Variation in Institutional Review processes for a multisite observational study
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 st...
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| Published in | The American journal of surgery Vol. 190; no. 5; pp. 805 - 809 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article Conference Proceeding |
| Language | English |
| Published |
New York, NY
Elsevier Inc
01.11.2005
Elsevier Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0002-9610 1879-1883 |
| DOI | 10.1016/j.amjsurg.2005.07.024 |
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| Abstract | 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.
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.
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).
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. |
|---|---|
| AbstractList | 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.
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.
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).
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. 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. 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. 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). 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. 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. 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. 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). 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. 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. 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.BACKGROUNDThe 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.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.METHODSData 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.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).RESULTSSignificant 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).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.CONCLUSIONSThe 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. |
| Author | Hawn, Mary T. Neumayer, Leigh Vick, Catherine C. Kiefe, Catarina Finan, Kelly R. |
| Author_xml | – sequence: 1 givenname: Catherine C. surname: Vick fullname: Vick, Catherine C. organization: Deep South Center on Effectiveness, Birmingham Veterans Administration Medical Center, Birmingham, AL, USA – sequence: 2 givenname: Kelly R. surname: Finan fullname: Finan, Kelly R. organization: Department of Surgery, University of Alabama, KB 429, 1530 3rd Ave S, Birmingham, AL 35294, USA – sequence: 3 givenname: Catarina surname: Kiefe fullname: Kiefe, Catarina organization: Deep South Center on Effectiveness, Birmingham Veterans Administration Medical Center, Birmingham, AL, USA – sequence: 4 givenname: Leigh surname: Neumayer fullname: Neumayer, Leigh organization: Department of Surgery, Salt Lake City Veterans Administration Health Care System, Salt Lake City, UT, USA – sequence: 5 givenname: Mary T. surname: Hawn fullname: Hawn, Mary T. email: mhawn@uab.edu organization: Deep South Center on Effectiveness, Birmingham Veterans Administration Medical Center, Birmingham, AL, USA |
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| Cites_doi | 10.1136/bmj.325.7372.1081 10.7326/0003-4819-139-1-200307010-00021 10.1111/j.1553-2712.2002.tb01612.x 10.1136/bmj.311.7006.659 10.1056/NEJM200205023461814 10.1097/00003246-200102000-00002 10.1111/j.1553-2712.2001.tb00177.x 10.1111/j.1475-6773.2005.00353.x 10.1111/j.1475-6773.2005.00354.x |
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| Keywords | Informed consent Observational Processes Variation Institutional Review Board Multisite Variations Clinical research Review Institution Medicine Ethics Treatment Informed consent; Institutional Review Board; Multisite: Observational. Processes Surgery Clinical trial Bibliographic review |
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| Title | Variation in Institutional Review processes for a multisite observational study |
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