Monrad JT. Ethical considerations for epidemic vaccine trials. J Med Ethics 2020;46:465–9. doi:10.1136/medethics-2020-106235 This ….

For decades a debate has played out in the literature about who bioethicists are, what they do, whether they can be considered professionals qua bioethicists, and, if so, what professional responsibilities they are called to uphold. Health care ethics consultants are bioethicists who work in health care settings. They have been seeking guidance documents that speak to their special relationships/duties toward those they serve. By approving a Code of Ethics and Professional Responsibilities for Health Care Ethics Consultants, the American Society (...) for Bioethics and Humanities (ASBH) has moved the professionalization debate forward in a significant way. This first code of ethics focuses on individuals who provide health care ethics consultation (HCEC) in clinical settings. The evolution of the code's development, implications for the field of HCEC and bioethics, and considerations for future directions are presented here. (shrink)

A twenty‐person working group convened to discuss the ethical and policy considerations of the controversial intervention called “growth attenuation,” and if possible to develop practical guidance for health professionals. A consensus proved elusive, but most of the members did reach a compromise.

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 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)

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)

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)

In a town near mine, a small business owner used their changeable-letter sign to wage a public protest against a variety of restrictions implemented during the COVID-19 pandemic. Unlike a great man...

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)

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 electronic databases: Ovid MEDLINE, Embase and CINAHL. We screened titles and abstracts using the following inclusion criteria: (1) a study population of PWLHIV or children under 5 years of age; and (2) collection of qualitative or quantitative data regarding ethics of research participation. Excluded were reviews, commentaries, policy statements, clinical care-related ethics concerns, abstracts, case studies, or studies unrelated to HIV research. Studies were appraised for quality, data were extracted, and studies were qualitatively analyzed using a principle-based ethical framework within the Belmont Report.ResultsOf the 7470 titles identified, 538 full-text articles were reviewed for eligibility and only three articles met full criteria for inclusion within this review. While we allowed for inclusion of studies involving young children born to mothers with HIV, only articles focused on PWLHIV were identified. Within the results of these studies, four themes emerged: (1) adequacy of informed consent; (2) consideration of paternal involvement; (3) balancing risks; and (4) access to research and treatment. A strength of this review is that it included perspectives of international research investigators, community leaders, and male partners. However, only two studies collected empiric data from PWLHIV regarding their experiences participating in researchConclusionResearchers and funding agencies should be aware of these considerations and appreciate the value of and critical need for formative research to ensure clinical trials involving PWLHIV promote ethical, well-informed research participation and, ultimately, improve care outcomes. More research is needed to create a comprehensive ethical framework for researchers when conducting studies with PWLHIV. (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 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)

This article argues that we could improve the design of research protocols by developing an awareness of and a responsiveness to the social contexts of all the actors in the research enterprise, including subjects, investigators, sponsors, and members of the community in which the research will be conducted. ?Social context? refers to the settings in which the actors are situated, including, but not limited to, their social, economic, political, cultural, and technological features. The utility of thinking about social contexts is (...) introduced and exemplified by the presentation of a hypothetical case in which one central issue is limitation of the probability of injury to subjects by selection of individuals who are not expected to live long enough for the known risks of the study to become manifest as harms. Benefits of such considerations may include enhanced subject satisfaction and cooperation, community acceptance, and improved data quality, among other desirable consequences. (shrink)

Over the past few years the use of stimulants such as methylphenidate and modafinil among the student population has attracted considerable debate in the pages of bioethics journals. Under the rubric of cognitive enhancement, bioethicists have discussed this use of stimulants—along with future technologies of enhancement—and have launched a sometimes forceful debate of such practices. In the following paper, it is argued that even if we focus solely upon current practices, the term cognitive enhancement encompasses a wide range of (...) class='Hi'>ethical considerations that can usefully be addressed without the need for speculation. In taking this position it is suggested that we divide cognitive enhancement into a series of empirically-constructed frameworks—medical risks and benefits, self-medication and under-prescription, prescription drug abuse and over-medication, and finally, the intention to cognitively enhance. These are not mutually exclusive frameworks, but provide a way in which to identify the scope of the issue at hand and particular ethical and medical questions that may be relevant to enhancement. By a process of elimination it is suggested that we can indeed talk of cognitive enhancement as an observable set of practices. However, in doing so we should be aware of how academic commentaries and discussion may be seen as both capturing reality and reifying cognitive enhancement as an entity. (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)

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)

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)

Humans have always played a crucial role in the evolutionary dynamics of agricultural biodiversity and thus there is a strong relationship between these resources and human cultures. These agricultural resources have long been treated as a global public good, and constitute the livelihoods of millions of predominantly poor people. At the same time, agricultural biodiversity is under serious threat in many parts of the world despite extensive conservation efforts. Ethical considerations regarding the collecting, research, and use of agricultural (...) biodiversity are currently topics of great concern. For example, easy access to genetic resources for breeding purposes is important, but international agreements and legal frameworks are necessary to ensure adequate recognition of the contributions of local communities and traditional farmers in creating and nurturing these resources. Here, we assess ethical principles in the context of existing codes of conduct that are relevant for agro-biodiversity researchers. We aim to create awareness among scientists and policy makers who are concerned with agro-biodiversity research and its potential impact on local communities. We encourage a serious assessment of the ethical principles presented here and hope to facilitate an integration of these principles into the reader’s personal ethical framework. Key ethical principles considered here include the importance of obtaining prior informed consent, equity, and the inalienability of rights of local communities and farmers. (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)

We argue that the ethical case for instituting vaccine benefit programs is justified by 2 widely recognized values: (1) reducing overall harm from COVID-19 and (2) protecting disadvantaged individuals. We then explain why they do not coerce, exploit, wrongfully distort decision-making, corrupt vaccination's moral significance, wrong those who have already been vaccinated, or destroy willingness to become vaccinated. However, their cost impacts and their effects on public perception of vaccines should be evaluated.

The debate about the use of robots in the care of older adults has often been dominated by either overly optimistic visions (coming particularly from Japan), in which robots are seamlessly incorporated into society thereby enhancing quality of life for everyone; or by extremely pessimistic scenarios that paint such a future as horrifying. We reject this dichotomy and argue for a more differentiated ethical evaluation of the possibilities and risks involved with the use of social robots. In a critical (...) discussion surrounding the capabilities approach to the ethical evaluation of quality of life, we develop an ethical framework that is more appropriate to the situation of the oldest old. We urge employment of a context-dependent approach to the ethical evaluation of new technologies in the care and therapy of older adults, and using the example of the robotic seal Paro, we show how this can be accomplished in a sensible and practical way. (shrink)

The aim of this study is to contribute to a conceptualization of organizational politics that underscores the possibility of developing positive political behavior at the workplace. In this respect, we seek to provide a context of re-evaluating the normative foundations of organizational politics. Normative issues are critically discussed in the context of mainstream ethical theories that illuminate the interaction of ethics and political behavior. More specifically, it is argued that a deontological framework is of particular importance for the proper (...) management of negative political behavior, whereas a virtue-ethics context can be employed so as to foster positive political behavior at the workplace. Finally, the implications of this approach for organizational life and HRM processes and practices are taken into consideration. (shrink)

Migrant workers in dormitories are an attractive source of clinical trial participants. However, they are a vulnerable population that has been disproportionately affected by the COVID-19 pandemic. Guidelines on recruiting vulnerable populations for clinical trials have long been established, but ethical considerations for migrant workers have been neglected. This article aims to highlight and explain what researchers recruiting migrant workers must be cognizant of, and offers recommendations to address potential concerns. The considerations raised in this article include: (...) three types of illiteracy, power dynamics, the risks associated with communal living and potential benefits to the migrant workers as well as researchers. No data are available. This article does not include original data. (shrink)

The impact on researchers of working with sensitive data is often not considered by ethics committees when approving research proposals. We conducted interviews with eight research assistants processing clinical notes on emergency department presentations for deliberate self-harm and suicide attempts during a suicide prevention trial. Common experiences of working with the data included feeling unprepared for the level of detail in the records, being drawn deeply into individual stories, emotional exhaustion from the cumulative exposure to the data over long periods (...) of time while working alone, and experiencing a heightened awareness of the fragility of life and the need for safety. The research assistants also reported on some of the strategies they had developed to cope with the sensitive nature of the data and the demands of the work. The ethical implications for suicide research reliant on non-clinically trained researchers exploring sensitive data are considered. These include the need for research l... (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)

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)

Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. (...) First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines. (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)

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)

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)

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)

As nations strengthen borders and restrict refugee admissions, national security officials are screening for fraudulent nationality claims. One tool to investigate nationality claims is DNA testing, either for claimed relationships or for ancestral origins. At the same time, the plight of global statelessness leaves millions without documentation of their nationality, and DNA testing might be the only recourse to provide evidence of heritage or relationships. DNA testing has been used sparsely to date to determine ancestral origin as a proxy for (...) nationality but could increase as border controls tighten. Given the historic lessons in eugenics and the potential for misuse of personal genetic information, it is essential to consider the ethical parameters in order to guide the implementation of genetic data for such purposes. Here, we break down examples of the use of DNA testing for nationality, and the risks and benefits of genetic testing for this purpose. Important ethical considerations discussed include (1) empowerment of stateless individuals with evidence for citizenship proceedings; (2) imprecise correlation between genetic heritage and nationality; (3) effective protection of state interests; and (4) practicalities of DNA testing. (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)

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)

Our ability to generate genomic data is currently well ahead of our ability to understand what they mean, raising challenges about how best to engage with them. This article considers ethical aspects of work with such data, focussing on research contexts that are intertwined with clinical care. We discuss the identifying nature of genomic data, the medical information intrinsic within them, and their linking of people within a biological family. We go on to consider what this means for consent, (...) the importance of thoughtful sharing of genomic data, the challenge of constructing meaningful findings, and the legacy of unequal representation in genomic datasets. We argue that the ongoing success of genomic data research relies on public trust in the enterprise: to justify this trust, we need to ensure robust stewarding, and wide engagement about the ethical issues inherent in such practices. (shrink)

The paper defines the practice of tanking in regard to sport organizations and differentiates this approach from activities such as match fixing and team building. Thereafter, the ethical implications tanking presents are developed using Alasdair MacIntyre’s neo-Aristotilean ethical framework. In particular, MacIntyre’s concept of a practice that supports both internal and external goods is discussed to examine the moral questions tanking presents. The insights developed within this analysis are applied throughout to the specific practice of basketball within the (...) discrete institution of the National Basketball Association. Finally, the paper discusses some broader implications the tanking strategy presents for the management and leadership of a sophisticated sport franchise. (shrink)

The growing importance of researching online activities, such as cyber-deviance and cyber-crime, as well as the use of online tools (e.g. questionnaires, games, and other interactive tools) has created new ethical and legal challenges for researchers, which can be even more complicated when researching adolescents. In this article, we highlight the risks emerging from the current European legal and ethical landscape when researching potentially vulnerable groups, with a special focus on online research. It is not always clear how (...) to differentiate research ethics consent from consent for data processing activities: when can an adolescent independently consent to research, or when is parental consent needed? Additional problems emerge when parents do not consent to research activities, but their adolescent children do. A serious ethical challenge can arise when the parents do not communicate with researchers, but the adolescent wishes to participate, especially when weak parental oversight is coupled with research on sensitive topics. We offer some guidance on what to keep in mind when conducting online research with adolescents and highlight possible ways that these issues can be dealt with in pan-European projects. (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)

Peterson et al. (2023) identify important ethical issues that are relevant to psychedelic therapy and research in various clinical populations and contexts. This is certainly the case in palliative...

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)

This study conducted the first empirical testing of Baker and Martinson's TARES test of ethical consideration factors for public relations practitioners. The TARES test is composed of 5 interconnected parts: truthfulness of the message, authenticity of the persuader, respect for the persuadee, equity of the appeal, and social responsibility for the common good. Results of an online exploratory survey indicate that the TARES test is better suited for a 3-factor configuration based on Day's definition of moral knowledge and that (...) ethical consideration levels differ based on age, education, gender, and political ideology. (shrink)

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)

Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are considered “developing” countries. Safeguarding the rights and welfare of individuals participating (...) as research subjects in developing countries is a priority. In September, 1997, the Joint United Nations Programme on HIV/AIDS embarked on a process of international consultation; its purpose was further to define the important ethical issues and to formulate guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts. This paper summarises the major outcomes of the UNAIDS consultative process. (shrink)

The growing number of older adults in America will result in an increasing demand for psychotherapists familiar with their psychological needs. To treat this population in an ethical manner, practitioners need to be aware of the unique characteristics of the aging process, especially in regards to age-related vulnerabilities, such as cognitive decline. Unfortunately, recent research has shown that those currently in practice do not have sufficient knowledge of the aging process and age specific issues of older adults. To address (...) these deficits the American Psychological Association published a report outlining six general concepts: attitudes, general knowledge about adult development, clinical issues, assessment, intervention, and education. These concepts are described. Furthermore, this article extends the current thinking on ethical issues regarding older adults by addressing their vulnerabilities. In addition, ethical issues such as informed consent, confidentiality, and elder abuse are addressed as they apply to both clinical and research situations. In addition, methods of resolving these important issues are suggested throughout the article. A depiction of the ethical issues of psychologists working with older adults is provided and practical procedures to help psychologists perform with high ethical standards of care for this age group are offered. (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)

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)