Evidence map›Paper›PMID 42695533›Full record

ArticleEthics & human research

Perspectives of Researchers and Research Team Members Regarding Their Experience with sIRBs.

Bhuchitra Singh, Aileen Zhang, Arun H Patil, Abigail Coco, Ibelle Madera, Sarah Olson, Kristin Voegtline, Enrique Schisterman, James Segars

Abstract read
In one paragraph

Article in Ethics & human research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Bhuchitra SinghDirector of clinical research in the Division of Reproductive Sciences & Women's Health Research in the Department of Gynecology & Obstetrics at Johns Hopkins School of Medicine.
Aileen ZhangMedical student during this research in the Division of Reproductive Sciences & Women's Health Research in the Department of Gynecology & Obstetrics at Johns Hopkins School of Medicine.
Arun H PatilStaff scientist at the Lieber Institute for Brain Development at Johns Hopkins University School of Medicine.
Abigail CocoMedical student during this research in the Division of Reproductive Sciences & Women's Health Research in the Department of Gynecology & Obstetrics at Johns Hopkins School of Medicine.
Ibelle MaderaUndergraduate during this research in the Division of Reproductive Sciences & Women's Health Research in the Department of Gynecology & Obstetrics at Johns Hopkins School of Medicine.
Sarah OlsonResearcher in the Biostatistics, Epidemiology and Data Management Core at Johns Hopkins School of Medicine.
Kristin VoegtlineAssociate in the Biostatistics, Epidemiology and Data Management Core at Johns Hopkins School of Medicine.
Enrique SchistermanPerelman Professor in Biostatistics, Epidemiology and Informatics in the Department of Biostatistics, Epidemiology and Informatics at the University of Pennsylvania Perelman School of Medicine.
James SegarsHoward and Georgeanna Jones Professor in the Division of Reproductive Sciences & Women's Health Research in the Department of Gynecology & Obstetrics at Johns Hopkins School of Medicine.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Our study examines the perspectives of researchers and other research team members who conducted National Institutes of Health (NIH)-funded studies about their use of a single institutional review board (sIRB) review and onboarding process. More than 84% (n = 639) of respondents agreed that NIH-sponsored multisite clinical trials benefit from sIRB use. A higher proportion of super-users (>10 studies) of an sIRB than moderate users (1-10 studies) described the onboarding process positively (n = 119, 56% vs. n = 225, 42%, p = .01) and found sIRBs to be more cost-effective than a site-specific model (n = 113, 53.05% vs. n = 221, 41%, p <.01). Timeline delays were experienced by over 90% (n = 680) of respondents and an increased administrative burden was reported by almost half (n = 353, 47%) of respondents. Respondents described increased administrative burden for sIRB approvals when an institution-specific application was required (n = 299, 51% vs. n = 30, 29%, p <.01). Most researchers judged sIRBs to be beneficial. However, delays in approval, increased administrative burden, and associated compulsory institution-specific applications posed logistical challenges for researchers. Reform efforts must focus on aligning sIRB and local study site standards to optimize sIRB study review.

Indexed as

Biomedical ResearchClinical Trials as TopicEthics Committees, ResearchResearch PersonnelCost-Benefit AnalysisHumansNational Institutes of Health (U.S.)United Stateshuman subjects researchmultisite clinical trialsNational Institutes of Health policyoversightresearch ethicssingle institutional review board (sIRB)

Identifiers

PMID42695533
PMCPMC13543756

What OpenQuestion holds

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Registered trials

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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.