Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study

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...

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Main Authors: Darpan I. Patel, Kathleen R. Stevens, Frank Puga
Format: Article
Language:English
Published: Wiley 2013-01-01
Series:Nursing Research and Practice
Online Access:http://dx.doi.org/10.1155/2013/548591
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author Darpan I. Patel
Kathleen R. Stevens
Frank Puga
author_facet Darpan I. Patel
Kathleen R. Stevens
Frank Puga
author_sort Darpan I. Patel
collection DOAJ
description 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 ± 31.8 days to submit the study to the IRB. IRB approvals were relatively quick with an average of 14 ± 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.
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institution Kabale University
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spelling doaj-art-6c69ea307f5c4c77bea4c9187f99a7d92025-02-03T01:04:50ZengWileyNursing Research and Practice2090-14292090-14372013-01-01201310.1155/2013/548591548591Variations in Institutional Review Board Approval in the Implementation of an Improvement Research StudyDarpan I. Patel0Kathleen R. Stevens1Frank Puga2Academic Center for Evidence-Based Practice, School of Nursing, University of Texas Health Science Center at San Antonio, MSC 7949, 7703 Floyd Curl Drive, San Antonio, TX 78229, USAAcademic Center for Evidence-Based Practice, School of Nursing, University of Texas Health Science Center at San Antonio, MSC 7949, 7703 Floyd Curl Drive, San Antonio, TX 78229, USAAcademic Center for Evidence-Based Practice, School of Nursing, University of Texas Health Science Center at San Antonio, MSC 7949, 7703 Floyd Curl Drive, San Antonio, TX 78229, USAThe 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 ± 31.8 days to submit the study to the IRB. IRB approvals were relatively quick with an average of 14 ± 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.http://dx.doi.org/10.1155/2013/548591
spellingShingle Darpan I. Patel
Kathleen R. Stevens
Frank Puga
Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study
Nursing Research and Practice
title Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study
title_full Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study
title_fullStr Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study
title_full_unstemmed Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study
title_short Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study
title_sort variations in institutional review board approval in the implementation of an improvement research study
url http://dx.doi.org/10.1155/2013/548591
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