Variation in Institutional Review processes for a multisite observational study
Title
Variation in Institutional Review processes for a multisite observational study
Creator
Vick CC; Finan KR; Kiefe C; Neumayer L; Hawn MT
Identifier
Publisher
American Journal Of Surgery
Date
2005
Subject
Humans; United States; Program Evaluation; Outcome Assessment (Health Care); Ethics Committees; Multi-site Ethics; Health Services Research/organization & administration; Hernia; Observation/methods; Research/organization & administration; United States Department of Veterans Affairs; Ventral/surgery
Description
BACKGROUND: The Veterans Administration is an ideal setting for multisite studies; however, individual VA Institutional Review Board (IRB) approval is necessary. This study examines the burden of multisite IRB approval on a Health Services Research and Development (HSRD) ventral hernia outcomes observational study. METHODS: Data gathered on the IRB process per site included time required for application completion, staff training and compliance, IRB affiliation (VA or university), approval status, and time to IRB approval. Wilcoxon rank sum tests were used to determine differences in median times for application completion and approval. Financial and temporal expenses were calculated. RESULTS: Significant differences were found in median time to complete applications by IRB affiliation (P < .01) and median time to approval by changes required to the consent letter (P < .05). CONCLUSIONS: The IRB process for a multisite observational study is expensive in both time and money. A VA national IRB for multisite studies would significantly decrease the financial and temporal burden for observational studies.
2005
Rights
Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Type
Journal Article
Citation List Month
Backlog
URL Address
Citation
Vick CC; Finan KR; Kiefe C; Neumayer L; Hawn MT, “Variation in Institutional Review processes for a multisite observational study,” Pediatric Palliative Care Library, accessed April 24, 2024, https://pedpalascnetlibrary.omeka.net/items/show/13752.