» Articles » PMID: 29546249

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

Overview
Date 2018 Mar 17
PMID 29546249
Citations 7
Authors
Affiliations
Soon will be listed here.
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.

Citing Articles

Multi-omic association study identifies DNA methylation-mediated genotype and smoking exposure effects on lung function in children living in urban settings.

Dapas M, Thompson E, Wentworth-Sheilds W, Clay S, Visness C, Calatroni A PLoS Genet. 2023; 19(1):e1010594.

PMID: 36638096 PMC: 9879483. DOI: 10.1371/journal.pgen.1010594.


Using single IRB consultations to meet the educational needs of investigative teams.

Johnson A, Pautler M, Burr J, Abdelsamad N, VanBuren J, Rigtrup L Contemp Clin Trials Commun. 2022; 29:100971.

PMID: 36033361 PMC: 9403494. DOI: 10.1016/j.conctc.2022.100971.


The IRB Reliance Exchange (IREx): A national web-based platform for operationalizing single IRB review.

Serdoz E, Edwards T, Pulley J, Beadles J, Ozier J, Harris P J Clin Transl Sci. 2022; 6(1):e39.

PMID: 35574155 PMC: 9066316. DOI: 10.1017/cts.2022.376.


Pediatric specific challenges of the single institutional review board mandate.

Hu A, Holl J, Raval M Trials. 2022; 23(1):224.

PMID: 35313943 PMC: 8935793. DOI: 10.1186/s13063-022-06141-y.


Recruiting underrepresented individuals in a double pandemic: Lessons learned in a randomized control trial.

White G, Proulx C, Morone N, Murrell A, Rubio D J Clin Transl Sci. 2021; 5(1):e185.

PMID: 34849260 PMC: 8596076. DOI: 10.1017/cts.2021.843.


References
1.
Busse 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):529-37. PMC: 2854660. DOI: 10.1016/j.jaci.2010.01.036. View

2.
Flynn K, Hahn C, Kramer J, Check D, Dombeck C, Bang S . Using central IRBs for multicenter clinical trials in the United States. PLoS One. 2013; 8(1):e54999. PMC: 3559741. DOI: 10.1371/journal.pone.0054999. View

3.
Check D, Weinfurt K, Dombeck C, Kramer J, Flynn K . Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature. Clin Trials. 2013; 10(4):560-7. DOI: 10.1177/1740774513484393. View