Regulations of the ethical evaluation system of scientific and clinical research in connection with Poland joining the European Union
Raszeja, S.
Archiwum Medycyny Sadowej i Kryminologii 54(2-3): 151-154
2004
ISSN/ISBN: 0324-8267 PMID: 15495560 Document Number: 582349
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.