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

被引：1

作者：

Martin, Samantha L. ^{[1
]}

Allman, Phillip H. ^{[2
]}

Dugoff, Lorraine ^{[3
]}

Sibai, Baha ^{[4
]}

Lynch, Stephanie ^{[5
]}

Ferrara, Jennifer ^{[6
]}

Aagaard, Kjersti ^{[7
]}

Zornes, Christina ^{[8
]}

Wilson, Jennifer L. ^{[9
]}

Gibson, Marie ^{[10
]}

Adams, Molly ^{[11
]}

Longo, Sherri A. ^{[12
]}

Staples, Amy ^{[13
]}

Saade, George ^{[14
]}

Beche, Imene ^{[15
]}

Carter, Ebony B. ^{[16
]}

Owens, Michelle Y. ^{[17
]}

Simhan, Hyagriv ^{[18
]}

Frey, Heather A. ^{[19
]}

Khan, Shama ^{[20
]}

Palatnik, Anna ^{[21
]}

August, Phyllis ^{[22
]}

Irby, Les'Shon ^{[23
]}

Lee, Tiffany ^{[24
]}

Lee, Christine ^{[25
]}

Schum, Paula ^{[26
]}

Chan-Akeley, Rosalyn ^{[27
]}

Duhon, Catera ^{[28
]}

Rincon, Monica ^{[29
]}

Gibson, Kelly ^{[30
]}

Wiegand, Samantha ^{[31
]}

Eastham, Donna ^{[32
]}

Oparil, Suzanne ^{[33
]}

Szychowski, Jeff M. ^{[1
,2
]}

Tita, Alan ^{[1
,34
]}

机构：

[1] Univ Alabama Birmingham, Ctr Womens Reprod Hlth, Birmingham, AL 35205 USA

[2] Univ Alabama Birmingham, Dept Biostat, Birmingham, AL USA

[3] Univ Penn, Dept Obstet & Gynecol, Philadelphia, PA USA

[4] Univ Texas Hlth Ctr Houston, Dept Maternal Fetal Med, Houston, TX USA

[5] Columbia Univ, Dept Obstet & Gynecol, New York, NY USA

[6] Duke Univ, Dept Obstet & Gynecol, Raleigh, NC USA

[7] Baylor Coll Med, Dept Obstet & Gynecol, Houston, TX USA

[8] Univ Oklahoma, Dept Obstet & Gynecol, Coll Med, Oklahoma City, OK USA

[9] Indiana Univ Sch Med, Dept Obstet & Gynecol, Indianapolis, IN USA

[10] Univ Utah, Dept Obstet & Gynecol, Salt Lake City, UT USA

[11] Intermt Healthcare, Salt Lake City, UT USA

[12] Ochsner Hlth, Dept Obstet & Gynecol, New Orleans, LA USA

[13] ChristianaCare Ctr Womens & Childrens Hlth Res, Newark, DE USA

[14] Univ Texas Med Branch, Dept Obstet & Gynecol, Galveston, TX USA

[15] St Peters Univ Hosp, Dept Obstet & Gyne col, New Brunswick, NJ USA

[16] Washington Univ, Dept Obstet & Gynecol, Sch Med, St Louis, MO USA

[17] Univ Mississippi, Dept Obstet & Gynecol, Med Ctr, Jackson, MS USA

[18] Univ Pittsburgh, Dept Obstet Gynecol & Reprod Sci, Sch Med, Pittsburgh, PA USA

[19] Ohio State Univ, Dept Obstet & Gynecol, Coll Med, Columbus, OH USA

[20] Rutgers Robert Wood Johnson Med Sch, Dept Obstet Gynecol & Reprod Sci, Brunswick, NJ USA

[21] Med Coll Wisconsin, Dept Obstet & Gynecol, Milwaukee, WI USA

[22] NewYork Presbyterian Weill Cornell Med, Dept Obstet & Gynecol, New York, NY USA

[23] Emory Univ, Dept Obstet & Gynecol, Sch Med, Atlanta, GA USA

[24] Univ Calif San Francisco, Dept Obstet Gynecol & Reprod Sci, San Francisco, CA USA

[25] Stanford Univ, Dept Obstet & Gynecol, Div Maternal Fetal Med, Stanford, CA USA

[26] NIH, Heart Lung & Blood Inst, Bethesda, MD USA

[27] NewYork Presbyterian Hosp, Lang Res Ctr, Queens, NY USA

[28] USA Childrens & Womens Hosp, Mobile, AL USA

[29] Oregon Hlth & Sci Univ, Dept Obstet & Gynecol, Portland, OR USA

[30] Metro Hlth Case Western Univ, Dept Obstet & Gynecol, Cleveland, OH USA

[31] Miami Valley Hosp, Dayton, OH USA

[32] Univ Arkansas Med Sci, Dept Obstet & Gynecol, Little Rock, AR USA

[33] Univ Alabama Birmingham, Dept Med, Birmingham, AL USA

[34] Univ Alabama Birmingham, Dept Obstet & Gynecol, Birmingham, AL USA

来源：

AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY MFM | 2023年 / 5卷 / 06期

基金：

美国国家卫生研究院;

关键词：

Chronic Hypertension and Pregnancy trial; federal regula-tions; institutional review boards; institutional review board efficiency; mul-ticenter studies; MULTICENTER; COSTS;

D O I：

10.1016/j.ajogmf.2023.100861

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

BACKGROUND: Institutional review boards play a crucial role in initi-ating clinical trials. Although many multicenter clinical trials use an individ-ual 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. Participat-ing 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 insti-tutional 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 stipula-tions (1 vs 4; P=.12) were lower for the group using the shared institu-tional 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 effi-cient 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 multi-center clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.

引用

页数：5

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