Transcript Cluster REC

HA Research Ethics Development
HA REC Meeting
6/2/2004
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
Progress
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
Progress – Establishing Standards & Operation
Procedures by a Quality System approach
Local requirements & practices
Standard Operating
Procedure & Forms
ICH GCP (E6)
Other references,
e.g. FDA IRB Guide
International
requirements
& practices
HA Guide for
Cluster REC
Declaration of Helsinki
Developed & approved
by Cluster REC (2-4Q
2003): Guide REC
operation
Developed & approved by
HA REC (Feb 2003):
Minimal standards,
framework for SOP &
Form development
HA policy, AP target,
Section III Standards
Progress - RE web-page launched Mar 2002
Progress - Commission Training (REC)
• A 12-hr course by CTC, HKU & CEU
• Organized 3 courses during 1-4Q 2003
Cluster REC
HKW-HKU
HKE
No. participated
33
31
KC&KE
KW
NTE-CU
NTW
29
33
11
9
HAHO & Universities
Total
8
154
Progress – Central Registry
• In progress
• Minimal dataset
1.
2.
3.
4.
5.
6.
7.
8.
9.
Application ref number
REC name
Study title
Name of PI
Affiliated institute of PI
Study sites (local)
Is this an international study
Study design
No. of local participants
planned
10. Investigational product
11. Phase of drug trial
12. Is the test drug licensed in HK?
13. Investigational invasive procedure
14. Is there an Independent Data Monitoring Committee?
15. REC review decision
16. Protocol submission date
17. REC decision date
18. Proposed study start date
19. Intended completion date
20. Source of funding
21. Pre-mature termination of study (date & reason)
22. Final report receipt date
Progress – Cluster REC
29 hospital-based RECs  6 cluster-based RECs &
merging with the respective medical faculty IRB
Cluster
Establish
Chairman
Secretary (FT
equivalent)
No. of
Members
No. of
panels
SOP &
Forms
2
61
6
yes
HKW-HKU
Mar 2003
Prof C L Lai
HKE
Sept 2003
Dr MA Hok Cheung
0.3
37
6
yes
KC&KE
Sept 2003
Dr LEE Kin Hung
0.4
29
3
yes
KW
Sept 2003
Dr Lawrence C H TANG
1
34
4
yes
NTE-CU
Nov 2002
Prof Jean Woo
2.4
15
2
yes
NTW
Feb 2003
Dr Albert C Y LO
0.7
15
1
yes
Cluster REC Operation
(From establishment to Dec 2003)
Cluster
Meeting
Frequency
Applications
received
Meetings
held
Approved
Expedited
review
HKW-HKU
Bi-weekly
743
20
725
658 (91%)
HKE
On demand
23
1
16
16 (100%)
KC&KE
Monthly
65
4
55
46 (84%)
KW
Monthly
102
4
92
53 (58%)
NTE
Monthly
609
14
492
41 (8%)
NTW
1-2 monthly
59
8
40
12 (30%)
Major Concerns
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.
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
Indemnity & Insurance
Indemnity by Sponsor usually excludes
malpractice, negligence, error, omission, or
protocol violation,
etc.
Insurance
company
Indemnifier
Indemnifier
Sponsor
Indemnitee
Indemnitee
Institute
Investigators
Research subjects
(Consent)
• 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
“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)
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):
i. One review by a lead REC
ii. Separate reviews by Cluster RECs
iii. Expedited review basing on documents of other
Cluster RECs
Cluster REC maintains autonomy
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