used at least two databases or search engines" (17). Similarly, Scott et al. state that “a comprehensive search of ethics issues around a health technology makes use of a variety of sources,” and that “both international and national sources should be searched” (20). In a study of 25 HTAs by Horton et al., databases used and the frequency they were employed illustrates a heavy reliance on biomedical and HTA databases. However, many other subject databases were searched on a one-off basis, emphasizing the prevalence of searching different subject areas depending on the research question (10). Strech et al. highlight that a librarian/information specialist should be consulted when considering which databases to search (21).  

As ethical aspects are related to individual and public preferences, norms, and values, they are regionally and nationally different. Thus, relevant national databases are also of interest for thorough retrieval of ethics information (4). In this context, Dracos assesses the value of Italian bioethics database SIBIL (22). 

As ethical aspects may at times encompass legal aspects, information sources recommended for legal issues are also of interest. ELSI​ (​ethics, legal, and social implications​) considerations are​ often thought of together and encompass many ethical issues (23, 24). Equity, which is defined by Cochrane as “judgement about fairness,” can also overlap with ethics, as it addresses differences in health and accessibility of care (25). More information on equity searching can be found in the Cochrane Handbook chapter 16, and the ISSG Search Filter Resource (25). Otto et al. add that when searching on “social or patient aspects,” one should consider looking in other social sciences fields including health sociology, science and technology studies, social psychology, and medical ethics (5). Strech et al also emphasize that not all literature that discusses ethical reasons presents itself as ethical literature (21). To avoid duplication of work, joint information retrieval processes for ethics, legal, social, and equity aspects may therefore be considered.  

Various authors recommend or report (4, 10, 17, 20-22), depending on the topic in question, the following sources in information retrieval for ethical issues: 

Scroll through the embedded document below to see all tables by subject area

Additional search approaches for ethics information include:  

• Hand searching of key journals, especially of journals not indexed in major databases (1, 4, 20, 21) and hand searching of anthologies (20, 26) 

• Scanning reference lists of key publications or included articles (20, 21) as well as the publications' tables and indexes (21) 

• Using 'related articles' database features (20) 

• Forward citation tracking (i.e. "cited by" features) using databases/search engines such as Google Scholar, Web of Science, or PubMed/PubMed Central (see Value of using different search approaches chapter section on citation tracking) 

• Contacting experts (4)
   

Grey literature searching is recommended in the guidance produced by the Haute Autorité de Santé in France (HAS), the European Network for Health Technology Assessment (EUnetHTA) HTA Core Model 3.0, and the PRISMA-Ethics Reporting Guideline for Systematic Reviews on Ethics Literature (1, 2). However, each of the​se​ organizations recommend different types of grey literature. These include: 

• Reports published by governmental, institutional, research, or other bodies (2, 4) 

• ​​Legal reports or case law (1, 2) ​(​see SuRe Info chapter on Legal Aspects for more information)​ 

• Conference abstracts and proceedings of colloquia, meetings, or workshops (2) 

• ​​Online forums, newspapers, and other less formal sources (2) ​(​​Note: these sources may be particularly relevant when the goal is to collect a thorough list of all arguments/opinions regardless of the rigour of the argument)​​ 

• Other HTAs with an ethics component (4) 

• Theses and dissertations (21)
   

Many of the databases listed above include grey literature. Some additional key sources of different types of grey literature ​of relevance to ethics issues specifically ​include: 

• Conference abstracts (2):  

• Databases that include conference abstracts (such as Embase) 

• Websites of specific conferences  

• HTAs:  

• CADTH's Grey Matters HTA section 

• Trip Database 

• Theses:  

• WorldCat Dissertations (21) 

• Ethos-Beta Electronic Theses Online Service (21) 

• Reports:  

• Websites of ethics institutes, for the purposes of finding their reports (4), such as: 

• EGE European Group on Ethics in Science and New Technologies  

• WHO Ethics and Health Initiative 
   

​​​Further sources of conference abstracts, HTAs, and theses can be found in the Appendix to the Clinical Effectiveness chapter of SuRe Info and the Grey Literature chapter of SuRe Info.​​ 

Grey literature may not commonly be searched in ethics reviews. ​The ​Mertz et al. 2017 survey of published reviews of normative ethics literature noted t​hat ​out of a total of 78 reviews that mentioned their search sources, 8 searched Google Scholar​, ​3 searched Google​, and ​2 each searched ETHXweb or BELIT​ (17). M​any grey literature sources were only searched in one review, including grey literature databases such as GreyNet, publisher-specific journal databases, and dissertation or thesis databases (17). The Horton et al. 2023 study of ethics HTAs found that none of the 25 HTAs studied explicitly discussed grey literature. However, sources for HTAs, dissertations, conference abstracts, and government documents were reportedly searched (10). 

Designing search strategies 

Contextualizing Search Topics 

No internationally established standard exists on how to develop search strategies ​for​ ethical analysis related to health technologies (4). As previously discussed, there is no single standard approach to ethics information retrieval (13).  Within EUnetHTA reports studied by Ekmekci and Güner, literature reviews were listed as the most common methodology, yet search strategies were not reported (27). Additionally, data sources were sparsely, if ever, reported.    

A study by Droste et al. ​proposed​​ ​an information retrieval procedure similar to the workflow of information retrieval for clinical or cost effectiveness assessments (4). One should first explore the ethical issues relevant to the topic of interest and the methods approach chosen for analysis. As discussed ​above​, there are multiple methods of ethical analysis. 

​It is key that the searcher communicates with the ​rest of the ​research​ ​team to ​understand ​the​ ​analytic approach and what that entails for information needs. This context informs how the search should be conducted (4). 

The EUnetHTA HTA Core Model 3.0 includes a set of nineteen issues related to ethical analysis (1). These issues, in the form of question prompts, help ​the ​research​ team​​ to​ focus in on what issues are relevant to a topic. The HTA Core Model also includes assessment element tables for each issue listed (1).  

Assasi et al. also provide a stepwise guide for undertaking ethical analysis in HTA. Steps of interest include Step 4, "Framing ethical evaluation questions,” and Step 5, “Ethical analysis” (28). 

Database Searching 

Droste et al. assert that although a structured systematic search of databases is important for ethics information retrieval, it is often challenging to identify all ethics information related to a topic (4). Thus, additional, non-systematic searches conducted after the main search are acceptable and recommended (2, 4). Supplementary searches may occur as new topics and questions emerge during the analysis. Similar to qualitative searching, an exploratory or iterative approach to ethics searches ensures that the most relevant information is captured.      

The National Reference Center for Bioethics Literature (National Reference Center for Bioethics) has a guide ​to​ the bioethics literature databases at Georgetown University, the National Library of Medicine (NLM), BELIT (German Reference Centre for Ethics in the Life Sciences, DRZE), and the Global Ethics Observatory (UNESCO), ​al​though some information on databases may be out of date (29).  

Droste et al. provides key terms and advice ​o​n searching for ethical aspects in MEDLINE and Embase (4). Horton et al. analyzed search strategy subject headings and keywords used in HTAs, listing frequency of terms employed across HTAs studied (10).The use of simpler search strategies should be considered for databases or resources​ which have less sophisticated search options​. 

Use of Filters 

As discussed above, ethics researchers may screen clinical literature results for ethics-related information, or they may request ​new or ​modified searches to explore specific aspects of a technology. Searches can also be run in databases​ of the ethics literature​. In these cases, an ethics search filter​, which provides a set of ethics search terms,​ is not necessary.  

Little evidence exists on a standard ethics​ filter.​ Key concepts related to ethics can be described in a variety of ways, and terms may not be​ used or​ indexed consistently (25, 30). Droste et al. provide​ ​ relevant subject headings for searching for ethical aspects in MEDLINE and Embase (4). New subject headings may have been added since the publication of this article. 

There have been efforts to develop a standard search filter for identifying publications on values by Petrova et al. but the study results show that a) “values” are hard to define and ​are ​topic specific, b) “values” cannot be fully represented by a brief search filter (124 MeSH terms, 144 free text words were identified), and c) sensitivity / external validity is too low for the filter to be applied in HTA or systematic reviews (30). ​Alt​hough not published in peer reviewed literature, filters ​are available including ​the CADTH Ethics, Legal, and Social Implications (ELSI) filter.   

Related SuRe Info Chapters 

SuRe Info has other chapters that, given the overlap of ethics and other subjects, may be useful​.​ The HTA Core Model includes basic patient rights and freedoms (autonomy, privacy, confidentiality) as one of the four categories of legal aspects important in HTA (1). The SuRe Info chapter on Legal Aspects can be found here. Another ​potentially relevant ​chapter is Qualitative Research, which goes into more detail on iterative searching and supplementary search methods. ​The chapter on​ grey literature ​is also potentially relevant, as is the future chapter on ​social aspects​.​​     ​ 

Reference list

1. EunetHta Joint Action WP. HTA Core Model version® 3.0 2016. Available from: https://www.eunethta.eu/wp-content/uploads/2018/03/HTACoreModel3.0-1.pdf. 

2. Methodological Guide: Assessment of Ethical Aspects. Saint-Denis (FR): Haute Autorite de Sante; 2013. Available from: https://www.has-sante.fr/upload/docs/application/pdf/2014-11/assessment_of_ethical_aspects.pdf. 

3. de Melo-Martín I. To Assess Technologies, Bioethicists Must Take Off Their Blinkers. Hastings Cent Rep. 2022;52(5):3. 

4. Droste S, Dintsios C-M, Gerber A. Information on ethical issues in health technology assessment: How and where to find them. Int J Technol Assess Health Care. 2010;26(4):441-9. [Publication Appraisal]

5. Otto I, Kahrass H, Mertz M. “Same same but different”? On the questionable but crucial differentiation between ethical and social aspects in health technology assessment. Z Evid Fortbild Qual Gesundhwes. 2021;164:1-10. 

6. Bellemare CA, Dagenais P, K.-Bédard S, Béland J-P, Bernier L, Daniel C-É, et al. Ethics in Health Technology Assessment: a Systematic Review. Int J Technol Assess Health Care. 2018;34(5):447-57.

7. Bakke Lysdahl K, Gerhardus A, Hofmann B, Oortwijn W, Refolo P, Sacchini D, et al. Integrating ethics in health technology assessment: many ways to Rome. International Journal of Technology Assessment in Health Care. 2015;31(3):131-7. 

8. Assasi N, Schwartz L, Tarride JE, Campbell K, Goeree R. Methodological guidance documents for evaluation of ethical considerations in health technology assessment: a systematic review. Expert Rev Pharmacoecon Outcomes Res. 2014;14(2):203-20. 

9. Bellemare CA, Bernier L, Béland J-P, Dagenais P, Daniel C-É, Gagnon H, et al. Integration of ethical considerations into HTA reports: an analysis of integration levels using a systematic review. International Journal of Technology Assessment in Health Care. 2021;37(1):e61.  

10. Horton J, DeJean D, Farrah K, Hodgson A, Kaunelis D, Walter M. Ethics information retrieval in HTA: state of current practice. International Journal of Technology Assessment in Health Care. 2023;39(1):e43. [Publication Appraisal]

11. Birchley G, Ives J. Fallacious, misleading and unhelpful: The case for removing 'systematic review' from bioethics nomenclature. Bioethics. 2022;36(6):635-47. 

12. Hofmann B, Droste S, Oortwijn W, Cleemput I, Sacchini D. Harmonization of Ethics in Health Technology Assessment: a Revision of the Socratic Approach. Int J Technol Assess Health Care. 2014;30(1):3-9. [Publication Appraisal]

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17. Mertz M, Strech D, Kahrass H. What methods do reviews of normative ethics literature use for search, selection, analysis, and synthesis? In-depth results from a systematic review of reviews. Syst Rev. 2017;6(1):261. [Publication Appraisal] 

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20. Scott AM, Hofmann B, Gutiérrez-Ibarluzea I, Bakke Lysdahl K, Sandman L, Bombard Y. Q-SEA - a tool for quality assessment of ethics analyses conducted as part of health technology assessments. GMS Health Technol Assess. 2017;13:Doc02. 

21. Strech D, Sofaer N. How to write a systematic review of reasons. J Med Eth. 2012;38(2):121. 

22. Dracos A. SIBIL: Uno strumento italiano per il reperimento dell'informazione in bioetica. Ann Ist Super Sanita. 2004;40(3):283-6. [Publication Appraisal] 

23. Krahn MD, Bielecki JM, Bremner KE, de Oliveira C, Almeida N, Clement F, et al. Picturing ELSI+: a visual representation of ethical, legal, and social issues, and patient experiences in Health Technology Assessment in Canada. Int J Technol Assess Health Care. 2020;36(1):40-9. 

24. Bernier L, Legault G-A, Daniel C-É, Bédard SK, Béland J-P, Bellemare C, et al. Legal Governance in HTA: Environment, Health and Safety Issues / Ethical, Legal and Social Issues (EHSI/ELSI), the Ongoing Debate. Can J Bioeth. 2020;3(1):83-92. 

25. Welch V, Petkovic J, Jull J, Hartling L, Klassen T, Kristjansson E, et al. Chapter 16: Equity and specific populations. 2021. In: Cochrane Handbook for Systematic Reviews of Interventions version 62 [Internet]. Chichester (UK): John Wiley & Sons. Available from: https://training.cochrane.org/handbook/current/chapter-16. 

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28. Assasi N, Tarride J-E, O’Reilly D, Schwartz L. Steps toward improving ethical evaluation in health technology assessment: a proposed framework. BMC Med Eth. 2016;17(1):34. [Publication Appraisal] 

29. Bioethics searcher’s guide to online information resources. Washington (DC): Kennedy Institute of Ethics, Georgetown University; 2009. Available from: https://repository.library.georgetown.edu/handle/10822/708917. 

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