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INFORMED CONSENT IN CROATIAN CLINICAL LABORATORY PRACTICE – CURRENT ISSUES AND FUTURE PERSPECTIVES

机译:克罗地亚临床实验室惯例的知情同意书–当前的问题和未来展望

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摘要

This paper deliberates on the place and role of informed consent in everyday clinical laboratory practice. Taking into account international ethical guidelines such as the UNESCO Universal Declaration on Bioethics and Human Rights, the Declaration of Helsinki of the World Medical Association, and Croatian national laws and codes such as the Act on the Protection of Patients’ Rights, the Act on Medical Biochemistry, the Code of Ethics of Medical Biochemists and Medical Deontology, the Act on Healthcare Services, and the Code of Ethics of the Croatian Chamber of Healthcare Workers, an overview is given on the actual implementation of the aforementioned recommendations and regulations. A distinction between consent to a medical procedure and consent to enrolment in a research protocol is strongly stressed out. Special emphasis is placed on the role of specialists in laboratory medicine and masters of medical biochemistry in the process of obtaining informed consent. The design of an ‘informed consent interview’ is to be taken into consideration. Additional deliberation is needed on the option of ‘broad consent’. It is concluded that informed consent should represent an important and routine activity within Croatian clinical laboratories.
机译:本文探讨了知情同意书在日常临床实验室实践中的位置和作用。考虑到国际道德准则,例如联合国教科文组织《世界生物伦理与人权宣言》,世界医学会赫尔辛基宣言以及克罗地亚的国家法律和法规,例如《患者权利保护法》,《医学法》 《生物化学》,《医学生物化学家和医学本体论道德守则》,《医疗保健服务法》以及克罗地亚医务工作者协会的《道德守则》概述了上述建议和法规的实际实施情况。强烈强调了同意医疗程序和同意参加研究方案之间的区别。特别强调实验室医学专家和医学生物化学硕士在获得知情同意的过程中的作用。应考虑“知情同意访谈”的设计。对于“广泛同意”选项,还需要进行进一步的审议。结论是,知情同意书应代表克罗地亚临床实验室的一项重要而常规的活动。

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