Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study
Identifieur interne : 000271 ( Main/Exploration ); précédent : 000270; suivant : 000272Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study
Auteurs : Darpan I. Patel [États-Unis] ; Kathleen R. Stevens [États-Unis] ; Frank Puga [États-Unis]Source :
- Nursing Research and Practice [ 2090-1429 ] ; 2013.
Abstract
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.
Url:
DOI: 10.1155/2013/548591
PubMed: 23738061
PubMed Central: 3655662
Affiliations:
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The delay in study submission may be attributed to a lack of clear definitions and differing interpretations of the regulations that challenge researchers.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Berwick, Dm" uniqKey="Berwick D">DM Berwick</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Stevens, Kr" uniqKey="Stevens K">KR Stevens</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Dziak, K" uniqKey="Dziak K">K Dziak</name></author><author><name sortKey="Anderson, R" uniqKey="Anderson R">R Anderson</name></author><author><name sortKey="Sevick, Ma" uniqKey="Sevick M">MA Sevick</name></author><author><name sortKey="Weisman, Cs" uniqKey="Weisman C">CS Weisman</name></author><author><name sortKey="Levine, Dw" uniqKey="Levine D">DW Levine</name></author><author><name sortKey="Scholle, Sh" uniqKey="Scholle S">SH Scholle</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Glasgow, Re" uniqKey="Glasgow R">RE Glasgow</name></author><author><name sortKey="Green, Lw" uniqKey="Green L">LW Green</name></author><author><name sortKey="Taylor, Mv" uniqKey="Taylor M">MV Taylor</name></author><author><name sortKey="Stange, Kc" uniqKey="Stange K">KC Stange</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Baily, Ma" uniqKey="Baily M">MA Baily</name></author><author><name sortKey="Bottrell, M" uniqKey="Bottrell M">M Bottrell</name></author><author><name sortKey="Lynn, J" uniqKey="Lynn J">J Lynn</name></author><author><name sortKey="Jennings, B" uniqKey="Jennings B">B Jennings</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Graham, Dg" uniqKey="Graham D">DG Graham</name></author><author><name sortKey="Pace, W" uniqKey="Pace W">W Pace</name></author><author><name sortKey="Kappus, J" uniqKey="Kappus J">J Kappus</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Green, La" uniqKey="Green L">LA Green</name></author><author><name sortKey="Lowery, Jc" uniqKey="Lowery J">JC Lowery</name></author><author><name sortKey="Kowalski, Cp" uniqKey="Kowalski C">CP Kowalski</name></author><author><name sortKey="Wyszewianski, L" uniqKey="Wyszewianski L">L Wyszewianski</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Thompson, Da" uniqKey="Thompson D">DA Thompson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lynn, J" uniqKey="Lynn J">J Lynn</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Palevsky, Pm" uniqKey="Palevsky P">PM Palevsky</name></author><author><name sortKey="Washington, Ms" uniqKey="Washington M">MS Washington</name></author><author><name sortKey="Stevenson, Ja" uniqKey="Stevenson J">JA Stevenson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Pronovost, P" uniqKey="Pronovost P">P Pronovost</name></author><author><name sortKey="Needham, D" uniqKey="Needham D">D Needham</name></author><author><name sortKey="Berenholtz, S" uniqKey="Berenholtz S">S Berenholtz</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Stevens, Kr" uniqKey="Stevens K">KR Stevens</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Puga, F" uniqKey="Puga F">F Puga</name></author><author><name sortKey="Stevens, Kr" uniqKey="Stevens K">KR Stevens</name></author><author><name sortKey="Patel, Di" uniqKey="Patel D">DI Patel</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Burman, Wj" uniqKey="Burman W">WJ Burman</name></author><author><name sortKey="Reves, Rr" uniqKey="Reves R">RR Reves</name></author><author><name sortKey="Cohn, Dl" uniqKey="Cohn D">DL Cohn</name></author><author><name sortKey="Schooley, Rt" uniqKey="Schooley R">RT Schooley</name></author></analytic></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Texas</li></region></list><tree><country name="États-Unis"><region name="Texas"><name sortKey="Patel, Darpan I" sort="Patel, Darpan I" uniqKey="Patel D" first="Darpan I." last="Patel">Darpan I. Patel</name></region><name sortKey="Puga, Frank" sort="Puga, Frank" uniqKey="Puga F" first="Frank" last="Puga">Frank Puga</name><name sortKey="Stevens, Kathleen R" sort="Stevens, Kathleen R" uniqKey="Stevens K" first="Kathleen R." last="Stevens">Kathleen R. Stevens</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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