Evidence map›Paper›PMID 37250991›Full record

ArticleJournal of clinical and translational science2023

Implementation of single IRB review for multisite human subjects research: Persistent challenges and possible solutions.

Jonathan M Green, Polly Goodman, Aaron Kirby, Nichelle Cobb, Barbara E Bierer

Abstract read
In one paragraph

Article in Journal of clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Responses to Commentaries on "Ethics as if Your Life Depended on It".Journal of empirical research on human research ethics : JERHRE · 2026
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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.

Jonathan M GreenOffice of Human Subjects Research Protections, Office of Intramural Research, National Institutes of Health, Bethesda, MD, USA.ORCID https://orcid.org/0000-0002-7449-4387
Polly GoodmanHarvard Catalyst, The Harvard Clinical & Translational Science Center, Harvard Medical School, Boston, MA, USA.
Aaron KirbyHarvard Catalyst, The Harvard Clinical & Translational Science Center, Harvard Medical School, Boston, MA, USA.
Nichelle CobbAssociation for the Accreditation of Human Research Protection Programs, Washington, DC, USA.ORCID https://orcid.org/0000-0003-4781-6915
Barbara E BiererHarvard Catalyst, The Harvard Clinical & Translational Science Center, Harvard Medical School, Boston, MA, USA.ORCID https://orcid.org/0000-0001-6448-8170

Funding

The Harvard Clinical and Translational Science CenterUL1TR002541 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2018 to 2022
$93.0M
NCATS NIH HHS UL1 TR002541
6 · The paper itself

Abstract

Revisions to the Common Rule and NIH policy require the use of a single Institutional Review Board (sIRB) for the review of most federally funded, multisite research, with the intent of streamlining the review process. However, since initial implementation in 2018, many IRBs and institutions continue to struggle with the logistics of implementing this requirement. In this paper, we report the findings of a workshop held in 2022 to examine why sIRB review remains problematic and propose possible solutions. Workshop participants identified several issues as major barriers, including new responsibilities for study teams, persistent duplicative review processes, the lack of harmonization of policies and practices across institutions, the absence of additional guidance from federal agencies, and the need for greater flexibility in policy requirements. Addressing these problems will require providing additional resources and training to research teams, the commitment of institutional leaders to harmonize practice, and policymakers to critically evaluate the requirement and provide flexibility in applicability.

Indexed as

clinical trialsethics reviewhuman subjects researchinstitutional review boardsSingle IRB

Identifiers

PMID37250991
PMCPMC10225260

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.