Despite the increased prevalence of bioethics research that seeks to use empirical data to answer normative research questions, there is no consensus as to what an appropriate methodology for this would be. This review aims to search the literature, present and critically discuss published Empirical Bioethics methodologies.

BackgroundThe use of great apes in invasive biomedical research is one of the most debated topics in animal ethics. GA are, thus far, the only animal group that has frequently been banned from invasive research; yet some believe that these bans could inaugurate a broader trend towards greater restrictions on the use of primates and other animals in research. Despite ongoing academic and policy debate on this issue, there is no comprehensive overview of the reasons advanced for or against restricting (...) invasive research with GA. To address this gap, we conducted a systematic review of the reasons reported in the academic literature on this topic.MethodsSeven databases were searched for articles published in English. Two authors screened the titles, abstracts, and full texts of all articles. Two journals specialized in animal ethics, and the reference lists of included articles were subsequently also reviewed.ResultsWe included 60 articles, most of which were published between 2006 and 2016. Twenty-five articles argued for a total ban of GA research, 21 articles defended partial restrictions, and 14 articles argued against restrictions. Overall, we identified 110 reason types, 74 for, and 36 against, restricting GA research. Reasons were grouped into nine domains: moral standing, science, welfare, public and expert attitudes, retirement and conservation, respect and rights, financial costs, law and legal status, and longer-term consequences.ConclusionOur review generated five main findings. First, there is a trend in the academic debate in favor of restricting GA research that parallels worldwide policy changes in the same direction. Second, in several domains, the reasons were rather one-sided in favor of restrictions. Third, some prominent domains featured considerable engagement between opposing positions. Fourth, there is low diversity and independence among authors, including frequent potential conflicts of interests in articles defending a strong position. Fifth, scholarly discussion was not the norm, as reflected in a high proportion of non-peer-reviewed articles and authors affiliated to non-academic institutions. (shrink)

Background In the last years, there has been an increase in publication of systematic reviews of normative literature or of normative information in bioethics. The aim of a systematic review is to search, select, analyse and synthesise literature in a transparent and systematic way in order to provide a comprehensive and unbiased overview of the information sought, predominantly as a basis for informed decision-making in health care. Traditionally, one part of the procedure when conducting a systematic review is an appraisal (...) of the quality of the literature that could be included. Main text However, while there are established methods and standards for appraising e.g. clinical studies or other empirical research, quality appraisal of normative literature in the context of a systematic review is still rather a conundrum – not only is it unclear how it could or should be done, but also the question whether it necessarily must be done is not settled yet. Based on a pragmatic definition of “normative literature” as well as on a typology of different types of systematic reviews of normative literature/information, this paper identifies and critically discusses three possible strategies of conducting quality appraisal. Conclusions The paper will argue that none of the three strategies is able to provide a general and satisfying solution to the problems associated with quality appraisal of normative literature/information. Still, the discussion of the three strategies allows outlining minimal conditions that elaborated strategies have to meet in future, and facilitates sketching a theoretically and practically promising strategy. (shrink)

Naturalistic philosophers rely on literature search and review in a number of ways and for different purposes. Yet this article shows how processes of literature search and review are likely to be affected by widespread and systematic biases. A solution to this problem is offered here. Whilst the tradition of systematic reviews of literature from scientific disciplines has been neglected in philosophy, systematic reviews are important tools that minimize bias in literature search and review and allow for greater reproducibility and (...) transparency. If naturalistic philosophers wish to reduce bias in their research, they should then supplement their traditional tools for literature search and review by including systematic methodologies. (shrink)

The objective of this study is to provide an overview over the ethical issues relevant to the assessment, implementation, and use of smart-glasses. The purpose of the overview is to facilitate deliberation, decision making, and the formation of knowledge and norms for this emerging technology. An axiological question-based method for human cognitive enhancement including an extensive literature search on smart-glasses is used to identify relevant ethical issues. The search is supplemented with relevant ethical issues identified in the literature on human (...) cognitive enhancement and in the study of the technical aspects of smart-glasses. Identified papers were subject to traditional content analysis: 739 references were identified of which 247 were regarded as relevant for full text examinations, and 155 were included in the study. A wide variety of ethical issues with smart-glasses have been identified, such as issues related to privacy, safety, justice, change in human agency, accountability, responsibility, social interaction, power and ideology. Smart-glasses are envisioned to change individual human identity and behavior as well as social interaction. Taking these issues into account appears to be relevant when developing, deliberating, deciding on, implementing, and using smart-glasses. (shrink)

The acquisition of genetic information (GI) confronts both the affected individuals and healthcare providers with difficult, ambivalent decisions. Genetic responsibility (GR) has become a key concept in both ethical and socioempirical literature addressing how and by whom decision-making with respect to the morality of GI is approached. However, despite its prominence, the precise meaning of the concept of GR remains vague. Therefore, we conducted a systematic literature review on the usage of the concept of GR in qualitative, socioempirical studies, to (...) identify the main interpretations and to provide conceptual clarification. The review identified 75 studies with primarily an Anglo-American setting. The studies focused on several agents: the individual, the family, the parent, the healthcare professional, and the institution and refer to the concept of GR on the basis of either a rational/principle-oriented approach or an affective/relational approach. A subtype of the rational/principle-oriented approach is the reactive approach. The review shows how the concept of GR is useful for analyzing and theorizing about socioempirical findings within qualitative socioempirical studies and also reveals conceptual deficits in terms of insufficient theoretical accuracy and heterogeneity, and in the rarity of reflection on cultural variance. The vagueness and multiplicity of meanings for GR in socioempirical studies can be avoided by more normative-theoretical explication of the underlying premises. This would provide a higher degree of differentiation of empirical findings. Thereby, the complex findings associated with the individual and social implications of genetic testing in empirical studies can be better addressed from a theoretical point of view and can subsequently have a stronger impact on normative and policy debates. (shrink)

The aim of this literature review was to compose a narrative review supported by a systematic approach to critically identify and examine concerns about accountability and the allocation of responsibility and legal liability as applied to the clinician and the technologist as applied the use of opaque AI-powered systems in clinical decision making. This review questions if it is permissible for a clinician to use an opaque AI system in clinical decision making and if a patient was harmed as a (...) result of using a clinician using an AIS’s suggestion, how would responsibility and legal liability be allocated? Literature was systematically searched, retrieved, and reviewed from nine databases, which also included items from three clinical professional regulators, as well as relevant grey literature from governmental and non-governmental organisations. This literature was subjected to inclusion/exclusion criteria; those items found relevant to this review underwent data extraction. This review found that there are multiple concerns about opacity, accountability, responsibility and liability when considering the stakeholders of technologists and clinicians in the creation and use of AIS in clinical decision making. Accountability is challenged when the AIS used is opaque, and allocation of responsibility is somewhat unclear. Legal analysis would help stakeholders to understand their obligations and prepare should an undesirable scenario of patient harm eventuate when AIS were used. (shrink)

The concept of benefit sharing pertains to the act of giving something in return to the participants, communities, and the country that have participated in global health research or bioprospecting activities. One of the key concerns of benefit sharing is the ethical justifications or reasons to support the practice of the concept in global health research and bioprospecting. This article evaluates one of such ethical justifications and its meaning to benefit sharing, namely justice. We conducted a systematic review to map (...) the various principles of justice that are linked to benefit sharing and analysed their meaning to the concept of benefit sharing. Five principles of justice have been shown to be relevant in the nuances of benefit sharing in both global health research and bioprospecting. The review findings indicate that each of these principles of justice provides a different perspective for a different benefit sharing rationale. For example, commutative justice provides a benefit sharing rationale that is focused on fair exchange of benefits between research sponsors and communities. Distributive justice produces a benefit sharing rationale that is focused on improving the health needs of the vulnerable research communities. We have suggested that a good benefit sharing framework particularly in global health research would be more beneficial if it combines all the principles of justice in its formulation. Nonetheless, there is a need for empirical studies to examine the various principles of justice and their nuances in benefit sharing among stakeholders in global health research. (shrink)

The use of empirical research methods in bioethics has been increasing in the last decades. It has resulted in discussions about the ‘empirical turn of bioethics’ and raised questions related to the value of empirical work for this field, methodological questions about its quality and rigor, and how this integration of the normative and the empirical can be achieved. The aim of this paper is to describe the attitudes of bioethics researchers in this field towards the use of empirical research, (...) and examine their actual conduct: whether they use empirical research methods, and whether they have made attempts at integrating the empirical and the normative. An anonymous online survey was conducted to reach scholars working in bioethics/biomedical ethics/ethics institutes or centers in 12 European countries. A total of 225 bioethics researchers participated in the study. Of those, 200 questionnaires were fully completed, representing a response rate of 42.6%. The results were analysed using descriptive statistics. Most respondents indicated that they use or have used empirical methods in their work. A similar proportion of respondents reported having had at least some training in qualitative or quantitative methods, respectively. Among the ‘empirical researchers’, more than a fifth had not received any methodological training. It appears that only 6% or less of the ‘empirical researchers’ considered themselves experts in the methods that they have used. Only 35% of the scholars who have used empirical methods reported having integrated empirical data with normative analysis, whereas for their current projects, 59.8% plan to do so. There is a need to evaluate the current educational programs in bioethics and to implement rigorous training in empirical research methods to ensure that ‘empirical researchers’ have the necessary skills to conduct their empirical research in bioethics. Also imperative is clear guidance on the integration of the normative and the empirical so that researchers who plan to do so have necessary tools and competences to fulfil their goals. (shrink)

Naturalistic philosophers rely on literature search and review in a number of ways and for different purposes. Yet this article shows how processes of literature search and review are likely to be affected by widespread and systematic biases. A solution to this problem is offered here. Whilst the tradition of systematic reviews of literature from scientific disciplines has been neglected in philosophy, systematic reviews are important tools that minimize bias in literature search and review and allow for greater reproducibility and (...) transparency. If naturalistic philosophers wish to reduce bias in their research, they should then supplement their traditional tools for literature search and review by including systematic methodologies. (shrink)

Freedom of conscience is a core element of human rights respected by most European countries. It allows abortion through the inclusion of a conscience clause, which permits opting out of providing such services. However, the grounds for invoking conscientious objection lack clarity. Our aim in this paper is to take a step in this direction by carrying out a systematic review of reasons by midwives and nurses for declining, on conscience grounds, to participate in abortion. We conducted a systematic review (...) of ethical arguments asking, “What reasons have been reported in the argument based literature for or against conscientious objection to abortion provision by nurses or midwives?” We particularly wanted to identify any discussion of the responsibilities of midwives and nurses in this area. Search terms were conscientious objection and abortion or termination and nurse or midwife or midwives or physicians or doctors or medics within the dates 2000–2016 on: HEIN legal, Medline, CINAHL, Psychinfo, Academic Search Complete, Web of Science including publications in English, German and Dutch. Final articles were subjected to a rigorous analysis, coding and classifying each line into reason mentions, narrow and broad reasons for or against conscientious objection. Of an initial 1085 articles, 10 were included. We identified 23 broad reasons, containing 116narrow reasons and 269 reason mentions. Eighty one narrow reasons argued in favour of and 35 against conscientious objection. Using predetermined categories of moral, practical, religious or legal reasons, “moral reasons” contained the largest number of narrow reasons. The reasons and their associated mentions in this category outnumber those in the sum of the other three categories. We identified no absolute argument either for or against conscientious objection by midwives or nurses. An invisibility of midwives and nurses exists in the whole debate concerning conscientious objection reflecting a gap between literature and practice, as it is they whom WHO recommend as providers of this service. While the arguments in the literature emphasize the need for provision of conscientious objection, a balanced debate is necessary in this field, which includes all relevant health professionals. (shrink)

BackgroundPrevention of mother to child transmission of HIV remains a key public health priority in most developing countries. The provider Initiated Opt – Out Prenatal HIV Screening Approach, recommended by the World Health Organization lately has been adopted and translated into policy in most Sub – Saharan African countries. To better ascertain the ethical reasons for or against the use of this approach, we carried out a literature review of the ethics literature.MethodsPapers published in English and French Languages between 1990 (...) and 2015 from the following data bases were searched: Pubmed, Cochrane literature, Embase, Cinhal, Web of Science and Google Scholar. After screening from 302 identified relevant articles, 21 articles were retained for the critical review.DiscussionMost authors considered this approach ethically justifiable due to its potential benefits to the mother, foetus and society. The breaching of respect for autonomy was considered acceptable on the grounds of libertarian paternalism. Most authors considered the Opt - Out approach to be less stigmatizing than the Opt - In. The main arguments against the Opt - Out approach were: non respect of patient autonomy, informed consent becoming a meaningless concept and the HIV test becoming compulsory, risk of losing trust in health care providers, neglect of social and psychological implications of doing an HIV test, risk of aggravation of stigma if all tested patients are not properly cared for and neglect of sociocultural peculiarities.ConclusionsThe Opt – Out approach could be counterproductive in case gender sensitive issues within the various sociocultural representations are neglected, and actions to offer holistic care to all women who shall potentially test positive for HIV were not effectively ascertained. The Provider Initiated Opt – Out Prenatal HIV Screening option remains ethically acceptable, but deserves caution, active monitoring and evaluation within the translation of this approach into to practice. (shrink)

BackgroundWhile evaluation of ethical aspects in health technology assessment has gained much attention during the past years, the integration of ethics in HTA practice still presents many challenges. In response to the increasing demand for expansion of health technology assessment methodology to include ethical issues more systematically, this article reports on a multi-stage study that aimed at construction of a framework for improving the integration of ethics in HTA.MethodsThe framework was developed through the following phases: 1) a systematic review and (...) content analysis of guidance documents for ethics in HTA; 2) identification of factors influencing the integration of ethical considerations in HTA; 3) preparation of an action-oriented framework based on the key elements of the existing guidance documents and identified barriers to and facilitators of their implementation; and 4) expert consultation and revision of the framework.ResultsThe proposed framework consists of three main components: an algorithmic flowchart, which exhibits the different steps of an ethical inquiry throughout the HTA process, including: defining the objectives and scope of the evaluation, stakeholder analysis, assessing organizational capacity, framing ethical evaluation questions, ethical analysis, deliberation, and knowledge translation; a stepwise guide, which focuses on the task objectives and potential questions that are required to be addressed at each step; and a list of some commonly recommended or used tools to help facilitate the evaluation process.ConclusionsThe proposed framework can be used to support and promote good practice in integration of ethics into HTA. However, further validation of the framework through case studies and expert consultation is required to establish its utility for HTA practice. (shrink)

Bioethics has made a compelling case for the role of experience and empirical research in ethics. This may explain why the movement for empirical ethics has such a firm grounding in bioethics. However, the theoretical framework according to which empirical research contributes to ethics—and the specific role it can or should play—remains manifold and unclear. In this paper, we build from pragmatic theory stressing the importance of experience and outcomes in establishing the meaning of ethics concepts. We then propose three (...) methodological steps according to which the meaning of ethics concepts can be refined based on experience and empirical research: function identification, function enrichment, and function testing. These steps are explained and situated within the broader commitment of pragmatic ethics to a perspective of moral growth and human flourishing. We hope that this proposal will give specific direction to the bridging of theoretical and empirical research in ethics and thus support stronger actualization of ethics concepts. (shrink)

There has recently been interest in applying the techniques of systematic review to bioethics literature. In this paper, I identify the three models of systematic review proposed to date in bioethics: systematic reviews of empirical bioethics research, systematic reviews of normative bioethics literature, and systematic reviews of reasons. I argue that all three types yield information useful to scholarship in bioethics, yet they also face significant challenges particularly in relation to terminology and time. Drawing on my recent experience conducting a (...) systematic review, I suggest that complete comprehensiveness may not always be an appropriate goal of a literature review in bioethics, depending on the research question. In some cases, all the relevant ideas may be captured without capturing all the relevant literature. I conclude that systematic reviews in bioethics have an important role to play alongside the traditional broadbrush approach to reviewing literature in bioethics. (shrink)

What is good bioethics? Addressing this question is key for reinforcing and developing the field. In particular, a discussion of potential quality criteria can heighten awareness and contribute to the quality of bioethics publications. Accordingly, the objective of this article is threefold: first, we want to identify a set of criteria for quality in bioethics. Second, we want to illustrate the added value of a novel method: in-depth analysis of a single article with the aim of deriving quality criteria. The (...) third and ultimate goal is to stimulate a broad and vivid debate on goodness in bioethics. An initial literature search reveals a range of diverse quality criteria. In order to expand on the realm of such quality criteria, we perform an in-depth analysis of an article that is acclaimed for being exemplary. The analysis results in eleven specific quality criteria for good bioethics in three categories: argumentative, empirical, and dialectic. Although we do not claim that the identified criteria are universal or absolute, we argue that they are fruitful for fueling a continuous constitutive debate on what is “good bioethics.” Identifying, debating, refining, and applying such criteria is an important part of defining and improving bioethics. (shrink)

The systematic review of reasons is a new way to obtain comprehensive information about specific ethical topics. One such review was carried out for the question of why post-trial access to trial drugs should or need not be provided. The objective of this study was to empirically validate this review using an author check method. The article also reports on methodological challenges faced by our study.