AIMS AND OBJECTIVES: 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. RELEVANCE TO CLINICAL PRACTICE: 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.
AIMS AND OBJECTIVES: 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. RELEVANCE TO CLINICAL PRACTICE: 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: Min-Fu Tsan; Bruce Ling; Ulrike Feske; Susan Zickmund; Roslyn Stone; Ali Sonel; Robert M Arnold; Michael Fine; Daniel E Hall Journal: J Empir Res Hum Res Ethics Date: 2020-09-11 Impact factor: 1.742
Authors: Patrick R Varley; Ulrike Feske; Shasha Gao; Roslyn A Stone; Sijian Zhang; Robert Monte; Robert M Arnold; Daniel E Hall Journal: J Surg Res Date: 2016-06-08 Impact factor: 2.192
Authors: Daniel E Hall; Ulrike Feske; Barbara H Hanusa; Bruce S Ling; Roslyn A Stone; Shasha Gao; Galen E Switzer; Aram Dobalian; Michael J Fine; Robert M Arnold Journal: AJOB Empir Bioeth Date: 2016-06-23
Authors: Stuart G Nicholls; Tavis P Hayes; Jamie C Brehaut; Michael McDonald; Charles Weijer; Raphael Saginur; Dean Fergusson Journal: PLoS One Date: 2015-07-30 Impact factor: 3.240
Authors: Adrian G Barnett; Megan J Campbell; Carla Shield; Alison Farrington; Lisa Hall; Katie Page; Anne Gardner; Brett G Mitchell; Nicholas Graves Journal: Res Integr Peer Rev Date: 2016-12-07