The Office for Research

The Western Health Office for Research oversees and co-ordinates research activities within Western Health.
By providing a high level of guidance to investigators and staff in the conduct of research, the Office for Research seeks to enhance the excellence, scope and efficiency of these research efforts. It does this by facilitating and integrating all required regulatory steps and by fostering clinical research activities throughout the institution.

Western Health has a Low Risk Human Research Ethics Review Panel (LREP) constituted as per the National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research (2007). Institutions may choose to establish their own processes for ethical review and approval for low risk research.

The Research Review Process:
Case Reports - The clinical review of a single case report does not require review by the WH Low Risk Ethics Panel or notification to the Office for Research. However journal editors may require evidence of project approval prior to publication, if required please email the Office for Research to request formal notification of exemption.

Quality Assurance (QA) Projects - It is the aim of the Office for Research to encourage and facilitate the approval and conduct of QA projects. QA projects are essentially an evaluation or monitoring of a current service or practice with the aim of improving that service or practice. They may also be audits to identify and/or quantify the extent of a problem, practice or behaviour to gain knowledge that may then be used to improve a service or practice. Projects that seek to gain knowledge from monitoring and evaluating the introduction of a new practice/procedure may also fit the criteria of quality assurance.

It is difficult to separate QA from research. For the purposes of simplicity you should answer the following questions about your project:

1. Is this project undertaken for a valid purpose and does it aim to use the outcomes to improve delivery of health care?
2. Does this project seek to identify and or quantify problems within, or impediments to, good health care delivery and to identify ways of   improving those problems?
3. Does this project seek to evaluate current health practices or to monitor the introduction of a new practice?
4. Could this project infringe on ethical principles that guide human research?

If you answer yes to questions 1 to 3 your project may fit the definition of a low risk QA project. To seek approval for a QA project, you need to complete the QA Application Form and if applicable, complete the QA Participant Information and Consent Form. QA projects are reviewed by one member of the WH Low Risk Ethics Panel.
If you answered yes to question 4 your project may fit the definition of a high risk QA project and may warrant ethical review and need to be submitted to the WH Low Risk Ethics Panel as a research project.


Research Projects

Low Risk Research
Western Health has established the WH Low Risk Ethics Panel to facilitate the review of low risk research projects. The Office for Research has moved to the online forms introduced by the Department of Health. Therefore the previously used application form has been replaced by the National Ethics Application Form (NEAF) available from the online forms website at https://ethicsform.org/au/SignIn.aspx and the Victorian Specific Module athttp://www.health.vic.gov.au/cchre/applications/applications_victorian_specific.htm

Therefore to submit a research application to the Low Risk Ethics Panel you will need to complete/provide the following documents for ethics and site approval (one electronic and one hard copy):

1) NEAF on-line form https://ethicsform.org/au/SignIn.aspx


2) Victorian Specific Module http://www.health.vic.gov.au/cchre/applications/applications_victorian_specific.htm


3) Project proposal


4) Participant Information and Consent Form (if applicable) WHLREP_PICF_ Internetversion1_28Feb2011.doc (51KB)


5) Site Specific Form for Western Health and authorised Statement of Approval forms for any departments involved in your project.


Research projects that request a "wavier of consent", i.e. request to use, collect or disclose participant's data without their consent for the purpose of Research will be referred to the Melbourne Health HREC for their consideration.

Please see the new 'Ethics' Tab under 'Research' on the left hand side of your screen to gain access to the submission information.

High Risk Research
Higher risk research projects are referred for full review to the Melbourne Health HREC. Melbourne Health submission details are available at http://research.mh.org.au Examples of projects considered higher risk would include the use of identifiable data in databanks, interventions or therapies, use of human genetic samples, participants unable to consent for themselves and research that may breach a National Privacy Principle.

Ethics Checklist Insert form: Available at website www.health.vic.gov.au/cchre

Multi-Centre Research
Western Health is an accepting site for the Consultative Council for Human Research Ethics ( CCHRE).Please refer to the CCHRE website for details of the streamlined ethical review process established by the Department of Health. www.health.vic.gov.au/cchre


All projects reviewed under the multi-centre research umbrella are required to submit a Research Governance application (Site Specific Approval) to the Office for Research.

Research Governance (Site Specific Approval)
All Research requires Site Specific Approval before it can be conducted at Western Health. To attain this approval Researchers must submit a Research Governance application to the Office for Research. The Research Governance application is the responsibility of the Principal Investigator of the project. Please be aware that approval will not be granted until all relevant Governance matters are attended and The Research Governance Officer is satisfied that the Research is appropriate to be conducted at Western Health.

You must complete and submit a copy of the Research Governance checklist which is provided for you below.


Research Governance Checklist  Available at website www.health.vic.gov.au/cchre

Please Note:  From  the 1st March 2011 Western Health will be charging a Research Governance fee for all Commercially sponsored Clinical Trials. The Fee will be $5500.00 (GST exclusive) The only Commercial Sponsored Clinical trials that this fee will not apply to are those which incur a HREC fee under the Department of Health centralised system. Please contact the Office for Research if you require clarification regarding what fee applys to your project.


Research Governance applications can be submitted at anytime and in parts ( ie. a complete application in one submission is not essential). We recommend submission of Part A of the checklist to the Office for Research at the same time your project is submitted for HREC review. Once all components of the checklist have been met, a Site Specific Assessment Authorisation letter will be issued for your project to commence at Western Health. All Research Projects must receive Site Specific Approval from the Office for Research before they can commence at Western Health.

Please use the following site specific forms and statements of approval forms as relevant to your project.

Please send your Research Governance submissions to:

Mrs Kerrie Russell - Office for Research                                                                                                                                                                           Western Centre for Health Research & Education (Western CHRE)
Sunshine Hospital, Furlong Road
St Albans Victoria 3021


Office for Research Contact Details:

Manager, Dr Tam C.Nguyen
Tel: 03 8395 8073
Email: tam.nguyen@wh.org.au

Admin Assistant, Kerrie Russell
Tel: 03 8395 8074 / 83958072
Email: kerrie.russell@wh.org.au

Location:

Western Centre for Health Research & Education (Western CHRE)
Sunshine Hospital, Furlong Road
St Albans 3021

Resources:

Western Health Research Code of Conduct: Research code of conduct 2007.1.pdf (61KB)