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  1. 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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  • A Critical Examination of Informed Consent Approaches in Pragmatic Cluster-Randomized Trials.Cory E. Goldstein - 2022 - Dissertation, University of Western Ontario
    This thesis addresses the tension in pragmatic cluster-randomized trials between their social value and the requirement to respect the autonomy of research participants. Pragmatic trials are designed to evaluate the effectiveness of treatments in real-world settings to inform clinical decision-making and promote cost-efficient care. These trials are often embedded into clinical settings and ideally include all patients who would receive the treatments under investigation as a part of routine care. Trialists increasingly adopt cluster-randomized designs—in which intact groups, such as hospitals (...)
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  • The Social Value Requirement in Research: From the Transactional to the Basic Structure Model of Stakeholder Obligations.Danielle M. Wenner - 2018 - Hastings Center Report 48 (6):25-32.
    It has long been taken for granted that clinical research involving human subjects is ethical only if it holds out the prospect of producing socially valuable knowledge. Recently, this social value requirement has come under scrutiny, with prominent ethicists arguing that the social value requirement cannot be substantiated as an ethical limit on clinical research, and others attempting to offer new support. In this paper, I argue that both criticisms and existing defenses of the social value requirement are predicated on (...)
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  • Collaborative partnership and the social value of clinical research: a qualitative secondary analysis.Sanna-Maria Nurmi, Arja Halkoaho, Mari Kangasniemi & Anna-Maija Pietilä - 2017 - BMC Medical Ethics 18 (1):57.
    Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that (...)
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  • Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy.Euzebiusz Jamrozik & Michael J. Selgelid - 2020 - Journal of Medical Ethics 46 (9):601-609.
    Human infection challenge studies (HCS) involve intentionally infecting research participants with pathogens (or other micro-organisms). There have been recent calls for more HCS to be conducted in low-income and middle-income countries (LMICs), where many relevant diseases are endemic. HCS in general, and HCS in LMICs in particular, raise numerous ethical issues. This paper summarises the findings of a project that explored ethical and regulatory issues related to LMIC HCS via (i) a review of relevant literature and (ii) 45 qualitative interviews (...)
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  • Reevaluating Benefits in the Moral Justification of Animal Research: A Comment on “Necessary Conditions for Morally Responsible Animal Research”.Matthias Eggel, Carolyn P. Neuhaus & Herwig Grimm - 2020 - Cambridge Quarterly of Healthcare Ethics 29 (1):131-143.
    :In a recent paper in Cambridge Quarterly of Healthcare Ethics on the necessary conditions for morally responsible animal research David DeGrazia and Jeff Sebo claim that the key requirements for morally responsible animal research are an assertion of sufficient net benefit, a worthwhile-life condition, and a no-unnecessary-harm condition. With regards to the assertion of sufficient net benefit, the authors claim that morally responsible research offers unique benefits to humans that outweigh the costs and harms to humans and animals. In this (...)
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  • Public interest in health data research: laying out the conceptual groundwork.Angela Ballantyne & G. Owen Schaefer - 2020 - Journal of Medical Ethics 46 (9):610-616.
    The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of (...)
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