| A guide to multi-centre ethics for surgical research in Australia and New Zealand. | |
| | |
MedLine Citation:
|
PMID: 21342383 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
|
Background: This paper describes existing inconsistencies as well as the disparate processes and logistics required when obtaining ethics approval in Australia and New Zealand in order to initiate a multi-centre bi-national surgical trial. Methods: The endovascular aortic aneurysm repair trial is a large multi-centre trial that aims to obtain pre- and post-operative data from patients in hospitals across Australia and New Zealand. As the trial was research based, ethics applications were submitted to all hospitals where surgeons wished to be involved in the trial. Results: Few ethics committees have embraced attempts to simplify the application process for multi-centre trials. There was limited mutual review between Human Research Ethics Committees necessitating the submission of multiple applications. Though the use of the National Ethics Application Form in ethical review is increasing, some Human Research Ethics Committees do not accept it in its entirety; many require site-specific applications or sections of the Common Application Form modules. Conclusions: Queensland, New South Wales and New Zealand were the easiest systems to prepare, submit and lodge ethics applications because of their understanding and accommodation of reviewing multi-centred trials. The time, expense and complexity of obtaining ethics approval for multi-centre research projects are impediments to their establishment and reduce the time available for research. Australia is working to implement a system named the Harmonisation of Multi-centre Ethical Review to ease the process of obtaining multi-centre ethics clearance. Our experience suggests there will be some teething problems with implementation and acceptance. |
| | |
Authors:
|
Maggi Boult; Kate Fitzpatrick; Guy Maddern; Robert Fitridge |
Related Documents
:
|
4692713 - Cryodestruction of haemorrhoids. 21675973 - Introduction. 20415043 - The 2008 icoh workshop on skin notation. |
Publication Detail:
|
Type: Journal Article Date: 2010-10-12 |
Journal Detail:
|
Title: ANZ journal of surgery Volume: 81 ISSN: 1445-2197 ISO Abbreviation: ANZ J Surg Publication Date: 2011 Mar |
Date Detail:
|
Created Date: 2011-02-23 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 101086634 Medline TA: ANZ J Surg Country: Australia |
Other Details:
|
Languages: eng Pagination: 132-6 Citation Subset: IM |
Copyright Information:
|
© 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons. |
Affiliation:
|
Department of Surgery, The University of Adelaide and Department of Surgery, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Ethical issues with the disclosure of surgical trial short-term data.
Next Document: Bone flap storage following craniectomy: a survey of practices in major Australian Neurosurgical cen...