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克罗地亚医疗机构中的伦理委员会:关于其结构与功能的首次研究,以及对主要问题的一些思考

Ethics committees in Croatia in the healthcare institutions: the first study about their structure and functions, and some reflections on the major issues and problems.

作者信息

Borovecki Ana, ten Have Henk, Oresković Stjepan

机构信息

Andrija Stampar School of Public Health, Medical School, University of Zagreb Rockefellerova 4, 10 000 Zagreb, Croatia.

出版信息

HEC Forum. 2006 Mar;18(1):49-60. doi: 10.1007/s10730-006-7987-4.

Abstract

OBJECTIVES

In Croatia, ethics committees are legally required in all healthcare institutions by the Law on the Health Protection. This paper explores for the first time the structure and function of ethics committees in the healthcare institutions in Croatia.

DESIGN

Cross-sectional survey of the healthcare institutions (excluding pharmacies and homecare institutions) to identify all ethics committees.

SETTING

Croatia six years after the implementation of the Law on the Health Protection.

MAIN MEASUREMENTS

Structure and function of ethic committees in the healthcare institutions.

RESULTS

46% of the healthcare institutions in Croatia (excluding pharmacies and homecare institutions) have an ethics committee; 89% of ethics committees have 5 members 3 of whom are from medical professions and 2 come from other fields; 49% of those committees stated that their main function is the analysis of research protocols. Only a small fraction of those ethics committees sent in standing orders, working guidelines or other documents that are connected with their work.

CONCLUSIONS

Although there are legal provisions for ethics committees in the healthcare institutions in Croatia, there is an evidence of discrepancies between the practice and the "Law on the Health Protection," suggesting the need for revision of the law. There is a need for creating separate networks of HECs and IRBs in Croatia. In comparison with other countries, the development of ethics committees in Croatia has some similarities with other transitional societies in Europe. Additional research should be undertaken in the work of ethics committees in Croatia in order to understand committees' group dynamics, attitudes, and knowledge.

摘要

目的

在克罗地亚,根据《健康保护法》,所有医疗机构都依法需要设立伦理委员会。本文首次探讨了克罗地亚医疗机构中伦理委员会的结构和功能。

设计

对医疗机构(不包括药店和家庭护理机构)进行横断面调查,以确定所有伦理委员会。

背景

《健康保护法》实施六年后的克罗地亚。

主要测量指标

医疗机构中伦理委员会的结构和功能。

结果

克罗地亚46%的医疗机构(不包括药店和家庭护理机构)设有伦理委员会;89%的伦理委员会有5名成员,其中3名来自医学专业,2名来自其他领域;49%的委员会表示其主要职能是分析研究方案。这些伦理委员会中只有一小部分提交了长期指令、工作指南或其他与工作相关的文件。

结论

尽管克罗地亚医疗机构中伦理委员会有法律规定,但有证据表明实际做法与《健康保护法》之间存在差异,这表明有必要修订该法律。克罗地亚需要建立独立的健康伦理委员会和机构审查委员会网络。与其他国家相比,克罗地亚伦理委员会的发展与欧洲其他转型社会有一些相似之处。为了解委员会的群体动态、态度和知识,应进一步研究克罗地亚伦理委员会的工作。

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