title: Research ethics committee decision-making in relation to an efficient neonatal trial.
abstract: OBJECTIVE
  Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs).
  
  
  METHODS
  We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC.
  
  
  METHODS
  RECs in the UK.
  
  
  RESULTS
  Number of REC granting favourable opinions.
  
  
  RESULTS
  The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid.
  
  
  CONCLUSIONS
  A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials.
authors.affiliation: Section of Neonatal Medicine, Department of Medicine, Imperial College London, Chelsea and Westminster Hospital Campus, London, UK.
authors.forename: C
authors.initials: C
authors.lastname: Gale
authors.affiliation: Section of Neonatal Medicine, Department of Medicine, Imperial College London, Chelsea and Westminster Hospital Campus, London, UK.
authors.forename: M J
authors.initials: MJ
authors.lastname: Hyde
authors.affiliation: Section of Neonatal Medicine, Department of Medicine, Imperial College London, Chelsea and Westminster Hospital Campus, London, UK.
authors.forename: N
authors.initials: N
authors.lastname: Modi
mesh_terms: D001800:Blood Specimen Collection / Q000941:ethics*; D057186:Comparative Effectiveness Research / Q000941:ethics*; D017707:Erythrocyte Transfusion / Q000941:ethics* / Q000379:methods; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000628:therapy*; D009359:Neonatology / Q000941:ethics*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D018570:Risk Assessment; D012307:Risk Factors; D036302:Therapeutic Human Experimentation / Q000941:ethics; D006113:United Kingdom
keywords: Electronic Health Records; Ethics Committees, Research; Ethics, Research; Informed Consent; Intensive Care, Neonatal