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  1. Protecting the Volunteer: A Question of Law versus Ethics.Leander A. A. Edmunds - 2007 - Research Ethics 3 (2):54-60.
    Human beings can be ethically frail under the pressure of situational forces, therefore the constraining force of the law is required. The ethics community need to have the confidence and courage to seek for the best ethical guidelines to become such constraining laws. However laws are themselves only ethical when they informed by a consensus that includes and represents the needs of the parties they are intended to protect, therefore the voice of the volunteer must be heard. Specific examples are (...)
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  • Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries.Avram Denburg, Carlos Rodriguez-Galindo & Steven Joffe - 2016 - American Journal of Bioethics 16 (6):3-11.
    Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a “trial effect,” however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure—the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research—may function as a quality improvement lever, improving the quality of care and outcomes of (...)
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  • Fostering IRB Collaboration for Review of International Research.Francis Barchi, Megan Kasimatis Singleton & Jon F. Merz - 2014 - American Journal of Bioethics 14 (5):3-8.
    This article presents a review of the literature, summarizes current initiatives, and provides a heuristic for assessing the effectiveness of a range of institutional review board collaborative strategies that can reduce the regulatory burden of ethics review while ensuring protection of human subjects, with a particular focus on international research. Broad adoption of IRB collaborative strategies will reduce regulatory burdens posed by overlapping oversight mechanisms and has the potential to enhance human subjects protections.
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