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Title: Variation in Human Research Ethics Committee and governance processes throughout Australia: a need for a uniform approach.
Austin Authors: Dudi-Venkata, Nagendra N ;Cox, Daniel R A ;Marson, Nicholas;Tan, Lorwai;Pockney, Peter;Muralidharan, Vijayaragavan ;Watson, David I;Richards, Toby
Affiliation: Discipline of Surgery, Faculty of Health and Medical Sciences, School of Medicine, The University of Adelaide, Adelaide, South Australia, Australia
South Australian Trainees Audit and Research Collaborative (STARC), Adelaide, South Australia, Australia
TROCAR, Trainee-led Research in Orthopaedics: Collaborative of Australian Registrars, Australia
VERITAS Collaborative
Flinders University Discipline of Surgery, Flinders Medical Centre, Adelaide, South Australia, Australia
Division of Surgery, University of Western Australia, Fiona Stanley Hospital, Perth, Western Australia, Australia
Clinical Trials Network of Australia and New Zealand (CTANZ), Research, Audit and Academic Surgery, Royal Australasian College of Surgeons, Adelaide, South Australia, Australia
Surgery (University of Melbourne)
Issue Date: Nov-2021
Date: 2021-04-13
Publication information: ANZ Journal of Surgery 2021; 91(11): 2263-2268
Abstract: In Australia, ethics committees across different states vary in application, requirement and process for the ethical review and approval for clinical research. This may lead to confusion and delays in the enablement of multicentre research projects. This study explores the effect of differing processes for Ethics and Governance in the establishment of the CovidSurg-Cancer study during the global COVID-19 pandemic. An anonymous, structured web-based questionnaire was designed using the Research Electronic Data Capture application (REDCap) platform to capture consultant surgeons, fellows, and trainees experience in the ethics application process. 'CovidSurg-Cancer' was an international multicentre collaborative study to assess the impact of COVID-19 on the outcomes of patients undergoing cancer surgery. The ethics process to set up this observational study was used as to explore the differing processes applied across Australia. The CovidSurg-Cancer study was successfully set up in 14 hospitals. Four hospitals approved the study directly as an audit. Of the remaining sites, 10 ethics applications underwent Human Research Ethics Committee review following which two (14%) were subsequently approved as an audit activity and eight hospitals (57%) were given formal ethical approval with waiver of consent. Ethics application acceptance from another Australian Human Research Ethics Committee was provided with six applications; however, only three were reciprocated without the requirement for further agreements. A third of (30%) respondents suggested that the details of the application pathway, process and documentation were unclear. Ethics processes are varied across Australia with considerable repetition. A centralized, harmonized application process would enhance collaborative research.
DOI: 10.1111/ans.16842
ORCID: 0000-0002-9775-3599
Journal: ANZ Journal of Surgery
PubMed URL: 33851489
Type: Journal Article
Subjects: collaborative research
research ethic
surgical research
Appears in Collections:Journal articles

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