Literature DB >> 26989449

Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study.

Elisabeth De Smit1, Lisa S Kearns1, Linda Clarke1, Jonathan Dick2, Catherine L Hill3, Alex W Hewitt4.   

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.

Entities:  

Keywords:  Australian Offices for Research; Ethics administration; Human Research Ethics Committees; Multisite Medical Research; Regional Governance Offices

Year:  2016        PMID: 26989449      PMCID: PMC4780210          DOI: 10.4066/AMJ.2015.2587

Source DB:  PubMed          Journal:  Australas Med J        ISSN: 1836-1935


  13 in total

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5.  Utility of temporal artery biopsy samples for genome-wide analysis of giant cell arteritis.

Authors:  K Cremin; P Leo; J E Harris; E De Smit; L Bradbury; P McKelvie; C L Hill; M A Brown; A W Hewitt
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8.  Problematic variation in local institutional review of a multicenter genetic epidemiology study.

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9.  The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: an innovative approach to multisite IRB review and oversight.

Authors:  Sabune J Winkler; Elizabeth Witte; Barbara E Bierer
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10.  Research governance impediments to clinical trials: a retrospective survey.

Authors:  Rustam Al-Shahi Salman; Timothy M Brock; Martin S Dennis; Peter A G Sandercock; Philip M White; Charles Warlow
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  4 in total

1.  Australian human research ethics committee members' confidence in reviewing genomic research applications.

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

2.  Geo-epidemiology of temporal artery biopsy-positive giant cell arteritis in Australia and New Zealand: is there a seasonal influence?

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

Review 3.  Australia: regulating genomic data sharing to promote public trust.

Authors:  Lisa Eckstein; Donald Chalmers; Christine Critchley; Ruthie Jeanneret; Rebekah McWhirter; Jane Nielsen; Margaret Otlowski; Dianne Nicol
Journal:  Hum Genet       Date:  2018-08-16       Impact factor: 4.132

4.  Huge variation in obtaining ethical permission for a non-interventional observational study in Europe.

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

  4 in total

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