The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network-initiated clinical trials
Open accessAbstract
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.
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Approval for the study was obtained from the University of Pennsylvania, which served as the single IRB for each site with additional local site review.
“Approval for the study was obtained from the University of Pennsylvania, which served as the single IRB for each site with additional local site review.(12)”
From The effect of antioxidants on male factor infertility: the Males, Antioxidants, and Infertility (MOXI) randomized clinical trial (2020) · cites this paper as [12]
The Methods say that the University of Pennsylvania was the single IRB of record for MOXI and FIT-PLESE at all participating primary sites, which also had to meet local institutional requirements. The Results report local protocol review at each site. The source does not establish that the citing document’s unspecified study received this approval; it says ACTorNOT was instead reviewed by IRBs at each institution. (LLM, conf=0.78)
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- Authors
- Diamond, M. P., Eisenberg, E., Huang, H., Coutifaris, C., Legro, R. S., Hansen, K. R., Steiner, A. Z., Cedars, M., Barnhart, K., Ziolek, T., Thomas, T. R., Maurer, K., Krawetz, S. A., Wild, R. A., Trussell, J., Santoro, N., Zhang, H., & for the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network
- Affiliations
- Augusta University (US)
- National Institutes of Health (US)
- Yale University (US)
- University of Pennsylvania (US)
- Pennsylvania State University (US)
- University of Oklahoma Medical Center (US)
- University of North Carolina at Chapel Hill (US)
- University of California, San Francisco (US)
- Wayne State University (US)
- Upstate University Hospital (US)
- University of Colorado Denver (US)
- Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA
- Corresponding author
- Diamond, Michael P
- ORCID
- Venue
- Clinical Trials
- Publisher
- SAGE Publications
- Published
- 2018-10-24
- Volume
- 16
- Issue
- 1
- Pages
- 3-10
- ISSN
- 1740-7745 (ISSN-L)
- 1740-7753
- PMC
- PMC6384136
- OpenAlex
- W2898581013
- Cited by
- 16
- References
- 21
- Citations by year
- 2026: 1 · 2025: 1 · 2023: 3 · 2022: 4 · 2021: 4 · 2020: 2 · 2019: 1
- FWCI
- 1.67
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10 HD055925, U10 HD077680, U10 HD077841, U10 HD077844, U10 HD27049, U10 HD38992, U10 HD39005)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Keywords
- research ethics committees, clinical trial initiation, informed consent forms, research ethics regulation
- MeSH terms
- Clinical Protocols, Humans, Time Factors, United States, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Reproductive Medicine, Ethics Committees, Research, National Institute of Child Health and Human Development (U.S.)
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