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A personalized Institutional Review Board Liaison Service: Evaluation over its initial 30 months.
Zainab Abedin1, Alan Teller2, Brenda Ruotolo2
1Evaluation and Continuous Improvement Resource of the Irving Institute for Clinical and Translation Research, Columbia University, New York, USA.
This study evaluated a new IRB Liaison Service designed to help researchers navigate the Institutional Review Board (IRB) process. Over 30 months, the service provided in-person consultations to study coordinators and investigators. These consultations focused on protocol development, IRB policy questions, and addressing IRB feedback. A survey of users showed 100% satisfaction, and analysis of 67 protocols revealed that 73% were approved within 14 days. The service was found to be a popular and useful resource, improving the research environment and potentially reducing IRB-related delays. The authors plan to continue the service and explore its impact on approval timelines and multi-site studies.
Area of Science:
- Health services research
- Institutional review board operations
- Research ethics administration
Background:
Research institutions face challenges in managing ethical and regulatory compliance for human subject studies. While Institutional Review Boards (IRBs) ensure ethical standards, the process can be complex and time-consuming for investigators. Prior research has shown that delays in IRB approval can slow down clinical and translational research. However, no prior work had resolved how best to streamline IRB interactions to improve efficiency without compromising ethical oversight. This gap motivated the development of dedicated support services to assist investigators with IRB processes. The question remained whether such services could meaningfully improve protocol submission and approval timelines. Existing knowledge suggested that investigator support could reduce administrative burdens, but specific impacts on IRB approval times were unclear. This study addresses that uncertainty by evaluating a new IRB Liaison Service model.
Purpose Of The Study:
The study aimed to assess the effectiveness of a dedicated IRB Liaison Service in supporting investigators during protocol development and IRB interactions. The primary goal was to determine whether such a service could improve the efficiency of the IRB review process. The specific problem addressed was the administrative burden investigators face when navigating IRB requirements. The motivation stemmed from institutional efforts to enhance research environments and reduce delays in protocol approvals. The study focused on a 30-month period to capture long-term impacts. The service was designed to provide in-person consultations, policy guidance, and feedback on IRB comments. The researchers proposed that this model could serve as a scalable solution for other institutions. The evaluation included both user satisfaction and protocol approval timelines as key metrics.
Main Methods:
The study employed a practice-based learning and improvement approach over a 2½-year period from January 2015 to June 2017. A dedicated IRB Liaison Service was established at the institution’s central location. The service offered in-person consultations during office hours, averaging 25–30 per month. A total of 501 consultations were conducted. The researchers analyzed user satisfaction through a survey with a 43% response rate. Of 215 completed surveys, all responses were positive. A subset of 67 unique protocols was selected for in-depth analysis of approval timelines. The study tracked whether protocols using the Liaison Service were approved within 14 days. The researchers also evaluated the types of requests, such as new protocol development and IRB policy questions. The analysis focused on the impact of the service on IRB interactions and approval efficiency.
Main Results:
The IRB Liaison Service conducted 501 in-person consultations over 30 months, with an average of 25–30 per month. The majority of consultations addressed new protocol development, IRB policy questions, and strategies for compliance. A user satisfaction survey showed a 100% positive rating among 215 respondents. Of 67 protocols analyzed in-depth, 73% were approved within 14 days. The service was most frequently used by study coordinators and investigators. The survey results indicated strong user satisfaction with the support provided. The service was found to be a popular and useful addition to research support. The researchers observed that the Liaison Service enhanced the institution’s research-friendly environment. The results suggest that the service may reduce IRB-related delays and improve protocol approval efficiency.
Conclusions:
The study found that the IRB Liaison Service was a popular and useful resource for investigators and study coordinators. The service provided consistent in-person consultations and addressed a wide range of IRB-related questions. The researchers observed that the service enhanced the institution’s research environment and improved user satisfaction. The 73% approval rate within 14 days for protocols using the service suggests potential efficiency gains. The authors propose that the service may help reduce IRB approval times and support the use of single IRBs for multi-site studies. The study does not claim that the service is essential but suggests it may be a valuable addition to institutional research support. The authors plan to continue evaluating the service’s impact on approval timelines. The findings align with broader efforts to streamline IRB processes while maintaining ethical standards.
Frequently Asked Questions
The service aimed to provide investigators with support for IRB interactions, including protocol development and addressing IRB comments.
A total of 501 in-person consultations were conducted over 30 months, averaging 25–30 per month.
Of 67 protocols analyzed, 73% were approved within 14 days after using the Liaison Service.
The service was most frequently used by study coordinators and investigators.
A 43% survey response rate yielded 100% positive feedback from 215 participants.
The authors plan to explore whether the service can reduce IRB approval times and support single IRB use for multi-site studies.
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