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. 2017 Dec:8:114-121.
doi: 10.1016/j.conctc.2017.09.001. Epub 2017 Sep 6.

Use of a Single, Independent IRB: Case Study of an NIH Funded Consortium

Brandy Stoffel  1 , Christine Sorkness  2 , Carol Pech  3
Affiliations

Use of a Single, Independent IRB: Case Study of an NIH Funded Consortium

Brandy Stoffel et al. Contemp Clin Trials Commun. 2017 Dec.

Abstract

In 2014, the Request for Applications from the National Institutes of Health (NIH) for continued funding of a multi-site clinical and mechanistic research network, Inner City Asthma Consortium (ICAC), called for "efficient IRB review and approval for multi-center studies" and "IRB approval within 30 days from submission". These requirements were precursors to the NIH policy of single IRB review for multi-site studies. Here we share our challenges, implementation processes, results, and recommendations, using a single, independent IRB.

Keywords: Consortium; Independent IRB; Multi-site studies; NIH Policy; Single IRB.

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Figures

Fig. 1
Fig. 1
ICAC single IRB process milestones.
See this image and copyright information in PMC

References

    1. Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research, NOT-OD-16-094, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html.
    1. Busse W.W. The national Institutes of allergy and infectious diseases networks on asthma in inner city children: an approach to improved care. J. Allergy Clin. Immunol. 2010;125(3):529–539. - PMC - PubMed
    1. 45 CFR 46.103(b)(5), and Terms of the Federal Wide Assurance for the Protection of Human Subjects (June 17, 2011) http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html.
    1. http://www.icaccirb.orghttp://www.icaccirb.org(July 2015).
    1. Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials (March 2006). http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127013.pdf.

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