title: Development of a multi-institutional clinical research consortium for pediatric surgery.
abstract: BACKGROUND
  Multicenter clinical research studies in pediatric surgery have been largely limited to relatively small case-series and retrospective reviews because of the rarity of many of the diseases we treat and difficulty coordinating and executing multi-institutional studies. Creation of a collaborative research network can provide the needed patient population and infrastructure to perform high quality multi-institutional studies.
  
  
  METHODS
  In 2013, eleven academic pediatric surgery centers within the United States formed a research consortium to develop and conduct multicenter clinical research projects to advance the practice of pediatric surgery.
  
  
  RESULTS
  We present our process for creating, developing, and maintaining this consortium including initial regional geographic limitation, charter development with by-laws and procedures for adopting studies, and research infrastructure including a central website for study monitoring and central reliance institutional review board process.
  
  
  CONCLUSIONS
  Our model could be reproduced or adapted by other institutions to develop or strengthen other research collaboratives.
  
  
  METHODS
  Type of study: retrospective, IV.
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States. Electronic address: rhirschl@med.umich.edu.
authors.forename: Ronald B
authors.initials: RB
authors.lastname: Hirschl
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Peter
authors.initials: P
authors.lastname: Minneci
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Samir
authors.initials: S
authors.lastname: Gadepalli
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Saito
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Johanna
authors.initials: J
authors.lastname: Askegard-Giesmann
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Katherine
authors.initials: K
authors.lastname: Deans
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Downard
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Mary
authors.initials: M
authors.lastname: Fallat
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Maria
authors.initials: M
authors.lastname: Finnell
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Michael
authors.initials: M
authors.lastname: Helmrath
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Rashmi
authors.initials: R
authors.lastname: Kabre
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: David
authors.initials: D
authors.lastname: Lal
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Charles
authors.initials: C
authors.lastname: Leys
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Grace
authors.initials: G
authors.lastname: Mak
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Daniel
authors.initials: D
authors.lastname: Ostlie
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Fred
authors.initials: F
authors.lastname: Rescorla
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Thomas
authors.initials: T
authors.lastname: Sato
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Shawn
authors.initials: S
authors.lastname: St Peter
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Daniel
authors.initials: D
authors.lastname: von Allmen
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
authors.forename: Brad
authors.initials: B
authors.lastname: Warner
authors.affiliation: Section of Pediatric Surgery, 1540 E. Hospital Drive, Ann Arbor, MI, United States.
mesh_terms: D000046:Academic Medical Centers / Q000458:organization & administration*; D035843:Biomedical Research / Q000458:organization & administration*; D003299:Cooperative Behavior; D006801:Humans; D015337:Multicenter Studies as Topic; D010372:Pediatrics / Q000458:organization & administration*; D016730:Program Development; D012189:Retrospective Studies; D013043:Specialties, Surgical / Q000458:organization & administration*; D014481:United States
keywords: Clinical research; Multi-institutional trials; Research consortium