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HA Research Ethics Development

HA Research Ethics Development. HA REC Meeting 6/2/2004. Revamp Exercise 2002-2003. Approved by MSDC (57 th meeting, MSDC-P140, Dec 17, 2001) A cluster-based REC approach, with a central mechanism for establishing standards & harmonizing development. Progress.

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HA Research Ethics Development

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  1. HA Research Ethics Development HA REC Meeting 6/2/2004

  2. Revamp Exercise 2002-2003 • Approved by MSDC (57th meeting, MSDC-P140, Dec 17, 2001) • A cluster-based REC approach, with a central mechanism for establishing standards & harmonizing development

  3. Progress

  4. Progress - HA REC with new TOR, Jun 2002 • Harmonize clinical research ethics in HA hospitals through standards setting • Coordinate training for REC members • Supervise a central registry of clinical trials involving HA patients • Supervise audit for clinical research ethics related performance in HA • Monitor and disseminate global developments in clinical research ethics • Handle appeal against Cluster REC decision

  5. Progress – Establishing Standards & Operation Procedures by a Quality System approach Local requirements & practices Developed & approved by Cluster REC (2-4Q 2003): Guide REC operation Standard Operating Procedure & Forms Developed & approved by HA REC (Feb 2003): Minimal standards, framework for SOP & Form development ICH GCP (E6) Other references, e.g. FDA IRB Guide HA Guide for Cluster REC International requirements & practices HA policy, AP target, Section III Standards Declaration of Helsinki

  6. Progress - RE web-page launched Mar 2002

  7. Progress - Commission Training (REC) A 12-hr course by CTC, HKU & CEU Organized 3 courses during 1-4Q 2003

  8. Progress – Central Registry In progress Minimal dataset

  9. Progress – Cluster REC 29 hospital-based RECs  6 cluster-based RECs & merging with the respective medical faculty IRB

  10. Cluster REC Operation(From establishment to Dec 2003)

  11. Major Concerns

  12. Liability of REC Member Chapter 113: HA Ordinance. Section 23: Protection of members of Authority, etc. . Subsection 1 . No member of the Authority or of any committee, acting in good faith, shall be personally liable for any act done or default made (a) by or on behalf of the Authority; or (b) by or on behalf of any committee, in the performance or purported performance of the functions, or the exercise or purported exercise of the powers, imposed or conferred on the Authority under this Ordinance.

  13. Mx of Research-related Liability • Liability cannot be waived • Indemnity/insurance is a mean to transfer/finance risk • Indemnity by a sponsor is conditional • Need to manage liability proactively • Ethical research conduct (code of practice & training for investigator) • Administrative approval • Ethical review & study monitoring • SOP for study site, study site inspection • REC performance monitoring

  14. Indemnity & Insurance Indemnity by Sponsor usually excludes malpractice, negligence, error, omission, or protocol violation, etc. Indemnitee Indemnifier Institute Investigators Insurance company Sponsor Research subjects (Consent) Indemnitee Indemnifier Indemnity should cover both the institute & all investigators An insurance backed indemnity is most desirable It is desirable for a research institute to acquire insurance for malpractice, negligence & when itself acts as a sponsor

  15. “HA med mal” will provide indemnity against claims in connection with Clinical Trial provided that there is negligence, error or omission on the part of HA (or other Insured party as defined)

  16. Multi-center Trials • The authority of each REC over study sites is defined, following the hospital cluster arrangement • HA REC endorsed overriding arrangements for cross cluster approval necessary in multi-centre trials (see section 3.3b, HA Guide for Cluster REC): • One review by a lead REC • Separate reviews by Cluster RECs • Expedited review basing on documents of other Cluster RECs

  17. Cluster REC maintains autonomy

  18. The Way Forward Approved by MSDC (72nd meeting, MSDC-P181, 15/12/2003) • Develop • Code of Practice for investigator • SOP for study site • Central Register (involving HA patients) • HA should develop its R&D capability by collaborating relevant resources, e.g. the KPO team • More training opportunities on research related matters • Monitor/audit Cluster REC performance

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