Human Subjects Review of a Multi-Site Quality Improvement Study Conducted through a National Research Network

2.50
Hdl Handle:
http://hdl.handle.net/10755/308036
Category:
Abstract
Type:
Presentation
Title:
Human Subjects Review of a Multi-Site Quality Improvement Study Conducted through a National Research Network
Author(s):
Patel, Darpan I.; Puga, Frank; Stevens, Kathleen R.
Lead Author STTI Affiliation:
Non-member
Author Details:
Darpan I. Patel, PhD, pateld7@uthscsa.edu; Frank Puga, PhD; Kathleen R. Stevens, RN, MS, EdD, ANEF, FAAN
Abstract:

Session presented on: Tuesday, November 19, 2013

Purpose: The need to conduct relevant quality improvement research is increasing across the country, however, confusion still exists on whether a project is considered quality improvement or research. This project reports the IRB review process for each of the 14 sites engaged in the STAR-2 study (paper 2).

Methodology: This study enrolled 14 hospitals engaging nurses within 3 medical-surgical units in each hospital to collect data on operational failures, in real time, using a index sized “Pocket Card” for 10 shifts over 20 days.  To assure scientific rigor and protocol fidelity was maintained each site was provided with a Protocol Implementation Kit (PIK) with standardized materials and IRB templates. Using the IRB application and correspondences as data, we identified the type of review conducted (exempt, expedited or full board) and noted any changes that were made in the final approved documents relative to the standardize protocol and consent form. The primary author reviewed the IRB application materials and correspondences. Where materials were unclear, the site PI and/or local IRB, if needed, was contacted for clarification. 

Results: Thirteen of the 14 sites engaged in this project conducted independent reviews of the project with one site deferring to the UTHSCSA IRB. Average review time ranged 4-6 weeks. Twelve IRB approved the study through expedited review, category 7 while 2 IRBs reviewed the project at their full board meeting due to engaging a vulnerable population (hospital employees). Lastly, 11 of the 14 sites required documented consent. IRBs did not request any changes or modifications to the study protocol.

Conclusions: QI research continues to be a challenge for IRBs, regardless of their institutional affiliation. IRB approvals, facilitated by the ISRN Coordinating Center, resulted in no resubmission and quick turnaround time with no major issues during the review process.

Keywords:
Human Subjects Protection; Quality Improvement; Institutional Review Board
Repository Posting Date:
19-Dec-2013
Date of Publication:
19-Dec-2013
Conference Date:
2013
Conference Name:
42nd Biennial Convention
Conference Host:
Sigma Theta Tau International, the Honor Society of Nursing
Conference Location:
Indianapolis, Indiana, USA
Description:
42nd Biennial Convention 2013 Theme: Give Back to Move Forward. Held at the JW Marriott
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission.

Full metadata record

DC FieldValue Language
dc.language.isoen_USen_GB
dc.type.categoryAbstracten_GB
dc.typePresentationen_GB
dc.titleHuman Subjects Review of a Multi-Site Quality Improvement Study Conducted through a National Research Networken_GB
dc.contributor.authorPatel, Darpan I.en_GB
dc.contributor.authorPuga, Franken_GB
dc.contributor.authorStevens, Kathleen R.en_GB
dc.contributor.departmentNon-memberen_GB
dc.author.detailsDarpan I. Patel, PhD, pateld7@uthscsa.edu; Frank Puga, PhD; Kathleen R. Stevens, RN, MS, EdD, ANEF, FAANen_GB
dc.identifier.urihttp://hdl.handle.net/10755/308036-
dc.description.abstract<p>Session presented on: Tuesday, November 19, 2013</p><b>Purpose:</b> The need to conduct relevant quality improvement research is increasing across the country, however, confusion still exists on whether a project is considered quality improvement or research. This project reports the IRB review process for each of the 14 sites engaged in the STAR-2 study (paper 2). <p><b>Methodology:</b> This study enrolled 14 hospitals engaging nurses within 3 medical-surgical units in each hospital to collect data on operational failures, in real time, using a index sized “Pocket Card” for 10 shifts over 20 days.  To assure scientific rigor and protocol fidelity was maintained each site was provided with a Protocol Implementation Kit (PIK) with standardized materials and IRB templates. Using the IRB application and correspondences as data, we identified the type of review conducted (exempt, expedited or full board) and noted any changes that were made in the final approved documents relative to the standardize protocol and consent form. The primary author reviewed the IRB application materials and correspondences. Where materials were unclear, the site PI and/or local IRB, if needed, was contacted for clarification.  <p><b>Results: </b>Thirteen of the 14 sites engaged in this project conducted independent reviews of the project with one site deferring to the UTHSCSA IRB. Average review time ranged 4-6 weeks. Twelve IRB approved the study through expedited review, category 7 while 2 IRBs reviewed the project at their full board meeting due to engaging a vulnerable population (hospital employees). Lastly, 11 of the 14 sites required documented consent. IRBs did not request any changes or modifications to the study protocol. <p><b>Conclusions: </b>QI research continues to be a challenge for IRBs, regardless of their institutional affiliation. IRB approvals, facilitated by the ISRN Coordinating Center, resulted in no resubmission and quick turnaround time with no major issues during the review process.en_GB
dc.subjectHuman Subjects Protectionen_GB
dc.subjectQuality Improvementen_GB
dc.subjectInstitutional Review Boarden_GB
dc.date.available2013-12-19T17:26:02Z-
dc.date.issued2013-12-19-
dc.date.accessioned2013-12-19T17:26:02Z-
dc.conference.date2013en_GB
dc.conference.name42nd Biennial Conventionen_GB
dc.conference.hostSigma Theta Tau International, the Honor Society of Nursingen_GB
dc.conference.locationIndianapolis, Indiana, USAen_GB
dc.description42nd Biennial Convention 2013 Theme: Give Back to Move Forward. Held at the JW Marriotten_GB
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission.en_GB
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