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Presentation at an ‘Ethics in Nursing Research’ held at King Fahad Medical City, Riyadh on 06 November 2019. By Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman, Institutional Review Board – KFMC
DEFINITION: IRB
} An
independent body reporting directly to the CEO through a report once or twice a
year.
} Members
from diverse disciplines including non-health professionals.
} Main
function is the protection of the rights and welfare of research subjects and
assures the public that this role is carried out well.
} Works
mainly to review and approve research protocols, investigator qualifications,
and methods of informed consent.
} Follow
up / monitor ongoing research for adverse effects, and protocol adherence.
DEFINITION: Investigator
} A
qualified person who is responsible for the conduct of research.
} Sub-investigators
assist the investigator in all aspects of the study.
} The
investigator or sub-investigator may or may not be a staff member at KFMC.
} The
investigator / sub-investigator may be a student, a health professional, or any
other profession if the project has a health-related component.
DEFINITION: Investigations in Humans &
Investigational Product
} Investigation
is research undertaken for the purposes of studying the absorption, distribution,
metabolism, efficacy, and safety of an investigational product.
} Investigational
product is a pharmaceutical form of an active ingredient or placebo being
tested in a clinical study.
DEFINITION: Review and Reviewer
} Review
is a rigorous and systematic process of assessing a research project regarding
its scientific merit, validity and reliability of the research methodology,
qualification of the investigators, research subject rights and safety, and
other ethical considerations.
} A
Reviewer is a person with specialist knowledge in a field of medicine,
healthcare, and research methodology asked to review a research project and
recommend to IRB its approval, modification, or rejection.
ROLES OF IRB 1: Overview
} The
primary role of the IRB is to protect the rights, safety, and welfare of the
subject/patient.
} The
secondary role is assuring that data from a study will be accurate, reliable,
and accurate.
ROLES OF IRB 2: Procedures of Assuring Objectives:
} Review
and approve the protocol.
} Assessing
the qualifications of the investigator.
} Assuring
that methods and materials for informed consent are appropriate.
} Reviewing
financial aspects to ensure no conflicts of interest.
} Monitoring
the conduct of the study.
} IRB
shall operate according to written SOPs.
ROLES OF IRB 3: Assurance of Patient Protection:
} Independent
review and monitoring of the protocol to ensure a favorable risk-benefit ratio.
} Putting
patient interests before public interest.
} Assuring
informed consent.
} Conducting
the study according to the protocol.
} Making
sure that the study is carried out by qualified personnel.
ROLES OF IRB 3: Assurance of Data Accuracy:
} Monitoring
reports.
} Auditing
reports.
} Inspection
reports.
MEMBERSHIP:
} IRB
shall consist of at least 5 members representing various disciplines of
science, medicine, and ethics.
} KFMC
IRB has 18 members including the chairman and a non-medical community
representative.
} At
least one member must be a non-scientist and one must be a lay community
representative.
} Alternate
members shall attend and vote if principal members notified the chairman of
their absence.
} Members
shall be independent of the sponsor and the investigator to avoid potential
conflicts of interest.
} Members
are appointed on the basis of their expertise and not as representatives of
their departments or units.
QUORUM:
} The
quorum shall be half of the members and decisions shall be carried by a simple
majority.
} Members
shall sign an attendance roster indicating the time of arrival and the time of
departure if they do not sit throughout the meeting.
} If
members do not attend the whole session a notation must be made in the minutes
on what protocol discussions they missed.
MEETINGS OF THE IRB:
} IRB
shall meet once every 4-6 weeks unless an emergency meeting is necessary.
} The
meeting dates and venues are advertised 6 months in advance.
} Members
receive the agenda and documents relating to the meeting 10 days in advance.
} The
chairman designates 1-2 members to make a detailed analysis of each submission
and report to the meeting.
} The
agenda includes the following sections: follow-up of previously approved
studies, safety reports, amendments, and new studies for approval (exempt,
expedited, and full review).
TYPES OF SUBMISSIONS FOR REVIEW:
} Exempt,
expedited, and full review submissions for projects to be carried out at KFMC
that have a KFMC staff member as an investigator or a co-investigator.
} Exempt,
expedited, and full review submissions of projects to be carried out at KFMC by
external investigators.
} At
its discretion the IRB shall review (a) exempt projects carried out in other
institutions if they have a KFMC staff as an investigator or a co-investigator.
(b) projects carried out at other institutions without a KFMC staff member as
investigator or co-investigator. At its discretion, IRB may charge for this
service.
DOCUMENTS SUBMITTED TO IRB:
} Exempt
studies: IRB application form, protocol/research proposal, informed consent
material if applicable, data collection instruments if applicable, current
curriculum vita(e) of the researcher(s).
} Clinical
research either expedited or full review: protocol and its amendments, written
information provided to the research subjects and the informed consent form
(ICF), the case report form (CRF), the investigator brochure (IB), study
recruitment procedures not in the protocol including recruitment
advertisements, insurance/payments for study subjects, financial agreements
between the sponsor and the investigator, any other applicable agreements, and
the current curriculum vita (e) of investigators, safety reports from this site
and other sites.
CRITERIA OF REVIEW FOR INITIAL APPROVAL:
} Risks
are minimal and reasonable in relation to the anticipated benefits.
} Consent
is informed and properly documented.
} Provisions
are adequate to ensure privacy and confidentiality.
} The
research plan contains adequate provisions for monitoring the data to ensure
safety.
} Subject
selection is equitable.
} There
are adequate safeguards to protect vulnerable subjects (children, pregnant
women, mental patients, etc.).
CRITERIA FOR REVIEWING A PROTOCOL:
} Simple
and logical eligibility and exclusion.
} Objective
and easy-to-assess outcome measures.
} Proper
subject selection and randomization.
} Simple
intervention is not likely to be mistaken.
} Adequate
sample size and power to detect a difference.
} Low
risk of missing important data by too short a follow-up.
} Overall
reliability of the trial results.
CRITERIA FOR REVIEWING THE QUALIFICATIONS OF THE
INVESTIGATOR:
} Education.
} Training.
} Experience.
} Familiar
with the investigational product.
} Knowledge
of GCP guidelines.
} Has
time to devote to the study.
} Has
sufficient qualified staff.
CRITERIA OF REVIEW FOR CONTINUING APPROVAL:
} Reports
of adverse effects.
} Protocol
amendments/violations/deviations.
} Patient
recruitment.
} Any
special problems.
CRITERIA FOR AUDITING, MONITORING, AND INSPECTIONS:
} Compliance
with the protocol.
} Submission
of necessary reports.
} Safety
reporting.
} Termination
or suspension.
} Final
report / close out.
IRB RECORDS:
} All
documents submitted by the PI, IRB correspondence, and IRB minutes are part of
IRB official records.
} IRB
official records must be kept for a minimum of 3 years after the end of the
study.