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  1. IRBs and the Protection-Inclusion Dilemma: Finding a Balance.Phoebe Friesen, Luke Gelinas, Aaron Kirby, David H. Strauss & Barbara E. Bierer - 2022 - American Journal of Bioethics 23 (6):75-88.
    Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at (...)
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  • Seven vulnerabilities in the pediatric research subject.Kenneth Kipnis - 2003 - Theoretical Medicine and Bioethics 24 (2):107-120.
    Most recent thinking about thevulnerability of research subjects uses a``subpopulation'' focus. So conceived, theproblem is to work out special standards forprisoners, pregnant women, the mentally ill,children, and similar groups. In contrast, an``analytical'' approach would identifycharacteristics that are criteria forvulnerability. Using these criteria, one couldsupport a judgment that certain individuals arevulnerable and identify needed accommodationsif they are to serve as research subjects.Seven such characteristics can be evident inchildren: they commonly lack the capacity tomake mature decisions; they are subject to theauthority of (...)
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  • Developing an ethics framework for living donor transplantation.Lainie F. Ross & J. Richard Thistlethwaite - 2018 - Journal of Medical Ethics 44 (12):843-850.
    Both living donor transplantation and human subjects research expose one set of individuals to clinical risks for the clinical benefits of others. In the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research articulated three principles to serve as the basis for a research ethics framework: respect for persons, beneficence and justice. In contrast, living donor transplantation lacks a framework. In this manuscript, we adapt the three principles articulated in the Belmont Report to (...)
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