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临床研究伦理与临床药物试验的开展:国际比较与行为准则

The ethics of clinical research and the conduct of clinical drug trials: international comparisons and codes of conduct.

作者信息

Beran R G

出版信息

Med Law. 2000;19(3):501-21.

Abstract

Human research must respect most rigorous ethical standards to protect both the investigators and subjects. Codes of ethical practice relevant to such research are subjected to reviews around the world including The European Union (EU), the Canadian Tri-Council Policy Statement (including the Medical Research Council, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council), the Finnish Parliament Research Act (April 1999) and the National Statement on Ethical Conduct in Research Involving Humans in accordance with the NHMRC Act 1992 (Cth) from the National Health and Medical Research Council of Australia. The Australian Statement was endorsed by the Australian Vice-Chancellors' Committee, the Australian Research Council, the Australian Academy of the Humanities, the Australian Academy of Science and the Academy of Social Sciences in Australia and supported by the Academy of Technological Sciences and Engineering. This reflects the extensive ramifications of human experimentation and the range of stack holders. Private organisations have also produced interpretations of minimum standards of good clinical practice. The paper that follows analyses approaches to human experimentation and the minimal ethical expectations in the conduct of such research.

摘要

人体研究必须遵循最严格的伦理标准,以保护研究者和受试者双方。与此类研究相关的伦理实践准则在世界各地都受到审查,包括欧盟(EU)、加拿大三理事会政策声明(包括医学研究理事会、自然科学与工程研究理事会以及社会科学与人文研究理事会)、芬兰议会研究法案(1999年4月)以及澳大利亚国家卫生与医学研究理事会根据1992年(澳大利亚联邦)《NHMRC法案》制定的《涉及人类的研究中的伦理行为国家声明》。澳大利亚的声明得到了澳大利亚副校长委员会、澳大利亚研究理事会、澳大利亚人文科学院、澳大利亚科学院以及澳大利亚社会科学院的认可,并得到了澳大利亚技术科学与工程学院的支持。这反映了人体实验的广泛影响以及利益相关者的范围。私人组织也对良好临床实践的最低标准做出了解释。以下论文分析了人体实验的方法以及此类研究开展过程中的最低伦理期望。

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