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:

  • 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);
  • 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.