Facilitating Timely Institutional Review Board Review: Common Issues and Recommendations

Area of Science:

• Medical Research Ethics
• Clinical Trial Management
• Health Policy and Administration

Background:

• Institutional Review Boards (IRBs) are crucial for protecting human subjects in clinical research.
• The IRB review process can be time-consuming and resource-intensive, leading to delays in research initiation.
• Identifying factors contributing to lengthy IRB approval times is essential for improving research efficiency.

Purpose of the Study:

• To identify common factors associated with significant delays in IRB approval for research protocols.
• To analyze characteristics of protocols requiring multiple IRB reviews.
• To propose strategies for streamlining the IRB review and approval process.

Main Methods:

• A quality improvement project was conducted at a large academic health center.
• Content analysis of convened IRB meeting minutes for initial protocol submissions between January and September 2019.
• Comparison of protocols requiring two or more reviews (n=33) versus those requiring less than two reviews (n=244) using statistical tests (e.g., chi-squared, Fisher's exact).

Main Results:

• Factors significantly associated with delayed IRB approval included researcher conflict of interest (30% vs. 12%), need for radiation safety evaluation (36% vs. 20%), and clinical trial protocols (73% vs. 60%).
• Other common issues leading to delays were excessive technical jargon (93.94%), inadequate data security descriptions (75.76%), protocol design affecting patient safety (57.58%), and unclear compensation or study duration information (54.54%).

Conclusions:

• Researcher conflict of interest, radiation safety requirements, and clinical trial status are key factors prolonging IRB review.
• Addressing issues such as technical language, data security, patient safety considerations, and clarity in protocol details can expedite the IRB approval process.
• Implementing targeted strategies to mitigate these common issues can enhance the efficiency and effectiveness of IRB reviews, facilitating timely research conduct.