title: Inconsistencies and time delays in site-specific research approvals hinder collaborative clinical research in Australia.
abstract: OBJECTIVE
  The aim of this study was to describe the time and documentation needed to gain ethics and governance approvals in Australian states with and without a centralised ethical review system.
  
  
  METHODS
  This is a prospective descriptive study undertaken between February 2012 and March 2015. Paediatric and adult hospitals (n = 67) in Australian states were approached to allow the review of their medical records. Participants included 15- to 24-year-olds diagnosed with cancer between 2008 and 2012. The main outcomes measures were time (weeks) to approval for ethics and governance and the number and type of documents submitted.
  
  
  RESULTS
  Centralised ethics approval processes were used in five states, with approval taking between 2 and 18 weeks. One state did not use a centralised process, with ethics approval taking a median of 4.5 weeks (range: 0-15) per site. In four states using a centralised ethics process, 33 governance applications were submitted, with 20 requiring a site clinician listed as an investigator. Governance applications required the submission of 11 documents on average, including a Site-Specific Assessment form. Thirty-two governance applications required original signatures from a median of 3.5 (range: 1-10) non-research persons, which took a median of 5 weeks (range: 0-15) to obtain. Governance approval took a median of 6 weeks (range: 1-45). Twelve research study agreements were needed, each taking a median of 7.5 weeks (range: 1-20) to finalise.
  
  
  CONCLUSIONS
  The benefits of centralised ethics review systems have not been realised due to duplicative, inflexible governance processes. A system that allowed the recognition of prior ethical approval and low-risk applications was more efficient than a central ethics and site-specific governance process.
authors.affiliation: Cancer Council Victoria, Melbourne, Victoria, Australia. Vicki.White@cancervic.org.au.
authors.forename: V M
authors.initials: VM
authors.lastname: White
authors.affiliation: Cancer Council Victoria, Melbourne, Victoria, Australia.
authors.forename: H
authors.initials: H
authors.lastname: Bibby
authors.affiliation: Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Green
authors.affiliation: Sydney Children's Hospital, Sydney, New South Wales, Australia.|Prince of Wales Hospital, Sydney, New South Wales, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Anazodo
authors.affiliation: Children's Health Queensland, Brisbane, Queensland, Australia.
authors.forename: W
authors.initials: W
authors.lastname: Nicholls
authors.affiliation: Children's Health Queensland, Brisbane, Queensland, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Pinkerton
authors.affiliation: Princess Margaret Hospital for Children, Perth, Western Australia, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Phillips
authors.affiliation: Royal Hobart Hospital, Hobart, Tasmania, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Harrup
authors.affiliation: Royal Adelaide Hospital, Adelaide, South Australia, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Osborn
authors.affiliation: Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: L M
authors.initials: LM
authors.lastname: Orme
authors.affiliation: Royal Children's Hospital, Melbourne, Victoria, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Conyers
authors.affiliation: Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: K
authors.initials: K
authors.lastname: Thompson
authors.affiliation: Murdoch Childrens Research Institute, Melbourne, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Coory
mesh_terms: D000293:Adolescent; D001315:Australia; D035843:Biomedical Research / Q000941:ethics*; D003299:Cooperative Behavior; D026724:Ethical Review / Q000592:standards*; D028744:Ethics Committees, Research / Q000458:organization & administration*; D006761:Hospitals / Q000941:ethics*; D006801:Humans; D011446:Prospective Studies; D013997:Time Factors; D055815:Young Adult
keywords: adolescents and young adults; cancer; ethical review; multi-centre research; research governance