naa a22 4500 51077864X CHVBK 20180411083239.0 cr unu---uuuuu 180411e20130901xx s 000 0 eng 10.1007/s11948-012-9400-9 doi (NATIONALLICENCE)springer-10.1007/s11948-012-9400-9 Waligora Marcin Department of Philosophy and Bioethics, Jagiellonian University, Medical College, ul. Michalowskiego 12, 31-126, Krakow, Poland aut Failures in Clinical Trials in the European Union: Lessons from the Polish Experience [Elektronische Daten] [Marcin Waligora] 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 occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. The Author(s), 2012 RECs nationallicence Clinical trials nationallicence Biomedical research nationallicence Poland nationallicence Central and Eastern Europe nationallicence Failures nationallicence Science and Engineering Ethics Springer Netherlands 19/3(2013-09-01), 1087-1098 1353-3452 19:3<1087 2013 19 11948 https://doi.org/10.1007/s11948-012-9400-9 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s11948-012-9400-9 text/html Onlinezugriff via DOI NATIONALLICENCE 100 1- Waligora Marcin Department of Philosophy and Bioethics, Jagiellonian University, Medical College, ul. Michalowskiego 12, 31-126, Krakow, Poland aut NATIONALLICENCE 773 0- Science and Engineering Ethics Springer Netherlands 19/3(2013-09-01), 1087-1098 1353-3452 19:3<1087 2013 19 11948 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer