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