2.50
Hdl Handle:
http://hdl.handle.net/10755/159307
Type:
Presentation
Title:
Protection of Human Subjects in Multi-Site Intervention Research
Abstract:
Protection of Human Subjects in Multi-Site Intervention Research
Conference Sponsor:Midwest Nursing Research Society
Conference Year:2005
Author:Bartz, Claudia, PhD, RN, FAAN
P.I. Institution Name:University of Wisconsin - Milwaukee
Title:Associate Professor
Contact Address:College of Nursing, POB 413, Milwaukee, WI, 53201, USA
Contact Telephone:414.229-4030
Co-Authors:Laura M. Anderko, PhD, RN, Associate Professor
Problem. Multi-site research in a network of community-based settings
presents new challenges for the protection of subjects by Institutional
Review Boards (IRBs) and researchers. There is a variance between the
requirements underlying human subject research and the process required
for a rigorous and meaningful study. The purpose of this paper is to
discuss the challenges encountered in multi-site intervention research
across nursing centers in the Midwest. Framework. The Health Belief Model
in concert with Lundeen's Nursing Center Model guided this study. Method.
The IRB applications to seven institutions for a multi-site study were
subjected to content analysis. Results. Due to changes suggested or
required by individual IRBs, potential threats to the study's reliability
and validity were identified. The following issues were recognized. 1) One
proposal for multiple-site research meant that the methods, especially for
data collection needed tailoring to meet local IRB requirements. 2) Site
IRBs varied in interpretation of HIPPA requirements, 3) Experience with
the IRB application process and multi-site studies varied among site
investigators, resulting in lengthened approval times. 4) Each IRB member
varied in understanding of community-based research. 5) The IRBs and
researchers faced challenges related to subjects from community-based
populations, such as the hesitance to participate in the research if legal
signatures were required. 6) Low literacy of many subjects lead to
concerns over the lengthy consents. Conclusion. Research in practice-based
research networks of nursing centers can provide subjects in significant
numbers across sites to positively influence nursing practice. The
resultant research develops the evidence needed to change primary care
practice. Strategies to lower IRB barriers to multi-site studies could
include a consortium IRB, site investigator input into the proposal
preparation, a template protocol for IRB submission, and a template for
consent forms. Funded: Robert Wood Johnson Foundation
Repository Posting Date:
26-Oct-2011
Date of Publication:
17-Oct-2011
Sponsors:
Midwest Nursing Research Society

Full metadata record

DC FieldValue Language
dc.typePresentationen_GB
dc.titleProtection of Human Subjects in Multi-Site Intervention Researchen_GB
dc.identifier.urihttp://hdl.handle.net/10755/159307-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Protection of Human Subjects in Multi-Site Intervention Research</td></tr><tr class="item-sponsor"><td class="label">Conference Sponsor:</td><td class="value">Midwest Nursing Research Society</td></tr><tr class="item-year"><td class="label">Conference Year:</td><td class="value">2005</td></tr><tr class="item-author"><td class="label">Author:</td><td class="value">Bartz, Claudia, PhD, RN, FAAN</td></tr><tr class="item-institute"><td class="label">P.I. Institution Name:</td><td class="value">University of Wisconsin - Milwaukee</td></tr><tr class="item-author-title"><td class="label">Title:</td><td class="value">Associate Professor</td></tr><tr class="item-address"><td class="label">Contact Address:</td><td class="value">College of Nursing, POB 413, Milwaukee, WI, 53201, USA</td></tr><tr class="item-phone"><td class="label">Contact Telephone:</td><td class="value">414.229-4030</td></tr><tr class="item-email"><td class="label">Email:</td><td class="value">cbartz@uwm.edu</td></tr><tr class="item-co-authors"><td class="label">Co-Authors:</td><td class="value">Laura M. Anderko, PhD, RN, Associate Professor</td></tr><tr><td colspan="2" class="item-abstract">Problem. Multi-site research in a network of community-based settings <br/> presents new challenges for the protection of subjects by Institutional <br/> Review Boards (IRBs) and researchers. There is a variance between the <br/> requirements underlying human subject research and the process required <br/> for a rigorous and meaningful study. The purpose of this paper is to <br/> discuss the challenges encountered in multi-site intervention research <br/> across nursing centers in the Midwest. Framework. The Health Belief Model <br/> in concert with Lundeen's Nursing Center Model guided this study. Method. <br/> The IRB applications to seven institutions for a multi-site study were <br/> subjected to content analysis. Results. Due to changes suggested or <br/> required by individual IRBs, potential threats to the study's reliability <br/> and validity were identified. The following issues were recognized. 1) One <br/> proposal for multiple-site research meant that the methods, especially for <br/> data collection needed tailoring to meet local IRB requirements. 2) Site <br/> IRBs varied in interpretation of HIPPA requirements, 3) Experience with <br/> the IRB application process and multi-site studies varied among site <br/> investigators, resulting in lengthened approval times. 4) Each IRB member <br/> varied in understanding of community-based research. 5) The IRBs and <br/> researchers faced challenges related to subjects from community-based <br/> populations, such as the hesitance to participate in the research if legal <br/> signatures were required. 6) Low literacy of many subjects lead to <br/> concerns over the lengthy consents. Conclusion. Research in practice-based <br/> research networks of nursing centers can provide subjects in significant <br/> numbers across sites to positively influence nursing practice. The <br/> resultant research develops the evidence needed to change primary care <br/> practice. Strategies to lower IRB barriers to multi-site studies could <br/> include a consortium IRB, site investigator input into the proposal <br/> preparation, a template protocol for IRB submission, and a template for <br/> consent forms. Funded: Robert Wood Johnson Foundation</td></tr></table>en_GB
dc.date.available2011-10-26T21:53:41Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-26T21:53:41Z-
dc.description.sponsorshipMidwest Nursing Research Societyen_GB
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