|
Cluster
REC
|
| (accessible only through HA intranet) | |||||
Jurisdiction
and Power of Cluster-REC
Full
Panel Review
Expedited Review
Study Oversight /
Continuing Review
Protection of
REC members
Conflicts of Interest
Links to HA Cluster
Research Ethics Committees' webpage
Links to CUHK
& HKU's Research Ethics webpage
Jurisdiction and Power of Cluster-REC
| 1. | Cluster REC is institutional (HA) based and charged with a mandate to protect research subjects |
| 2. | Jurisdiction applies to the respective cluster |
| 3. | Sole ethics review right (decision from another REC has reference value only) |
| 4. | Validity of approval links to study oversight |
| 5. | Authority to examine all aspects of study and intervene, even terminating a study |
A review panel must consist of at
least five persons who collectively have the ability and experience to evaluate
the scientific, medical and ethical aspects of research proposals to be considered.
Each panel must include
i) at least one member whose primary concerns are in scientific areas
ii) at least one member whose primary concerns are in nonscientific areas
iii) at least one member who is not otherwise affiliated with the institution
and who is not part of the immediate family of a person who is affiliated with
the institution.
Note. A member who is not affiliated with the research institution and has a
primary interest in a non-scientific area would satisfy two of the membership
requirements.
If possible, effort should be made to ensure that it does not consist entirely
of men or entirely of women.
Expedited review is permitted for clinical research
that satisfies ALL the following conditions:
i) does not incur an additional clinical intervention (drug or invasive procedure)
or involves no more than minimal risk to study subjects, and
ii) does not include vulnerable subjects, and
iii) does not raise sensitive privacy concerns.
The reviewer(s) in an expedited review may exercise all the authorities of the
REC, except disapproval, which should be made by a Full Panel Review.
Study Oversight / Continuing Review
| 1. | Any revision to a previously approved clinical research requires submission to the REC for approval before implementation. |
| 2. | All SAE must be promptly reported to the REC for review. |
| 3. | All clinical trials are subjected to continual review by the REC. PI must report progress at least annually until study closure unless otherwise stipulated by the REC. Determination for more frequent review is based on the degree of risk associated with participation and/or the involvement of subjects that require additional protections. |
| 4. | PI must submit a final report to REC after study closure. |
| 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. [Source: Chapter 113 HOSPITAL AUTHORITY ORDINANCE; Section 23 Protection of members of Authority, etc. Version date 30/06/1997]. Please check update version in the Bilingual Laws Information System, The database of the Laws of Hong Kong, in http://www.justice.gov.hk/Home.htm |
| - | Member with significant conflict of interest should not participate in ethics review. |
| - | Member must declare potential conflict of interest to the chairman for his/her consideration to continue involving in the review process. |
| - | Members have to sign declaration of conflict of interest for all cases being reviewed. |
| - | Meeting minutes should document the discussion and vote for each case. |
| - | Relevant information: |
| • NIH Announces Sweeping Ethics Reform | |
| • Proposal to reform NIH ethics process |
Links to HA Cluster Research Ethics Committees'
webpage
(accessible only through HA intranet)
| Hong
Kong East Cluster REC (http://hkec.home/HKEC/TaskGp/wget/et-home/ET-EC.htm) |
|
HKU
IRB / Hong Kong West Cluster REC |
| Kowloon
Central Cluster REC / Kowloon East Cluster REC (http://kcc.home/intranet/html/REC/REC%20webpage.htm) |
| Kowloon
West Cluster REC (http://kwc.home/KWC_Intranet.cfm?nextURL=http%3A//kwc.home/mod_researchEthics/researchEthicsMainPage.cfm?cid=kwcEvent) |
| Joint
CUHK-NTEC Clinical REC (http://ntec.home/Research Ethics/main.asp) |
| New
Territories West Cluster REC (http://ntwc.home/ccrec/) |
Links to CUHK & HKU's Research Ethics webpage
(accessible through internet)
| The
Chinese University of Hong Kong (http://www.crec.cuhk.edu.hk/) |
| The
University of Hong Kong (http://www.hku.hk/facmed/research/ec.html) |
Webpage developed and maintained by
Clinical Effectiveness Section,
Clinical Standards & Technology Assessment Department
Quality & Safety Division,
Hospital Authority Head Office
Last update: 3 August 2007