| Summary: | Scientific research has to be based on ethical standards that promote the protection of human rights.
On a national level, the domestic legislation of the Republic of Bulgaria foresees a procedure for obtaining an opinion from the Ethics Committee for Multicentre Trials in order to introduce a substantial change in a clinical trial and non-interventional study. The procedure aims to evaluate the compliance of the planned clinical trial with the norms of good clinical practice, the requirements of the Medicinal Products in Human Medicine Act. On European Union level, standards have been set down in Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use.
The licensing regime that has been introduced on a national level requires the performance of documentation evaluation that addresses a major change in a clinical trial and non-interventional research. Legal definitions of the terms "principal investigator" and "coordinating investigator" have been introduced. The "principal investigator" is the medical doctor or the dentist, designated by the sponsor, who leads the overall execution of the clinical trial in accordance with the approved protocol and good clinical practice guidelines and is responsible for the researchers. The "coordinating researcher" is a researcher appointed to coordinate researchers from different centres participating in a multicentre trial.
Ethic committees performing review have to provide independent advice on the extent to which a biomedical research proposal complies with recognized ethical standards. Scientific research must necessarily conform to commonly accepted scientific principles and be based on thorough knowledge of scientific literature and other relevant sources of information.
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