75 - Shedding Light on the Gray Area: Process Improvement in Exempt-Level Reviews

Background:  Review of exempt-level research exists in a “gray area.” The federal regulations do not dictate how to review exempt-level research, so the process varies across institutions. While this may cause inconsistency across institutions, this can be an opportunity for each institution to develop processes that best fit their needs.

Program

Description:  Researchers' complaints prompted an evaluation of the review process for improvements due to longer review times and over-reviews. Protocol Coordinators, the HRPP Director, and the Associate Vice President for Research and Innovation met to dissect and evaluate reviews of exempt-level research and brainstormed how this process could be improved. By analyzing protocols and synthesis of coordinator reviews, it was evident that unnecessary criteria were applied, as the same protocol was being used for both exempt and nonexempt research. To address this, a new social-behavioral-specific protocol and exempt assessment tool were introduced. Stakeholder groups of researchers provided input and feedback to the documents developed. In August 2022, this institution implemented the new process for exempt research, reducing review times for exempt research by approximately 30% from 23 to 16 days.

Program

Assessment:  To assess the implementation of the new review process and assessment tool, we began by first gathering data on the review times of exempt-level reviews from one year before and from one year after the changes were implemented. Following analysis of these data, we were able to see a marked improvement in the efficiency of reviews for exempt-level research.
In addition to the quantitative improvements, qualitative improvements were also provided from both the research community and the HRPP. These improvements include: the ease of submission, decreased review times, and decreased revision requests required for approval.
One aspect of these new review processes and documents that presented a challenge was each protocol coordinator having to learn a new way of reviewing exempt-level research. While not impossible, having to relearn a review process is time-consuming and necessitates additional training and support.
Overall, the new review process, and accompanying documents, has proven effective by increased efficiency in reviews and the positive reception from the research community regarding the changes implemented.

Limitations: The exempt assessment tool has only been piloted with a select group of researchers, so effectiveness cannot be evaluated fully yet. This process is one that was developed and catered by the ones implementing it, which can introduce a level of bias to consider. Allowing researchers to provide feedback and input also introduced the bias of those who may have had ulterior motives, such as ease of submission rather than capturing needed information.

Discussion:  Exempt-level research is the majority of research done at this institution. Exempt-level review process is one that is used every single day, and therefore should continue to be optimized. Since the implementation of this new review process, and the development of new tools, we have been able to measure the effectiveness and efficiency for both internally and externally. This institution has been able to cater this process, and these tools, to the specific needs of both the HRPP and the university. Continual and consistent evaluation and improvement of this process will allow for effective and efficient exempt-level reviews.