title: Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.
abstract: OBJECTIVE
  To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study.
  
  
  BACKGROUND
  Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects.
  
  
  METHODS
  The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC.
  
  
  RESULTS
  Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study.
  
  
  CONCLUSIONS
  Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services.
  
  
  CONCLUSIONS
  The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.
authors.affiliation: Department of Epidemiology and Preventative Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Victoria, Australia.
authors.forename: Andrea
authors.initials: A
authors.lastname: Driscoll
authors.forename: Judy
authors.initials: J
authors.lastname: Currey
authors.forename: Linda
authors.initials: L
authors.lastname: Worrall-Carter
authors.forename: Simon
authors.initials: S
authors.lastname: Stewart
mesh_terms: D001315:Australia / Q000453:epidemiology; D019985:Benchmarking / Q000941:ethics / Q000458:organization & administration; D054869:Clinical Audit / Q000941:ethics / Q000458:organization & administration; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000941:ethics / Q000458:organization & administration; D019317:Evidence-Based Medicine / Q000941:ethics / Q000458:organization & administration; D006301:Health Services Needs and Demand; D006333:Heart Failure / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000941:ethics; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care / Q000941:ethics / Q000458:organization & administration; D011795:Surveys and Questionnaires; D013997:Time Factors