Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments
Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments
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DOI：
10.1007/s11948-009-9113-x
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发表时间：
2009-06-01
影响因子：
3.7
通讯作者：
Rozanowski, Krzysztof
中科院分区：
文献类型：
--
作者：
Czarkowski, Marek;Rozanowski, Krzysztof
波兰的研究伦理委员会是生物伦理委员会。为了确定他们的情况，进行了一项问卷调查。BC通常由13名成员组成。其中9人是医生，4人不是医生。2006年，BCs平均评估了27.3 +/-A31.7（范围：0-131）临床试验项目和71.1 +/-A139.8（范围：0-638）其他类型医学研究项目。在一次巴塞尔公约会议期间，平均评估了10.3 +/- A 14.7（范围：0-71）个医学研究项目（2006年）。根据第2001/20/EC号指令对波兰法律进行的修订导致每年评估少于20个项目的预算委员会的百分比增加（2003年为16%，2005年为33%，2006年为42%，p <0.05）。结果证实了目前由医科大学、医疗机构和地区医师和牙医协会建立BCs的做法是有用的，但有必要使各个BCs的工作量合理化。
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.