Failures in Clinical Trials in the European Union: Lessons from the Polish Experience

Science and Engineering Ethics 19 (3):1087-1098 (2013)

Authors
Marcin Waligora
Jagiellonian University
Abstract
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
Keywords RECs  Clinical trials  Biomedical research  Poland  Central and Eastern Europe  Failures
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DOI 10.1007/s11948-012-9400-9
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Towards Progress in Resolving Dilemmas in International Research Ethics.Solomon R. Benatar - 2004 - Journal of Law, Medicine and Ethics 32 (4):574-582.
Towards Progress in Resolving Dilemmas in International Research Ethics.Solomon R. Benatar - 2004 - Journal of Law, Medicine and Ethics 32 (4):574-582.

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