Zainab Abedin1, Alan Teller2, Brenda Ruotolo2, Kawthar Muhammad1, Deborah F Stiles3, Rui Ferreira2, Nancy Green4,5. 1. Evaluation and Continuous Improvement Resource of the Irving Institute for Clinical and Translation Research, Columbia University, New York, USA. 2. Institutional Review Board of the Human Research Protection Office, Columbia University, New York, USA. 3. Office of Vice President for Research, Columbia University, New York, USA. 4. Regulatory Knowledge and Ethics Support (RKSER) of the Irving Institute for Clinical and Translation Research, Columbia University, New York, USA. 5. Department of Pediatrics, Columbia University, New York, USA.
Abstract
BACKGROUND: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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. THE FOLLOWING CORE COMPETENCIES ARE ADDRESSED IN THIS ARTICLE: Practice-based learning and improvement.
BACKGROUND: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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. THE FOLLOWING CORE COMPETENCIES ARE ADDRESSED IN THIS ARTICLE: Practice-based learning and improvement.
Entities:
Keywords:
Ethics; Institutional Review Board; research support; translational research
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