Bioethics Research Research Articles

Aspects of Contractual Relations in Healthcare

The article aims to determine the scope and limitations of ethical duties and legal responsibilities of the medical practitioner within the professional-patient relationship (PPR), identify shortcomings of the legal framework and gaps in ethical principles, and propose solutions to them. It argues that in private law the healthcare shares many similarities with conractual law; therefore, the legal basis for physician-patient relationship is the special legal capacity of the contract parties and their free will, but ethical basis ‒ their good faith. One important finding is that physician right and obligation to refuse is an aspect of patient safety and quality of healthcare and has to be acknowledged by ethics and stipulated by law. In addition, it detects that medical professionals are ethically and legally vulnerable and need special protection. All this calls to carving out the proper place of medical practitioners’ professional autonomy and freedom in current legal regulation. Used materials include literature and scientific publications on clinical and research bioethics, contractual and medical law, regulatory enactments, court judgments. Methods used in the study include descriptive, analysis, synthesis, dogmatic, induction and deduction; legal interpretation methods such as grammatical and systemic. Keywords: patient’s rights, physician’s rights, physician’s autonomy, professional-patient relationship, right to refuse, medical liability

Expanding the Role of Bioethics in Translational Research

Expanding the Role of Bioethics in Translational Research

Towards Culturally Sensitive Shared Decision-Making in Oncology A Study Protocol Integrating Bioethical Qualitative Research on Shared Decision-Making Among Ethnic Minorities With Ethical Reflection

Background Shared decision-making (SDM) is often considered the ideal for decision-making in oncology. Views of specific groups such as ethnic minorities have seldom been considered in its development. Aim In this study we seek to assess in oncology if there is a need for adaptation of the current SDM model to ethnic minorities and to formulate possible adjustments. Design This study is embedded in empirical bioethics, an interdisciplinary approach integrating empirical data with ethical reasoning to formulate normative conclusions regarding a practice. For the empirical social scientific part, a cross-sectional qualitative study will be conducted; for the ethical reflection the Reflective Equilibrium will be used to develop a coherent view on the application of SDM among ethnic minorities in oncology. Method Semi-structured interviews combined with visual methods (timelines and relational maps) will be held with healthcare professionals (HCPs), ethnic minority patients, and their relatives to identify values steering the behavior of these actors in SDM. In addition, focus groups (FGs) will be held with ethnic minority community members to identify value structures at the group level. Respondents will be recruited through organizations with access to ethnic minorities and collaborating hospitals. Data will be analyzed using a reflexive thematic analysis through the lens of Schwartz’s value theory. The results of the empirical phase will be included in the RE to formulate possible adjustments of the SDM model, if needed. Discussion The integration of empirical data with ethical reflection is an innovative method in decision-making. This method enables a systematic and profound assessment of the need for adaptation of SDM and the formulation of theoretically and empirically based suggestions for adaptations of the model. Findings of this study may enrich the SDM model.

Impacts of the Early COVID-19 Pandemic on the Work of Bioethicists in Canada

Bioethics experts played a key role in ensuring a coherent ethical response to the COVID-19 pandemic in the fields of healthcare, public health, and scientific research in Canada. In the province of Quebec, a group of academic and practicing bioethicists met periodically in the early months of the pandemic to discuss approaches and solutions to ethical dilemmas encountered during the crisis. These meetings created the opportunity for a national survey of bioethics practitioners from different fields. The survey, in which forty-five Canadian bioethics practitioners (clinical ethicists, ethicist members of REBs and government health policy ethicists, or any bioethicist practicing outside of academia) participated, explored their concerns, challenges and opportunities during the first wave of the pandemic, with the objective of informing bioethics research about the difficulties experienced by bioethicists “in the field”. Participants reported increased stress levels, increased workloads, and a greater proportion of their work being devoted to public health ethics. Most of their concerns focused on groups other than themselves, such as health professionals, patients, research participants, and people in vulnerable socio-economic situations. An optimism about the future of bioethics was noted due to an increased awareness of the importance of bioethics by the public and by health and research institutions.

Bioethics and Gerontology: The Value of Thinking Together.

The interdisciplinary field of bioethics focuses on what it means to be a person, flourish as a person, and be respected as a person in different conditions of health, illness, or disability. Bioethics and policy research considers normative questions such as how a good society, through its priorities and investments, should demonstrate its commitments to the lives of different populations. Bioethics and humanities scholarship, often known as "health humanities," shares affinities with age studies and disability studies and with narrative-based approaches to the study of human experience. Gerontology is concerned with the many aspects of life that affect how people age, including social structures and values that influence the experience of growing old. In this article, we briefly explore the evolution of bioethics, from a discourse that emerged in relation to developments in biomedicine, bioscience, and biotechnology; to research ethics; to broader ethical questions emerging from real-world conditions, with attention to how bioethics has considered the experience of aging. Until recently, most age-focused work in bioethics has concerned age-associated illness, particularly end-of-life decision making. Given the reality of population aging and the ethical concerns accompanying the shift in age for most places in the world, the further evolution of bioethics involves greater attention to the support of flourishing in late life and to social justice and health equity in aging societies. We argue that the discourses of bioethics and critical gerontology, in dialogue, can bring a new understanding of privilege and preference, disparity and disadvantage, and reflection and respect for aging individuals.

AB028. Teaching bioethics and bioethics research using inquiry-based pedagogy

Background: Bioethics, which was previously confined to the related studies of philosophy, ethics, biology, and medicine is a growing field of study that has broadened to include public health, law, and globalization among others. This has made the teaching of bioethics and bioethics research education increasingly significant. In this light, this paper discusses how bioethics and bioethics research can be taught using an inquiry-based pedagogy, particularly, through building a community of inquiry.

Bioethics research under European and national regulations

The timeliness of the subject is due to the interest shown in knowledge of the European and national legislative framework in bioethical research. The European and national legislative framework for bioethical research is clarified in this Article, and the biophysical issues are classified into domestic legislation. It also assesses certain rules and legal regulations contained in the Treaties drawn up by the European institutions, which aim at establishing and operating best the Community institutions on bioethics and which are useful for the national legislative framework.

The Trauma of Disregard

The Trauma of Disregard

How to build a game for empirical bioethics research: The case of 'Tracing Tomorrow'.

It is becoming increasingly clear that the field of empirical bioethics requires methodological innovations that can keep up with the scale and pace of contemporary research in health and medicine. With that in mind, we have recently argued for Design Bioethics—the use of purpose‐built, engineered research tools that allow researchers to investigate moral decision‐making in ways that are embodied and contextualized. In this paper, we outline the development, testing and implementation of a novel prototype tool in the Design Bioethics Workshop—with each step illustrated with collected data. Titled ‘Tracing Tomorrow’ (www.tracingtomorrow.org), the tool is a narrative game to investigate young people's values and preferences in the context of digital phenotyping for mental health. The process involved (1) Working with young people to discover, validate and define the morally relevant cases or problems, (2) Building and testing the game concept in collaboration with relevant groups and game developers, (3) Developing prototypes that were tested and iterated in partnership with groups of young people and game developers and (4) Disseminating the game to young people to collect data to investigate research questions. We argue that Design Bioethics yields tools that are relevant, representative and meaningful to target populations and provide improved data for bioethics analysis.Patient or Public ContributionIn planning and conducting this study, we consulted with young people from a diverse range of backgrounds, including the NeurOX Young People's Advisory Group, the What Lies Ahead Junior Researchers Team, Censuswide youth participants and young people from the Livity Youth Network.

2.Q. Workshop: Intersex human rights and wellbeing - Part I: From frameworks to ethics and lived experiences

Abstract Intersex newborns, children and adolescents frequently are subjected to not clinically necessary surgeries and other non-consensual treatments. According to the UN Factsheet Intersex, “Intersex people are born with sex characteristics (including genitals, gonads and chromosome patterns) that do not fit typical binary notions of male or female bodies”. The intersex movement, international and regional human rights bodies, clinical practitioners, bioethicists and researchers have contributed reflections and recommendations related to intersex human rights, wellbeing, health and healthcare. International intersex activism demands, among other claims, the cessation of not clinically necessary surgeries and other non-consensual treatments performed on intersex newborns, children and adolescents, as well as access to clinical records, continued healthcare and psychosocial support. International and regional human rights bodies have supported these demands, calling on member states to prohibit not clinically necessary intersex-related surgeries. The discussion in the field of intersex studies includes the review of human rights and bioethical principles, clinical and research practices, as well as lived experiences, social circumstances and healthcare needs of intersex people. The workshop series “Intersex human rights and wellbeing” is structured in two parts “Part I: From frameworks to ethics and lived experiences” and “Part II: From ethics to healthcare approaches and experiences”. The first workshop in the series aims at exploring theoretical frameworks, ethical aspects in intersex research and lived experiences of intersex people. The presentations provide a review of the human rights framework (Presenter: Morgan Carpenter, Australia), the presentation of a European research project on intersex wellbeing and rights (Presenter: Dr. Surya Monro, United Kingdom), reflections on relevant ethical aspects in intersex studies (Presenters: Dr. Amets Suess Schwend and Yessica Mestre Martínez, Spain), as well as the presentation of research projects on the lived experiences of intersex youth in Aotearoa /New Zealand (Presenter: Dr. Denise Steers, Aoteearoa/New Zealand) and cultural aspects in intersex healthcare in Italy (Presenter: Marta Prandelli, Italy). Key messages The protection of intersex people’s human rights, health and wellbeing requires a critical review of current clinical and research practices. Human rights frameworks, bioethics, public health approaches and social sciences can provide relevant contributions to this discussion.

4.Q. Workshop: Intersex human rights and wellbeing - Part II: From ethics to healthcare approaches and policies

Abstract Intersex newborns, children and adolescents frequently are subjected to not clinically necessary surgeries and other non-consensual treatments. According to the UN Factsheet Intersex, “Intersex people are born with sex characteristics (including genitals, gonads and chromosome patterns) that do not fit typical binary notions of male or female bodies”. Since the 1950s, Western medicine developed a clinical model of early surgeries and other treatments performed on intersex newborns, children and adolescents. In October 2005, an expert meeting elaborated on the Consensus of Chicago, establishing clinical recommendations for intersex healthcare and introducing a new nomenclature: Disorders of Sex Development, a document criticised from activist and academic perspectives. Human rights bodies, intersex activists and allies demand the cessation of not clinically necessary genital surgeries and other treatments performed on intersex children, recommending the postponement of these interventions until the intersex person can give informed consent. Furthermore, they highlight the relevance of providing access to clinical information and medical records, continued healthcare and psychosocial support, if needed. In the clinical field, different approaches for intersex healthcare are currently being discussed, including the elaboration of clinical recommendations. The discussion in the field of intersex studies includes the review of human rights and bioethical principles, clinical and research practices, as well as lived experiences, social circumstances and healthcare needs of intersex people. This workshop is the second part of the workshop series “Intersex human rights and wellbeing”. Part I “From frameworks to ethics and lived experiences” presented theoretical frameworks, ethical aspects in intersex studies and lived experiences of intersex people. Part II “From ethics to healthcare approaches and policies” aims at opening up a shared reflection on clinical practices, health policies and legal frameworks related to intersex health and healthcare needs. The presentations include a review of the right of intersex children to autonomy and informed consent in the Belgian clinical practice and legislation (Presenter: Dr. Pieter Cannoot, Belgium), the presentation of a qualitative research project on the perspectives of intersex people, parents, medical doctors and psychologists regarding intersex healthcare (Presenter: Dr. Ute Lampalzer, Germany), a reflection on the experience of a multidisciplinary team specialised in intersex healthcare in Switzerland (Presenter: Cynthia Kraus, Switzerland), the review of cross-cultural differences in psychosocial intersex healthcare in Germany and Israel (Presenter: Dr. Meoded Danon, Germany), as well as the proposal of an agency-based model of health in intersex healthcare (Presenter: Daniela Crocetti, Italy). Key messages The questioning of not clinically necessary surgeries and other non-consensual treatments performed on intersex children motivates a discussion on new clinical approaches in intersex healthcare. Activists, practitioners and researchers call for clinical recommendations and policies that focus on human rights, informed consent, decisional autonomy, agency and multidisciplinary collaboration.

Фундаментальные проблемы правовых исследований в биоэтике

Formulation of the problem . Rapid global scientific and technological progress has an increasing impact on the quality of life and human health and urgently requires fundamental legal research in connection with the ethical consequences of the ongoing fundamental changes. Analysis of scientific trends and paradigms in the field of medical law and legal support of innovative biomedical technologies is the goal of this study. Goals and objectives . Modern innovations in the field of bioethics, which fundamentally change a person's attitude to the world and to himself, are ahead of the formation of appropriate legal decisions. The challenges and biomedical collisions that occurred to humanity by the middle of the 20th century and continue to this day lead to a violation of the harmony of nature and man. Additional, primarily legal, efforts are required to restore balance and ensure the future of humanity. The range of tasks of this research includes: to identify social and social needs and features of the formation of ethical and legal institutions in the field of bioethics; to identify research trends in the field of implementation of international bioethical norms in national legislation and optimization of government policies. Results and brief conclusions . This study makes it possible to differentiate multidirectional bioethical research into formalized and non-formalizable issues of biomedicine in the context of the effective implementation of innovations from science and technology and the potential for their compliance with legal paradigms. Fundamental research in the field of bioethics concentrates around the study of gaps and conflicts in the regulatory framework, precise definition of basic concepts, establishment of legal responsibility for violation of human rights and freedoms, distribution of powers and responsibilities of state bodies to ensure human rights to safety of life and health. Insufficient detailing of legislation in the field of bioethics and medical law does not meet modern requirements in the relationship between the state, patients and the biomedical community, and minimizes the human rights to a quality level of health guaranteed by the constitution and laws.

Defining ethical challenge(s) in healthcare research: a rapid review

BackgroundDespite its ubiquity in academic research, the phrase ‘ethical challenge(s)’ appears to lack an agreed definition. A lack of a definition risks introducing confusion or avoidable bias. Conceptual clarity is a key component of research, both theoretical and empirical. Using a rapid review methodology, we sought to review definitions of ‘ethical challenge(s)’ and closely related terms as used in current healthcare research literature.MethodsRapid review to identify peer-reviewed reports examining ‘ethical challenge(s)’ in any context, extracting data on definitions of ‘ethical challenge(s)’ in use, and synonymous use of closely related terms in the general manuscript text. Data were analysed using content analysis. Four databases (MEDLINE, Philosopher’s Index, EMBASE, CINAHL) were searched from April 2016 to April 2021.Results393 records were screened, with 72 studies eligible and included: 53 empirical studies, 17 structured reviews and 2 review protocols. 12/72 (17%) contained an explicit definition of ‘ethical challenge(s), two of which were shared, resulting in 11 unique definitions. Within these 11 definitions, four approaches were identified: definition through concepts; reference to moral conflict, moral uncertainty or difficult choices; definition by participants; and challenges linked to emotional or moral distress. Each definition contained one or more of these approaches, but none contained all four. 68/72 (94%) included studies used terms closely related to synonymously refer to ‘ethical challenge(s)’ within their manuscript text, with 32 different terms identified and between one and eight different terms mentioned per study.ConclusionsOnly 12/72 studies contained an explicit definition of ‘ethical challenge(s)’, with significant variety in scope and complexity. This variation risks confusion and biasing data analysis and results, reducing confidence in research findings. Further work on establishing acceptable definitional content is needed to inform future bioethics research.

Developing new ways to listen: the value of narrative approaches in empirical (bio)ethics

The use of qualitative research in empirical bioethics is becoming increasingly popular, but its implementation comes with several challenges, such as difficulties in aligning moral epistemology and methods. In this paper, we describe some problems that empirical bioethics researchers may face; these problems are related to a tension between the different poles on the spectrum of scientific paradigms, namely a positivist and interpretive stance. We explore the ideas of narrative construction, ‘genres’ in medicine and dominant discourses in relation to empirical research. We also reflect on the loss of depth and context that may occur with thematic or content analyses of interviews, and discuss the need for transparency about methodologies in empirical bioethics. Drawing on insights from narrative approaches in the social sciences and the clinical-educational discipline of Narrative Medicine, we further clarify these problems and suggest a narrative approach to qualitative interviewing in empirical bioethics that enables researchers to ‘listen (and read) in new ways’. We then show how this approach was applied in the first author’s research project about euthanasia decision-making. In addition, we stress the important ethical task of scrutinizing methodologies and meta-ethical standpoints, as they inevitably impact empirical outcomes and corresponding ethical judgments. Finally, we raise the question whether a ‘diagnostic’, rather than a ‘problem-solving’, mindset could and should be foregrounded in empirical ethics, albeit without losing a commitment to ethics’ normative task, and suggest further avenues for theorizing about listening and epistemic (in)justice in relation to empirical (bio)ethics.

Digital bioethics: introducing new methods for the study of bioethical issues

The online space has become a digital public square, where individuals interact and share ideas on the most trivial to the most serious of matters, including discussions of controversial ethical...

The ethical implications of verbal autopsy: responding to emotional and moral distress

BackgroundVerbal autopsy is a pragmatic approach for generating cause-of-death data in contexts without well-functioning civil registration and vital statistics systems. It has primarily been conducted in health and demographic surveillance systems (HDSS) in Africa and Asia. Although significant resources have been invested to develop the technical aspects of verbal autopsy, ethical issues have received little attention. We explored the benefits and burdens of verbal autopsy in HDSS settings and identified potential strategies to respond to the ethical issues identified.MethodsThis research was based on a case study approach centred on two contrasting HDSS in Kenya and followed the Mapping-Framing-Shaping Framework for empirical bioethics research. Data were collected through individual interviews, focus group discussions, document reviews and non-participant observations. 115 participants were involved, including 86 community members (HDSS residents and community representatives), and 29 research staff (HDSS managers, researchers, census field workers and verbal autopsy interviewers).ResultsThe use of verbal autopsy data for research and public health was described as the most common potential benefit of verbal autopsy in HDSS. Community members mentioned the potential uses of verbal autopsy data in addressing immediate public health problems for the local population while research staff emphasized the benefits of verbal autopsy to research and the wider public. The most prominent burden associated with the verbal autopsy was emotional distress for verbal autopsy interviewers and respondents. Moral events linked to the interview, such as being unsure of the right thing to do (moral uncertainty) or knowing the right thing to do and being constrained from acting (moral constraint), emerged as key causes of emotional distress for verbal autopsy interviewers.ConclusionsThe collection of cause-of-death data through verbal autopsy in HDSS settings presents important ethical and emotional challenges for verbal autopsy interviewers and respondents. These challenges include emotional distress for respondents and moral distress for interviewers. This empirical ethics study provides detailed accounts of the distress caused by verbal autopsy and highlights ethical tensions between potential population benefits and risks to individuals. It includes recommendations for policy and practice to address emotional and moral distress in verbal autopsy.

A Second Chance at Health

Mass incarceration and the aging prison population in the United States is an ethical crisis, understudied in empirical bioethics research. In this article, I share one woman’s narrative to illustrate how older Black women describe accessing healthcare while incarcerated and identify sites for bioethical exploration. I argue that, due to the punitive nature of prison healthcare interactions, wherein women are seen as inmates first and patients second, healthcare providers are caught in a trap of competing ethical commitments to their patients and the state. As the prison population ages, these challenges will become more acute. Feminist bioethics has a critical role to play in imagining new possibilities for accessing, giving, and receiving care in the carceral context.

A questionnaire based institutional assessment of ‘knowledge’, ‘attitude’ and ‘practice’ about bio-ethics in clinical research among postgraduate residents

Background: Research ethics govern the standards of conduct for scientific researchers. Post graduate residents are one of the key stakeholders in clinical research. Therefore, the present study is designed to assess the Knowledge, Attitude and Practice about bio-ethics in clinical research among post-graduate residents.Methods: A self-administered pretested questionnaire was given to 40 students selected on the basis of convenience sampling. The questionnaire consists of questions related to knowledge and attitude toward principles and practice of bioethics in clinical research, informed consent, and role of the ethics committee in the institution. Descriptive statistics was used to analyse the results.Results: 70% of the students have formally taken Hippocratic Oath. Knowledge, attitude, and practice regarding Institutional Ethics Committee, and informed consent were more among final year students when compared to their juniors. Source of knowledge of bioethics were multiple. Department lectures were not a preferred mode of learning.Conclusions: There is an urgent need to include practical education of ethics to bridge the gap in the knowledge, attitude, and practices regarding ethics in clinical practice and research.

Phytochemicals with nanoparticles and their potential applications in medicine – A review

Phytochemicals having multiple properties which are used to cure various diseases such as cancer, diabetes, neurodegeneration, angiogenesis, aging, inflammatory, cardiovascular and arthritic disease, etc., Extensive use of phytochemicals and their derivatives leads to unavailability or scarcity of products in nature. Despite this episode, the nanotechnology resolves the setback of handling phytochemicals by increasing their bioavailability, long-lost acting, target-specific and less or no toxicity. Here, we focused on the 24 known phytochemicals and preparation of NPs without discriminating the polymers and metals in NPs. All the phytochemicals did not fully satisfy the toxicological hazards, physical-pharmaceutical challenges, bioethical and health issues research. Hence these NPs and their NP incorporated phytochemicals need to be characterized in a way to give direct usage to the common man. Commercialization of NP formulations in pharmaceuticals needs statutory regulation norms for complete satisfaction and safety for end-users. As of now, many NP mediated pharmaceutical products are available in the market with full-fledged but still many unrevealed about their fate in the environment. In this review, the characterization of nanoparticles, the transparent benefit of nanoparticles (NPs), and their current application in various fields has been discussed.

Interview with professor of philosophy Hans-Martin Sass. November 15-18, 2020

Hans-Martin Sass, Honorary Professor of Philosophy (Ruhr University, Bochum, Germany). Founder and board member of the Centre for Medical Ethics (CME), Bochum, Germany. Honorary Senior Research Fellow at Kennedy Institute of Ethics at Georgetown University, Washington, DC. Honorary Professor of the Bioethics Research Centre, Beijing. He has written more than 60 books and pamphlets, more than 250 articles in professional journals. Editor of the Ethik in der Praxis/ Practical ethics, Muenster: Lit. Founder and co-editor of the brochures “Medizinethische Materialien”, Bochum: ZME. He has lectured in Argentina, Austria, Belgium, Bulgaria, Brazil, Canada, Croatia, the Chech Republic, India, Iran, Israel, Italy, Japan, France, the Netherlands, the Philippines, Poland, Portugal, Russia, Spain, Switzerland and Taiwan. The interview devoted to exposition of the concept of bioethics in America and Germany, as well as the professor`s attitude to the idea of the integrative concept of bioethics. The concept of integrative bioethics has been developed in different countries, a component of this concept is the idea of the need for discussion on bioethics in various sectors of society (not only medical). Equally important in this concept are the definitions of bioethics and the bioethical imperative proposed by Fritz Jahr in 1926. The scientist`s article, which was discovered in 1997, contains a new format of bioethical ideas, as well as a valuable opportunity to enhance understanding the term of bioethics as an integrative science. Interview has been conducted by Hanna Hubenko as a part of the joint international course «Integrative Bioethics». At the meeting it was discussed the experience of cooperation and plans for the future. Cooperation and feedback between scientists remains an unconditional prerogative, also in a pandemic situation (to be continued).