Failures in clinical trials in the European Union: lessons from the Polish experience.
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.
Department of Philosophy and Bioethics, Jagiellonian University, Krakow, Poland. m.waligora@uj.edu.pl
Marcin
M
Waligora
D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D005062:European Union; D019983:Guideline Adherence; D006801:Humans; D061214:Patient Safety; D011044:Poland; D035842:Research Subjects / Q000331:legislation & jurisprudence