Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2018 Mar 10;36(8):819-824.
doi: 10.1200/JCO.2017.76.9836. Epub 2018 Jan 31.

Meeting the Challenge: The National Cancer Institute's Central Institutional Review Board for Multi-Site Research

Holly A Massett  1 , Sharon L Hampp  1 , Jacquelyn L Goldberg  1 , Margaret Mooney  1 , Linda K Parreco  1 , Lori Minasian  1 , Mike Montello  1 , Grace E Mishkin  1 , Catasha Davis  1 , Jeffrey S Abrams  1
Affiliations
Review

Meeting the Challenge: The National Cancer Institute's Central Institutional Review Board for Multi-Site Research

Holly A Massett et al. J Clin Oncol. .

Abstract

The National Institutes of Health (NIH) issued a new policy that requires a single institutional review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs. Since 2001, the National Cancer Institute (NCI) has funded a central IRB (CIRB) that provides human patient reviews for its extensive national cancer clinical trials program. This paper presents data to show the adoption, efficiencies gained, and satisfaction of the CIRB among NCI trial networks and reviews key lessons gleaned from 16 years of experience that may be informative for others charged with implementation of the new NIH single-IRB policy.

PubMed Disclaimer

Figures

Fig 1.
Fig 1.
Representation of the National Cancer Institute central institutional review board (CIRB) model.
Fig 2.
Fig 2.
Enrollment status in the National Cancer Institute (NCI) central institutional review board (CIRB) of total unique institutions per year, from 2013 through 2016.
See this image and copyright information in PMC

References

    1. Klitzman R: How local IRBs view central IRBs in the US. BMC Med Ethics 12:13, 2011 - PMC - PubMed
    1. The Lancet Neurology : NeuroNEXT: accelerating drug development in neurology. Lancet Neurol 11:119, 2012 - PubMed
    1. National Conference on Alternative IRB Models: Optimizing human subject protection, 2006:1-53. (2017). In: National conference on alternative IRB models: Optimizing human subject protection. https://www.aamc.org/download/75240/data/irbconf06rpt.pdf.
    1. Pyle S.: Benefits of working with a central IRB. Improved efficiencies and enhanced human subject protections. Monitor (Charlottet):9-12, 2013
    1. Weschler J: Commentary- View from Washington-Central vs. Local: Rethinking IRBs-regulators and sponsors encourage alternative review models to fit a growing research enterprise. Appl Clin Trials 16:24-26, 2007

MeSH terms

LinkOut - more resources