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

Samantha L Martin¹, Phillip H Allman², Lorraine Dugoff³, Baha Sibai⁴, Stephanie Lynch⁵, Jennifer Ferrara⁶, Kjersti Aagaard⁷, Christina Zornes⁸, Jennifer L Wilson⁹, Marie Gibson¹⁰, Molly Adams¹¹, Sherri A Longo¹², Amy Staples¹³, George Saade¹⁴, Imene Beche¹⁵, Ebony B Carter¹⁶, Michelle Y Owens¹⁷, Hyagriv Simhan¹⁸, Heather A Frey¹⁹, Shama Khan²⁰, Anna Palatnik²¹, Phyllis August²², Les'Shon Irby²³, Tiffany Lee²⁴, Christine Lee²⁵, Paula Schum²⁶, Rosalyn Chan-Akeley²⁷, Catera Duhon²⁸, Monica Rincon²⁹, Kelly Gibson³⁰, Samantha Wiegand³¹, Donna Eastham³², Suzanne Oparil³³, Jeff M Szychowski³⁴, Alan Tita³⁵; Chronic Hypertension and Pregnancy Consortium

Affiliations

¹ Center for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL (Drs Martin, Szychowski, and Tita). Electronic address: jcvessel@uab.edu.
² Department of Biostatics, The University of Alabama at Birmingham, Birmingham, AL (Drs Allman and Szychowski).
³ Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA (Dr Dugoff).
⁴ Department of Maternal-Fetal Medicine, University of Texas Health Center at Houston, Houston, TX (Dr Sibai).
⁵ Department of Obstetrics and Gynecology, Columbia University, New York City, NY (Ms Lynch).
⁶ Department of Obstetrics and Gynecology, Duke University, Raleigh, NC (Ms Ferrara).
⁷ Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX (Dr Aagaard).
⁸ Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK (Ms Zornes).
⁹ Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN (Ms Wilson).
¹⁰ Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT (Ms M Gibson).
¹¹ Intermountain Healthcare, Salt Lake City, UT (Ms Adams).
¹² Department of Obstetrics and Gynecology, Ochsner Health, New Orleans, LA (Dr Longo).
¹³ ChristianaCare Center for Women's and Children's Health Research, Newark, DE (Ms Staples).
¹⁴ Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX (Dr Saade).
¹⁵ Department of Obstetrics and Gynecology, Saint Peter's University Hospital, New Brunswick, NJ (Ms Beche).
¹⁶ Department of Obstetrics and Gynecology, Washington University School of Medicine, St Louis, MO (Dr Carter).
¹⁷ Department of Obstetrics and Gynecology, University of Mississippi Medical Center, Jackson, MS (Dr Owens).
¹⁸ Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA (Dr Simhan).
¹⁹ Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH (Dr Frey).
²⁰ Department of Obstetrics, Gynecology, and Reproductive Sciences, Rutgers Robert Wood Johnson Medical School, Brunswick, NJ (Ms Khan).
²¹ Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI (Dr Palatnik).
²² Department of Obstetrics and Gynecology, NewYork-Presbyterian/Weill Cornell Medicine, New York City, NY (Dr August).
²³ Department of Obstetrics and Gynecology, Emory University School of Medicine, Atlanta, GA (Ms Irby).
²⁴ Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, CA (Ms T Lee).
²⁵ Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Stanford University, Stanford, CA (Ms C Lee).
²⁶ National Institute of Health's Heart, Lung, and Blood Institute, Bethesda, MD (Ms Schum).
²⁷ Lang Research Center, NewYork-Presbyterian Hospital, Queens, NY (XX Chan-Akeley).
²⁸ USA Children's & Women's Hospital, Mobile, AL (Ms Duhon).
²⁹ Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR (Dr Rincon).
³⁰ Department of Obstetrics and Gynecology, Metro Health/Case Western University, Cleveland, OH (Dr K Gibson).
³¹ Miami Valley Hospital, Dayton, OH (Dr Wiegand).
³² Department of Obstetrics and Gynecology, University of Arkansas for Medical Sciences, Little Rock, AR (Ms Eastham).
³³ Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL (Dr Oparil).
³⁴ Center 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).
³⁵ Center 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).

PMID: 36669562
PMCID: PMC10627520
DOI: 10.1016/j.ajogmf.2023.100861

Randomized Controlled Trial

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

Samantha L Martin et al. Am J Obstet Gynecol MFM. 2023 Jun.

. 2023 Jun;5(6):100861.

doi: 10.1016/j.ajogmf.2023.100861. Epub 2023 Jan 17.

Authors

Affiliations

¹ Center for Women's Reproductive Health, The University of Alabama at Birmingham, Birmingham, AL (Drs Martin, Szychowski, and Tita). Electronic address: jcvessel@uab.edu.
² Department of Biostatics, The University of Alabama at Birmingham, Birmingham, AL (Drs Allman and Szychowski).
³ Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA (Dr Dugoff).
⁴ Department of Maternal-Fetal Medicine, University of Texas Health Center at Houston, Houston, TX (Dr Sibai).
⁵ Department of Obstetrics and Gynecology, Columbia University, New York City, NY (Ms Lynch).
⁶ Department of Obstetrics and Gynecology, Duke University, Raleigh, NC (Ms Ferrara).
⁷ Department of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital, Houston, TX (Dr Aagaard).
⁸ Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK (Ms Zornes).
⁹ Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN (Ms Wilson).
¹⁰ Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT (Ms M Gibson).
¹¹ Intermountain Healthcare, Salt Lake City, UT (Ms Adams).
¹² Department of Obstetrics and Gynecology, Ochsner Health, New Orleans, LA (Dr Longo).
¹³ ChristianaCare Center for Women's and Children's Health Research, Newark, DE (Ms Staples).
¹⁴ Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX (Dr Saade).
¹⁵ Department of Obstetrics and Gynecology, Saint Peter's University Hospital, New Brunswick, NJ (Ms Beche).
¹⁶ Department of Obstetrics and Gynecology, Washington University School of Medicine, St Louis, MO (Dr Carter).
¹⁷ Department of Obstetrics and Gynecology, University of Mississippi Medical Center, Jackson, MS (Dr Owens).
¹⁸ Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, PA (Dr Simhan).
¹⁹ Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, OH (Dr Frey).
²⁰ Department of Obstetrics, Gynecology, and Reproductive Sciences, Rutgers Robert Wood Johnson Medical School, Brunswick, NJ (Ms Khan).
²¹ Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI (Dr Palatnik).
²² Department of Obstetrics and Gynecology, NewYork-Presbyterian/Weill Cornell Medicine, New York City, NY (Dr August).
²³ Department of Obstetrics and Gynecology, Emory University School of Medicine, Atlanta, GA (Ms Irby).
²⁴ Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, CA (Ms T Lee).
²⁵ Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Stanford University, Stanford, CA (Ms C Lee).
²⁶ National Institute of Health's Heart, Lung, and Blood Institute, Bethesda, MD (Ms Schum).
²⁷ Lang Research Center, NewYork-Presbyterian Hospital, Queens, NY (XX Chan-Akeley).
²⁸ USA Children's & Women's Hospital, Mobile, AL (Ms Duhon).
²⁹ Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR (Dr Rincon).
³⁰ Department of Obstetrics and Gynecology, Metro Health/Case Western University, Cleveland, OH (Dr K Gibson).
³¹ Miami Valley Hospital, Dayton, OH (Dr Wiegand).
³² Department of Obstetrics and Gynecology, University of Arkansas for Medical Sciences, Little Rock, AR (Ms Eastham).
³³ Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL (Dr Oparil).
³⁴ Center 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).
³⁵ Center 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).

PMID: 36669562
PMCID: PMC10627520
DOI: 10.1016/j.ajogmf.2023.100861

Abstract

Background: Institutional 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.

Objective: This 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 design: This 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.

Results: A 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.

Conclusion: The 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.

Keywords: Chronic Hypertension and Pregnancy trial; federal regulations; institutional review board efficiency; institutional review boards; multicenter studies.

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Conflict of interest statement

Conflict of Interest

The authors report no conflict of interest.

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources