Document Development for Research Ethics Clinical Effectiveness Unit Division, PS & MD 2005

1. Document Development forResearch EthicsClinical Effectiveness UnitDivision, PS & MD 2005

3. BACKGROUND • HK has no specific Statute on clinical research • Rely on professional self-discipline & administrative control

4. Important Policy Considerations • Protection of human research subjects • Comply with Declaration of Helsinki, ICH-GCP, international best practices & local regulations • Mandatory ethical review, approval & monitoring by a recognized REC/ IRB • Management of research-related liabilities • Basic competence of investigators & facilities • Should not compete with service needs

5. Development: Past & Present

6. Reason for change • Ensure HK’s participation in drug trials by complying with ICH-GCP • Address system weakness • Variation in standards • Few REC met to vet • Documents not user-friendly & may be inadequate • Process relied heavily on REC secretaries • Insufficient support to most RECs • Lack of training • To consolidate resource, expertise & harmonize practices

7. Progress

8. APPROACH Quality System Documentation as backbone of Research Ethics practice (& development) in HA

9. Why ?

10. Provides Anchorage • Align structure, process & output requirements to policy • Delineate responsibility / accountability of relevant parties & personnel • Convert knowledge & accepted practices to institution rules • Guide specific tasks • Describe expectation on performance (competence) • Basis for training & audit

11. In-process Metrics for CQI

12. Ensures Applicability • Internalizing: convert knowledge & accepted practices into institution rules (deliberation to adapt into local context) • From generic to specific requirements • Customize with system, expertise & resources (practical consideration) • Tailor requirement to audiences’ perspectives (drafting skill for technical communication) • Approval: assign authority to document

13. Assures Right Information • To preclude use of obsolete documents, documents are • uniquely identified • filed in a readily accessible source • distributed to concerned personnel & workplaces (consider web-based technology) • Obsolete document for archive is clearly denoted • Scheduled review to ensure continual validity

14. QS documentation is especially important for: • Large organization • High stake activities • Narrow safety margin • Involves multi-parties • Labor intensive

15. 3 Pillars ProtectingResearch Subjects REC / IRB Protection of Human Research Subjects Investigators (research team) They have related but different roles & responsibilities, thus require correspondingly different guiding documents Study Site Authority (hospital/ HA, University)

16. Document Should Accommodate Audience’s Perspective REC / IRB • Require PI to report SAE to REC • Review SAE reports • Notify HA REC if SAE demands study termination (Alert/Recall) Investigators 1. Institute measures for early detection & Mx of possible adverse outcomes • 2. Report SAE to • Participants (& their clinicians if indicated) • Sponsors & REC (in accordance with ICH-GCP) • Legal Services Section of HAHO (if there is potential claim & legal implication) • Regulatory agency (if required by law) e.g. on handling SAE 3. Update participants if the SAE may be relevant to their willingness to continue participate in study Study Sites • Ensure all SAEs with potential claim & legal implication are reported to Legal Services Section of HAHO • Ensure investigator competence

17. 1. REC / IRB Guide (internalizing good practices) Local requirements & practices Cluster REC Standard Operating Procedure & Forms • Established by Cluster REC: • Guides operation • Enables audit • Established by HA REC: • HA-wide Standards • Framework for SOP & Form development in clusters ICH GCP (E6) Other references, e.g. FDA IRB Guide HA Guide for Cluster REC International requirements & practices Local regulation HA policy Declaration of Helsinki

18. 2. Investigator’s Code of Practice Investigators have the primary responsibility for protecting the rights & welfare of human research subjects. They must comply with all applicable provisions, such as • Ethical responsibility • Right of participants • Consent to research • Regulatory requirements, professional standard, institutional policies & procedures • Relationship with external sponsor • Interaction with REC & study site administration • Handling potential conflict of interest

19. 3. HA Study Site Guide • All institutions involved in clinical research have a responsibility to protect research participants • Explicit policy & procedures on human protection in research • Sufficient facilities & competent investigators • Formal vetting & approval procedure • Study monitoring, esp. record management, SAE handling, complaint management, procedure to deal with incompetence & misconduct • Training, risk management • Interfaces with REC & HAHO Administrative procedures may be handled differently from one institution to another

20. Level of Document Internalization