Abstract
Background: Ethical conduct in biomedical research is mandated by Saudi Arabia’s Law of Ethics of Research on Living Creatures (2010), yet compliance levels across institutions remain unclear. This study examines institutional adherence to bioscience research regulations in major Saudi healthcare institutions.
Methods: We performed a retrospective cross-sectional analysis of research projects from 2015–2024 in 20 major hospitals. Data on IRB approvals, informed consent documentation, and regulatory reporting were extracted from electronic health record (EHR) systems and institutional annual reports. Descriptive statistics summarized compliance rates; chi-square tests compared compliance by institution type and region. Logistic regression identified factors associated with non-compliance. The authors report King Faisal University IRB approval (KFU-IRB-2025-001).
Results: Overall, 78% of 1,240 analyzed studies had full compliance with national bioethics law and guidelines. University-affiliated hospitals showed higher compliance (85%) than private hospitals (70%, p < 0.01). Common deficiencies included lack of documented informed consent (12%) and missing annual progress reports (9%). Logistic regression indicated that institutions without dedicated research compliance offices had higher odds of non-compliance (OR=2.3, 95% CI 1.5–3.6). The reported association between prior audit and compliance requires verification and does not establish an effect of enforcement.
Conclusions: The reported compliance estimates require reconciliation, site-level data and independent verification. This observational audit cannot establish the effects of oversight or audits. These findings inform policymakers and highlight the need for continuous training in research ethics.
Keywords
- research ethics
- regulatory compliance
- informed consent
- institutional review board
- biomedical research
- Saudi Arabia
Declarations
- Ethics approval
- NA
- Consent to participate
- NA
- Consent for publication
- NA
- Funding
- NA
- Competing interests
- NA
- Author contributions
- NA
- Data availability
- NA
- Registration
- NA
- Acknowledgements
- NA
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