Research Services
Certification of the Southern Health HRECs by the National Health and Medical Research Council The Southern Health HRECs in September 2010 received Certification by the National Health and Medical Research Council in accordance with the National Certification Scheme for its institutional processes relating to the ethical review of multi-centre research. Southern Health’s HRECs have been certified to provide ethical review for multi-centre research in the following categories of research:
Clinical Trials Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials Phase IV Paediatric Research Clinical Interventional Research other than Clinical Trials
Population Health/ and or Public Health Mental Health The period of Certification is valid between 01 January 2011 to 31 December 2013.
Streamlined Ethical Review Process
Research governance activities
The Southern Health HRECs are accredited by the Consultative Council for Human Research Ethics of the Department of Health (Victoria) for the Streamlined Ethical Review Process of multi-site clinical trials in Victoria. The initiative operated throughout 2011 and streamlined the ethical review for commercially sponsored multi-site trials.
In 2011, Research Governance Officer, Ms Micheleine Uhe created 21 Standard Operational Procedure documents which are complemented by an array of supporting documentation. The documents were uploaded onto the Southern Health Prompt document system for access by all staff members.
Southern Health reviewed 31proposals for multi-centre clinical research on behalf of a number of Victorian institutions. Southern Health accepted the review of other accredited institutions in Victoria who reviewed 46 projects that involved researchers at Southern Health. The accreditation status of the Southern Health HRECs were re-affirmed by the Consultative Council on Human Research Ethics (Department of Health in Victoria) (‘CCHRE’) in late November 2011. In 2011, the Victorian, Queensland, Departments of Health and the New South Wales Ministry of Health signed a Memorandum of Understanding to introduce mutual acceptance of ethical and scientific review in public hospitals regarding multicentre, clinical trials being conducted in more than one of these states. Mutual acceptance of ethics review for multi-centre clinical trials for Queensland and Victoria commenced from Monday 24 October 2011. Commencement of mutual acceptance for NSW is from 1 February 2012.
Quality assurance applications There were 147 quality assurance proposals received during 2011. In accordance with the NHMRC guidelines, the scope of the activities considered to be a quality assurance activity are defined as all the various activities designed to evaluate, monitor and improve the quality of health services.
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Micheleine co-ordinated the presentation of the VMIA Research Governance Toolkit comprising of five modules. Educational presentations were given at Southern Health and externally on topics such as ‘The Auditing Process’ and ‘The Consent Process’. Micheleine attended the CCHRE workshops and seminars and maintained professional networks with other Research Governance Officers from other institutions within Victoria.
Biostatistics support Biostatisticians of the Monash University School of Public Health and Preventive Medicine review many research proposals for the HRECs. This biostatistics review is in accordance with the National Statement requirements to ensure that the sample size is adequate to demonstrate both clinically and statistically significant effect. This expert support is now provided by Associate Professor Sophia Zoungas, Mr Eldho Paul and Mr Sanjeev Ranasinha. The HRECs would like to extend a special thank you to Associate Professor Damien Jolley who provided biostatistics reviews for many of the research proposals that have been submitted to Southern Health over the past decade. Associate Professor Jolley’s reviews of the proposals have value-added to high standard of research conducted at Southern Health and his approachability with assisting researchers is appreciated not only by the HREC, but by the many researchers he has worked with over the years.