Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study
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.
History
Publication title
Australasian Medical JournalVolume
9Pagination
33-39ISSN
1836-1935Department/School
Menzies Institute for Medical ResearchPublisher
Australasian Medical Journal Pty. Ltd.Place of publication
Hillarys, GPO Box 367 Perth, W.A. 6923 AustraliaRights statement
Copyright 2016 AMJRepository Status
- Restricted