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

Research represents an essential component of the response to infectious disease outbreaks and to other public health emergencies, whether they are localised, of international concern, or global. Research conducted in such contexts also comes with particular ethics challenges, the awareness of which has significantly grown following the Ebola outbreak in West Africa, the Zika outbreak in Latin America and the COVID-19 pandemic. These challenges include the need for implementing meaningful community engagement with the researched communities, not just to build unidirectional (...) trust towards the research team, but to achieve a genuine and mutually respectful partnership before, during and after the research. Here, we describe the real-life experience of 10 well-established research clinics in Nairobi, where a successful experience of community engagement linking prevention and care to research was interrupted during the COVID19 pandemic. We contrast this experience with the concept and processes of community engagement as described in selected scientific manuscripts and guidelines, to formulate some conclusions and recommendations. We contend that more action is needed, from research ethics committees and other key-research stakeholders, to align policies and practices with ethics guidance and with evidence-based recommendations from the academic literature, to achieve meaningful community engagement during emergency research, irrespective of the scale and location of an outbreak or public health crisis. Failure to do so, will aggravate the (postcolonial) asymmetries of power in global health and local systems. (shrink)

In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of (...) socio-economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low-literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power-unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research-related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees. (shrink)

The Médecins Sans Frontières ethics review board has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues (...) in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees, we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process. (shrink)

Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in international research ethics guidelines to be upheld during public health emergencies is widely recognized. Public health officials, researchers and other concerned stakeholders also have to carefully balance time and resources allocated to immediate treatment and control activities, with an approach that integrates research as part of the outbreak response. Under such circumstances, research (...) “ethics preparedness” constitutes an important foundation for an effective response to infectious disease outbreaks and other health emergencies. A two-day workshop was convened in March 2018 by the World Health Organisation Global Health Ethics Team and the African coaLition for Epidemic Research, Response and Training, with representatives of National Ethics Committees, to identify practical processes and procedures related to ethics review preparedness. The workshop considered five areas where work might be undertaken to facilitate rapid and sound ethics review: preparing national ethics committees for outbreak response; pre-review of protocols; multi-country review; coordination between national ethics committees and other key stakeholders; data and benefit sharing; and export of samples to third countries. In this paper, we present the recommendations that resulted from the workshop. In particular, the participants recommended that Ethics Committees would develop a formal national standard operating procedure for emergency response ethical review; that there is a need to clarify the terminology and expectations of pre-review of generic protocols and agree upon specific terminology; that there is a need to explore mechanisms for multi-country emergency ethical consultation, and to establish procedures for communication between national ethics committees and other oversight bodies and public health authorities. In addition, it was suggested that ethics committees should request from researchers, at a minimum, a preliminary data sharing and sample sharing plan that outlines the benefit to the population from which data and samples are to be drawn. This should be followed in due time by a full plan. It is hoped that the national ethics committees, supported by the WHO, relevant collaborative research consortia and external funding agencies, will work towards bringing these recommendations into practice, for supporting the conduct of effective research during outbreaks. (shrink)

Over recent years, the research community has been increasingly using preprint servers to share manuscripts that are not yet peer-reviewed. Even if it enables quick dissemination of research findings, this practice raises several challenges in publication ethics and integrity. In particular, preprints have become an important source of information for stakeholders interested in COVID19 research developments, including traditional media, social media, and policy makers. Despite caveats about their nature, many users can still confuse pre-prints with peer-reviewed manuscripts. If unconfirmed but (...) already widely shared first-draft results later prove wrong or misinterpreted, it can be very difficult to “unlearn” what we thought was true. Complexity further increases if unconfirmed findings have been used to inform guidelines. To help achieve a balance between early access to research findings and its negative consequences, we formulated five recommendations: (a) consensus should be sought on a term clearer than ‘pre-print’, such as ‘Unrefereed manuscript’, “Manuscript awaiting peer review” or ‘’Non-reviewed manuscript”; (b) Caveats about unrefereed manuscripts should be prominent on their first page, and each page should include a red watermark stating ‘Caution—Not Peer Reviewed’; (c) pre-print authors should certify that their manuscript will be submitted to a peer-review journal, and should regularly update the manuscript status; (d) high level consultations should be convened, to formulate clear principles and policies for the publication and dissemination of non-peer reviewed research results; (e) in the longer term, an international initiative to certify servers that comply with good practices could be envisaged. (shrink)

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

Médecins Sans Frontières is one of the world’s leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper.

People enroll in medical research for many reasons ranging from decisions regarding their own or family members' health situation to broader considerations including access to health and financial resources. In socially vulnerable communities the choice to participate is often based on a risk-benefit assessment that goes beyond the medical aspects of the research, and considers the benefits received. In this qualitative study, we examined the motivations of Rwandan women to participate in a non-commercial collaborative research study examining the safety, acceptability, (...) and adherence of a contraceptive vaginal ring in Rwanda juxtaposed with the perceptions of the research within the community. 351 women attended the screening visit, four were excluded because they were not able to complete the assessment of understanding. The remaining participants' ages ranged from 17 to 38 and 80% had primary level of education or below. 120 were enrolled. Findings highlighted motivations for joining the study that were relayed both formally by the clinic and informally by the community including the positive aspects of the ring. There were also some negative rumors circulating regarding the research site, likely from excluded participants who faced potential stigma based on that exclusion. It was understood by most participants that they were enrolled in a research study and participants actively sought out enrollment in the research for a variety of reasons. The experiences demonstrate that although inequalities in access to health care may create conflicting situations around the study, it is possible to form partnerships between a research center and participants/their partners, for research about reproductive health. (shrink)

Background Ensuring individual free and informed decision‐making for research participation is challenging. It is thought that preliminarily informing communities through ‘community sensitization’ procedures may improve individual decision‐making. This study set out to assess the relevance of community sensitization for individual decision‐making in research participation in rural Gambia. Methods This anthropological mixed‐methods study triangulated qualitative methods and quantitative survey methods in the context of an observational study and a clinical trial on malaria carried out by the Medical Research Council Unit Gambia. (...) Results/discussion Although 38.7% of the respondents were present during sensitization sessions, 91.1% of the respondents were inclined to participate in the trial when surveyed after the sensitization and prior to the informed consent process. This difference can be explained by the informal transmission of information within the community after the community sensitization, expectations such as the benefits of participation based on previous research experiences, and the positive reputation of the research institute. Commonly mentioned barriers to participation were blood sampling and the potential disapproval of the household head. Conclusion Community sensitization is effective in providing first‐hand, reliable information to communities as the information is cascaded to those who could not attend the sessions. However, further research is needed to assess how the informal spread of information further shapes people's expectations, how the process engages with existing social relations and hierarchies (e.g. local political power structures; permissions of heads of households) and how this influences or changes individual consent. (shrink)

People enroll in medical research for many reasons ranging from decisions regarding their own or family members' health situation to broader considerations including access to health and financial resources. In socially vulnerable communities the choice to participate is often based on a risk‐benefit assessment that goes beyond the medical aspects of the research, and considers the benefits received. In this qualitative study, we examined the motivations of Rwandan women to participate in a non‐commercial collaborative research study examining the safety, acceptability, (...) and adherence of a contraceptive vaginal ring in Rwanda juxtaposed with the perceptions of the research within the community. 351 women attended the screening visit, four were excluded because they were not able to complete the assessment of understanding. The remaining participants' ages ranged from 17 to 38 and 80% had primary level of education or below. 120 were enrolled. Findings highlighted motivations for joining the study that were relayed both formally by the clinic (e.g. testing and treatment) and informally by the community including the positive aspects of the ring. There were also some negative rumors circulating regarding the research site, likely from excluded participants who faced potential stigma based on that exclusion. It was understood by most participants that they were enrolled in a research study and participants actively sought out enrollment in the research for a variety of reasons. The experiences demonstrate that although inequalities in access to health care may create conflicting situations around the study, it is possible to form partnerships between a research center and participants/their partners, for research about reproductive health. (shrink)

This article focuses on the assessment of mechanistic relations with specific attention to medicine, where mechanistic models are widely employed. I first survey recent contributions in the philosophical literature on mechanistic causation, and then take issue with Federica Russo and Jon Williamson’s thesis that two types of evidence, probabilistic and mechanistic, are at stake in the health sciences. I argue instead that a distinction should be drawn between previously acquired knowledge of mechanisms and yet-to-be-discovered knowledge of mechanisms and that both (...) probabilistic evidence and manipulation are essential with respect to newly discovered mechanisms. (shrink)

This contribution claims that the two fundamental notions of causation at work in the health sciences are manipulative and mechanistic, and investigates what kinds of evidence matter for the assessment of causal relations. This article is a development of our 2007 article, ‘Plurality of Causality’, where we argue for a pluralistic account of causation with an eye to econometrics and a single medical example. The present contribution has a wider focus, and considers the notion of evidence within a whole range (...) of disciplines belonging to the health sciences. Section 1 addresses the relations between kinds of evidence and causal accounts, and it is shown how different notions of causation can be employed in various medical cases. Section 2 calls attention to issues crucial for any adequate epistemological theory of causation, such as the distinctions between types and tokens, observational and experimental regimes, explanation and prediction. Lastly, the notion of context is articulated, highlighted in its role in the assessment of causal links. All these issues are tackled in the framework of what we label a ‘bottom–up’ epistemology. (shrink)

Alison Simmons, in Simmons (1999), argues that Descartes in Meditation Six offered a teleological account of sensory representation. According to Simmons, Descartes’ view is that the biological function of sensations explains both why sensations represent what they do (i.e., their referential content) and why they represent their objects the way they do (i.e., their presentational content). Moreover, Simmons claims that her account has several advantages over other currently available interpretations of Cartesian sensations. In this paper, I argue that Simmons’ teleological (...) account cannot be sustained for both theoretical and textual reasons and that it does not have the advantages it is claimed to have. (shrink)

This book examines the role of note-taking in ancient education as a pedagogical method, by taking readers on a stimulating analysis of lectures by ancient philosophers that were recorded by their students.

The essay analyses utopia as a key concept to investigate modern politics. It argues that looking at the works of Machiavelli and More in order to retrace the utopia-realism nexus permits to develop a valuable analytical tool to interpret the outset of political modernity.

In this paper I argue against the received view that the anti‐nativist arguments of Book I of Locke's Essay conclusively challenge nativism. I begin by reconstructing the chief argument of Book I and its corollary arguments. I call attention to their dependence on (what I label) “the Awareness Principle”, viz., the view that there are no ideas in the mind of which the mind either isn't currently aware or hasn't been aware in the past. I then argue that the arguments' (...) dependence on this principle is question begging on two counts. Unless this principle is defended, Locke's arguments beg the question against Descartes and Leibniz because their nativism implies the denial of the Awareness Principle. And even when Locke defended the principle, his arguments remain question begging because they presuppose the empiricism they aim to prove. The disclosure of the question‐begging status of these arguments debunks a seemingly powerful way of attacking nativism. (shrink)

This paper uses a partially ordered set of syntactic categories to accommodate optionality and licensing in natural language syntax. A complex but well-studied data set pertaining to the syntax of quantifier scope and negative polarity licensing in Hungarian is used to illustrate the proposal. The presentation is geared towards both linguists and logicians. The paper highlights that the main ideas can be implemented in different grammar formalisms, and discusses in detail an implementation where the partial ordering on categories is given (...) by the derivability relation of a calculus with residuated and Galois-connected unary operators. (shrink)

Reductionism and antireductionism are among the most largely and hotly debated topics in philosophy of biology today. In this section of the volume, aiming to convey the current situation in the philosophy of the natural and life sciences, these topics are specifically addressed in Mehmet Elgin’s paper, focusing on biochemistry. Elgin strongly supports reductionism, first by claiming that the now classical argument based on multiple realizability does not entail anti-reductionism and secondly highlighting how the version of methodological reductionism that biochemistry (...) has been adopting – centered on “the principle that biological functions of biomolecules in living cells can be understood in terms of chemical and physical properties of those molecules”1 – has proved largely successful, teaching “us new knowledge about the biological systems”. Taken together, these two arguments are deemed to provide good grounds for a thorough defence of reductionism. While Elgin chooses biochemistry as his privileged standpoint on the issue, I shall dwell on the stances emerging in the health sciences. Although the health sciences are closely intertwined with – amongst others – biology and biochemistry, they also have their own peculiar features. Referring to some examples taken from different medical disciplines, I will question whether reductionism can be regarded as not only a viable, option, but as the best solution to gain new knowledge about biomedical systems. I shall suggest that considerations arising from current medical research and practice support a pluralistic approach to the topic, in which both reductionist and antireductionist stances can be accommodated in different ways. (shrink)

A theater that heals is not a theater that offers answers and ?medicines? that guarantee to cure weaknesses and fragilities people meet but it is an open organization, which questions itself, which brings out ambivalence and ambiguity, diversity, weaknesses, and which leaves room for possible interpretations and narratives, the play of imagination, and the development of innovative and creative processes of people in society.

i. M is positive in M . ii. M is positive (negative) in P Q iff M is positive (negative) in P . iii. M is positive (negative) in P Q iff M is positive (negative) in Q, and P denotes..

1 Recognition Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2 Classical Categorial Grammar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3 Classical (...) Categorial Grammar. Examples . . . . . . . . . . . . . . . . . . . . . 5 4 Logic Grammar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5 Lambek calculus. Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6 Lambek calculus. Semantics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 7 Lambek calculus. Advantages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 8 Derivations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 9 Residuated and Galois Connected Functions . . . . . . . . . . . . . . . . . . 14 10 Interpretation of the Constants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 11 Nonveridical Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 12 Dutch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 13 Classification of NPIs in Dutch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 14 Antilicensing Relation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20.. (shrink)

Polarity Items are linguistic expressions known for being a ‘lexically controlled’ phenomenon. In this paper we show how their behavior can be implemented in a deductive system. Further- more, we point out some possible directions to recast the deductive solution into a Tree Ad- joining Grammar system. In particular, we suggest to compare the proof system developed for Multimodal Categorial Grammar (Moot & Puite, 1999) with the Partial Proof Trees proposed in (Joshi & Kulick, 1997).

In this paper we draw some connection between the relation linking polarity items with their licensors, and the one holding between wh-phrases and weak-islands. Moreover, we briefly sketch how these relations can be modelled into Categorial Type Logic.

The article presents the first results we have obtained studying natural reasoning from a proof-theoretic perspective. In particular we focus our attention on monotonic reasoning. Our system consists of two parts: (i) A Formal Grammar – a multimodal version of classical Categorial Grammar – which while syntactically analysing linguistic expressions given as input, computes semantic information (In particular information about the monotonicity properties of the components of the input string are displayed.); (ii) A simple Natural Logic which derives (monotonicity) inferences (...) using as vehicle the parsed output. The monotonicity markers assigned in the lexicon are propagated through the proofs via a combination of the structural and the logical rules for the unary operators of Multimodal Categorial Grammar (MMCG) [Moo97]. We have chosen to work with an expressive ‘grammar logic’, in order to avoid the use of extra-logical marking devices and extra-logical structural reasoning. Having MMCG as parser, our system is able to make the derivations simply within the logic. This new approach makes the implementation of the theory an easier task. We have implemented the theoretical results, so far obtained, using Grail, a theorem prover for Categorial Grammar Logics [Moo98]. (shrink)

A partire dal corpus degli Scritti sulla donna, l'articolo intende mostrare come nel pensiero di Edith Stein vi sia il ricorrere di alcuni nuclei tematici soggetti a un sempre maggiore lavoro di scavo e di approfondimento, nella consapevolezza - maturata alla scuola di Husserl -della inesauribilitÀ della realtÀ. In particolare, dopo aver ricordato la funzione ontologica della filosofia nell'indagine sull'essere umano, che consente di parlare di specie e di individualitÀ, vengono qui toccate le questioni del rapporto fra specie e tipo, (...) della mutabilitÀ o meno della specie, della peculiaritÀ dell'anima femminile, e viene evidenziato come esse o siano il risultato di ricerche condotte in precedenza o contengano in nuce elementi di una riflessione portata avanti dalla filosofa tedesca in tempi e opere successivi. (shrink)

The notion of causal evidence in medicine has been the subject of wide philosophical debate in recent years. The notion of evidence has been discussed mostly in connection with Evidence Based Medicine and, more in general, with the assessment of causal nexus in medical, and especially research contexts. “Manipulative evidence” is one of the notions of causal evidence that has stimulated much debate. It has been defined in slightly different ways, attributed different relevance, and recently placed at the core of (...) Gillies’ “action-related theory of causality”, a view specifically meant to address causation in medicine. While in general sympathetic to Gillies’ account, and totally convinced of the relevance of manipulative evidence and different sorts of interventions in the biomedical sciences, we believe that some further qualifications are needed to allow the notion of manipulative evidence to better express features of medical practice. In particular, we provide some qualification of the role of “interventional evidence” proposed by Gillies, suggesting a distinction between “interventional evidence” and “evidence for interventions”. A case study from research on rare diseases is analyzed in depth and a multifaceted notion of manipulative evidence put forward that allows better understanding of what manipulations in medical contexts amount to and what their targets are. (shrink)

Current research on choice overload has been mainly conducted with choice options not associated with specific brands. This study investigates whether the presence of brand names in the choice set affects the occurrence of choice overload. Across four studies, we find that when choosing among an overabundance of alternatives, participants express more positive feelings (i.e., higher satisfaction/confidence, lower regret and difficulty) when all the options of the choice set are associated with familiar brands, rather than unfamiliar brands or no brand (...) at all. We also find that choice overload only appears in the absence of brand names, but disappears when all options contain brand names—either familiar or unfamiliar. Theoretical and practical implications are discussed. (shrink)