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Rethinking the ethics of clinical research: widening the lens

New York: Oxford University Press (2011)

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  1. Are Multinational Companies Responsible for Working Conditions in Their Supply Chains? From Intuition to Argument.Sonja Dänzer - 2011 - Analyse & Kritik 33 (1):175-194.
    Although many people seem to share the intuition that multinational companies carry a responsibility for the working conditions in their supply chains, the justification offered for this assumption is usually rather unclear. This article explores a promising strategy for grounding the relevant intuition and for rendering its content more precise. It applies the criteria of David Miller's connection theory of remedial responsibility to different forms of supply chain governance as characterized by the Global Value Chains framework. The analysis suggests that (...)
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  • Unfair Trade, Exploitation, and Below-Subsistence Wages.Sonja Dänzer - 2014 - Moral Philosophy and Politics 1 (2):269-288.
    The article discusses the relation between the concepts of unfair trade, exploitation, and below-subsistence wages with regard to individual economic transactions. Starting from the common notion that exploitation involves some kind of unfair advantage taking, it asks how “unfair” is to be understood, and what it is that is taken advantage of in exploitative exchanges. On this basis it then explores a line of argument for grounding the claim that below-subsistence wages are exploitative, focusing on the condition of morally transformative (...)
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  • The Context of Clinical Research and Its Ethical Relevance: The COMPAS Trial as a Case Study.Silvia Camporesi & Matteo Mameli - 2012 - American Journal of Bioethics 12 (1):39 - 40.
    The American Journal of Bioethics, Volume 12, Issue 1, Page 39-40, January 2012.
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  • Still Human: A Call for Increased Focus on Ethical Standards in Cadaver Research.Michelle C. Bach - 2016 - HEC Forum 28 (4):355-367.
    Research on human cadavers is an important mechanism of scientific progress and comprises a large industry in the United States. However, despite its importance and influence, there is little ethical or regulatory oversight of cadaver-based research. This lack of transparency raises important ethical questions. Thus, this paper serves as a call for ethicists and regulators to pay increased attention to cadaver research. I argue that cadaver research ought to be considered a subset of human subjects research and held accountable to (...)
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  • Exploitation.Matt Zwolinski, Benjamin Ferguson & Alan Wertheimer - 2022 - Stanford Encyclopedia of Philosophy.
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  • Informed Consent, Error and Suspending Ignorance: Providing Knowledge or Preventing Error?Arnon Keren & Ori Lev - 2022 - Ethical Theory and Moral Practice 25 (2):351-368.
    The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent (...)
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  • For the Common Good: Philosophical Foundations of Research Ethics.Alex John London - 2021 - New York, NY, USA: Oxford University Press.
    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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  • The rationality of political experimentation.Gregory Robson - 2020 - Politics, Philosophy and Economics 20 (1):67-98.
    Theorists from John Stuart Mill to Robert Nozick have argued that citizens can gain insight into the demands of justice by experimenting with diverse forms of political life. I consider the rationa...
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  • Coercive Offers Without Coercion as Subjection.William R. Smith & Benjamin Rossi - 2019 - American Journal of Bioethics 19 (9):64-66.
    Volume 19, Issue 9, September 2019, Page 64-66.
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  • Exploitation and Joint Action.Erik Malmqvist & András Szigeti - 2019 - Journal of Social Philosophy 50 (3):280-300.
    Journal of Social Philosophy, EarlyView.
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  • Gamification of Labor and the Charge of Exploitation.Tae Wan Kim - 2018 - Journal of Business Ethics 152 (1):27-39.
    Recently, business organizations have increasingly turned to a novel form of non-monetary incentives—that is, “gamification,” which refers to a motivation technique using video game elements, such as digital points, badges, and friendly competition in non-game contexts like workplaces. The introduction of gamification to the context of human resource management has immediately become embroiled in serious moral debates. Most notable is the accusation that using gamification as a motivation tool, employers exploit workers. This article offers an in-depth analysis of the moral (...)
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  • Modelo de reciprocidad democrática: una justificación de la continuidad de tratamiento beneficioso en la investigación clínica.Ignacio Mastroleo - 2016 - Journal of Science Humanities and Arts 3 (7):1-33.
    En este trabajo desarrollo un modelo normativo sobre la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación desde la perspectiva de la justicia social o distributiva, inspirado en la teoría de la justicia de John Rawls. Llamo a esto, el modelo de reciprocidad democrática. La idea original del modelo de reciprocidad democrática es defender que la obligación de continuidad de tratamiento beneficioso tiene como derecho correlativo el derecho a la salud. Así, dentro del marco rawlsiano, argumento que (...)
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  • The ethics of people smuggling.Javier Hidalgo - 2016 - Journal of Global Ethics 12 (3):311-326.
    ABSTRACTPeople smugglers help transport migrants across international borders without authorization and in return for compensation. Many people object to people smuggling and believe that the smuggling of migrants is an evil trade. In this paper, I offer a qualified defense of people smuggling. In particular, I argue that people smuggling that assists refugees in escaping threats to their rights can be morally justified. I then rebut the objections that people smugglers exploit migrants, have defective motivations, and wrongly violate the law. (...)
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  • Ancillary Care Obligations in Light of an African Bioethic: From Entrustment to Communion.Thaddeus Metz - 2017 - Theoretical Medicine and Bioethics 38 (2):111–126.
    Henry Richardson has recently published the first book ever devoted to ancillary care obligations, which roughly concern what medical researchers are morally required to provide to participants beyond what safety requires. In it Richardson notes that he has presented the ‘only fully elaborated view out there’ on this topic, which he calls the ‘partial-entrustment model’. In this article, I provide a new theory of ancillary care obligations, one that is grounded on ideals of communion salient in the African philosophical tradition (...)
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  • Against Permitted Exploitation in Developing World Research Agreements.Danielle M. Wenner - 2015 - Developing World Bioethics 16 (1):36-44.
    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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  • Introducción al problema de la continuidad del tratamiento beneficioso para los sujetos de investigación.Ignacio Mastroleo - 2015 - In Jorge Alberto Álvarez Díaz (ed.), Ensayos sobre ética de la salud. Universidad Autónoma Metropolitana - Unidad Xochimilco. pp. 67 - 99.
    ¿Qué ocurre con la continuidad del tratamiento de los sujetos de investigación después de que realizan la última visita del ensayo en el que participan? En algunos casos, la falta de continuidad de atención de la salud apropiada podría poner en peligro la salud de estas personas. Por lo tanto, es probable que los sujetos de investigación que al terminar su participación en un ensayo todavía se encuentran enfermos, necesiten continuar con el tratamiento en estudio u otra atención de la (...)
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  • Disadvantage, Social Justice and Paternalism.A. M. Viens - 2013 - Public Health Ethics 6 (1):28-34.
    While Powers and Faden do not consider possible anti-paternalism objections to their view, there are two variants of this objection that a social justice perspective is susceptible to. It is worth exploring which responses to such objections may be less promising than others. It is argued that for most public health measures targeting the disadvantaged, theorists and practitioners taking a social justice perspective should bite the paternalist bullet. Insofar as the government has the ability to reduce mortality and morbidity within (...)
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  • Discharging the Duty to Conduct International Clinical Research.Danielle M. Wenner - 2012 - American Journal of Bioethics 12 (11):44-46.
    Pratt, Zion, and Loff (2012) correctly point out that most international clinical research (ICR) is not intended to address the vast inequities in access to health care between developed and develo...
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  • Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research.Rebecca L. Walker, Marci D. Cottingham & Jill A. Fisher - 2018 - Journal of Medicine and Philosophy 43 (1):83-114.
    Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...)
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  • Our Life Depends on This Drug: Competence, Inequity, and Voluntary Consent in Clinical Trials on Supervised Injectable Opioid Assisted Treatment.Daniel Steel, Kirsten Marchand & Eugenia Oviedo-Joekes - 2017 - American Journal of Bioethics 17 (12):32-40.
    Supervised injectable opioid assisted treament prescribes injectable opioids to individuals for whom other forms of addiction treatment have been ineffective. In this article, we examine arguments that opioid-dependent people should be assumed incompetent to voluntarily consent to clinical research on siOAT unless proven otherwise. We agree that concerns about competence and voluntary consent deserve careful attention in this context. But we oppose framing the issue solely as a matter of the competence of opioid-dependent people and emphasize that it should be (...)
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  • Misleading by Omission: Rethinking the Obligation to Inform Research Subjects about Funding Sources.Neil C. Manson - 2017 - Journal of Medicine and Philosophy 42 (6):720-739.
    Informed consent requirements for medical research have expanded over the past half-century. The Declaration of Helsinki now includes an explicit positive obligation to inform subjects about funding sources. This is problematic in a number of ways and seems to oblige researchers to disclose information irrelevant to most consent decisions. It is argued here that such a problematic obligation involves an “informational fallacy.” The aim in the second part of the paper is to provide a better approach to making sense of (...)
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  • Beyond Fair Benefits: Reconsidering Exploitation Arguments Against Organ Markets.Julian J. Koplin - 2018 - Health Care Analysis 26 (1):33-47.
    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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  • In Defense of a Social Value Requirement for Clinical Research.David Wendler & Annette Rid - 2017 - Bioethics 31 (2):77-86.
    Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this (...)
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  • Referral of Research Participants for Ancillary Care in Community-Based Public Health Intervention Research: A Guiding Framework.Maria W. Merritt, Joanne Katz, Ramin Mojtabai & Keith P. West - 2016 - Public Health Ethics 9 (1):104-120.
    Researchers conducting large community-based studies among underserved populations may collect data on health conditions that are little-acknowledged in the local setting, and for which there are few if any services for referral of participants who need follow-up diagnosis and care. In the design and planning of studies for such settings, investigators and research ethics committees may struggle to determine what constitutes effective referral and whether it is reasonably available. We offer a guiding framework for referral planning, informed by our experiences (...)
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  • The Social Value of Knowledge and International Clinical Research.Danielle M. Wenner - 2013 - Developing World Bioethics 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 (...)
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  • Individual risk and community benefit in international research.Robert C. Hughes - 2012 - Journal of Medical Ethics 38 (10):626-629.
    It is widely agreed that medical researchers who conduct studies in low- and middle-income countries (LMICs) are morally required to ensure that their research benefits the broader host community, not only the subjects. The justification for this moral requirement has not been adequately examined. Most attempts to justify this requirement focus on researchers' interaction with the community as a whole, not on their relationship with their subjects. This paper argues that in some cases, research must benefit the broader host community (...)
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  • A framework for risk-benefit evaluations in biomedical research.Annette Rid & David Wendler - 2011 - Kennedy Institute of Ethics Journal 21 (2):141-179.
    One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...)
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  • Consent, Threats, and Offers.Maximilian Kiener - 2019 - American Journal of Bioethics 19 (9):66-68.
    Volume 19, Issue 9, September 2019, Page 66-68.
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  • Ethical Issues in Field Trials of Genetically Modified Disease-Resistant Mosquitoes.David B. Resnik - 2012 - Developing World Bioethics 12 (3):37-46.
    Mosquito-borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito-borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease-resistant, genetically modified mosquitoes. Some of these (...)
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  • Taking Respect Seriously: Clinical Research and the Demands of Informed Consent.Lynn A. Jansen - 2018 - Journal of Medicine and Philosophy 43 (3):342-360.
    There is broad agreement among research ethicists that investigators have a duty to obtain the informed consent of all subjects who participate in their research trials. On a common view, the duty to obtain this informed consent follows from the need to respect persons and their autonomous decisions. However, the nature of informed consent and the demands it places on investigators are open to dispute and recently have been challenged. Respect for persons, it has been claimed, does not require investigators (...)
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  • Paternalism and Utilitarianism in Research with Human Participants.David B. Resnik - 2012 - Health Care Analysis (1):1-13.
    In this article I defend a rule utilitarian approach to paternalistic policies in research with human participants. Some rules that restrict individual autonomy can be justified on the grounds that they help to maximize the overall balance of benefits over risks in research. The consequences that should be considered when formulating policy include not only likely impacts on research participants, but also impacts on investigators, institutions, sponsors, and the scientific community. The public reaction to adverse events in research (such as (...)
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  • Book review Jeremy Snyder, “Exploiting Hope. How the Promise of New Medical Interventions Sustains Us—and Makes Us Vulnerable”, 2021, Oxford University Press. [REVIEW]Felicitas Sofia Holzer - 2021 - Ethical Theory and Moral Practice 24 (5):1261-1263.
    This article discussed Jeremy Snyder’s book “Exploiting Hope. How the Promise of New Medical Interventions Sustains Us—and Makes Us Vulnerable”, 2021, Oxford University Press.
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  • Exploitation and International Clinical Research: The Disconnect Between Goals and Policy.Danielle M. Wenner - 2018 - In David Boonin (ed.), Palgrave Handbook of Philosophy and Public Policy. Cham: Palgrave Macmillan. pp. 563-574.
    A growing proportion of clinical research funded by pharmaceutical companies, high-income country research agencies, and not-for-profit funders is conducted in low- and middle-income settings. Disparities in wealth and access to healthcare between the populations where new interventions are often tested and those where many of them are ultimately marketed raise concerns about exploitation. This chapter examines several ethical requirements frequently advanced as mechanisms for protecting research subjects in underserved communities from exploitation and evaluates the effectiveness of those mechanisms as responses (...)
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  • Sweatshops: Economic Analysis and Exploitation as Unfairness.Gordon G. Sollars & Fred Englander - 2018 - Journal of Business Ethics 149 (1):15-29.
    The economic and moral defense of sweatshops given by Powell and Zwolinski has been criticized in two recent papers. Coakley and Kates focus on putative weaknesses in the logic of Powell’s and Zwolinski’s argument. Preiss :55–82, 2014) argues that, even granting the validity of their economic argument, Powell’s and Zwolinski’s defense is without force when viewed from a Kantian republican viewpoint. We are concerned that sweatshop critics have misinterpreted the economic literature and overstated the conclusions that follow from their ethical (...)
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  • Substantiating the Social Value Requirement for Research: An Introduction.Annette Rid & Seema K. Shah - 2017 - Bioethics 31 (2):72-76.
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  • Waiving legal rights in research.David B. Resnik & Efthimios Parasidis - 2014 - Journal of Medical Ethics 40 (7):475-478.
    The US federal research regulations prohibit informed consent, whether written or oral, from including provisions in which human subjects waive or appear to waive legal rights. We argue that policies that prevent human subjects from waiving legal rights in research can be ethically justified under the rationale of group, soft paternalism. These policies protect competent adults from making adverse decisions about health and legal matters that they may not understand fully. However, this rationale is less defensible if there is a (...)
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  • On Wendler's New Justification for Pediatric Research.Robert Wachbroit - 2012 - American Journal of Bioethics 12 (1):40 - 42.
    The American Journal of Bioethics, Volume 12, Issue 1, Page 40-42, January 2012.
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  • Ethics, Justice and Community Participation in the Microbicides Development Programme (MDP) Phase III Trial in Mwanza, Tanzania.Andrew Vallely, Shelley Lees, Charles Shagi, Saidi Kapiga, Sheena McCormack & Richard Hayes - 2012 - American Journal of Bioethics 12 (11):46-48.
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