Practice-Based Research Networks Ceding to a Single Institutional Review Board
Historically, a single research project involving numerous practice-based research networks (PBRNs) required multiple institutional review boards (IRBs) to be involved in approval of the project. However, to avoid redundancies, federal IRB regulations now allow cooperative research projects that inv...
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Aurora Health Care
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doaj-9c20b7093e9a4247b8532d1725ad641b2020-11-24T21:47:53ZengAurora Health CareJournal of Patient-Centered Research and Reviews 2330-06982018-10-015430431010.17294/2330-0698.1632Practice-Based Research Networks Ceding to a Single Institutional Review BoardJeanette M. Daly0Tabria Weiner Harrod1Kate Judge2LeAnn C. Michaels3Barcey T. Levy4David L. Hahn5Lyle J. Fagnan6Donald E. Nease Jr.7University of Iowa (Iowa City, IA)Oregon Health & Science University (Portland, OR)University of Wisconsin School of Medicine and Public Health (Madison, WI)Oregon Health & Science University (Portland, OR)University of Iowa (Iowa City, IA)University of Wisconsin School of Medicine and Public Health (Madison, WI)Oregon Health & Science University (Portland, OR)University of Colorado School of Medicine (Aurora, CO)Historically, a single research project involving numerous practice-based research networks (PBRNs) required multiple institutional review boards (IRBs) to be involved in approval of the project. However, to avoid redundancies, federal IRB regulations now allow cooperative research projects that involve more than one institution to use reasonable methods of cooperative IRB review and to cede authority for review and oversight of the project to a single lead IRB. Through ceding, a lead IRB has the authority for review and oversight of the project delegated by all participating sites’ IRBs and becomes the IRB of record for the ceded sites. In the conduct of cooperative research projects, each institution or primary care office site is still responsible for safeguarding the rights and welfare of human subjects and for complying with applicable regulations. The purpose of this report is to delineate the process, including cooperation and effort of personnel, for accomplishing IRB approval for the Implementing Networks’ Self-management Tools Through Engaging Patients and Practices (INSTTEPP) clinical trial. This process involved 4 PBRNs, 16 family physician offices, 4 academic institution’s IRBs, and 4 family practice office external IRBs ceding to the lead IRB. Once ceding was accomplished, subsequent IRB modifications and continuing reviews were the responsibility of the lead IRB, ultimately saving time for all participants and keeping the project on schedule.https://digitalrepository.aurorahealthcare.org/cgi/viewcontent.cgi?article=1632&context=jpcrrinstitutional review boardcooperative researchpractice-based research networksregulationceding |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jeanette M. Daly Tabria Weiner Harrod Kate Judge LeAnn C. Michaels Barcey T. Levy David L. Hahn Lyle J. Fagnan Donald E. Nease Jr. |
spellingShingle |
Jeanette M. Daly Tabria Weiner Harrod Kate Judge LeAnn C. Michaels Barcey T. Levy David L. Hahn Lyle J. Fagnan Donald E. Nease Jr. Practice-Based Research Networks Ceding to a Single Institutional Review Board Journal of Patient-Centered Research and Reviews institutional review board cooperative research practice-based research networks regulation ceding |
author_facet |
Jeanette M. Daly Tabria Weiner Harrod Kate Judge LeAnn C. Michaels Barcey T. Levy David L. Hahn Lyle J. Fagnan Donald E. Nease Jr. |
author_sort |
Jeanette M. Daly |
title |
Practice-Based Research Networks Ceding to a Single Institutional Review Board |
title_short |
Practice-Based Research Networks Ceding to a Single Institutional Review Board |
title_full |
Practice-Based Research Networks Ceding to a Single Institutional Review Board |
title_fullStr |
Practice-Based Research Networks Ceding to a Single Institutional Review Board |
title_full_unstemmed |
Practice-Based Research Networks Ceding to a Single Institutional Review Board |
title_sort |
practice-based research networks ceding to a single institutional review board |
publisher |
Aurora Health Care |
series |
Journal of Patient-Centered Research and Reviews |
issn |
2330-0698 |
publishDate |
2018-10-01 |
description |
Historically, a single research project involving numerous practice-based research networks (PBRNs) required multiple institutional review boards (IRBs) to be involved in approval of the project. However, to avoid redundancies, federal IRB regulations now allow cooperative research projects that involve more than one institution to use reasonable methods of cooperative IRB review and to cede authority for review and oversight of the project to a single lead IRB. Through ceding, a lead IRB has the authority for review and oversight of the project delegated by all participating sites’ IRBs and becomes the IRB of record for the ceded sites. In the conduct of cooperative research projects, each institution or primary care office site is still responsible for safeguarding the rights and welfare of human subjects and for complying with applicable regulations. The purpose of this report is to delineate the process, including cooperation and effort of personnel, for accomplishing IRB approval for the Implementing Networks’ Self-management Tools Through Engaging Patients and Practices (INSTTEPP) clinical trial. This process involved 4 PBRNs, 16 family physician offices, 4 academic institution’s IRBs, and 4 family practice office external IRBs ceding to the lead IRB. Once ceding was accomplished, subsequent IRB modifications and continuing reviews were the responsibility of the lead IRB, ultimately saving time for all participants and keeping the project on schedule. |
topic |
institutional review board cooperative research practice-based research networks regulation ceding |
url |
https://digitalrepository.aurorahealthcare.org/cgi/viewcontent.cgi?article=1632&context=jpcrr |
work_keys_str_mv |
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