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  1. Research-Related Injury: Problems and Solutions.Larry D. Scott - 2003 - Journal of Law, Medicine and Ethics 31 (3):419-428.
    The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, (...)
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  • Research-Related Injury: Problems and Solutions.Larry D. Scott - 2003 - Journal of Law, Medicine and Ethics 31 (3):419-428.
    The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, (...)
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  • Appraising Harm in Phase I Trials: Healthy Volunteers' Accounts of Adverse Events.Lisa McManus, Arlene Davis, Rebecca L. Forcier & Jill A. Fisher - 2019 - Journal of Law, Medicine and Ethics 47 (2):323-333.
    While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of (...)
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  • Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation.Matt Lamkin & Carl Elliott - 2018 - Journal of Law, Medicine and Ethics 46 (1):52-63.
    Lowering compensation to research subjects to protect them from “undue inducement” is a misguided attempt to shoehorn a concern about exploitation into the framework of autonomy. We suggest that oversight bodies should be less concerned about undue influence than about exploitation of subjects. Avoiding exploitation in human subjects research requires not only increasing compensation, but enhancing the dignity of research participation.
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  • Appropriateness of no-fault compensation for research-related injuries from an African perspective: an appeal for action by African countries: Table 1.Patrick Dongosolo Kamalo, Lucinda Manda-Taylor & Stuart Rennie - 2016 - Journal of Medical Ethics 42 (8):528-533.
    Compensation for research-related injuries (RRIs) remains a challenge in the current environment of global collaborative biomedical research as exemplified by the continued reluctance of the US government, a major player in international biomedical research, to enact regulation for mandatory compensation for RRIs. This stance is in stark contrast to the mandatory compensation policies adopted by other democracies like the European Union (EU) countries. These positions taken by the USA and the EU create a nexus of confusion when research is exported (...)
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  • Moral Gridlock: Conceptual Barriers to No‐Fault Compensation for Injured Research Subjects.Leslie Meltzer Henry - 2013 - Journal of Law, Medicine and Ethics 41 (2):411-423.
    The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects (...)
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  • Moral Gridlock: Conceptual Barriers to No-Fault Compensation for Injured Research Subjects.Leslie Meltzer Henry - 2013 - Journal of Law, Medicine and Ethics 41 (2):411-423.
    The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, are a product of their time. Born in the aftermath of wartime atrocities committed by Nazi doctors, and influenced by domestic research scandals like the Willowbrook and Tuskegee studies, the regulations express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. Requirements for informed consent, risk minimization, equitable subject selection, and peer review of proposed research rest on (...)
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  • The French Law on "Protection of Persons Undergoing Biomedical Research": Implications for the U.S.Ivan Berlin & David A. Gorelick - 2003 - Journal of Law, Medicine and Ethics 31 (3):434-441.
    Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: research participants are protected and benefited according to the highest ethical standards, while, on the other hand, researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.The balancing of the risk to research participants versus the benefits derived from the research is performed in (...)
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  • The French Law on “Protection of Persons Undergoing Biomedical Research”: Implications for the U.S.Ivan Berlin & David A. Gorelick - 2003 - Journal of Law, Medicine and Ethics 31 (3):434-441.
    Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: research participants are protected and benefited according to the highest ethical standards, while, on the other hand, researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.The balancing of the risk to research participants versus the benefits derived from the research is performed in (...)
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