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Clin Trials. 2018 Oct 24:1740774518807888. doi: 10.1177/1740774518807888. [Epub ahead of print]

The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network-initiated clinical trials.

Author information

1
1 Department of Obstetrics & Gynecology, Medical College of Georgia, Augusta University, Augusta, GA, USA.
2
2 Fertility and Infertility Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA.
3
3 Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.
4
4 Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
5
5 Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, PA, USA.
6
6 Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK, USA.
7
7 Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.
8
8 Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.
9
9 Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI, USA.
10
10 Upstate University Hospital, Syracuse, NY, USA.
11
11 Department of Obstetrics and Gynecology, University of Colorado Denver, Denver, CO, USA.

Abstract

BACKGROUND/AIMS::

Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network.

METHODS::

Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included.

RESULTS::

While time required for actual institutional review board submission's review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7-24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities.

CONCLUSION::

A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health's goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.

KEYWORDS:

Institutional review board; multicenter studies; single institutional review board

PMID:
30354458
DOI:
10.1177/1740774518807888

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