Experience of Institutional Review Board at Tabuk Region, Saudi Arabia

PTB Reports, 2024, 10, 3, 99-106.
DOI: 10.71092/PTB.2024.10.20
Published: December 2024
Type: Research Article
Authors: Sami Mahmoud Assil*, Ghormallah Abdullah Alaghamdi,  Abdulateef Sayed Elbadawi, Abeer Saeed Alatawi, Safa Salih Ahmed Fadul, Abeer Hussin Almasoudi,

Author(s) affiliations:

Sami Mahmoud Assil*, Consultant of Preventive Medicine, MoH, Tabuk, SAUDI ARABIA.

Ghormallah Abdullah Alaghamdi, Consultant of Family Medicine, MoH, Tabuk,SAUDI ARABIA.

Abdulateef Sayed Elbadawi, Consultant of Preventive Medicine, MoH, Tabuk,  SAUDI ARABIA.

Abeer Saeed Alatawi, Associated Professor of Pediatric Nursing, University of Tabuk, SAUDI ARABIA.

Safa Salih Ahmed Fadul, Consultant of Preventive Medicine, MoH, Tabuk, SAUDI ARABIA.

Abeer Hussin Almasoudi, Pharmacist, MoH, Tabuk, SAUDI ARABIA.

Abstract

Background: The Institutional Review Board is the essential committee at healthcare facilities that protects the patient from risk-related factors before, during, and after clinical research. The current investigation aims to explore the regional committee’s local experiences. Materials and Methods: A retrospective review design was used. This study included all research proposals submitted for the IRB during 2022-2023. A restructured data tool was used. It consisted of two parts. The first part contained general information about the research proposal. The 2nd part included the items on the checklist that were used to evaluate the research proposals. Results: IRB received 124 proposals during the study period. The majority of research was submitted from outside MOH facilities 121 (97.6%) and conducted in the medical or surgical fields 46 (57%) at healthcare facilities 116 (93.5%), with universityaffiliated 91 (73.4%). Most of the research designs proposed were cross-sectional 104 (83.9%), with a low percentage of randomized controlled studies 3 (2.4%). Most of participants authorship were multiple 102 (82.3%) with students sharing 85 (68.5%), academic proposal 91 (73.4%) with academic supportive 73 (59%). Among the proposals submitted to IRB, most of them were approved 109 (87.9%) and needed single 56 (45.2%) or double revision 43 (38%). The faith of researches submitted was data collection process 47 (37.9%), and published 31 (25%) or under publication 25 (20.2%). The average time for proposal approval was 35.37+/-83.447 days. The multiple linear regression analysis confirmed that the Number of reviews explained 32.4% of the positive relationship to the variation in approval time, with a statistically significant difference (p=0.000). The relationship between decision-making and all checklist items as factors affecting decision-making: All checklist items were not statistically significant (p>0.05) except the proposal title, data analysis plan (p=0.014), and ethical consideration (p=0.012). Conclusion: The regional Institutional Review Board committee addresses certain aspects of the research proposal to influence positive outcomes. They provide valuable information to update the regional clinical research policy and procedures.
Keywords: Institutional Review Board, Research Proposals, Saudi Arabia, Tabuk.


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