Biobanking can promote valuable health research that may lead to significant societal benefits. However, collecting, storing and sharing human samples and data for research purposes present numerous ethical challenges. These challenges are exacerbated when the biobanking efforts aim to facilitate research on public health emergencies and include the sharing of samples and data between low/middle-income countries (LMICs) and high-income countries (HICs). In this article, we explore ethical challenges for COVID-19 biobanking, offering examples from two past infectious disease outbreaks in (...) LMICs where biobanking activities contributed to the perpetuation of global inequities. We focus on how the ethical imperative to promote the common good during public health emergencies can conflict with protecting the interests of biobank participants. We discuss how conducting biobank research under a waiver of informed consent during public health emergencies is ethically permissible, provided guidance is in place to prevent biopiracy and exploitation of vulnerable communities. We also highlight the need for biobank collaborations between LMICs and HICs to promote capacity building and benefit sharing. Finally, we offer guidance to promote the ethical oversight of biobanks and biobank research during the COVID-19 pandemic or other future public health emergencies. (shrink)

The rapidly expanding universe of information, media, and learning experiences available through digital technology is creating unique opportunities and vulnerabilities for children and adolescents. These issues are particularly salient during the developmental window at the transition from childhood into adolescence. This period of early adolescence is a time of formative social and emotional learning experiences that can shape identity development in both healthy and unhealthy ways. Increasingly, many of these foundational learning experiences are occurring in on-line digital environments. These expanding (...) vulnerabilities and opportunities are being further amplified for young adolescents growing up in low resourced settings around the world. Cultural and contextual factors influence access, use, and appropriation of digital technology. Further, neurobehavioral changes associated with the onset of puberty often coincide with entry into social media and more autonomous use of technology. In low-and-middle-income countries (LMICs), disparities in access, use, and appropriation of digital media can amplify prevailing economic gaps, and compound gender inequalities during early adolescence. In LMICs, adolescents are often the early adopters of mobile technology and social media platforms. While the impact of social media on the well-being, particularly mental health, of young adolescents has been a focus of research in high-income countries (HICs), much less is known about the impacts of social media use on young adolescents in LMICs. In this paper, we review what is known about the interaction between digital media and early adolescent development. We highlight crucial gaps in the evidence in LMICs; and describe some hypotheses and areas for future research to address these compelling issues. (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)

Parsa-Parsi et al bring attention to the World Medical Association (WMA) and transparency to its International Code of Medical Ethics (ICoME) revisions.1 We value their report and the revised ICoME but explain here that the ICoME cannot reflect consensus among all WMA members, or the wider medical profession, given structural and epistemic injustices that restrain low-income and middle-income country (LMIC) physicians from participating in activities such as WMA revisions. Such injustices overlook experiences and contributions of those from LMICs and (...) marginalised groups, hindering their access to and influence within medicine.2 They also undermine access to information about, and from, the WMA. Recruiting new members from, and better engaging members in, LMICs would strengthen the WMA and its influence across the medical profession, and better elevate environmental sustainability as a biomedical and bioethical concern. This would be beneficial because there is controversy among physicians, bioethicists and other stakeholders about the relevance of environmental sustainability to medicine.3 4 That its addition to the ICoME was ‘uncontentious’ hints at structural and epistemic injustices in the revision process and homogeneity of those most involved in the revisions. Based on our observations as medical educators, it appears that few medical students and physicians at our institution, and few across the Caribbean and …. (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...

In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informed consent of participants, especially those who may not be literate or have limited education. In some (...) CHIs in LMICs, researchers have attempted to address this potential concern by limiting access to literate or educated populations. In this paper, we argue that this practice is unjustified, as it does not increase the chances of obtaining valid informed consent and therefore unfairly excludes illiterate populations and populations with lower education. Instead, we recommend that investigators improve the informed consent process by drawing on existing data on obtaining informed consent in these populations and interventions aimed at improving their understanding. Based on a literature review, we provide concrete suggestions for how to follow this recommendation and ensure that populations with lower literacy or education are given a fair opportunity to protect their rights and interests in the informed consent process. (shrink)

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by social/communicative difficulties and perseverative behaviours. While research on autism has flourished recently, few studies have been conducted on the disorder in non‐Western contexts. In low‐ and middle‐income countries (LMICs), biomedical research on autism is required to better understand the needs of the population and to develop contextually appropriate interventions. However, autistic individuals are a vulnerable study population and LMICs present with various considerations. While the presentation of autism is (...) heterogeneous, stigma is a common social consequence affecting research. Drawing specifically on the South African context, the ethical intersections of these issues are discussed, along with the limitations of the current informed consent process. Community engagement is recommended as an adjunct to informed consent to ensure that biomedical research is conducted in a more inclusive way. Practical pointers are provided for implementing systematic support for conducting community engagement alongside biomedical research. (shrink)

Infertility is an unpredictable but widespread condition. While high‐income countries grapple with when, or how to cover the costs of assisted reproductive technology (ART), such as in‐vitro fertilisation (IVF), these services are generally only available to wealthy persons at private facilities in low‐ and middle‐income countries (LMICs). Although the principle of non‐interference with normal individual reproductive rights is robust, whether it is also the responsibility of collective society to provide the means (when ART applies) to achieve pregnancy, is controversial. (...) Recently, a low‐cost model was developed at a South African public institution. The target population for this model was “helpless and marginalised, childless couples”, but a new threat has arisen, namely, infertile couples who could conceivably afford private care. In the allocation of this scarce resource, we argue for a prioritarian response that first addresses the worst‐off, in order to even out unequal access imposed by sharp differences in income. (shrink)

Development-oriented funding schemes such as the UK Global Challenges Research Fund (GCRF) have opened up opportunities for collaborations between low-middle income countries (LMICs) and high-income country (HIC) researchers. In particular, funding for medical technology research has seen a rise in previously under-represented disciplines such as physics and engineering. These collaborations have considerable potential to advance healthcare in LMICs, yet can pose challenges experienced to researchers undertaking these collaborations. Key challenges include a lack of tradition of HIC/LMIC collaborations within (...) participating departments, lack of experience with development agendas, designing contextually-appropriate technologies and ensuring long-term viability of research outputs. This paper reflects on these key challenges, using the experiences of the authors on the Open Laboratory Instrumentation (OLI) project as a focalizing lens. This project was a GCRF-funded collaboration between physicists in the UK and engineers in Tanzania to develop an open-source, 3D-printed, fully-automated laboratory microscope. The paper highlights key ethics lessons learnt. (shrink)

Development-oriented funding schemes such as the UK Global Challenges Research Fund (GCRF) have opened up opportunities for collaborations between low-middle income countries (LMICs) and high-income country (HIC) researchers. In particular, funding for medical technology research has seen a rise in previously under-represented disciplines such as physics and engineering. These collaborations have considerable potential to advance healthcare in LMICs, yet can pose challenges experienced to researchers undertaking these collaborations. Key challenges include a lack of tradition of HIC/LMIC collaborations within (...) participating departments, lack of experience with development agendas, designing contextually-appropriate technologies and ensuring long-term viability of research outputs. This paper reflects on these key challenges, using the experiences of the authors on the Open Laboratory Instrumentation (OLI) project as a focalizing lens. This project was a GCRF-funded collaboration between physicists in the UK and engineers in Tanzania to develop an open-source, 3D-printed, fully-automated laboratory microscope. The paper highlights key ethics lessons learnt. (shrink)

Development-oriented funding schemes such as the UK Global Challenges Research Fund (GCRF) have opened up opportunities for collaborations between low-middle income countries (LMICs) and high-income country (HIC) researchers. In particular, funding for medical technology research has seen a rise in previously under-represented disciplines such as physics and engineering. These collaborations have considerable potential to advance healthcare in LMICs, yet can pose challenges experienced to researchers undertaking these collaborations. Key challenges include a lack of tradition of HIC/LMIC collaborations within (...) participating departments, lack of experience with development agendas, designing contextually-appropriate technologies and ensuring long-term viability of research outputs. This paper reflects on these key challenges, using the experiences of the authors on the Open Laboratory Instrumentation (OLI) project as a focalizing lens. This project was a GCRF-funded collaboration between physicists in the UK and engineers in Tanzania to develop an open-source, 3D-printed, fully-automated laboratory microscope. The paper highlights key ethics lessons learnt. (shrink)

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research to improve emergency (...) care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health. (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)

In this review, I survey theoretical accounts of exploitation in business, chiefly through the example of low wage or sweatshop labor. This labor is associated with wages that fall below a living wage standard and include long working hours. Labor of this kind is often described as self-evidently exploitative and immoral (Van Natta 1995). But for those who defend sweatshop labor as the first rung on a ladder toward greater economic development, the charge that sweatshop labor is self-evidently exploitative fails (...) adequately to explain the nature of the alleged wrongdoing. While all sides might agree that poor working conditions are unfortunate and undesirable, defenders of sweatshop labor argue that they provide the best available employment alternative for some workers and the best chance at economic development for many low and middle income countries (LMICs). Some defenders of sweatshop labor even embrace the label of exploitation. <br><br>Unless there is a clear, widely understood account by which exploitation is a moral wrong, then charging a practice as exploitative will do little to advance debates over whether and why a practice is morally problematic. A considerable body of work has been developed applying a growing literature on exploitation to sweatshop labor. While many forms of moral wrong are associated with sweatshop labor, I will focus specifically on the worry that low wages allow relatively wealthy employers wrongfully to take advantage of or gain from relatively poor workers, especially in LMICs. In particular, I will focus on instances of alleged exploitation in employment relationships that are voluntary and mutually beneficial. I have two reasons for doing so. First, by restricting this review to voluntary and mutually beneficial instances of exploitation, I can isolate the moral wrong of exploitation from other moral wrongs, especially the wrongs of coercion and outright harms to workers. Second, the focus on mutually beneficial and voluntary relationships will allow for arguments that sweatshop labor is not only not exploitative, but is a morally praiseworthy means of helping to encourage economic growth in poor areas of the world and to provide jobs that pay better and are more stable than any existing alternatives.<br><br>In this review, I aim to accomplish three goals. First, I will provide an overview of the many different uses of the charge of exploitation in business practice through an examination of the uses of the term in the literature on sweatshop labor. While it is often not clear what kind of moral wrong is assumed to take place when the charge of exploitation is used, I will demonstrate that many distinct types of exploitation, connected to distinct moral wrongs, are used in the literature on sweatshop labor and elsewhere in business ethics. Specifically, I will identify two broad categories of exploitation—exploitation as unfairness and exploitation as the mere use of others—with subgroups under each main category of exploitation. Second, I will discuss which of these senses of exploitation are defensible as identifying clear moral wrongs that take place in the context of business and, specifically, sweatshop labor. As I will argue, not all uses of the charge of exploitation are capable of persuasively identifying clear moral wrongs. Moreover, there is not a single, clear type of exploitation that takes place in business but, rather, several distinct forms. Third, I will apply the lessons learned from my exploration of exploitation in sweatshop labor to other specific areas of business. As I will argue, there are multiple viable models of exploitation in the sweatshop literature that can illuminate exploitative practices of relatively well compensated employees, customers, suppliers, and entire communities. <br><br>While discussions of theories of exploitation tend to argue for a single, correct account of this moral wrong, my review of the literature on exploitation in sweatshop labor supports the conclusion that there are multiple defensible accounts of the moral wrong of exploitation. For this reason, those who would charge that a relationship is exploitative should specify the form of exploitation that they believe is taking place. (shrink)

Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a “trial effect,” however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure—the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research—may function as a quality improvement lever, improving the quality of care and outcomes of (...) all patients within an institution or region independent of their individual participation in trials. We further contend that this “infrastructure effect” can yield particular benefits for patients in low- and middle-income countries. The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development. (shrink)

Scholarship focusing on how international research can contribute to justice in global health has primarily explored requirements for the conduct of clinical trials. Yet health systems research in low- and middle-income countries has increasingly been identified as vital to the reduction of health disparities between and within countries. This paper expands an existing ethical framework based on the health capability paradigm – research for health justice – to externally-funded health systems research in LMICs. It argues that a specific form (...) of health systems research in LMICs is required if the enterprise is to advance global health equity. “Research for health justice” requirements for priority setting, research capacity strengthening, and post-study benefits in health systems research are derived in light of the field's distinctive characteristics. Specific obligations are established for external research actors, including governments, funders, sponsors, and investigators. How these framework requirements differ from those for international clinical research is discussed. (shrink)

Collaborations in global health research are on the rise because they enhance productivity, facilitate capacity building, accelerate output and make tackling big, multifactorial research questions possible. In this paper, I examine the concepts of trust and reliance in scientific collaborations in general, but also in the particular context of collaborations in global health research between high‐income countries and low‐and‐middle income countries (LMIC). I propose and defend the argument that given the particular characteristics of collaborations and demands of trust relationships, reliance (...) is a better relational mode for successful collaborations. Although reliance can be difficult to establish in situations where asymmetry of power exists, trust should not be the only relational mode available to LMIC researchers because of the type of vulnerability it introduces to the relationship. I conclude that the promotion of good collaborations requires addressing the power imbalances between partners, and establishing an even playing field in global health research. (shrink)

To counter the imbalance in vaccine distribution during the COVID-19 pandemic, Albertsen and more recently Germaniet alhave suggested a new system of taxation coined as ‘VaxTax’ that would force higher-income countries to fund the access of low-income and middle-income countries (LMICs) to new vaccines in times of pandemic. I will argue that this idea faces numerous challenges of ethical, sociopolitical and economical nature that may hinder any effort to solve the numerous health challenges that LMICs face. I argue (...) that while it is an interesting idea, it is neither sufficient nor will it ever be easily implemented because of socioeconomic or practical reasons. (shrink)

The field of bioethics has evolved over the past half-century, incorporating new domains of inquiry that signal developments in health research, clinical practice, public health in its broadest sense and more recently sensitivity to the interdependence of global health and the environment. These extensions of the reach of bioethics are a welcome response to the growth of global health as a field of vital interest and activity. This paper provides a critical interpretive review of how the term “global health ethics” (...) has been used and defined in the literature to date to identify ethical issues that arise and need to be addressed when deliberating on and working to improve the discourse on ethical issues in health globally. Selected publications were analyzed by year of publication and geographical distribution, journal and field, level of engagement, and ethical framework. Of the literature selected, 151 articles were written by authors in high-income countries, as defined by the World Bank country classifications, 8 articles were written by authors in low- or middle-income countries, and 13 articles were collaborations between authors in HIC and LMIC. All of the articles selected except one from 1977 were published after 1998. Literature on global health ethics spiked considerably from the early 2000s, with the highest number in 2011. One hundred twenty-seven articles identified were published in academic journals, 1 document was an official training document, and 44 were chapters in published books. The dominant journals were the American Journal of Bioethics, Developing World Bioethics, and Bioethics. We coded the articles by level of engagement within the ethical domain at different levels: interpersonal, institutional, international, and structural. The ethical frameworks at use corresponded to four functional categories: those examining practical or narrowly applied ethical questions; those concerned with normative ethics; those examining an issue through a single philosophical tradition; and those comparing and contrasting insights from multiple ethical frameworks. This critical interpretive review is intended to delineate the current contours and revitalize the conversation around the future charge of global health ethics scholarship. (shrink)

Human subject trials of pharmaceuticals in low and middle income countries have been associated with the moral wrong of exploitation on two grounds. First, these trials may include a placebo control arm even when proven treatments for a condition are in use in other parts of the world. Second, the trial researchers or sponsors may fail to make a successful treatment developed through the trial available to either the trial participants or the host community following the trial.Many commentators have argued (...) that a single form of exploitation takes place during human subject research in LMICs. These commentators do not, however, agree as to what kind of moral wrong exploitation is or when exploitation is morally impermissible. In this paper, I have two primary goals. First, I will argue for a taxonomy of exploitation that identifies three distinct forms of exploitation. While each of these forms of exploitation has its critics, I will argue that they can each be developed into plausible accounts of exploitation tied to different vulnerabilities and different forms of wrongdoing. Second, I will argue that each of these forms of exploitation can coexist in single situations, including human subject trials of pharmaceuticals. This lesson is important, since different forms of exploitation in a single relationship can influence, among other things, whether the relationship is morally permissible. (shrink)

BackgroundArtificial intelligence has been described as the “fourth industrial revolution” with transformative and global implications, including in healthcare, public health, and global health. AI approaches hold promise for improving health systems worldwide, as well as individual and population health outcomes. While AI may have potential for advancing health equity within and between countries, we must consider the ethical implications of its deployment in order to mitigate its potential harms, particularly for the most vulnerable. This scoping review addresses the following question: (...) What ethical issues have been identified in relation to AI in the field of health, including from a global health perspective?MethodsEight electronic databases were searched for peer reviewed and grey literature published before April 2018 using the concepts of health, ethics, and AI, and their related terms. Records were independently screened by two reviewers and were included if they reported on AI in relation to health and ethics and were written in the English language. Data was charted on a piloted data charting form, and a descriptive and thematic analysis was performed.ResultsUpon reviewing 12,722 articles, 103 met the predetermined inclusion criteria. The literature was primarily focused on the ethics of AI in health care, particularly on carer robots, diagnostics, and precision medicine, but was largely silent on ethics of AI in public and population health. The literature highlighted a number of common ethical concerns related to privacy, trust, accountability and responsibility, and bias. Largely missing from the literature was the ethics of AI in global health, particularly in the context of low- and middle-income countries.ConclusionsThe ethical issues surrounding AI in the field of health are both vast and complex. While AI holds the potential to improve health and health systems, our analysis suggests that its introduction should be approached with cautious optimism. The dearth of literature on the ethics of AI within LMICs, as well as in public health, also points to a critical need for further research into the ethical implications of AI within both global and public health, to ensure that its development and implementation is ethical for everyone, everywhere. (shrink)

Cognitive enhancement (CE) covers a broad spectrum of methods, including behavioral techniques, nootropic drugs, and neuromodulation interventions. However, research on their use in children has almost exclusively been carried out in high-income countries with limited understanding of how experts working with children view their use in low- and middle- income countries (LMICs). This study examines perceptions on cognitive enhancement, their techniques, neuroethical issues about their use from an LMICs perspective.Seven Indian experts were purposively sampled for their expertise in (...) bioethics, child development and child education. In-depth interviews were conducted using a semi-structured topic guide to examine (1) understanding of CE, (2) which approaches were viewed as cognitive enhancers, (3) attitudes toward different CE techniques and (4) neuroethical issues related to CE use within the Indian context. All interviews were audio recorded and transcribed before thematic analysis.Findings indicate Indian experts view cognitive enhancement as a holistic positive impact on overall functioning and well-being, rather than improvement in specific cognitive abilities. Exogenous agents, and neuromodulation were viewed with skepticism, whereas behavioral approaches were viewed more favorably. Neuroethical concerns included equitable access to CE, limited scientific evidence and over-reliance on technology to address societal problems. This highlights the need for more contextually relevant neuroethics research in LMICs. (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)

What has the past reaction to the COVID-19 pandemic taught us? We have seen that many low and middle-income countries (LMICs) still lack access to vaccines, and it seems little progress has been made in the last few months and year. This article discusses whether the current strategies, most notably, vaccine donations by the international community and the COVID-19 global access facility COVAX, offer meaningful solutions to tackle the problem. At the centre of our analysis, we compare the concepts (...) of “donations” and “charity” with “vaccine equity” and the “empowerment” of poorer countries. We suggest that the achievement of fair global vaccine production requires that our global approach is supportive of the idea of empowerment. We, therefore, need structural reforms, which would most importantly include capacity building, to positively impact this goal and to take the interests of the global poor seriously. (shrink)

The year 2020 is facing one of the worst public health situations in decades. The world is experiencing a pandemic that has triggered significant challenges to healthcare systems in both high and low‐middle income countries (LMICs). Government policymakers and healthcare personnel are experiencing real‐life ethical dilemmas and are pressed to respond to these situations. Many possible treatments are being investigated, one of which is the use of hydroxychloroquine or chloroquine. These drugs are approved for use by patients with systemic (...) lupus erythematosus (SLE), rheumatoid arthritis, and malaria. The demand for these products has increased, and the stocks are depleting for the patient population for whom the drugs are intended initially. Although both innovator and generic pharmaceutical manufacturers are making plans for increased production, there are challenges with global supply chains disruption and the retention of supplies for local markets. This may cause countries that rely on the importation of pharmaceuticals to be out of stock of supplies for an extended period. There are allegations of off‐label prescribing and hoarding. Pharmacists are the custodians and dispensers of medications and are faced with the task of assessing prescriptions and making decisions about the allocation of these products. This paper seeks to 1) highlight some of the ethical challenges of dispensing hydroxychloroquine by pharmacists during the COVID‐19 pandemic, 2) identify some of the responses to these issues from various regulatory authorities in the USA, and 3) recommend approaches to assist pharmacists in their decision‐making process, especially in LMICs. (shrink)

Global health is in desperate need of greater solidarity between high-income countries (HICs) and low- and middle-income countries (LMICs) as a means to reduce the inequity that pervades all aspect...

Background The field of bioethics has evolved over the past half-century, incorporating new domains of inquiry that signal developments in health research, clinical practice, public health in its broadest sense and more recently sensitivity to the interdependence of global health and the environment. These extensions of the reach of bioethics are a welcome response to the growth of global health as a field of vital interest and activity. Methods This paper provides a critical interpretive review of how the term “global (...) health ethics” has been used and defined in the literature to date to identify ethical issues that arise and need to be addressed when deliberating on and working to improve the discourse on ethical issues in health globally. Results Selected publications were analyzed by year of publication and geographical distribution, journal and field, level of engagement, and ethical framework. Of the literature selected, 151 articles were written by authors in high-income countries, as defined by the World Bank country classifications, 8 articles were written by authors in low- or middle-income countries, and 13 articles were collaborations between authors in HIC and LMIC. All of the articles selected except one from 1977 were published after 1998. Literature on global health ethics spiked considerably from the early 2000s, with the highest number in 2011. One hundred twenty-seven articles identified were published in academic journals, 1 document was an official training document, and 44 were chapters in published books. The dominant journals were the American Journal of Bioethics, Developing World Bioethics, and Bioethics. We coded the articles by level of engagement within the ethical domain at different levels: interpersonal, institutional, international, and structural. The ethical frameworks at use corresponded to four functional categories: those examining practical or narrowly applied ethical questions; those concerned with normative ethics; those examining an issue through a single philosophical tradition; and those comparing and contrasting insights from multiple ethical frameworks. Conclusions This critical interpretive review is intended to delineate the current contours and revitalize the conversation around the future charge of global health ethics scholarship. (shrink)

Background Community advisory boards have expanded beyond high-income countries and play an increasing role in low- and middle-income country research. Much research has examined CABs in HICs, but less is known about CABs in LMICs. The purposes of this scoping review are to examine the creation and implementation of CABs in LMICs, including identifying frequently reported challenges, and to discuss implications for research ethics. Methods We searched five databases for publications describing or evaluating CABs in LMICs. Two (...) researchers independently reviewed articles for inclusion. Data related to the following aspects of CABs were extracted from included publications: time, country, financial support, research focus, responsibilities, and challenges. Thematic analyses were used to summarize textual data describing challenges. Results Our search yielded 2005 citations, 83 of which were deemed eligible for inclusion. Most studies were published between 2010 and 2017. Upper-middle-income countries were more likely to have studies describing CABs, with South Africa, China, and Thailand having the greatest numbers. The United States National Institutes of Health was the main source of financial support for CABs. Many CABs focused on HIV research. Thirty-four studies reported how CABs influenced the informed consent process for clinical trials or other aspects of research ethics. CAB responsibilities were related to clinical trials, including reviewing study protocols, educating local communities about research activities, and promoting the ethical conduct of research. Challenges faced by CABs included the following: incomplete ethical regulations and guidance; limited knowledge of science among members of communities and CABs; unstable and unbalanced power relationships between researchers and local communities; poor CAB management, including lack of formal participation structures and absence of CAB leadership; competing demands for time that limited participation in CAB activities; and language barriers between research staff and community members. Several challenges reflected shortcomings within the research team. Conclusions Our findings examine the formation and implementation of CABs in LMICs and identify several ethical challenges. These findings suggest the need for further ethics training among CAB members and researchers in LMICs. (shrink)

Medical migration appears to be an increasing global phenomenon, with complex contributing factors. Although it is acknowledged that such movements are inevitable, given the current globalized economy, the movement of health professionals from their country of training raises questions about equity of access and quality of care. Concerns arise if migration occurs from low- and middle-income countries to high-income countries. The actions of HICs receiving medical practitioners from LMICs are examined through the global justice theories of John Rawls and (...) Immanuel Kant. These theories were initially proposed by Pogge and Tan and, in this work, are extended to the issue of medical migration. Global justice theories propose that instead of looking at health needs and workforce issues within their national boundaries, HICs should be guided by principles of justice relevant to the needs of health systems on a global scale. Issues of individual justice are also considered within the framework of rights and social responsibilities of individual medical practitioners. Local and international policy changes are suggested based on both global justice theories and the ideals of individual justice. (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)

To address the burden of maternal morbidity and mortality in low‐ and middle‐income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC‐context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle‐income setting. This qualitative research used participant observation, in‐depth interviews, and (...) focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision‐making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context‐specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner. (shrink)

South Africa shared with the world the warning of a new strain of SARS-CoV2, Omicron, in November 2021. As a result, many high-income countries (HICs) instituted complete travel bans on persons leaving South Africa and other neighbouring countries. These bans were unnecessary from a scientific standpoint, and they ran counter to the International Health Regulations. In short, South Africa was penalized for sharing data. Data sharing during pandemics is commonly justified by appeals to solidarity. In this paper, we argue that (...) solidarity is, at best, an aspirational ideal to work toward but that it cannot ground an obligation to share data. Instead, low-and-middle income countries (LIMCs) should be guided by the principle of reciprocity, which states that we ought to return good for good received. Reciprocity is necessarily a conditional principle. LMICs, we argue, should only share data during future pandemics on the condition that HICs provide enforceable assurances that the benefits of data sharing will be equitably distributed and that LMICs won’t be penalized for sharing information. (shrink)

The curriculum design, faculty characteristics, and experience of implementing masters' level international research ethics training programs supported by the Fogarty International Center was investigated. Multiple pedagogical approaches were employed to adapt to the learning needs of the trainees. While no generally agreed set of core competencies exists for advanced research ethics training, more than 75% of the curricula examined included international issues in research ethics, responsible conduct of research, human rights, philosophical foundations of research ethics, and research regulation and ethical (...) review process. Common skills taught included critical thinking, research methodology and statistics, writing, and presentation proficiency. Curricula also addressed the cultural, social, and religious context of the trainees related to research ethics. Programs surveyed noted trainee interest in Western concepts of research ethics and the value of the transnational exchange of ideas. Similar faculty expertise profiles existed in all programs. Approximately 40% of faculty were female. Collaboration between faculty from low- and middleincome countries (LMICs) and high-income countries (HICs) occurred in most programs and at least 50% of HIC faculty had previous LMIC experience. This paper is part of a collection of papers analyzing the Fogarty International Research Ethics Education and Curriculum Development program. (shrink)

BackgroundHuman infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMICs) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMICs.MethodsWe conducted 6 deliberative focus groups (...) and 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members, and district health government officials.ResultsStakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to the safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example, balancing equity, safety, and relevance in inclusion criteria.ConclusionsOur findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out. (shrink)

BackgroundStreet-connected children and youth in low- and middle-income countries have multiple vulnerabilities in relation to participation in research. These require additional considerations that are responsive to their needs and the social, cultural, and economic context, while upholding core ethical principles of respect for persons, beneficence, and justice. The objective of this paper is to describe processes and outcomes of adapting ethical guidelines for SCCY’s specific vulnerabilities in LMIC.MethodsAs part of three interrelated research projects in western Kenya, we created procedures to (...) address SCCY’s vulnerabilities related to research participation within the local context. These consisted of identifying ethical considerations and solutions in relation to community engagement, equitable recruitment, informed consent, vulnerability to coercion, and responsibility to report.ResultsSubstantial community engagement provided input on SCCY’s participation in research, recruitment, and consent processes. We designed an assent process to support SCCY to make an informed decision regarding their participation in the research that respected their autonomy and their right to dissent, while safeguarding them in situations where their capacity to make an informed decision was diminished. To address issues related to coercion and access to care, we worked to reduce the unequal power dynamic through street outreach, and provided access to care regardless of research participation.ConclusionsAlthough a vulnerable population, the specific vulnerabilities of SCCY can to some extent be managed using innovative procedures. Engaging SCCY in ethical research is a matter of justice and will assist in reducing inequities and advancing their health and human dignity. (shrink)

COVID-19 continues to spread across the globe at an exponential speed, infecting millions and overwhelming even the most prepared healthcare systems. Concerns are looming that the healthcare systems in low- and middle-income countries are mostly unprepared to combat the virus because of limited resources. The problems in LMICs are exacerbated by the fact that citizens in these countries generally exhibit low trust in the healthcare system because of its low quality, which could trigger a number of uncooperative behaviors. In (...) this paper, we focus on one such behavior and investigate the relationship between trust in the healthcare system and the probability of potential treatment-seeking behavior upon the appearance of the first symptoms of COVID-19. First, we provide motivating evidence from a unique national online survey administered in Armenia–a post-Soviet LMIC country. We then present results from a large-scale survey experiment in Armenia that provides causal evidence supporting the investigated relationship. Our main finding is that a more trustworthy healthcare system enhances the probability of potential treatment-seeking behavior when observing the initial symptoms. (shrink)

What has the past reaction to the COVID-19 pandemic taught us? We have seen that many low and middle-income countries (LMICs) still lack access to vaccines, and it seems little progress has been made in the last few months and year. This article discusses whether the current strategies, most notably, vaccine donations by the international community and the COVID-19 global access facility COVAX, offer meaningful solutions to tackle the problem. At the centre of our analysis, we compare the concepts (...) of “donations” and “charity” with “vaccine equity” and the “empowerment” of poorer countries. We suggest that the achievement of fair global vaccine production requires that our global approach is supportive of the idea of empowerment. We, therefore, need structural reforms, which would most importantly include capacity building, to positively impact this goal and to take the interests of the global poor seriously. (shrink)

BackgroundBiobanks have recently been established in several low- and middle-income countries in the Arab region of the Middle East. We aimed to explore the views of biobank managers regarding the challenges, ethical issues, and governance arrangements of their biobanks.MethodsIn-depth semi-structured qualitative interviews were conducted with a purposive sample of eight biobank managers from Egypt, Jordan, and Sudan. Interviews were performed either face-to-face, by phone, or via Zoom and lasted approximately 45–75 min. After verbal consent, interviews were recorded and then transcribed. (...) The authors performed a thematic analysis of the transcripts independently and then integrated the themes via a consensus process.ResultsBiobank managers discussed the main challenges in establishing their biobanks. These included the staff’s lack of experience and training, limited funds, deficit awareness of biobanks, obtaining funding from different sources. Only four reported they were active in distributing biospecimens and health data to researchers. Six biobanks used a broad consent model, one used tiered consent, and another allowed participants to opt-out of being recontacted. Five managers avoided partnerships with pharmaceutical companies due to concerns with unfavorable reactions from the community. Five managers did not have clear policies for returning research results to the donors. Five expressed challenges with sample and data sharing with international collaborators; all five used material transfer agreements. The biobank managers revealed variable governance arrangements and activities with community involving awareness and educational efforts rather than active engagement. Several expressed the importance of transparency with the operations of their biobanks and gaining the trust of their stakeholders.ConclusionManagers of biobanks in LMICs in the Arab Middle East encounter financial, operational, and social challenges toward their sustainability efforts. Discussions with key stakeholders are warranted to manage ethical issues involving informed consent, privacy, data sharing, and the return of results. We recommend that biobank managers in the Arab Middle East form collaborative networks within the region and internationally, develop trusting governance relationships with their stakeholders, and pursue engagement activities with their communities to enhance trust. (shrink)

The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries perceive as the (...) key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants’ vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster setting over and above those typically encountered in global health research to achieve meaningful community engagement. Disaster research presents distinctive ethical considerations that require attention to ensure that participants are protected. As RECs review disaster research protocols, they should address these concerns and consider how justification, vulnerability, security and confidentially, and community engagement are shaped by the realities of conducting research in a disaster. (shrink)

The emergence of predatory journals is a global threat for scientific integrity, particularly in under-resourced settings such as low- and middle-income countries (LMICs). A bilingual course on predatory publishing using a distance education approach was developed for Moroccan researchers as a response to the imperative need for training on research ethics to implement good scientific practices. A cross-sectional survey-based study was conducted to evaluate outcomes after delivering two education sessions in both French and English. Before this course, 40% of (...) participants indicated that they don’t verify journal quality before manuscript submission and most of them consider Scopus indexing and the impact factor as the best criteria for journal publication. Approximately 50% of surveyees did not have previous information on predatory journals before the webinar. Pressure to publish by supervisors, institutions of affiliation, or funding agencies, was noticed in 43.4% of participants. After the webinar course was delivered, remarkably, the proportion of participants with knowledge on predatory publishing was meaningfully increased from 48.9% to 81%. Importantly, 83.7% of participants indicated that they are motivated to share their new knowledge on predatory publishing with their colleagues. Moreover, the majority of respondents (73.8%) reported that publishing their research in predatory journals may damage their career and professional future. Promisingly, nearly a half or more of participants recommended the use of training based on distance education, surveillance of researchers by their mentors and affiliations, and social networks to increase awareness on predatory publishing. Almost all participants were satisfied with the content of the webinar. Trainers and research institutions in LMICs should benefit from the advent of distance education using webinar platforms to increase awareness on the issue of predatory publishing in their settings. (shrink)

continent. 2.1 (2012): 2–5 To begin with, as we understand from a remote place like Seoul, there have been two different conceptions of materiality in the Western experimental ?lm history: materiality of cinema and of ?lm. The former has been represented by the practitioners of the so-called the “Expanded Cinema” and the latter by the tradition of the “Hand-made” ?lm. Whereas for the Expanded Cinema, the materiality or the “medium-speci?city” includes not only the ?lm material but also the entire condition (...) and environment in which the cinematic experience is situated (i.e.: screen, projector, audience and theatre); for the Hand-made ?lm, it is the whole ?lmic process prior to the screening in front of the audience (i.e.: hand-processing and optical-printing). The two practices share in the materialist turn that opens up the radical possibilities of aesthetic (and even political) interventions into a process previously considered seamless and transparent. What can be called to attention through the materialist turn includes the aesthetic-institutional process in the projection-spectator relation and the (non-) representational process in ?lm-making. Moreover, these interventions bring their own temporalities back to those processes, and this returning emancipates the temporalities from their subordination to the cinema-as-commodity. Hangjun Lee is a ?lm-based artist whose practice is concerned with Hand-made Film and Experimental Cinema. Given these interests, Lee questions the linkage between materiality and temporality. This was his preoccupation around 2006, the time at which he started to collaborate with Chulki Hong, the noise improviser. The improvisational nature of their audio-visual performances opened means of detouring from the conventional editing techniques. Their collaboration also afforded critical investigations into the performativity of the practices in both the darkroom and the screening room, as well as in the private recording/practicing studio, and public performance spaces for the improvising musician. In fact, it was a kind of common interest shared by both us from the outset. In our collaboration, we avoid sacri?cing/concealing/minimizing one form of performativity (the performative nature and temporality of compositional process) for the sake of the other (i.e. those in improvisational and executional process). In the ?eld of experimental music and sound, this kind of approach has been comprehensively called “cracking” or “hacking”. The concepts are ?nely formulated in the coinage of “Cracked Everyday Electronics” (by Voice Crack) or more generally “Handmade Electronic Music” (by Nicolas Collins). 1 And this was a pure but perhaps necessary coincidence. the original title of the work of our collaboration and, retrospectively, of the set of our working principles at the same time, “The Cracked Share” was named by Lee after Georges Bataille’s masterwork, The Accursed Share , with the substitution of the adjective with “Cracked” as a synonym for ‘reticulated’ in the photographic image. We think the ascetic and subtractive aesthetic turn of the contemporary non-idiomatic improvised (and even somewhat non-improvised) music 2 pushed us further towards more radical dissociation with the empty temporality of commodi?ed audio-visual experience. It can be called the aesthetics of “without,” and exemplars include Yoshihide Otomo’s Turntable Without Records , Sachiko M’s Sampler without Samples . There are also other radical experiments even with the (non-)improvised music without noise and sounds that neatly meet the rules and idioms of the existing/established experimental music. For us, this thread among the experimental music currents weighs in its emphasis on subtractive and dissociational power unique to improvisational action. Surely, the tradition of the Cracked and Handmade improvised music teaches us the crucial lesson that “[m]edia and mediation are never transparent” and that “[m]ediation actively transforms data from one form to another and is never passive.” 3 We couldn’t agree to this statement more. However, without the removal and withdrawal power of improvisation that poses and keeps both subjects (performer and audience) and objects (projector and instrument) in “inferiority,” 4 generalized cracking and hacking practices—or simply “glitch”—in music and visuals would be either sublimated into the mystical and ritualistic forms of “Film Alchemy” and “Noise Music” (to which both of us still strongly feel a belonging but also, more or less, ambivalent sentiments), or else assimilated into the logic of the commodi?ed audio-visual communication. Today in music, this principle of improvisational performativity should be formulated as the dis-organization of sound against the associational de?nition of (electronic) music and it needs to be translated into audio-visual experiences. In other words, cracking practices of free improvisation need not be limited in artistic creativity, in a darkroom, in a studio, or on the stage; the principle of the dis-organization of sound should be the principle of dis-organization (or cracked organization) of audio-visual performance space itself. NOTES 1) Norbert Möslang, “How Does a Bicycle Light Sound?: Cracked Everyday Electronics,” Leonardo Music Journal 14 (2004): 83; Nicolas Collins, Handmade Electronic Music: The Art of Hardware Hacking (New York: Rutledge, 2006). 2) We refer this not to the historical style or genre but rather the idea and practice that ?free improvisation? stands for. On the distinction between idiomatic and non-idiomatic improvisation, see Derek Bailey, Improvisation: Its Nature and Practice in Music (Cambridge, MA: Da Capo, 1993). On radically politico-histrorical interpretations of free improvisation and noise music from various present viewpoints, see Noise and Capitalism , (eds.) Mattin & Anthony Iles (Arteleku Audiolab, 2009). 3) Caleb Kelly, Cracked Media: The Sound of Malfunction (Cambridge: MIT Press, 2009), p. 29. 4) I borrow the term from my long-time collaborator, Choi Joonyong. See Ryu Hankil, Hong Chulki & Choi Joonyong, Inferior Sounds (Balloon and Needle, CD, 2011). (shrink)

Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role and form of (...) information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. We conducted a qualitative study on the role of information sharing and governance processes for inpatient data re-use, using in-depth interviews with 34 health stakeholders at two public hospitals on the Kenyan coast, including health managers, providers and researchers. Data were collected between March and July 2016 and analysed using a framework approach, with Nvivo 10 software to support data management. Most forms of clinical data re-use were seen as an important public health good. Individual consent and general notification processes were often argued as important, but contingent on interrelated influences of the type of data, use and secondary user. Underlying concerns were linked to issues of patient privacy and autonomy; perceived risks to trust in health systems; and fairness in how data would be used, particularly for non-public sector re-users. Support for engagement often turned on the anticipated outcomes of information-sharing processes, as building or undermining trust in healthcare systems. As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs. (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...

Post-abortion care research is increasingly being conducted in low- and middle-income countries to help reduce the high burden of unsafe abortion. This study aims to help address the evidence gap about ethical challenges that researchers in LMICs face when carrying out PAC research with adolescents. Employing an explorative qualitative approach, the study identified several ethics challenges encountered by PAC researchers in Zambia, including those associated with seeking ethics and regulatory approvals at institutional and national levels. Persistent stigma around abortion (...) and community perceptions that PAC studies encourage adolescents to seek abortion affected adolescents’ right to exercise their autonomy and to make decisions as well as exposed adolescents to social stigmatization risks. Challenges with recruitment was reported to result in abandoning of studies, thereby undermining development of PAC services that are more responsive to adolescent needs. Training needs identified included knowledge of best practices for conducting and disseminating PAC research. Strategies for addressing the ethical challenges included trust building and using less value-laden terminology when seeking permission and consent. It is essential to the future of PAC research in Zambia and globally that these important challenges be addressed through the development of comprehensive ethics guidance. (shrink)

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of the (...) Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ health research ethics committees in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs. (shrink)

The governance of pharmaceutical medicines entails complex ethical decisions that should, in theory, be the responsibility of democratically accountable government agencies. However, in many Low- and Middle-Income Countries (LMICs), regulatory and health systems constraints mean that many people still lack access to safe, appropriate and affordable medication, posing significant ethical challenges for those working on the “front line”. Drawing on 18 months of fieldwork in Ghana, we present three detailed case studies of individuals in this position: an urban retail (...) pharmacist, a rural over-the-counter medicine retailer, and a local inspector. Through these case studies, we consider the significant burden of “ethical labour” borne by those operating “on the ground”, who navigate complex moral, legal and business imperatives in real time and with very real consequences for those they serve. The paper ends with a reflection on the tensions between abstract, generalised ethical frameworks based on high-level principles, and a pragmatic, contingent ethics-in-practice that foregrounds immediate individual needs – a tension rooted in the gap between the theory and the reality of pharmaceutical governance that shifts the burden of ethical labour downwards and perpetuates long-term public health risks. (shrink)

BackgroundDescriptive studies examining publication rates and citation counts demonstrate a geographic skew toward high-income countries (HIC), and research from low- or middle-income countries (LMICs) is generally underrepresented. This has been suggested to be due in part to reviewers’ and editors’ preference toward HIC sources; however, in the absence of controlled studies, it is impossible to assert whether there is bias or whether variations in the quality or relevance of the articles being reviewed explains the geographic divide. This study synthesizes (...) the evidence from randomized and controlled studies that explore geographic bias in the peer review process.MethodsA systematic review was conducted to identify research studies that explicitly explore the role of geographic bias in the assessment of the quality of research articles. Only randomized and controlled studies were included in the review. Five databases were searched to locate relevant articles. A narrative synthesis of included articles was performed to identify common findings.ResultsThe systematic literature search yielded 3501 titles from which 12 full texts were reviewed, and a further eight were identified through searching reference lists of the full texts. Of these articles, only three were randomized and controlled studies that examined variants of geographic bias. One study found that abstracts attributed to HIC sources elicited a higher review score regarding relevance of the research and likelihood to recommend the research to a colleague, than did abstracts attributed to LIC sources. Another study found that the predicted odds of acceptance for a submission to a computer science conference were statistically significantly higher for submissions from a “Top University.” Two of the studies showed the presence of geographic bias between articles from “high” or “low” prestige institutions.ConclusionsTwo of the three included studies identified that geographic bias in some form was impacting on peer review; however, further robust, experimental evidence is needed to adequately inform practice surrounding this topic. Reviewers and researchers should nonetheless be aware of whether author and institutional characteristics are interfering in their judgement of research. (shrink)

The COVID‐19 pandemic has raised important universal public health challenges. Conceiving ethical responses to these challenges is a public health imperative but must take context into account. This is particularly important in sub‐Saharan Africa (SSA). In this paper, we examine how some of the ethical recommendations offered so far in high‐income countries might appear from a SSA perspective. We also reflect on some of the key ethical challenges raised by the COVID‐19 pandemic in low‐income countries suffering from chronic shortages in (...) health care resources, and chronic high morbidity and mortality from non‐COVID‐19 causes. A parallel is drawn between the distribution of severity of COVID‐19 disease and the classic “Fortune at the bottom of the pyramid” model that is relevant in SSA. Focusing allocation of resources during COVID‐19 on the ‘thick’ part of the pyramid in Low‐to‐Middle Income Countries (LMICs) could be ethically justified on utilitarian and social justice grounds, since it prioritizes a large number of persons who have been economically and socially marginalized. During the pandemic, importing allocation frameworks focused on the apex of the pyramid from the global north may therefore not always be appropriate. In a post‐COVID‐19 world, we need to think strategically about how health care systems can be financed and structured to ensure broad access to adequate health care for all who need it. The root problems underlying health inequity, exposed by COVID‐19, must be addressed, not just to prepare for the next pandemic, but to care for people in resource poor settings in non‐pandemic times. (shrink)

In response to commentators, we argue that whether waiving patent rights will meaningfully improve access to COVID-19 vaccines for low income and middle-income countries (LMICs), particularly in the short term, is an empirical matter. We also reject preferentially allocating vaccines to countries that hosted trials because doing so unethically favours those with research infrastructure, rather than those facing the worst burdens from COVID-19.