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Effects of Local Institutional Review Board Review on Participation in National Practice-Based Research Network Studies

Effects of Local Institutional Review Board Review on Participation in National Practice-Based... ARTICLE Effects of Local Institutional Review Board Review on Participation in National Practice-Based Research Network Studies Stacia A. Finch, MA; Shari L. Barkin, MD, MSHS; Richard C. Wasserman, MD, MPH; Niramol Dhepyasuwan, MEd; Eric J. Slora, PhD; Robert D. Sege, MD, PhD Objective: To describe the process and outcomes of lo- Results: Practices requiring additional local IRB ap- cal institutional review board (IRB) review for 2 Pediat- proval agreed to participate less than those that did not ric Research in Office Settings (PROS) studies. (CARES: 33% vs 52%; Safety Check: 41% vs 56%). Of the 88 practices requiring local IRB approval, 55 re- Design: Pediatric Research in Office Settings con- ceived approval, with nearly 50% needing active PROS ducted 2 national studies concerning sensitive topics: help, many requiring consent changes (eg, contact name (1) Child Abuse Recognition Experience Study (CARES), additions, local IRB approval stamps), and 87% begin- an observational study of physician decision making, and ning data collection. Median days to obtain approval were (2) Safety Check, a violence prevention intervention trial. 81 (CARES) and 109 (Safety Check). Practices requir- Institutional review board approval was secured by in- ing local IRB approval were less likely to complete data http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Pediatrics American Medical Association

Effects of Local Institutional Review Board Review on Participation in National Practice-Based Research Network Studies

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References (16)

Publisher
American Medical Association
Copyright
Copyright 2009 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6203
eISSN
2168-6211
DOI
10.1001/archpediatrics.2009.206
pmid
19996050
Publisher site
See Article on Publisher Site

Abstract

ARTICLE Effects of Local Institutional Review Board Review on Participation in National Practice-Based Research Network Studies Stacia A. Finch, MA; Shari L. Barkin, MD, MSHS; Richard C. Wasserman, MD, MPH; Niramol Dhepyasuwan, MEd; Eric J. Slora, PhD; Robert D. Sege, MD, PhD Objective: To describe the process and outcomes of lo- Results: Practices requiring additional local IRB ap- cal institutional review board (IRB) review for 2 Pediat- proval agreed to participate less than those that did not ric Research in Office Settings (PROS) studies. (CARES: 33% vs 52%; Safety Check: 41% vs 56%). Of the 88 practices requiring local IRB approval, 55 re- Design: Pediatric Research in Office Settings con- ceived approval, with nearly 50% needing active PROS ducted 2 national studies concerning sensitive topics: help, many requiring consent changes (eg, contact name (1) Child Abuse Recognition Experience Study (CARES), additions, local IRB approval stamps), and 87% begin- an observational study of physician decision making, and ning data collection. Median days to obtain approval were (2) Safety Check, a violence prevention intervention trial. 81 (CARES) and 109 (Safety Check). Practices requir- Institutional review board approval was secured by in- ing local IRB approval were less likely to complete data

Journal

JAMA Pediatrics – American Medical Association

Published: Dec 1, 2009

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