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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Main Authors: Jeanette M. Daly, Tabria Weiner Harrod, Kate Judge, LeAnn C. Michaels, Barcey T. Levy, David L. Hahn, Lyle J. Fagnan, Donald E. Nease Jr.
Format: Article
Language:English
Published: Aurora Health Care 2018-10-01
Series:Journal of Patient-Centered Research and Reviews
Subjects:
Online Access:https://digitalrepository.aurorahealthcare.org/cgi/viewcontent.cgi?article=1632&context=jpcrr
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spelling 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
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