In 2006, the Indonesian government decided to withhold avian flu samples from the World Health Organization. They argued that even though Indonesian samples were crucial to the development of vaccines, the results of vaccine research would be unaffordable for its citizens. Commentaries on the case varied from alleging blackmail to welcoming this strong stance against alleged exploitation. What is clear is that the concern expressed is related to benefit sharing.Benefit sharing requires resource users to return benefits to resource providers in (...) order to achieve justice. One benefit sharing tool within health research is the duty to provide a health care intervention which has been proven to be beneficial (or alternative benefits) to research participants after a study has been concluded. This duty is generally known as a post-study obligation. It was enshrined in the Declaration of Helsinki in 2000 and re-emphasized in 2008. Yet, there are few, if any, examples of good practice.In this article, we analyse the obstacles to giving more bite to benefit sharing provisions in health research through ethical review. We conclude that the provision of post-study access to healthcare interventions is not a promising mechanism when monitored through research ethics committees. Alternative benefit provision is preferable if one focuses on achieving compliance. However, even the latter faces challenges, which we address in specific recommendations. (shrink)

In 2006, the Indonesian government decided to withhold avian flu samples from the World Health Organization. They argued that even though Indonesian samples were crucial to the development of vaccines, the results of vaccine research would be unaffordable for its citizens. Commentaries on the case varied from alleging blackmail to welcoming this strong stance against alleged exploitation. What is clear is that the concern expressed is related to benefit sharing. Benefit sharing requires resource users to return benefits to resource providers (...) in order to achieve justice. One benefit sharing tool within health research is the duty to provide a health care intervention which has been proven to be beneficial (or alternative benefits) to research participants after a study has been concluded. This duty is generally known as a post-study obligation. It was enshrined in the Declaration of Helsinki in 2000 and re-emphasized in 2008. Yet, there are few, if any, examples of good practice. In this article, we analyse the obstacles to giving more bite to benefit sharing provisions in health research through ethical review. We conclude that the provision of post-study access to healthcare interventions is not a promising mechanism when monitored through research ethics committees. Alternative benefit provision is preferable if one focuses on achieving compliance. However, even the latter faces challenges, which we address in specific recommendations. (shrink)

Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n = 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts blood (...) glucose to help keep it within clinically recommended ranges. Individuals were recruited from UK sites and interviewed following trial close-out, at which point the closed-loop had been withdrawn. While individuals were stoical and accepting of the requirement to return the closed-loop, they also conveyed varying degrees of distress. Many described having relaxed diabetes management practices while using the closed-loop and having become deskilled as a consequence, which made reverting back to pre-trial regimens challenging. Participants also described unanticipated consequences arising from using a closed-loop. As well as deskilling, these included experiencing psychological and emotional benefits that could not be sustained after the closed-loop had been withdrawn and participants reevaluating their pre- and post-trial life in light of having used a closed-loop and now perceiving this life much more negatively. Participants also voiced frustrations about experiencing better blood glucose control using a closed-loop and then having to revert to using what they now saw as antiquated and imprecise self-management tools. We use these findings to argue that ethical debates about post-trial provisioning need to be broadened to consider potential psychological and emotional harms, and not just clinical harms, that may result from withdrawal of investigated treatments. We also suggest that individuals may benefit from information about potential nonclinical harms to help make informed decisions about trial participation. (shrink)

The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial obligations, (...) specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. (shrink)

Following the conclusion of a period of educational expansion during the last two decades, developing nations are now focusing attention upon adjusting some of those innovations made during the recent period of quantitative expansion. The paper examines how Trinidad and Tobago has responded to the need for adjustments in education provision during the current post‐expansionist period. In particular the paper analyzes Trinidad and Tobago's current reaction to the nation's system of double‐shift schooling, a device instituted during the 1970s as (...) part of Government's strategy for universal secondary education. Arguments both for and against the shift‐system are presented, and Trinidad and Tobago's insistence that the mechanism should be dismantled is critically examined. Explanations for the approach taken by Trinidad and Tobago towards the nation's double‐shift schooling are drawn from two sources: arguments about the state of the nation's economy, and policies regarding approaches to educational development planning in developing nations. (shrink)

This paper explores food commoning through an ethnographic case study in Catalonia as our primary site while the Norwegian case is juxtaposed as a comparison, two agriculturally and economically different European countries. The ethnography analyses cooperation networks between organic food producers’ and consumers’ involving different nodes of community gardening initiatives, self-employed growers, local farmers and all of them under a unique cooperative integrating a community economy. The result it is a myriad of exchange practices ranging from reciprocity and barter (...) to market exchange without intermediaries through on-line platforms. Along these exchanges different options of currency intervene giving rise to novel social and cooperative relations. Similar initiatives in Norway show less variation and are less experimental regarding forms of payment but share similarities in relation to material articulations, concerns and forms of alternative practice. Although these novel forms do not represent a complete break from the more standardized supply chains, and hence from the oppositions/contradictions of production and consumption, the participants see themselves as contributing to a more general process of de-commodification of food. We explore the extent to which the meaning and moral values are mutually constituted in relation to socioeconomic exchanges and environmental caring that each person experiences based on different forms of cooperation and reciprocity. Food, we suggest, is more than a commodity on the market that we may influence through our role as consumers. It is a significant focal point connecting our lives to those of others that articulates one’s relations to society in a political manner. (shrink)

This paper explores food commoning through an ethnographic case study in Catalonia as our primary site while the Norwegian case is juxtaposed as a comparison, two agriculturally and economically different European countries. The ethnography analyses cooperation networks between organic food producers’ and consumers’ involving different nodes of community gardening initiatives, self-employed growers, local farmers and all of them under a unique cooperative integrating a community economy. The result it is a myriad of exchange practices ranging from reciprocity and barter (...) to market exchange without intermediaries through on-line platforms. Along these exchanges different options of currency intervene giving rise to novel social and cooperative relations. Similar initiatives in Norway show less variation and are less experimental regarding forms of payment but share similarities in relation to material articulations, concerns and forms of alternative practice. Although these novel forms do not represent a complete break from the more standardized supply chains, and hence from the oppositions/contradictions of production and consumption, the participants see themselves as contributing to a more general process of de-commodification of food. We explore the extent to which the meaning and moral values are mutually constituted in relation to socioeconomic exchanges and environmental caring that each person experiences based on different forms of cooperation and reciprocity. Food, we suggest, is more than a commodity on the market that we may influence through our role as consumers. It is a significant focal point connecting our lives to those of others that articulates one’s relations to society in a political manner. (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and (...) Harvard University (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, (...) sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. (shrink)

The present article asks what lessons the empirical case of institutional change in post-Soviet Russia yields for the recent research on ideas and institutions. Its main point is that in post-Soviet Russia a clash between imported foreground ideas and deep domestic background ideas led to an ideational division among the elite of the country that became a main obstacle to the provision of coherent economic reforms. This story stands in some contrast to much of the newer literature on (...) ideas and institutions, which tends to see critical junctures as leading from one equilibrium to another. I argue that tensions between imported foreground ideas and deep domestic backgrounds are likely to occur in other cases of far-reaching processes of institutional change based on Western ideas but taking place beyond the realm of Western, industrialized countries. Therefore, I argue, some general lessons on the interplay between ideas and institutions might be drawn from this case study. (shrink)

Rwanda witnessed devastating conflicts leading to genocidal attacks in 1994 with active participation of the police in the pogrom. Various reports implicated the police in high-handedness, torture, extra judicial killings, intimidation, rape, and other heinous crimes during the conflicts. The police force was reformed for optimal performance. This paper examines the impact of the post-conflict reconstruction of the police on internal security management in Rwanda. Findings from the study, which relied on secondary data, are that reform impacted positively (...) on the performance of the police, sharpening its skills in crime detection and prevention and leading to improved security for lives and property in Rwanda. Over-reliance on dwindling external sources and dysfunctional equipment still undermines maximum performance by the police. There should be adequate provision of advanced security devices and better funding of the police for the optimal discharge of their constitutional mandates of securing lives and property in Rwanda. (shrink)

This paper critically evaluates the transition from crisis to development in northern Uganda from the perspective of agricultural service provision. It contributes to debates on how efforts to link relief to rehabilitation and development may bypass the underlying challenges in linking humanitarian aid to prevailing national development policies and structures. This paper is based on research into agricultural services undertaken in Pader district, northern Uganda, between 2010 and 2012. It studied the interplay between humanitarian interventions and the parallel development of (...) the government’s agricultural departments and services in northern Uganda. The article brings out how Ugandan agricultural policies do not suit the post-conflict realities of northern Uganda. The evolving policies affect power relations and processes of inclusion and exclusion in northern Uganda. As a result, at the time that the government is ready to integrate northern Uganda into the mainstream development of agricultural policy, the gap between addressing humanitarian needs and development has become larger. (shrink)

The impact of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 on the economic circumstances of women and children has received substantial research attention, but provisions of the act that attempt to influence women's reproductive behaviors have been much less studied. Provisions of PRWORA encouraged states to intensify efforts to restrict access to abortion and to decrease rates of nonmarital births, particularly among teenagers. Using state-level data, this study analyzes the effects of state policies enacted (...) in the wake of welfare reform, controlling for prior rates of abortion and unwed births. The authors find that economic-based incentives have only minor, and inconsistent, influence on statewide rates of abortion and nonmarital births in 2000. Results are consistent with feminist scholarship proposing that noneconomic considerations are more central in women's decision making about reproduction than economic factors. (shrink)

The provision of services by companies in specific domains requires continuous commitment and a constructive approach to meet customer requirements, however, it is often challenging to determine the level of customer satisfaction without their feedback. Therefore, this paper attempts to provide a solution to this problem by using comments from social networks and evaluating their sentiment using the VADER model. In order to accomplish the aim of our research, a lexicon has been built with more than 9500 adjectives and verbs (...) from the Albanian language based on VADER which is just in the initial form and the sentiments are evaluated as positive, neutral, or negative. The lexicon was constructed for the Albanian language and two companies of the Republic of Kosovo were researched as case studies. Furthermore, the sentiment estimation, using the VADER model, in case of our datasets, we obtained a high accuracy, approximately between 89% and 95%. This level of accuracy has been primarily attributed to the application of all preprocessing steps within the dataset, which significantly enhances the model’s performance. (shrink)

The article is a presentation and analysis of the main provisions of 16 works of the world's leading experts on religious tourism and pilgrimage, published in a special issue of the International Journal of Religious Tourism and Pilgrimage. 2020. Vol.8. This special issue was dedicated to the impact of the COVID-19 pandemic on religious tourism, and in particular pilgrimage, in the world. Religious tourism has a strong socio-cultural potential and demand - it is the value status of any person (...) who feels the need for cultural, religious and recreational facilities important for spiritual, ideological and physical existence. It is also the availability of opportunities to meet the social and cultural needs of people in tourism services, because it has such a socio-cultural characteristic as a social practice that changes a person and positions him in the social space. Religious tourism became in the XXI century. significant, socially significant phenomenon. But the current pandemic has dealt a very painful blow to the entire tourism sector of the world economy, including religious tourism. Under the influence of the pandemic, the country banned pilgrimage. So the question arose: what's next? Is there a radical transformation of the religious life of mankind, including religious tourism? Isn't this the beginning of the end of religions, as some sociologists of the past predicted? This article is devoted to finding answers to these and other, no less complex, questions. The author set a goal - based on the analysis of the latest research on the impact of the COVID-19 pandemic on religious tourism to identify and present those important points that are already relevant for religious tourism in Ukraine, as well as those that are just beginning to appear and will be relevant in the post. -pandemic era. In almost all articles of this Special Issue, the authors emphasized that religious tourism and pilgrimage are very sustainable and will meet the challenges posed by the pandemic. The question for the religious tourism and pilgrimage industry is how they will develop and transform new approaches that will help the growth strategies of key stakeholders. However, due to pandemic restrictions, it may not be possible to resume travel to holy sites and pilgrimage sites and trails without the assistance of national governments, international agencies, and relief organizations. Thus, the authors predict that the religious tourism industry will face very difficult circumstances in the near future. All articles in the special issue of this journal express extremely relevant, deep and valuable opinions of scientists, which make us all think about what lessons Ukraine should learn about religious tourism, and in particular pilgrimage, and what should be its state policy and public opinion in this regard. further. And the author in the conclusions expresses her point of view on the content of these lessons, based on the views set out in this article of the world's best experts in religious tourism and pilgrimage. (shrink)

The introduction of mass public education posed unfamiliar problems for the governments of modern states, and the ways in which governments worked through those problems can reveal much about the culture and values of a state. This paper focuses on central Government officials and the Ministers they advised, with particular attention to the pivotal period 1960-1976. Trends identified include: the shift from post-War optimism to the more pessimistic view of schooling since the late 1960s; the dynamics of professional development (...) amid over-rapid expansion and contraction; relationships between training institutions and schools; and policy-makers' changing perceptions of teachers as professionals. Four themes are considered in detail: the imperatives of numbers; status concerns as a driver of change; linkages among the 'partners' in the schooling enterprise; and accountability. Some questions are posed about the sustainability of the schooling enterprise in England and Wales. (shrink)

We examine the extent to which multiple social identities are associated with enhanced health and well-being in retirement because they provide a basis for giving and receiving social support. Results from a cross-sectional study show that retirees ( N = 171) who had multiple social identities following (but not prior to) retirement report being (a) more satisfied with retirement, (b) in better health, and (c) more satisfied with life in general. Furthermore, mediation analyses revealed an indirect path from multiple (...) social identities to greater satisfaction with retirement and better health through greater provision, but not receipt, of social support to others. These findings are the first to point to the value of multiple group membership post-retirement as a basis for increased opportunities to give meaningful support to others. We discuss the theoretical and practical implications for the management of multiple identities in the process of significant life transitions such as retirement. (shrink)

ABSTRACT: The Smith Report has generated central questions about the mathematics education of UK adolescents. This paper highlights the close match between the goals of school mathematics, adolescence and exploratory pedagogy. This is contrasted with the prescriptive nature of current regimes. In particular, without careful attention to pedagogy it is possible that the introduction of different pathways may lead to a failure to achieve the outcomes desired by employers and universities, and to inequity in provision for students.

This article reflects on the increasing roles of faith-based organisations (FBOs) and individual followers in the provision of health services in Zimbabwe within the context of declining capabilities of state-funded and state-owned health facilities. In colonial and post-colonial Africa in general and Zimbabwe in particular, FBOs have consistently contributed to the provision of public services and social security. We contend that state fragilities in the Zimbabwean political landscape result in severe public service delivery deficits that are often filled by (...) FBOs and individual followers. The implications for FBOs and individual followers are twofold. Firstly, the increased involvement of FBOs in the production and provision of public services such as education and health services afford FBOs with opportunities and spaces to evangelise. Secondly, and on the downward side, the provision of health services can often be expensive and diverts attention from the core business of these religious organisations. The article reveals that in the context of economic and governance crises, FBOs play an increasingly momentous role in providing health care services in Zimbabwe. The article focuses on Zimbabwe during the crisis periods of 2007–2009 and 2018 up to the current (2022) socio-economic and political declines, poor governance, and the subsequent fragilities in the state.Contribution: Faith-based organisations assume increasing roles in the provision of health services in place of failing states. Those increased roles provide FBOs opportunities to evangelise. However, FBOs are not a sustainable replacement because they become afflicted with the same financial challenges that bedevil the state. (shrink)

A feminist stock-taking on ‘post-conflict’, this paper revisits a study made by the author in 1996–1997, when the women's community sector was a lively actor in the processes leading to the Good Friday Peace Agreement of 1998. Refusing to observe sectarian conflict lines, women's centres were re-writing official ‘community development’ policy as community empowerment and political challenge. The author draws on new interviews conducted in 2012 with feminist community activists of that earlier period of ‘frontline feminism’, associated with (...) the Belfast Women's Support Network. The women reveal how continuing poverty, discrimination, violence and unhealed trauma still characterise working-class life in the post-conflict period, and impede the integration of Protestant and Catholic communities. Official provisions for gender equality have been interpreted in gender-neutral ways, and in some cases turned against women. The demilitarisation of masculinity has been painfully slow. The women's community sector has experienced a loss of political drive as women's centres have become service providers, dependent on state funding. Feminism is renewing itself, but in fresh forms with different priorities. Will it recover a voice that ‘speaks truth to power’? (shrink)

BackgroundThe number of autistic students graduating is increasing; however, little is known regarding their transition out of university. Understanding this transition is particularly pertinent with regard to the employment of autistic graduates. It is vital that we understand autistic people’s experiences of the transition and identify what support would be beneficial during this time.MethodThirty-four autistic graduates from the United Kingdom took part in a mixed-methods study exploring their transition experience. Both quantitative and qualitative questions were used to obtain in-depth (...) information concerning participants’ experiences. Participants completed questions regarding their experiences and emotions in relation to the transition, the support they received for the transition, and their career and post-graduation plans.ResultsParticipants reported high levels of fear and low preparedness for the transition. They did not feel well supported in preparing for the transition or for their future career. In the 6 months pre-graduation, 59% of participants had accessed emotion-related transition support and 70% accessed career-related support. Post-graduation, one-third accessed emotion-related or career-related support. Perspectives on this accessed support were mixed, as were transition experiences. Additional support desired included preparation for life changes, career planning, employment accessibility, and autism-specific support. Advice for future students centered on forward planning.ConclusionThese results highlight the importance of supporting autistic students with the transition out of university. Service provision should be tailored to autistic students’ needs and support early planning for the transition. (shrink)

Globalization and rapid information processes that are inherent in today's post-pandemic society, contributing to the reorganization of the authorities of many countries and their contacts with regions, local territorial units or civil society. Such changes, first of all, provide for delegation of authority at the level of regional and local authorities. However, many developing and today position their own society as post-modern, continue to be in a state of disunity of the branches of government, with a high level (...) of corruption and abuse of official position, improper distribution of resources, inappropriate tax system and incompetent provision of services by relevant authorities. This affects the relevance of studying foreign experience in building a rational, effective, balanced public administration system, the leading place in which in almost all developed countries is the decentralization of the state and, above all, the executive branch. The foreign experience of the successful implementation of decentralization reforms is investigated. The main characteristics inherent in the decentralization of power in European countries are given, including in the context of the existence of a pandemic. The features of decentralization of power in France, the UK, Germany and other countries are highlighted. It is substantiated that the experience of decentralization reforms in each country is unique and reflects the specifics of the development of a particular country, and therefore it is impractical to introduce foreign experience without taking into account the particular economic and political development of a particular country. (shrink)

Government policy aims at a 'seamless web' of learning provision. This is exemplified in a local Learning and Skills Council supported by work on widening participation to higher education (HE) in another London sub-region. The emerging system described is comprehended as a whole from 'Foundation Learning' in compulsory schooling to post-compulsory 'Lifelong Learning' in further, higher and continuing education and training thereafter.

We address the considerations of the European Commission Expert Group on the ethics of connected and automated vehicles regarding data provision in the event of collisions. While human drivers’ appropriate post-collision behavior is clearly defined, regulations for automated driving do not provide for collision detection. We agree it is important to systematically incorporate citizens’ intuitions into the discourse on the ethics of automated vehicles. Therefore, we investigate whether people expect automated vehicles to behave like humans after an accident, even (...) if this behavior does not directly affect the consequences of the accident. We find that appropriate post-collision behavior substantially influences people’s evaluation of the underlying crash scenario. Moreover, people clearly think that automated vehicles can and should record the accident, stop at the site, and call the police. They are even willing to pay for technological features that enable post-collision behavior. Our study might begin a research program on post-collision behavior, enriching the empirically informed study of automated driving ethics that so far exclusively focuses on pre-collision behavior. (shrink)

Care after research is for participants after they have finished the study. Often it is NHS-provided healthcare for the medical condition that the study addresses. Sometimes it includes the study intervention, whether funded and supplied by the study sponsor, NHS or other party. The NHS has the primary responsibility for care after research. However, researchers are responsible at least for explaining and justifying what will happen to participants once they have finished. RECs are responsible for considering (...) the arrangements. There are ethical and practical issues, in particular when participants may wish to continue on the study intervention after the study. There are also various guidelines and legislation. This document presents a framework of questions to help NHS RECs and their applicants. Information on this document’s development is here. (shrink)

Food is becoming an increasingly important issue in the urban context. Urban food policies are a new phenomenon in Czechia, where urban food alternatives to the current food regime are promoted by food movements or take the form of traditional self-provisioning. This paper examines how urban food governance in Prague and Brno is constituted based on the municipalities’ relations with actors engaged in urban food alternatives. We argue that prioritizing aspects of local food system transformation compliant with the status quo (...) is non-systemic and implies a fragmentation of urban food alternatives based on different levels of social capital and radicality. We conceptualize urban food alternatives as values-based modes of production and consumption and focus on values that guide urban food governance in its participatory and territorial interplay with the actors of urban food alternatives. Our analysis reveals that the values underpinning the two cities’ progressive food policies do not match reality on the ground. We propose four types of relations between the two examined cities and aspects of the local food system transformation. Aspects compliant with the status quo, such as food waste reduction and community gardening are embraced, whereas those requiring more public intervention, such as public procurement, short supply chains, or the protection of cultivable land are disregarded, degraded, or, at most, subject to experimentation as part of biodiversity protection. Chances for a successful transformation of the local food system under such governance are low but can be increased by strengthening social capital and coalition work among urban food alternatives. (shrink)

The book offers insights on whether international law can shape the politics of the Security Council and, conversely, the extent to which the latter contribute to the development of international law. By providing a systematic analysis of the quantity and quality of international legal instruments referred to in the text of resolutions, the book reconstructs patterns of the Security Council's behavioural regularities and assesses them against the provisions of the United Nations Charter, which establishes its mandate. The analysis is (...) divided into three periods - the origins and Cold War period, post-Cold War period and the twenty-first century - and assesses the resolutions passed in each period by thematic category. The book argues that while international law plays an important role in shaping the politics of the Security Council, the Council's resolutions do not contribute significantly to the development of international law. (shrink)

There has been a backlash from recently graduated proponents of the Dutch Reformed Church of South Africa that they are unemployed not just because of dwindling church member numbers, but mainly because contract posts are being filled by retired ministers and not by the proponents. International research suggests that the reason retired ministers continue working is not necessarily because they want to, but because they do not have sufficient retirement savings. The aim of this study was to examine the (...) perceptions of Dutch Reformed ministers who would reach retirement age within the next 5 years, in an effort to establish their preparedness for retirement. The respondents were sent a link to an online questionnaire and 147 useable questionnaires were returned, representing a response rate of 47.7%. The results indicated that almost half of the respondents stated that they would want to continue working in a part-time ministerial post after retirement and that the ministers’ motivation to continue working was directly linked to their lack of financial provision for retirement. A major cause for concern is the high number of respondents who selected the ‘uncertain’ response option for most of the retirement questions, as they are so close to retirement. An intervention to incorporate financial management specifically in theological training is urgently needed. (shrink)

Recent scholarship has considered what, if anything, rich people owe to poor people to achieve justice in global health and the implications of this for international research. Yet this work has primarily focused on international clinical research. Health systems research is increasingly being performed in low and middle income countries and is essential to reducing global health disparities. This paper provides an initial description of the ethical issues related to priority setting, capacity-building, and the provision of post-study benefits (...) that arise during the conduct of such research. It presents a selection of issues discussed in the health systems research literature and argues that they constitute ethical concerns based on their being inconsistent with a particular theory of global justice (the health capability paradigm). Issues identified include the fact that priority setting for health systems research at the global level is often not driven by national priorities and that capacity-building efforts frequently utilize one-size-fits-all approaches. (shrink)

The need for continuing provision of beneficial experimental interventions after research is concluded remains a controversial topic in bioethics for research. Based on the principle of beneficence, justice as reciprocity, concerns about exploitation and fair benefits, participants should be able to have continuing access to benefits beyond the research period. However, there is no consensus about whether or not post-trial provision of beneficial interventions should be mandatory for participants from developing countries. This paper summarises recommendations from international and national (...) guidelines. Ethical principles and practical issues relating to post-trial provision are also discussed. In conclusion, post-trial provision is not necessary in all situations and a set of criteria are proposed to identify the situations that beneficial interventions should be provided beyond the research period. However, mandatory post-trial supply of beneficial experimental interventions should be assured for those who still need and are able to benefit from them but have no alternative access. Mandatory provision is based on universal bioethical principles such as beneficence and justice. Furthermore, difficulties associated with implementation of post-trial provision are not unmanageable. Careful advanced planning and a comprehensive partnership among relevant parties would be very helpful in solving these difficulties in practice, which therefore should not be taken as an excuse to escape post-trial responsibility. (shrink)

The ethical value—and to some scholars, necessity—of providing trial patients with post-trial access (PTA) to an investigational drug has been subject to significant attention in the field of research ethics. Although no consensus has emerged, it seems clear that, in some trial contexts, various factors make PTA particularly appropriate. We outline the atypical aspects of psychedelic clinical trials that support the case for introducing the provision of PTA within research in this field, including the broader legal status of psychedelics, (...) the nature of the researcher-therapist/participant relationship, and the extended time-frame of the full therapeutic process. As is increasingly understood, the efficacy of psychedelic-assisted psychotherapy is driven as much by extrapharmacological elements and the cultural therapeutic container as by the drug itself. As such, we also advocate for a refocusing of attention from post-trial access to a broader concept encompassing other elements of post-trial care. We provide an overview of some of the potential post-trial care provisions that may be appropriate in psychedelic clinical trials. Although the World Medical Association’s Declaration of Helsinki calls on researchers, sponsors, and governments to make provisions for post-trial access, such provision may feel impracticable or out-of-reach within psychedelic trials that are already constrained by a high resource demand and significant bureaucratic burden. We show how conceiving of post-trial provision as an integral site of the research process, and an appropriate destination for research funding, will serve to develop the infrastructure necessary for the post-legalisation psychedelic medicine ecosystem. (shrink)

Todos los días se prueban nuevos psicofármacos, tratamientos para el VIH/SIDA o el cáncer, entre otras enfermedades. Algunos de esos tratamientos son lo suficientemente exitosos como para cronificar enfermedades antes consideradas mortales, como los antirretrovirales para el VIH/SIDA o el imatinib para la leucemia mieloide a principios del 2000. No obstante, antes de que puedan ser comercializados o estar disponibles en los sistemas de salud pública, deben pasar por una serie de rigurosas pruebas de calidad, seguridad y eficacia. Estas pruebas (...) implican el testeo de las drogas en animales y su estudio en seres humanos, sanos o enfermos. Estrictas normas de buenas prácticas científicas y éticas regulan todo el proceso de las investigaciones biomédicas. El problema de mi tesis se centra en el momento de la finalización de los estudios en seres humanos. Alguien podría preguntarse qué pasa con las personas si se benefician clínicamente del tratamiento experimental durante el estudio cuando este finaliza. La interrupción abrupta de un tratamiento beneficioso podría poner en peligro la salud de los sujetos. Y en el caso de sujetos de investigación afectados por enfermedades crónicas, es probable que deban continuar con el tratamiento beneficioso u otra atención adecuada por el resto de sus vidas. Un sujeto de investigación estadounidense sin seguro de salud que participó en un estudio de largo plazo de diabetes resume estas preocupaciones: "de repente cortan la cuerda, y uno está solo por su cuenta ... O conseguís trescientos o cuatrocientos dólares por mes para seguir con esto o simplemente seguís adelante y morís". Este tipo de casos me llevaron a preguntar si existe alguna obligación moral de proveer el tratamiento beneficioso a un sujeto de investigación que no puede pagárselo. Muchas personas podrían pensar que interrumpir el tratamiento beneficioso al sujeto de investigación que padece de diabetes y no tiene seguro para cubrir un tratamiento es incorrecto, porque nadie debería morir de una enfermedad o dedicar todos los recursos disponibles para sobrevivir, especialmente cuando se contribuyó a encontrar una cura o a obtener la evidencia científica necesaria para desarrollar un mejor tratamiento que el existente. Otras personas podrían pensar que lo correcto es ofrecer el tratamiento a un "precio justo", y si la persona no puede pagar por la continuidad de tratamiento es su responsabilidad. Mi intuición es que una sociedad democrática justa tiene una obligación moral de establecer un sistema de continuidad de tratamiento beneficioso para los sujetos de investigación. En esta tesis intento justificar filosóficamente esta última intuición básica utilizando el marco teórico de la teoría de la justicia de Rawls. Elijo utilizar la teoría rawlsiana, porque esta teoría me permite ubicar los problemas morales con respecto a la continuidad de tratamiento beneficioso en su contexto social adecuado y en el contexto de la búsqueda general de una sociedad más justa. En particular, la encuentro especialmente adecuada para explicar fenómenos complejos de responsabilidad social como los que creo que subyacen en el problema de la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Como mostraré más adelante, es imposible tener en cuenta los aspectos morales de la continuidad de tratamiento beneficioso aislada de la sociedad en la que se realizan los estudios con seres humanos. En el capítulo 1 presento una introducción general al tema de la ética de la investigación y al problema de la continuidad de tratamiento beneficioso. En el capítulo 2 intento determinar el campo de estudio de la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Para eso, mi estrategia es la siguiente. Primero, busco identificar los casos de estudios clínicos donde se daría la obligación de continuidad beneficiosa hacia los sujetos de investigación. Segundo, presento el problema de la justificación moral de la obligación de continuidad y la necesidad de discutir las justificaciones basadas en la idea de justicia como reciprocidad. Para esto, en la sección 2, identifico la obligación de continuidad de tratamiento a través de una selección de sus casos paradigmáticos en la literatura. Comienzo con el caso de los estudios clínicos con antirretrovirales llevados a cabo en Sudáfrica en personas con VIH/SIDA. Luego, introduzco el concepto teórico de sistema de continuidad de tratamiento beneficioso. Este concepto me permite evaluar y comparar teóricamente cómo diferentes sociedades hacen frente al problema de proveer la continuidad de tratamiento beneficioso a los sujetos de investigación. Por último, rastreo los casos ejemplares de obligación de continuidad de tratamiento beneficioso hacia los sujetos en países desarrollados, con énfasis especial en los Estados Unidos. En la sección 3, analizo algunos problemas de confusión o ambigüedad más importantes en torno a la obligación. Primero, analizo el nombre de la obligación. Luego, trato de distinguir la obligación de continuidad de tratamiento hacia los sujetos de investigación de la obligación de disponibilidad razonable, una confusión muy común en la literatura de la ética de la investigación. Finalmente, me detengo a analizar una posible ambigüedad en el concepto de "tratamiento beneficioso" y utilizo algunos de los casos paradigmáticos identificados para argumentar a favor de mi interpretación. Atacado el primer problema, en la sección 4 y 5 me vuelco a relevar el problema de la justificación moral de la obligación de continuidad. En la sección 4, reconstruyo lo que llamo la "versión simple" del concepto de obligación a partir de la discusión sobre las fuentes de la obligación de continuidad de tratamiento beneficioso. Luego, planteo la necesidad de investigar las justificaciones basadas en la idea de justicia como reciprocidad debido a las ambigüedades y la falta de un marco teórico claro dentro del campo de la ética de la investigación en seres humanos. Finalmente, en la sección 5, introduzco algunas distinciones clásicas con el fin de complejizar el marco teórico de las obligaciones, el cual será utilizado en la discusión de los próximos dos capítulos. En el capítulo 3 discuto la justificación de la obligación de continuidad de tratamiento que da el modelo económico de Alan Wertheimer. En la sección 1 del capítulo, debido a lo específico del tema y lo poco conocido del autor, introduzco a la persona y el contexto institucional de su obra. En la sección 2 del capítulo, distingo tres interpretaciones del concepto de justicia como reciprocidad e intento mostrar que Wertheimer utiliza una interpretación caracterizada por el uso mutuo y el intercambio de beneficios, a la cual llamo "reciprocidad de mercado". En la sección 3, presento el marco teórico del modelo económico. La pregunta fundamental de Wertheimer es la siguiente: ¿tienen los investigadores o patrocinadores una obligación supercontractual de proporcionar la continuidad de tratamiento u otros beneficios a los sujetos de investigación? Según el autor, el consenso en ética de la investigación responde de manera afirmativa a esta pregunta y como fundamento de esta obligación se encontraría lo que Wertheimer llama "el principio de interacción". Analizo este principio y presento las críticas que hace Wertheimer al mismo. En la sección 4, presento la respuesta a la pregunta fundamental que da Wertheimer mediante su "argumento estratégico". En la sección 5 analizo la solución dada por Wertheimer e intento explicar algunos de los supuestos principales del modelo, a saber, (i) la lógica del argumento estratégico, (ii) la fuerza moral de los conceptos de Pareto y (iii) el compromiso del modelo económico con la restricción de la información. Por último, en la sección 6 presento mis críticas al modelo económico. En el capítulo 4 presento el modelo de reciprocidad democrática, inspirado en la teoría de la justicia de Rawls. Este modelo se presenta como un marco teórico y una interpretación de la justicia como reciprocidad alternativos al modelo económico presentado en el capítulo anterior. En la sección 2 del presente capítulo, explicito los problemas del marco teórico relacionados con el concepto de justicia como reciprocidad que subyacen a la discusión sobre la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Para esto, me centro en tres puntos: (i) la relación del principio de justicia como reciprocidad y el concepto de obligación; (ii) el problema del alcance del principio de reciprocidad, y (iii) la relación entre el principio de reciprocidad y el concepto de equidad, o lo que llamo "el problema de la medida de la reciprocidad". En la sección 3, defino con mayor claridad el enfoque rawlsiano de la justicia distributiva y expongo una crítica a los argumentos antirrawlsianos esgrimidos por los defensores del modelo económico que afirman que los principios de justicia política de Rawls no se aplican a los individuos. Si mi respuesta a los defensores del modelo económico es correcta, los principios de justicia política se aplican a los individuos de manera indirecta, mediante la asignación de obligaciones posicionales por parte de la estructura básica de instituciones de una sociedad democrática, y permiten garantizar igual justicia a todos los miembros de la sociedad. En la sección 4, presento mi propuesta original de cómo entender la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Esta sería una obligación posicional perfecta correlativa con el derecho a la salud en sociedades democráticas justas o moderadamente injustas. En la sección 5, muestro de manera detallada el mecanismo apropiado para extender los principios de justicia política al caso de la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Con este objetivo, introduzco la idea de secuencia en cuatro etapas, que permite evaluar y diseñar nuevos esquemas institucionales para dar contenido a la obligación de continuidad de tratamiento. Y presento los principios de obligaciones y deberes individuales, que cierran el sistema rawlsiano brindando razones morales a los individuos para extender los esquemas institucionales justos a nuevas situaciones, reformar los existentes y cumplir con las obligaciones posicionales asignadas por estos nuevos esquemas. Por último, en la sección 6, discuto las objeciones más importantes al modelo de justificación de reciprocidad democrática. Por último, en la conclusión general, hago un intento de aplicación del marco teórico del modelo de reciprocidad democrática al análisis de los sistemas de continuidad de tratamiento para países como Argentina o Brasil y presento las líneas más importantes para la investigación futura. (shrink)

This study investigates factors that motivate users of social network sites to write responses to support-seeking posts on SNS. In particular, support-seeking message valence and support providers’ efficacy perceptions were examined. An online experiment with 209 participants revealed that participants reported lower support provision efficacy and impression management efficacy when responding to a negative post than a positive post. Message valence and efficacy perceptions impacted word count and emotion words in their responses. Theoretical and pragmatic implications for (...) supportive communication and computer-mediated communication were discussed. (shrink)

A growing body of work suggests that the presence of women and of independent directors on boards of directors is associated with higher corporate environmental performance. However, the mechanisms linking board composition to corporate environmental performance are not well understood. This study proposes and empirically tests the mediating role of sustainability-themed alliances in the relationship between board composition and corporate environmental performance. Using the population of public oil and gas firms in the United States as the sample, the (...) class='Hi'>study relies on renewable energy alliances to measure sustainability-themed alliances and longitudinally analyzes lagged data for independent and control variables. The study found that the higher the representation of women on a firm’s board, the more likely the firm is to form sustainability-themed alliances, and the higher the representation of independent directors on a firm’s board, the more likely the firm is to form sustainability-themed alliances. Such alliances, in turn, positively contribute to corporate environmental performance. This paper discusses the study’s contributions to the board composition-social performance literature. (shrink)

The concept of altruism, or disinterested concern for another's welfare, has been discussed by everyone from theologians to psychologists to biologists. In this book, evolutionary, neurological, developmental, psychological, social, cultural, and religious aspects of altruistic behavior are examined. It is a collaborative examination of one of humanity's essential and defining characteristics by renowned researchers from various disciplines. Their integrative dialogue illustrates that altruistic behavior is a significant mode of expression that can be studied by various scholarly methods and understood from (...) a variety of perspectives in both the humanities and the sciences. Altruism and Altruistic Love establishes a framework for scholarship on altruism by presenting definitions, a historical overview, a review of contemporary research, and debates in various disciplines, as well as a discussion of directions for future work. (shrink)

Although studies show that those who are physically or psychologically overwhelmed by the needs of others do experience a stressful burden that can have significant negative health consequences, little attention has been given to whether there are health benefits from helping behaviour that is fulfilling, not overwhelming. In this book, Stephen Post brings together distinguished researchers from basic science to address this question in objective terms. The book provides heuristic models, from evolution and neuroscience, to explain the association between (...) altruism and health, and examine potential public health and practical implications of the existing data. (shrink)

This article describes the nature of ethical dilemmas in perioperative nursing practice. Using the Critical Incident Technique, common ethical dilemmas experienced by periop erative nurses are explored. The aim of the study was to elicit the ethical dilemmas that arise in perioperative nurses' practice. The study has a descriptive design and the data are critical incidents described by 48 anaesthetic nurses and 76 operating theatre nurses. An analysis of the critical incidents gave four domains of ethical dilemmas: those (...) arising as value conflicts in the intraoperative phase of surgery; those emanating from the patient's right of self- determination ; those arising in caring for patients; and those resulting from the alloca tion of scarce resources and the demands of increased effectiveness. (shrink)

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires as a condition of accreditation that every health care institution -- hospital, nursing home, or home care agency -- have a standing mechanism to address ethical issues. Most organizations have chosen to fulfill this requirement with an interdisciplinary ethics committee. The best of these committees are knowledgeable, creative, and effective resources in their institutions. Many are wellmeaning but lack the information, experience, and skills to negotiate adequately the complex ethical (...) issues that arise in clinical and organizational settings. Handbook for Health Care Ethics Committees is the first resource designed to address the range of work performed by ethics committees as part of their multiple responsibilities, including education, case consultation, and policy development. It features an eight-chapter curriculum reviewing the content of contemporary health care bioethics and discussing the ethical foundations of clinical practice, with each subsequent section focusing on a set of ethical issues that commonly arise in the clinical setting. Through case studies, the authors explore issues such as informed consent and refusal, decision making and decisional capacity, truth telling, decision-making concerns of minors, end-of-life issues, palliation, justice in and access to health care services, and organizational ethics. They offer sample policies and procedures, draft guidelines and protocols, and key legal cases. Providing both a strong theoretical foundation and practical applications, this handbook will be essential reading for every member of a health care ethics committee. (shrink)

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, (...) courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. (shrink)

This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical (...) products in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs. (shrink)