title: The Department of Health's research governance framework remains an impediment to multi-centre studies: findings from a national descriptive study.
abstract: OBJECTIVE
  We describe our experience of using the standard application form, designed to streamline applications for multi-centre research, to seek approval from all primary care organizations (PCOs) in England and Wales to undertake a single telephone interview with a health service manager.
  
  
  METHODS
  We sent applications (n=316), by email to each PCO, or consortium of PCOs, attaching a completed standard application form, the 15 required documents, and the approval we had been granted by the lead NHS organization. We maintained detailed records of the responses to our application, subsequent correspondence, additional paperwork requested, and time spent on the approval process.
  
  
  METHODS
  The UK Research Governance Framework, which regulates all research conducted in health and social care settings.
  
  
  METHODS
  All PCOs in England and Wales.
  
  
  METHODS
  None.
  
  
  METHODS
  Time taken to obtain approval to undertake a telephone interview with a health service manager.
  
  
  RESULTS
  We were unable to establish contact with 13 (4%) PCOs. Six months after submitting our application we had received approval from 259/316 (82%) PCOs and were still awaiting a verdict from 41 (13%). The median time to approval was 56 days (IQR 42-72). Overall, an estimated 318 staff-hours were spent completing supplementary forms, providing additional information and chasing up dormant applications.
  
  
  CONCLUSIONS
  Recent initiatives to 'streamline' research governance approval have failed to address the problems that face researchers undertaking multi-centre studies. There is an urgent need to develop a simpler process that allows low risk research to take place without threatening staff morale and endangering the quality of the research outputs. In the meantime, we advise researchers to allow far greater time than might reasonably be envisioned to obtain research governance approval.
authors.affiliation: Division of Community Health Sciences, GP Section, University of Edinburgh, Edinburgh, EH8 9DX, UK. tara.kielmann@ed.ac.uk
authors.forename: Tara
authors.initials: T
authors.lastname: Kielmann
authors.forename: Alison
authors.initials: A
authors.lastname: Tierney
authors.forename: Rosemary
authors.initials: R
authors.lastname: Porteous
authors.forename: Guro
authors.initials: G
authors.lastname: Huby
authors.forename: Aziz
authors.initials: A
authors.lastname: Sheikh
authors.forename: Hilary
authors.initials: H
authors.lastname: Pinnock
mesh_terms: D000068:Accreditation / Q000331:legislation & jurisprudence*; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D004739:England; D032984:Ethics, Research; D006077:Government Agencies; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence*; D011320:Primary Health Care / Q000331:legislation & jurisprudence*; D013997:Time Factors; D014852:Wales