Conceptual framework for models that may help establish national IRB committee to serve health research community

1. ‫السعودي‬ ‫العربية‬ ‫اململكة‬
‫السعودي‬ ‫الصحي‬ ‫اجمللس‬
‫للدراسات‬ ‫الوطين‬ ‫املركز‬‫والبحوث‬‫الصحية‬
SHC.CHRS.LOGISTICS.ETHICALCOMMITTEE.WMB.V2.AUG282016
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Ethical Committee
at Center of Health Research and Studies
“Executive Summary”
Document focus: Models for Ethical Committee at Center of Health Research and Studies

2. ‫السعودي‬ ‫العربية‬ ‫اململكة‬
‫السعودي‬ ‫الصحي‬ ‫اجمللس‬
‫للدراسات‬ ‫الوطين‬ ‫املركز‬‫والبحوث‬‫الصحية‬
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Model-I: AtthelevelofCenterofHealthResearchandStudies
Central Committee for Biomedical Research
Ethics
Responsibilities:
1.Review and update current guidelines
2.Review multi-center research project for
initial approval
3.Coordinate IRB committee approval
across participating institution
4.Release final approval letter
5.Monitor institutional IRB performance
(quality assurance)
6.Ensure compliance to good clinical
practice and good laboratory practice
7.Review and decide upon research
activities sponsored and operated by
Center of Health Research and Studies
8.Circulate decision on amendments
across participating research
institutions
Structure:
1.Chairman: a member of Center of
Health Research and Studies
2.Members; representative from each
intuitional IRB committee registered at
National Committee of Bio-ethics
3.Representative from National
Committee of Bioethics.

3. ‫السعودي‬ ‫العربية‬ ‫اململكة‬
‫السعودي‬ ‫الصحي‬ ‫اجمللس‬
‫للدراسات‬ ‫الوطين‬ ‫املركز‬‫والبحوث‬‫الصحية‬
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AtthelevelofInstitution
Registered IRB committees will continue to
maintain its regular activities:
1.Review research proposals that are
intra-institutional and submit quarterly
reports to central committee for
biomedical research ethics that include:
activity summary, number of approved/
declined proposals along with
justification, timeline of research activity
progress, details on early terminations,
details on project involved vulnerable
population, and any challenges
2.Review multi-center research proposals
that had been approved by Central
Committee for Biomedical Research
Ethics
3.Monitor compliance of ongoing research
activities to ethical principals
Pros Cons
1. Time saving
2. More economic/ cost
effective
3. Politically safe
4. Decentralization
5. Independency
1. Relay on judgement of
institution-based IRB
2. Overlap and cross-
functionality with National
Committee for Bio-Ethics

4. ‫السعودي‬ ‫العربية‬ ‫اململكة‬
‫السعودي‬ ‫الصحي‬ ‫اجمللس‬
‫للدراسات‬ ‫الوطين‬ ‫املركز‬‫والبحوث‬‫الصحية‬
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Model-II:
AtthelevelofCenterofHealthResearchandStudies Center of Health Research and Studies will
establish its IRB Committee that would be
called National Central IRB Committee
Responsibilities:
1.Review and evaluate research proposal
from pharmaceutical companies (local
and international)
2.Review and evaluate research
proposals that involve collaboration
with international bodies
3.Review and evaluate research
proposals submitted by researchers at
Center of Health Research and Studies
research proposals
4.Quality assurance; monitor compliance
of ongoing research activities to good
clinical practice and good laboratory
practice
Structure:
Classical IRB committee Structure in addition
to IRB committee office at Center of Health
Research and Studies for administrative
paper work
Atthelevelof
Institution
Memoranda of understanding will be carried
out with registered IRB committee that they
would:
1.Facilitate research projects approved by
central IRB committee
2.Submit quarterly reports to Central
National IRB committee with respect to
internal research activities
3.Facilitate the function of quality
assurance contractors
Pros Cons
1. Close monitoring
2. Faster track, if IRB
1. Time consuming
2. Higher cost

5. ‫السعودي‬ ‫العربية‬ ‫اململكة‬
‫السعودي‬ ‫الصحي‬ ‫اجمللس‬
‫للدراسات‬ ‫الوطين‬ ‫املركز‬‫والبحوث‬‫الصحية‬
SHC.CHRS.LOGISTICS.ETHICALCOMMITTEE.WMB.V2.AUG282016
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committee members were
available
3. Politically sensitive
4. Needs registration at National
Committee for Bioethics
Model- III: AtthelevelofCenterofHealthResearchandStudies
Center of Health Research and Studies will
subcontract at least three top IRB
committees. Performance of IRB committees
will be assessed as per reports from National
Committee of Bioethics. Each of which will
cover a predesignated area of research
An IRB committee office at Center of Health
Research and Studies will be launched to
fulfill the following responsibilities:
1.Review submitted proposals and ensure
documents completion
2.Re-direct research proposals to
designated IRB committee
3.Provide principal investigator (PI) with
final designated IRB committee
decision
Subcontracted IRB committee will receive
designated specialization from Center of
Research and Studies and should fulfill the
following responsibilities:
1.Initial review of submitted proposal
2.Coordinate review of proposals by IRB
committees of institutions participating
in the study
3.Quality assurance
4.Provide IRB committee office at Center
of Health Research and Studies with
quarterly progress reports
Atthelevelof
Institution
Memoranda of understanding will be carried
out with registered IRB committee that they
would:
1.Review and make decision on upon
submitted proposals
2.Close monitoring of ongoing project
3.Provide subcontractors with quarterly
progress report

6. ‫السعودي‬ ‫العربية‬ ‫اململكة‬
‫السعودي‬ ‫الصحي‬ ‫اجمللس‬
‫للدراسات‬ ‫الوطين‬ ‫املركز‬‫والبحوث‬‫الصحية‬
SHC.CHRS.LOGISTICS.ETHICALCOMMITTEE.WMB.V2.AUG282016
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Pros Cons
1. Shortcuts
2. Less logistics
3. Less operational interference
1. Time consuming
2. Higher cost
3. Politically sensitive
4. Two stage reporting may lead to
information alteration
5. Needs registration at National
Committee for Bioethics