Ethics and Integrity
Human Ethics

• Terms of Reference - Governance Committee of HKU/HA HKW IRB
• Terms of Reference - HKU/HA HKW IRB
• Membership
• M1 - General Research Ethics Information and Definitions for Investigators and IRB Members
• IRB Standard Operating Procedures
• Standard Operating Procedure (SOP) of the Joint Scientific Committee for Phase 1 Clinical Trial
• Guideline on Ethics Oversight and Scientific Evaluation of Phase 1 Clinical Trials
• Lead Time of IRB Reviews for Applicants' Reference

• Sample Submission Letter
• Clinical Study Categorisation Form by Principal Investigator (PI)
• Protocol Amendment Form
• Declaration of Support from Other Departments/Services of HKW Cluster Hospitals
• Investigator's Conflict of Interest Declaration Form
• Guideline Notes - for Preparation of a Study Protocol
• Guideline Notes - for Preparation of Subject Information Sheet and Informed Consent Form
• Guideline Notes - for the Preparation of an Investigator's Short CV

Application for Clinical Trial Certificate
Under the Pharmacy & Poisons Regulations (36B), before the commencement of a clinical trial for drugs or medicinal test, a clinical trial certificate must be obtained. The procedure for the application can be found here.

• WHO Statement on Public Disclosure of Clinical Trial Results
• Research Progress Report Form
• Research Final Report Form
• Serious Adverse Event (SAE) Report Form
• SAE Initial Report Form for Phase 1 Clinical Trials

• Clinical Research: Management and Compliance at Study Sites
• Standard Indemnity Form for Phases 1, 2 and 3 Clinical Drug Trials (HA Staff) - January 2016 version 
• Standard Indemnity Form for Phases 1, 2 and 3 Clinical Drug Trials (University Staff) - January 2016 version
• Investigator's Code of Practice
• Hospital Authority (HA) Guide on Research Ethics (for Study Site & Research Ethics Committee)

• Hong Kong West Cluster (accessible only via HKWC's intranet)
• Queen Mary Hospital (accessible only via QMH's intranet)