Evidence map›Paper›PMID 35656335›Full record

ArticleJournal of clinical and translational science2022

Key lessons and strategies for implementing single IRB review in the Trial Innovation Network.

Ann R Johnson, Megan Kasimatis Singleton, Julie Ozier, Emily Serdoz, Jennifer G Beadles, Janelle Maddox-Regis, Sarah Mumford, Jeri Burr, J Michael Dean, Daniel E Ford and 1 more

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.4field-weighted citation impact, top 20% of its field
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

11 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Insights from the trial innovation network's initial consultation process.Journal of clinical and translational science · 2025
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
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

11 authors at 3 institutions in 1 country.

Ann R JohnsonUniversity of Utah Health Sciences Center, Salt Lake City, UT, USA.ORCID https://orcid.org/0000-0001-8532-5688
Megan Kasimatis SingletonJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Julie OzierVanderbilt University Medical Center, Nashville, TN, USA.
Emily SerdozVanderbilt University Medical Center, Nashville, TN, USA.ORCID https://orcid.org/0000-0003-2512-7019
Jennifer G BeadlesVanderbilt University Medical Center, Nashville, TN, USA.
Janelle Maddox-RegisJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Sarah MumfordUniversity of Utah Health Sciences Center, Salt Lake City, UT, USA.
Jeri BurrUniversity of Utah School of Medicine, Salt Lake City, UT, USA.
J Michael DeanUniversity of Utah School of Medicine, Salt Lake City, UT, USA.
Daniel E FordJohns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-2549-2289
Gordon R BernardVanderbilt University Medical Center, Nashville, TN, USA.
University of Utah · USVanderbilt University Medical Center · USJohns Hopkins University · US

Funding

COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K., BERNARD, GORDON RAPHAEL · 2016 to 2022
$177.0M
Utah Trial Innovation CenterU24TR001597 · NCATS · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2016 to 2022
$39.6M
Johns Hopkins-Tufts Trial Innovation Center HEAL Pain ERN SupplementU24TR001609 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2016 to 2022
$36.3M
Improving Clinical trial Education, Recruitment, and Enrollment at CTSA Hubs (I-CERCH) - HEAL SupplementU24TR001579 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HARRIS, PAUL A., WILKINS, CONSUELO HOPKINS · 2016 to 2022
$34.1M
Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
NCATS NIH HHS U24 TR001579NCATS NIH HHS U24 TR001597NCATS NIH HHS U24 TR001608NCATS NIH HHS U24 TR001609NCATS NIH HHS UL1 TR002538
6 · The paper itself

Abstract

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network's single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.

Indexed as

Human Research ProtectionIRBLocal contextReliance agreementSingle IRB

Identifiers

PMID35656335
PMCPMC9120617
OpenAlexW4224243408

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.