68 - Quality Assurance of IRB Meeting Documents

Background: : As errors were identified with Institutional Review Board (IRB) meeting documents, a quality assurance (QA) monitoring program was implemented for the targeted review of meeting minutes, rosters, voting logs, and short agendas to assess regulatory compliance.

Program

Description: : During September 2023, a data collection spreadsheet was created and has since been updated throughout the QA process of reviewing IRB meeting documents, which consist of meeting minutes, rosters, voting logs, and short agendas, to identify errors. Data was collected by QA reviewers from the IRB meeting documents of 5 IRBs that held convened meetings between August 2022 and December 2024. Once all of the data was collected for each month during the aforementioned time period, the data was also reviewed by senior staff to determine findings that required correction within the documents. The managers of the 5 IRBs were then designated to execute appropriate corrective actions, such as creating addendums to the meeting minutes and updating changes within the rosters, to address the findings. After all corrective actions were implemented each month, a report was generated and submitted to office leadership to assess trends, and implement preventive actions.

Program

Assessment: : All documents from the 50 IRB meetings held between August 2022 and December 2022, the 117 IRB meetings held throughout 2023, and the 118 IRB meetings held throughout 2024 were reviewed. All findings within the IRB meeting documents created during this interval that were caused by human error have been corrected. Examples of these findings include IRB members incorrectly being documented as present or absent for the vote and discussion of particular events, the events that an alternate member was present for and voted on not being specified within the meeting minutes, and the IRB rosters requiring corrections. The majority of the findings within the IRB meeting documents that were caused by programming issues within the electronic system have also been resolved, such as voting information not appearing within the voting log for a specific category of agenda items (referred to as “old business” events). For yet unresolved findings, we are currently working with the team that manages the system to develop resolutions through weekly meetings.

Limitations:: One limitation of this QA monitoring program is that the QA reviewers are not present at the IRB meetings, which results in reduced efficiency as incorrectly identified findings must be confirmed by the IRB managers. Another limitation is that programming issues arise within our electronic system, which can affect information that is conveyed in the IRB meeting documents, whenever a system update is implemented.

Discussion: : Our QA program has created an efficient system for proactively identifying issues and implementing corrective and preventive actions within IRB meeting documents. We will continue to use gathered information from this initiative to improve our IRB meeting documentation to maintain regulatory compliance. This program should be implemented within the Human Research Protection Programs of other institutions to decrease the number of errors identified and preserve quality standards within IRB meeting documents. This initiative has general relevance as a mechanism for institutions to conduct ongoing quality assurance of IRB meeting documents.