A comprehensive data analysis of the full iRIS new submission data set (Feb 2010-July 2013) showed:
- More than 80% of new submissions are returned at least once for pre-review corrections
- Most studies undergo several submission and review rounds prior to approval
- Close to 50% of the total T2A is time spent waiting for the study team to respond to requests for corrections or changes
The project team identified several factors contributing to lengthy turnaround times:
Quality:
- Many submissions are sent in incomplete and/or with improperly formatted consent forms
- Studies submitted to CHR without required feasibility and scientific merit review add to the overall T2A
- Poorly-prepared applications take excessive time and resources to screen and review
- Multiple rounds require the analyst to review the same submission several times
Application Issues
- The current Study Application is ill-suited for social and behavioral research and other non-clinical research study submissions, causing confusion and incomplete or incorrectly prepared submissions
- Some sections of the application in clinical research submissions are frequently completed incorrectly, indicating users may not fully understand what information is being requested
60-day response window contributes to delays
- CHR Coordinators often have to screen more studies than they need to try to get back enough studies to fill agenda slots
- Agenda spots go unfilled if corrections aren’t submitted in time
- Over-screening delays preparation of correspondence from committee reviews after the CHR meetings