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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
Case 2: Risk-Benefit Considerations - 2:► A resident refused to assist his consultant in a clinical trial because, from his personal experience, the side effects and reaction to the experimental drug were worse than the migraine headache. The consultant had a different view of the risk-benefit equation. The IRB had approved the study based on similar studies overseas with no reports of severe adverse reactions.
Case Scenario 3: The Processes of Informed Consent - 1:► A systematic review of the literature showed that the proposed study had already been carried out in several countries and that the research question had been answered. The researchers still went ahead to submit the study to the IRB, which approved it on the basis that the study had not been carried out locally.
Case Scenario 4: The Processes of Informed Consent - 2:► A randomized study was carried out among non-anemic sickle cell children aged 5-10 to study the impact of daily folic acid supplementation on hemoglobin levels.
► Informed consent was obtained from both parents after full disclosure of all facts, but the children were not informed.
► Parents signed the informed consent form without reading and were not given a copy.
► A questionnaire at the end of the study surprised researchers because the parents could not remember that any research was carried out; they knew it was all routine medical care.
Case Scenario 5: Conflict of Interests - 1:► Parents were informed that their child had terminal cancer and was put on DNA.
► The parents refused participation in a randomized trial of a new chemotherapeutic agent, claiming that he had a right to refuse and that the research was not in the interests of their child.
► The principal investigator, who was a senior and famous professor, was called to convince the parents. He told them that participation was a duty on each citizen and that it was immoral to shirk that duty. He said, ‘If everybody refused to participate, how can we develop new drugs?’ The parents reluctantly signed the informed consent form.
► An auditor noticed that the father had written against his signature, امرنا لله.
Case Scenario 6: Conflict of Interests - 2:► The local branch of the pharmaceutical companies was very careful not to violate ethical guidelines while sponsoring physicians to conferences overseas. They never required them to say or write anything in favor of the company or any of its products.
► One day, one researcher was surprised when his young daughter complained that the family had gone on company-sponsored summer trips to attend scientific conferences in Europe every year for 3 consecutive years, but they had not gone this year.
► The researcher thought very hard; he remembered his last publication that had generated controversy about a new drug manufactured by the pharmaceutical company. They had made no public comment on the paper.
Case Scenario 7: Payment to Research Subjects - 1:► The pharmaceutical company wanted to conduct a 4th phase study of its new unpopular headache medication and offered SAR500 to physicians in private practice and SAR20 to physicians in public hospitals for every patient recruited into the study.
► All the physician had to do was to prescribe the drug and complete a short 5-item questionnaire. A company representative would pick up the data sheets at the end of every day’s work.
Case Scenario 8: Payment to Research Subjects - 2:► A researcher on cloning advertised in the newspapers with wide distribution in a poor inner-city neighborhood for a clinic admitting patients with threatened abortion.
► If the abortion became inevitable, all procedures would be completed for free, with USD3000 being given to help in the recuperation phase.
► The woman would have to sign a statement releasing the abortus for research purposes. No questions were asked about the causes of the abortion.
Case Scenario 9: Payment to Research Subjects - 3:► A researcher interested in the effect of daily aspirin on fine motor activity advertised for volunteers in the local newspaper with a payment of USD50 per 10-minute visit to the study center for completing a questionnaire and undergoing some tests.
► Volunteers could make as many visits as they liked, but no more than 5 in a week. The researchers were overwhelmed by the response.
► They were also surprised that none of the volunteers had admitted having gastric ulcers or reported any previous gastric problems with aspirin.
Case Scenario 10: Research Without Consent - 1:► Researchers advertised for male obese youths aged 18-25 years to join a randomized study that compared dietary control to surgical control of obesity.
► The surgery used was innovative, including laparotomy and surgical dissection of lipid tissue from the abdominal cavity.
► Subjects undergoing surgery were each paid USD2000 before the operation and USD8000 after 6 months of follow-up.
Case Scenario 11: Research Without Consent - 2:► Researchers wanted to study the effect of restricting teenagers’ pocket money on their cigarette addiction. Parents were randomized to various amounts of pocket money for teenagers every day. Observers acting as spies hung out with the teenagers and reported on their smoking behaviors. IRB was asked to approve the study without disclosure of its objectives and procedures to the teenagers because that would invalidate the results.
Case Scenario 12: Research Without Consent - 3:► The IRB refused to approve a randomized study of the impact of explanation of the mechanisms of drug action on the response to an analgesic because the principal investigator wanted to research without informed consent. He argued that informed consent would require excessive disclosure, thereby invalidating the study.
Case Scenario 13: Justice - 1:► We want to research the impact of an emergency room intervention, but all patients are brought in unconscious, and we cannot get informed consent. Neither are relatives available. How can we improve our care without research?
Case Scenario 14: Justice - 2:► Patients excluded from a randomized clinical trial on valid exclusion criteria complained to the Ministry of Health because they were denied access to a new experimental therapy available only to those in the randomized trial. They argued that since the drug was brought using public funds, they had a right to it. They had heard that the drug was known from phase 1 and phase 2 studies to be effective.
Case Scenario 15: Justice - 3:► Patients in the control arm of a randomized trial were angry that they had not benefited from the drug that proved to be effective. They planned to take the principal investigator to court. They argued that animal, phase 1, and phase 2 studies had already shown the benefit of the drug. They thought that the principal investigator misled them when he recruited them in the phase 3 study because there was nothing new to find out.
Case Scenario 16: Publication Bias - 1:► The consultant warned his resident to make sure no women of childbearing age are systematically excluded from a randomized study of a new drug whose teratogenic properties were unknown.
Case Scenario 17: Publication Bias - 2:► A researcher studying two treatments compared outcomes on discharge from the hospital. The outcome results of 10 out of 90 patients were lost due to a computer error, and there was no paper backup because all the research was computerized. The patients could also not be traced. The researcher decided on a worst-case scenario and assigned all 10 to the worst outcome and analyzed the results. Fearing confusing the reviewers and readers, he did not mention the assignment of outcome.
Case Scenario 18: Publication Bias - 3:► A systematic literature review carried out before writing the proposal on the use of an existing drug for a new indication led to contradictory conclusions. Research overseas of >5 years ago indicated low adverse effects, while research <5 years ago indicated high adverse reactions. Local experience with the drug showed it to be very safe. The researchers who already had a grant from the pharmaceutical company went ahead with the research but decided to exclude the negative information from their literature review in order not to confuse the IRB members who would review the proposal.
Case Scenario 19: Plagiarism - 1:► The head of the department, a senior professor of surgery, asked his residents to undertake research comparing two surgical techniques. He gave them detailed guidelines on literature survey, study design, and study execution. He never took part in the actual research or the writing of the paper, but gave advice daily whenever they asked him. When the manuscript was ready for publication, he asked that his name be put as the first author. The residents wanted him to be the last author.
Case Scenario 20: Plagiarism - 2:► Two professors cooperated on a study and shared the work; one wrote the introduction and methods, while the other wrote the results and the discussion. The study was published in a reputable journal. The first professor wanted to publish a follow-up study on his own and reproduced, with paraphrasing, some paragraphs from the introduction of the first paper. Since this was his own work, he saw no reason to cite the paper. The second professor was angry and complained to the journal editor.
Case Scenario 21: Senior Author:► A famous research professor submitted a clinical trial in which he was comparing the efficacy and safety of an established therapy against the same therapy using a different vehicle. He refused to submit details about the vehicle, arguing that it was a patentable secret formula that he feared could be stolen by members of IRB and disclosed to others, causing him financial loss. The IRB refused to approve the proposal, and the professor appealed to the National Ethics Commission, threatening that if not satisfied, he would go to court.
► Residents submitted a proposal promptly rejected by the IRB for lack of proper consent procedures and inexperience of the investigators. They resubmitted it with a senior consultant as principal investigator, changed the wording of the title, and changed nothing else. The proposal was accepted.