%0 Journal Article
%T Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study
%A Darpan I. Patel
%A Kathleen R. Stevens
%A Frank Puga
%J Nursing Research and Practice
%D 2013
%I Hindawi Publishing Corporation
%R 10.1155/2013/548591
%X The purpose of this paper is to report the variance in institutional review board (IRB) reviews as part of the implementation of a multisite, quality improvement study through the Improvement Science Research Network (ISRN) and recommend strategies successful in procuring timely IRB approval. Using correspondence documents as data sources, the level of review was identified and time to submission, time to approval, and time to study start were analyzed. Thirteen of the 14£¿IRBs conducted independent reviews of the project. Twelve IRBs approved the study through expedited review while two IRBs reviewed the project at a full board meeting. Lastly, 11 of the 14 sites required documented consent. The greatest delay in approval was seen early on in the IRB process with site PIs averaging 45.1 ¡À 31.8 days to submit the study to the IRB. IRB approvals were relatively quick with an average of 14 ¡À 5.7 days to approval. The delay in study submission may be attributed to a lack of clear definitions and differing interpretations of the regulations that challenge researchers. 1. Introduction With the push to increase the quantity, quality, and generalizability of improvement research [1¨C3], networks such as the Improvement Science Research Network (ISRN) provide an opportunity to conduct rigorous multisite studies; however, the inconsistency of review for improvement research brings challenges to both academic- and hospital- based IRBs. A formidable barrier to carrying out multisite improvement research is the IRB review process itself. Completion of the IRB application is a necessary yet time-consuming process [4]. The ISRN has developed a streamlined approach to facilitate IRB submissions at the local site through the use of the protocol implementation kit (PIK). Quality improvement in the healthcare industry has gone through a major change. With the landmark report from the Institute of Medicine indicating the need to transform the healthcare system [2], quality improvement research must go beyond the single site, single investigator mindset. Using the implementation science framework focusing on participatory implementation process [5], many clinicians are working alongside their academic partners engaging in quality improvement activities to improve healthcare processes and patient outcomes. With the need to disseminate best practices, publication of quality improvement activities is warranted; however, many journals and publishers will not publish original data if the project was not approved by an accredited institutional review board. IRB review and federal
%U http://www.hindawi.com/journals/nrp/2013/548591/