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Presented at the Organisational Details-IRB Meeting at King Khalid Specialist Eye Hospital held on April 21, 2026, by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard), Chairman, Institutional Review Board, King Abdullah bin Abdulaziz University Hospital
Basic Terminology, con’t:► Institutional Review Board (IRB) is a body constituted by the institution's highest authorities but works independently to make ethical reviews and approve proposed research, as well as follow up on the implementation of the research.► Research is the systematic collection and analysis of empirical data to describe a phenomenon or to establish causal linkages between and among phenomena.► Clinical research is research carried out on patients and healthy volunteers to test new treatment modalities.
Risk (A potential harm or the potential of an action or event to cause harm):► Informed consent is the agreement of the research subject to participate in research after full disclosure and explanation of details about the research.► Research Subject is an individual patient or healthy volunteer who consents to participate in research. Research submissions will be classified as exempted, expedited, or full review.
Types of Review:► Minimal risk is no greater than the risk encountered in normal day-to-day activities or during routine physical or psychological examinations.► Low Risk - Involves a minor increase over minimal risk- the intervention or procedure presents experiences that are reasonably commensurate with those inherent in actual or expected medical, dental, physiological, social, or educational situations.► Moderate Risk - Risks are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.► High Risk - Involves greater than minimal risk with no prospect of direct benefit to individual subjects but is likely to yield generalized knowledge about the subject’s disorder or condition. Studies that are of high levels of risk may result in permanent physical and/or mental changes, hospitalization, and/or death.
Adverse Event:► Exempt research is approved without review by the full IRB committee. It is research using questionnaires, interviews, or data abstraction from charts. It poses no risk to humans.► Expedited research is approved by the Chair, with information to the IRB later. It involves minimal risk, such as procedures typically performed in the outpatient clinic.► Full Review research involves intervention with human subjects, drugs, or devices, and must be approved by the full IRB committee.NB: New NCBE policy includes exempt within expedited.
Authorization:► Definition: Any untoward or unfavourable medical occurrence in a human study participant, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant’s involvement in the research, whether or not considered related to participation in the research.► Serious Adverse Events: Any adverse event that: results in death, is life-threatening, or places the participant at immediate risk of death from the event as it occurred, requires or prolongs hospitalization, causes persistent or significant disability or incapacity, results in congenital anomalies or birth defects.► Unanticipated Problem: is defined as any incident, experience, or outcome that meets all of the following criteria: unexpected, related/possibly related to the research, and places research participants at greater risk of harm.
Scope of Research: IRB Covers the Following Types of Research:► Research involving human subjects must be reviewed and approved by an Institutional Review Board (IRB) before any research intervention with participants. The approval of full review projects is at a full board meeting or by the chairman for expedited studies.► The Institutional Review Board (IRB) is the body responsible for ethical approval and regulation of all research proposals and protocols on humans in the institution that have ethical implications to ensure that the highest research ethical standards are met and assure the safety of research subjects and protect the institution and its staff from ethical violations.
Primary Role of IRB: Patient Safety:► Research by clinical observation► Controlled clinical comparative research► Laboratory research► Epidemiological research► Genetic research► Qualitative research► Genetic research► Research based on questionnaires/interviews or analysis of collected data► Animal research for IRBs is authorized► Non-human related research
Secondary Role of IRB:► The primary role of the IRB is to protect the rights, safety, and welfare of the subject/patient.► This is achieved by the following measures: independent review and monitoring of the protocol to ensure a favorable risk-benefit ratio, putting the patient's 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.
Actions of IRB on Research Proposals:► The secondary role is assuring that data from a study will be accurate and reliable, and accurate.► Data accuracy is ensured by review of monitoring, auditing, and inspection reports where applicable.► Approval of the manuscript before submission to the journal.
IRB Personnel:► Review and approval of the protocol: No research shall start before IRB approval.► 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 and monitoring the conduct of the study.
IRB Members:► The IRB Chair and Membership are appointed by and report to the hospital CEO.► IRB is not just a committee; it is a board (has legal authority) and an administration.► The IRB Chair is responsible for the day-to-day operations of the IRB, including IRB regular meetings.
IRB Members, con’t.:► At least five members.► Representatives of varying racial, cultural, and professional backgrounds.► Both genders.► At least one member whose primary concern is a non-scientific area.► At least one member who is not otherwise affiliated with the institution himself or through his immediate family.► At least one member from the community.► Professionally qualified members.
IRB Governance:► Members are selected on their own personal merit as people with knowledge, skills, and sound judgment, and not as members or advocates of any profession or organization.► Members should not be changed frequently because it takes 1-2 years of membership to become an expert.► Members may not understand the science of a specialized project, but they can assess the ethical issues.► The period of service on the committee is renewable and is usually three years.
IRB Operational Policy Guidelines:► The CEO is the Institutional Officer (IO), i.e., head of IRB.► IO appoints the chairman and members and confirms the termination of members.► Chair of IRB reports to IO in administrative matters: a 6-month report and adverse events.► Chair of IRB reports to the monitoring office of the National Council on Bioethics; 6-month report and Serious Adverse Events.► IRB acts independently in professional matters.
IRB Operational Policy Guidelines, con’t.:► Balance between research and care delivery research such that research that is a departure from the commonly accepted treatment does not adversely affect the patient’s treatment.► Equity and justice in research to ensure that recruitment into studies should reflect the community’s ethnic, gender, and age distribution, since results of an unbalanced study may not apply to all groups.► The source of funding of research should not, indirectly and discreetly, influence the conduct of research and the report of its findings, thus leading to a lack of objectivity.
IRB Procedures:► Research malpractice is prevented, and if it occurs is detected early. Examples of malpractice include cooking or doctoring data, selective reporting of data, suppression of negative information, and ‘stealing’ others’ work.► Expedited review procedures can also be used to review minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
IRB Procedures, con’t.:► The Principal Investigator dialogues with applicable departments that will be involved in the proposed study before the submission of a research proposal to the KFMC IRB.► The Principal Investigator submits the IRB research application package in standard format for IRB review. The package varies according to the type of research.► The IRB committee requests a quorum of at least half of the members for holding a meeting. Members who cannot attend can send written comments and can vote.
Documents Submitted to IRB by email to irb1@kfmc.med.sa - 1:► Proposals, protocols, and reports to be tabled are sent to the members in advance so that they have a chance to study them. Some members may be allocated specific projects to study in detail and report to others.► IRB meets in private to preserve confidentiality.► IRB Committee Member excuses himself/herself if a project is for review that they are associated with.
Documents Submitted to IRB by email - 2:► All documents submitted by the PI, IRB correspondence, and IRB minutes are part of the IRB official records that must be kept for a minimum of 3 years post-study completion.► Initial application forms: (a) Exempt form, (b) Expedited form, (c) Full review form.► Consent form and information forms: survey cover for questionnaires, minimal risk, and full.► Follow-up forms: annual progress, continuing review, and amendment.► Proposal/protocol.► Questionnaire/CRF.► Investigators: CV and evidence of research ethics training (NIH and NCBE)
Role of the IRB Chairman - 1:► Subject recruitment procedures (e.g., advertisements).► Written information to be provided to subjects.► Investigational product brochure (IB).► Available safety information.► Information about payments and compensation available to the subject.
Role of the IRB Chairman - 2:► Receives research application submission materials, determines their appropriateness for review, and assigns research review to IRB member(s).► Prepares the IRB committee agenda.► Ensuring reviewers are qualified to perform the review. The chairman will designate 1-2 members to make a detailed analysis of each submission and report to the meeting.► Supervises the IRB Administrative Coordinator and ensures that tasks are performed accurately and according to timelines, including but not limited to: (a).► Maintenance of IRB Administrative and Research Study Files and other IRB documentation.► Chairs the IRB meeting every 2 weeks.
Follow-up of Research Implementation:► Addresses any conflict of interest at the beginning of the committee meeting.► Issue letters of approval or rejection of submissions within 45 days for full review studies and within 5 days for exempt and expedited studies.► Decision shall be sent by email to the principal investigator with a copy to the study coordinator; the original can be collected from the IRB office.
Roles of the Principal Investigator (PI):► IRB monitors the progress of the research and receives reports of all adverse reactions, whether related to the drug tested or not.► IRB makes on-site inspections to ensure the approved protocol is adhered to and to inspect research documents and records as per IRB audit and monitoring procedures.► IRB holds regular monitoring meetings to review the progress of recruitment of research subjects, changes to the protocol, adverse reactions, the process of informed consent, refusals and withdrawals, and case record forms.
Roles of the Principal Investigator (PI), con’t.:► Submits the required documents through the Research Center to the Saudi Food and Drug Administration if applicable to research.► Submits the study documents along with the IRB approval letter to the IRB and NCBE for approval to send tissue abroad for research.► Submits annual or 6-monthly progress reports to the Chair of the IRB. Intervention studies require annual renewal of approvals► Submits an Adverse Events Report as per policy to the IRB Chair.
Process of IRB Review:► Submits a Final Report for IRB Study Completion or Study Termination to the Chair of the IRB.► Declares conflict of interest.► Keep full records of all its actions.► Ensures secure location for records (locked door, password-protected computer).
Decisions of the IRB:► Exempt proposals reviewed by the chairman or 1-2 members and are approved within 2 business days if no queries. The IRB endorses the approval at its next scheduled meeting.► Expedited proposals are reviewed by the chairman and or 1-2 members and are approved within 5 business days if no queries. The IRB endorses the approval at its next scheduled meeting.► Full proposals are distributed to all members, and 1-2 members are assigned to make a special study and report to the IRB meeting. The PI is usually invited to attend the meeting. Approval is based on 51% vote.
Approval of Amendments:► Approval,► Conditional approval,► Modifications required before its approval,► Disapproval; and► Termination/suspension of any prior approval.
IRB Approval Letters Contents -1:► No deviations from, or changes to, the protocol should be initiated without prior written IRB approval of an appropriate amendment, except when necessary to eliminate immediate hazards to the subjects.► Any change, even administrative or grammatical, has to be reported.
IRB Approval Letters Contents -2:► IRB registration number with the National Bioethics Commission,► IRB registration number with NIH and FWA,► IRB log number,► Date of the letter, and► Date of submission, any conditions.
► Listing of documents submitted for approval,► Date by which a progress report shall be submitted,► Date by which the approval will be voided if the progress report is not received,► Statement that the IRB complies with the guidelines, such as ICH-GCP,► Statements about privacy and confidentiality, reporting suspected adverse effects promptly, and► Statement about keeping the IDS form in the patient files.