Integrated Medical Education Resources: 210223P - CONSULTANT and TRAINER R2 RESEARCH TRANSFORMATION: KFMC IRB to R2 IRB and Research Budget to Research

Presentation prepared by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard)

ACHIEVABLE TASKS:

Set up and train personnel for the R2 IRB system to approve and monitor research with sub-committees in hospitals, centers, and PHCs
Train personnel for a one-stop R2-sponsored research coordination office covering hospitals, centers, and PHCs
Provide consultation and training for the KFMC Research Center

EXPERIENCE:

KFMC IRB has a long experience 2007-present. Most active IRB in the Kingdom based on projects approved.

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.

R2 IRB’s ROLE IN TRANSFORMATION FROM ‘RESEARCH BUDGET’ TO ‘RESEARCH REVENUE’ - 1:

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 Saudi market.
R2 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 SAR20m on SAR100 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].

WHAT IS NEEDED - 1?:

The R2 IRB must be backed up by a one-stop research office that will handle the execution of research projects in all R2 facilities. The office must be run on a business model.
The office shall be manned by ex-FOM professors, managers, and accountants
An efficient marketing team will attract a large number of pharmaceutical companies to seek quick R2 IRB reviews.

WHAT IS NEEDED 2?:

Assign IRB members to cover each hospital, center, or PHC this being crucial for IRB's proper functioning.
The assigned IRB member will become a one-stop center in the hospital or Center undertaking the following tasks:

Motivate, guide, train, and mentor consultants, nurses, and other health workers to submit research proposals.
Review and approve on the spot all exempt non-intervention research proposals.
Monitor and audit ongoing research projects.
Approve manuscripts for submission to journals.
Training administrative and professional staff of all levels on the IRB process and the transformation to 'research revenue'.

EXPERIENCE AND REPUTATION OF IRB:

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 Damman, 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:

National Bioethics Commission at KACST (Reg. No. H-01-R-012).
Directorate of Research and Studies at the Ministry of Health, KSA
The National Institutes of Health Bethesda MD USA OHRP/NIH Reg. No IRB00010471),
The US World Wide Assurance Bethesda MD NIH Reg. No. FWA00018774

FUNCTIONS and ACTIVITIES OF IRB:

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 the society

FUNCTIONS and ACTIVITIES OF IRB:

IRB reviews research protocols for initial approval by making sure that they

approves amendments and renewals
investigates protocol violations and adverse events which may lead to study termination
monitors and audits practical research procedures
approves manuscripts for publication.

WHAT IS NEEDED?:

Recognize an R2 mother IRB with 5-member branch IRB committees in hospitals, centers, and primary health centers.
Enhance the cluster IRB negotiation capabilities (for higher IRB review, audit, and monitoring fees) 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. This will require more time commitment by members

REFERENCES:

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.
ARAMCO, SABIC, Jubail and Yanbu Commission, Tourism Authority, etc.
Insurance, pharma, nutrition, and other companies.
Study design and analysis, research writing and publication, research training, and research laboratories