24 - IRB Pre-Review Tools Reduce Expedited Initial Application Median Turn-Around Times (mTAT)

Background:  A shifting regulatory landscape and expanding IRB responsibilities make it challenging to keep track of applicable regulations, laws, and policies. To address this, our institution (a university with a large academic medical center) implemented a suite of tools to improve compliance, efficiency, and staff confidence when conducting pre-review.

Program

Description:  Our institution has four IRBs, each supported by a staff team. Staff are designated reviewers and conduct nearly all expedited reviews. The pre-review suite was designed to: 1) increase compliance; 2) increase efficiency and consistency; 3) produce clear researcher communications that are within IRB purview; and 4) provide staff with a sense of confidence and self-sufficiency. The Pre-review Worksheet provides the reviewer with a single resource to ensure they have considered all applicable regulations, laws, and policies. The Pre-review Guidance describes our Review Strategy Principles, which we think are unique, and which provide reviewers with guidelines for constructing reviews that are: 1) rooted in regulatory requirements; 2) clearly constructed using plain language; and 3) calibrated to the study risk (e.g., embrace flexibility in lower risk research).

We assessed the success of the pre-review suite using: 1) pre- and post-implementation median turn-around times; and 2) staff satisfaction survey data.

Program

Assessment:  We assessed median turn-around-time (mTAT) for initial review of single institution expedited applications pre- and post-implementation of the pre-review guidance. We observed a distinct decrease in mTAT from 22.8 days in 2018 and 20.06 days in 2019 compared to 12.97 days in 2020 (suite implemented Jan. 2020). Median TAT remained lower in 2021 (14.98 days), 2022 (14.75 days), and 2023 (11.18 days).

A staff satisfaction survey was implemented in 2017 and asked the following question: “I have access to the resources and training I need to be successful in my job”. On a scale of 0-5, 80% of staff responded with an average response of 3.34. The survey was administered again in 2023 with a response rate of 85% and an average response for that same question of 4.45. We have made other improvements to staff resources since 2017, but staff use the pre-review tools daily and we believe they are a contributing factor to the improved survey response.

Limitations: Implementation of the pre-review guidance in January 2020 coincided with the start of the COVID pandemic when our office worked hard to rapidly approve COVID research. Additionally, we now receive about 200 fewer expedited initial applications annually compared to pre-2020, likely as a result of the expanded exempt categories in the 2018 Common Rule. It is possible that these factors also contributed to the decrease in mTAT.

Discussion:  We believe the implementation of the pre-review tools described here has accomplished our goal to improve pre-review for our internally reviewed studies. We used the same model to develop pre-review materials for our Regulatory Affairs and Reliance teams. We think this model and our materials could be adapted by other IRBs to fit their own policies and procedures. Our data indicate that implementation of the pre-review guidance coincided with a nearly 8-days reduction in mTAT for our review of internal single-site expedited applications. We believe it could have a similar impact at other academic medical centers or smaller SBER-focused institutions.