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Related Concept Videos

Ethics in Research01:56

Ethics in Research

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
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Related Experiment Video

Updated: Jun 21, 2026

Working with Human Tissues for Translational Cancer Research
07:48

Working with Human Tissues for Translational Cancer Research

Published on: November 26, 2015

Practice-based research network studies and institutional review boards: two new issues.

Barbara P Yawn1, Deborah G Graham, Susan L Bertram

  • 1Department of Research, Olmsted Medical Center, Rochester, MN 55904, USA. yawnx002@umn.edu

Journal of the American Board of Family Medicine : JABFM
|July 10, 2009
PubMed
Summary

Institutional Review Boards (IRBs) imposed extra training and consent form requirements on a large practice-based research network (PBRN) study, causing delays and burdens. These non-federal mandates increased costs and frustration for PBRN research.

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Area of Science:

  • Medical Research
  • Public Health
  • Clinical Trials

Background:

  • Practice-based research networks (PBRNs) face challenges coordinating with multiple Institutional Review Boards (IRBs).
  • Many IRBs lack familiarity with the unique structure and needs of PBRN research.
  • Navigating IRB processes is crucial for the success of multi-site PBRN studies.

Purpose of the Study:

  • To highlight two novel IRB-related issues encountered during a large, 5-year PBRN study.
  • To document the impact of these issues on study operations and participants.
  • To inform future PBRN research regarding potential IRB-related challenges.

Main Methods:

  • A 5-year PBRN study involving 32 diverse sites across the United States.
  • The study focused on postpartum depression screening and follow-up.
  • IRB approvals were obtained from 19 different institutional review boards.

Main Results:

  • Two unanticipated IRB issues significantly increased workload: repeated human subjects training and annual consent form re-stamping.
  • 92 staff members completed redundant training, and 17 IRBs required yearly consent form updates.
  • Study enrollment was interrupted at 4 sites due to delays in receiving updated consent forms.

Conclusions:

  • IRB requirements exceeding federal regulations impose substantial burdens on PBRN studies.
  • Non-federally mandated IRB requirements should be evidence-based and justified by demonstrated need.
  • Streamlining IRB processes is essential to reduce costs and frustrations in PBRN research.