Elisabeth De Smit1, Lisa S Kearns1, Linda Clarke1, Jonathan Dick2, Catherine L Hill3, Alex W Hewitt4. 1. Centre for Eye Research Australia, The University of Melbourne, Royal Victorian Eye & Ear Hospital, East Melbourne, VIC, Australia. 2. Centre for Inflammatory Diseases, Monash University, Monash Medical Centre, Clayton, VIC, Australia. 3. Rheumatology Unit, The Queen Elizabeth Hospital, Woodville, SA, Australia. 4. Menzies Institute for Medical Research, School of Medicine, University of Tasmania, TAS, Australia.
Abstract
BACKGROUND: Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. AIMS: To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. METHODS: In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. RESULTS: Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). CONCLUSION: We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.
BACKGROUND: Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. AIMS: To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. METHODS: In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. RESULTS: Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). CONCLUSION: We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.
Entities:
Keywords:
Australian Offices for Research; Ethics administration; Human Research Ethics Committees; Multisite Medical Research; Regional Governance Offices
Authors: K Cremin; P Leo; J E Harris; E De Smit; L Bradbury; P McKelvie; C L Hill; M A Brown; A W Hewitt Journal: Genes Immun Date: 2014-05-15 Impact factor: 2.676
Authors: David M Studdert; Tamara M Vu; Sarah S Fox; Ian P Anderson; Jill E Keeffe; Hugh R Taylor Journal: Med J Aust Date: 2010-03-01 Impact factor: 7.738
Authors: Rustam Al-Shahi Salman; Timothy M Brock; Martin S Dennis; Peter A G Sandercock; Philip M White; Charles Warlow Journal: J R Soc Med Date: 2007-02 Impact factor: 5.344
Authors: Ryan Pysar; Courtney K Wallingford; Jackie Boyle; Scott B Campbell; Lisa Eckstein; Rebekah McWhirter; Bronwyn Terrill; Chris Jacobs; Aideen M McInerney-Leo Journal: Eur J Hum Genet Date: 2021-08-26 Impact factor: 4.246
Authors: Elisabeth De Smit; Linda Clarke; Paul G Sanfilippo; Tony R Merriman; Matthew A Brown; Catherine L Hill; Alex W Hewitt Journal: RMD Open Date: 2017-08-29
Authors: Dylan W de Lange; Bertrand Guidet; Finn H Andersen; Antonio Artigas; Guidio Bertolini; Rui Moreno; Steffen Christensen; Maurizio Cecconi; Christina Agvald-Ohman; Primoz Gradisek; Christian Jung; Brian J Marsh; Sandra Oeyen; Bernardo Bollen Pinto; Wojciech Szczeklik; Ximena Watson; Tilemachos Zafeiridis; Hans Flaatten Journal: BMC Med Ethics Date: 2019-06-03 Impact factor: 2.652