Bioethics Research Research Articles

Historical aspects of bioethics of research and innovation in pediatric surgery

The article reveals historical aspects of the bioethics of research and innovation in pediatric surgery. Surgical innovations are inherently noble efforts aimed at improving the health of patients through a new method of diagnosis or treatment. Together with the freedom to create something new and innovate comes the need to protect patients from the potential risks associated with a new way of diagnosis or treatment. Throughout the development of medicine, from the Hammurabi Code to the adoption of international ethical guidelines for human health research in 2016, a tendency has been traced aimed at addressing the issue of the legality of using research on humans in general and in performing pediatric surgical interventions, in particular. From the time of the Belmont Report to the present, the guidelines for conducting human experiments have been based on four core values or principles underlying modern medical ethics: benevolence, non-harm, justice and personal autonomy. Children deserve special treatment from researchers and research ethics committees. For more than a hundred years, participation of children in scientific research has been disputed, nevertheless, there is a large number of examples in the scientific literature of involving children in this kind of activity. Children were previously seen as important participants in the progress of medical knowledge and the development of new drugs and vaccines. The development of pediatric surgery and the establishment of bioethical principles have led to the restriction of such reckless experiments on children. The development of pediatric surgery and the establishment of bioethical principles have led to the limitation of such reckless experiments on children. Monitoring of such investigations by the medical community is very important, in which ethics committees play a central role. The work of these committees is based on a set of international legal and advisory acts accumulated by humanity, which are fundamental in the field of bioethics.

Doing ethics with microbes: toward a queer feminist posthuman framework for bioethics.

The Centre for the Social Study of Microbes (CSSM) at University of Helsinki, Finland is a Wellcome-funded hub for creating new approaches to human-microbial relations. Most urgently, the complex relations between microbes, antimicrobial resistance (in its human-health centered definition, understood as infection and disease now uncurable by antibiotics, threatening human life and wellbeing), animals, environments and climate emergency require new theoretical and methodological approaches. These include a variety of research interest from global fermentation practices and cultures to microbial bioremediation techniques, from aquatic microbes to urban gardens. A key orientation of CSSM is also combining ethnography with artistic and performative practice such as felting, painting, installation, sculpture and audiovisual means, to gain a deeper, more sensory and embodied perspective of our shared lives with microbes. As their agency exists outside textuality, new experimental methodology is needed to engage with it. Thinking with microbes invites many ethical issues that often remain unaddressed in medical and scientific approach. As one of such contributions, we suggest a new framework for bioethics. In a conceptual analysis, a queer feminist posthuman framework aims for radical reorientation of human exceptionalism for more-than-human justice while keeping existing social justice issues between groups of people, such as vulnerabilities cascading around gender and sexual variance, in the same framework. Both a theoretical and practical initiative, seeking to forge solidarity between justice movements, this framework could ground policies relevant to a broader bioethical and philosophical research community, and social scientists studying microbes. This open letter discusses this work at the CSSM.

What factors influence patient autonomy in healthcare decision-making? A systematic review of studies from the Global South.

The principle of respect for autonomy (PRA) is a central tenet of bioethics. In the quest for a global bioethics, it is pertinent to ask whether this principle can be applied as it is to cultures and societies that are devoid of the Western sociopolitical historical pressures that led to its emergence. Relational autonomists have argued for a more inclusive approach to patient autonomy which takes into account factors such as interdependency and social relations. However, at the outset of any relational approach, it is necessary to identify underlying factors that influence patient autonomy in non-Western cultures. To conduct a review of the literature to uncover the mechanisms through which social, cultural, and religious factors influence and impact the application of the PRA in healthcare decision-making in non-Western cultures and societies. We conducted a systematic review through a comprehensive search of three major electronic databases of biomedical sciences. Returned citations were imported to Covidence, full texts were assessed for eligibility, included articles were thoroughly reviewed and data was synthesized. PRISMA guidelines were followed. Our search retrieved 590 non-duplicate results, 50 of which were included after screening and full-text eligibility checks. The included studies were predominantly qualitative in nature, with few quantitative, mixed-methods, and review studies included. Our synthesis of data identified nine key factors that influenced patients' autonomous decision-making through cultural, social, religious, or intersectional pathways. Two main conclusions emerge from this review. Firstly, there is a notable dearth of bioethical research examining the influence of diverse factors on patients' inclination towards different conceptions of autonomy. Secondly, the analysis of prevalent collectivist cultures and deference of autonomy adds value to the solution-oriented relational autonomy debate. This raises questions regarding how decision-making can be truly autonomous in the presence of such large-scale factors, warranting further attention.

Applying relational autonomy in US special education: Educators’ role in supporting parents’ decisions for deaf or hard-of-hearing children

ABSTRACT The concept of relational autonomy is widely applied in bioethics research to elucidate how patients’ abilities in agentively making medical decisions are constrained within a complex structural system and set of relations; thus, rather than being individualistic in nature, autonomy is relationally and interdependently situated. While this perspective is thought-provoking, it is seldom explored in settings outside of healthcare. An equally critical site of decision-making processes is found in special education, where parents of children with disabilities must contend with information from both teachers and physicians to make choices that best support their child’s learning and development. Families of deaf or hard-of-hearing (D/HH) children in particular are uniquely positioned to encounter decisions that intersect educational, medical, and sociocultural levels – that is, in the earliest years of a D/HH child’s life, parents must make decisions about the child’s medical care and whether they will receive hearing technology or treatments, which in turn shapes the inherently cultural decision of linguistic choice, which in turn shapes educational decisions about the type of schooling environment for the child. This study broadly asks: In the field of special education, how do parents make decisions for their D/HH child? Data is drawn from semi-structured, ethnographic interviews with 16 educators of the deaf or hard-of-hearing (EODs) across public, private, and state levels in California. IMPACT STATEMENT The findings can help contribute academic research into conversation with social justice-oriented work to improve language and educational access for D/HH children.

Non-empirical methods for ethics research on digital technologies in medicine, health care and public health: a systematic journal review

Bioethics has developed approaches to address ethical issues in health care, similar to how technology ethics provides guidelines for ethical research on artificial intelligence, big data, and robotic applications. As these digital technologies are increasingly used in medicine, health care and public health, thus, it is plausible that the approaches of technology ethics have influenced bioethical research. Similar to the “empirical turn” in bioethics, which led to intense debates about appropriate moral theories, ethical frameworks and meta-ethics due to the increased use of empirical methodologies from social sciences, the proliferation of health-related subtypes of technology ethics might have a comparable impact on current bioethical research. This systematic journal review analyses the reporting of ethical frameworks and non-empirical methods in argument-based research articles on digital technologies in medicine, health care and public health that have been published in high-impact bioethics journals. We focus on articles reporting non-empirical research in original contributions. Our aim is to describe currently used methods for the ethical analysis of ethical issues regarding the application of digital technologies in medicine, health care and public health. We confine our analysis to non-empirical methods because empirical methods have been well-researched elsewhere. Finally, we discuss our findings against the background of established methods for health technology assessment, the lack of a typology for non-empirical methods as well as conceptual and methodical change in bioethics. Our descriptive results may serve as a starting point for reflecting on whether current ethical frameworks and non-empirical methods are appropriate to research ethical issues deriving from the application of digital technologies in medicine, health care and public health.

MyBioethics: How Ed-Tech Enables Discovery-Driven Empirical Bioethics Research

Digital tools have granted new opportunities to engage people with bioethical discussion and rehearsed decision-making. The ongoing development of the MyBioethics mobile application links these together within a digital space designed to encourage deliberation and research participation by inviting users into the process of discovery. Besides educational purposes, this has enabled a unique way to gather real-world observations. A research procedure was designed to harness the functionality of a mobile application. Quantitative data was generated by dilemma scenarios and integrated surveys that measure and inform users about their psychological and epistemic tendencies. The resulting analysis enabled the possible influence of these factors on moral judgment formation to be investigated—leading to the preliminary identification of prospective relationships. The adopted methodology is crowdsourced and explorative. We seek to generate hypotheses as well as facilitate ethical reflection among users. This work is a proof-of-concept. The main finding is the tentative confirmation of the approach. A digital teaching tool can function to advance empirical bioethics research. The gathered data unveiled prospective areas of academic interest and yielded observations that may contain valuable reflective insights for individual end users. Digital bioethics brings along new opportunities to engage a diverse user base in a way that provides educational resources, challenges ethical preconceptions and intuitions, allows inclusion in research efforts, and encourages autonomous decision-making. Ed-tech applications appear suitable for investigating personal tendencies that are influencing our moral judgments. Digital environments could be designed to surface unarticulated factors behind our held positions and challenge unquestioned moral notions.

FUNDAMENTOS DEL POR QUÉ SE DEBE DESARROLLAR INVESTIGACIÓN CLÍNICA EN REGIONES

Chile spends 0.34% of GDP on research vs. the OECD which declares an average of 2.66%. Measured the result in number of publications and citations of articles originating in our country, by 2021 we had 19,413 publications and 82,289 citations in 11 years. When a coun­try has low income, and the percentage allocated to research is very low, it must be extremely careful in determining what topics will be financed, the quality of the researchers and the projects they apply for, and the benefit they will bring to the country. The waste of resources is caused by expenditure on poorly designed research with useless, non-publishable results. Within this panorama, one migth ask: where to invest in research? Is it justified to conduct research in the provinces or to allocate scarce resources only to centers with a long history and high research productivity? The fundamentals for supporting research in provinces, where are young universities are as follows: 1) Great ideas can be born anywhere, which must give way to research. 2) The methodology must be accurate so that the results are useful and publishable in prestigious journals. What is not published does not exist. 3) There are problems specific to some regions that require a response based on research. 4) The published data, originating from studies in other populations and other realities, are not always applicable to our entire population. 5) Medical schools have emerged in various regions, and their students need an “academic environment” and part of this is having clinical researchers. 6) The main principles of research bioethics must always be respected.

The concept of intersectionality in bioethics: a systematic review

BackgroundIntersectionality is a concept that originated in Black feminist movements in the US-American context of the 1970s and 1980s, particularly in the work of feminist scholar and lawyer Kimberlé W. Crenshaw. Intersectional approaches aim to highlight the interconnectedness of gender and sexuality with other social categories, such as race, class, age, and ability to look at how individuals are discriminated against and privileged in institutions and societal power structures. Intersectionality is a “traveling concept”, which also made its way into bioethical research.MethodsWe conducted a systematic review to answer the question of where and how the concept of intersectionality is applied in bioethical research. The PubMed and Web of Science databases were systematically searched and 192 articles addressing bioethical topics and intersectionality were finally included.ResultsThe qualitative analysis resulted in a category system with five main categories: (1) application purpose and function, (2) social dimensions, (3) levels, (4) health-care disciplines and academic fields, and (5) challenges, limitations, and critique. The variety of academic fields and health-care disciplines working with the concept ranges from psychology, through gynaecology to palliative care and deaf studies. Important functions that the concept of intersectionality fulfils in bioethical research are making inequities visible, creating better health data collections and embracing self-reflection. Intersectionality is also a critical praxis and fits neatly into the overarching goal of bioethics to work toward social justice in health care. Intersectionality aims at making research results relevant for respective communities and patients, and informs the development of policies.ConclusionsThis systematic review is, to the best of our knowledge, the first one to provide a full overview of the reference to intersectionality in bioethical scholarship. It creates a basis for future research that applies intersectionality as a theoretical and methodical tool for analysing bioethical questions.

Emerging Ideas: Personal identity and mother–child relationship: Experiences of young adults raised by single mothers by choice

ABSTRACTObjectiveThis qualitative study examined the experiences of young adults raised by single mothers by choice and the way the circumstances of their upbringing have modeled their personal identity and mother–child relationships.BackgroundBeing conceived through anonymous sperm donation may create uncertainty among children and young adults. However, there is little research on the implications of this situation from the perspective of young adults.MethodIn‐depth narrative interviews were conducted with 21 young Israeli adults born to single mothers by choice as a result of anonymous sperm donation.ResultsThe findings revealed several themes regarding the relationship with the mother, including her image as influential, exclusive, and deeply invested in the relationship. The interviews highlighted anxiety of abandonment and dependency on the mother, who was presented as both powerful and vulnerable or dependent on her child. Participants expressed mix of appreciation and anger toward their mothers' decision. They often conveyed that their mothers had openly and transparently discussed the circumstances surrounding their birth.ConclusionThe experience of children of single mothers by choice conceived by sperm donation is complex, including mixed feelings regarding their relationship with their mother and the effects of the father's absence on their life and identity.ImplicationsThe findings underscore the importance of considering anonymity in sperm donation within policy and bioethical research. Additionally, they carry implications for interventions aimed at supporting single‐mother‐by‐choice families.

Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research

BackgroundThe ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022.MethodsThe GFBR is an annual meeting organized by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022.ResultsWe describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships.ConclusionsThe 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research.

How patients experience respect in healthcare: findings from a qualitative study among multicultural women living with HIV

BackgroundRespect is essential to providing high quality healthcare, particularly for groups that are historically marginalized and stigmatized. While ethical principles taught to health professionals focus on patient autonomy as the object of respect for persons, limited studies explore patients’ views of respect. The purpose of this study was to explore the perspectives of a multiculturally diverse group of low-income women living with HIV (WLH) regarding their experience of respect from their medical physicians.MethodsWe analyzed 57 semi-structured interviews conducted at HIV case management sites in South Florida as part of a larger qualitative study that explored practices facilitating retention and adherence in care. Women were eligible to participate if they identified as African American (n = 28), Hispanic/Latina (n = 22), or Haitian (n = 7). They were asked to describe instances when they were treated with respect by their medical physicians. Interviews were conducted by a fluent research interviewer in either English, Spanish, or Haitian Creole, depending on participant’s language preference. Transcripts were translated, back-translated and reviewed in entirety for any statements or comments about “respect.” After independent coding by 3 investigators, we used a consensual thematic analysis approach to determine themes.ResultsResults from this study grouped into two overarching classifications: respect manifested in physicians’ orientation towards the patient (i.e., interpersonal behaviors in interactions) and respect in medical professionalism (i.e., clinic procedures and practices). Four main themes emerged regarding respect in provider’s orientation towards the patient: being treated as a person, treated as an equal, treated without blame or prejudice, and treated with concern/emotional support. Two main themes emerged regarding respect as evidenced in medical professionalism: physician availability and considerations of privacy.ConclusionsFindings suggest a more robust conception of what ‘respect for persons’ entails in medical ethics for a diverse group of low-income women living with HIV. Findings have implications for broadening areas of focus of future bioethics education, training, and research to include components of interpersonal relationship development, communication, and clinic procedures. We suggest these areas of training may increase respectful medical care experiences and potentially serve to influence persistent and known social and structural determinants of health through provider interactions and health care delivery.

How Populism Affects Bioethics.

This article aims at raising awareness about the intersection of populism and bioethics. It argues that illiberal forms of populism may have negative consequences on the evolution of bioethics as a discipline and on its practical objectives. It identifies at least seven potential negative effects: (1) The rise of populist leaders fosters "epistemological populism," devaluing the expert and scientific perspectives on which bioethics is usually based, potentially steering policies away from evidence-based foundations. (2) The impact of "moral populism" is evident in legislative prioritization of the "morality of common people," often solicited through popular consultations on issues like abortion, drug legalization, or LGBT issues. (3)Populist distrust in autonomous governmental agencies and advisory bodies, including national bioethics commissions, can compromise expert advice, challenging both their authority and decisions. (4) Populists may erode transparency by undermining institutions responsible for it, hindering access to vital information for bioethical research. (5)"Medical populism" creates adversarial dynamics, prompting politicians to make simplistic healthcare policy decisions based on political rather than informed criteria, adversely affecting vulnerable populations. (6)Radical-right populist parties' "welfare chauvinism" may shape healthcare policies, impacting service access and resource allocation, disproportionately affecting vulnerable groups such as migrants, but indirectly affecting the rest of the population. (7)Nationalist sentiments associated with populism may obstruct international collaborations, posing challenges for global bioethics that seeks to address ethical concerns beyond national borders. In summary, these dynamics raise significant bioethical concerns encompassing evidence-based decision-making, transparency, healthcare equity, and global collaboration. How bioethicists may respond to these challenges is discussed.

Research priority-setting is an ethics exercise: lessons from the Global Forum on Bioethics in Research for the Region of the Americas.

Research priority-setting is an ethics exercise: lessons from the Global Forum on Bioethics in Research for the Region of the Americas.

Realist evaluation of maternity waiting home intervention models in Inhambane, Mozambique: protocol for a comparative embedded case study, the Mozambique-Canada Maternal Health Project

IntroductionThis is a study protocol that tests and refines realist theories regarding the uptake and scale-up of the linked maternity waiting home (hereafter MWH) and facility birth intervention in the...

From book to bedside? A critical perspective on the debate about "translational bioethics".

The concept of "translational bioethics" has received considerable attention in recent years. Most publications draw an analogy to translational medicine and describe bioethical research that aims at implementing and evaluating ethical interventions. However, current accounts of translational bioethics are often rather vague and seem to differ with regard to conceptual and methodological assumptions. It is not clear and scarcely analyzed what exactly "translation" in the field of bioethics means, in particular regarding goals and processes so that it is justified to appeal to translational medicine. In this article, we thus explore possible analogies and disanalogies between translational medicine and translational bioethics to establish whether the often occurring reference to concepts of translational medicine in the field of bioethics can be justified by substantial analogies. We will first provide an account of different models of translational medicine. In a second step, we will propose an analytic definition that explicitly articulates the essential characteristics of "translational research" irrespective of the research field (i.e., biomedicine, bioethics). Subsequently, we will explore whether and in how far general characteristics and phases of translational research in medicine can be applied to translational research in bioethics. Based on our analyses, we will come to the skeptical conclusion that at present there are considerable conceptual disanalogies and unsolved conceptual problems that disallow using "translational bioethics" in a meaningful analogy to respective accounts in biomedicine. Nevertheless, we will demonstrate that some insights gained by the conceptual accounts of translational medicine can contribute to advance current research activities in bioethics.

Applying the ecosystem approach to global bioethics: building on the Leopold legacy

ABSTRACTFor Van Rensselaer Potter (1911–2001), Global Bio-Ethics is about building on the legacy of Aldo Leopold (1887–1948), one of the most notable forest managers of the twentieth century who brought to light the importance of pragmatism in the sciences and showed us a new way to proceed with environmental ethics. Following Richard Huxtable and Jonathan Ives's methodological 'Framework for Empirical Bioethics Research Projects' called 'Mapping, framing, shaping,' published in BMC Medicine Ethics (2019)), we propose operationalizing a framework for Global Bio-Ethics by hybridizing approaches in empirical bioethics and ecosystem management. We explain this framework using the metaphor of forest management. This mixed approach is articulated through three phases: (1) mapping the “landscape” to build a working theory, (2) framing the “scene” to prepare the fieldwork, and (3) shaping bioethics “tools” to stimulate cooperation. Applying this methodology, an adaptive management cycle is outlined to help ensure that political processes are sustainable and socially acceptable, still based on strategic and ethical thinking, but also capable of reshaping failing policies.

The Vagueness of Integrating the Empirical and the Normative: Researchers' Views on Doing Empirical Bioethics.

The integration of normative analysis with empirical data often remains unclear despite the availability of many empirical bioethics methodologies. This paper sought bioethics scholars' experiences and reflections of doing empirical bioethics research to feed these practical insights into the debate on methods. We interviewed twenty-six participants who revealed their process of integrating the normative and the empirical. From the analysis of the data, we first used the themes to identify the methodological content. That is, we show participants' use of familiar methods explained as "back-and-forth" methods (reflective equilibrium), followed by dialogical methods where collaboration was seen as a better way of doing integration. Thereafter, we highlight methods that were deemed as inherent integration approaches, where the normative and the empirical were intertwined from the start of the research project. Second, we used the themes to express not only how we interpreted what was said but also how things were said. In this, we describe an air of uncertainty and overall vagueness that surrounded the above methods. We conclude that the indeterminacy of integration methods is a double-edged sword. It allows for flexibility but also risks obscuring a lack of understanding of the theoretical-methodological underpinnings of empirical bioethics research methods.

Developing translational bioethics-Suggestions for ways forward.

This paper will take as its starting point the premise that developing translational bioethics is a worthwhile endeavour. I will develop an account of translational bioethics and discuss what implications this would have for the wider discipline of bioethics and argue that this would be a useful development for bioethics. The paper will conduct a form of 'translational meta-bioethics analysis', in the words of Baerøe. I will argue that if we are serious about instituting translational bioethics, then it will need to look and be organised in a very different way from current bioethics research, this will be a radically different form of bioethics from what we currently have. In this paper I will sketch what translational bioethics might look like. My proposal here is not that translational bioethics should supplant existing ways of doing bioethics, but rather that it should be an addition to it, another subdiscipline of bioethics.

The risk of normative bias in reporting empirical research: lessons learned from prenatal screening studies about the prominence of acknowledged limitations

Empirical data can be an extremely powerful and influential tool in bioethical research. However, when researchers or policy makers look for answers to ethical questions by engaging with empirical research, there can be a tendency (conscious or unconscious) to shape, report, and use empirical research in a way that confirms their own preferred ethical conclusions. This skewing effect - what we call ‘normative bias’ - is often so subtle it falls short of clear misconduct and thus can be difficult to call out. However, we argue that this subtle influence of bias has the potential to significantly influence debate and policy around highly sensitive ethical issues and must be guarded against. In this paper we share the lessons we have learned through a journey of self-reflection around the effect that normative bias can have when reporting on and referring to empirical data relating to ethical issues. We use a variety of papers from our area of the ethics of routine prenatal screening to illustrate these subtle but often powerfully distorting effects of bias. Our aim in doing so is not to criticise the work of others, as we recognise our own normative bias, but to improve awareness of this issue, remind the need for reflexivity to guard against our own biases, and introduce a new criterion - the idea of a ‘limitation prominence assessment’ - that can work as a practical way to evaluate the seriousness of the limitations of an empirical study and thus, the risks of the study being misread or misinterpreted through superficial reading.

Might the bioethical principle of individual decisional autonomy have a politically liberalizing effect on soft authoritarian communities?

According to the bioethical principle of individual decisional autonomy, the patient has a right of informed consent to any medical or experimental procedure. The principle is politically liberal by advocating significant individual freedom as guaranteed by law and secured by civil liberties. When practiced in illiberal communities, might it have a political liberalizing effect? I respond first by analyzing cross-national norms of individual decisional autonomy to identify tensions with illiberal community; second, by examining examining Singapore in a single case study to show that liberal bioethics does not promote political liberalization; and third, by showing that the possibility of practicing liberal bioethics in research, clinically as well as in education, does not require a democratic order, and that liberal bioethics is unlikely to encourage the liberalization of illiberal political communities. Hence, it may never contribute to the development of globally effective cross-national norms for the legal regulation of bioethical research and clinical practice. Fourth, to bolster this analysis, I anticipate several possible objections to various of its aspects.