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Presentation at a ‘Basic Quantitative Nursing Research Course’ held at King Fahad Medical City, Riyadh on 16-17 April 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
if 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.