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Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments

机译:欧盟评估医学实验系统中的波兰研究伦理委员会

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摘要

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 +/- A 31.7 (range: 0-131) projects of clinical trials and 71.1 +/- A 139.8 (range: 0-638) projects of other types of medical research. During one BC meeting an average of 10.3 +/- A 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.
机译:波兰的研究伦理委员会的等效物是生物伦理委员会(BCs)。已经进行了问卷调查以确定他们的状况。卑诗省通常由13名成员组成。其中有九位是医生,四位是非医生。在2006年,BC评估了平均27.3 +/- A 31.7(范围:0-131)的临床试验项目和71.1 +/- A 139.8(范围:0-638)的其他医学研究项目。在一次公元前会议上,评估了医学研究项目的平均10.3 +/- A 14.7(范围:0-71)(2006年)。根据2001/20 / EC指令对波兰法律进行的修订导致BC的百分比增加,而BC每年评估的项目少于20个(2003年与2005年或2006年相比,分别为16%对33%或42%,p <0, 05)。结果证实了由医科大学,医学机构以及医师和牙医的区域分会创建BC的当前实践的有用性,但是合理化单个BC的工作量是必要的。

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