In the last two centuries, our world would have been a safer place if philosophers such as Rousseau, Marx, and Nietzsche had not given intellectual encouragement to the radical ideologies of Jacobins, Stalinists, and fascists. Maybe the world would have been better off, from the standpoint of sound practice, if philosophers had engaged in only modest, decent theory, as did John Stuart Mill. Yet, as Ronald Beiner contends, the point of theory is not to think safe thoughts; the point is (...) to open intellectual horizons. In Philosophy in a Time of Lost Spirit, Beiner reflects on the dualism of theory and practice. The purpose of the theorist is not to offer sensible guidance on the conduct of social life but to test the boundaries of our vision of social order. Whereas the liberal citizen should embody the practical virtues of prudence and moderation, the theorist should be radical, probing, and immoderate. Looking back at the liberal-communitarian debate of the 1980s, Beiner recognizes that the antidote to our spiritless times lies neither in the embrace of community over individualism nor of individualism over community: both individual and community need to be submitted to radical questioning. It is by exposing ourselves to the challenge of fearless thinking encountered at the philosophical extremities that we are most likely to understand our own world at a deeper level. In this collection of essays and reviews, Ronald Beiner helps us to think critically about the thought-worlds of our foremost contemporary thinkers, including Hannah Arendt, Allan Bloom, Michel Foucault, Hans-Georg Gadamer, J¦rgen Habermas, Will Kymlicka, Christopher Lasch, Richard Rorty, Judith Shklar, Leo Strauss, Charles Taylor, and Michael Walzer. (shrink)

How did the events of the early modern period affect the way gender and the self were represented? This collection of essays attempts to respond to this question by analysing a wide spectrum of cultural concerns - humanism, technology, science, law, anatomy, literacy, domesticity, colonialism, erotic practices, and the theatre - in order to delineate the history of subjectivity and its relationship with the postmodern fragmented subject. The scope of this analysis expands the terrain explored by feminist theory, while its (...) feminist focus reveals that the subject is always gendered - although the terms in which gender is conceived and represented change across history. Feminist Readings of Early Modern Culture not only explores the representation of gendered subjects, but in its commitment to balancing the productive tensions of methodological diversity, also speaks to contemporary challenges facing feminism. (shrink)

How do we deal with difference personally, interpersonally, nationally? Can we weave a cohesive social fabric in a religiously plural society without suppressing differences? This collection of significant essays suggests that to truly honour differences in matters of faith and religion we must publicly exercise and celebrate them. The secular/sacred, public/private divisions long considered sacred in the West need to be dismantled if Canada (or any nation state) is to develop a genuine mosaic that embraces fundamental differences instead of a (...) melting pot that marginalizes. An ethics of difference starts with a recognition of difference, not as deviance or deficit that threatens but as otherness to connect with, cherish, and celebrate. The book begins with the suggestion that our inability to come to terms with social plurality is not fundamentally the fault of religious differences, and that a public/private split inadequately deals with matters of basic difference. It then explores how encouraging people to live out their respective faiths may open new possibilities for respectful, honourable, and just negotiations of contemporary dilemmas arising out of the multicultural fabric of Canadian life. Towards an Ethics of Community introduces readers to some of the most challenging and divisive dilemmas we face in this increasingly pluralistic, postmodern world — issues such as family and domestic violence, Aboriginal rights, homosexuality and public policy, and female genital mutilation. This is a book truly global in scope and significance. (shrink)

There is a long history of medical research that involves intentionally infecting healthy people in order to study diseases and their treatments. Such research—what might be called “human challenge studies”—are an important strand of much current research—for example, in the development of vaccinations. The many international and national guidelines about the proper conduct of medical research do not specifically address human challenge studies. In this paper we review the guidelines on the risk of harm that healthy (...) volunteers may be exposed to in the course of medical research. We examine the ethical arguments that are implicit or explicit in these guidelines. We then ask whether there is reason for limiting such studies on grounds independent of risk of harm. We conclude that the major ethical concern with challenge studies is that of risk of harm and that the fact that a study is a challenge study is not a wrong in itself. (shrink)

COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies ) with SARS-CoV-2. Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes. Systematic risk evaluations are critical to inform assessments of the ethics of any proposed SARS-CoV-2 (...) CHIs. Such evaluations will necessarily take place within a rapidly changing and at times contested epidemiological landscape, in which differing criteria for the ethical acceptability of research risks have been proposed. This paper critically reviews two such criteria and evaluates whether the use of effective treatment should be a necessary condition for the ethical acceptability of SARS-CoV-2 CHIs, and whether the choice of study sites should be influenced by COVID-19 incidence levels. The paper concludes that ethical evaluations of proposed SARS-CoV-2 CHIs should be informed by rigorous, consultative and holistic approaches to systematic risk assessment. (shrink)

Controlled Human Infection Model (CHIM) research involves the infection of otherwise healthy participants with disease often for the sake of vaccine development. The COVID-19 pandemic has emphasised the urgency of enhancing CHIM research capability and the importance of having clear ethical guidance for their conduct. The payment of CHIM participants is a controversial issue involving stakeholders across ethics, medicine and policymaking with allegations circulating suggesting exploitation, coercion and other violations of ethical principles. There are multiple approaches to payment: reimbursement, wage (...) payment and unlimited payment. We introduce a new Payment for Risk Model, which involves paying for time, pain and inconvenience and for risk associated with participation. We give philosophical arguments based on utility, fairness and avoidance of exploitation to support this. We also examine a cross-section of the UK public and CHIM experts. We found that CHIM participants are currently paid variable amounts. A representative sample of the UK public believes CHIM participants should be paid approximately triple the UK minimum wage and should be paid for the risk they endure throughout participation. CHIM experts believe CHIM participants should be paid more than double the UK minimum wage but are divided on the payment for risk. The Payment for Risk Model allows risk and pain to be accounted for in payment and could be used to determine ethically justifiable payment for CHIM participants.Although many research guidelines warn against paying large amounts or paying for risk, our empirical findings provide empirical support to the growing number of ethical arguments challenging this status quo. We close by suggesting two ways (value of statistical life or consistency with risk in other employment) by which payment for risk could be calculated. (shrink)

Human infection challenge studies (HCS) involve intentionally infecting research participants with pathogens (or other micro-organisms). There have been recent calls for more HCS to be conducted in low-income and middle-income countries (LMICs), where many relevant diseases are endemic. HCS in general, and HCS in LMICs in particular, raise numerous ethical issues. This paper summarises the findings of a project that explored ethical and regulatory issues related to LMIC HCS via (i) a review of relevant literature and (ii) 45 (...) qualitative interviews with scientists and ethicists. Among other areas of consensus, we found that there was widespread agreement that LMIC HCS can be ethically acceptable, provided that they have a sound scientific rationale, are accepted by local communities and meet usual research ethics requirements. Unresolved issues include those related to (i) acceptable approaches to trade-offs between the scientific aim to produce generalisable results and the protection of participants, (iii) the sharing of benefits with LMIC populations, (iii) the acceptable limits to risks and burdens for participants, (iv) the potential for third-party risk and whether the degree of acceptable third-party risk is different in endemic settings, (v) the conditions under which (if any) it would be appropriate to recruit children for disease-causing HCS, (v) appropriate levels of payment to participants and (vi) appropriate governance of (LMIC) HCS. This paper provides preliminary analyses of these ethical considerations in order to (i) inform scientists and policymakers involved in the planning, conduct and/or governance of LMIC HCS and (ii) highlight areas warranting future research. Insofar as this article focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided is relevant to HCS (in HICs or LMICs) involving pandemic diseases including COVID19. (shrink)

Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries. Most of these concerns are based on theoretical considerations and there exists little data on the attitudes of stakeholders in these countries. This study examines the view of researchers and REC members in Thailand regarding the design and conduct of challenge studies in the country. A questionnaire was developed based on ethical frameworks for human challenge studies. (...) The target respondents included those who had experience with health-related research at universities, non-university hospitals, and research institutes. A total of 240 respondents completed the on-line survey. In general, the respondents felt that the ethical issues raised by human challenge studies in LMICS do not differ significantly from those in high income countries, including: scientific rationale, safety, appropriate risks, and robust informed consent process. In contrast, issues that have been described as important for human challenge studies in LMICs were rated as having lower importance, including: a publicly available rationale, national priority, and community engagement. Responses did not vary significantly between researchers in different fields, nor between researchers and REC members. These findings provide an important perspective for assessing existing frameworks for human challenges studies in LMICs. (shrink)

Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed ‘controlled human infection studies’, this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currently available to assist researchers and research ethics committees in negotiating the distinct issues raised (...) by research involving purposefully infecting healthy volunteers. In this article, we present two separate challenge studies and highlight the ethical issues of human challenge studies as seen through a well-constructed framework. Beyond the same stringent ethical standards seen in other areas of medical research, we conclude that human challenge studies should also include: independent expert reviews, including systematic reviews; a publicly available rationale for the research; implementation of measures to protect the public from spread of infection beyond the research setting; and a new system for compensation for harm. We hope these additions may encourage safer and more ethical research practice and help to safeguard public confidence in this vital research alternative in years to come. (shrink)

Grimwade et al highlight the current lack of a universal, standardised approach to the payment of participants taking part in controlled human infection model studies.1 As they discuss, payment for these studies is controversial, with many voicing arguments for and against higher payments, particularly for those studies which involve significant burdens to the participant. The main concerns about overpayment relate to the concepts of undue inducement or coercion, whereas underpayment raises concern about exploitation and unfair treatment. In (...) many healthy volunteer trials compensation for travel, time and inconvenience are generally accepted as fair payment, but payment for risk is less accepted, with a belief that non-therapeutic studies should only incur minimal risks, so payment for risk should not be necessary.2 This paper argues that payment for risk should be included for CHIM studies. Their findings among members of the UK public and CHIM experts from a variety of centres suggest that there is support for greater risks being associated with higher payments for participants. The amount of compensation offered by a trial has to be approved by an ethics committee/institutional review board, and some research suggests that IRB members have concerns about higher payments being offered, with only approximately one-third agreeing that payment should be offered for risk.3 Without agreement and clear guidance for calculating compensation for these types of trial, there is bound to be …. (shrink)

Human infection challenge studies have been proposed as a means to accelerate SARS-CoV2 vaccine development and thereby help to mitigate a prolonged global public health crisis. A key criterion for the ethical acceptability of SARS-CoV2 HCS is that potential benefits outweigh risks. Although the assessment of risks and benefits is meant to be a standard part of research ethics review, systematic comparisons are particularly important in the context of SARS-CoV2 HCS in light of the significant potential benefits and (...) harms at stake as well as the need to preserve public trust in research and vaccines. In this paper we explore several considerations that should inform systematic assessment of SARS-CoV-2 HCS. First, we detail key potential benefits of SARS-CoV-2 HCS including, but not limited to, those related to the acceleration of vaccine development. Second, we identify where modelling is needed to inform risk-benefit assessments. Modelling will be particularly useful in comparing potential benefits and risks of HCS with those of vaccine field trials under different epidemiological conditions and estimating marginal risks to HCS participants in light of the background probabilities of infection in their local community. We highlight interactions between public health policy and research priorities, including situations in which research ethics assessments may need to strike a balance between competing considerations. (shrink)

We largely agree with Grimwade et al ’s1 conclusion that challenge trial participants may ethically be paid, including for risk. Here, we add further arguments, clarify some points from the perspective of economics and indicate areas where economists can support the development of a framework for ethically justifiable payment. Our arguments apply to carefully constructed and monitored controlled human infection model trials that have been appropriately reviewed and approved. Participants in medical studies perform a service. Outside the domain (...) of research participation, there is nearly universal agreement that workers providing a service should be compensated fairly, and that work involving more discomfort and risk should be compensated more generously. Accordingly, labour regulations impose floors, not caps on compensation. Caps, even if intended to protect against undue inducement, also raise concerns about illegal price-fixing that disadvantages workers. Such limits on payment for egg donors have successfully been challenged in court.i Moreover, caps on compensation may harm everyone at risk of infection, not just potential participants. Insufficient compensation may impede the recruitment of enough suitable subjects, for example, when representativeness of the subject sample is required. Delays in vaccine development not only prolong disruption of social, educational and economic activity but also lead to excess infections and deaths. Unlike paid CHIM participants, individuals exposed to such infection do not accept it voluntarily, are not compensated for it, and are unlikely to receive the level of medical supervision afforded to closely monitored CHIM participants. Payment caps can lead to attempts to circumvent the regulation. For example, many countries …. (shrink)

Controlled human infection challenge studies (CHIs) involve intentionally exposing research participants to, and/or thereby infecting them with, micro‐organisms. There have been increased calls for more CHIs to be conducted in low‐ and middle‐income countries (LMICs) where many relevant diseases are endemic. This article is based on a research project that identified and analyzed ethical and regulatory issues related to endemic LMIC CHIs via (a) a review of relevant literature and (b) qualitative interviews involving 45 scientists and ethicists with (...) relevant expertise. In this article we argue that though there is an especially strong case for conducting CHIs in endemic (LMIC) settings, certain ethical issues related to the design and conduct of such studies (in such settings) nonetheless warrant particularly careful attention. We focus on ethical implications of endemic LMIC CHIs regarding (a) potential direct benefits for participants, (b) risks to participants, (c) third‐party risks, (d) informed consent, (e) payment of participants, and (f) community engagement. We conclude that there is a strong ethical rationale to conduct (well‐designed) CHIs in endemic LMICs, that certain ethical issues warrant particularly careful consideration, and that ethical analyses of endemic LMIC CHIs can inform current debates in research ethics more broadly. (shrink)

Antibiotic resistance is one of the most pressing public health problems humanity faces. Research into new classes of antibiotics and new kinds of treatments – including risky experimental treatments such as phage therapy and vaccines – is an important part of improving our ability to treat infectious diseases. In order to aid this research, we will argue that we should permit researchers to pay people any amount of money to compensate for the risks of participating in clinical trials, including ‘ (...) class='Hi'>challenge studies’ that involve deliberately infecting patients. We think that standard worries about paying for participation in risky research are reducible to concerns that can be addressed with the right screening mechanisms. (shrink)

To prepare for potential human infection challenge studies involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SAR...

Human challenge studies, in which human research subjects are intentionally exposed to pathogens to contribute to scientific knowledge, raise many ethical complexities. One controversial question is whether it is ethically permissible to include children as participants. Commentary of the past decades endorses the exclusion of children, while new guidance suggests that pediatric human challenge studies can be ethically permissible. This paper argues that neither children's exclusion nor their inclusion are well justified. I examine and reject three (...) arguments for exclusion, but suggest that these arguments establish pediatric human challenge studies as a complex ethical category of research that requires caution. I then argue for a strong presumption against children's inclusion, by drawing on an analogy to children's inclusion in phase I trials, emphasizing a requirement of necessity, and suggesting that accommodating children's vulnerability promotes an age de-escalation approach for pediatric human challenge studies research. In the final section, I suggest a procedure for ethics review. (shrink)

The paper by Lynch et al. raises interesting ethical questions regarding whether and how much SARS-CoV-2 Human Challenge Studies participants should be paid. We appreciate the timely e...

Human infection challenge studies provide illuminating case studies for several ongoing debates in research ethics, including those related to research risks and payment of participants. Grimwade et al 1 add to previous public engagement, qualitative evidence and philosophical literature on these topics.1–8 The authors advocate revision of research payment policy and practice based on their main finding that members of the public endorse ex ante payment of participants proportional to research-related risk exposure, in addition to post hoc (...) compensation for any lasting harms that occur.1 Although ‘payment for risk’ would diverge from most current research ethics guidelines, it is noteworthy that the difference in payment to participants that their framework would allow might only be small, at least in the case of currently accepted studies. The absolute difference would likely be small because the risk of currently accepted HCS participation is usually very low.9 10 On a ‘value of statistical life’ approach, mirroring actuarial accounting for fatal risks, a 1 in 100 000 risk of death might attract an extra payment of only US$96.1 Most HCS do not involve fatality risks this high, although, on pessimistic estimates, the risk of COVID-19 HCS in young healthy adults might involve similar levels of risk.11 Such risks might arguably be justified by large expected public health benefits,12,9 11 13 but it remains controversial whether higher levels of payment could …. (shrink)

This commentary shall focus on the central claim made in Lynch et al.’s paper “Promoting Ethical Payment in Human Infection Challenge Studies.” According to their paper, there is a threefold...

This paper describes the UK Research Ethics Committee’s (REC) preparations and review of the global first SARS-CoV-2 human infection challenge studies. To frame our review, we used the WHO guidance and our UK Health Research Authority ethical review framework. The WHO criteria covered most issues we were concerned about, but we would recommend one further criterion directing RECs to consider alternative research designs. Could research questions be equally well answered by less intrusive studies? The committee met virtually, (...) ensuring broad representation across the UK nations and also ensuring applicants could attend easily. We worked in collaboration with the applicants but while we recognise that such proximity might raise the accusation of ‘collusion’, we made every effort to maintain ‘moral distance’ and all decisions were made by the committee alone. Prior existing processes and policy facilitated training and review but even with this preparation, review took time and this could have hindered a rapid response to the emergency. Review for the various follow-on studies will now be speedier and once the pandemic has subsided, our group could be reconvened in future emergencies. In conclusion, we have tried to make decisions in good faith. We know there is controversy and disagreement and reasonable people may feel we have made the wrong decision. A more detailed analysis, built on the WHO guidance, is provided in online supplemental material. (shrink)

AbstractDuring the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies (...) in 2020 and 2021. The pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom’s consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts. (shrink)

Volume 20, Issue 7, July 2020, Page 80-82.

ObjectiveThe coronavirus pandemic affects all areas of life. Performing arts and music studies have also experienced considerable changes, with university closures and a fluctuating return to normal and more limited operations. Prior studies detail the impact of the pandemic on college students, but we do not yet know what specific consequences it has for music students. The aim of this study is to examine the impact of the coronavirus pandemic on music students’ health, practicing behavior, and everyday life.MethodsIn (...) July 2020, we conducted an online survey of 80 students enrolled in performance and music education programs at a German music university and compared these data with data from a survey of 75 students at the same music university carried out in summer 2019.ResultsThe survey revealed that the coronavirus pandemic led to a decrease in practicing hours and an increase of stressful thoughts and feelings. Students were mostly satisfied with Corona-measures taken by the university. Of analyzed determinants, only general fear of health problems was identified as a significant predictor of mental health status. Mental health status did not significantly differ between students surveyed in 2019 and 2020.ConclusionKnowledge about the specific challenges the pandemic poses for music students can help conservatories to better respond to the needs of their students. Specifically, this study will inform future measures supporting music students in coping with difficult situations like a pandemic. (shrink)

Background and aim Child and adolescent forensic psychiatry is fraught with complex medical, legal, and social tensions. The ethical challenges this entails for inhospital treatment have hardly been investigated, and specific support for health care professionals is lacking. This study identifies ethical issues and problems in this area and develops a tool for early detection and intervention of ethical problems in clinical practice. Methods A systematic literature search and an observational study in adolescent forensics at the University Psychiatric Clinics Basel (...) are conducted. The observation data are evaluated using a qualitative content analysis. The instrument is developed based on the results using a new method. Results In the literature search, 14 valid publications were identified that mainly address ethical conflicts in legal psychiatry, such as professional role conflicts, ethical problems in diagnostics and assessment, or confidentiality issues. Empirical or empirical–normative studies are missing. In the observational study, 24 ethical issues and specific conflicts were identified. Ethical questions about moral competencies of the adolescents, the quality of treatment, the handling of rules and sanctions, and freedom and privacy are particularly common. The Instrument for Early Detection and Intervention of Ethical Problems (FIEP) contains the four core elements risk factors, indicators, intervention planning and decision-making. Conclusions Inhospital treatment in forensic child and adolescent psychiatry reveals a broad spectrum of ethical issues with specific ethical problems, which are hardly investigated in literature so far. The FIEP instrument developed here supports health care practitioners in recognizing ethical problems at an early stage and addressing them efficiently. (shrink)

Background:Clinical investigation is a growing field employing increasing numbers of nurses. This has created a new specialty practice defined by aspects unique to nursing in a clinical research context: the objectives, setting, and nature of the nurse–participant relationship. The clinical research nurse role may give rise to feelings of ethical conflict between aspects of protocol implementation and the duty of patient advocacy, a primary nursing responsibility. Little is known about whether research nurses experience unique ethical challenges distinct from those experienced (...) by nurses in traditional patient-care settings.Research objectives:The purpose of the study was to describe the nature of ethical challenges experienced by clinical research nurses within the context of their practice.Research design:The study utilized a qualitative descriptive design with individual interviews.Participants and research context:Participating nurses self-identified as having experienced ethical challenges during screening. The majority were Caucasian, female, and worked in outpatient settings. Approximately 50% had > 10 years of research experience.Ethical considerations:The human subjects review board approved the study. Written informed consent was obtained.Findings:Predominant themes were revealed: the inability to provide a probable good, or/do no harm, and dual obligations. The following patterns and subthemes emerged: conflicted allegiances between protocol implementation, needs of the participant, desire to advance science, and tension between the nurse–patient therapeutic relationship versus the research relationship.Discussion:Participants described ethical challenges specific to the research role. The issues are central to the nurse–participant relationship, patient advocacy, the nurse’s role in implementing protocols, and/or advancing science.Conclusion:Ethical challenges related to the specialized role of clinical research nurses were identified. More research is warranted to fully understand their nature and frequency and to identify support systems for resolution. (shrink)

In this article, we discuss a number of challenges with the empirical study of emotion and its relation to moral judgment. We examine a case study involving the moral foreign-language effect, according to which people show an increased utilitarian response tendency in moral dilemmas when using their non-native language. One important proposed explanation for this effect is that using one’s non-native language reduces emotional arousal, and that reduced emotion is responsible for this tendency. We offer reasons to think that there (...) is insufficient evidence for accepting this explanation at present. We argue that there are three themes that constrain our current ability to draw firm empirical conclusions: 1) the frequent use of proxies or partial measures for emotions, 2) the lack of a predictive and generalizable theory of emotion and specific emotion-types, and 3) the obscurity of a baseline level of neutrality with respect to participant emotion. These lessons apply not only to research on the moral foreign-language effect, but to empirical research in moral psychology more generally. (shrink)

Beyond impressionistic observations, little is known about the role and influence of scientific societies on research conduct. Acknowledging that the influence of scientific societies is not easily disentangled from other factors that shape norms and practices, this article addresses how best to study the promotion of research integrity generally as well as the role and impact of scientific societies as part of that process. In setting forth the parameters of a research agenda, the article addresses four issues: (1) how to (...) conceptualize research on scientific societies and research integrity; (2) challenges and complexities in undertaking basic research; (3) strategies for undertaking basic research that is attentive to individual, situational, organizational, and environmental levels of analysis; and (4) the need for evaluation research as integral to programmatic change and to assessment of the impact of activities by scientific societies. (shrink)

In recent years, the attention on the use of coercion in mental health care has increased. The use of coercion is common and controversial, and involves many complex ethical challenges. The research question in this study was: What kind of ethical challenges related to the use of coercion do health care practitioners face in their daily clinical work?

Several conceptual and methodological challenges must be solved in order to create knowledge that can be useful to pregnant women, their families, and any clinicians who serve them: (1) going beyond nominal and ordinal hypotheses and presenting estimates of conditional probabilities; (2) focusing on clearly defined outcomes; (3) modeling the relationship of fetal growth and length of gestation; (4) understanding the process of fetal growth even though most of our data is cross-sectional; (5) estimating the independent effects of genetics, race, (...) ethnicity, maternal risk behaviors, medical prenatal care, and socioeconomic status on fetal growth and length of gestation; and (6) estimating the independent effects of maternal pre-pregnancy weight, weight gain during pregnancy, and nutrition on fetal growth and length of gestation. (shrink)

BackgroundDecision-making in end-stage dementia is a complex process involving medical, social, legal and ethical issues. In ESD, the person suffers from severe cognitive problems leading to a loss of capacity to decide matters regarding health and end-of-life issues. The decisional responsibility is usually passed to clinicians and relatives who can face significant difficulty in making moral decisions, particularly in the presence of life-threatening swallowing problems.AimThis study aimed to understand the decision-making processes of clinical teams and relatives in addressing life-threatening swallowing (...) difficulties in ESD in long-term care in Malta.MethodThe study followed a qualitative approach where six case studies, involving six different teams and relatives of six different patients, were interviewed retrospectively to understand their decision-making in connection with the management of swallowing difficulties in ESD. Data were collected through semistructured interviews with each stakeholder. All data were transcribed and subjected to thematic analysis.ResultsFour themes were identified: the vulnerability of patients in dementia decision-making; the difficult role of relatives in decision-making; the decisional conflict between aggressive care through tube feeding versus oral comfort feeding; a consensus-building decision-making process as ideal to facilitate agreement and respect for patient’s dignity.ConclusionDecision-making to manage swallowing difficulties in ESD is a challenging process, which involves an interpretation of personal values, beliefs, patient preferences, care needs and clinical practice. Better communication between clinicians and relatives in dementia helps promote agreement between stakeholders leading to a care plan that respects the dignity of patients at their end of life. (shrink)

There is a need for empirically based research on social and ethical challenges related to informed consent processes, particularly in studies focusing on adolescent sexual and reproductive health. In a pilot study of a school-based pregnancy prevention intervention in rural Zambia, the majority of the guardians who were asked to consent to their daughters’ participation, refused. In this paper we explore the reasons behind the low participation in the pilot with particular attention to challenges related to the community engagement (...) and informed consent process. The pilot was implemented in two schools and examined the acceptability of a package of interventions including economic support to families to keep their girls in school, pocket money for girls, youth club meetings on reproductive health, and community meetings to sensitize the community. Focus group discussions were conducted with girls who participated in the pilot, boys in their class and with parents. Individual semi-structured interviews were conducted with teachers, peer educators and community health workers involved in the coordination of the intervention as well as with religious and traditional leaders. Data were analyzed through thematic analysis. The findings indicate that inadequate use of recognized community communication channels during the community engagement process and dissemination of information about the pilot resulted in limited understanding of the pilot concept by the community. This surfaced through uncertainty and fear that the intervention may result in loss of control over daughters, worries about why money was provided unconditionally to girls, and suspicion of links to satanism. The sense of insecurity appeared to be exacerbated by low literacy levels, poverty, fear of loss of bride wealth, perceived disregard for local perceptions of social status, and scanty trust in the actors implementing the pilot. Inadequate use of locally appropriate channels in the dissemination of information created room for interpretation and facilitated development of mistrust, undermining the conditions for community engagement and actual informed consent. A key lesson learnt is the importance of taking seriously the complexity of local values and structures that may impact people’s capability to consent or not consent to a study in an informed manner. (shrink)

The research fieldwork dedicated to trend analysis and foresight/forecast scenarios building, represents an unusual raid in an area where economic and social sciences have invested many efforts. Nevertheless, the semiotic dimension of this subject is not sufficiently thorough; many issues are at stake:We are going to investigate this area of analysis, for its relevance in post-Greimassian studies, for its interface with social sciences, as well as for its relevance for the legitimacy of semiotics in contemporary discussions of innovation and (...) evolution. (shrink)

In 1997 President Clinton apologized to the survivors of the U.S. Public Health Service Syphilis Study. Since then, two of his recommendations have received little attention. First, he emphasized the need to remember the shameful past so we can build a better future for racial'ethnic minority populations. Second, he directed the creation in partnership with higher education to prepare training materials that would instruct biomedical researchers on the application of ethical principles to research with racial/ethnic minority populations. This article proposes (...) the inclusion of these issues in the implementation of the Affordable Care Act. It asks, What is the right or good thing to do? What are our obligations to one another? Two challenges are examined: (a) Conducting research with African Americans without knowledge of bioethics specific to this population, and (b) the ethical dilemma of conducting research that does not adequately take into account the diversity within the Black population that is a contributing factor in health disparities. Training and policy recommendations responsive to President Clinton's Apology are presented. (shrink)

This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.

Background Achieving meaningful consent can be challenging, particularly in contexts of diminished literacy, yet is a vital part of participant protection in global health research. Method We explored the challenges and potential solutions of achieving meaningful consent through a qualitative study in a predominantly hill tribe ethnic minority population in northern Thailand, a culturally distinctive population with low literacy. Semi-structured interviews were conducted with 37 respondents who had participated in scrub typhus clinical research, their family members, researchers and other key (...) informants. A thematic analysis was conducted. Results Our analysis identified four interrelated themes surrounding participants’ ability to give consent: varying degrees of research understanding, limitations of using informal translators, issues impacting decisions to join research, and voluntariness of consent. Suggestions for achieving more meaningful consent included the use of formal translators and community engagement with research populations. Conclusions Participant’s agency in decision making to join research should be supported, but research information needs to be communicated to potential participants in a way that they can understand. We found that improved understanding about the study and its potential benefits and harms goes beyond literacy or translation and requires attention to social and cultural factors. (shrink)

Background Studying global health problems requires international multidisciplinary teams. Such multidisciplinarity and multiculturalism create challenges in adhering to a set of ethical principles across different country contexts. Our group on health system responses to violence against women (VAW) included two universities in a European high-income country (HIC) and four universities in low-and middle-income countries (LMICs). This study aimed to investigate professional and policy perspectives on the types, causes of, and solutions to ethical challenges specific to the ethics approval stage of (...) the global research projects on health system responses to VAW. Methods We used the Network of Ethical Relationships model, framework method, and READ approach to analyse qualitative semi-structured interviews (n = 18) and policy documents (n = 27). In March-July 2021, we recruited a purposive sample of researchers and members of Research Ethics Committees (RECs) from the five partner countries. Interviewees signposted policies and guidelines on research ethics, including VAW. Results We developed three themes with eight subthemes summarising ethical challenges across three contextual factors. The global nature of the group contributed towards power and resource imbalance between HIC and LMICs and differing RECs’ rules. Location of the primary studies within health services highlighted differing rules between university RECs and health authorities. There were diverse conceptualisations of VAW and vulnerability of research participants between countries and limited methodological and topic expertise in some LMIC RECs. These factors threatened the timely delivery of studies and had a negative impact on researchers and their relationships with RECs and HIC funders. Most researchers felt frustrated and demotivated by the bureaucratised, uncoordinated, and lengthy approval process. Participants suggested redistributing power and resources between HICs and LMICs, involving LMIC representatives in developing funding agendas, better coordination between RECs and health authorities and capacity strengthening on ethics in VAW research. Conclusions The process of ethics approval for global research on health system responses to VAW should be more coordinated across partners, with equal power distribution between HICs and LMICs, researchers and RECs. While some of these objectives can be achieved through education for RECs and researchers, the power imbalance and differing rules should be addressed at the institutional, national, and international levels. Three of the authors were also research participants, which had potential to introduce bias into the findings. However, rigorous reflexivity practices mitigated against this. This insider perspective was also a strength, as it allowed us to access and contribute to more nuanced understandings to enhance the credibility of the findings. It also helped to mitigate against unequal power dynamics. (shrink)

Researching two different work settings, police work and hospice care, the authors experienced a strange sense of discomfort in their bodies during their fieldwork when investigating professional training and work situations, especially in encounters with citizens and patients. In some of those situations, the authors withdrew physically or mentally from the situation without wanting to do so, feeling emotionally affected by the uncertainty of the situations, not fully grasping the meaning of what was going on. In a strange way they (...) felt awkwardly detached from their research activities and their bodily involvement in their fieldwork. In this article, the authors seek to explore the meaning of awkwardness embedded in some kinds of ethical dilemma. Through a phenomenological analysis based on the concept of intentionality of the body and a model of inner dilemmas, they reach a renewed understanding on the phenomenon of awkwardness as a natural way for researchers to respond to challenging fieldwork situations. Finally, they propose and unfold mutual interviewing and cooperative analysis as methods of investigating researcher's subjectivity in facing such situations. (shrink)

Much of the current literature on plagiarism focuses on students, attempting to understand how students view the concept of plagiarism, the best ways to prevent it, and the impact of collaboration on the concept of original authorship. In this article, we look at the role of plagiarism in 761 conference abstracts written by graduate students, early- to late-career faculty, and industry representatives, representing institutions from nearly 70 countries. These abstracts were submitted for participation in an international conference focused on the (...) liberal arts hosted by our institution over the past four years. This study analyzes the corpus for patterns of plagiarism among professional academic writers. Our findings indicate that, while other demographic categories were not consistent indicators of text-matching, full professors were the most prevalent group to produce self-plagiarized abstracts. Overall, our study illuminates the significance of power dynamics in conferences’ efforts to maintain academic integrity. (shrink)

In this paper the current legislative landscape and the challenges researchers face in obtaining informed consent in acute situations are explored. In such situations, some current guidelines can be difficult or impossible to apply. Capacity should be formally assessed before consent is sought to ensure that vulnerable persons are neither inappropriately recruited to a study nor denied the opportunity to participate. However, there is little guidance in current legislation as to how this should be achieved. When the patient is considered (...) to be unable to provide prospective informed consent, other forms are sometimes permissible, although all have specific drawbacks. First, it is argued that a brief instrument, suitable for the acute situation, is needed to determine whether patients have the capacity to consent to clinical trials. Secondly, it is argued that there are areas of the informed consent process that require review, and ways that improvements could be made are suggested. (shrink)

Psycholinguistics as a discipline can be traced back further than one would think, but what we refer to as modern psycholinguistics emerged in the 1950s. The gradual accumulation of interdisciplinary knowledge, cross-linguistic research, and the development of ideas formed the foundation for new approaches. Indeed, interdisciplinarity, multi-methodology, and linguistic diversity are to this day inevitable and integral parts of psycholinguistics. The aim of this paper is to argue the interplay of different approaches and methodologies, namely in relation to syntactic processing. (...) The paper provides a general overview of former state-of-the-art and newer research trends, discusses the challenges of new approaches, and presents them in the context of a recently performed attachment preference study in Croatian. Using multiple methodologies, the study shows that Croatian is a high attachment preference language. More importantly, it illustrates the significance of a carefully planned research design and the relevance of obeying the properties of the studied language. These considerations are crucial in order to avoid that someone’s choice of theoretical framework and methods influences results. (shrink)

The present work examines the role of persuasive lexicon in legal discourse through the analysis of emotional devices at a lexical and rhetorical level. Our preliminary premise is that emotion is deployed by experts to convey the sentiment of shared values and epistemic trust: the need to rely on the tenets of the law as fair and conducive to the common good. The corpus of our study is constituted by the conclusions in their original Spanish, and their translation into English, (...) by the Advocate General Manuel Campos on the challenge by Hungary and Poland of the regulation establishing a “conditionality regime” in the event of a rule-of-law breach in a EU Member State. To this end, we undertake a two-pronged analysis of legal persuasion to find out what emotional devices are deployed to convey the rule-of-law principles of justice, non-discrimination, equality and solidarity. At a first stage, we concentrate upon the polarity and intensity of emotion words and their categories. Emotional implicatures in the shape of legal technolects and metaphorical ontologies and the way they are deployed in each text constitutes the second part of our study. Among our conclusions are that both the original and target texts have a strong persuasive character, mainly grounded in the negative emotion of fear and the positive emotion of trust, and that there are variances in the emotional language deployed in either version due to the different mechanics of each law system and to functional differences between English and Spanish. (shrink)

Background Healthcare professionals face a myriad of ethical challenges during the coronavirus disease 2019 pandemic. However, there is limited literature examining the ethical challenges faced by HCPs in low- and medium-income countries. The research was designed to explore the ethical challenges experienced by HCPs in a Malaysian hospital setting during the pandemic. Methods Semistructured interviews were conducted via video calls with 10 Malaysian HCPs across different clinical disciplines involved in managing patients diagnosed with COVID-19 infections. The calls were audio-recorded, transcribed (...) verbatim and checked. Thematic analysis with constant comparison across transcripts was carried out to identify categories and themes. Results Three main themes emerged. Firstly, there was deprioritisation of care for non-COVID-19 patients resulting from resource limitations. HCPs raised concerns that there was curtailed access to various healthcare services by non-COVID-19 patients. There was also a trade-off between protecting individual patient safety and public health interests. Secondly, patients were disempowered from decision-making; the decision to segregate suspected COVID-19 patients to high-risk areas without seeking patients’ approval may result in an increased risk of infection. Lastly, HCPs expressed internal conflicts when balancing the professional duty of care against concerns about contracting COVID-19 and spreading it to their family members. Conclusion The study highlighted ethical issues faced by HCPs in Malaysia during the pandemic. It underscores the need for clinical ethics consultation services in hospitals to navigate the various ethical dilemmas. (shrink)

BackgroundThe Arab population in Israel is a minority ethnic group with its own distinct cultural subgroups. Minority populations are known to underutilize genetic tests and counseling services, thereby undermining the effectiveness of these services among such populations. However, the general and culture-specific reasons for this underutilization are not well defined. Moreover, Arab populations and their key cultural-religious subsets (Muslims, Christians, and Druze) do not reside exclusively in Israel, but are rather found as a minority group in many European and North (...) American countries. Therefore, focusing on the Arab population in Israel allows for the examination of attitudes regarding genetic testing and counseling among this globally important ethnic minority population.MethodsWe used a qualitative research method, employing individual interviews with 18 women of childbearing age from three religious subgroups (i.e., Druze, Muslim, and Christian) who reside in the Acre district, along with focus group discussions with healthcare providers (HCPs; 9 nurses and 7 genetic counselors) working in the same geographical district.ResultsA general lack of knowledge regarding the goals and practice of genetic counseling resulting in negative preconceptions of genetic testing was identified amongst all counselees. Counselors’ objective of respecting patient autonomy in decision-making, together with counselees’ misunderstanding of genetic risk data, caused uncertainty, frustration, and distrust. In addition, certain interesting variations were found between the different religious subgroups regarding their attitudes to genetic counseling.ConclusionsThe study highlights the miscommunications between HCPs, particularly counselors from the majority ethno-cultural group, and counselees from a minority ethno-cultural group. The need for nuanced understanding of the complex perspectives of minority ethno-cultural groups is also emphasized. Such an understanding may enhance the effectiveness of genetic testing and counseling among the Arab minority group while also genuinely empowering the personal autonomy of counselees from this minority group in Israel and other countries. (shrink)

Background: Ethical challenges are common in clinical nursing practice, and an infectious environment could put nurses under ethical challenges more easily, which may cause nurses to submit to negative emotions and psychological pressure, damaging their mental health. Purpose: To examine the ethical challenges encountered by nurses caring for patients with the novel coronavirus pneumonia and to provide nurses with suggestions and support regarding promotion of their mental health. Research design and method: A qualitative study was carried out using a qualitative (...) content analysis. The participants were 18 nurses who agreed to attend an interview and describe their own experiences of providing care to COVID-19 patients in China. They were purposively sampled, and structured, in-depth interviews were performed. Data were iteratively collected and analyzed from February to March 2020. Ethical considerations: The proposal was approved by the Research Ethics Committee of the Second Hospital of Shandong University, China. Findings: The findings revealed three main themes and 10 categories. The themes were the following: ethical challenges ; coping styles ; and impacts on career. Conclusion: Nurses faced ethical challenges on multiple fronts in caring for COVID-19 patients. The results may help nurses with more safety, ethics, and humanistic care in nursing practice. (shrink)