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Presentation at the Postgraduate Mandatory Educational Workshop held at King Fahad Medical City, Riyadh on 21st January 2019. By Prof. Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard) DrPH (Harvard) Chairman, Institutional Review Board - KFMC
OUTLINE:
} Introduction
} Vision of the Program
} Mission of the Program
} Goals of the Program
} Program Governance
} Scope of the Program
} Services Offered to Researchers by the
Program
} Research Facilities
} Research Funding
} The Institutional Review Board
VISION OF THE PROGRAM:
} To achieve research excellence at the
national and international level.
MISSION OF THE PROGRAM:
} To assume a national leadership role in
innovative, priority-driven, health care research, through supporting and
nurturing high-quality multidisciplinary research.
GOALS OF THE PROGRAM:
} To provide distinguished research support
services to KFMC investigators.
} To enhance KFMC research capacity through
multidisciplinary research.
} To facilitate the conduct of high-quality
clinically and translational research.
} Create a generation of highly trained
researchers.
} To recognize KFMC research staff
achievements.
} To ensure compliance of KFMC research with
Good Clinical Practice Guidelines.
} Improve the quality and effectiveness of
patient care, and health care delivery systems.
PROGRAM GOVERNANCE:
} The Research Center reports to the Chief
Executive Officer.
} IRB reports directly to the CEO in a
6-monthly/annual report. It reports every quarter to the Quality Council. It
also reports annually to the National Commission on Bioethics at King Abdul
Aziz City for Science and Technology (KACST).
SCOPE OF THE PROGRAM:
} Basic science research with/without clinical
correlation.
} Phase III Randomized Clinical Trials (RCT).
} Phase IV post-marketing studies.
} Non-randomized studies.
} Retrospective or prospective research
chart-based research.
} Socio-behavioral studies.
} Medical education research.
} Phase I and II studies are rarely accepted
and are treated as an exception.
} KFMC support trials that use new investigational
interventional products which are at least phase II or phase III, following the
regulations of the Saudi Food and Drug Authority (SFDA) guidelines and
regulations
CATEGORIES OF RESEARCH:
} Exempt approval: Despite
its name, “exempt” status means exempt from the full review but does not mean
exempt from human subjects protection, and does not relieve investigators from
applying and reporting to the IRB. Confirmation of exempt status must obtain
from the IRB, and continuing assurance that the research continues to fulfill
exempt requirements must obtain. Approval can be communicated from the IRB
Chair to the PI at his earliest convenience, after which the research can begin.
Examples: questionnaire surveys, data collection from patient charts.
} Expedited approval: Research
activities that present no more than minimal risk to human subjects may deem an
expedited review. The IRB chairperson can award approval and communicated to
the PI, after which the research can begin. Example: observational
studies in which the investigators are taking a small amount of blood for biochemical
analysis or testing patient limb movements.
} Full review approval: must be obtained at a
convened IRB meeting where a quorum is present and majority approval achieved;
after which notification provided and the research may begin. Examples: testing
of a new drug, testing of a new cardiac pacing device.
SERVICES OFFERED TO RESEARCHERS BY THE PROGRAM:
} Provides expert consultation on the following
aspects: study design, proposal writing, data management, statistical analysis,
and manuscript preparation.
} Assists researchers in technical and
administrative aspects of research (review of contract application agreement
forms, IRB submission, data collection…)
} Allocates research Specialists/coordinators
to different hospitals and clients to facilitate the conduct of clinical
research.
} Establishes an electronic research
investigator toolkit.
} Educates and spread the research culture via
a year-round educational research calendar.
SERVICES OFFERED TO RESEARCHERS BY THE PROGRAM, Con’t. - 1:
} Provide outreach on-site practical research
training to different hospitals, centers, and administrations.
} Develop Research Mentorship for improvement
in research knowledge and practice.
} Conducts an annual research conference for
KFMC staff to share research experiences.
} Continuing basic and advanced principles of
methodological aspects of best practice in the development, conduct, and
publication of research.
} Develops collaboration with national and
international institutions.
} Initiates and contribute to multi-center
trials.
SERVICES OFFERED TO RESEARCHERS BY THE PROGRAM, Con’t. - 2:
} Highlights KFMC staff research achievement in
the yearly newsletter.
} Solicits external funding sources and
partnership to support KFMC research agenda.
} Develops and maintain intramural funding
opportunities.
} Recognizes KFMC researchers by offering
incentives for publications in peer-reviewed journals.
} IRB reviews proposals of studies before
starting and grants approval, and then monitors and audits the conduct
according to approved methods.
RESEARCH FACILITIES:
} Clinical laboratories.
} Research laboratories in the Faculty of
Medicine Building.
} Diagnostic facilities, such as imaging.
} Inpatient and outpatient treatment
facilities.
} Patients’ medical records.
RESEARCH FUNDING:
} KFMC indirectly funds research by making
available at no charge staff time, equipment, and supplies.
} An annual budget allocated to the Research
Center and released according to the detailed Intramural Research Fund policy.
} Pharmaceutical sponsors provide funding for
clinical studies under contracts signed with the Research Center.
THE INSTITUTIONAL REVIEW BOARD:
} The Institutional Review Board (IRB) is an
independent body, which reports directly to KFMC CEO, and constituted of
medical/scientific professionals and non-medical, non-scientific members.
} The primary role of the IRB is protecting the
rights, safety, and welfare of the subject/patient. The secondary role is
assuring that data from a study will be
accurate and reliable.
} Patient protection is achieved by independent
review and monitoring of the protocol to ensure a favorable risk-benefit
ratio, putting the patient interest
before public interest, assuring informed consent, conducting the study
according to the protocol, and making sure that the study is carried out by
qualified personnel.
THE INSTITUTIONAL REVIEW BOARD, Con’t.:
} Data accuracy ensured by review of
monitoring, auditing, and inspection reports where applicable. In accordance
with KFMC CPPs, which guided by the KSA National Committee of Biomedical
Ethics, international research guidelines, and standard practices, all research
with human subjects must be submitted to the KFMC IRB for review prior to commencing
study, even if the definitions of “research” and/or “human subject” may not
appear to be met.
} IRB CPPs and forms are available for review
by any KFMC staff on the KFMC Intranet. Electronic (email) submission of
research to IRB is either by the principal investigator (PI) or the research
coordinator acting on behalf of the PI.