Evidence map›Paper›PMID 34192061›Full record

ArticleJournal of clinical and translational science2021

Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic.

Daniel E Ford, Ann Johnson, Jason J Nichols, Erin Rothwell, Steve Dubinett, Arash Naeim

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical and translational science, 2021. 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
3.5field-weighted citation impact, top 7% 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, 19 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Impact of the COVID-19 pandemic on CTSA Clinical Research Centers over 2 years.Journal of clinical and translational science · 2023
    Article
  7. Article
  8. Article
  9. Article
  10. Managing the risks and benefits of clinical research in response to a pandemic.Journal of clinical and translational science · 2021
    Article
  11. Review
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

6 authors at 4 institutions in 1 country.

Daniel E FordSchool of Medicine, Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-2549-2289
Ann JohnsonSchool of Medicine, IRB Office, University of Utah, Salt Lake City, UT, USA.
Jason J NicholsSchool of Optometry, Department of Vision Sciences, School of Medicine, Center for Clinical and Translational Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.ORCID https://orcid.org/0000-0003-1519-7734
Erin RothwellSchool of Medicine, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, USA.ORCID https://orcid.org/0000-0002-2294-2299
Steve DubinettDepartment of Medicine, David Geffen School of Medicine at UCLA, Clinical and Translational Sciences Institute, Los Angeles, CA, USA.
Arash NaeimDepartment of Medicine, David Geffen School of Medicine at UCLA, Clinical and Translational Sciences Institute, Los Angeles, CA, USA.
Southern California Clinical and Translational Science Institute · USUniversity of Utah · USJohns Hopkins University · USUniversity of Alabama at Birmingham · US

Funding

UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
QAQC Johns Hopkins Institute for Clinical and Translational ResearchUL1TR003098 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2019 to 2023
$57.7M
CTSA Coordinating Center for Leading Innovation and Collaboration (CLIC)U24TR002260 · NCATS · UNIVERSITY OF ROCHESTER · PI OSSIP, DEBORAH J, ZAND, MARTIN S · 2017 to 2021
$19.0M
NCATS NIH HHS U24 TR002260NCATS NIH HHS UL1 TR001881NCATS NIH HHS UL1 TR003098
6 · The paper itself

Abstract

The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was conducted with the IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well as two focus groups. Across the CTSA institutions, 66% reviewed COVID-19 protocols across all their IRB committees, 22% assigned protocols to just one committee, and 10% created a new committee for COVID-19 protocols. Fifty-two percent reported COVID-19 protocols were reviewed much faster, 41% somewhat faster, and 7% at the same speed as other protocols. Three percent reported that the COVID-19 protocols were reviewed with much better quality, 32% reported slightly better quality, and 65% reported the reviews were of the same quality as similar protocols before the COVID-19 pandemic. IRBs were able to respond to the emergent demand for reviewing COVID-19 protocols. Most of the increased review capacity was due to extra effort by IRB staff and members and not changes that will be easily implemented across all research going forward.

Indexed as

COVID-19informed consentInternal review boardprotection of human subjectsprotocol review

Identifiers

PMID34192061
PMCPMC8220014
OpenAlexW3137142820

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.