倫理原則及指引
伦理原则及指引
Ethical Principles & Guidelines

為保障研究參加者的權利、安全及健康,港大臨床試驗中心根據適用國際、國家及本地有關人體研究倫理的準則,管理及協調臨床研究。有關準則的例子包括︰

为保障研究参加者的权利、安全及健康,港大临床试验中心根据适用国际、国家及本地有关人体研究伦理的准则,管理及协调临床研究。有关准则的例子包括︰

To safeguard the rights, safety and well-being of study participants, HKU-CTC manages and coordinates clinical studies based on the applicable international, national and local standards on human research ethics. Examples of such standards include:

  • 世界醫學協會 (World Medical Association) 的赫爾辛基宣言(Declaration of Helsinki) 2013版
  • 貝爾蒙特報告(Belmont Report) (即由U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research在貝爾蒙特會議中心 (Belmont Conference Center) 起草的Ethical Principles and Guidelines for the Protection of Human Subjects of Research,並於1979年獲前美國衛生、教育及福利部正式編製);
  • ICH GCP指引 (the International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice);
  • 中國藥物臨床試驗質量管理規範(中國GCP);
  • 香港大學/醫院管理局港島西聯網的研究倫理委員會的SOP(HKU/HA HKW IRB SOP); 及
  • 臨床研究機構要求協調聯盟(Consortium on Harmonization of Institutional Requirements for Clinical Research) 在香港頒佈的一期臨床試驗倫理監督及科學評估指引(Guideline on Ethics Oversight and Scientific Evaluation of Phase 1 Clinical Trials)
  • 世界医学协会(World Medical Association) 的赫尔辛基宣言(Declaration of Helsinki) 2013版
  • 贝尔蒙特报告(Belmont Report) (即由U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research在贝尔蒙特会议中心 (Belmont Conference Center) 起草的Ethical Principles and Guidelines for the Protection of Human Subjects of Research,并于1979年获前美国卫生、教育及福利部正式编制);
  • ICH GCP指引 (the International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice);
  • 中国药物临床试验质量管理规范(中国GCP);
  • 香港大学/医院管理局港岛西聯网的研究伦理委员会的SOP(HKU/HA HKW IRB SOP); 及
  • 临床研究机构要求协调联盟(Consortium on Harmonization of Institutional Requirements for Clinical Research) 在香港颁布的一期临床试验伦理监督及科学评估指引(Guideline on Ethics Oversight and Scientific Evaluation of Phase 1 Clinical Trials)
  • the Declaration of Helsinki 2013 of the World Medical Association;
  • the Belmont Report (i.e. the Ethical Principles and Guidelines for the Protection of Human Subjects of Research which was first drafted by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research at the Belmont Conference Center and officially created by the former U.S. Department of Health, Education, and Welfare in 1979);
  • the ICH GCP Guideline (the International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice);
  • China Good Clinical Practice Guideline for Drug Clinical Trials (China GCP);
  • the SOP of the Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB SOP); and
  • the Guideline on Ethics Oversight and Scientific Evaluation of Phase 1 Clinical Trials issued by the Consortium on Harmonization of Institutional Requirements for Clinical Research in Hong Kong.

如果適合,其他倫理標準亦會納入考慮。

如果适合,其他伦理标准亦会纳入考虑。

Other ethical standards may also be taken into consideration as appropriate.