Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few guidelines addressed (...) specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research. (shrink)

Industry involvement in the machine learning (ML) community seems to be increasing. However, the quantitative scale and ethical implications of this influence are rather unknown. For this purpose, we have not only carried out an informed ethical analysis of the field, but have inspected all papers of the main ML conferences NeurIPS, CVPR, and ICML of the last 5 years—almost 11,000 papers in total. Our statistical approach focuses on conflicts of interest, innovation, and gender equality. We have obtained (...) four main findings. (1) Academic–corporate collaborations are growing in numbers. At the same time, we found that conflicts of interest are rarely disclosed. (2) Industry papers amply mention terms that relate to particular trending machine learning topics earlier than academia does. (3) Industry papers are not lagging behind academic papers with regard to how often they mention keywords that are proxies for social impact considerations. (4) Finally, we demonstrate that industry papers fall short of their academic counterparts with respect to the ratio of gender diversity. We believe that this work is a starting point for an informed debate within and outside of the ML community. (shrink)

BackgroundInvolvement of adolescent girls in biomedical HIV research is essential to better understand efficacy and safety of new prevention interventions in this key population at high risk of HIV infection. However, there are many ethical issues to consider prior to engaging them in pivotal biomedical research. In Uganda, 16–17-year-old adolescents can access sexual and reproductive health services including for HIV or other sexually transmitted infections, contraception, and antenatal care without parental consent. In contrast, participation in HIV prevention research involving (...) investigational new drugs requires adolescents to have parental or guardian consent. Thus, privacy and confidentiality concerns may deter adolescent participation. We describe community perspectives on ethical considerations for involving adolescent girls in the MTN 034 study in Uganda.MethodsFrom August 2017 to March 2018, we held five stakeholder engagement meetings in preparation for the MTN 034 study in Kampala, Uganda (NCT03593655): two with 140 community representatives, two with 125 adolescents, and one with 50 adolescents and parents. Discussions were moderated by the study team. Proceedings were documented by notetakers. Summary notes described community perspectives of adolescent participation in HIV research including convergent, divergent or minority views, challenges, and proposed solutions.ResultsMost community members perceived parental or guardian consent as a principal barrier to study participation due to concerns about adolescent disclosure of pre-marital sex, which is a cultural taboo. Of 125 adolescent participants, 119 (95%) feared inadvertent disclosure of sexual activity to their parents. Community stakeholders identified the following critical considerations for ethical involvement of adolescents in HIV biomedical research: (1) involving key stakeholders in recruitment, (2) ensuring confidentiality of sensitive information about adolescent sexual activity, (3) informing adolescents about information to be disclosed to parents or guardians, (4) offering youth friendly services by appropriately trained staff, and (5) partnering with community youth organizations to maximize recruitment and retention.ConclusionsStakeholder engagement with diverse community representatives prior to conducting adolescent HIV prevention research is critical to collectively shaping the research agenda, successfully recruiting and retaining adolescents in HIV clinical trials and identifying practical strategies to ensure high ethical standards during trial implementation. (shrink)

Parental consent poses challenges to needed research with adolescents who identify as lesbian, gay, bisexual, transgender, queer and/or questioning (LGBTQ+) and are at heightened risk for negative health outcomes. Obtaining parental consent in studies focused on LGBTQ+ issues can prove arduous if adolescents have not yet disclosed their identity or have unsupportive guardians. Institutional Review Boards (IRBs) may be hesitant to grant waivers of parental consent, yet research suggests that studies requiring parental consent deter the participation of adolescents who identify (...) as LGBTQ+. In this article, ethical considerations regarding waivers of parental consent in the context of the American Psychological Association’s (APA) general ethical principles are reviewed and recommendations for psychological researchers seeking waivers of parental consent are offered. A vignette is used to demonstrate a question-and-answer guide to help determine if a waiver of parental consent is ethically justified. (shrink)

The COVID-19 pandemic and its related policies (e.g., stay at home and social distancing orders) have increased people’s use of digital technology, such as social media. Researchers have, in turn, utilized artificial intelligence to analyze social media data for public health surveillance. For example, through machine learning and natural language processing, they have monitored social media data to examine public knowledge and behavior. This paper explores the ethical considerations of using artificial intelligence to monitor social media to understand (...) the public’s perspectives and behaviors surrounding COVID-19, including potential risks and benefits of an AI-driven approach. Importantly, investigators and ethics committees have a role in ensuring that researchers adhere to ethical principles of respect for persons, beneficence, and justice in a way that moves science forward while ensuring public safety and confidence in the process. (shrink)

Since the early 1980’s, with the clinical advent of in vitro fertilization resulting in so-called “test tube babies,” a wide array of ethical considerations and concerns regarding artificial womb technology (AWT) have been described. Recent breakthroughs in the development of extracorporeal neonatal life support by means of AWT have reinitiated ethical interest about this topic with a sense of urgency. Most of the recent ethical literature on the topic, however, pertains not to the more imminent scenario (...) of a physiologically improved method of neonatal care through AWT, but instead to the remote scenario of “complete ectogenesis” that imagines human gestation occurring entirely outside of the womb. This scoping review of the ethical literature on AWT spans from more abstract concerns about complete ectogenesis to more immediate concerns about the soon-to-be-expected clinical life support of what we term the fetal neonate or fetonate. Within an organizing framework of different stages of human gestational development, from conception to the viable premature infant, we discuss both already identified and newly emerging ethical considerations and concerns regarding AWT and the care of the fetonate. (shrink)

El diagnóstico prenatal como opción reproductiva más difundida a nivel mundial se refiere a métodos para investigar la salud del feto. Entre sus objetivos está la detección de malformaciones congénitas en la vida fetal y permitir la interrupción del embarazo. Un enfoque ético, basado en el respeto por las personas y a la confidencialidad, evitando el daño y respetando la autonomía, son las claves de un asesoramiento genético óptimo. Se realizó una revisión bibliográfica con el objetivo de exponer algunas consideraciones (...) éticas en la práctica asistencial de la genética médica, a partir de los principios fundamentales de la bioética vinculados al diagnóstico prenatal y al proceso de asesoramiento genético, ya que estos aspectos éticos en la práctica de la genética médica es una temática relativamente joven que ha estado influida por el desarrollo de la bioética y la solución de los dilemas éticos y sociales en la práctica médica. Prenatal diagnosis, as the world widest spread reproductive option, refers to fetus health research methods. Fetal life congenital malformation detection and allowing termination of pregnancy are among its main objectives. An ethical approach, based on respect for people and for confidentiality, avoiding hurt and respecting autonomy, is the key towards optimum genetic counseling. A bibliographic review was conducted. Its objective is to set out some ethical considerations in medical genetics health care practice starting from bioethics fundamental principles, which are linked to prenatal diagnosis and to the genetic counseling process; since dealing with issues related to these ethical aspects in medical genetics practice is a relatively new subject that has been influenced by the development of bioethics and the solution to ethical and social dilemmas in medical practice. (shrink)

Background Biobanking and genomic research requires collection and storage of human tissue from study participants. From participants’ perspectives within the African context, this can be associated with fears and misgivings due to a myriad of factors including myths and mistrust of researchers. From the researchers angle ethical dilemmas may arise especially with consenting and sample reuse during storage. The aim of this paper was to explore these ethical considerations in the establishment and conduct of biobanking and genomic (...) studies in Africa. Methods We conducted a narrative synthesis following a comprehensive search of nine (9) databases and grey literature. All primary research study designs were eligible for inclusion as well as both quantitative and qualitative evidence from peer reviewed journals, spanning a maximum of 20 years (2000–2020). It focused on research work conducted in Africa, even if data was stored or analysed outside the region. Results Of 2,663 title and abstracts screened, 94 full texts were retrieved and reviewed for eligibility. We included 12 studies (7 qualitative; 4 quantitative and one mixed methods). Ethical issues described in these papers related to community knowledge and understanding of biobanking and genomic research, regulation, and governance of same by research ethics committees, enrolment of participants, types of informed consents, data collection, storage, usage and sharing as well as material transfer, returning results and benefit sharing. ca. Biospecimen collection and storage is given in trust and participants expect confidentially of data and results generated. Most participants are comfortable with broad consent due to trust in researchers, though a few would like to be contacted for reconsenting in future studies, and this would depend on whether the new research is for good cause. Sharing data with external partners is welcome in some contexts but some research participants did not trust foreign researchers. Conclusion Biobanking and genomic studies are a real need in Africa. Linked to this are ethical considerations related to setting up and participation in biobanks as well as data storage, export, use and sharing. There is emerging or pre-existing consensus around the acceptability of broad consent as a suitable model of consent, the need for Africans to take the lead in international collaborative studies, with deliberate efforts to build capacity in local storage and analysis of samples and employ processes of sample collection and use that build trust of communities and potential study participants. Research ethics committees, researchers and communities need to work together to work together to adapt and use clearly defined ethical frameworks, guidelines, and policy documents to harmonize the establishment and running of biobanking and genomic research in Africa. (shrink)

Along with potential benefits to healthcare delivery, machine learning healthcare applications raise a number of ethical concerns. Ethical evaluations of ML-HCAs will need to structure th...

The use of drones (or unmanned aerial vehicles, UVAs) in humanitarian action has emerged rapidly in the last decade and continues to expand. These so-called ‘humanitarian drones’ represent the first wave of robotics applied in the humanitarian and development contexts, providing critical information through mapping of crisis-affected areas and timely delivery of aid supplies to populations in need. Alongside these emergent uses of drones in the aid sector, debates have arisen about potential risks and challenges, presenting diverse perspectives on the (...) ethical, legal, and social implications of humanitarian drones. Guided by the methodology introduced by Arksey and O’Malley, this scoping review offers an assessment of the ethical considerations discussed in the academic and gray literature based on a screening of 1,188 articles, from which we selected and analyzed 47 articles. In particular, we used a hybrid approach of qualitative content analysis, along with quantitative landscape mapping, to inductively develop a typology of ethical considerations associated with humanitarian drones. The results yielded 11 key areas of concern: (1) minimizing harm, (2) maximizing welfare, (3) substantive justice, (4) procedural justice, (5) respect for individuals, (6) respect for communities, (7) regulatory gaps, (8) regulatory dysfunction, (9) perceptions of humanitarian aid and organizations, (10) relations between humanitarian organizations and industry, and (11) the identity of humanitarian aid providers and organizations. Our findings illuminate topics that have been the focus of extensive attention (such as minimizing risks of harm and protecting privacy), traces the evolution of this discussion over time (i.e., an initial focus on mapping drones and the distinction of humanitarian from military use, toward the ethics of cargo drones carrying healthcare supplies and samples), and points to areas that have received less consideration (e.g., whether sustainability and shared benefits will be compromised if private companies’ interest in humanitarian drones wanes once new markets open up). The review can thus help to situate and guide further analysis of drone use in humanitarian settings. (shrink)

The prevalence of chronic diseases has increased in recent decades. Some forms of the built environment adopted during the 20th century—e.g., urban sprawl, car dependency, and dysfunctional streetscapes—have contributed to this. In this article, I summarise ways in which the built environment influences health and how it can be constructed differently to promote health. I argue that urban planning is inevitably a social and political activity with many ethical dimensions, and I illustrate this with two examples: the construction of (...) a hypothetical new suburb and a current review of planning legislation in Australia. I conclude that (1) constructing the built environment in ways that promote health can be ethically justified, (2) urban planners and public health workers should become more skilled in the application of ethical considerations to practical problems, and (3) the public health workforce needs to become more competent at influencing the activities of other sectors. (shrink)

Ethical Considerations at the Intersection of Psychiatry and Religion aims to give mental health professionals a conceptual framework for understanding the role of R/S in ethical decision-making and serve as practical guidance for approaching challenging cases. Part I addresses general considerations, including the basis of therapeutic values in a pluralistic context, the nature of theological and psychiatric ethics, spiritual issues arising in diagnosis and treatment, unhealthy and harmful uses of religion, and practical implications of personal spirituality. (...) Part II examines how these considerations apply in specific contexts: inpatient and outpatient, consultation-liaison, child and adolescent, geriatric, disability, forensic, community, international, addiction and disaster and emergency psychiatry, as well as in the work of religious professionals, ethics committees, psychiatric education, and research. Thick descriptions of case examples analyzed using the framework of Jonson and Winslow show the clinical relevance of understanding the contributions of religion and spirituality to patient preferences, quality of life, decision making, and effective treatment. (shrink)

Human Infection Studies have emerged as an important research approach with the potential to fast track the global development of vaccines and treatments for infectious diseases, including in low resource settings. Given the high level of burdens involved in many HIS, particularly prolonged residency and biological sampling requirements, it can be challenging to identify levels of study payments that provide adequate compensation but avoid ‘undue’ levels of inducement to participate. Through this embedded ethics study, involving 97 healthy volunteers and other (...) research stakeholders in a malaria HIS programme in Kenya, and using in-depth interviews, focus group discussions and observations during and after a malaria HIS, we give a grounded account of ethical issues emerging in relation to study payments in this setting. While careful community, national, international scientific and ethics review processes meant that risks of serious harm were highly unlikely, the levels of motivation to join HIS seen could raise concerns about study payments being too high. Particular value was placed on the reliability, rather than level, of study payment in this setting, where subsistence livelihoods are common. Study volunteers were generally clear about the study aims at the point of recruitment, and this knowledge was retained over a year later, although most reported experiencing more burdens than anticipated at enrolment. Strict study screening procedures, regular clinical and laboratory monitoring of volunteers, with prompt treatment with antimalarial at predetermined endpoints suggested that the risks of serious harm were highly unlikely. Ethical concerns emerged in relation to volunteers’ attempts to conceal symptoms, hoping to prolong residency periods and increase study payments; and volunteers making decisions that compromised important family relationships and personal values. Our findings support an interpretation that, although study volunteers were keen to join the study to access cash payments, they also paid attention to other features of the study and the general clinical research landscape, including levels of risk associated with study participation. Overall, our analysis shows that the ethical concerns emerging from the study payments can be addressed through practical measures, hinged on reducing burdens and strengthening communication, raising important issues for research policy and planning. (shrink)

Background The global migration of nurses from resource-constrained to affluent nations raises complex ethical concerns, often rooted in historical power imbalances and neocolonial legacies. The Nepal-UK Memorandum of Understanding (MoU) on nurse recruitment, while presented as a solution to workforce shortages, exemplifies this complex dynamic, prompting critical questions about its implications for individual nurses and the healthcare systems involved. Aim This qualitative study explored the ethical complexities and dilemmas associated with the Nepal-UK nurse recruitment Memorandum of Understanding (MoU). (...) This bilateral agreement has sparked debate about its potential impact on both individual nurses and the healthcare systems of Nepal and the UK. Research Design A qualitative exploratory design utilizing semi-structured interviews was employed. Data were analyzed using reflexive thematic analysis. Participants and Research Context Twelve Nepali nurses from two private hospitals in Kathmandu, Nepal, participated in the study. Ethical Considerations The study was approved by the Nepal Health Research Council. All participants provided informed consent and were assured of confidentiality and anonymity. Results Four themes emerged from the data: (1) The lingering legacy of colonialism casts a shadow on the Nepal-UK relationship, raising concerns about potential exploitation and unequal power dynamics. (2) Nepali nurses grapple with the ethical dilemmas of pursuing personal dreams while acknowledging their responsibilities towards their communities and Nepal’s healthcare system. (3) The MoU’s claims of ethical recruitment are scrutinized, with nurses questioning its fairness and sustainability. (4) The agreement is challenged as a potential band-aid solution that may perpetuate global health inequities rather than fostering a genuine partnership. Conclusions The Nepal-UK MoU, while offering opportunities for individual nurses, also raises alarms about brain drain, exploitation, and the perpetuation of global health disparities. The study underscores the urgent need for a paradigm shift in international nurse recruitment practices, prioritizing genuine partnership, equitable distribution of benefits, and sustainable solutions that address the root causes of healthcare workforce challenges in both source and destination countries. (shrink)

Online social networks have rapidly become a prominent and widely used service, offering a wealth of personal and sensitive information with significant security and privacy implications. Hence, OSNs are also an important—and popular—subject for research. To perform research based on real-life evidence, however, researchers may need to access OSN data, such as texts and files uploaded by users and connections among users. This raises significant ethical problems. Currently, there are no clear ethical guidelines, and researchers may end up (...) performing ethically questionable research, sometimes even when more ethical research alternatives exist. For example, several studies have employed “fake identities” to collect data from OSNs, but fake identities may be used for attacks and are considered a security issue. Is it legitimate to use fake identities for studying OSNs or for collecting OSN data for research? We present a taxonomy of the ethical challenges facing researchers of OSNs and compare different approaches. We demonstrate how ethical considerations have been taken into account in previous studies that used fake identities. In addition, several possible approaches are offered to reduce or avoid ethical misconducts. We hope this work will stimulate the development and use of ethical practices and methods in the research of online social networks. (shrink)

Prehospital ambulance based research has unique ethical considerations due to urgency, time limitations and the locations involved. We sought to explore these issues through interviews with experts in this research field. We undertook semi-structured interviews with expert informants, primarily based in the UK, seeking their views and experiences of ethics in ambulance based clinical research. Participants were questioned regarding their experiences of ambulance based research, their opinions on current regulations and guidelines, and views about their general ethical (...) considerations. Participants were chosen because they were actively involved in, or in their expert capacity expressed an interest in, ambulance based research. Fourteen participants were interviewed including principal investigators, researchers, ethicists and medical lawyers. Five major themes were identified: Capacity, Consent, Clinical Considerations, Consultation and Regulation. Questions regarding consent and capacity were foremost in the discussions as all participants highlighted these as areas for concern. The challenges and use of multiple consent models reflected the complexity of research in this environment. The clinical theme referred to the role of paramedics in research and how research involving ambulance services is increasingly informing improvements to patient care and outcomes and reducing the burden on hospital services. Most felt that, although current regulations were fit for purpose, more specific guidance on implementing these in the ambulance setting would be beneficial. This related closely to the theme of consultation, which examined the key role of ethics committees and other regulatory bodies, as well as public engagement. By interviewing experts in research or ethics in this setting we were able to identify key concerns and highlight areas for future development such as improved guidance. (shrink)

Managing non-communicable diseases (NCDs) in crisis-affected and fragile humanitarian contexts requires special attention because primary health care systems often collapse or become compromised in such settings. As a result, addressing and managing these diseases become more challenging. Humanitarian organizations that intervene in crisis situations are increasingly including NCD management in the services they support and provide; however, they encounter a range of issues such as ensuring the quality of care, sustainability of programs, and the possibility of unintended harms. This case (...) study explores ethical considerations raised by a mobile NCD program run by an international humanitarian organization in a country affected by a protracted civil war. (shrink)

It has now become a realistic prospect for smart care to be provided at home for those living with long-term conditions such as dementia. In the contemporary smart care scenario, homes are fitted with an array of sensors for remote monitoring providing data that feed into intelligent systems developed to highlight concerning patterns of behaviour or physiological measurements and to alert healthcare professionals to the need for action. This paper explores some ethical issues that may arise within such smart (...) care systems, focusing on the extent to which ethical issues can be addressed at the system design stage. Artificial intelligence has been widely portrayed as an ethically risky technology, posing challenges for privacy and human autonomy and with the potential to introduce and exacerbate bias and inequality. While broad principles for ethical artificial intelligence have become established, the mechanisms for governing ethical artificial intelligence are still evolving. In healthcare settings the implementation of smart technologies falls within the existing frameworks for ethical review and governance. Feeding into this ethical review there are many practical steps that designers can take to build ethical considerations into the technology. After exploring the pre-emptive steps that can be taken in design and governance to provide for an ethical smart care system, the paper reviews the potential for further ethical challenges to arise within the everyday implementation of smart care systems in the context of dementia, despite the best efforts of all concerned to pre-empt them. The paper concludes with an exploration of the dilemmas that may thus face healthcare professionals involved in implementing this kind of smart care and with a call for further research to explore ethical dimensions of smart care both in terms of general principles and lived experience. (shrink)

Recruitment challenges in clinical research are widespread, particularly for traditionally under-represented groups. Referral relationships—in which research partners and clinical partners agree to collaborate on selected research studies or programmes, with the expectation that the clinical partners refer appropriate patients as potential participants—may help alleviate these challenges. Referral relationships allow research partners access to expanded and more diverse pools of participants by increasing the engagement of medical providers, leveraging providers’ connections with patients and providing structural support for study participation. Clinical partners (...) can also benefit from the resources offered by research involvement, and patients may benefit from improved access to studies. Yet despite their potential, referral relationships can raise ethical concerns. Here, we discuss ethical considerations for referral relationships in clinical research to address these concerns. When establishing relationships, fair participant selection should guide the sites and studies involved. When defining the terms of a relationship, partners should build trust and respect, collaborating so that health centres or hospitals and communities benefit from their research involvement with the mitigation of associated burdens. When implemented, referral relationships should continue to honour fair participant selection, reduce misunderstanding or miscommunication about research and protect patients’ privacy and confidentiality. Overall, when conducted ethically, referral relationships can help address study recruitment challenges and promote fair access to research opportunities. (shrink)

Healthcare user fees present an important barrier for accessing services for the poorest (indigents) in Burkina Faso and selective removal of fees has been incorporated in national healthcare planning. However, establishing fair, effective and sustainable mechanisms for the removal of user fees presents important challenges. A participatory action-research project was conducted in Ouargaye, Burkina Faso, to test mechanisms for identifying those who are indigents, and funding and implementing user fee removal. In this paper, we explore stakeholder perceptions of ethical (...) considerations relating to participation and partnership arising in the action-research. (shrink)

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources (...) about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations. (shrink)

To assist in resolving ethical questions surrounding unregulated mHealth research, we conducted in-depth qualitative interviews with experts from four key stakeholder groups: patient/research advocates, researchers, regulatory professionals, and mobile app/device developers. They discussed challenges and potential solutions in the context of two hypothetical scenarios involving unregulated mHealth research, including notifications/permissions for research use of mHealth data, data access procedures, new primary data collection, offering individual research results, and data sharing and dissemination.

Although touch frequently occurs in psychotherapy with children, there is little written on the ethical considerations of therapeutic touch. Because physical contact does occur, therapists must consider if, how, and when it is used, for both their clients' safety and their own. In this review, I further develop the issues suggested by Aquino and Lee (2000) in the use of nurturing touch in therapy by considering many types of touch that occur in psychotherapy with children; the possible positive (...) role of touch; clients' perception of touch in therapy; considerations related to the therapist, the child's safety, and any history of abuse in the child's and family's background; and other practical considerations. I list guidelines. (shrink)

Evidence-based nursing practice is based on three pillars: the available research, known preferences of the patient or patient group and the professional experience of the nurse. For all pillars, research is the tool to expand the evidence we have, but when implementing evidence-based practice in paediatric nursing two of the pillars demand that children are included as respondents: practice research on the nursing interventions in paediatrics and the preferences of patients, something recognized by scholars and practitioners. But including a vulnerable (...) group as children in nursing research raises specific ethical issues that need to be considered by researchers. What are ethical considerations that are currently raised about doing research with children and what do we learn by synthesizing the narrative of these studies of why the issues are raised and which solutions can be offered for these issues? In this article, considerations on three ethical principles according to the Belmont report are described by examining recent research. Twenty-one studies were found addressing relevant ethical aspects including vulnerability, gaining consent, designing quantitative or qualitative research methods and considerations regarding the execution of the study. Ethical considerations should be much more a case of continuous awareness and attitude, then box-ticking exercise, although there are sufficient international guidelines available specifically for research that includes children to aid researchers. (shrink)

In a typical comparative clinical trial the randomization scheme is fixed at the beginning of the study, and maintained throughout the course of the trial. A number of researchers have championed a randomized trial design referred to as ‘outcome-adaptive randomization.’ In this type of trial, the likelihood of a patient being enrolled to a particular arm of the study increases or decreases as preliminary information becomes available suggesting that treatment may be superior or inferior. While the design merits of outcome-adaptive (...) trials have been debated, little attention has been paid to significant ethical concerns that arise in the conduct of such studies. These include loss of equipoise, lack of processes for adequate informed consent, and inequalities inherent in the research design which could lead to perceptions of injustice that may have negative implications for patients and the research enterprise. This article examines the ethical difficulties inherent in outcome-adaptive trials. (shrink)

Aim: This study explores experiences of patients suffering from Korsakoff’s syndrome. It contributes to improved reflection on the value of patient knowledge. Background: An ethics of care perspective states the importance of moving to patients in their vulnerable state of being, and to figure out patients’ individual needs necessary to provide good care. The information given by patients suffering from Korsakoff’s syndrome might be mistaken, invented and even not true. The value of these patients’ experiences and knowledge had not been (...) researched to date. Method: Data from six in-depth interviews were analysed concurrently through the constant comparative method. Ethical considerations: The principles of voluntariness, confidentiality and anonymity were respected during the research process. Findings: Four important themes within patients’ knowledge emerged: health condition, involuntary admission into the nursing home, the daily routine and interpretation of the caring abilities of healthcare professionals. The findings show that our respondents were able to provide a window into their inner perspective. Conclusion: This study deepens our understanding of the value of patient knowledge in situations where patients see the world in a different manner as do healthcare professionals. The conversations revealed personal subjective knowledge which our respondents create and live by. Healthcare professionals are encouraged to discover and affirm the understandings of these patients, and not be prepossessed due to the diagnosis or general nursing home rules. Understanding patients’ unique knowledge through appreciation of the complexity and richness of different views on the situation can assist to give a more humane response to individual needs and pain. Health staff in healthcare institutions are encouraged to evaluate the – unintended – effect of rigidly applied nursing home rules, and the government is challenged to rethink its policy about care, and provide more resources permitting relational care that nurtures the dignity of patients suffering from Korsakoff’s syndrome. (shrink)

Background The use of tissue collected at a forensic post-mortem for forensic genetics research purposes remains of ethical concern as the process involves obtaining informed consent from grieving family members. Two forensic genetics research studies using tissue collected from a forensic post-mortem were recently initiated at our institution and were the first of their kind to be conducted in Cape Town, South Africa. Main body This article discusses some of the ethical challenges that were encountered in these research (...) projects. Among these challenges was the adaptation of research workflows to fit in with an exceptionally busy service delivery that is operating with limited resources. Whilst seeking guidance from the literature regarding research on deceased populations, it was noted that next of kin of decedents are not formally recognised as a vulnerable group in the existing ethical and legal frameworks in South Africa. The authors recommend that research in the forensic mortuary setting is approached using guidance for vulnerable groups, and the benefit to risk standard needs to be strongly justified. Lastly, when planning forensic genetics research, consideration must be given to the potential of uncovering incidental findings, funding to validate these findings and the feedback of results to family members; the latter of which is recommended to occur through a genetic counsellor. Conclusion It is hoped that these experiences will contribute towards a formal framework for conducting forensic genetic research in medico-legal mortuaries in South Africa. (shrink)

In all fields of clinical medicine, there is an increasing awareness that outcome must be assessed in terms of quality of life and cost effectiveness, rather than merely length of survival. This is especially the case when considering decompressive craniectomy for severe traumatic brain injury. The procedure itself is technically straightforward and involves temporarily removing a large section of the skull vault in order to provide extra space into which the injured brain can expand. A number of studies have demonstrated (...) many patients going on to make a good long-term functional recovery, however, this is not always the case and a significant number survive but are left with severe neurocognitive impairment. Unfortunately, many of these patients are young adults who were previously fit and well and are, therefore, likely to spend many years in a condition that they may feel to be unacceptable, and this raises a number of ethical issues regarding consent and resource allocation. In an attempt to address these issues, we have used the analytical framework proposed by Jonsen, that requires systematic consideration of medical indications, patient preferences, quality of life and contextual features. (shrink)

It has been argued that a biomarker-informed classification system for antisocial individuals has the potential to overcome many obstacles in current conceptualizations of forensic and psychiatric constructs and promises better targeted treatments. However, some have expressed ethical worries about the social impact of the use of biological information for classification. Many have discussed the ethical and legal issues related to possibilities of using biomarkers for predicting antisocial behaviour. We argue that prediction should not raise the most pressing (...) class='Hi'>ethical worries. Instead, issues connected with ‘biologisation’, such as stigmatization and negative effects on self-image, need more consideration. However, we conclude that also in this respect there are no principled ethical objections against the use of biomarkers to guide classification and treatment of adult antisocial individuals. (shrink)

This essay focuses on the ethical considerations and implications of providing a universal multi-cancer screening test as the best approach to reduce societal cancer burden in a society with limited funds, resources, and infrastructure. With 1.9 million cancer diagnoses each year in the United States, with 86% of all cancers diagnosed in individuals over the age of 50, and with screening tools approved for only four cancer types (breast, cervical, colorectal, and lung cancer), it seems that a multi-cancer (...) screening test to detect most cancer early that is easy to administer, and is accurate and cost-effective, would be worth considering. Whole-body magnetic resonance imaging and a multi-marker blood test are the two main technologies that we will discuss as a universal screening test. However, to understand and appreciate the societal and clinical breakthrough of such a screening test, we must first consider the accessibility and efficacy of current screening methods. We conclude with a closer examination of the ethical implications of implementing the Galleri test as a multi-cancer detection screening tool as adamantly advocated by the company that developed this blood-based test. (shrink)

The purpose of this study was to examine how ethical approval and competing interests are addressed by medical journals in Iran. In a cross-sectional study, 151 journals accredited by the Publications Commission of the Ministry of Health and Medical Education were reviewed. Data collection was carried out by assessing journal guidelines and conducting structured phone interviews with journal managers, focusing on how ethical considerations and conflicts of interest (COI) are addressed. Overall, 135 of the 151 journals (89.4 (...) percent) examined some aspect of ethical considerations of submitted articles. Authors were required to disclose their financial sponsors by 98 journals (64.9 percent), while COI disclosure was required by 67 journals (44.4 percent). We conclude that the rate of addressing ethical considerations is not far from ideal, but the requirement for COI disclosure needs more attention. (shrink)

Drawing on the author’s experience carrying out qualitative research in the field of occupational therapy with people with intellectual disabilities, this article explores ethical issues inherent in ethnographic and case study research, where study designs can evolve over time. Such qualitative methodologies can enable deep understanding of research topics, but detailed description of methods and of the range of potential experiences participants may have is necessary to ensure that they are fully informed and ethics committees satisfied. Thorough consideration is (...) required of ethical issues related to topic relevance and design, recruitment, collection of data and portrayal of participants in the eventual case report. The article illustrates a way in which research of this type can be explained and justified, including how recruitment can be achieved of participants likely to lack capacity to consent to participation themselves. (shrink)

With technical sophistication and innovation in the field of medical science, a considerable proportion of medical diagnosis now rely on laboratory analyses, which emphasises the crucial role of laboratory physicians in patient care. Sustaining high ethical standards remains crucial in both clinical biochemistry and laboratory medicine, and several ethical dilemmas are faced by laboratory physicians in day-to-day practice. In a low-resource country like Bangladesh, formal ethics education or ethical framework in laboratory practice is still absent; ethics has (...) not received that much attention it this field. This paper has considered ethical issues encountered during the daily routine work of laboratory physicians and specially focused on the ethical issues encountered during the pre-analytical, analytical and post-analytical phases of laboratory medicine practice and discuss those issues in light of ‘The Belmont Report’ (1978) perspective. It is not intended to be a comprehensive one, rather it aims to complement existing guidelines and documents that are available in some institutions and to offer a framework for addressing ethical issues encountered in the practice of clinical biochemistry and laboratory medicine in Bangladesh. (shrink)

As a consequence of the COVID-19 pandemic, the number of decentralized clinical trials, trials conducted in whole or in part at locations other than traditional clinical trial sites, significantly increased. While these trials have the potential advantage of access, participant centricity, convenience, lower costs, and efficiency, they also raise a number of important ethical and practical concerns. Here we focus on a number of those concerns, including participant safety, privacy and confidentiality, remote consent, digital access and proficiency, and trial (...) oversight. Awareness of these ethical complexities will help foster the development of processes and cooperative solutions to promote safe, ethical trials going forward, optimized to decrease burden and increase access for all participants. (shrink)

ABSTRACT Recent police brutality has reminded people in the United States of America that racism and discrimination toward Black Americans is still prevalent. Evidence supports the claim that many Black Americans experience racial trauma due to the relatively common occurrence of discriminatory racial encounters in their life. Racial traumas are events of danger related to real or secondary experiences of racial discrimination that may cause psychological, emotional, or physical injury. The goal of this article is to identify the ethical (...) complexities for psychologists in addressing racial trauma among Black Americans. First, the article describes examples of racial traumas for Black Americans and their impact on overall mental health. Second, there is an in-depth analysis of ethical issues for psychologists relevant to racial trauma in areas such as competency, discrimination and harassment, bias, assessment, training programs, and harm. Finally, recommendations for psychologists are provided to address racial trauma among Black American clients, students, supervisees, and colleagues. (shrink)

Within the context of global health development approaches, surgical missions to provide care for underserved populations remain the least studied interventions with regard to their methodology. Because of the unique logistical needs of delivering operative care, surgical missions are often described solely in terms of cases performed, with a paucity of discourse on medical ethics. Within surgery, subspecialties that serve patients on a non-elective basis should, it could be argued, create mission strategies that involve a didactic approach and the propagation (...) of sustainable surgical care. The ethical considerations have yet to be described for paediatric neurosurgical outreach missions. We present here the perspectives of neurosurgeons who have participated in surgical outreach missions in Central America, South America, Eastern Europe and sub-Saharan Africa from the vantage point of both the visiting mission team and the host team that accommodates the mission efforts. (shrink)

Managing non-communicable diseases (NCDs) in crisis-affected and fragile humanitarian contexts requires special attention because primary health care systems often collapse or become compromised in such settings. As a result, addressing and managing these diseases become more challenging. Humanitarian organizations that intervene in crisis situations are increasingly including NCD management in the services they support and provide; however, they encounter a range of issues such as ensuring the quality of care, sustainability of programs, and the possibility of unintended harms. This case (...) study explores ethical considerations raised by a mobile NCD program run by an international humanitarian organization in a country affected by a protracted civil war. (shrink)

The success of deep brain stimulation (DBS) for movement disorders and the improved understanding of the neurobiologic and neuroanatomic bases of psychiatric diseases have led to proposals to expand current DBS applications. Recent preclinical and clinical work with Alzheimer's disease and obsessive-compulsive disorder, for example, supports the safety of stimulating regions in the hypothalamus and nucleus accumbens in humans. These regions are known to be involved in addiction and overeating associated with obesity. However, the use of DBS targeting these areas (...) as a treatment modality raises common ethical considerations, which include informed consent, coercion, enhancement, threat to personhood, and manipulation of the reward center. Pilot studies for both of these conditions are currently investigational. If these studies show promise, then there is a need to address the ethical concerns related to the initiation of clinical trials including the reliability of preclinical evidence, patient selection, study design, compensation for participation and injury, cost-effectiveness, and the need for long-term follow-up. Multidisciplinary teams are necessary for the ethical execution of such studies. In addition to establishing safety and efficacy, the consideration of these ethical issues is vital to the adoption of DBS as a treatment for these conditions. We offer suggestions about the pursuit of future clinical trials of DBS for the treatment of addiction and overeating associated with obesity and provide a framework for addressing ethical concerns related to treatment. (shrink)

HIV remission clinical researchers are increasingly seeking study participants who are diagnosed and treated during acute HIV infection—the brief period between infection and the point when the body creates detectable HIV antibodies. This earliest stage of infection is often marked by flu-like illness and may be an especially tumultuous period of confusion, guilt, anger, and uncertainty. Such experiences may present added ethical challenges for HIV research recruitment, participation, and retention. The purpose of this paper is to identify potential (...) class='Hi'>ethical challenges associated with involving acutely diagnosed people living with HIV in remission research and considerations for how to mitigate them. We identify three domains of potential ethical concern for clinicians, researchers, and ethics committee members to consider: 1) Recruitment and informed consent; (2) Transmission risks and partner protection; and (3) Ancillary and continuing care. We discuss each of these domains with the aim of inspiring further work to advance the ethical conduct of HIV remission research. For example, experiences of confusion and uncertainty regarding illness and diagnosis during acute HIV infection may complicate informed consent procedures in studies that seek to recruit directly after diagnosis. To address this, it may be appropriate to use staged re-consent procedures or comprehension assessment. Responsible conduct of research requires a broad understanding of acute HIV infection that encompasses its biomedical, psychological, social, and behavioral dimensions. We argue that the lived experience of acute HIV infection may introduce ethical concerns that researchers and reviewers should address during study design and ethical approval. (shrink)

The rapid development of Artificial Intelligence (AI) has raised concerns regarding the potential risks it may pose to humans, society, and the environment. Recent advancements have intensified these concerns, emphasizing the need for a deeper understanding of the technical, societal, and ethical aspects that could lead to adverse or harmful failures in decisions made by autonomous and intelligent systems (AIS). This paper aims to examine the ethical dimensions of risk management in AIS. Its objective is to highlight the (...) significance of ethical considerations in mitigating risks associated with the development, deployment, and use of AIS. The paper provides an overview of various types of AI risks and risk management procedures aimed at mitigating the negative impacts of those risks. We employ a comprehensive risk management approach that combines technical expertise with ethical analysis to ensure alignment with human values and societal objectives. Through the analysis of AI risks and risk management procedures, we advocate for establishing effective mechanisms for ethical oversight and legal control to promote ethical and trustworthy AIS. The findings reveal key risks associated with transparency, accountability, privacy infringement, algorithmic bias, and unintended consequences. To address these challenges, we consider integrating ethical principles into risk management practices, transparent risk communication, continuous engagement with all stakeholders, establishing robust accountability mechanisms, and regular ethical oversight as imperative in ethically designing and operating AI systems. Given the diminished effectiveness of internal audits compared to external audits, we also recommend the implementation of regular monitoring mechanisms through independent external audits when evaluating risk management practices. (shrink)

Parents play an integral role in the mental health service provision of children and adolescents, and they can have significant effects on the outcomes of youth. A growing body of research has linked parents’ own mental health status to numerous outcomes for their children, and recent guidelines have emerged recommending the assessment of parent psychopathology when treating child patients. However, these recommendations present a range of ethical considerations. Mental health professionals must determine if the assessment of a parent (...) is empirically supported and that an assessment procedure appropriate for parents can be feasibly implemented. They must also respect the autonomy and confidentiality of parents while ensuring that assessment findings can be translated to meaningful benefits for child patients. This article details and discusses each of these concerns within the context of the relevant principles and standards of the 2016 American Psychological Association’s Code of Ethics. Further, it provides guidelines, relevant clinical examples, and an applied model for mental health professionals to consider the ethical implications of assessing parent mental health when serving child patients. (shrink)

The recent review by Monrad1 presents several issues about secondary vaccine trials. It lays out the case in which a vaccine has been tested through phases I–III and is being deployed. Subsequently, consideration is being given to conducting ‘trials for another vaccine for the pathogen’. Monrad states: ‘In summary, we may say that researchers have strong prima facie reasons not to conduct a secondary vaccine trial.’ Monrad discusses several factors meriting careful consideration about the need for developing and testing more (...) than one vaccine: relative efficacy, length of immunity, adverse reactions, ease of storage and administration, economic and logistical factors. What is not addressed are the ethical duties that exist when there are competing phase III vaccine candidates for COVID-19. We have serious concerns about potential ethical inadequacies about these ongoing trials and …. (shrink)

Recent estimates suggest that the number of people seeking mental health treatment has increased significantly in the past 20 years (Kessler et al., 2005; Lipson et al., 2019; Mojtabai, 2005). Many...

Ethical issues arise for nurses involved in all phases of clinical trials regardless of whether they are caregivers, research nurses, trial co-ordinators or principal investigators. Potential problem areas centre on nurses’ moral obligation related to methodological issues as well as the notions of beneficence/non-maleficence and autonomy. These ethical concerns can be highly upsetting to nurses if they are not addressed, so it is imperative that they are discussed fully prior to the initiation of a trial. Failure to resolve (...) these issues can place both the conduct and the results of research in jeopardy. (shrink)

Despite evidence in college students indicating a hunger for spiritual insight and spirituality’s application in health care, there continues to be guardedness within the academy towards inclusion of curricula that address spirituality. The purpose of this article is to examine the ethical considerations of teaching spirituality in the academy by describing current trends, issues relevant to nursing education and practice, legitimate concerns of the academy, and the importance of an ethical instructional response when teaching about spirituality. Data (...) supporting the interest and desire by students to explore meaning and purpose in the context of spirituality will be presented. Challenges and barriers inherent in teaching this topic will be described, including the affective response, the lack of a universally accepted definition of spirituality, and spirituality’s relationship to religion. Pedagogical strategies consistent with an ethical instructional response will be discussed as the key to eliciting trust within the academy. A model of teaching spirituality and health will be offered to illustrate these possibilities. (shrink)

Psychedelic treatments, particularly 3,4-methylenedioxymethamphetamine (MDMA)-assisted and psilocybin-assisted therapies, have recently seen renewed interest in their clinical potential to treat various mental health conditions. Clinical trials for both MDMA-assisted and psilocybin-assisted therapies have shown to be highly efficacious for post-traumatic stress disorder and major depression. Recent research trials for psychedelic-assisted therapies (PAT) have demonstrated that although they are resource-intensive, their effects are rapid-acting, durable and cost-effective. These results have generated enthusiasm among researchers seeking to investigate psychedelic therapies in active-duty service members (...) of the US military, particularly those with treatment refractory mental health conditions. At the same time, psychedelics remain in early stages of clinical investigation, have not yet achieved regulatory approval for general clinical use and may confer unique psychological and neurobiological effects that could raise novel ethical considerations when treating active-duty service members. Should psychedelics achieve regulatory approval, military relevant considerations may include issues of access to these treatments, appropriate procedures for informed consent, confidentiality standards, and possible unanticipated mental health risks and other psychological sequelae. A service member’s deployability, as well as their ability to return to full military duty following PAT, may also be of unique concern. The authors argue that MDMA-assisted therapy currently represents a promising treatment that should be more rapidly investigated as a clinical therapy for service members while still taking a measured approach that accounts for the many military-specific uncertainties that remain. (shrink)

Ethical issues in international nursing research are identified and the perspectives of the International Centre for Nursing Ethics are offered in an effort to develop an international consensus of ethical behaviour in research. First, theoretical issues are reviewed, then initial conditions for ethical conduct are defined, and protocol design and procedure considerations are examined. A concerted effort is made to identify and avoid a western bias. Broad guiding principles for designing and reviewing research are offered: (1) (...) respect for persons; (2) beneficence; (3) justice; (4) respect for community; and (5) contextual caring. A collaborative model of the researcher-participant relationship is suggested and discussed. (shrink)

The U.S. National Institute of Allergies and Infectious Diseases and the National Institute of Mental Health have a new research priority: inclusion of terminally ill persons living with HIV in HIV cure-related research. For example, the Last Gift is a clinical research study at the University of California San Diego for PLWHIV who have a terminal illness, with a prognosis of less than 6 months. As end-of-life HIV cure research is relatively new, the scientific community has a timely opportunity to (...) examine the related ethical challenges. Following an extensive review of the EOL and HIV cure research ethics literature, combined with deliberation from various stakeholders and our experience with the Last Gift study to date, we outline considerations to ensure that such research with terminally ill PLWHIV remains ethical, focusing on five topics: 1) protecting autonomy through informed consent, 2) avoiding exploitation and fostering altruism, 3) maintaining a favorable benefits/risks balance, 4) safeguarding against vulnerability through patient-participant centeredness, and 5) ensuring the acceptance of next-of-kin/loved ones and community stakeholders. EOL HIV cure-related research can be performed ethically and effectively by anticipating key issues that may arise. While not unique to the fields of EOL or HIV cure-related research, the considerations highlighted can help us support a new research approach. We must honor the lives of PLWHIV whose involvement in research can provide the knowledge needed to achieve the dream of making HIV infection curable. (shrink)

Natural disasters in populated areas may result in massive casualties and extensive destruction of infrastructure. Humanitarian aid delegations may have to cope with the complicated issue of patient prioritization under conditions of severe resource scarcity. A triage model, consisting of five principles, is proposed for the prioritization of patients, and it is argued that rational and reasonable agents would agree upon them. The Israel Defense Force's humanitarian mission to Haiti following the 2010 earthquake serves as a case study for the (...) various considerations taken into account when designing the ethical-clinical policy of field hospitals. The discussion focuses on three applications: the decision to include an intensive care unit, the decision to include obstetrics and neonatal units, and the treatment policy for compound fractures. (shrink)

_BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study (...) or its likely impact. Studies must be scientifically valid; for research articles this includes a scientifically sound research question, the use of suitable methods and analysis, and following community-agreed standards relevant to the research field. Specific criteria for other article types can be found in the submission guidelines. _BMC series - open, inclusive and trusted_. (shrink)