85 - Holding Out for Approval: Navigating Protocol Approval Holds Using Digital Organizational Tools

Background:  Certain requirements for protocol approval can be addressed while it is under review (e.g., full committee review), but this demands that IACUC administrative personnel track the status of these concurrent processes to ensure that an approval letter is only sent to the Principal Investigator (PI) once all requirements are met.

Program

Description:  The institution's IACUC Office uses a smartsheet to track new protocols, de novo renewals, and amendments that have one or more pre-approval requirements, such as occupational health, training requirements, pending full committee review, or Institutional Biosafety Committee (IBC) approval of the PI’s biological registration. Given the volume of protocol submissions with a pre-approval requirement, the IACUC Office uses a Protocol Approval Holds smartsheet to track key information (e.g., protocol number, the PI’s name, the reason why the submission is being held) to remain organized and on-top of each review. The smartsheet is shared with members of IBC to facilitate communication on submissions awaiting IBC approval, and the smartsheet sends reminders to IACUC, IBC, and laboratory personnel to ensure that no submissions are forgotten. The measure for success is demonstrated in the timely processing of protocol holds when pending requirements have been met as well as the submission turnaround times.

Program

Assessment:  Collected data will establish how the implementation of the Protocol Approval Holds smartsheet was extremely successful in preventing premature protocol approval and heightening the IACUC Office’s organization of these submissions. Whereas before it would fall to an individual team member to watch a protocol submission to which they were assigned, the Protocol Approval Holds smartsheet ensures that all IACUC administrative personnel are aware of every submission awaiting a pre-approval requirement. Leveraging the smartsheet reminder function streamlined staff tracking and processing of submissions.

Limitations: Assessing whether the Protocol Approval Holds smartsheet reduced administrative burden was not difficult. Monitoring pending approvals became noticeably simpler and better organized. However, quantifying the full benefit of the Protocol Approval Holds smartsheet’s implementation would be difficult since team members were previously able to manage this information however they chose, and different approaches could influence the net benefit from switching to the smartsheet. This may prove to be a limitation in other programs as well.

Discussion:  Animal research programs vary (e.g., number of PIs and protocols, species housed), but every IACUC has certain requirements (e.g., required training) that must be satisfied prior to approving a submission. While smaller programs may have fewer protocols, it is not uncommon for them to also have fewer administrative personnel supporting their IACUC. Therefore, an efficient means of tracking protocol submissions with incomplete pre-approval requirements has general appeal. Different programs also have different resources at their disposal, and while this institution organizes this information in Smartsheet, it can also be captured with commonly available Microsoft Office products (e.g., Excel, SharePoint).