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PMID: 26989449 已发表 · epublish 英语

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

The Australasian medical journal ·第 9 卷 ·第 2 期 ·2016-03-18

De Smit Elisabeth, Kearns Lisa S, Clarke Linda, Dick Jonathan, Hill Catherine L, Hewitt Alex W

摘要

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.,To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia.,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.,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).,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.

关键词
Australian Offices for Research Ethics administration Human Research Ethics Committees Multisite Medical Research Regional Governance Offices
文献信息
期刊
The Australasian medical journal
期刊简称
Australas Med J
ISSN
1836-1935
发表日期
2016-03-18
收录日期
2016-03-18
更新日期
2016-10-21
语言
英语
国家/地区
Canada
NLM ID
101558564
外部链接
PubMed 原文
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