In this paper, we discuss challenges associated with implementing a policy for Ancillary Care (AC) for related and unrelated (serious) adverse events during an Ebola vaccine trial conducted in a remote area of the Democratic Republic of the Congo. Conducting clinical trials in resourceconstrained settings can raise context-related challenges that have implications for study participants’ health and wellbeing. During the Ebola vaccine study, three participants were injured in road traffic accidents, but there were unexpected difficulties when trying to apply (...) the AC policy. First, because of the nature of the adverse events, the insurer refused to cover the costs. Second, the AC policy did not address treatments by traditional medicine, even though traditional medicines are frequently used and highly trusted in the study community. This highlighted a contrast between the researchers’ well-intentioned AC approach and the participants’ legitimate preferences. The way in which researchers should address their responsibility to provide AC is not straightforward; it requires contextualization. Our experience highlights the importance of involving community representatives and the local ethics committee to ensure development of an AC policy that is culturally and ethically appropriate. Additionally, the insurance contract should clearly stipulate which adverse events are linked to the trial participation, and thus eligible for coverage, to avoid controversies when claims are made. (shrink)

Controversies still exists within the research fraternity on the form and level of incentives, compensation and reimbursement to study participants in resource-constrained settings. While most research activities contribute significantly to advancement of mankind, little has been considered in rewarding directly the research participants from resource-constrained areas. A study was conducted in Zimbabwe to investigate views and expectations of various stakeholders on study participation incentives, compensation and reimbursement issues. Data was collected using various methods including a (...) survey of about 1,008 parents/guardians of school children participating in various immunological cohort studies and parasitology surveys. Community advisory boards (CABs) at 9 of the sites were also consulted. Further, information was gathered during discussions held at a basic research ethics training workshop. The workshop had 45 participants that including 40 seasoned Zimbabwean researchers and 5 international research collaborators. About 90% (907) of the study participants and guardians expected compensation of reasonable value, in view of the researchers' value and comparison to other sites regardless of economic status of the community. During discussion with researchers at a basic ethics training workshop, about 80% (32) believed that decisions on level of compensation should be determined by the local research ethics committees. While, the few international research collaborators were of the opinion that compensation should be in accordance with local guidelines, and incentives should be in line with funding. Both the CAB members and study participants expressed that there should be a clear distinction between study incentive and compensation accorded to individual and community expectations on benefits from studies. However, CABs expressed that their suggestions on incentives and compensation are often moderated by the regulatory authorities who cite fear of unknown concerns. Overall, both personal and community benefits need to be considered colectively in future studies to be conducted in resource-constrained communities. There is projected fear that recruitment in future may be a challenge, now that almost every community, has somehow been reached and participated in some form of studies. A major concern on reimbursement, compensation or incentives should be internationally pegged regardless of different economic status of the individuals or communities where the study is to be conducted. (shrink)

The capacity-building strategy used by a US-based research organisation, the Pacific Institute for Research and Evaluation , to strengthen the system for the protection of human research subjects and the infrastructure of its international collaborating partner, the University of Liberia, are discussed. To conduct the much-needed biomedical and social science-based research-related activities in the future, this partnership is expected by PIRE to gradually evolve over time to strengthen the capacity of the local investigators and administrators of the University of Liberia. (...) Accordingly, a unique opportunity to share technology and resources with a post-conflict, resource-constrained country is created by this partnership. This capacity-building model to strengthen the protection of human subjects in research can also be replicated in similar resource-constrained international settings and, accordingly, our experiences and limitations are shared in this paper. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Introduction:Developing Health Care in Severely Resource-Constrained SettingsPaul Farmer and Sadath SayeedThis symposium of Narrative Inquiry in Bioethics catalogues the experiences of health care providers working in resource-poor settings, with stories written by those on the frontlines of global health. Two commentaries by esteemed scholars Renee Fox and Byron and Mary-Jo Good accompany the narratives, helping situate the lived experiences of global health practitioners within the (...) frameworks of sociology and medical anthropology respectively.The burgeoning interest in global health among students, health science trainees, clinical practitioners, social entrepreneurs, philanthropists, and government officials is often linked with substantial moral claims. People working in global health often start with the rhetorical premise that each and every human being, regardless of economic, social, or political circumstances that lie beyond his or her control, deserves equal access to quality health care services. This is a bold position at risk of trivialization, in part because the sentiment is so commonplace among global health equity activists.Despite this relatively recent global outpouring of solidarity and concern, billions of poor people still lack access to basic health services. All too often, interventions that perpetuate existing trade practices and market economics are promoted, usually to the detriment of the poor. As our good friend and colleague Arthur Kleinman warns:The irrelevance of ethics can be seen when considering universal ethical formulations of justice and equity that do not begin with the local moral conditions of poor people, those experiencing the systematic injustice of higher disease rates and fewer health-care resources because of their positioning at the bottom of local social structures of power.(1999, p.72)If we are serious about reducing health disparities globally, we must be prepared to mobilize resources in Africa just as we would in the United States or in Europe. If we fetishize cost-effective (read: low-cost) interventions for the poor, we must ask whether we use the same metrics in other situations. In other words, we must always strive to address the fundamental structural and social causes of health inequity.We believe that global health must avoid the "iron cage of rationality," to use sociologist Max Weber's words. One unanticipated consequence of the growth of global health as a field is that the "audit culture"—which encourages accountability and effectiveness—can at times reinforce power differentials between donors (whether government agencies or multilateral foundations) and their intended beneficiaries. Agendas are often set not by community members but by global health leaders who rarely demonstrate sustained commitments to a local community. [End Page 73]As the guest editors of this issue, we hope to recapture the soul of global health work through the art of storytelling. Narratives, even when presented as raw and unrefined as many within this issue, remind us of the immense challenges—both programmatic and moral—involved in this work. The profound scarcity of resources available to health providers in poor countries forces ethical questions on doctors, nurses, pharmacists, social workers, and other health care workers, who make difficult choices every day about what to do with the few resources they have. These are the ethical dilemmas of mortal dramas at their most dire. Global health work demands of its practitioners an alternate mode of audit than academic methodologies can provide. Narratives return us to the basic human commitments that led many of us to this work, and they remind us to use words like equality and justice meaningfully.The narratives that follow offer unmitigated perspectives on the working lives of global health practitioners. They highlight the translation of the moral and programmatic challenges of health care delivery into real choices: for example, between a visiting surgeon's desire to treat a patient and his capacity (or really incapacity) to provide follow-up care. They acknowledge the necessity of interdisciplinary cooperation in resource-constrained settings, as well as the difficulties in collaborating across cultures and continents. Most importantly, they make the claim that a newborn in distress in a tent in Port-au-Prince merits the same resources and attention as one in Boston, and that his or her death merits the same indignation. They demonstrate the radical solidarity inherent in the... (shrink)

There is a need to increase the number of practicing medical doctors in South Africa. We examine the ethical implications of patients’ rights being affected in medical education in a South African context.The South African legal framework advocates public healthcare access. Yet, the State’s ethical obligations when it comes to guaranteeing public healthcare access, conflict with its utilitarian policy, that allows for medical education to help achieve the State’s public healthcare commitments, at the cost of eroding patients’ rights, and accepts (...) that certain actions are imperative, in line with Ubuntu, which is tenable yet nuanced. A patient treated by a licenced doctor today, benefits because other patients have allowed themselves to be used as hands-on learning material for medical students yesterday.Healthcare institutions need to take cognisance of the numbers of medical students that patients can reasonably be expected to endure. There is a need for the Health Professions Council of South Africa and medical schools to adopt guidelines on reasonable levels of medical student-patient interaction, and medical student-to-patient ratios in healthcare delivery. (shrink)

Background:While there have been studies exploring moral habitability and its impact on the work environments of nurses in Western countries, little is known about the moral habitability of the work environments of nurses and midwives in resource-constrained settings.Research objective:The purpose of this research was to examine the moral habitability of the work environment of nurses and midwives in Ghana and its influence on their moral agency using the philosophical works of Margaret Urban Walker.Research design and participants:A critical (...) moral ethnography was conducted through the analysis of interviews with 30 nurses and midwives, along with observation, and documentary materials.Ethical considerations:After receiving ethics approval, signed informed consent was obtained from participants before data collection.Results:Five themes were identified: (1) holding onto the values, identities, and responsibilities of being a midwife/nurse; (2) scarcity of resources as limiting capacity to meet caring responsibilities; (3) gender and socio-economic inequities shaping the moral-social context of practice; (4) working with incoherent moral understandings and damaged identities in the context of inter- and intra-professional relationships; and (5) surviving through adversity with renewed commitment and courage.Discussion:The nurses and midwives were found to work in an environment that was morally uninhabitable and dominated by the scarcity of resources, overwhelming and incoherent moral responsibilities, oppressive conditions, and workplace violence. These situations constrained their moral agency and provoked suffering and distress. The nurses and midwives negotiated their practice and navigated through morally uninhabitable work environment by holding onto their moral values and commitments to childbearing women.Conclusion:Creating morally habitable workplaces through the provision of adequate resources and instituting interprofessional practice guidelines and workplace violence prevention policies may promote safe and ethical nursing and midwifery practice. (shrink)

Resource constraints in developing countries compel policy makers to ration the provision of healthcare services. This article examines one such set of Guidelines: A patient dialysing in the state sector in South Africa may not refuse renal transplantation when a kidney becomes available. Refusal of transplantation can lead to exclusion from the state-funded dialysis programme. This Guideline is legally acceptable as related to Constitutional stipulations which allow for rationing healthcare resources in South Africa. Evaluating the ethical merit of the (...) Guideline, and exploring the ethical dilemma it poses, proves a more complex task. We examine the actions of healthcare professionals as constrained by the Guideline. From a best interests framework, we argue that in these circumstances directing patient decision making is not necessarily unethical or unacceptably paternalistic. We then scrutinise the guideline itself through several different ethical ‘lenses’. Here, we argue that bioethics does not provide a definitive answer as to the moral merit of rationing dialysis under these circumstances, however it can be considered just in this context. We conclude by examining a potential pitfall of the Guideline: Unwilling transplant recipients may not comply with immunosuppressive medication, which raises questions for policies based on resource management and rationing. (shrink)

Norman Daniels’ theory of justice and health faces a serious practical problem: his theory can ground the special moral importance of health and allows distinguishing just from unjust health inequalities, but it provides little practical guidance for allocating resources when they are especially scarce. Daniels’ solution to this problem is a fair process that he specifies as "accountability for reasonableness". Daniels claims that accountability for reasonableness makes limit-setting decisions in healthcare not only legitimate, but also fair. This paper assesses the (...) latter claim. Does accountability for reasonableness result in fair limit-setting decisions? It is argued that the answer to this question is not a clear yes. Daniels is remarkably unclear about the criterion of fairness that accountability for reasonableness satisfies. The paper discusses different options for resolving this lack of clarity and examines how they apply to Daniels’ accountability for reasonableness framework. It is concluded, first, that accountability for reasonableness is not a paradigm case of any of the classic notions of procedural justice; second, that what might be called "constrained pure procedural justice" best reflects how accountability for reasonableness results in fair limit-setting decisions; and third, that the procedural conditions of accountability for reasonableness must be further specified and amended to better achieve a fair process, and hence fair limit-setting decisions. (shrink)

From a simple idea to unite asset owners in their quest for responsible investment at its launch in April 2006, the United Nations supported Principles for Responsible Investment have grown in just one decade into an initiative with more than 1500 fee-paying signatories. Jointly, the PRI’s signatories hold assets worth more than $80 trillion, making it one of the more prevalent not-for-profit organizations worldwide. Furthermore, the PRI’s ambitious mission to transform the financial system at large into a more sustainable one (...) makes it a worthwhile subject of inquiry from an institutional perspective. We undertake an empirical investigation of the adoption of the PRI by asset owners during five crucial years of the association’s emergence: 2007–2011. Following a tripartite view of institutional theory proposed by Scott, we explore if regulative, normative, and cultural–cognitive factors influence an asset owner’s decision to subscribe to the PRI. Applying both parametric and non-parametric survival analysis, we find that asset owners are indeed significantly affected by normative, cultural–cognitive, and regulative aspects. In particular, public service employee and labor union pension funds from social backgrounds more culturally aligned with values represented by the RI movement with historically more voluntary legislation on environmental, social, and governance issues are most likely to sign the PRI. In contrast, institutional environments with a higher number of pre-existing mandatory ESG regulation decrease the likelihood of signing the PRI. Our results indicate that normative and cultural–cognitive factors were crucial contributors to the PRI’s growth. With respect to the regulative environments, our results imply that some asset owners may use the PRI as a collective industry initiative to substitute for mandatory legislation. Conversely, a high level of historical mandatory legislation may constrain organizational resources that could otherwise be dedicated to voluntary initiatives such as PRI. Our findings are robust to relevant controls and econometric concerns. (shrink)

BackgroundMedical researchers in resource-constrained settings must make difficult moral decisions about the provision of ancillary care to participants where additional healthcare needs fall outside the scope of the research and are not provided for by the local healthcare system. We examined research stakeholder perceptions and experiences of ancillary care in biomedical research projects in Malawi. MethodsWe conducted 45 qualitative in-depth interviews with key research stakeholders: researchers, health officials, research ethics committee members, research participants and grants officers from (...) international research funding organisations. Thematic analysis was used to analyse and interpret the findings. FindingsAll stakeholders perceived the provision of ancillary care to have potential health benefits to study participants in biomedical research. However, they also had concerns, particularly related to the absence of guidance to support it. Some suggested that consideration for ancillary care provision could be possible on a case-by-case basis but that most of the support from research projects should be directed towards strengthening the public health system, emphasising public good above individual or personal benefits. Some researchers and ethics committee members raised concerns about potential tensions in terms of funding, for example balancing study demands with addressing participants’ additional health needs.ConclusionOur findings highlight the complexities and gaps in the guidance around the provision of ancillary care in Malawi and other resource-constrained settings more generally. To promote the provision of ancillary care, we recommend that national and international guidelines for research ethics include specific recommendations for resource-constrained settings and specific types of research. (shrink)

We identify the ways the policies of leading international bioethics journals limit the participation of researchers working in the resource-constrained settings of low- and middle-income countries in the development of the field of bioethics. Lack of access to essential scholarly resources makes it extremely difficult, if not impossible, for many LMIC bioethicists to learn from, meaningfully engage in, and further contribute to the global bioethics discourse. Underrepresentation of LMIC perspectives in leading journals sustains the hegemony of Western (...) bioethics, limits the presentation of diverse moral visions of life, health, and medicine, and undermines aspirations to create a truly “global” bioethics. Limited attention to this problem indicates a lack of empathy and moral imagination on the part of bioethicists in high-income countries, raises questions about the ethics of bioethics, and highlights the urgent need to find ways to remedy this social injustice. (shrink)

Introduction Numerous guidelines and policies for ethical research practice have evolved over time, how this translates to global health practice in resource-constrained settings is unclear. The purpose of this paper is to describe how the concept of ancillary care has evolved over time and how it is included in the ethics guidelines and policy documents that guide the conduct of research in the global south with both an international focus and providing a specific example of Malawi, where (...) the first author lives and works, as a case study. Methods Discourse analysis was conducted on 34 international ethics guidelines and policy documents. Documents were purposively selected if they contained a set of key terms that reflect the concept of ancillary care. Following a process of inductive discourse analysis, five key interrelated text phrases relating to ancillary care were extracted from the documents. The evolution of these phrases over time was explored as they represented the development of the concept of ancillary care as a component of ethical health research guidance and practice. Results We found key interrelated phrases that represent discourses regarding the evolution of ancillary care including participant protection; provide care as appropriate; supererogation; patient needs prevail over science; and ancillary care as an obligation. Arguments for the provision of ancillary care were characterised by safeguarding the safety, health rights and well-being of study participants. However, despite the evolution of discourse around ethical obligations to provide ancillary care, this is rarely made explicit within guidance documents, leaving interpretive space for differential application in practice. Conclusion While there have been major changes to the ethics guidance that reflect significant evolution in the ethical conduct of research, the specific vocabulary or language used to explain the ethics of researchers' ancillary care obligations to the health needs of their research participants, lacks clarity and consistency. As a result, the concept of ancillary care continues to be under-represented in local ethical guidelines and regulations, with no clear directives for country-level research ethics committees to apply in regulating ancillary care responsibilities. (shrink)

The Global Code of Conduct for Research in Resource-Poor Settings (GCC) aims to stop the export of unethical research practices from higher to lower income settings. Launched in 2018, the GCC was immediately adopted by European Commission funding streams for application in research that is situated in lower and lower-middle income countries. Other institutions soon followed suit. This article reports on the application of the GCC in two of the first UK-funded projects to implement this new code, (...) one situated in India and one in Pakistan. Through systematic ethics evaluation of both projects, the practical application of the GCC in real-world environments was tested. The findings of this ethics evaluation suggest that while there are challenges for implementation, application of the GCC can promote equity in international research collaborations. (shrink)

When constrained by limited resources, how do we choose axioms of rationality? The target article relies on Bayesian reasoning that encounter serioustractabilityproblems. We propose another axiomatic foundation: quantum probability theory, which provides for less complex and more comprehensive descriptions. More generally, defining rationality in terms of axiomatic systems misses a key issue: rationality must be defined by humans facing vague information.

Residents with dementia in long-term care facilities (LTCFs) often receive antipsychotic (AP) medications without clear clinical indications. One non-clinical factor influencing the use of APs in LTCFs is low staff levels. Often, using APs is viewed and rationalised by healthcare professionals in LTCFs as a lesser evil option to manage low staff levels. This paper investigates the ethical plausibility of using APs as a lesser of two evils in resource-constrained LTCFs. I examine the practice vis-à-vis the three frequently (...) invoked conditions of lesser evil justifications as specified in the wider philosophical literature. These conditions include (1) the necessity condition, (2) the condition of sensitivity to both deontic (ie, constraint-based) and non-deontic (ie, outcome-based) considerations and (3) the commensurability condition. I argue that there are considerable difficulties in demonstrating that the practice in question satisfies the conditions of lesser evil justifications. In particular, there are major difficulties in satisfying the condition of sensitivity to deontic and outcome-based considerations, and the commensurability condition. I also argue that the current philosophical debate on lesser-evil justifications is not straightforwardly applicable to the practice of using APs for non-clinical purposes in LTCFs. I contend that caregivers are not so-called ‘generic’ agents, and the assumed rarity of lesser evil cases is questionable. I conclude that until further work is done to resolve these issues, the lesser evil reasoning cannot be, at least routinely, used to formulate robust moral justifications for the practice in question. (shrink)

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging (...) a site visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide. (shrink)

The South African government’s COVID-19 pandemic risk mitigation strategies significantly limited social contact, which necessitated a novel approach to existing face-to-face career guidance practices. The Grade 9 Career Guidance Project, originally developed as a group-based career development intervention, required radical adaptation into a self-directed, manualized format to offer career guidance to Grade 9 learners from low-income communities amid a global pandemic. The adaptation and continuation of the project was deemed essential as secondary school learners in low-income communities have limited career (...) guidance support. Furthermore, a close collaboration with the teachers at eight resource-constrained South African secondary schools was vital for successful implementation. To assess the success of the adaptation to a self-directed format, a mixed-methods design was employed, and Life Orientation teachers’ evaluative feedback was solicited. Favorable quantitative results were obtained; majority of teachers agreed that learners enjoyed the booklet and that it was deemed an adequate substitute to the previous contact-based format of the Career Guidance Project. This was also confirmed by the qualitative findings revealing teachers’ satisfaction with the booklet’s content, specifically that the booklet is complementary to the Life Orientation curriculum. Qualitative findings identified specific contextual barriers that contributed to some learners struggling to use the booklet optimally. The results suggest that it is feasible and acceptable to implement a self-directed career guidance intervention among secondary school learners amid a global pandemic. Teachers recommended ways to integrate the booklet, resources, and contact sessions as a preferred way forward. These findings have important implications for similar resource-constrained settings that may not have readily access to in-person career guidance and counseling human development. (shrink)

This study examines the process of knowledge transfer between a pair of social enterprises, organizations that are embedded in competing social and economic logics. Drawing on a longitudinal case study of the interaction between social enterprises operating in emerging economy settings, it uncovers factors which influence the transfer of a social innovation from a dense, population-rich setting to one where beneficiaries are geographically dispersed and the costs of service delivery are correspondingly elevated. Evidence from the case study suggests that (...) institutional bricolage—the crafting of improvised solutions in resource-constrained settings—can serve as potent driving force in driving innovation transfer, and that this process of re-combining available resources may be facilitated by the extent to which the values between partner social enterprises are aligned. With such alignment, social enterprise partners may be able to increase trust, develop a smoother knowledge-transfer process, and find practical solutions which facilitate the transfer of life-enhancing social innovations to neglected rural settings. (shrink)

The number of people in immediate need of anti‐retroviral treatment (ART) in the southern African region continues to significantly exceed the capacity of health systems there to provide it. Approaches to this complex rationing dilemma have evolved in different directions. The ethical concepts of fairness and equity have been suggested as a basis to guide the development of approaches to select patients for ART. This article reports the results of a case study on patient selection at a rural ART clinic (...) in Lesotho. The purpose of the study was to examine whether or not such concepts had relevance or operative value for a treatment team providing ART in rural Lesotho. The study found that while concepts of fairness and equity were relevant to the work of the treatment team, patient selection practices did not necessarily reflect what these concepts entail. The idea of fairness as a structured, formalized selection process did not figure in the approach to ART provision at the site. A less formal, ‘first‐come‐first‐served’ approach was adopted. While there was knowledge among some team members that social, economic or geographic conditions inhibit individuals and groups from gaining access to ART and that this was inequitable, it was felt that there was little they could do to try to mediate the impact of these conditions. The study's findings pose importance questions about the approach to ART programming in resource constrained settings. The findings also question the relevance of trying to achieve fairness and equity when the gap between need for care and capacity to provide it remains so large. (shrink)

BackgroundHealthcare ethics is neglected in clinical practice in LMICs such as Nepal. The main objective of this study was to assess the current status of knowledge, attitude and practice of healthcare ethics among resident doctors and ward nurses in a tertiary teaching hospital in Nepal.MethodsThis was a cross sectional study conducted among resident doctors and ward nurses in the largest tertiary care teaching hospital of Nepal during January- February 2016 with a self-administered questionnaire. A Cramer’s V value was assessed to (...) ascertain the strength of the differences in the variables between doctors and nurses. Association of variables were determined by Chi square and statistical significance was considered if p value was less than 0.05.ResultsOur study demonstrated that a significant proportion of the doctors and nurses were unaware of major documents of healthcare ethics: Hippocratic Oath, Nuremberg code and Helsinki Declaration. A high percentage of respondents said that their major source of information on healthcare ethics were lectures, books, and journals. Attitude of doctors and nurses were significantly different in 9 out of 22 questions pertaining to different aspects of healthcare ethics. More nurses had agreement than doctors on the tested statements pertaining to different aspects of healthcare ethics except for need of integration of medical ethics in ungraduate curricula,paternalistic attitude of doctor was disagreed more by doctors. Notably, only few doctors stood in support of physician-assisted dying.ConclusionsSignificant proportion of doctors and nurses were unaware of three major documents on healthcare ethics which are the core principles in clinical practice. Provided that a high percentage of respondents had motivation for learning medical ethics and asked for inclusion of medical ethics in the curriculum, it is imperative to avail information on medical ethics through subscription of journals and books on ethics in medical libraries in addition to lectures and training at workplace on medical ethics which can significantly improve the current paucity of knowledge on medical ethics. (shrink)

Pietraszewski's representation scheme is parsimonious and intuitive. However, internal mental representations may be subject to resource constraints that prefer more unusual systems such as sparse coding or compressed sensing. Pietraszewski's scheme may be most useful for understanding how agents communicate. Conflict may be driven in part by the complex interplay between parsimonious public representations and more resource-efficient internal ones.

Background Increase in global health research undertaken in resource poor settings in the last decade though a positive development has raised ethical concerns relating to potential for exploitation. Some of the suggested strategies to address these concerns include calls for providing universal standards of care, reasonable availability of proven interventions and more recently, promoting the overall social value of research especially in clinical research. Promoting the social value of research has been closely associated with providing fair benefits to (...) various stakeholders involved in research. The debate over what constitutes fair benefits; whether those that addresses micro level issues of justice or those focusing on the key determinants of health at the macro level has continued. This debate has however not benefited from empirical work on what stakeholders consider fair benefits. This study explores practical experiences of stakeholders involved in global health research in Kenya, over what benefits are fair within a developing world context. Methods and results We conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups. The range of benefits articulated by stakeholders addresses both micro and macro level concerns for justice by for instance, seeking to engage with interests of those facilitating research, and the broader systemic issues that make resource poor settings vulnerable to exploitation. We interpret these views to suggest a need for global health research to engage with current crises that face people in these settings as well as the broader systemic issues that produce them. Conclusion Global health research should provide benefits that address both the micro and macro level issues of justice in order to forestall exploitation. Embracing the two is however challenging in terms of how the various competing interests/needs should be balanced ethically, especially in the absence of structures to guide the process. This challenge should point to the need for greater dialogue to facilitate value clarification among stakeholders. (shrink)

BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate (...) within academic bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.MethodsWe reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.ResultsAccess to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.ConclusionAlthough in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. (shrink)

BackgroundRespecting patients’ confidentiality is an ethical and legal responsibility for health professionals and the cornerstone of care excellence. This study aims to assess health professionals’ knowledge, attitudes, and associated factors towards patients’ confidentiality in a resource-limited setting.MethodsInstitutional based cross-sectional study was conducted among 423 health professionals. Stratified sampling methods were used to select the participants, and a structured self-administer questionnaire was used for data collection. The data was entered using Epi-data version 4.6 and analyzed using SPSS, version 25. Bi-variable (...) and multivariable binary logistic regression analyses were used to measure the association between the dependent and independent variables. Odds ratio with 95% confidence intervals and P value was calculated to determine the strength of association and to evaluate statistical significance.ResultOut of 410 participants, about 59.8% with [95% CI (54.8–68.8%)] and 49.5% with [95% CI (44.5–54.5%)] had good knowledge and favorable attitude towards patents confidentiality respectively. Being male (AOR = 1.63, 95% CI [1.03–2.59]), taking training on medical ethics (AOR = 1.73, 95% CI = [1.11–2.70]), facing ethical dilemmas (AOR = 3.07, 95% CI [1.07–8.79]) were significantly associated factors for health professional knowledge towards patients’ confidentiality. Likewise, taking training on medical ethics (AOR = 2.30, 95% CI [1.42–3.72]), having direct contact with the patients (AOR = 3.06, 95% CI [1.12–8.34]), visiting more patient (AOR = 4.38, 95% CI [2.46–7.80]), and facing ethical dilemma (AOR = 3.56, 95% CI [1.23–10.26]) were significant factors associated with attitude of health professionals towards patient confidentiality.ConclusionThe findings of this study revealed that health professionals have a limited attitude towards patient confidentiality but have relatively good knowledge. Providing a continuing medical ethics training package for health workers before joining the hospital and in between the working time could be recommended to enhance health professionals’ knowledge and attitude towards patient confidentiality. (shrink)

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.

Ethics dumping is a global phenomenon involving the ‘off-shoring’of research. Research that would be prohibited, severely restrictedor regarded as highly patronizing in high-income regions is instead conducted inresource-poor settings. Twenty-eight case studies of ethics dumping were examined through inductive thematic analysis to reveal predisposing factors from the perspective of researchers from high-income regions. Six categories were agreed and further illuminated: Patronizing conduct, unfair distribution of benefits and/or burdens, culturally inappropriate conduct, double standards, lack of due diligence and lack of (...) transparency. The ultimate aim of the paper is to deepen understanding of thesehighly unethical practicesamongst academics who stand against poverty, leading to theirfurther reduction. (shrink)

Healthy Volunteers (HVs) who participate in clinical trials are a vulnerable group that deserves specific protection. We assessed the number and types of studies that involve HVs around the world and outline the methodological barriers to their analysis. We found that tens of thousands of HVs are involved every year in clinical trials in a large variety of countries and that the overwhelming majority of studies are not “first-in-human” but pharmacokinetic studies. The two cornerstones for both ethical and safe participation (...) of HVs in clinical trials are properly obtained informed consent, and a minimization of exposure to risk, in particular by avoiding concealed participation in multiple trials. To minimize the risk of exploitation of HVs and their exposure to risk, we propose ways to ensure genuine informed consent, and advocate setting up national Healthy Volunteer volunteer registries as established in France and the U.K. (shrink)

Decision-making regarding treatment for newborns with disabilities in resource-poor settings is a difficult process that can put parents and caregivers in conflict. Despite several guidelines that have helped to clarify some of the medical decision-making in Ghana, there is still no clear consensus on the specific moral criteria to be used. This article presents the case of a mother who expressed her wish that her child with Down syndrome should not have been resuscitated at birth. It explores the (...) ethical issues at stake in both her misgivings about the resuscitation and her unwillingness to consider surgical repair of an atrioventricular (AV) canal defect. Knowing that children born with Down syndrome are able to pursue life’s goals, should our treatment of complete AV canal defect in such children be considered morally obligatory, even in resource-poor settings like Ghana? (shrink)

As it seems impossible to find reliable evidence to back up hypotheses on the origin of our use of the linguistic tool in our acts of communication, I believe that we may start by pointing as accurately as possible to the processes involved, using a methodology that attempts to reach the levels of adequacy proposed by Chomsky, complemented by those suggested by David Marr. If we conclude that human communication and human language may have had different origins, we might find (...) a new perspective which opens a vast field of research. (shrink)

Background. Responsible clinical research drives the advancement of healthcare. Despite tremendous improvements in the globalresearch and development environment since the 1950s, low- and middle-income countries (LMICs) are often left behind. There are several reasons for this. Firstly, operational, social, ethical and regulatory challenges in LMICs make it difficult for researchers to conduct clinical studies in those settings in line with international requirements. Secondly, many people living in low-resource settings distrust research because some past studies have not benefited (...) the participants or the communities involved.Objectives. To present the consensus recommendations by a Council for International Organizations of Medical Sciences (CIOMS) Working Group on how to advance good-quality, ethical clinical research in resource-limited settings.Methods. CIOMS convened a Working Group of senior scientists from drug regulatory authorities, the pharmaceutical industry, publicprivate partnerships for product development, and academia.Results. This article summarises the Working Group’s report.Conclusion. The report recommendations can foster the creation of a more enabling ecosystem for clinical research and promotecollaboration between policymakers, regulators, researchers and funders. (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. (shrink)

A paediatric clinical trial conducted in a developing country is likely to encounter conditions or illnesses in participants unrelated to the study. Since local healthcare resources may be inadequate to meet these needs, research clinicians may face the dilemma of deciding when to provide ancillary care and to what extent. The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research infrastructure. The (...) model lends itself to a decision tree that can be adapted to the local context and resources so as to provide procedural guidance. This approach can help in planning and establishing organisational policies that govern the provision of ancillary care. (shrink)

ABSTRACTThe quality of medicines is generally adequately assured by manufacturers and regulatory authorities for well-resourced settings, while the implementation of existing quality standards is challenged in many low- and middle-income countries. This situation of multiple pharmaceutical standards raises the question whether it could ever be ethically justified to compromise on the quality assurance of medicines depending on what individuals, communities, or societies can afford. In this paper, we contend that ethically, any unjustified exceptions to medicines’ quality assurance represents a (...) violation of the principles of beneficence and non-maleficence. Exceptions are only acceptable in exceptional and temporary circumstances, if based on a meaningful quality risk assessment, guided by a rigorous ethical framework built on the principles of independence, technical competence, transparency, and accountability. We also discuss how such exceptional and temporary circumstances should be defined/justified.... (shrink)

In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea.

Lower respiratory tract infections are a leading cause of paediatric morbidity and mortality worldwide. Children in low-income countries are disproportionately affected. This is in large part due to limitations in healthcare resources and medical technologies. Mechanical ventilation can be a life-saving therapy for many children with acute respiratory failure. The scarcity of functioning ventilators in low-income countries results in countless preventable deaths. Some hospitals have attempted to adapt to this scarcity by using hand-bag ventilation, as either a bridge to a (...) mechanical ventilator, or until clinical improvement occurs rendering mechanical ventilation no longer necessary. In instances of hand-bag ventilation, an endotracheal tube is first placed. Family members are then asked to play the role of a ventilator, manually compressing a bag repeatedly to inflate the child’s lungs. This approach is fraught with numerous ethical challenges. A careful examination of the data and a nuanced approach to the ethical considerations are imperative. Ethical arguments in support of and in opposition to allowing parental hand-bag ventilation are explored, including the best interests of the child, the child’s right to an open future, beneficence and parental protection, legitimising substandard care, and finally, contextual concerns. An algorithmic, potentially ethically permissible approach to parental participation in manual ventilation is proposed. (shrink)

Healthcare ethics is neglected in clinical practice in LMICs such as Nepal. The main objective of this study was to assess the current status of knowledge, attitude and practi...

Background: The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods: Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective (...) clinical studies had been administered to each study participant. Results: Of the 600 participants interviewed, two thirds (64.2 %, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9 %, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7 %, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7 %, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50 % less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95 % CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions: Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care. (shrink)

The effectiveness of antiretroviral regimes (ARVs) to reduce risk of HIV transmission from mother to child and as post-exposure prophylaxis has been known for almost two decades. Recent research indicates ARVs can also reduce the risk of HIV transmission via sexual intercourse in two other ways. With pre-exposure prophylaxis (PrEP), ARVs are used to reduce risk of HIV acquisition among persons who are HIV negative and significantly exposed to the virus. With treatment as prevention (TasP), ARVs are used to reduce (...) risk of HIV transmission from persons who are already HIV positive. The development of these new prevention strategies raises a rationing problem: given the chronic shortage of ARVs for HIV-infected persons in need of treatment, is it ethically justified to allocate ARVs for PrEP and/or TasP? This article examines the intuitively appealing view that allocation of ARVs for treatment should be the highest priority, the use of ARVs for TasP should be a secondary priority, and that utilizing ARVs for PrEP would be unethical. I will argue that selective, evidence-based allocation of ARVs for prevention in certain cases could be ethically justified even when there is insufficient anti-retroviral access for all those needing it for treatment. (shrink)

The HIV/AIDS epidemic has placed increasing demands on limited paediatric intensive care services in developing countries. The decision to admit HIV infected children with Pneumocystis carinii pneumonia into the paediatric intensive care unit has to be made on the best available evidence of outcome and the ethical principles guiding appropriate use of scarce resources. The difficulty in confirming the diagnosis of HIV infection and PCP in infancy, issues around HIV counselling, and the variance in the outcome of HIV infected children (...) with PCP admitted to the PICU in African studies compound this process. Pragmatic decision making will require evaluation of at least three ethical questions: are there clinical and moral reasons for admitting HIV positive children with PCP to the PICU, should more resources be committed to caring for HIV children who require the PICU, and how can we morally choose candidates for the PICU? Those working in the PICU in HIV endemic regions need to make difficult personal decisions on effective triage of admissions of HIV infected children with PCP based on individual case presentation, availability of resources, and applicable ethical principles. (shrink)

Background Compensating participants of biomedical research is a common practice. However, its proximity with ethical concerns of coercion, undue influence, and exploitation, demand that participant compensation be regulated. The objective of this paper is to discuss the current regulations for compensation of research participants in Malawi and how they can be improved in relation to ethical concerns of coercion, undue influence, and exploitation. Main text In Malawi, national regulations recommend that research subjects be compensated with a stipend of US$10 per (...) study visit. However, no guidance is provided on how this figure was determined and how it should be implemented. While necessary to prevent exploitation, the stipend may expose the very poor to undue influence. The stipend may also raise the cost of doing research disadvantaging local researchers and may have implications on studies where income stipend is the intervention under investigation. We recommend that development and implementation of guidelines of this importance involve interested parties such as the research community and patient groups. Conclusion Compensating human research subjects is important but can also act as a barrier to voluntary participation and good research efforts. Deliberate measures need to be put in place to ensure fair compensation of research participants, avoid their exploitation and level the field for locally funded research. (shrink)

Background Caring is a core function of nurses and it confers upon them ethical obligations as ethical agents. Failure to carry out such ethical obligations raises ethical concerns. This study was not intended to explore ethical concerns, but the reported findings reveal problems which have ethical implications. This paper aims to elucidate the ethical issues inherent in the findings and propose strategies to mitigate them. Research design and methods An exploratory-descriptive qualitative design was used within a larger Action Research Study. (...) Data were collected through focus group discussions with nurse/midwives, and through exit interviews which were conducted with the women who participated in the study on their day of discharge. Six focus group discussions and thirty exit interviews were conducted, and data were analysed through thematic analysis. Participants and research context The study took place at selected maternal and child healthcare settings in Lilongwe, Malawi. The participants were nurse/midwives and women who were admitted in maternal and child healthcare settings and were purposively sampled. Ethical considerations Ethical approval was obtained from the relevant ethics committee and all ethical guidelines were followed in the conduct of the study. Findings The findings are presented under three themes which emerged from the data. The findings reveal effects of staff shortages on patient outcomes, problems experienced in low resource clinical settings and disrespectful nurse/patient communication. Conclusion The findings reveal that institutional factors constrain moral agency and patient safety is severely compromised in some of the clinical settings in Malawi which raises serious ethical concerns. (shrink)

This note is a reply to ‘On the Lumping Semantics of Counterfactuals’ by Makoto Kanazawa, Stefan Kaufmann and Stanley Peters. It shows first that the first triviality result obtained by Kanazawa, Kaufmann, and Peters is already ruled out by the constraints on admissible premise sets listed in Kratzer (1989). Second, and more importantly, it points out that the results obtained by Kanazawa, Kaufmann, and Peters are obsolete in view of the revised analysis of counterfactuals in Kratzer (1990, 2002).

Distributed cognition provides a theoretical framework for the analysis of data from socio-technical systems within a problem-solving framework. While the approach has been applied in tightly constrained activity domains, composed of well-structured problems and highly organised infrastructures, little is known about its use in other forms of activity systems. In this paper, we explore how distributed cognition could be applied in less well-constrained settings, with ill-structured problems and loosely organised resource sets, critically reflecting on this using (...) data from a field study. The findings suggest that the use of distributed cognition in an augmented form can be useful in the analysis of a wide range of activity systems in loosely coupled settings. (shrink)

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are (...) not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. (shrink)

Broadening access to both computational and educational resources is crit- ical to diffusing machine learning (ML) innovation. However, today, most ML resources and experts are siloed in a few countries and organizations. In this article, we describe our pedagogical approach to increasing access to applied ML through a massive open online course (MOOC) on Tiny Machine Learning (TinyML). We suggest that TinyML, applied ML on resource-constrained embedded devices, is an attractive means to widen access because TinyML leverages low-cost (...) and globally accessible hardware and encourages the development of complete, self-contained applications, from data collection to deployment. To this end, a collaboration between academia and industry produced a four part MOOC that provides application-oriented instruction on how to develop solutions using TinyML. The series is openly available on the edX MOOC platform, has no prerequisites beyond basic programming, and is designed for global learners from a variety of backgrounds. It introduces real-world applications, ML algorithms, data-set engineering, and the ethi- cal considerations of these technologies through hands-on programming and deployment of TinyML applications in both the cloud and on their own microcontrollers. To facili- tate continued learning, community building, and collaboration beyond the courses, we launched a standalone website, a forum, a chat, and an optional course-project com- petition. We also open-sourced the course materials, hoping they will inspire the next generation of ML practitioners and educators and further broaden access to cutting-edge ML technologies. (shrink)