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institutional review board Compliance with National Regulatory Body: A Successful Experience from Saudi Arabia

Open Journal of Preventive Medicine 2022年第5期12卷 96-110页

作者： Amel A. Sulaiman Abdullah M. Al-Saigul Ahmed A. Al Meman Omar Abdulaziz Al Yahia Saleh A. Al Gabbany El-Gamri El-Rady Fahad Al Bejaidi Khaled N. AlKhitan Family Medicine Academy Qassim Health Cluster Buraydah Saudi Arabia Department of Clinical Pharmacology Faculty of Medicine Qassim University Buraydah Saudi Arabia Department of Public Health Qassim Ministry of Health Buraydah Saudi Arabia Department of Neuro-Medicine King Fahad Specialist Hospital Buraydah Saudi Arabia College of Public Health and Informatics Qassim University Buraydah Saudi Arabia Department of Planning and Research Qassim Health Directorate Buraydah Saudi Arabia

Background: The institutional review board (IRB) or Research Ethics Committees (RECs) is established to review the research proposals and ensure that participants’ ethical standards, scientific merit, and human rights are protected. Purpose: The authors report the experience of the REC at Qassim Region, Saudi Arabia over 10 years period. Methods: All proposals submitted to Qassim REC during the period 2008-2017 were studied using a 30 items data collection form based on The National Committee of Bioethics Regulations. Data extracted included;principal investigator characteristics, numbers of proposals reviewed, applications completeness, approval decision status, reported ethical issues, classification of the ethical review, and committee review duration. The structure, workload, and review process of Qassim REC were addressed redundant. Results: During 10 years, Qassim Research Ethics Committee (QREC) witnessed a progressive increase in the number of submitted proposals, from 9 to 149 proposals. Out of 508 submitted applications, 439 (86.4%) proposals were eligible for ethical review. Of these, 50 (11.4%) proposals were incomplete due to nonresponse of the principal investigators to the QREC comments. The final decision was made for 389 (88.6%) completed proposals. The approval rate was 85.4%, while the rejection rate was only 1.1%. The median time taken for ethical review was 13 days. Proposals that underwent full board review had a long review duration (Median: 19 days) in comparison to the expedited review (Median: 10 days). Incomplete Committee requirements, unclear research methodology, or possible ethical violation opportunities were the main reasons for delayed decisions. Conclusion: The workload of the Qassim ethics committee is high and growing progressively. However, the process indicators as per National Bioethics Committee rules were satisfactory. Rejection of proposals was rare as most of the reviewed proposals were descriptive studies with infrequent

关键词： Research Ethics Committee institutional review board Informed Consent Ethical Approval Qassim Saudi Arabia

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