Evidence map›Paper›PMID 31660237›Full record

ArticleJournal of clinical and translational science2019

The SMART IRB platform: A national resource for IRB review for multisite studies.

Nichelle Cobb, Elizabeth Witte, Maria Cervone, Aaron Kirby, Douglas MacFadden, Lee Nadler, Barbara E Bierer

Abstract read
In one paragraph

Article in Journal of clinical and translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed.

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  14. Opportunities and challenges in translational science.Clinical and translational science · 2021
    Review
  15. Article
  16. Article
  17. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Nichelle CobbHealth Sciences IRBs Office, University of Wisconsin - Madison, Madison, WI, USA.
Elizabeth WitteHarvard Catalyst | The Harvard Clinical and Translational Science Center, Harvard Medical School, Boston, MA, USA.
Maria CervoneHarvard Catalyst | The Harvard Clinical and Translational Science Center, Harvard Medical School, Boston, MA, USA.
Aaron KirbyHarvard Catalyst | The Harvard Clinical and Translational Science Center, Harvard Medical School, Boston, MA, USA.
Douglas MacFaddenHarvard Catalyst | The Harvard Clinical and Translational Science Center, Harvard Medical School, Boston, MA, USA.
Lee NadlerHarvard Catalyst | The Harvard Clinical and Translational Science Center, Harvard Medical School, Boston, MA, USA.
Barbara E BiererHarvard Catalyst | The Harvard Clinical and Translational Science Center, Harvard Medical School, Boston, MA, USA.

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
The Harvard Clinical and Translational Science CenterUL1TR002541 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2018 to 2022
$93.0M
University of Wisconsin Institute for Clinical and Translational ResearchUL1TR002373 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI ELIZABETH S BURNSIDE, Allan R. Brasier · 2017 to 2026
$75.9M
SYNERGY: The Dartmouth Center for clinical and Translational ScienceUL1TR001086 · NCATS · DARTMOUTH COLLEGE · PI GREEN, ALAN I · 2013 to 2017
$18.3M
NCATS NIH HHS UL1 TR001086NCATS NIH HHS UL1 TR001102NCATS NIH HHS UL1 TR002373NCATS NIH HHS UL1 TR002541
6 · The paper itself

Abstract

Single institutional review board (IRB) review of multisite research increased in frequency over a decade ago with a proliferation of master IRB reliance agreements supporting statewide and regional consortia and disease- and population-specific networks. Although successful, the increasing number of agreements presented significant challenges and illuminated potential benefits of a single, nationwide agreement. Anticipated changes in federal regulations highlighted the need to systematize and simplify IRB reliance. To address these challenges, the NIH National Center for Advancing Translational Sciences funded a project to establish a national IRB reliance network that would support national adoption of single IRB (sIRB) review. The Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform launched in July 2016 to facilitate dissemination, adoption, and implementation of a collaboratively developed master IRB reliance agreement and supportive tools and resources. More than 580 institutions have joined SMART IRB's Master Common Reciprocal Institutional Review Board Authorization Agreement and begun using the SMART IRB platform to support sIRB arrangements. Here, we describe the tenets of the agreement and operational benefits and challenges of its use. SMART IRB's early success affirms the utility of collaborative, flexible, and centralized approaches to supporting sIRB review while highlighting the need for further national harmonization.

Indexed as

bioethicscede reviewcooperative agreementhuman subject protectionsInstitutional review boardsIRB authorization agreementmaster IRB agreementsmulticenter clinical researchNIH single IRB policyreliance agreementresearch ethicssingle IRB reviewsIRB

Identifiers

PMID31660237
PMCPMC6798516

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.