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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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  • 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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  • Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?Seema K. Shah - 2013 - Journal of Law, Medicine and Ethics 41 (2):397-410.
    The Common Rule creates a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants, thereby fostering a culture of compliance, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem. To harness the expressive power of the law, I propose the Common Rule be revised to include the ethical responsibilities of investigators and sponsors.
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  • Outsourcing Ethical Obligations: Should the Revised Common Rule Address the Responsibilities of Investigators and Sponsors?Seema K. Shah - 2013 - Journal of Law, Medicine and Ethics 41 (2):397-410.
    Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides (...)
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  • A comparison of justice frameworks for international research: Table 1.Bridget Pratt & Bebe Loff - 2015 - Journal of Medical Ethics 41 (7):539-544.