Important Policy Considerations
1. Protect human research subjects
2. Uphold standard of research conduct among employees and affiliated investigators
3. Manage research-related liabilities
4. Ensure service priority

Goal
To develop a sound ethical framework for clinical research

Strategy to develop Research Ethics
Measures should be explicit, enforceable and transparent.
By adopting a structured documentation system, HA internalizes ethical principles and global best practices into explicit standards, which help
Link ethics theory with practice ( into explicit HA standards)
  - Internalize ethical principles and global best practices into explicit HA standards
  - Define expectation on performance
  - Align system and process to HA policy
(Enforceability)
Assure consistent, impartial and transparent processes
(Procedural justice)
Delineate responsibilities among relevant parties
(Sharing ethical responsibilities)
Facilitate feedback, training and compliance oversight
(Compliance, continuous improvement)

Jurisdiction: Limits to HA's facilities, HA employees and HA patients



HA RE003 Investigator's Code of Practice in Undertaking Clinical Research
HA RE004 Hospital Authority Guide on Research Ethics (for Study Site & Research Ethics Committee)



HA RE001F1 Declaration of Confidentiality Form
HA RE001F2 Reviewer's Conflict of Interest Declaration Form
HA RE001F3 Clinical Research Ethics Review Application Form
HA RE001F3b Expedited Review Form for Multi-center Trial approved by another Cluster REC
HA RE001F4 Investigator's Conflict of Interest Declaration Form
HA RE001F5 REC Review Checklist
HA RE001F6a REC Approval Form
HA RE001F6b REC Clarification Form
HA RE001F6c REC Disapproval Form
HA RE001F7 Protocol Amendment Application Form
HA RE001F8 Serious Adverse Event (SAE) Report Form
HA RE001F9a Research Progress Report Form
HA RE001F9b Research Final Report Form



Draft for consultation



Under further review and revision


 

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Clinical Standards & Technology Assessment Department
Quality & Safety Division,
Hospital Authority Head Office

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Last update: 21 February 2008