Year:

  1.  2
    Knowledge, Attitudes, Ethical and Social Perspectives Towards Fecal Microbiota Transplantation (FMT) Among Jordanian Healthcare Providers.Amal G. Al-Bakri, Amal A. Akour & Wael K. Al-Delaimy - 2021 - BMC Medical Ethics 22 (1):1-10.
    Background Fecal microbiota transplant is a treatment modality that involves the introduction of stool from a healthy pre-screened donor into the gastrointestinal tract of a patient. It exerts its therapeutic effects by remodeling the gut microbiota and treating microbial dysbiosis-imbalance. FMT is not regulated in Jordan, and regulatory effort for FMT therapy in Jordan, an Islamic conservative country, might be faced with unique cultural, social, religious, and ethical challenges. We aimed to assess knowledge, attitudes, and perceptions of ethical and social (...)
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  2. Ethical Concerns in Suicide Research: Thematic Analysis of the Views of Human Research Ethics Committees in Australia.Karl Andriessen, Jane Pirkis, Jo Robinson, Lennart Reifels, Karolina Krysinska, Georgia Dempster & Emma Barnard - 2021 - BMC Medical Ethics 22 (1):1-10.
    Background Suicide research aims to contribute to a better understanding of suicidal behaviour and its prevention. However, there are many ethical challenges in this research field, for example, regarding consent and potential risks to participants. While studies to-date have focused on the perspective of the researchers, this study aimed to investigate the views and experiences of members of Human Research Ethics Committees in dealing with suicide-related study applications. Methods This qualitative study entailed a thematic analysis using an inductive approach. We (...)
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  3.  1
    Grounds for Surrogate Decision-Making in Japanese Clinical Practice: A Qualitative Survey.Atsushi Asai, Taketoshi Okita, Aya Enzo, Kayoko Ohnishi & Masashi Tanaka - 2021 - BMC Medical Ethics 22 (1):1-12.
    BackgroundIn the coming years, surrogate decision-making is expected to become highly prevalent in Japanese clinical practice. Further, there has been a recent increase in activities promoting advance care planning, which potentially affects the manner in which judgements are made by surrogate decision-makers. This study aims to clarify the grounds on which surrogate decision-makers in Japan base their judgements.MethodsIn this qualitative study, semi-structured interviews were conducted to examine the judgement grounds in surrogate decision-making for critical life-sustaining treatment choices in acute care (...)
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  4.  4
    Experts’ Moral Views on Gene Drive Technologies: A Qualitative Interview Study.Annelien L. Bredenoord, Karin R. Jongsma & N. de Graeff - 2021 - BMC Medical Ethics 22 (1):1-15.
    BackgroundGene drive technologies promote the rapid spread of a particular genetic element within a population of non-human organisms. Potential applications of GDTs include the control of insect vectors, invasive species and agricultural pests. Whether, and if so, under what conditions, GDTs should be deployed is hotly debated. Although broad stances in this debate have been described, the convictions that inform the moral views of the experts shaping these technologies and related policies have not been examined in depth in the academic (...)
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  5.  4
    Frankenstein; or, the Modern Prometheus: A Classic Novel to Stimulate the Analysis of Complex Contemporary Issues in Biomedical Sciences.Irene Cambra-Badii, Elena Guardiola & Josep-E. Baños - 2021 - BMC Medical Ethics 22 (1):1-8.
    Background Advances in biomedicine can substantially change human life. However, progress is not always followed by ethical reflection on its consequences or scientists’ responsibility for their creations. The humanities can help health sciences students learn to critically analyse these issues; in particular, literature can aid discussions about ethical principles in biomedical research. Mary Shelley’s Frankenstein; or, the modern Prometheus is an example of a classic novel presenting complex scenarios that could be used to stimulate discussion. Main text Within the framework (...)
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  6. Ethical and Procedural Issues for Applying Researcher-Driven Multi-National Paediatric Clinical Trials in and Outside the European Union: The Challenging Experience of the DEEP Project.Adriana Ceci, Giorgio Reggiardo, Bianca Tempesta, Slaheddine Fattoum, Lamis Ragab, George Papanikolaou, Hugo Devlieger, Donato Bonifazi, Mariagrazia Felisi & Viviana Giannuzzi - 2021 - BMC Medical Ethics 22 (1):1-11.
    BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial. This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated. Descriptive analysis, Wilcoxon (...)
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  7.  6
    “It’s All About Delivery”: Researchers and Health Professionals’ Views on the Moral Challenges of Accessing Neurobiological Information in the Context of Psychosis.Paolo Corsico - 2021 - BMC Medical Ethics 22 (1):1-15.
    Background The convergence of neuroscience, genomics, and data science holds promise to unveil the neurobiology of psychosis and to produce new ways of preventing, diagnosing, and treating psychotic illness. Yet, moral challenges arise in neurobiological research and in the clinical translation of research findings. This article investigates the views of relevant actors in mental health on the moral challenges of accessing neurobiological information in the context of psychosis. Methods Semi-structured individual interviews with two groups: researchers employed in the National Health (...)
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  8.  4
    Perceptions of and Barriers to Ethical Promotion of Pharmaceuticals in Pakistan: Perspectives of Medical Representatives and Doctors.Zeeshan Danish, Syed Atif Raza, Imran Imran, Muhammad Islam, Furqan Kurshid Hashmi, Fawad Rasool, Zikria Saleem, Hamid Saeed & Rehan Gul - 2021 - BMC Medical Ethics 22 (1):1-16.
    BackgroundIn Pakistan, drug promotion practices, ethical or unethical, have rarely been in the spotlight. We aimed to assess the perception and barriers of medical representatives and doctors regarding ethical promotion of pharmaceuticals in Pakistan.MethodsA cross sectional survey was conducted in seven major cities of Pakistan for 6-months period. Self-administered questionnaire was used for data collection. Logistic regression and five-point Likert scale scoring was used to estimate the perceptions and barriers.ResultsCompared to national companies, the medical representatives of multinational companies strongly believed (...)
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  9. Among Equity and Dignity: An Argument-Based Review of European Ethical Guidelines Under COVID-19.Ludovica De Panfilis & Marta Perin - 2021 - BMC Medical Ethics 22 (1):1-29.
    BackgroundUnder COVID-19 pandemic, many organizations developed guidelines to deal with the ethical aspects of resources allocation. This study describes the results of an argument-based review of ethical guidelines developed at the European level. It aims to increase knowledge and awareness about the moral relevance of the outbreak, especially as regards the balance of equity and dignity in clinical practice and patient’s care. MethodAccording to the argument-based review framework, we started our research from the following two questions: what are the ethical (...)
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  10.  4
    Should Biomedical Research with Great Apes Be Restricted? A Systematic Review of Reasons.David DeGrazia, Javiera Perez Gomez & Bernardo Aguilera - 2021 - BMC Medical Ethics 22 (1):1-20.
    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 (...)
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  11.  10
    Trust and Professionalism in Science: Medical Codes as a Model for Scientific Negligence?Hugh Desmond & Kris Dierickx - 2021 - BMC Medical Ethics 22 (1):1-11.
    Background Professional communities such as the medical community are acutely concerned with negligence: the category of misconduct where a professional does not live up to the standards expected of a professional of similar qualifications. Since science is currently strengthening its structures of self-regulation in parallel to the professions, this raises the question to what extent the scientific community is concerned with negligence, and if not, whether it should be. By means of comparative analysis of medical and scientific codes of conduct, (...)
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  12. A Q Methodology Study on Divergent Perspectives on CRISPR-Cas9 in the Netherlands.Anne M. Dijkstra, Menno D. T. De Jong & Mirjam Schuijff - 2021 - BMC Medical Ethics 22 (1):1-13.
    BackgroundCRISPR-Cas9, a technology enabling modification of the human genome, is developing rapidly. There have been calls for public debate to discuss its ethics, societal implications, and governance. So far, however, little is known about public attitudes on CRISPR-Cas9. This study contributes to a better understanding of public perspectives by exploring the various holistic perspectives Dutch citizens have on CRISPR-Cas9.MethodsThis study used Q methodology to identify different perspectives of Dutch citizens on the use of CRISPR-Cas9. The Q-sort method aims at segmenting (...)
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  13. Regulatory, Scientific, and Ethical Issues Arising From Institutional Activity in One of the 90 Italian Research Ethics Committees.F. Drago & G. Benfatto - 2021 - BMC Medical Ethics 22 (1):1-9.
    BackgroundThis paper highlights the issues that one of the 90 Italian Research Ethics Committees might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial.MethodsWe retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by REC, (...)
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  14.  1
    Considerations for Applying Bioethics Norms to a Biopharmaceutical Industry Setting.Luann E. Van Campen, Tatjana Poplazarova, Donald G. Therasse, Michael Turik & The Biopharmaceutical Bioethics Working Group - 2021 - BMC Medical Ethics 22 (1):1-11.
    Background The biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope. Main text Any institution with a scientific or healthcare mission should engage bioethics norms to navigate (...)
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  15.  2
    Québec Health Care Professionals’ Perspectives on Organ Donation After Medical Assistance in Dying.Marie-Chantal Fortin, Fabian Ballesteros & Julie Allard - 2021 - BMC Medical Ethics 22 (1):1-12.
    BackgroundMedical assistance in dying has been legal in Québec since December 2015 and in the rest of Canada since July 2016. Since then, more than 60 people have donated their organs after MAID. Such donations raise ethical issues about respect of patients’ autonomy, potential pressure to choose MAID, the information given to potential donors, the acceptability of directed donations in such a context and the possibility of death by donation. The objective of this study was to explore Québec professionals’ perspectives (...)
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  16. Considerations for Applying Bioethics Norms to a Biopharmaceutical Industry Setting.Wendell Fortson, Kathleen Novak Stern, Curtis Chang, Angela Rossetti, Ariella Kelman, Michael Turik, Donald G. Therasse, Tatjana Poplazarova & Luann E. Van Campen - 2021 - BMC Medical Ethics 22 (1).
    BackgroundThe biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.Main textAny institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that (...)
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  17. Inter-Physician Variability in Strategies Linked to Treatment Limitations After Severe Traumatic Brain Injury; Proactivity or Wait-and-See.Reidun Førde, Eirik Helseth & Annette Robertsen - 2021 - BMC Medical Ethics 22 (1):1-9.
    BackgroundPrognostic uncertainty is a challenge for physicians in the neuro intensive care field. Questions about whether continued life-sustaining treatment is in a patient’s best interests arise in different phases after a severe traumatic brain injury. In-depth information about how physicians deal with ethical issues in different contexts is lacking. The purpose of this study was to seek insight into clinicians’ strategies concerning unresolved prognostic uncertainty and their ethical reasoning on the issue of limitation of life-sustaining treatment in patients with minimal (...)
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  18. Priority Setting at the Clinical Level: The Case of Nusinersen and the Norwegian National Expert Group.Reidun Førde, Sean Wallace, Magnhild Rasmussen & Morten Magelssen - 2021 - BMC Medical Ethics 22 (1).
    BackgroundNusinersen is one of an increasing number of new, expensive orphan drugs to receive authorization. These drugs strain public healthcare budgets and challenge principles for resource allocation. Nusinersen was introduced in the Norwegian public healthcare system in 2018. A national expert group consisting of physicians was formed to oversee the introduction and continuation of treatment in light of specific start and stop criteria.MethodsWe have studied experiences within the expert group with a special emphasis on their application of the start and (...)
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  19.  4
    Digital Tools in the Informed Consent Process: A Systematic Review.Francesco Gesualdo, Margherita Daverio, Laura Palazzani, Dimitris Dimitriou, Javier Diez-Domingo, Jaime Fons-Martinez, Sally Jackson, Pascal Vignally, Caterina Rizzo & Alberto Eugenio Tozzi - 2021 - BMC Medical Ethics 22 (1):1-10.
    Background Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the (...)
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  20.  4
    Artificial Intelligence for Good Health: A Scoping Review of the Ethics Literature.Jennifer Gibson, Vincci Lui, Nakul Malhotra, Jia Ce Cai, Neha Malhotra, Donald J. Willison, Ross Upshur, Erica Di Ruggiero & Kathleen Murphy - 2021 - BMC Medical Ethics 22 (1):1-17.
    BackgroundArtificial intelligence has been described as the “fourth industrial revolution” with transformative and global implications, including in healthcare, public health, and global health. AI approaches hold promise for improving health systems worldwide, as well as individual and population health outcomes. While AI may have potential for advancing health equity within and between countries, we must consider the ethical implications of its deployment in order to mitigate its potential harms, particularly for the most vulnerable. This scoping review addresses the following question: (...)
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  21.  3
    The Full Spectrum of Ethical Issues in Dementia Research: Findings of a Systematic Qualitative Review.Tim G. Götzelmann, Daniel Strech & Hannes Kahrass - 2021 - BMC Medical Ethics 22 (1):1-11.
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  22. Under Consent: Participation of People with HIV in an Ebola Vaccine Trial in Canada.Janice E. Graham, Oumy Thiongane, Benjamin Mathiot & Pierre-Marie David - 2021 - BMC Medical Ethics 22 (1):1-8.
    BackgroundLittle is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate.MethodsObservation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were recorded, transcribed (...)
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  23.  1
    Dialysis Decisions Concerning Cognitively Impaired Adults: A Scoping Literature Review.Jonathan Ives & Jordan A. Parsons - 2021 - BMC Medical Ethics 22 (1):1-17.
    BackgroundChronic kidney disease is a significant cause of global deaths. Those who progress to end-stage kidney disease often commence dialysis as a life-extending treatment. For cognitively impaired patients, the decision as to whether they commence dialysis will fall to someone else. This scoping review was conducted to map existing literature pertaining to how decisions about dialysis are and should be made with, for, and on behalf of adult patients who lack decision-making capacity. In doing so, it forms the basis of (...)
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  24.  6
    The Anatomy of Electronic Patient Record Ethics: A Framework to Guide Design, Development, Implementation, and Use.Tim Jacquemard, Colin P. Doherty & Mary B. Fitzsimons - 2021 - BMC Medical Ethics 22 (1):1-14.
    Background This manuscript presents a framework to guide the identification and assessment of ethical opportunities and challenges associated with electronic patient records. The framework is intended to support designers, software engineers, health service managers, and end-users to realise a responsible, robust and reliable EPR-enabled healthcare system that delivers safe, quality assured, value conscious care. Methods Development of the EPR applied ethics framework was preceded by a scoping review which mapped the literature related to the ethics of EPR technology. The underlying (...)
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  25.  2
    A Scoping Review of the Literature Featuring Research Ethics and Research Integrity Cases.Péter Kakuk, Soren Holm, János Kristóf Bodnár, Mohammad Hosseini, Jonathan Lewis, Bert Gordijn & Anna Catharina Vieira Armond - 2021 - BMC Medical Ethics 22 (1):1-14.
    BackgroundThe areas of Research Ethics and Research Integrity are rapidly evolving. Cases of research misconduct, other transgressions related to RE and RI, and forms of ethically questionable behaviors have been frequently published. The objective of this scoping review was to collect RE and RI cases, analyze their main characteristics, and discuss how these cases are represented in the scientific literature.MethodsThe search included cases involving a violation of, or misbehavior, poor judgment, or detrimental research practice in relation to a normative framework. (...)
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  26.  2
    Lay Persons’ Perception of the Requirements for Research in Emergency Obstetric and Newborn Care.Dan Kabonge Kaye - 2021 - BMC Medical Ethics 22 (1):1-13.
    Background Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons’ understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care. Methods This was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6–8 weeks after surviving severe obstetric complications during pregnancy or childbirth. The (...)
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  27. Ethical Challenges of the Healthcare Transition to Adult Antiretroviral Therapy (ART) Clinics for Adolescents and Young People with HIV in Uganda.Dan Kabonge Kaye, Philippa Musoke, Eleanor Namusoke Magongo, Derrick Lusota Amooti, Sabrina Bakeera-Kitaka & Scovia Nalugo Mbalinda - 2021 - BMC Medical Ethics 22 (1):1-14.
    BackgroundWhereas many adolescents and young people with HIV require the transfer of care from paediatric/adolescent clinics to adult ART clinics, this transition is beset with a multitude of factors that have the potential to hinder or facilitate the process, thereby raising ethical challenges of the transition process. Decisions made regarding therapy, such as when and how to transition to adult HIV care, should consider ethical benefits and risks. Understanding and addressing ethical challenges in the healthcare transition could ensure a smooth (...)
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  28.  5
    Women’s Viewpoints on Egg Freezing in Austria: An Online Q-Methodology Study.Johanna Kostenzer, Antoinette de Bont & Job van Exel - 2021 - BMC Medical Ethics 22 (1):1-12.
    Background Egg freezing has emerged as a technology of assisted reproductive medicine that allows women to plan for the anticipated loss of fertility and hence to preserve the option to conceive with their own eggs. The technology is surrounded by value-conflicts and is subject to ongoing discussions. This study aims at contributing to the empirical-ethical debate by exploring women’s viewpoints on egg freezing in Austria, where egg freezing for social reasons is currently not allowed. Methods Q-methodology was used to identify (...)
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  29. Facing New Challenges to Informed Consent Processes in the Context of Translational Research: The Case in CARPEM Consortium.Marie-France Mamzer, Anita Burgun, Cécile Badoual, Pierre Laurent-Puig & Elise Jacquier - 2021 - BMC Medical Ethics 22 (1):1-13.
    BackgroundIn the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. To explore informed consent practices, we conducted a retrospective study on informed consent documents that were used for CARPEM’s translational research programs. This review focused on detailing their form, their informational content, and the adequacy of these documents with the international ethical principles and participants’ rights.MethodsInformed consent forms were collected from CARPEM investigators. A content analysis focused on information related to biological (...)
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  30. What Does It Take to Consent to Islet Cell Xenotransplantation?: Insights From an Interview Study with Type 1 Diabetes Patients and Review of the Literature.Georg Marckmann, Jochen Seissler, Barbara Ludwig, Sandra Thiersch & Johannes Kögel - 2021 - BMC Medical Ethics 22 (1):1-11.
    BackgroundThe transplantation of porcine islet cells provides a new potential therapy to treat patients with type 1 diabetes mellitus. Compared to other biomedical technologies, xenotransplantation stands out in terms of its involvement of animals as graft sources, as well as the possible transmission of infectious diseases. As these aspects are especially relevant for potential xenotransplantation recipients, it is important to assess their opinion regarding this technology, in particular in terms of the requirements that should be met in the informed consent (...)
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  31. Ethical Considerations for Research Involving Pregnant Women Living with HIV and Their Young Children: A Systematic Review of the Empiric Literature and Discussion.Megan S. McHenry, Mary A. Ott, Elizabeth C. Whipple, Katherine R. MacDonald, Leslie A. Enane & Catherine G. Raciti - 2021 - BMC Medical Ethics 22 (1):1-18.
    BackgroundThe proper and ethical inclusion of PWLHIV and their young children in research is paramount to ensure valid evidence is generated to optimize treatment and care. Little empirical data exists to inform ethical considerations deemed most critical to these populations. Our study aimed to systematically review the empiric literature regarding ethical considerations for research participation of PWLHIV and their young children.MethodsWe conducted this systematic review in partnership with a medical librarian. A search strategy was designed and performed within the following (...)
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  32. Recognising Values and Engaging Communities Across Cultures: Towards Developing a Cultural Protocol for Researchers.Rakhshi Memon, Muqaddas Asif, Ameer B. Khoso, Sehrish Tofique, Tayyaba Kiran, Nasim Chaudhry, Nusrat Husain & Sarah J. L. Edwards - 2021 - BMC Medical Ethics 22 (1):1-8.
    Efforts to build research capacity and capability in low and middle income countries has progressed over the last three decades, yet it confronts many challenges including issues with communicating or even negotiating across different cultures. Implementing global research requires a broader understanding of community engagement and participatory research approaches. There is a considerable amount of guidance available on community engagement in clinical trials, especially for studies for HIV/aids, even culturally specific codes for recruiting vulnerable populations such as the San or (...)
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  33. Ethical Challenges of Caring for Burn Patients: A Qualitative Study.Fateme Mohammadi & Mostafa Bijani - 2021 - BMC Medical Ethics 22 (1):1-10.
    BackgroundBurn patients are among the most vulnerable groups of patients requiring principled ethical care. Caring for these patients often brings various ethical challenges for the members of the health care teams, especially nurses, which affect the clinical decisions made for these patients. A limited number of studies have addressed the ethical challenges of caring for burn patients for the responsible caregivers, so the present study attempted to identify these challenges. The present study aimed to explore the health professionals' experiences of (...)
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  34.  1
    Prioritising ‘Already-Scarce’ Intensive Care Unit Resources in the Midst of COVID-19: A Call for Regional Triage Committees in South Africa.Kantharuben Naidoo & Reshania Naidoo - 2021 - BMC Medical Ethics 22 (1):1-9.
    BackgroundThe worsening COVID-19 pandemic in South Africa poses multiple challenges for clinical decision making in the context of already-scarce ICU resources. Data from national government and the last published national audit of ICU resources indicate gross shortages. While the Critical Care Society of Southern Africa guidelines provide a comprehensive guideline for triage in the face of overwhelmed ICU resources, such decisions present massive ethical and moral dilemmas for triage teams. It is therefore important for the health system to provide clinicians (...)
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  35. A Scoping Review of Genetics and Genomics Research Ethics Policies and Guidelines for Africa.Joseph Ochieng, Nelson K. Sewankambo, John Barugahare, Betty Kwagala, Juli M. Bollinger, Erisa Mwaka, Betty Cohn & Joseph Ali - 2021 - BMC Medical Ethics 22 (1):1-15.
    BackgroundGenetics and genomics research is increasingly being conducted around the world; yet, researchers and research oversight entities in many countries have struggled with ethical challenges. A range of ethics and regulatory issues need to be addressed through comprehensive policy frameworks that integrate with local environments. While important efforts have been made to enhance understanding and awareness of ethical dimensions of GGR in Africa, including through the H3Africa initiative, there remains a need for in-depth policy review, at a country-level, to inform (...)
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  36.  4
    Normative Framework of Informed Consent in Clinical Research in Germany, Poland, and Russia.Marcin Orzechowski, Katarzyna Woniak, Cristian Timmermann & Florian Steger - 2021 - BMC Medical Ethics 22 (1):1-10.
    Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...)
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  37. Is There a Need for a Clear Advice? A Retrospective Comparative Analysis of Ethics Consultations with and Without Recommendations in a Maximum-Care University Hospital.Roman Pauli, Dominik Groß & Dagmar Schmitz - 2021 - BMC Medical Ethics 22 (1):1-10.
    BackgroundThe theory and practice of ethics consultations in health care are still characterized by many controversies, including, for example, the practice of giving recommendations. These controversies are complicated by an astonishing lack of evidence in the whole field. It is not clear how often a recommendation is issued in ethics consultations and when and why this step is taken. Especially in a facilitation model in which giving recommendations is optional, more data would be helpful to evaluate daily practice, ensure that (...)
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  38.  3
    Improving Pharmacy Practice in Relation to Complementary Medicines: A Qualitative Study Evaluating the Acceptability and Feasibility of a New Ethical Framework in Australia.Amber Salman Popattia, Laetitia Hattingh & Adam La Caze - 2021 - BMC Medical Ethics 22 (1):1-13.
    Background There is a need for clearer guidance for pharmacists regarding their responsibilities when selling complementary medicines. A recently published ethical framework provides guidance regarding the specific responsibilities that pharmacists need to meet in order to fulfil their professional obligations and make a positive contribution to health outcomes when selling complementary medicines. Objective Evaluate the acceptability and feasibility of a new ethical framework for the sale of complementary medicines in community pharmacy. Methods Australian community pharmacists were invited to participate in (...)
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  39.  1
    Systematic Review: Bioethical Implications for COVID-19 Research in Low Prevalence Countries, a Distinctly Different Set of Problems.Rohan Rodricks, Constance Law & Tony Skapetis - 2021 - BMC Medical Ethics 22 (1):1-8.
    BackgroundThe COVID-19 pandemic has presented extraordinary challenges to worldwide healthcare systems, however, prevalence remains low in some countries. While the challenges of conducting research in high-prevalence countries are well published, there is a paucity from low COVID-19 countries.MethodsA PRISMA guided systematic review was conducted using the databases Ovid-Medline, Embase, Scopus and Web of Science to identify relevant articles discussing ethical issues relating to research in low prevalence COVID-19 countries.ResultsThe search yielded 133 original articles of which only 2 fit the inclusion (...)
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  40. Enhancing Patient Safety by Integrating Ethical Dimensions to Critical Incident Reporting Systems.Annette Rogge, Alena Buyx, Rainer Petzina, Eva Kuhn & Kai Wehkamp - 2021 - BMC Medical Ethics 22 (1):1-8.
    BackgroundCritical Incident Reporting Systems provide a well-proven method to identify clinical risks in hospitals. All professions can report critical incidents anonymously, low-threshold, and without sanctions. Reported cases are processed to preventive measures that improve patient and staff safety. Clinical ethics consultations offer support for ethical conflicts but are dependent on the interaction with staff and management to be effective. The aim of this study was to investigate the rationale of integrating an ethical focus into CIRS.MethodsA six-step approach combined the analysis (...)
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  41. Do-Not-Attempt-Resuscitation Orders: Attitudes, Perceptions and Practices of Swedish Physicians and Nurses.Samuel Sandboge, Jörg Carlsson, Ewa Rosengren, Kristofer Årestedt & Anders Bremer - 2021 - BMC Medical Ethics 22 (1):1-10.
    BackgroundThe values and attitudes of healthcare professionals influence their handling of ‘do-not-attempt-resuscitation’ orders. The aim of this study was a) to describe attitudes, perceptions and practices among Swedish physicians and nurses towards discussing cardiopulmonary resuscitation and DNAR orders with patients and their relatives, and b) to investigate if the physicians and nurses were familiar with the national ethical guidelines for cardiopulmonary resuscitation.MethodsThis was a retrospective observational study based on a questionnaire and was conducted at 19 wards in two regional hospitals (...)
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  42.  2
    HIV Prevention Research and COVID-19: Putting Ethics Guidance to the Test.Jeremy Sugarman, Steven Wakefield, Brandon Brown, Ernest Moseki, Robert Klitzman, Florencia Luna, Leah A. Schrumpf, Wairimu Chege & Stuart Rennie - 2021 - BMC Medical Ethics 22 (1):1-10.
    BackgroundCritical public health measures implemented to mitigate the spread of the novel coronavirus disease pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/aids pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network Ethics Guidance Document to situate and analyze key ethical challenges related (...)
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  43.  5
    Unapproved Clinical Trials in Russia: Exception or Norm?Petr Talantov, Ravil Niyazov, Galina Viryasova, Margarita Dranitsyna & Ilya Yasny - 2021 - BMC Medical Ethics 22 (1):1-8.
    Background In modern Russia, any clinical investigation of a pharmaceutical for use in humans is subject to prior evaluation and approval by the Ministry of Health and its Central Ethics Committee. Despite this, some researchers and trial sponsors fail to comply, this is particularly true in case of the studies initiated by domestic sponsors or sponsor-investigators and published in Russian language medical journals. This exploratory research aims to discover whether it is a sporadic non-compliance with regulations or a common practice. (...)
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  44.  4
    Enhancing the Ethical Conduct of a Longitudinal Cluster-Randomized Trial of Psychosocial Stimulation Intervention for Children with Complicated Severe Acute Malnutrition Through Rapid Ethical Assessment: A Qualitative Study.Tesfalem T. Tessema, Andamlak G. Alamdo, Eyoel B. Mekonnen, Fanna A. Debele, Juhar A. Bamud, Teklu G. Abessa & Tefera Belachew Lema - 2021 - BMC Medical Ethics 22 (1):1-13.
    Background Informed consent is a universally accepted precondition for scientific researches involving human participants. However, various factors influence the process of obtaining authentic informed consent, and researchers particularly working in resource-poor countries often face considerable difficulties in implementing the universally recommended procedures for obtaining informed consent. We have conducted this Rapid Ethical Assessment to accommodate the local cultural norms and to understand the relevant ethical issues in the Silti community before the conduct of a cluster-randomized controlled trial. Methods This REA (...)
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  45.  3
    The Use of Personal Health Information Outside the Circle of Care: Consent Preferences of Patients From an Academic Health Care Institution.Sarah Tosoni, Indu Voruganti, Katherine Lajkosz, Flavio Habal, Patricia Murphy, Rebecca K. S. Wong, Donald Willison, Carl Virtanen, Ann Heesters & Fei-Fei Liu - 2021 - BMC Medical Ethics 22 (1):1-14.
    Background Immense volumes of personal health information are required to realize the anticipated benefits of artificial intelligence in clinical medicine. To maintain public trust in medical research, consent policies must evolve to reflect contemporary patient preferences. Methods Patients were invited to complete a 27-item survey focusing on: broad versus specific consent; opt-in versus opt-out approaches; comfort level sharing with different recipients; attitudes towards commercialization; and options to track PHI use and study results. Results 222 participants were included in the analysis; (...)
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  46. Using Practical Wisdom to Facilitate Ethical Decision-Making: A Major Empirical Study of Phronesis in the Decision Narratives of Doctors.Chris Turner, Alan Brockie, Catherine Weir, Catherine Hale, Aisha Y. Malik & Mervyn Conroy - 2021 - BMC Medical Ethics 22 (1):1-13.
    BackgroundMedical ethics has recently seen a drive away from multiple prescriptive approaches, where physicians are inundated with guidelines and principles, towards alternative, less deontological perspectives. This represents a clear call for theory building that does not produce more guidelines. Phronesis offers an alternative approach for ethical decision-making based on an application of accumulated wisdom gained through previous practice dilemmas and decisions experienced by practitioners. Phronesis, as an ‘executive virtue’, offers a way to navigate the practice virtues for any given case (...)
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  47. Health Workers’ Perspectives on Informed Consent for Caesarean Section in Southern Malawi.Thomas van den Akker, Jos van Roosmalen, Kelvin Kilowe, Felix Nansongole, Siem Zethof & Wouter Bakker - 2021 - BMC Medical Ethics 22 (1):1-11.
    ObjectiveInformed consent is a prerequisite for caesarean section, the commonest surgical procedure in low- and middle-income settings, but not always acquired to an appropriate extent. Exploring perceptions of health care workers may aid in improving clinical practice around informed consent. We aim to explore health workers’ beliefs and experiences related to principles and practice of informed consent.MethodsQualitative study conducted between January and June 2018 in a rural 150-bed mission hospital in Southern Malawi. Clinical observations, semi-structured interviews and a focus group (...)
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  48.  1
    Ethics Review of Big Data Research: What Should Stay and What Should Be Reformed?Effy Vayena, Minerva Rivas Velarde, Mahsa Shabani, Gabrielle Samuel, Camille Nebeker, S. Matthew Liao, Peter Kleist, Walter Karlen, Jeff Kahn, Phoebe Friesen, Bobbie Farsides, Edward S. Dove, Alessandro Blasimme, Mark Sheehan, Marcello Ienca & Agata Ferretti - 2021 - BMC Medical Ethics 22 (1):1-13.
    BackgroundEthics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts.Main textIn this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map these (...)
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  49.  3
    Adding Dynamic Consent to a Longitudinal Cohort Study: A Qualitative Study of EXCEED Participant Perspectives.Susan E. Wallace & José Miola - 2021 - BMC Medical Ethics 22 (1):1-10.
    Background Dynamic consent has been proposed as a process through which participants and patients can gain more control over how their data and samples, donated for biomedical research, are used, resulting in greater trust in researchers. It is also a way to respond to evolving data protection frameworks and new legislation. Others argue that the broad consent currently used in biobank research is ethically robust. Little empirical research with cohort study participants has been published. This research investigated the participants’ opinions (...)
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  50.  4
    Perceptions of Important Outcomes of Moral Case Deliberations: A Qualitative Study Among Healthcare Professionals in Childhood Cancer Care.Charlotte Weiner, Pernilla Pergert, Bert Molewijk, Anders Castor & Cecilia Bartholdson - 2021 - BMC Medical Ethics 22 (1):1-11.
    Background In childhood cancer care, healthcare professionals must deal with several difficult moral situations in clinical practice. Previous studies show that morally difficult challenges are related to decisions on treatment limitations, infringing on the child's integrity and growing autonomy, and interprofessional conflicts. Research also shows that healthcare professionals have expressed a need for clinical ethics support to help them deal with morally difficult situations. Moral case deliberations are one example of ethics support. The aim of this study was to describe (...)
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  51.  1
    Pharmacy Stakeholder Reports on Ethical and Logistical Considerations in Anti-Opioid Vaccine Development.Cody Wenthur, Amy Stewart, Grace Chung & Vincent Wartenweiler - 2021 - BMC Medical Ethics 22 (1):1-18.
    BackgroundAs opioid use disorder incidence and its associated deaths continue to persist at elevated rates, the development of novel treatment modalities is warranted. Recent strides in this therapeutic area include novel anti-opioid vaccine approaches. This work compares logistical and ethical considerations surrounding currently available interventions for opioid use disorder with an anti-opioid vaccine approach.MethodsThe opinions of student pharmacists and practicing pharmacists assessing knowledge, perceptions, and attitudes toward current and future OUD management strategies were characterized using a staged, multi-modal research approach (...)
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  52. Health Data Research on Sudden Cardiac Arrest: Perspectives of Survivors and Their Next-of-Kin.Dick L. Willems, Hanno L. Tan, Marieke T. Blom, Rens Veeken & Marieke A. R. Bak - 2021 - BMC Medical Ethics 22 (1):1-15.
    BackgroundConsent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and (...)
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  53.  6
    Patient Privacy and Autonomy: A Comparative Analysis of Cases of Ethical Dilemmas in China and the United States.Hui Zhang, Hongmei Zhang, Zhenxiang Zhang & Yuming Wang - 2021 - BMC Medical Ethics 22 (1):1-8.
    Background Respect for patients’ autonomy is usually considered to be an important ethical principle in Western countries; privacy is one of the implications of such respect. Healthcare professionals frequently encounter ethical dilemmas during their practice. The past few decades have seen an increased use of courts to resolve intractable ethical dilemmas across both the developed and the developing world. However, Chinese and American bioethics differ largely due to the influence of Chinese Confucianism and Western religions, respectively, and there is a (...)
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  54.  1
    Identifying Disincentives to Ethics Consultation Requests Among Physicians, Advance Practice Providers, and Nurses: A Quality Improvement All Staff Survey at a Tertiary Academic Medical Center.Yiran Zhang, Laura Dibsie, Cassia Yi, Lawrence Friedman, Edward Cachay, Jamie Nicole LaBuzetta & Lynette Cederquist - 2021 - BMC Medical Ethics 22 (1):1-8.
    BackgroundEthics consult services are well established, but often remain underutilized. Our aim was to identify the barriers and perceptions of the Ethics consult service for physicians, advance practice providers, and nurses at our urban academic medical center which might contribute to underutilization.MethodsThis was a cross-sectional single-health system, anonymous written online survey, which was developed by the UCSD Health Clinical Ethics Committee and distributed by Survey Monkey. We compare responses between physicians, APPs, and nurses using standard parametric and non-parametric statistical methods. (...)
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