Czarkowski Marek, Rózanowski Krzysztof
Department of Endocrinology and Internal Medicine, Medical University of Warsaw, ul. Banacha 1a, 02-097 Warszawa, Poland.
Sci Eng Ethics. 2009 Jun;15(2):201-12. doi: 10.1007/s11948-009-9113-x. Epub 2009 Jan 21.
The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 +/- 31.7 (range: 0-131) projects of clinical trials and 71.1 +/- 139.8 (range: 0-638) projects of other types of medical research. During one BC meeting an average of 10.3 +/- 14.7 (range: 0-71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary.
波兰的研究伦理委员会对应的机构是生物伦理委员会(BCs)。已开展一项问卷调查研究以确定它们的情况。生物伦理委员会通常由13名成员组成。其中9名是医生,4名是非医生。2006年,生物伦理委员会平均评估27.3±31.7项(范围:0 - 131项)临床试验项目和71.1±139.8项(范围:0 - 638项)其他类型医学研究项目。在一次生物伦理委员会会议期间,平均评估10.3±14.7项(范围:0 - 71项)医学研究项目(2006年)。根据2001/20/EC号指令对波兰法律进行修订后,每年评估项目少于20项的生物伦理委员会的比例有所增加(2003年为16%,2005年为33%,2006年为42%,p < 0.05)。结果证实了医科大学、医学研究所及地区医师和牙医协会目前设立生物伦理委员会做法的有效性,但有必要对单个生物伦理委员会的工作量进行合理调整。