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1.
Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines. 相似文献
2.
Health research has been identified as a vehicle for advancing global justice in health. However, in bioethics, issues of global justice are mainly discussed within an ongoing debate on the conditions under which international clinical research is permissible. As a result, current ethical guidance predominantly links one type of international research (biomedical) to advancing one aspect of health equity (access to new treatments). International guidelines largely fail to connect international research to promoting broader aspects of health equity – namely, healthier social environments and stronger health systems. Bioethical frameworks such as the human development approach do consider how international clinical research is connected to the social determinants of health but, again, do so to address the question of when international clinical research is permissible. It is suggested that the narrow focus of this debate is shaped by high‐income countries' economic strategies. The article further argues that the debate's focus obscures a stronger imperative to consider how other types of international research might advance justice in global health. Bioethics should consider the need for non‐clinical health research and its contribution to advancing global justice. 相似文献
3.
Many guidelines for international research require that studies be responsive to host community health needs or health priorities. Although responsiveness possesses great intuitive and rhetorical appeal, existing conceptions are confusing and difficult to apply. Not only are there few examples of what research the responsiveness requirement permits and what it rejects, but its application can lead to contradictory results. Because of the practical difficulties in applying responsiveness and the danger that misapplying responsiveness could harm the interests of developing countries, we argue that responsiveness should be refocused in three ways: in terms of (1) who enforces it, (2) under what standard, and (3) in what cases. We conclude that responsiveness should be applied by host country officials at the policy level with the exercise of judgment when externally funded research threatens to displace scarce local resources. 相似文献
4.
Danielle M. Wenner 《Developing world bioethics》2015,15(2):76-84
In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is fundamentally grounded in the social value of knowledge, and that this value is context‐dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings. 相似文献
5.
Community engagement is gaining prominence in global health research. So far, a philosophical rationale for why researchers should perform community engagement during such research has not been provided by ethics scholars. Its absence means that conducting community engagement is still often viewed as no more than a ‘good idea’ or ‘good practice’ rather than ethically required. In this article, we argue that shared health governance can establish grounds for requiring the engagement of low‐ and middle‐income country (LMIC) community members in global health research, where such research aims to help reduce health disparities. This philosophical basis has important implications for the ethical goals ascribed to engagement and the approach adopted to undertake it. We suggest the ethical goals of engagement in equity‐oriented global health research should include: (a) generating research topics and questions that reflect the key problems disadvantaged groups face in accessing healthcare, services and broader social determinants of health and (b) promoting the translation of research findings into policy and practice in ways that benefit the health of disadvantaged groups. We propose engagement practice should have the following features: deliberation with LMIC community members to make a range of project decisions, beginning with setting research topics and questions; inclusion of members of disadvantaged groups and those with the power to change policy and practice to benefit them; and purposeful structuring of deliberations to minimize the impact of power disparities between LMIC community members. Finally, we reflect on how these features differ from those typical of much current community engagement practice in LMICs. 相似文献
6.
Carl H. Coleman Chantal Ardiot Sverine Blesson Yves Bonnin Francois Bompart Pierre Colonna Ames Dhai Julius Ecuru Andrew Edielu Christian Herv Franois Hirsch Bocar Kouyat Marie‐France Mamzer‐Bruneel Dionko Maound Eric Martinent Honor Ntsiba Grard Pel Gilles Quva Marie‐Christine Reinmund Samba Cor Sarr Abdoulaye Sepou Antoine Tarral Djetodjide Tetimian Olaf Valverde Simon Van Nieuwenhove Nathalie Strub‐Wourgaft 《Developing world bioethics》2015,15(3):241-247
Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel ‘pre‐review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. 相似文献
7.
MATTHEW R. HUNT 《Developing world bioethics》2008,8(2):59-69
Health professionals are involved in humanitarian assistance and development work in many regions of the world. They participate in primary health care, immunization campaigns, clinic- and hospital-based care, rehabilitation and feeding programs. In the course of this work, clinicians are frequently exposed to complex ethical issues. This paper examines how health workers experience ethics in the course of humanitarian assistance and development work. A qualitative study was conducted to consider this question. Five core themes emerged from the data, including: tension between respecting local customs and imposing values; obstacles to providing adequate care; differing understandings of health and illness; questions of identity for health workers; and issues of trust and distrust. Recommendations are made for organizational strategies that could help aid agencies support and equip their staff as they respond to ethical issues. 相似文献
8.
As a result of increased interest in global health, more and more medical students and trainees from the 'developed world' are working and studying in the 'developing world'. However, while opportunities to do this important work increase, there has been insufficient development of ethical guidelines for students. It is often assumed that ethics training in developed world situations is applicable to health experiences globally. However, fundamental differences in both clinical and research settings necessitate an alternative paradigm of analysis. This article is intended for teachers who are responsible for preparing students prior to such experiences. A review of major ethical issues is presented, how they pertain to students, and a framework is outlined to help guide students in their work. 相似文献
9.
Rebekah Sibbald Bethina Loiseau Benedict Darren Salem A. Raman Helen Dimaras Lawrence C. Loh 《Developing world bioethics》2016,16(1):55-60
Contemporary emphasis on creating culturally relevant and context specific knowledge increasingly drives researchers to conduct their work in settings outside their home country. This often requires researchers to build relationships with various stakeholders who may have a vested interest in the research. This case study examines the tension between relationship development with stakeholders and maintaining study integrity, in the context of potential harms, data credibility and cultural sensitivity. We describe an ethical breach in the conduct of global health research by a arising from the ad‐hoc participation of a community stakeholder external to the visiting research group. A framework for reflection is developed from a careful examination of underlying factors and presented with a discussion of consequences and mitigation measures. This framework aims to present lessons learned for researchers working abroad who might face similar situations in their work. 相似文献
10.
Tom Andreassen 《Developing world bioethics》2015,15(3):152-161
Instead of impeding access to essential medicines in developing countries, the essay explores why and how patents can serve as a source of funding for the much needed access to medicine. Instead of a weakening of patents, prolonged protection periods are suggested in circumstances where there is widespread lack of access. The revenues from extended patents are seen as a source of funding for drug donations to the least developed countries. 相似文献
11.
'Researcher identity' affects global health research in profound and complex ways. Anthropologists in particular have led the way in portraying the multiple, and sometimes tension-generating, identities that researchers ascribe to themselves, or have ascribed to them, in their places of research. However, the central importance of researcher identity in the ethical conduct of global health research has yet to be fully appreciated. The capacity of researchers to respond effectively to the ethical tensions surrounding their identities is hampered by lack of conceptual clarity, as to the nature and scope of the issues involved. This paper strives to provide some clarification of these ethical tensions by considering researcher identity from the perspective of (1) Guillemin and Heggen's (2009) key distinction between procedural ethics and ethics in practice, and (2) our own distinction between perceptions of identity that are either symmetrical or asymmetrical, with the potential to shift research relationships toward greater or lesser ethical harmony. Discussion of these concepts is supported with ethnographic examples from relevant literature and from our own (United States (US) Government-funded) research in South Africa. A preliminary set of recommendations is provided in an effort to equip researchers with a greater sense of organization and control over the ethics of researcher identity. The paper concludes that the complex construction of researcher identity needs to be central among the ethical concerns of global health researchers, and that the conceptual tools discussed in the paper are a useful starting point for better organizing and acting on these ethical concerns. 相似文献
12.
This article draws attention to the limited amount of scholarship on what constitutes fairness and equity in resource allocation to health research by individual funders. It identifies three key decisions of ethical significance about resource allocation that research funders make regularly and calls for prioritizing scholarship on those topics – namely, how health resources should be fairly apportioned amongst public health and health care delivery versus health research, how health research resources should be fairly allocated between health problems experienced domestically versus other health problems typically experienced by disadvantaged populations outside the funder's country, and how domestic and non‐domestic health research funding should be further apportioned to different areas, e.g. types of research and recipients. These three topics should be priorities for bioethics research because their outcomes have a substantial bearing on the achievement of health justice. The proposed agenda aims to move discussion on the ethics of health research funding beyond its current focus on the mismatch between worldwide basic and clinical research investment and the global burden of disease. Individual funders’ decision‐making on whether and to what extent to allocate resources to non‐domestic health research, health systems research, research on the social determinants of health, capacity development, and recipients in certain countries should also be the focus of ethical scrutiny. 相似文献
13.
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. 相似文献
14.
Growing demand for direct care workers to assist care‐dependent elderly people has created an opening for migrant workers from low‐ income nations to sell their services to middle and high‐income nations. Using Singapore as a case example, we draw on capability theory to make the case that receiving nations that import direct care workers should be held to global justice standards that protect workers’ floor level human capabilities. Specifically, we (1) show that Singapore and other receiving nations fail to protect human capabilities at a threshold level required by dignity; (2) identify specific human capabilities placed at risk; and (3) recommend standards for receiving nations that support central capabilities. As populations in both developed and developing nations are rapidly aging, these concerns could not be timelier. 相似文献
15.
TRISHA PHILLIPS 《Bioethics》2012,26(1):49-56
This paper challenges the fitness of Angela Ballantyne's proposed theory of exploitation by situating her ‘fair risk account’ in an ongoing dialogue about the adequacy conditions for benchmarks of fairness. It identifies four adequacy conditions: (1) the ability to focus on level rather than type of benefit; (2) the ability to focus on micro‐level rather than macro‐level fairness; (3) the ability to prevent discrimination based on need; and (4) the ability to prescribe a certain distribution as superior to all others. While the fair risk account satisfies the first condition, this paper argues that it has difficulty satisfying the last three conditions. Ballantyne's proposal includes several new and promising features, but in order for the fair risk account to be useful in identifying and preventing exploitation, Ballantyne must either clarify and augment her theory or challenge the relevance of the adequacy conditions it fails to meet. 相似文献
16.
Angeliki Kerasidou 《Bioethics》2019,33(4):495-501
Collaborations in global health research are on the rise because they enhance productivity, facilitate capacity building, accelerate output and make tackling big, multifactorial research questions possible. In this paper, I examine the concepts of trust and reliance in scientific collaborations in general, but also in the particular context of collaborations in global health research between high‐income countries and low‐and‐middle income countries (LMIC). I propose and defend the argument that given the particular characteristics of collaborations and demands of trust relationships, reliance is a better relational mode for successful collaborations. Although reliance can be difficult to establish in situations where asymmetry of power exists, trust should not be the only relational mode available to LMIC researchers because of the type of vulnerability it introduces to the relationship. I conclude that the promotion of good collaborations requires addressing the power imbalances between partners, and establishing an even playing field in global health research. 相似文献
17.
In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health‐care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health‐care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy‐making levels. 相似文献
18.
ANGELA BALLANTYNE 《Developing world bioethics》2008,8(3):178-191
There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally‐sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. It proceeds from the premise that there are good grounds for thinking that, at least some, international research sponsors exploit trial participants because they do not provide the research population with a fair share of the benefits of research. This provides a prima facie argument for increasing the benefits for research participants. Concern over undue inducement is a legitimate moral concern; however, if this concern is to prevent research populations from receiving their fair share of benefits from research there must be sufficient evidence that these benefits will unduly influence patients’ decision‐making regarding trial participation. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants’ motivations and the influence of payments on research subjects’ behaviour and risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects’ behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. 相似文献
19.
Bridget Pratt 《Developing world bioethics》2019,19(1):45-60
Engaging citizens is vital to achieving people‐centred health research. This paper aims to put attention to dynamics of power and dynamics of difference back at the centre of citizen engagement in health research priority‐setting. Without attention to power and difference, engagement can lead to presence without voice and voice without influence, particularly for disadvantaged and marginalised groups. By analysing six key bodies of literature, the paper first identifies the different components of engagement—who initiates, for what purpose, who participates, and how they participate—and the dynamics of power and dynamics of difference relevant to them. For each component of engagement, the ethical considerations relating to those dimensions of power and dimensions of difference are characterised for the research priority‐setting context and preliminary guidance on how they might be addressed is provided. An initial framework comprised of a series of questions reflecting these ethical considerations has been developed for use by researchers and citizens when designing engagement processes for research projects. Where researchers and citizens attend to the framework's questions and then revise their priority‐setting processes’ design to better represent diversity and mitigate power disparities, more inclusive citizen engagement is promoted. Disadvantaged and marginalised groups are more likely to be present and heard, which, in turn, will help generate research projects with topics and questions that encompass and more accurately reflect their health needs. 相似文献
20.
Nancy S. Jecker 《Developing world bioethics》2023,23(1):5-14
Global scarcity of COVID-19 vaccines raises ethical questions about their fair allocation between nations. Section I introduces the question and proposes that wealthy nations have a duty of justice to share globally scarce COVID-19 vaccines. Section II distinguishes justice from charity and argues that beneficiaries of unjust structures incur duties of justice when they are systematically advantaged at others expense. Section III gives a case-based argument describing three upstream structural injustices that systematically advantaged wealthy countries and disadvantaged poorer countries, contributing to global disparities of COVID-19 vaccines. Section IV examines more closely the duties of justice owed, including a duty to relinquish holdings, restitute victims, and restore relationships. Section V concludes that wealthy nations have a duty of justice to share COVID-19 vaccines with poor nations and to restore relationships damaged by injustice. All nations should take steps to transform unjust structures. 相似文献