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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 (...) |
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The distribution of resources around the globe is characterized by staggering inequalities and inequities, with the result that individuals in lower income countries have greater disease burden and... |
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This paper examines the moral force of exploitation in developing world research agreements. Taking for granted that some clinical research which is conducted in the developing world but funded by developed world sponsors is exploitative, it asks whether a third party would be morally justified in enforcing limits on research agreements in order to ensure more fair and less exploitative outcomes. This question is particularly relevant when such exploitative transactions are entered into voluntarily by all relevant parties, and both research (...) |
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(2010). Response to Open Peer Commentaries on “How to Do Research Fairly in an Unjust World”. The American Journal of Bioethics: Vol. 10, No. 6, pp. W4-W6. |
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Ballantyne correctly notes the need for clarification as to the standard of fairness that should guide nonexploitative international research on human subjects. When accounts of exploitation are applied to pharmaceutical development (as well as other areas), there is too often an uncritical acceptance that exploitation involves a form of unfairness. Moreover, these authors typically fail to produce an account of fairness by which exploitation should be identified. Ballantyne should be applauded for her attempt to inject greater clarity into these debates. (...) |
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Angela Ballantyne (2010) argues that international research is exploitative when the transactions between researchers and participants who lack basic goods do not provide participants with the maxi... |
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INTRODUCTION: The COVID-19 pandemic has necessitated revisiting the matter of allocating scarce healthcare resources. During pandemics and natural disasters, applying certain allocation methods is inevitable due to an uncontrollable surge in the need for scarce resources, and those methods should distribute potential benefits and burdens according to the principle of justice. This article briefly studies four allocation models and proposes a new approach to maximize total benefits with social and ethical acceptability, equality, and equitability. For accomplishing that goal, the Acceptability, (...) |
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The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) |
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This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of the (...) |
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One common objection to establishing regulated live donor organ markets is that such markets would be exploitative. Perhaps surprisingly, exploitation arguments against organ markets have been widely rejected in the philosophical literature on the subject. It is often argued that concerns about exploitation should be addressed by increasing the price paid to organ sellers, not by banning the trade outright. I argue that this analysis rests on a particular conception of exploitation, and outline two additional ways that the charge of (...) |
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The concept of benefit sharing pertains to the act of giving something in return to the participants, communities, and the country that have participated in global health research or bioprospecting activities. One of the key concerns of benefit sharing is the ethical justifications or reasons to support the practice of the concept in global health research and bioprospecting. This article evaluates one of such ethical justifications and its meaning to benefit sharing, namely justice. We conducted a systematic review to map (...) |
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There is wide agreement that communities in lower-income countries should benefit when they participate in multinational research. Debate now focuses on how and to what extent these communities should benefit. This debate has identified compelling reasons to reject the claim that whatever benefits a community agrees to accept are necessarily fair. Yet, those who conduct clinical research may conclude from this rejection that there is no reason to involve communities in the process of deciding how they benefit. Against this possibility, (...) |
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With increasing calls for global health research there is growing concern regarding the ethical challenges encountered by researchers from high-income countries (HICs) working in low or middle-income countries (LMICs). There is a dearth of literature on how to address these challenges in practice. In this article, we conduct a critical analysis of three case studies of research conducted in LMICs. We apply emerging ethical guidelines and principles specific to global health research and offer practical strategies that researchers ought to consider. (...) |
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Donor-funded research is research funded by private donors in exchange for research-related benefits, such as trial participation or access to the trial intervention. This has been pejoratively referred to as ‘pay to play’ research, and criticised as unethical. We outline three models of donor-funded research, and argue for their permissibility on the grounds of personal liberty, their capacity to facilitate otherwise unfunded health research and their consistency with current ethical standards for research. We defend this argument against objections that donor-funded (...) |
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Background. The increased number of clinical trials taking place in developing countries and the complexity of trial protocols mandate that local ethics review committees reviewing them have the capacity to ensure that they are conducted to the highest ethical standards.Methods. The Kenya AIDS Vaccine Initiative Institute of Clinical Research and the Kenyan National Council for Science and Technology embarked on an exercise to enhance the capacity of ERCs in Kenya to review such protocols. This process involved conducting an audit of (...) |
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There are now at least two different views that fall under the heading of the “fair benefits” approach (FBA) to international research. These views share a number of important commitments, such as... |
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The prevailing discourse around AI ethics lacks the language and formalism necessary to capture the diverse ethical concerns that emerge when AI systems interact with individuals. Drawing on Sen and Nussbaum’s capability approach, we present a framework formalizing a network of ethical concepts and entitlements necessary for AI systems to confer meaningful benefit or assistance to stakeholders. Such systems enhance stakeholders’ ability to advance their life plans and well-being while upholding their fundamental rights. We characterize two necessary conditions for morally (...) |
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The ethics of benefit sharing has been a topical issue in global health research in resource-limited countries. It pertains to the distribution of goods, benefits and advantages to the research participants, communities and countries that are involved in research. One of the nuances in benefit sharing is the ethical justification on which the concept should be based. Extensive literature outlining the different principles underlying benefit sharing is available. The purpose of this paper is to examine the proposed principles using Aristotelian (...) |
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El presente artículo tiene como objetivo destacar la problemática de las prácticas de extensión o prolongación de los derechos de exclusividad sobre los medicamentos, llevadas a cabo por la industria farmacéutica, una vez el término de protección vía patente está por finalizar. A través de tres escenarios se pone de manifiesto las implicaciones de este fenómeno, destacándose la necesidad de involucrar activamente al Estado para garantizar así unas condiciones equitativas de acceso a los medicamentos. |
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At the end of a paper on international research ethics published in the July-August 2010 issue of the Hastings Center Report, London and Zollman argue the need for grounding our duties in international medical and health-related research within a broader normative framework of social, distributive, and rectificatory justice. The same goes for Thomas Pogge, who, in a whole range of publications during the past years, has argued for a human-rights-based approach to international research. In a thought-provoking paper in the June (...) |
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(2010). International Research and Positive Obligations: Are They “Transaction Specific”? The American Journal of Bioethics: Vol. 10, No. 6, pp. 49-51. |
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(2010). For-Profit Clinical Trials in Developing Countries—Those Troublesome Patient Benefits. The American Journal of Bioethics: Vol. 10, No. 6, pp. 52-54. |
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Concerns about exploitation pervade the literature on commercial cross-border reproductive care, particularly egg selling and surrogacy. But what constitutes exploitation, and what moral weight does it have? I consider the relationship between vulnerability, limited choice, consent, and mutually advantageous exploitation. To elucidate the difference between limited choice and consent, I draw on an account of relational autonomy. In the absence of a normative principle of fair distribution, it is unclear whether the providers of reproductive goods and services are treated fairly (...) |
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The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South (...) |
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The concept of benefit sharing has been a topical issue on the international stage for more than two decades, gaining prominence in international law, research ethics and political philosophy. In spite of this prominence, the concept of benefit sharing is not devoid of controversies related to its definition and justification. This article examines the discourses and justifications of benefit sharing concept. |
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The acceleration of the market globalisation process over the last three decades has internationalised clinical research and influenced both the way in which it is funded and the development and application of research practices. In addition, in recent years international multicentre randomised clinical trials have become the model par excellence for research on new medicines. The neoliberal model of globalisation has induced a decline in state power, both with regard to establishing national research for health priorities and to influencing the (...) |
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The nature of the relationship between clinical investigator and research participant continues to be contested. The related discussions have largely focused on the doctor-researcher dichotomy thought to permeate the work of a clinical investigator with research participants, whom in turn occupy two corresponding roles: patient and subject. This paper contributes to current debates on the topic by providing a voice to research participants, whose perspectives have been largely invisible. It draws on 42 in-depth interviews conducted in Ghana and South Africa (...) |
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(2010). Human Rights: The Normative Engine of Fairness and Research in Developing Countries. The American Journal of Bioethics: Vol. 10, No. 6, pp. 47-49. |
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Clinical trials are essential to establish the safety and efficacy of investigational products, contributing to risk/benefit assessments that ultimately determine whether these products meet the criteria for market authorisation. Clinical trials are also an important source of revenue and expertise generation for countries in which they are conducted. In developing countries, they represent substantial foreign direct investment. In spite of the substantial capital input that clinical trials require, the issue of funding post-trial access to beneficial therapies remains contentious, especially in (...) |
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Unequal treatment of human research subjects is a significant ethical concern, because justice in research involving human subjects requires equal protection of rights and equal protection from harm and exploitation. Disputes sometimes arise concerning the issue of unequal treatment of research subjects. Allegedly unequal treatment occurs when subjects are treated differently and there is a genuine dispute concerning the appropriateness of equal treatment. Patently unequal treatment occurs when subjects are treated differently and there is not a genuine dispute about the (...) |
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