title: Institutionalisation of Bulgarian ethics committees: history and current status.
abstract: This paper provides an overview of the institutionalisation of the ethics review process in Bulgaria in accordance with the worldwide trend in establishment of ethics committees. Historical and current politico-legal changes influencing the work of ethics committees are analysed. The paper focuses on ethics committees which review biomedical research involving humans, with an emphasis on their composition, functions, training of members, and decision-making processes. Recent positive changes addressing insufficient training of ethics committees'members are highlighted. Recommendations are made for enhancement of the ethics review process and improved transparency.
authors: Centre for Primary Health Care and Equity, University of New South Wales, Sydney, NSW 2052 Australia. y.krastev@unsw.edu.au
authors: Yordanka
authors: Y
authors: Krastev
mesh_terms: D002031:Bulgaria; D002986:Clinical Trials as Topic / Q000941:ethics; D004341:Drug Evaluation / Q000941:ethics; D004517:Education, Professional; D028744:Ethics Committees, Research / Q000266:history / Q000458:organization & administration* / Q000639:trends; D049673:History, 20th Century; D006805:Human Experimentation / Q000941:ethics; D006801:Humans; D015337:Multicenter Studies as Topic / Q000941:ethics