DefinePK

Abstract

Ethical review processes safeguard the rights and welfare of participants in health research, ensuring compliance with international guidelines. However, variability in review efficiency across institutions affects research timelines and outcomes. This study quantitatively evaluates review processes in public and private institutional review boards (IRBs) to identify factors influencing review timelines, approval rates, and procedural efficiency. A cross-sectional study was conducted involving IRBs from diverse medical institutions. Data were collected through structured questionnaires, document analysis, and interviews with IRB members. Key metrics included review duration, decision outcomes, protocol risk levels, and resource availability. Descriptive and inferential statistical analyses were performed using SPSS, with significance at p < 0.05. Public institutions exhibited longer mean review durations (53.7 days) than private institutions (38.5 days). Private IRBs processed more expedited reviews (55.2%) and had higher approval rates (80%) than public IRBs (66%). Protocol complexity significantly influenced review timelines, with high-risk protocols averaging 61.4 days. Resource availability was positively associated with efficiency; institutions with dedicated staff demonstrated shorter review times. Significant variability exists in ethical review processes, driven by resource constraints, institutional frameworks, and protocol complexity. Streamlining review procedures, adopting risk-based strategies, and implementing technology-driven solutions are recommended to enhance efficiency without compromising ethical standards. Future research should explore automated review systems and international harmonization of moral guidelines to promote consistency and equity in research governance.