Variability in Ethics Review for Multicenter Protocols in Buenos Aires, Argentina. An Observational Study

Area of Science:

• Health Research Ethics
• Clinical Trial Management
• Regulatory Science

Background:

• Multisite studies face ethical review process variability.
• This variability can impact study timelines and consistency.
• Standardized metrics for assessing this variability are needed.

Purpose of the Study:

• To analyze the variability in ethics review timelines and risk assignment for multicenter studies.
• To identify factors contributing to this variability.
• To present methods for measuring ethics review process delays and variations.

Main Methods:

• Analysis of 1,305 applications for multicenter studies (409 unique protocols) from January 2020 to September 2021.
• Examination of variability in time to approval and time to first observation.
• Assessment of variation in assigned risk levels by Research Ethics Committees (RECs).

Main Results:

• Median variability in time to approval was 42.19 days; time to first observation was 8.00 days.
• Disagreement in risk level assignment by RECs occurred in 24.0% of cases.
• The number of REC members was an independent predictor of variability.

Conclusions:

• Substantial variability exists in the ethics review process for health research protocols.
• Quantifiable metrics can measure delays and variations in ethics review.
• Addressing variability is crucial for efficient and consistent multisite study conduct.