title: Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project.
abstract: Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views.
  
  
  
  Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis.
  
  
  
  6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants.
  
  
  
  Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review.
  
  
  
  This study was a non-randomised comparison cohort study. Some data were missing.
  
  
  
  An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision.
authors: Institute of Public Health, Forvie Site, University of Cambridge School of Clinical Medicine, Cambridge, UK.
authors: Mary
authors: M
authors: Dixon-Woods
authors: R&D, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.
authors: Chris
authors: C
authors: Foy
authors: North Bristol NHS Trust, Southmead Hospital, Bristol, UK.
authors: Charlotte
authors: C
authors: Hayden
authors: Centre for Clinical Brain Sciences, School of Clinical Sciences, College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, UK.
authors: Rustam
authors: R
authors: Al-Shahi Salman
authors: Health Research Authority, London, UK.
authors: Stephen
authors: S
authors: Tebbutt
authors: BMJ, BMA House, London, UK.
authors: Sara
authors: S
authors: Schroter
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D015331:Cohort Studies; D003657:Decision Making; D028744:Ethics Committees, Research / Q000592:standards*; D006801:Humans; D011795:Surveys and Questionnaires; D013997:Time Factors; D006113:United Kingdom
keywords: controlled study; process evaluation; quality improvement; research ethics