Abedin Zainab, Teller Alan, Ruotolo Brenda, Muhammad Kawthar, Stiles Deborah F, Ferreira Rui, Green Nancy
Evaluation and Continuous Improvement Resource of the Irving Institute for Clinical and Translation Research, Columbia University, New York, USA.
Institutional Review Board of the Human Research Protection Office, Columbia University, New York, USA.
Int J Acad Med. 2020 Apr-Jun;6(2):96-102. Epub 2020 Jun 29.
The aim of this study is to evaluate whether a dedicated Institutional Review Board (IRB) Liaison Service situated at our Institute's central location could provide additional useful staff support to the investigator community for interactions with the IRB at various levels of protocol submission and review.
Over a period of 2½ years, from January 2015 to June 2017, a total of 501 in-person consultations were performed during office hours, usually 25-30 per month. Most requests concerned new protocol development, IRB policy questions, and strategies for compliance or assistance in addressing IRB comments on returned protocols. We analyzed the results of a user evaluation survey for in-person consults and performed a focused in-depth analysis of the impact of the IRB Liaison Service.
Survey response rate was 43%. Results of 215 completed satisfaction surveys were 100% positive. Users were primarily study coordinators and investigators. Of a randomly selected sample of consultations analyzed in-depth for 67 unique protocols, 73% were subsequently approved within 14 days.
National concerns about IRB-related research delays have led to the re-assessment of IRB review processes at institutional levels. Overall, we have found the Liaison Service to be a popular, useful addition to research support for a meaningful number of researchers, enhancing our already research-friendly environment. We plan to continue the service and the evaluation going forward. We will focus in the next phase on exploring whether the Liaison Service can reduce IRB approval times for protocols using its services and on providing support for the use of single IRBs for multi-site studies.
Practice-based learning and improvement.
本研究旨在评估位于我院中心位置的专门机构审查委员会（IRB）联络服务是否能够在方案提交和审查的各个层面为研究人员群体与IRB的互动提供额外的有益人员支持。
在2015年1月至2017年6月的2年半时间里，共在办公时间进行了501次面对面咨询，通常每月25 - 30次。大多数请求涉及新方案制定、IRB政策问题以及合规策略或协助处理IRB对退回方案的意见。我们分析了面对面咨询的用户评估调查结果，并对IRB联络服务的影响进行了重点深入分析。
调查回复率为43%。215份完成的满意度调查结果全部为正面。用户主要是研究协调员和研究人员。在对67个独特方案进行深入分析的随机抽取的咨询样本中，73%随后在14天内获得批准。
国家对与IRB相关的研究延迟的关注导致了机构层面IRB审查流程的重新评估。总体而言，我们发现联络服务对于相当数量的研究人员来说是研究支持中一项受欢迎且有用的补充，改善了我们本就利于研究的环境。我们计划继续提供该服务并持续进行评估。下一阶段我们将专注于探索联络服务是否能够缩短使用其服务的方案获得IRB批准的时间，以及为多中心研究使用单一IRB提供支持。
基于实践的学习与改进。
