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  1. Failures in Clinical Trials in the European Union: Lessons from the Polish Experience.Marcin Waligora - 2013 - Science and Engineering Ethics 19 (3):1087-1098.
    When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good Clinical Practice, these irregularities (...)
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  • Performance of IRBs in China: a survey on IRB employees and researchers’ experiences and perceptions.Xing Liu, Ying Wu, Min Yang, Yang Li, Kaveh Khoshnood, Esther Luo, Lun Li & Xiaomin Wang - 2022 - BMC Medical Ethics 23 (1):1-13.
    Background Performance evaluation is vital for IRB operations. As the number of IRBs and their responsibilities in reviewing and supervising clinical research grow in China, there is a significant need to evaluate their performances. To date, little research has examined IRB performance within China. The aim of this study was to ascertain the perspectives and experiences of IRB employees and researchers to understand the current status of IRBs; compare collected results with those of other countries; and identify shortcomings to improve (...)
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  • Broadening the “Infrastructure Effect”: Lessons from the Early Development of Research Ethics in Eastern Europe.Vilius Dranseika, Eugenijus Gefenas & Marcin Waligora - 2016 - American Journal of Bioethics 16 (6):26-28.
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  • Evaluation of the work of hospital districts’ research ethics committees in Finland: Table 1.Ritva Halila - 2014 - Journal of Medical Ethics 40 (12):866-868.
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  • Research Ethics in the Context of Transition: Gaps in Policies and Programs on the Protection of Research Participants in the Selected Countries of Central and Eastern Europe.Andrei Famenka - 2016 - Science and Engineering Ethics 22 (6):1689-1706.
    This paper examines the ability of countries in Central and Eastern Europe to ensure appropriate protection of research participants in the field of increasingly globalizing biomedical research. By applying an analytical framework for identifying gaps in policies and programs for human subjects protection to four countries of CEE—Belarus, Latvia, Lithuania, and Poland, substantial gaps in the scope and content of relevant policies and major impediments to program performance have been revealed. In these countries, public policies on the protection of research (...)
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