Evidence map›Paper›PMID 36316971›Full record

ArticleEthics & human research2022

Demonstration Project: Transitioning a Research Network to New Single IRB Platforms.

Jeri S Burr, Ann Johnson, Annie Risenmay, Stephanie Bisping, Emily S Serdoz, Whit Coleman, Katherine A Sward, Erin Rothwell, J Michael Dean

Abstract readMulticenter Study
In one paragraph

Article in Ethics & human research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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

9 authors.

Jeri S BurrExecutive director of the Trial Innovation Center at the University of Utah.
Ann JohnsonDirector of the Institutional Review Board and Human Research Protection Program at the University of Utah.
Annie RisenmayIRB operations manager at the University of Utah.
Stephanie BispingCPCCRN program director at the University of Utah.
Emily S SerdozManager of translational research at the Vanderbilt University Medical Center.
Whit ColemanEducation support manager at Ashfield Healthcare.
Katherine A SwardProfessor at the College of Nursing in the Department of Biomedical Informatics.
Erin RothwellAssociate vice president for research and a professor in the Department of Obstetrics and Gynecology at the University of Utah.
J Michael DeanAssociate dean for clinical research and a director and principal investigator at Trial Innovation Center and the Collaborative Pediatric Critical Care Research Network, and a professor in the Department of Pediatrics at the University of Utah School of Medicine.

Funding

Utah Trial Innovation CenterU24TR001597 · NCATS · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2016 to 2022
$39.6M
Data Coordinating Center for the Collaborative Pediatric Critical Care Research NetworkU01HD049934 · NICHD · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2005 to 2020
$35.2M
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 TR001597NCATS NIH HHS U24TR001597NCATS NIH HHS UL1 TR002538NICHD NIH HHS U01 HD049934
6 · The paper itself

Abstract

Since the 2016 National Institutes of Health (NIH) mandate to use a single IRB (sIRB) in multicenter research, institutions have struggled to operationalize the process. In this demonstration project, the University of Utah Trial Innovation Center assisted the Collaborative Pediatric Critical Care Research Network to transition from using individually negotiated reliance agreements and paper-based documentation to a new sIRB master agreement and an informatics platform to capture reliance documentation. Lessons learned that can guide other academic institutions and IRBs as they operationalize sIRBs included the need for sites to understand what type of engagement or reliance is required and their need to understand the difference between reliance and activation. Requirements around local review remain poorly understood. Further research is needed to determine approaches that can achieve the NIH vision of reviews becoming more efficient and improving study start-up times, relieving administrative burden while advancing human research protections.

Indexed as

Ethics Committees, ResearchNational Institutes of Health (U.S.)ChildHumansUnited Statesinstitutional review boardreliance agreementresearch ethicssingle institutional review boardSMART IRB

Identifiers

PMID36316971
PMCPMC10328109

What OpenQuestion holds

Textmetadata
LicenceTDM
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.