To protect the rights, safety and well-being of human subjects with respect to their participation in clinical studies under its jurisdiction through:

• receiving applications for initial review of clinical studies from principal investigators, performing initial ethics and scientific review of such studies, and giving its decision(s)/opinion(s) on each application;

• performing continuous ethics and scientific oversight during the period of each approved clinical study and giving its decision(s)/opinion(s);

• creating and maintaining necessary records with respect to ethics and scientific review and oversight of clinical studies;

• allowing and facilitating inspections by competent regulatory authorities; and

• performing other duties related to ethics and scientific review and oversight of clinical studies.

To request for, collect and review information, documents and materials necessary for performance of ethics and scientific review and oversight;

To recommend modifications to study designs and arrangements on sound ethical or scientific basis and in line with HKCREC’s mission;

To approve or disapprove clinical studies and give other opinions with respect to the ethical and scientific aspects of such clinical studies;

To suspend or terminate any approved clinical study if unacceptable risk to subjects arises;

To audit clinical studies to assess compliance with study protocols, HKCREC’s requirements and other applicable standards and requirements;

To disclose information of clinical studies to competent regulatory authorities; and exercise other authorities related to ethics and scientific review and oversight of clinical studies.