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Presented at an IRB meeting at King Khalid Eye Specialist Hospital, Riyadh on April 21, 2026, by Prof Omar Hasan Kasule Sr MB ChB (MUK), MPH (Harvard), DrPH (Harvard), Chairman of the IRB at King Abdullah bin Abdulaziz University Hospital
RESEARCHER-RELATED ISSUES• Member IRB fatigue: same KAP proposals, too much to read, and no time.
• No time to read long and badly written proposals.
• Attempting to correct the PI or tell him what to research. Focus on ethics.
• Vote or opinion of a non-specialist member or a member who cannot understand the specialized subject.
• Disagreement among members.
• Conflict of interest.
• Payment for time spent serving on IRB.
• Member approached by a colleague who submitted a proposal.
PROCESS RELATED ISSUES• PI taking a leave of absence or leaving the institution.
• Authorship: addition, removal, order of authors.
• Dispute on who is a co-researcher, especially when dealing with promotions.
• PI coming with a project approved in a previous institution.
• PI continuing the research in a new institution.
• KKESH staff studying abroad and doing research for their degrees.
RESEARCH PROPOSAL ISSUES• Speed of review.
• Rubber stamp function.
• Is it an ethical review or a scientific review or both?
• Scientific review by IRB/others: before or after IRB. Is it mandatory?
• Do members review and send their reviews, or do we need a face-to-face meeting?
• Exempt or expedited studies approved by the chairman or any member, and the committee is informed at the next meeting.
• Only a full review requires all members, quorum 50%, approval 51+%.
• Approval process for multi-center or multidisciplinary studies.
• IRB decisions (approval, conditional approval, rejection (rare).
AMENDMENT OF PROPOSALS• Free format or use a template?
• Incomplete submissions, no ethics, no CV, all sections added? (Title, intro, background, methods, ethical considerations, references.
• Standard/quality of proposals: low quality, rush to publish anything, and student proposals.
• Amendments to title, co-researchers, and late amendments.
• Confusion between research project vs quality assurance projects.
• Research on sensitive issues.
• Scope of research: clinical trials phases 1-4.
• Mention of the hospital’s name in the proposal and the publication.
REPORTS AND AUDITS• Amendment and never re-issue of approval (can cause confusion).
• What is amended? title, co-researchers (remove or add), spelling of names, methods.
• When amended? before approval, after approval, during review by journals, and during application for promotion.
RESEARCH MALPRACTICES1. Excel sheet showing the following columns about each submission: IRB log number, submission date, category, PI and co-researchers, department, email, final approval date, and auditing status.
2. Process of auditing: submit an annual report, they select 3-5 studies, and tell you they will come and audit. Friendly advice and new policies or procedures
3. Monitoring and auditing by IRB.
4. Annual report to CEO.
1. Plagiarism and use of AI.
2. Authorship: gift, drop. Fights among co-researchers.
3. Research without IRB.
4. Ethical issues.
5. Scientific validity.
6. Challenges of approving a manuscript without the resources to check it thoroughly.