Spotlight on an abstract from the 2009 AER Conference

Title: Improving Turn-Around Time for Initial IRB Review of Minimal Risk Studies

Authors: Cerdi Beltre, CIP and Hallie Kassan, MS, CIP

Affiliation: North Shore-Long Island Jewish Medical Center, the Feinstein Institute for Medical Research

Abstract summary: This program sought to improve the turnaround time for initial IRB review of minimal risk studies. After evaluating the causes for delays, the authors identified the following improvements that could provide the highest benefit with the least amount of effort:

• Rotation of exempt studies among four (rather than one) IRB staff members for review;
• Increase use of all IRB committee members on expedited reviews;
• Develop reviewer sheet for expedited review to assist committee members;
• Develop office checklist to standardize initial review process;
• Establish process for coverage when staff is out of the office; and
• One-on-one meetings with the director to hold staff accountable and provide education.

After three months of program implementation the data was reviewed again. The average turn-around time for initial response on exempt studies decreased from 10.1 to 3.1 business days. The average turnaround time for initial response on expedited studies decreased from 14.6 business days to 7.5.

PRIM&R Staff (PS): In the months since you presented this abstract at PRIM&R’s 2009 AER Conference, how has your program changed or evolved?

Hallie Kassan, MS, CIP (HK): The turnaround time in our office has improved significantly, especially for exempt studies. We are constantly working on our processes and trying to choose that which is most efficient.

To further improve efficiency, we have moved from a system in which the IRB staff reviews submissions based on submission type (such as new studies, progress reports, etc.) to a system where the IRB staff reviews submissions based on the department. Thus, each staff member is an expert in the departments to which they are assigned. This strategy should help to fulfill our turnaround time goals.

PS: What challenges have you faced in implementing this program?

HK: Workload is still a challenge. Depending on the week and month, some IRB staff are so busy that it is not possible to meet our turnaround time goals and still provide an adequate review. We are currently trying to work on ways to redistribute the work in a timely fashion.

For questions or comments about this program, please contact Hallie Kassan.

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