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Presentation on 15 June 2019 prepared by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman, IRB at King Fahad Medical City.
EXPERIENCE AND REPUTATION - 1:
- Has long experience 2007-present.
- Most active IRB in the Kingdom based on
projects approved.
|
Year |
KFMC project |
Non-KFMC projects |
University projects |
Total Projects |
|
2017 |
285 |
224 |
256 |
765 |
|
2018 |
361 |
337 |
382 |
1080 |
|
TOTAL |
646 |
561 |
638 |
1845 |
- Respected by pharmaceutical companies because
of its professionalism quick and accurate reviews (within 1 week), and prompt
responses.
- Regarded by MOH as the national IRB to which
all MOH hospitals with no local IRB submitted their projects.
EXPERIENCE AND REPUTATION - 2:
- Processes research proposals of Saudi Students
pursuing master's and doctoral degrees in the UK, USA, Australia, New Zealand,
Netherlands
- Requested by MOH and others to train
researchers and members of IRB in Dammam, Madinah, Qurayat, Abha, Najran,
Jeddah, Makkah, and Riyadh.
- Has dedicated highly qualified members with an average IRB experience of 6 years.
- Recognized nationally and internationally:
o National Bioethics Commission at KACST (Reg. No.
H-01-R-012).
o Directorate of Research and Studies at the Ministry
of Health, KSA
o The National Institutes of Health Bethesda MD USA
OHRP/NIH Reg. No IRB00010471),
o The US World Wide Assurance Bethesda MD NIH Reg. No.
FWA00018774
FUNCTIONS AND ACTIVITIES OF IRB - 1:
- IRB operates under Royal Decree No M/59 dated
14-9-1431 H.
- To ensure independence, IRB reports
administratively to the Institution Official (IO) the CEO/President and
professionally to the Monitoring Office of the National Bioethics
Commission at KACST.
- IRB has two three functions:
a)
Protect
the safety and welfare of human research subjects.
b)
Assure
validity of the scientific data generated.
c)
Assure
that the research has social value for society.
FUNCTIONS AND ACTIVITIES OF IRB -
2:
- IRB reviews research protocols for initial
approval by making sure that they
o have a sound scientific design according to
international guidelines
o are free of ethical violations,
o the researchers are qualified by education and
experience
o the facilities are adequate
- Post approval IRB
o approves amendments and renewals
o investigates protocol violations and adverse events
which may lead to study termination
o monitors and audits practical research procedures
o approves manuscripts for publication.
CLUSTER IRB’s ROLE IN
TRANSFORMATION FROM ‘RESEARCH BUDGET’ TO ‘RESEARCH REVENUE’:
- The Saudi pharma business will grow to SAR36 billion
by 2022. Pharma companies would like to expand their market shares by
testing their new and existing products in the local market.
- Cluster 2 with 2-3 million population, 12
hospitals, and 67 health centers will be a great laboratory for all types of
research approved by IRB and managed by the one-stop research office.
- An efficient and reputable IRB backed up by a
one-stop research management office will attract 30 and more clinical
trial projects a year plus national research grants to make a profit of SAR
20m on SAR 100 annual revenue.
- *https://www.argaam.com/en/article/articledetail/id/526595
CLUSTER IRB’s ROLE IN
TRANSFORMATION FROM ‘RESEARCH BUDGET’ TO ‘RESEARCH REVENUE’ 2: Breakdown of
expected revenue:
- SAR70m from 15-30 pharma clinical trials. Unit
billing for all services offered.
- SAR5m research grants from KACST.
- SAR5m government research grants [1].
- SAR5m research contracts from para-statal
bodies.[2]
- SAR5m research contracts with private
organizations, profit and non-profit.[3]
- SAR5km from the sale of anonymized hospital and health
center data.
- SAR5m from the sale of research-related services to
organizations and individual researchers. [4].
1.
Ministry of
Health, Ministry of Education, Ministry of Labor and Social Affairs, Ministry
of Agriculture, Ministry of the Interior, Ministry of Urban and Rural
Affairs, Ministry of Pilgrimage.
2.
ARAMCO, SABIC,
Jubail and Yanbu Commission, Tourism Authority, etc.
3.
Insurance,
pharma, nutrition, and other companies.
4.
Study design
and analysis, research writing and publication, research training, and research
laboratories
WHAT IS NEEDED - 1?:
- The decision to transform the existing KFMC IRB to
become the cluster IRB.
- All cluster IRB products shall benefit all
components of the cluster
- Enhance the cluster IRB negotiation
capabilities with pharmaceutical and medical equipment companies that
require its services
- Enhance the cluster IRB’s capacity to compete
with counterparts in East Asia by reducing its approval time to 1 week.
- The cluster IRB needs to recruit 5 full-time
and 7 part-time positions to be able to review and approve massive
clinical trial materials in a week. These professionals will review and
monitor research to the highest standards.
WHAT IS NEEDED - 2?:
- The cluster IRB must be backed up by a one-stop
research office that will handle the execution of research projects in all
cluster facilities. The office must be run on a business model.
- An efficient marketing team will attract a
large number of pharmaceutical companies to seek the quick cluster IRB review
in Cluster 2.
WHAT IS NEEDED - 3?:
- Allocate one anchor full-time IRB member to
serve in each of the 5 hospitals in the cluster this being crucial for IRB's
proper functioning. The member will have an office and will stay in the
hospital at all times when not attending IRB meetings.
- The anchor IRB member will become a one-stop
center in the hospital undertaking the following tasks:
o Motivate, guide, train, and mentor consultants,
nurses, and other health workers to submit research proposals.
o Review and approve on the spot all exempt
non-intervention research proposals.
o Monitor and audit ongoing research projects.
o Approve manuscripts for submission to journals.
o Training administrative and professional staff of
all levels on the IRB process and the transformation to 'research revenue'.