In their article ‘Consent-GPT: is it ethical to delegate procedural consent to conversational AI?’, Allen et al 1 explore the ethical complexities involved in handing over parts of the process of obtaining medical consent to conversational Artificial Intelligence (AI) systems, that is, AI-driven large language models (LLMs) trained to interact with patients to inform them about upcoming medical procedures and assist in the process of obtaining informed consent.1 They focus specifically on challenges related to accuracy (4–5), trust (5), privacy (5), (...) click-through consent (5) and responsibility (5–6), alongside some pragmatic considerations (6). While the authors competently navigate these critical issues and present several key perspectives, we posit that their discussion on trust in what they refer to as ‘Consent-GPT’ significantly underestimates one vital factor: the interpersonal aspect of trust. Admittedly, this …. (shrink)

This paper presents the problem of robust and nonfragile stabilization of nonlinear systems described by multivariable Hammerstein models. The objective is focused on the design of a nonfragile feedback controller such that the resulting closed-loop system is globally asymptotically stable with robust H ∞ disturbance attenuation in spite of controller gain variations. First, the parameters of linear and nonlinear blocks characterizing the multivariable Hammerstein model structure are separately estimated by using a subspace identification algorithm. Second, approximate inverse nonlinear functions of (...) polynomial form are proposed to deal with nonbijective invertible nonlinearities. Thereafter, the Takagi–Sugeno model representation is used to decompose the composition of the static nonlinearities and their approximate inverses in series with the linear subspace dynamic submodel into linear fuzzy parts. Besides, sufficient stability conditions for the robust and nonfragile controller synthesis based on quadratic Lyapunov function, H ∞ criterion, and linear matrix inequality approach are provided. Finally, a numerical example based on twin rotor multi-input multi-output system is considered to demonstrate the effectiveness. (shrink)

BackgroundVerbal autopsy is a pragmatic approach for generating cause-of-death data in contexts without well-functioning civil registration and vital statistics systems. It has primarily been conducted in health and demographic surveillance systems (HDSS) in Africa and Asia. Although significant resources have been invested to develop the technical aspects of verbal autopsy, ethical issues have received little attention. We explored the benefits and burdens of verbal autopsy in HDSS settings and identified potential strategies to respond to the ethical issues identified.MethodsThis research was (...) based on a case study approach centred on two contrasting HDSS in Kenya and followed the Mapping-Framing-Shaping Framework for empirical bioethics research. Data were collected through individual interviews, focus group discussions, document reviews and non-participant observations. 115 participants were involved, including 86 community members (HDSS residents and community representatives), and 29 research staff (HDSS managers, researchers, census field workers and verbal autopsy interviewers).ResultsThe use of verbal autopsy data for research and public health was described as the most common potential benefit of verbal autopsy in HDSS. Community members mentioned the potential uses of verbal autopsy data in addressing immediate public health problems for the local population while research staff emphasized the benefits of verbal autopsy to research and the wider public. The most prominent burden associated with the verbal autopsy was emotional distress for verbal autopsy interviewers and respondents. Moral events linked to the interview, such as being unsure of the right thing to do (moral uncertainty) or knowing the right thing to do and being constrained from acting (moral constraint), emerged as key causes of emotional distress for verbal autopsy interviewers.ConclusionsThe collection of cause-of-death data through verbal autopsy in HDSS settings presents important ethical and emotional challenges for verbal autopsy interviewers and respondents. These challenges include emotional distress for respondents and moral distress for interviewers. This empirical ethics study provides detailed accounts of the distress caused by verbal autopsy and highlights ethical tensions between potential population benefits and risks to individuals. It includes recommendations for policy and practice to address emotional and moral distress in verbal autopsy. (shrink)

Journal Name: Apeiron Issue: Ahead of print.

There is a growing interest in the ethics of Health Policy and Systems Research, and especially in areas that have particular ethical salience across HPSR. Hyder et al provide an initial framework to consider this, and call for more conceptual and empirical work. In this paper, we respond by examining the ethical issues that arose for researchers over the course of conducting three HPSR studies in Kenya in which health managers and providers were key participants. All three studies involved qualitative (...) work including observations and individual and group interviews. Many of the ethical dilemmas researchers faced only emerged over the course of the fieldwork, or on completion, and were related to interactions and relationships between individuals operating at different levels or positions in health/research systems. The dilemmas reveal significant ethical challenges for these forms of HPSR, and show that potential ‘solutions’ to dilemmas often lead to new issues and complications. Our experiences support the value of research ethics frameworks, and suggest that these can be enriched by incorporating careful consideration of context embedded social relations into research planning and conduct. Many of these essential relational elements of ethical practice, and of producing quality data, are given stronger emphasis in social science research ethics than in epidemiological, clinical or biomedical research ethics, and are particularly relevant where health systems are understood as social and political constructs. We conclude with practical and research implications. (shrink)

In recent years, there has been an increase in the establishment of biobanks for genetic and genomic studies around the globe. One example of this is the Human Heredity and Health in Africa Initiative (H3Africa), which has established biobanks in the sub‐region to facilitate future indigenous genomic studies. The concept of ‘broad consent’ has been proposed as a mechanism to enable potential research participants in biobanks to give permission for their samples to be used in future research studies. However, questions (...) remain about the acceptability of this model of consent. Drawing on findings from empirical research about the role of trust in decision‐making, we argue that an account of entrustment may be an appropriate way of addressing current challenges of seeking consent for biobank research in Africa. We propose a set of key points to consider that can support the proposed entrustment framework. (shrink)

BackgroundThere is general consensus internationally that unfair distribution of the benefits of research is exploitative and should be avoided or reduced. However, what constitutes fair benefits, and the exact nature of the benefits and their mode of provision can be strongly contested. Empirical studies have the potential to contribute viewpoints and experiences to debates and guidelines, but few have been conducted. We conducted a study to support the development of guidelines on benefits and payments for studies conducted by the KEMRI-Wellcome (...) Trust programme in Kilifi, Kenya.MethodsFollowing an initial broad based survey of cash, health services and other items being offered during research by all programme studies (n = 38 studies), interviews were held with research managers (n = 9), and with research staff involved in 8 purposively selected case studies (n = 30 interviewees). Interviews explored how these ‘benefits’ were selected and communicated, experiences with their administration, and recommendations for future guidelines. Data fed into a consultative workshop attended by 48 research staff and health managers, which was facilitated by an external ethicist.FindingsThe most commonly provided benefits were medical care (for example free care, and strengthened quality of care), and lunch or snacks. Most cash given to participants was reimbursement of transport costs (for example to meet appointments or facilitate use of services when unexpectedly sick), but these payments were often described by research participants as benefits. Challenges included: tensions within households and communities resulting from lack of clarity and agreement on who is eligible for benefits; suspicion regarding motivation for their provision; and confusion caused by differences between studies in types and levels of benefits.ConclusionsResearch staff differed in their views on how benefits should be approached. Echoing elements of international benefit sharing and ancillary care debates, some research staff saw research as based on goodwill and partnership, and aimed to avoid costs to participants and a commercial relationship; while others sought to maximise participant benefits given the relative wealth of the institution and the multiple community needs. An emerging middle position was to strengthen collateral or indirect medical benefits to communities through collaborations with the Ministry of Health to support sustainability. (shrink)

BackgroundHealth service delivery should ensure ethical principles are observed at all levels of healthcare. Working towards this goal requires understanding the ethics-related priorities and concerns in the day-to-day activities among different health practitioners. These practitioners include community health workers (CHWs) who are involved in healthcare delivery in communities in many low-and middle-income countries such as Uganda. In this study, we used photovoice, an innovative community based participatory research method that uses photography, to examine CHWs' perspectives on ethical concerns in their (...) work.MethodsWe explored perspectives of 10 CHWs (5 females and 5 males) on ethical dimensions of their work for 5 months using photovoice in a rural community in Wakiso district, Uganda. As part of the study, we: 1. Oriented CHWs on photovoice research and ethics; 2. Asked CHWs to take photographs of key ethical dimensions of their work; 3. Held monthly meetings to discuss and reflect on the photos; and 4. Disseminated the findings. The discussions from the monthly meetings were audio recorded, transcribed, and emerging data analysed using conventional content analysis with the help of Atlas ti version 6.0.15.ResultsCHWs were aware of and highly concerned about the need to observe ethical principles while carrying out their roles. The ethical principles CHWs were aware of and endeavoured to observe during their work were: maintaining professional integrity and abiding by ethical principles of practice; ethical responsibility in patient care; maintaining confidentiality while handling clients; respect for persons and communities; and enhancing their knowledge and skills for better practice. However, CHWs also identified challenges concerning their observance of ethical principles including: low commitment to their work due to other obligations; availability of some reference materials and guidelines in English yet majority could only read in the local language; and minimal avenues for knowledge enhancement such as trainings.ConclusionsCHWs were aware of and keen to discuss ethical issues in their work. However, there is need to address the challenges they face so as to facilitate observing ethical principles during the course of their work in communities. (shrink)

Our modern scientific explanation of colour as a subjective impression has replaced a ‘pre-theoretical’ notion of colour as an intrinsic property of objects, which was mainstream in ancient thought. Why have we lost such pre-theoretical notion, and what have we lost by losing it? I argue that most ancient Greek philosophers exploited this pre-theoretical assumption – one that was obvious to them – in terms and ways that are still worthy of attention in the context of contemporary philosophy of colour. (...) I offer an in-depth analysis of the theories of a number of early Greek philosophers, as well as of Plato in the Timaeus, showing that they tend to share the idea that colour is an essential property of external bodies and therefore plays a causal role in perception. Then I focus on a comparison between Democritus’ stance and Aristotle’s in order to highlight a significant contrast between the two. Democritus' theory is an exception in ancient thought because it traces the colour phenomenon back to a refraction of atmospheric light through atomic aggregates. Aristotle, instead, posits the presence of colour and light in the bodies themselves. Finally, I interpret Aristotle's account as the most complex attempt in ancient thought to weld together what we call the ‘manifest image’ of colour and its ‘scientific image’. (shrink)

A celebrated study of the origins of ancient Greek philosophy, now in English for the first time How can we talk about the beginnings of philosophy today? How can we avoid the conventional opposition of mythology and the dawn of reason and instead explore the multiple styles of thought that emerged between them? In this acclaimed book, available in English for the first time, Maria Michela Sassi reconstructs the intellectual world of the early Greek "Presocratics" to provide a richer (...) understanding of the roots of what used to be called "the Greek miracle." The beginnings of the long process leading to philosophy were characterized by intellectual diversity and geographic polycentrism. In the sixth and fifth centuries BC, between the Asian shores of Ionia and the Greek city-states of southern Italy, thinkers started to reflect on the cosmic order, elaborate doctrines on the soul, write in solemn Homeric meter, or, later, abandon poetry for an assertive prose. And yet the Presocratics whether the Milesian natural thinkers, the rhapsode Xenophanes, the mathematician and "shaman" Pythagoras, the naturalist and seer Empedocles, the oracular Heraclitus, or the inspired Parmenides all shared an approach to critical thinking that, by questioning traditional viewpoints, revolutionized knowledge. A unique study that explores the full range of early Greek thinkers in the context of their worlds, the book also features a new introduction to the English edition in which the author discusses the latest scholarship on the subject. (shrink)

The focus of this essay is on Xenophanes’ criticism of anthropomorphic representation of the gods, famously sounding like a declaration of war against a constituent part of the Greek religion, and adopting terms and a tone that are unequalled amongst “pre-Socratic” authors for their directness and explicitness. While the main features of Xenophanes’ polemic are well known thanks to some of the most studied fragments of the pre-Socratic tradition, a different line of enquiry from the usual one is attempted by (...) considering the multi-layered background of the religious beliefs revolving around the idea that the gods have human form as outlined in the tradition of epic poetry or represented in cult statues: in the light of this consideration Xenophanes’ text can take on some new characteristics. In the second part of the article, emphasis is put on the importance of the correlation Xenophanes established between the issue of the appearance of the gods and that of the certainty of knowledge, in terms that have exerted tremendous influence on later thought, most notably on Plato in the Timaeus. (shrink)

L’adjectif eoikos apparaît dans trois passages cruciaux de la pensée grecque (Xénophane, fr. B35 ; Parménide, fr. B8, 60 ; Platon, Timée, 29b3-c3), caractérisant une certaine « ressemblance » à la vérité qui se veut constitutive du discours du savant. En fait, le long de cet examen on découvre que les trois usages du terme ne peuvent pas être disposés le long d’une ligne continue, vu la difficulté de comprendre à quelle notion de vérité, sous quel point de vue, et (...) avec quel degré d’évidence, ce discours se veut « ressemblant » selon l’occasion. Dans le cas de Parménide, cet aspect passe même au second plan, puisqu’on assiste à la prédominance d’une autre connotation qui accompagne le terme eoikos à partir de l’usage homérique, à savoir celle de la « convenance » à un contexte communicatif. L’article cherche dans l’ensemble à éclairer les déplacements que subit la logique de la similitude (et des procédés analogiques qui s’y greffent) en passant par des cadres ontologiques et épistémologiques aussi différents que le sont ceux de Xénophane, Parménide et Platon. (shrink)

In this paper I first address what I consider a central issue in the account of perception in Plato’s Timaeus, namely, how the pathemata pass through the body to reach the soul, and thus become aistheseis. My point in Section 1 is that in tackling this issue Plato aims to provide a firm physiological basis to the notion of perception that starts to emerge in the Theaetetus and the Philebus and is crucial to the late development of his theory of (...) cognition. In the ensuing section I try to put the account of perception in the Timaeus into a historical perspective, aiming to highlight two points: a) Plato’s description of the way in which sensible impressions “travel” inside the body and interact with its parts and other constituents is largely indebted to previous theories, such as those we find, for example, in Empedocles and a few Hippocratic writers; b) The leading role in this story (where internal air plays a significant supporting role) is played by blood flowing through the vascular system and thus performing a crucial cognitive function. Moreover, emphasizing the role of blood as well as analyzing the elaborate way in which perceptions are transmitted through the body to the soul proves vital to appreciate (in Section 3) the cognitive status of the lower parts of the soul (which are more involved in perception) and their relation to reason. Overall, the paper adds further elements to our understanding of Plato’s embodied approach to cognition. I had already written (and submitted) this article when Johansen (2021) was published. The latter’s approach to the role of blood in Plato’s physiology of knowledge in the Timaeus converges in part with mine (as I was pleased to find out), partly due to our overlapping sources and bibliography. (shrink)

Mon but est d’examiner en détail les arguments avancés par Vernant au début des années soixante du siècle dernier, quand il a caractérisé, selon une formule célèbre, la philosophie comme « fille de la Cité » (fille de la polis). Mon argument principal est que le concept d’isonomia, qui n’est central dans le débat politique athénien que depuis les dernières décennies du vie siècle, ne peut être aussi facilement utilisé pour rendre compte de la nouvelle conception de l’espace physique, qui (...) émerge à Milet au début de ce siècle. En tout cas, l’utilisation de modèles politiques dans la science grecque ancienne de la nature est un procédé conscient, comme je tente de le montrer en analysant certains textes célèbres comme le fragment 4 d’Alcméon et le fragment 1 d’Anaximandre. De plus, dans le cas d’Anaximandre on peut se demander si l’explanandum dans l’analogie était l’ordre du monde ou plutôt celui de la polis. (shrink)

For this English translation, Sassi has rewritten the introduction and updated the text and references throughout, and Sir Geoffrey Lloyd has provided a new foreword.

The ideal which Plato consistently endorses and develops in the Laws is one of a city which, like the ideal soul, is perfectly at peace with its inner conflicts. The law is presented as a remedy for the destabilizing influence of the sensations and emotions which make every human being an individual, before he is a citizen. The authoritarian aspect of this remedy may worry contemporary readers, but Plato supports it with his presupposition regarding the extreme weakness of human nature. (...) In particular, the law imposes that rational regulation which each man potentially possesses within himself in so far as he is a divine creature, but which only a ‘small stock of men’ (918 c) is able to exercise. In short, the price that Plato asks us to pay for political order is the suppression of our ‘worse’, yet more human, selves. (shrink)

J’aimerais commencer par une expression italienne qui décrit très bien, grâce à une assonance efficace, mes sentiments actuels, à savoir, je sens tutto l’onore e l’onere de la charge qui m’a été confiée. D’un côté, c’est évidemment un grand honneur de pouvoir présenter précisément au Centre Léon Robin mes remarques sur le nouveau recueil de textes de la tradition « présocratique » édité par André Laks et Glenn Most : et je tiens à remercier ici M. Gourinat en tant que (...) Directeur du Centre Léo... (shrink)

Cet article vise à faire ressortir les fils hétérogènes de la pensée sur les émotions qui traversent la littérature philosophique et médicale grecque des cinquième et quatrième siècles avant J.‑C., contribuant à l’émergence de la sphère des passions en tant que territoire autonome pour l’exploration des faits mentaux. Nous examinons d’abord le modèle psychologique homérique dans le but de mettre en évidence son influence sur la littérature philosophique et non philosophique grecque des siècles suivants. Les auteurs hippocratiques, en particulier, se (...) révèlent redevables du monisme «materialiste» d’Homère, mais on retrouve également des traces du modèle épique chez les penseurs qui, par la suite, se sont intéressés à la relation entre le corps et l’entité‑âme. Nous reconstituons ensuite l’évolution au cours de laquelle, d’Héraclite à Démocrite, de Platon à Aristote et au Péripatos, une notion du pathos en tant qu’emotion finit par émerger, prête à être acceptée et bien sûr précisée autant que retravaillée par les philosophies des âges hellénistique et romain. (shrink)

Cet ouvrage vigoureux, fruit d’une longue recherche que Christopher Moore a menée au cours des dix dernières années, propose une perspective nouvelle et stimulante sur les origines de la philosophie grecque. Plus précisément, comme l’explique Moore dans le premier chapitre introductif (p. 1-33), il ne s’est pas fixé pour objectif de reconstituer (la nième fois) le déroulement des doctrines des penseurs grecs à partir de Thalès, mais d’enquêter sur les significations prises par le terme philos...

This essay provides a comprehensive and detailed analysis of a cluster of Heraclitus’ fragments that revolve around an image of ‘musical’ harmony (B 8, 10, and 51 Diels-Kranz). The aim is to demonstrate that more numerous as well as more specific references to contemporary musical practice can be found in these fragments than is usually thought. In particular, it is argued that in his talk of cosmic harmonia Heraclitus might well know and exploit a musical sense of this word, namely, (...) that of ‘attunement’, which was already developing at his time from the primary meaning of ‘connection’ and ‘agreement’. Furthermore, it is shown that the investigation of musical patterns with which Heraclitus was clearly acquainted offered him a significant analogical ground for his reflection on the order and rationality of kosmos. He was not apparently interested in the numerical definition of musical patterns, and thus there is no need to assume any influence of earlier Pythagorean research on his theory of cosmic harmony: the other way round, this theory was likely food for thought for Philolaus. (shrink)

This paper analyses chapter 58 of Theophrastus’ De sensibus, where Democritus’ account of phronein is famously presented. Democritus traces phronein to symmetria of the soul, that is conceived, in turn, as a state of thermic equilibrium, depending on his consideration of psyche as an aggregate of spherical and thin atoms flowing throughout the body and giving it life, movement, and perception. As a consequence, according to him, psychic states go hand in hand with changes in the body. In the following (...) section of this paper, I offer additional evidence in favor of the controversial manuscript reading μετὰ τὴν κίνησιν. As a result, a consistent theory by Democritus can be reconstructed, according to which the balanced state of mobility and temperature of the psychic atoms concentrated in the head that generates a correct thinking necessarily follows the movement of sensible eidola throughout the body. In fact, a number of passages from Hippocratic writings attest that Democritus shared the key features of this explanation with the physiological and medical approach of the time. (shrink)

J’essaie d’explorer la vision religieuse d’Euripide en le considérant comme un penseur en même temps qu’un artiste, ou mieux, comme un auteur qui soulève en artiste des questions essentielles sur le sens de l’existence humaine par rapport à celle des dieux, non pas tellement en mettant dans la bouche de ses personnages certaines doxai, mais plutôt en les faisant parler et agir d’une certaine façon dans une situation dramatique particulière. En me détachant aussi bien des savants qui ont vu dans (...) Euripide un défenseur de la tradition religieuse, que de ceux qui ont tendance à déconstruire ses figures des dieux dans un jeu de projections de la psychologie humaine, je soutiens qu’Euripide a mis en question dès le début la consistance des croyances traditionnelles, avec une inquiétude grandissante qui a abouti, sinon à une négation de l’existence des dieux, du moins à une attitude exaspérée de doute sur leur rôle dans l’existence humaine : ce qui est suffisant pour qu’il puisse être compté parmi les auteurs que Platon accuse d’impiété dans le livre X des Lois. (shrink)

L’arte della memoria è uno degli archetipi della cultura occidentale fin dall’antica Grecia: è stato Platone ad ‘inventare’ l’immagine dell’anima come blocco di cera, su cui le sensazioni si imprimono come segni di sigilli; ed è stato poi Aristotele a riprendere in parte questo modello, arricchendolo però di temi fondamentali. Ma anche in epoche successive l’arte della memoria ha svolto una funzione fondamentale intrecciandosi a temi sia epistemologici che di schietta natura metafisica. Questo volume, frutto di un seminario tenuto alla (...) Scuola Normale nel settembre 2006, intende ripercorrere alcune delle principali stazioni della riflessione sulla memoria fra antichità e mondo moderno chiedendosi se, e in quale misura, questa relativa continuità di approccio si debba ad un consapevole attingere alla tradizione platonica e aristotelica; se, e in quale misura, elementi comuni o varianti del modello iniziale siano riportabili alle metafore adottate, sin da subito, per la descrizione dei processi mentali – riconducibili in ogni caso all’idea comune di ‘tracce’ che la sensazione imprime nell’anima. (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)

Despite advances in theory, often driven by feminist ethicists, research ethics struggles in practice to adequately account for and respond to the agency and autonomy of people considered vulnerable in the research context. We argue that shifts within feminist research ethics scholarship to better characterise and respond to autonomy and agency can be bolstered by further grounding in discourses from the social sciences, in work that confirms the complex nature of human agency in contexts of structural and other sources of (...) vulnerability. We discuss some of the core concepts and critiques emerging from the literature on women and children's agency in under‐resourced settings, highlighting calls to move from individualistic to relational models of agency, and to recognise the ambiguous, value‐laden, and heterogeneous nature of the concept. We then draw out what these conceptual shifts might mean for research ethics obligations and guidance, illustrating our analysis using a case vignette based on research ethics work conducted in South Africa. We conclude that if research practices are to be supportive of agency, it will be crucial to scrutinise the moral judgements which underpin accounts of agency, derive more situated definitions of and responses to agency, and enable people and participants to influence these based on their own experiences and self‐perceptions. (shrink)

Background: There is general consensus internationally that unfair distribution of the benefits of research is exploitative and should be avoided or reduced. However, what constitutes fair benefits, and the exact nature of the benefits and their mode of provision can be strongly contested. Empirical studies have the potential to contribute viewpoints and experiences to debates and guidelines, but few have been conducted. We conducted a study to support the development of guidelines on benefits and payments for studies conducted by the (...) KEMRI-Wellcome Trust programme in Kilifi, Kenya. Methods: Following an initial broad based survey of cash, health services and other items being offered during research by all programme studies (n = 38 studies), interviews were held with research managers (n = 9), and with research staff involved in 8 purposively selected case studies (n = 30 interviewees). Interviews explored how these ‘benefits’ were selected and communicated, experiences with their administration, and recommendations for future guidelines. Data fed into a consultative workshop attended by 48 research staff and health managers, which was facilitated by an external ethicist.FindingsThe most commonly provided benefits were medical care (for example free care, and strengthened quality of care), and lunch or snacks. Most cash given to participants was reimbursement of transport costs (for example to meet appointments or facilitate use of services when unexpectedly sick), but these payments were often described by research participants as benefits. Challenges included: tensions within households and communities resulting from lack of clarity and agreement on who is eligible for benefits; suspicion regarding motivation for their provision; and confusion caused by differences between studies in types and levels of benefits. Conclusions: Research staff differed in their views on how benefits should be approached. Echoing elements of international benefit sharing and ancillary care debates, some research staff saw research as based on goodwill and partnership, and aimed to avoid costs to participants and a commercial relationship; while others sought to maximise participant benefits given the relative wealth of the institution and the multiple community needs. An emerging middle position was to strengthen collateral or indirect medical benefits to communities through collaborations with the Ministry of Health to support sustainability. (shrink)

There is wide agreement that community engagement is important for many research types and settings, often including interaction with ‘representatives’ of communities. There is relatively little published experience of community engagement in international research settings, with available information focusing on Community Advisory Boards or Groups (CAB/CAGs), or variants of these, where CAB/G members often advise researchers on behalf of the communities they represent. In this paper we describe a network of community members (‘KEMRI Community Representatives’, or ‘KCRs’) linked to a (...) large multi-disciplinary research programme on the Kenyan Coast. Unlike many CAB/Gs, the intention with the KCR network has evolved to be for members to represent the geographical areas in which a diverse range of health studies are conducted through being typical of those communities. We draw on routine reports, self-administered questionnaires and interviews to: 1) document how typical KCR members are of the local communities in terms of basic characteristics, and 2) explore KCR's perceptions of their roles, and of the benefits and challenges of undertaking these roles. We conclude that this evolving network is a potentially valuable way of strengthening interactions between a research institution and a local geographic community, through contributing to meeting intrinsic ethical values such as showing respect, and instrumental values such as improving consent processes. However, there are numerous challenges involved. Other ways of interacting with members of local communities, including community leaders, and the most vulnerable groups least likely to be vocal in representative groups, have always been, and remain, essential. (shrink)

Background The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). Methods We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public (...) health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. Results Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. Conclusions There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics. (shrink)

Controlled human malaria infection (CHMI) studies involve the deliberate infection of healthy volunteers with malaria parasites under controlled conditions to study immune responses and/or test drug or vaccine efficacy. An empirical ethics study was embedded in a CHMI study at a Kenyan research programme to explore stakeholders’ perceptions and experiences of deliberate infection and moral implications of these. Data for this qualitative study were collected through focus group discussions, in‐depth interviews and non‐participant observation. Sixty‐nine participants were involved, including CHMI study (...) volunteers, community representatives and research staff. Data were managed using QSR Nvivo 10 and analysed using an inductive‐deductive approach, guided by ethics literature. CHMI volunteers had reasonable understanding of the study procedures. Decisions to join were influenced by study incentives, trust in the research institution, their assessment of associated burdens and motivation to support malaria vaccine development. However, deliberate malaria infection was a highly unusual research strategy for volunteers, community representatives and some study staff. Volunteers’ experiences of physical, emotional and social burdens or harms were often greater than anticipated initially, and fluctuated over time, related to specific procedures and events. Although unlikely to deter volunteers' participation in similar studies in furture, we argue that the dissonance between level of understanding of the burdens involved and actual experiences are morally relevant in relation to community engagement, informed consent processes, and ongoing support for volunteers and research staff. We further argue that ethics oversight of CHMI studies should take account of these issues in deciding whether consent, engagement and the balance of benefits and harms are reasonable in a given context. (shrink)

Benefit sharing in health research has been the focus of international debates for many years, particularly in developing countries. Whilst increasing attention is being given to frameworks that can guide researchers to determine levels of benefits to participants, there is little empirical research from developing countries on the practical application of these frameworks, including in situations of extreme poverty and vulnerability. In addition, the voices of those who often negotiate and face issues related to benefits in practice - frontline researchers (...) and fieldworkers - are rarely included in these debates. Against this background, this paper reports on experiences of negotiating research participation and benefits as described by fieldworkers, research participants and researchers in two community based studies. (shrink)

Fieldworkers (FWs) are community members employed by research teams to support access to participants, address language barriers, and advise on culturally appropriate research conduct. The critical role that FWs play in studies, and the range of practical and ethical dilemmas associated with their involvement, is increasingly recognised. In this paper, we draw on qualitative observation and interview data collected alongside a six month basic science study which involved a team of FWs regularly visiting 47 participating households in their homes. The (...) qualitative study documented how relationships between field workers and research participants were initiated, developed and evolved over the course of the study, the shifting dilemmas FWs faced and how they handled them. Even in this one case study, we see how the complex and evolving relationships between fieldworkers and study participants had important implications for consent processes, access to benefits and mutual understanding and trust. While the precise issues that FWs face are likely to depend on the type of research and the context in which that research is being conducted, we argue that appropriate support for field workers is a key requirement to strengthen ethical research practice and for the long term sustainability of research programmes. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page 31-33, August 2011.