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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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  • Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?E. Gefenas, V. Dranseika, A. Cekanauskaite, K. Hug, S. Mezinska, E. Peicius, V. Silis, A. Soosaar & M. Strosberg - 2010 - Journal of Medical Ethics 36 (7):435-439.
    We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical (...)
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  • Emergency research without consent under polish law.Joanna Różyńska & Marek Czarkowski - 2007 - Science and Engineering Ethics 13 (3):337-350.
    Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give (...)
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