Evidence map›Paper›PMID 34956653›Full record

ArticleJournal of clinical and translational science2021

A snapshot of U.S. IRB review of COVID-19 research in the early pandemic.

Holly A Taylor, Kimberley Serpico, Holly Fernandez Lynch, John Baumann, Emily E Anderson

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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.8field-weighted citation impact, top 15% 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

7 citing papers in PubMed, 12 citations in OpenAlex.

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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

5 authors at 5 institutions in 1 country.

Holly A TaylorDepartment of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA.ORCID https://orcid.org/0000-0001-6811-9356
Kimberley SerpicoOffice of Regulatory Affairs and Research Compliance, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Holly Fernandez LynchDepartment of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
John BaumannOffice of Research Compliance, Indiana University, Bloomington, IN, USA.
Emily E AndersonNeiswanger Institute for Bioethics, Stritch School of Medicine, Loyola University Chicago, Maywood, IL, USA.
Harvard University · USIndiana University Bloomington · USLoyola University Chicago · USNational Institutes of Health Clinical Center · USUniversity of Pennsylvania · US

Funding

Strengthening Stakeholder Engagement in Human Research Protections.UL1TR002003 · NCATS · UNIVERSITY OF ILLINOIS AT CHICAGO · PI KARNIK, NIRANJAN SUBHASH, MERMELSTEIN, ROBIN J. · 2016 to 2024
$33.7M
NCATS NIH HHS UL1 TR002003
6 · The paper itself

Abstract

BACKGROUND/

objectiveAlong with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating strict public health measures and a workforce largely relegated to working from home. Our objectives were to measure adjustments to standard IRB review processes, IRB turnaround time and document and any novel ethical issues encountered.

methodsStructured data requests were sent to members of the Consortium to Advance Effective Research Ethics Oversight directing Human Research Protection Programs (HRPP).

resultsFourteen of the 32 HRPP director members responded to a questionnaire about their approach to review and oversight during COVID-19. Eleven of the 14 provided summary data on COVID-19-specific protocols and six of the 11 provided protocol-related documents for our review. All respondents adopted at least one additional COVID-19-specific step to their usual review process. The average turnaround time for convened and expedited IRB reviews was 15 calendar days. In our review of the documents from 194 COVID-19-specific protocols (

conclusionsOur data provide a snapshot of how HRPPs approached the review of COVID-19-specific protocols at the start of the pandemic in the USA. While not generalizable to all HRPPs, these data indicate that HRPPs can adapt and respond quickly response to a pandemic and likely need little novel expertise in the review and oversight of COVID-19-specific protocols.

Indexed as

content analysisCOVIDIRBreview processturnaround time

Identifiers

PMID34956653
PMCPMC8692853
OpenAlexW3199652777

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.