86 - The importance of the Research Protocol Analyst (RPA) in the administrative pre-review as part of the animal care and use program quality assurance

Background:  All regulations for animal care and use include protocol review requirements. At the institutional level, a policy for protocol review includes an administrative pre-review. It is completed by the RPA as a continuum from preparation through review and approval. The administrative pre-review increases the efficiency and quality of protocols submitted.

Program

Description:  The administrative pre-review starts when the protocol is initiated in the electronic system; it is highly recommended that the researchers work with the RPA before submission. Since 2022, the IACUC office added three RPAs to facilitate protocol submissions and availability to assist researchers. The RPAs created an administrative pre-review checklist which has been critical to ensure consistency and that designated items are checked in all submissions. The “checklist” includes elements such as 1) completion of required information, 2) inclusion of ancillary reviews, 3) grant-to-protocol congruency, and 4) pre-approval training verification and 5) OHS (Occupational Health Services) audit. To assess the effectiveness of using the checklist, we use total review times as monthly key performance indicators (KPIs). The data is retrieved through two independent systems; one tool provides information on submissions under review and the other tool provides retrospective data on approved protocols.

Program

Assessment:  It was expected that a consistent administrative pre-review would help to minimize the number of times a submission goes between reviewer and PI (i.e. review cycle), reduce review time, and reduce the number of reviewer comments related to the proposed animal activities. Importantly, during the administrative pre-review, the RPAs communicate with the PI regarding ancillary reviews, per policy, and any other training requirements before finalizing the IACUC protocol approval. Beginning in Fiscal Year 2024, we have tracked the total review times of approved protocols as part of our KPIs. Our experience is that when a thorough review of the protocol is conducted before it is assigned to the IACUC reviewers, then it allows the reviewer to focus on aspects related to the proposed animal experiments. In addition, the RPAs collaborate with the post-approval monitoring team to ensure that during the administrative pre-review, needed changes to protocols are included. Data will be presented showing the trends for review cycles and review times.

Limitations: The effectiveness of the administrative pre-review checklist to improve the protocol review process was limited by the familiarity of the RPAs in the electronic system, their knowledge of the regulatory background, and institutional policies for animal care and use. The overall review time includes variables not affected by the checklist. Examples of other factors affecting a submission review time include other institutional approvals such as environmental health and safety or testing of biologicals.

Discussion:  At our institution, the RPAs use the administrative pre-review checklist to consistently ensure that protocol submission minimally includes the elements of the checklist. PIs receive notification of pending items, so these are addressed before assigning to a Designated Reviewer. Consistently reviewing protocol submission using the checklist also supported the training of the RPAs using the electronic platform, while applying the regulations and institutional policies. During this implementation, we have continuously reviewed the process and identified areas for improvement including, for example, how the RPA can help the investigator improve their submission and strengthening the checklist itself.