Evidence map›Paper›PMID 36669562›Full record

Trial reportAmerican journal of obstetrics & gynecology MFM2023

Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial.

Samantha L Martin, Phillip H Allman, Lorraine Dugoff, Baha Sibai, Stephanie Lynch, Jennifer Ferrara, Kjersti Aagaard, Christina Zornes, Jennifer L Wilson, Marie Gibson and 26 more

Open access · greenAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of obstetrics & gynecology MFM, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 25% 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

5 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Multinational Pediatric Critical Care Research in the Arab Gulf Region across 35 Pediatric Intensive Care Units: Ethical Approval Timelines and Lessons Learned.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2026
    Article
  3. Article
  4. Article
  5. 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

36 authors at 20 institutions in 1 country.

Samantha L MartinCenter for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL (Drs Martin, Szychowski, and Tita). Electronic address: jcvessel@uab.edu.
Phillip H AllmanDepartment of Biostatics, The University of Alabama at Birmingham, Birmingham, AL (Drs Allman and Szychowski).
Lorraine DugoffDepartment of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA (Dr Dugoff).
Baha SibaiDepartment of Maternal-Fetal Medicine, University of Texas Health Center at Houston, Houston, TX (Dr Sibai).
Stephanie LynchDepartment of Obstetrics and Gynecology, Columbia University, New York City, NY (Ms Lynch).
Jennifer FerraraDepartment of Obstetrics and Gynecology, Duke University, Raleigh, NC (Ms Ferrara).
Kjersti AagaardDepartment of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX (Dr Aagaard).
Christina ZornesDepartment of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK (Ms Zornes).
Jennifer L WilsonDepartment of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN (Ms Wilson).
Marie GibsonDepartment of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT (Ms M Gibson).
Molly AdamsIntermountain Healthcare, Salt Lake City, UT (Ms Adams).
Sherri A LongoDepartment of Obstetrics and Gynecology, Ochsner Health, New Orleans, LA (Dr Longo).
Amy StaplesChristianaCare Center for Women's and Children's Health Research, Newark, DE (Ms Staples).
George SaadeDepartment of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX (Dr Saade).
Imene BecheDepartment of Obstetrics and Gynecology, Saint Peter's University Hospital, New Brunswick, NJ (Ms Beche).
Ebony B CarterDepartment of Obstetrics and Gynecology, Washington University School of Medicine, St Louis, MO (Dr Carter).
Michelle Y OwensDepartment of Obstetrics and Gynecology, University of Mississippi Medical Center, Jackson, MS (Dr Owens).
Hyagriv SimhanDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA (Dr Simhan).
Heather A FreyDepartment of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH (Dr Frey).
Shama KhanDepartment of Obstetrics, Gynecology, and Reproductive Sciences, Rutgers Robert Wood Johnson Medical School, Brunswick, NJ (Ms Khan).
Anna PalatnikDepartment of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI (Dr Palatnik).
Phyllis AugustDepartment of Obstetrics and Gynecology, NewYork-Presbyterian/Weill Cornell Medicine, New York City, NY (Dr August).
Les'Shon IrbyDepartment of Obstetrics and Gynecology, Emory University School of Medicine, Atlanta, GA (Ms Irby).
Tiffany LeeDepartment of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, CA (Ms T Lee).
Christine LeeDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Stanford University, Stanford, CA (Ms C Lee).
Paula SchumNational Institute of Health's Heart, Lung, and Blood Institute, Bethesda, MD (Ms Schum).
Rosalyn Chan-AkeleyLang Research Center, NewYork-Presbyterian Hospital, Queens, NY (XX Chan-Akeley).
Catera DuhonUSA Children's & Women's Hospital, Mobile, AL (Ms Duhon).
Monica RinconDepartment of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR (Dr Rincon).
Kelly GibsonDepartment of Obstetrics and Gynecology, Metro Health/Case Western University, Cleveland, OH (Dr K Gibson).
Samantha WiegandMiami Valley Hospital, Dayton, OH (Dr Wiegand).
Donna EasthamDepartment of Obstetrics and Gynecology, University of Arkansas for Medical Sciences, Little Rock, AR (Ms Eastham).
Suzanne OparilDepartment of Medicine, The University of Alabama at Birmingham, Birmingham, AL (Dr Oparil).
Jeff M SzychowskiCenter for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL (Drs Martin, Szychowski, and Tita); Department of Biostatics, The University of Alabama at Birmingham, Birmingham, AL (Drs Allman and Szychowski).
Alan TitaCenter for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL (Drs Martin, Szychowski, and Tita); Department of Obstetrics and Gynecology, The University of Alabama, Birmingham, AL (Dr Tita).
Chronic Hypertension and Pregnancy Consortium
University of Alabama at Birmingham · USBaylor College of Medicine · USChristiana Care Health System · USColumbia University · USCornell University · USDuke University · USEmory University · USIndiana University School of MedicineIntermountain Healthcare · USMedical College of Wisconsin · USMetroHealth · USMiami Valley Hospital · USNational Heart Lung and Blood Institute · USNewYork–Presbyterian Hospital · USOchsner Health System · USOregon Health & Science University · USRutgers, The State University of New Jersey · USSaint Peter's University Hospital · USStanford University · USThe Ohio State University · US

Funding

Chronic Hypertension and Pregnancy-CHAP Clinical Coordinating CenterU01HL120338 · NHLBI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI TITA, ALAN THEVENET N. · 2014 to 2020
$16.5M
MECHANISMS OF HYPERTENSION AND CARDIOVASCULAR DISEASEST32HL007457 · NHLBI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Martin E Young · 1985 to 2026
$8.6M
NHLBI NIH HHS T32 HL007457NHLBI NIH HHS U01 HL120338
6 · The paper itself

Abstract

backgroundInstitutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol.

objectiveThis study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. STUDY

designThis was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process.

resultsA total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant.

conclusionThe findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.

Indexed as

Ethics Committees, ResearchFemaleHumansPregnancyRetrospective StudiesSurveys and QuestionnairesChronic Hypertension and Pregnancy trialfederal regulationsinstitutional review board efficiencyinstitutional review boardsmulticenter studies

Identifiers

PMID36669562
PMCPMC10627520
OpenAlexW4316810534

What OpenQuestion holds

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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.