How Instituting a Formalized Pre-IRB Review Process Improves IRB Review Outcomes


Description of the Research
In an effort to improve IRB outcomes and efficiency, research administration at a health institute initiated a change in the IRB submission process by instituting a formal pre-IRB review mechanism. This change occurred in the fall of 2010. IRB support staff now carefully evaluates protocols using a pre-IRB review checklist before the submission is scheduled for IRB review. The pre-review focuses not only on the completeness of the application, but also identifies regulatory and ethical issues that likely need to be addressed prior to full committee or IRB Chair review.

Our inquiry examines how instituting a robust pre-IRB review process can facilitate increased IRB efficiency and improve IRB outcomes by minimizing the number of protocol stipulations and aiding in more timely initiation of research by decreasing IRB approval timelines.

Using our protocol database, we queried the system to obtain our sample size. We randomly selected 30 protocols that were submitted and reviewed before the pre-IRB review program went into effect and 30 protocols that were submitted and reviewed after the pre-IRB review program had been established (N=60). We only analyzed the initial review for each of these protocols and ensured that we had an equitable mix of protocol types and complexity (i.e., clinical trials, natural history, etc.).

Using worksheets that we created to record IRB review results, types of stipulations, and number of meetings before approval was granted, we then reviewed and compared the data.

We discovered a 38% decrease in the number of stipulations in the sample of protocols that underwent pre- IRB review versus those that did not. It was also noted in the group that did not undergo pre-IRB review that 60% of new protocols required two or more meetings before receiving IRB approval. This was in stark contrast to the pre-IRB reviewed protocols, which showed that 60% were approved in a single IRB meeting.

It is evident that the pre-IRB review process improved IRB review outcomes by decreasing approval timelines (fewer number of IRB meetings) and improving the quality of IRB submissions (decrease in the number of stipulations). Therefore, investigators who submit to our IRB are successful in getting their studies approved within a shorter timeframe, which in turn allows them to implement their studies sooner. This facilitates the research process and mission of the institute and National Institute of Health, improves efficiencies, and decreases/lessens what is by some to be an onerous process by investigators.