Internal QA/QI Process for an University IRB


Description of the Research
IRBs are required to verify that federal, sponsor, and other applicable requirements, regulations, and laws are being followed during the review of research studies. The work of an IRB professional is challenged by time constrains and volume, especially in a dynamic university setting where the demands are higher. 

Our institution holds six IRB meetings each month to satisfy the demands of our busy research community while simultaneously ensuring a thorough ethical review of these studies. Approximately, 20 to 24 items (including up to six new studies) are reviewed at each meeting. In order to process this volume and maintain quality, our IRB created a QA/QI program to evaluate the reviewers’ accuracy in a sample of new studies, continuing reviews, and amendments. Because of this program, we were able to identify several areas of improvement without using extensive resources. The process includes the review of three items per IRB professional, with the corresponding IRB member or board. 

During the review we look at many criteria such as the time from submission to approval, correct use of categories, use of device and drugs, waivers approved, correspondence letters, and recorded minutes. If any findings are identified, they are first reviewed by the IRB team leads and director before being reported to the IRB staff/members for correction and education. 

Through this review process we have been able to substantially decrease errors made by our staff and members, increase productivity and efficiency, and establish new tools and procedures to help with quality improvement.