A Risk-Based Approach to Designing an Academic Research Project: Comparing the Effects of X- and Gamma-Ray Irradiation on the Lymphocytes of Blood Bags Publisher



Shojaei M¹ ; Mohammadi S^{2, 3} ; Shirani NV⁴ ; Bakhshandeh M⁵ ; Rafiee MH¹
Source: Iranian Journal of Pediatric Hematology and Oncology Published:2025

Abstract

Background: The risk assessment of research projects provides a valuable approach for designing proper methodology, assuring data reliability, and accurately forecasting the resource requirements. Although X-ray irradiation has been globally recognized as a safe method for blood bag sterilization, it has not replaced gamma irradiation in Iran. To facilitate this replacement, a suitable methodology and the assessment of the intervening factors and the risks involved are required. Therefore, this study aims to evaluate the risks associated with X-ray and gamma irradiation using Failure Mode and Effects Analysis (FMEA) as a preliminary model applied in various scientific centers. Materials and Methods: This interventional study uses FMEA to identify the failure modes in six primary processes. Severity (S), occurrence (O), and detection (D) scores were assigned to each failure mode, and their product, the Risk Priority Number (RPN), was calculated to rank the risk levels and compare the failure modes. Control and preventive measures were defined for the failure modes, and the RPN scores were re-evaluated six months later to assess their effectiveness. Results: Twenty-two failure modes with RPN scores ranging from 24 to 360 were identified and evaluated. Through defining control and preventive measures for all the analyzed failure modes, the overall risk level was reduced from a baseline RPN of 114.36 ± 94.97 to a re-scored RPN of 12.18 ± 7.64. This represents an approximately 89.45% reduction from the baseline. The reduction in RPN was primarily due to the changes in the occurrence and then detection. Conclusion: FMEA is a robust tool for analyzing and mitigating risks in research projects, enhancing their quality before implementation. By this method, the risks associated with replacing gamma irradiation with X-ray irradiation for blood bags can be identified and controlled, leading to the elimination of irradiation limitations for blood bags nationwide. © (2025), (Shahid Sadoughi University of Medical Sciences). All rights reserved.