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Ethical dilemmas of a large national multi-centre study in Australia

Driscoll, Andrea, Currey, Judy, Worrall-Carter, Linda and Stewart, Simon 2008, Ethical dilemmas of a large national multi-centre study in Australia, Journal of clinical nursing, vol. 17, no. 16, pp. 2212-2220, doi: 10.1111/j.1365-2702.2007.02219.x.

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Title Ethical dilemmas of a large national multi-centre study in Australia
Author(s) Driscoll, AndreaORCID iD for Driscoll, Andrea orcid.org/0000-0002-6837-0249
Currey, JudyORCID iD for Currey, Judy orcid.org/0000-0002-0574-0054
Worrall-Carter, Linda
Stewart, Simon
Journal name Journal of clinical nursing
Volume number 17
Issue number 16
Start page 2212
End page 2220
Total pages 9
Publisher Wiley-Blackwell Publishing
Place of publication Oxford, England
Publication date 2008-08
ISSN 0962-1067
1365-2702
Keyword(s) Australia
clinical audit
ethics
nurses
nursing
research
Summary Aims and objectives: To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study.

Background
: Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects.

Methods: The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC.

Results
: Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study.

Conclusions
: Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services.

Relevance to clinical practice: The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.
Language eng
DOI 10.1111/j.1365-2702.2007.02219.x
Field of Research 110201 Cardiology (incl Cardiovascular Diseases)
Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences
HERDC Research category C1 Refereed article in a scholarly journal
HERDC collection year 2008
Copyright notice ©2008, Wiley-Blackwell Publishing
Persistent URL http://hdl.handle.net/10536/DRO/DU:30017680

Document type: Journal Article
Collections: School of Nursing and Midwifery
Higher Education Research Group
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