A rigorous and balanced pre-review of submissions is an important part of our institution's IRB review process. A pre-review process provides a checkpoint in approval readiness and can substantially reduce the number of deferred submissions. The pre-review phase begins when a submission is received for IRB review and ends when the submission is assigned to reviewer(s). During pre-review, assigned IRB personnel conduct thorough administrative and regulatory analysis of the submission. Deficiencies to be addressed are communicated to the study team through an electronic submission system. At times, there are significant delays in responding to requests for clarification. These delays negatively impact IRB metrics.
Description/Evaluation of Program
In an effort to improve efficiency of the process, we identified a number of barriers that contributed to delays during the pre-review phase. We reviewed and tracked all clarification requests that were not responded to within seven calendar days for new studies, modifications, and continuations over a period of six months. Based on feedback from the study teams obtained via questionnaire and our evaluation of clarification requests, we identified the major barriers encountered during pre-review and examined their impact on turnaround time. We were then able to develop strategies to minimize the factors that contributed to the common barriers. In this poster, we will identify the causes of delay, and provide correlation between the causes of the delay, the length of the delay and the strategies to eliminate the barriers.
Future Use/Suggestions for Implementation
Our institution's School of Medicine's IRB undertook this quality improvement analysis and identified barriers that are specific to the institution's IRB. Understanding these factors can assist other organizations in the evaluation and eliminations of delays in response time. Once the barriers are identified, the organization can focus on ways to improve the length of the pre-review process that are specific to its barriers.