Amidst growing global endorsements of new biomedical HIV prevention strategies, ARV-based pre-exposure prophylaxis (ARV PrEP) has garnered considerable attention as a potentially promising prevention strategy. Though it may offer more effective protection for certain at-risk groups than conventional prevention strategies (such as sexual partner reduction, condom use, and prevention of mother-to-child transmission), PrEP is more costly. PrEP requires more ongoing contact between individuals and providers, and a level of surveillance from the health system that is not necessary with other preventive (...) measures. In this sense, it represents a new bio-technology for HIV prevention that poses particular challenges for worldwide implementation, given developing countries’ struggling health systems and incomplete HIV treatment programs. Since the emergence of PrEP has stimulated ethical discussions premised on incomplete knowledge of efficacy and implementation, this paper explores the ethical parameters of a likely scenario for PrEP usage in a single, resource-poor country. We first develop a plausible model for PrEP deployment and utilization based on current PrEP research, while carefully considering the reigning institutional values of feasibility and effectiveness in global health approaches. Drawing on ethnographic research of HIV treatment and prevention approaches in Lesotho, we address ethical questions arising from this scenario of PrEP delivery. Lesotho presents a compelling and emblematic case study of PrEP's potential successes and pitfalls in a developing country, given the country's high HIV prevalence, struggles to achieve universal access to HIV treatment regimes, continued existence of stigma around the epidemic, and difficulties in addressing persistent social inequalities that fuel infections. (shrink)

Chapter i The study of moral judgement The contemporary scene We are witnessing today a dramatic growth of interest in the processes of giving moral ...

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

Amidst growing global endorsements of new biomedical HIV prevention strategies, ARV‐based pre‐exposure prophylaxis (ARV PrEP) has garnered considerable attention as a potentially promising prevention strategy. Though it may offer more effective protection for certain at‐risk groups than conventional prevention strategies (such as sexual partner reduction, condom use, and prevention of mother‐to‐child transmission), PrEP is more costly. PrEP requires more ongoing contact between individuals and providers, and a level of surveillance from the health system that is not necessary with other preventive (...) measures. In this sense, it represents a new bio‐technology for HIV prevention that poses particular challenges for worldwide implementation, given developing countries’ struggling health systems and incomplete HIV treatment programs. Since the emergence of PrEP has stimulated ethical discussions premised on incomplete knowledge of efficacy and implementation, this paper explores the ethical parameters of a likely scenario for PrEP usage in a single, resource‐poor country. We first develop a plausible model for PrEP deployment and utilization based on current PrEP research, while carefully considering the reigning institutional values of feasibility and effectiveness in global health approaches. Drawing on ethnographic research of HIV treatment and prevention approaches in Lesotho, we address ethical questions arising from this scenario of PrEP delivery. Lesotho presents a compelling and emblematic case study of PrEP's potential successes and pitfalls in a developing country, given the country's high HIV prevalence, struggles to achieve universal access to HIV treatment regimes, continued existence of stigma around the epidemic, and difficulties in addressing persistent social inequalities that fuel infections. (shrink)

Background Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis) in southern Ethiopia. Methodology/Principal Findings We adapted (...) a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO) working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent. Conclusions Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis. (shrink)

BackgroundGenome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS is taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.DiscussionWe explore ethical (...) issues in three key areas: protecting the interests of research participants, regulation of international collaborative genomics research and protecting the interests of scientists in low income countries. With regard to participants, important challenges are raised about community consultation and consent. Genomics research raises ethical and governance issues about sample export and ownership, about the use of archived samples and about the complexity of reviewing such large international projects. In the context of protecting the interests of researchers in low income countries, we discuss aspects of data sharing and capacity building that need to be considered for sustainable and mutually beneficial collaborations.SummaryMany ethical issues are raised when genomics research is conducted on populations that are characterised by lower average income and literacy levels, such as the populations included in MalariaGEN. It is important that such issues are appropriately addressed in such research. Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics is embedded in the design and implementation of such research projects. (shrink)

Originally published in 1969 this book analyzes the development of moral judgement in children and adolescents. Interviews were held with 360 children aged 7 to 17, with equal numbers of either sex. Original visual devices were planned to elicit judgements in moral areas known to be of universal significance, such as the value of life, cheating, stealing and lying. In addition, analyses of concepts of reciprocity, of the development of conscience and of specificity in moral judgement were derived from the (...) tests. The book inlcudes a critical survey of previous work in this field and places the research in its wider philosophical, psychological and sociological context. (shrink)

This open access casebook addresses complex and important ethical challenges arising when health-related research in conducted in the context of epidemics and pandemics. This book provides contextually-rich real-world case studies illustrating research ethics issues encountered by researchers, ethics reviewers and regulators around the globe during the COVID-19 pandemic. The accompanying commentaries outline relevant conceptual approaches and ethical considerations. These promote understanding and reflection on relevant ethical issues, ethical approaches and competing considerations in a manner supporting thoughtful evaluation of their implications (...) for practice. As such the casebook is relevant to academic and professional audiences with an interest in global health, research ethics, and outbreaks and epidemics. (shrink)

Consideration of the experimental activities carried out in one discipline, through the lens of another, can lead to novel insights. Here, we comment from a biological perspective upon experiments in quantum mechanics proposed by physicists that are likely to feasible in the near future. In these experiments, an entire living organism would be knowingly placed into a coherent quantum state for the first time, i.e. would be coerced into demonstrating quantum phenomena. The implications of the proposed experiment for a biologist (...) depend to an extent upon the outcomes. If successful, then the organism will have been temporarily in a state where it has an unmeasurable metabolism—not because a metabolic rate is undetectable, but because any attempt to measure it would automatically bring the organism out of the state. We argue that this would in essence represent a new category of cryptobiosis. Further, the organism would not necessarily retain all of the characteristics commonly attributed to living systems, unlike the currently known categories of cryptobiosis. If organisms can survive having previously been in a coherent state, then we must accept that living systems do not necessarily need to remain in a decoherent state at all times. This would be something new to biologists, even if it might seem trivial to physicists. It would have implications concerning the physical extremes organisms can tolerate, the search for extraterrestrial life, and our philosophical view of animation. (shrink)

BackgroundThe consent process for a genetic study is challenging when the research is conducted in a group stigmatized because of beliefs that the disease is familial. Podoconiosis, also known as 'mossy foot', is an example of such a disease. It is a condition resulting in swelling of the lower legs among people exposed to red clay soil. It is a very stigmatizing problem in endemic areas of Ethiopia because of the widely held opinion that the disease runs in families and (...) is untreatable. The aim of this study was to explore the impact of social stigma on the process of obtaining consent for a study on the genetics of podoconiosis in Southern Ethiopia.MethodsWe adapted a rapid assessment tool validated in The Gambia. The methodology was qualitative involving focus-group discussions (n = 4) and in-depth interviews (n = 25) with community members, fieldworkers, researchers and staff of the Mossy Foot Treatment and Prevention Association (MFTPA) working on prevention and treatment of podoconiosis.ResultsWe found that patients were afraid of participation in a genetic study for fear the study might aggravate stigmatization by publicizing the familial nature of the disease. The MFTPA was also concerned that discussion about the familial nature of podoconiosis would disappoint patients and would threaten the trust they have in the organization. In addition, participants of the rapid assessment stressed that the genetic study should be approved at family level before prospective participants are approached for consent. Based on this feedback, we developed and implemented a consent process involving community consensus and education of fieldworkers, community members and health workers. In addition, we utilized the experience and established trust of the MFTPA to diminish the perceived risk.ConclusionThe study showed that the consent process developed based on issues highlighted in the rapid assessment facilitated recruitment of participants and increased their confidence that the genetic research would not fuel stigma. Therefore, investigators must seek to assess and address risks of research from prospective participants' perspectives. This involves understanding the issues in the society, the culture, community dialogues and developing a consent process that takes all these into consideration. (shrink)

Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrolment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study.

This paper questions an exclusively state-centred framing of global health justice and proposes a multilateral alternative. Using the distribution of COVID-19 vaccines to illustrate, we bring to light a broad range of global actors up and down the chain of vaccine development who contribute to global vaccine inequities. Section 1 (Background) presents an overview of moments in which diverse global actors, each with their own priorities and aims, shaped subsequent vaccine distribution. Section 2 (Collective action failures) characterises collective action failures (...) at each phase of vaccine development that contributed to global vaccine disparities. It identifies as critical the task of establishing upstream strategies to coordinate collective action at multiple stages across a range of actors. Section 3 (A Multilateral model of global health governance) takes up this task, identifying a convergence of interests among a range of stakeholders and proposing ways to realise them. Appealing to a responsibility to protect (R2P), a doctrine developed in response to human rights atrocities during the 1990s, we show how to operationalise R2P through a principle of subsidiarity and present ethical arguments in support of this approach. (shrink)

Since January 2016, the Mahidol Oxford Tropical Medicine Research Unit has trialled a data-sharing policy where requests to access research datasets are processed through a Data Access Committee. In this paper, we share our experiences establishing data management systems and data-sharing infrastructure including a data-sharing policy, data access committee and related procedures. We identified a number of practical and ethical challenges including requests for datasets collected without specific or broad consent to data sharing and requests from pharmaceutical companies for data (...) to support drug registration applications. We also encountered significant resource constraints which required the development of appropriate human resources and infrastructure. We suggest a research agenda to promote responsible and equitable data sharing while safeguarding the rights and interests of research participants and researchers. (shrink)

Objective: To determine the views of people with multiple sclerosis (MS) and professionals in relation to confidentiality, consent and access to data within a proposed MS register in the UK. Design: Qualitative study using focus groups (10) and interviews (13). Setting: England and Northern Ireland. Participants: 68 people with MS, neurologists, MS nurses, health services management professionals, researchers, representatives from pharmaceutical companies and social care professionals. Results: People with MS expressed open and altruistic views towards the use of their personal (...) information to facilitate service provision and research, placing trust in responsible guardianship and legitimate use of their information. Participant’s proposed that people with MS should be able to select their individual level of involvement in a register using levels of consent. It was agreed that access to the register should be governed by a guardianship committee composed of a range of stakeholders. People with MS did not wish their details to be used by marketing agencies and did not consider this a legitimate use of their data. Whilst participants were positive of the role a register could play in promoting research, participants felt that access to data by pharmaceutical industries should be administered by the guardianship committee. People with MS are concerned should their employers be able to access their personal information. Professionals were more cautious than people with MS in their approach to the use of patient personal data within a register. Conclusions: Whilst all stakeholders were positive of the benefits of an MS register, development of such a resource must incorporate robust data security and guardianship measures in order to ensure that, whilst opportunities are maximised, risks to the privacy of individuals and legal challenges to professionals are avoided. (shrink)

Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data sharing policy and broad consent (...) to data sharing in January 2016. Between February and August 2017 qualitative data were collected at two sites, Bangkok and the Thai-Myanmar border town of Mae Sot. We conducted eighteen semi-structured interviews. We also conducted four focus group discussions with a total of nineteen people. Descriptive and thematic coding informed analysis of aspects of data sharing that are considered most important to inform participants about, and the best ways to explain complex and abstract topics relating to data sharing. The findings demonstrated that clinical trial participants prioritise information about the potential benefits and harms of data sharing. Stakeholders made multiple suggestions for clarifying information provided about data sharing on such topics. There was significant variation amongst stakeholders’ perspectives about how much information should be provided about data sharing, and it was clear that effective information provision should be responsive to the study, the study population, the individual research participant and the research context. Effectively communicating about data sharing with research participants is challenging in practice, highlighting the importance of robust and effective data sharing governance in this context. Broad consent should incorporate effective and efficient explanations of data sharing to promote informed decision-making, without impeding research participants’ understandings of key aspects of the research from which data will be shared. Further work is required to refine both the development of core information about data sharing to be provided to all research participants, and appropriate solutions for context specific-challenges arising when explaining data sharing. (shrink)

It is some 900 years before Christ that we find the most ancient traces of two innovations which were to have incalculable consequences for the future of mankind. The evolution of civilization has, in fact, been marked by a clean break located at the era when man discovered the rudiments of agriculture and animal husbandry and began to produce his own food. Whereas for the three million years during which he had to provide for his needs exclusively through hunting, fishing (...) and gathering, his progress was extremely slow, the adoption of a new way of life based on agriculture and animal husbandry allowed man to transform himself in less than twelve thousand years from deer hunter into astronaut. (shrink)

In this paper we study the variety of order Hilbert algebras, which is the equivalent algebraic semantics of the order implicational calculus of Bull.

Leitch speaks of his procedure with my work as employing an "abrupt asyndetic format" and as being "a metonymic montage in which themes and citations are playfully and copiously combined." One form of this playfulness is the panoply of figures he uses to describe me and my criticism. The need to use figures for this is interesting, as is their incoherence, though the figures can be shown to fall into a rough antithetical pattern. At one moment the deconstructive critic is (...) a fairy godmother able to turn the pumpkin of the Western tradition into a phantasmal coach. He is a magician or wizard who shows that things are not what they have seemed with the great texts of our tradition or who turns them into something other than what they have seemed solidly to be, pragmatic pumpkins, unequivocally there. At the next moment the deconstructer is a disco dancer, moving sideways in the "lateral dance of interpretation" . The more or less benign fairy godmother and dancer then turns into a "nihilistic magician - who dances demonically upon the broken and scattered fragments of the Western tradition." He becomes a ferocious shaman, "Ravening, raging, and uprooting that he may come/Into the desolation of reality" . He is "a bull-deconstructer loose in the china shop of Western tradition" . In the next moment the bull metamorphoses into a lamb, as Leitch realizes the conservative aspects of deconstruction, the way it claims to be rescuing and preserving aspects of our culture which have always been there, both in literary and philosophical works and in the techniques of interpreting them. The same point is made more sharply and critically by William E. Cain in another recent essay on my work . In the final paragraph of his essay, Leitch has fun inventing permutations of an image of sand in the salad from one of my essays. Will deconstruction sandblast the whole shebang, or will the alien grain of sand turn into a pearl of price? J. Hillis Miller is Frederick W. Hilles Professor of English at Yale. His previous contributions to Critical Inquiry are "Ariadne's Thread: Repetition and the Narrative Line" and "The Critic as Host". (shrink)

An attractively bound volume bringing together four previously published works--101 Zen Stories, The Gateless Gate, 10 Bulls, and Centering. The book contains accounts of Zen experiences, parables, thought problems, and epigrammatic Zen teachings.--P. J.

This is a collection of papers read at an international logic colloquium held at Oxford in 1963. The first half contains articles on intuitionistic and modal logics, the propositional calculus, and languages with infinitely long expressions by such logicians as Kripke, Bull, Harrop, and Tait. The second part is primarily concerned with recursive functions and features a monograph by Crossley on constructive order types, as well as contributions by Goodstein, Schütte, and Wang, among others. Especially noteworthy is Kripke's paper (...) which applies Cohen's methods to the semantics of intuitionistic logic.—P. J. M. (shrink)

The ritual tympanum of the god Mithra has no clear interpretation to date. In particular, the animals under the bull remain mysterious. If they have been considered as representations of certain constellations, this esoteric hypothesis remains disputed. Could the god Mithra, symbol of the Roman army, be attracted by the stars? Another hypothesis is to consider this religion as pragmatic. These small animals would be familiar to the Romans. They would symbolise trust. To understand Mithra, don't we have to (...) change our way of seeing the Roman mentality? (shrink)

Dogmen are individuals who fight their pit bulls in matches against other pit bulls. This paper uses neutralization theory to examine the rationalizations of dogmen as they attempt to counter stigma and criminal identity in a world that is becoming increasingly intolerant of dogfighting. To maintain their rationalizations, the dogmen use four recurring techniques : denial of injury; condemnation of the condemners; appeal to higher loyalties; and a defense that says dogmen are good people. The authors conducted interviews with 31 (...) individuals who fight and breed pit bulls and with significant others in the dogfighting enterprise, including Society for the Prevention of Cruelty to Animals officials, veterinarians, and local law enforcement officers. The research also examined newspaper accounts of dogfighting. This article provides some insights into the social construction of reality of individuals who engage in an activity that most of us find reprehensible. As with any criminal/deviant behavior, understanding and subsequent solving of the problem begin with knowledge of the offender's perspective. (shrink)

Dogmen are individuals who fight their pit bulls in matches against other pit bulls. This paper uses neutralization theory to examine the rationalizations of dogmen as they attempt to counter stigma and criminal identity in a world that is becoming increasingly intolerant of dogfighting. To maintain their rationalizations, the dogmen use four recurring techniques : denial of injury; condemnation of the condemners; appeal to higher loyalties; and a defense that says dogmen are good people. The authors conducted interviews with 31 (...) individuals who fight and breed pit bulls and with significant others in the dogfighting enterprise, including Society for the Prevention of Cruelty to Animals officials, veterinarians, and local law enforcement officers. The research also examined newspaper accounts of dogfighting. This article provides some insights into the social construction of reality of individuals who engage in an activity that most of us find reprehensible. As with any criminal/deviant behavior, understanding and subsequent solving of the problem begin with knowledge of the offender's perspective. (shrink)