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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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  • A European consistency for functioning of RECs? We just lost our chance.Marcin Waligora - 2013 - Journal of Medical Ethics 39 (6):408-409.
    On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC. The main reasons for the revision were: (1) the decreasing number of clinical trials in the region and (2) harsh criticism of the present version of the Directive. The proposed regulation could simplify the rules for conducting clinical trials and also rebuild the entire system of clinical trial assessment. However, it (...)
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  • Learning to Regulate Learning Healthcare Systems.Jan Piasecki & Vilius Dranseika - 2019 - Cambridge Quarterly of Healthcare Ethics 28 (2):369-377.
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  • Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards.Vilma Lukaseviciene, Joerg Hasford, Dirk Lanzerath & Eugenijus Gefenas - 2021 - Journal of Medical Ethics 47 (12):e82-e82.
    The upcoming Regulation No 536/2014 on clinical trials on medicinal products for human use, which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will (...)
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  • Can significant difference in regulating medical and non-medical research be justified?David Hunter - 2014 - Monash Bioethics Review 32 (3-4):254-267.
    It is now typical for human subjects research to be regulated by review by an independent research ethics committee in most jurisdictions. However it is common for countries to opt to only compulsorily regulate medical research while leaving some or all non-medical research either unregulated or only regulated on a voluntary basis. In this paper I will argue, using regulation in the UK as an example, that it is difficult to justify this sharp distinction in practices. While I won’t come (...)
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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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  • 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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  • Publication Ethics in Biomedical Journals from Countries in Central and Eastern Europe.Mindaugas Broga, Goran Mijaljica, Marcin Waligora, Aime Keis & Ana Marusic - 2013 - Science and Engineering Ethics (1):1-11.
    Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of the European Union.The (...)
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  • Publication Ethics in Biomedical Journals from Countries in Central and Eastern Europe.Mindaugas Broga, Goran Mijaljica, Marcin Waligora, Aime Keis & Ana Marusic - 2014 - Science and Engineering Ethics 20 (1):99-109.
    Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union and South-East European countries that are not members of the European Union. The most common ethical (...)
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