[Regulations of the ethical evaluation system of scientific and clinical research in connection with Poland joining the European Union].
The author has discussed the procedures of the Bioethical Commission of a biomedical research assessment and clinical trials based on analysis of the directives of the European Commission. Particularly criticized was the omission of the role of local committees in the case of the multi-center studies. Also underlined was a necessity to inform the examined persons, in a wider and more understandable fashion, about an essence of the examination and the expected level of risk.
Raszeja
Stefan
S
Z Katedry i Zakładu Medycyny Sadowej AM w Gdańsku.
D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards; D018864:Cultural Diversity; D028744:Ethics Committees, Research; D026690:Ethics, Clinical; D032984:Ethics, Research; D005060:Europe; D005062:European Union; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000941:ethics / Q000592:standards; D011044:Poland; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D012959:Socioeconomic Factors