P117: Gaps in IRB Oversight and Ethical Compliance: A Case Study from a University-Based Human Subjects Research
Poster Presenter
TzuYuan Kao
Student
University of Washington United States
Objectives
To analyze gaps in IRB oversight and ethical compliance revealed by a university-based human subjects case, using IRB regulations, GCP, and research ethics frameworks to assess participant protection.
Method
A case-based regulatory and ethics analysis was conducted using a university-based human subjects research case, informed by IRB oversight principles, GCP standards, and established research ethics frameworks.
Results
The analysis identified multiple gaps in IRB oversight and ethical compliance. First, IRB review was largely limited to submitted documents, providing limited visibility into actual study conduct. Second, in hierarchical academic settings, existing safeguards were insufficient to prevent participant coercion. Third, protocol deviations were difficult to detect due to reliance on document-based review, and mechanisms for ongoing monitoring after approval were limited. Finally, while GCP principles emphasize participant protection, they lack enforceability in non-commercial academic research contexts.
Conclusion
This case-based analysis suggests that IRB oversight and ethical compliance in academic human subjects research are inherently limited when monitoring relies primarily on document-based review. While IRBs serve as an essential safeguard prior to study initiation, their ability to detect coercion, protocol deviations, and ethical risks during study conduct remains constrained, particularly in hierarchical academic environments. The findings further indicate that although GCP principles articulate clear expectations for participant protection, their lack of enforceability in non-commercial research settings limits their practical impact. Collectively, these observations highlight the need to recognize the structural boundaries of existing oversight mechanisms and to reinforce a culture of ethical responsibility beyond formal compliance. Strengthening participant protection in academic research therefore requires not only regulatory frameworks, but also heightened ethical awareness and accountability among investigators throughout the research lifecycle.
