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Research Outcomes - Translation into Health Care Practice
As part of Melbourne Health's ongoing commitment to excellence in research and clinical practice, we are asking researchers to provide us with information about how research outcomes are implemented in our organisation and used to improve health care.
To assist us with this information, please download the Research Outcomes form.
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Australian Code for the Responsible Conduct of Research
What is the purpose of the Code?
The NHMRC, in partnership with the Australian Research Council and Universities Australia, and through extensive public consultation, has developed the Australian Code for the Responsible Conduct of Research. The Code replaces the Joint NHMRC/AVCC Statement and Guidelines on Research Practice (1997).
The purpose of the Code is to guide institutions and researchers in responsible research practices. The Code prmotoes integrity in research and explains what is expected of researchers by the community. The Code assists researchers, administrators and the community with how to manage departures from best research practice.
Who should use the Code?
The Code is written specifically for universities and other public sector research institutions. However, all organisations involved in research will be encouraged to incorporate it as far as possible in their operating environments. The Code is also a reference for people outside the research community who require information on the standards expected in responsible conduct of research within Australia.
Compliance with the Code is a prerequisite for National Health and Medical Research Council.
Download Australian Code for the Responsible Conduct of Research
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VMIA Clinical Trials Website
The new VMIA Clinical Trials Website has been completed and uploaded with the latest VMIA news and project deliverables. In particular you will find the latest VMIA CTN Guidelines, the standard Clinical Trial Research Agreement, the First Time In Human protocols with attachments and other relevant updates.
Principal Investigators and related staff are encouraged to visit the VMIA weblink below for detailed information. http://www.vmia.vic.gov.au/display.asp?entityid=3023
We will keep you posted on the upcoming Clinical Trials Seminar conducted by VMIA in Feb/Mar of 2008.
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Clinical Trial Research Agreement - Medicines Australia
This is a legally binding Agreement between the Sponsor responsible for the initiation, management and financing of the study and the Institution responsible for the conduct of the study at the study site.
This Standard Clinical Trial Research Agreement is an industry standard and approved by VMIA, Medicines Australia and the Department of Human Services as appropriate for commercially sponsored clinical trial research. If this Agreement is used in its unaltered form there should not be a requirement for further legal counsel review except for possible inclusions submitted under Schedule 7.
The VMIA strongly encourages its insured to use this agreement for all commercially sponsored trials to ensure that cover under the VMIA policy is not compromised.
Use of this template for all clinical trial agreements between Melbourne Health and commercial sponsors of clinical trials, will be mandatory from 1 November 2007 (for sponsors who are Australian legal entities).
Standard Clinical Trial Research Agreement - Medicines Australia
Note: Medicines Australia and VMIA are currently creating a clinical trial agreement template for use by: (a) clinical research organisations, and (b) collaborative research groups. These should be available in early 2008.
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New National Statement on Ethical Conduct in Human Research 2007
This National Statement on Ethical Conduct in Human Research (‘National Statement’) is intended for use by:
- any researcher conducting research with human participants;
- any member of an ethical review body reviewing that research;
- those involved in research governance; and
- potential research participants.
This brief guide describes the structure of the document and suggests how each of these groups might use it. Note that ‘review body’ refers both to Human Research Ethics Committees (HRECs) and to non-HREC review bodies.
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INIT II - Intranasal Insulin Trial - Participants Needed
Prof Len Harrison and A/Prof Peter Colman at The Royal Melbourne Hospital have designed a nationwide, ground-breaking trial which will tell whether an intranasal insulin vaccine can prevent progression to type 1 diabetes in children and young adults at risk. It is hoped that this vaccine will stop the immune attack on the insulin-producing beta cells of the pancreas and prevent diabetes and the need for insulin injections. INIT II is currently seeking 13,000 first- and second-degree relatives of people with type 1 diabetes to register and undergo a blood test (checking for antibodies) to determine their eligibility to participate in the trial.
RMH is the Sponsor and lead site of the trial, which is funded by the National Health and Medical Research Council and the Juvenile Diabetes Research Foundation through the Diabetes Vaccine Development Centre (DVDC). The trial has been approved by MH Human Research and Ethics Committee.
You may be eligible for the trial if you are:
- A blood relative of someone with type 1 diabetes
- Interested to know more about your own risk of getting type 1 diabetes
- Aged 4-30 years
- Generally healthy
Only about 3% of people tested will have a positive antibody test - this means that they are at higher risk of getting type 1 diabetes and may be eligible for the trial. Most people will have a negative test for antibodies and can be assured that they are not at higher risk.
If you are interested in being tested, you should:
The Call Centre staff will work out if you are eligible for testing. If you are eligible, they will post you an information and consent form which you will need to read, sign and return (if you register via the website you can download the consent form).
The staff will then post you a form that you take to your nearest Gribbles pathology service. The Gribbles staff will take your blood for the test, free of charge, and courier the sample to the laboratory here at RMH.
If your blood test is negative for antibodies, you will receive your results by letter. If your blood test is positive, you will be contacted and given guidance by the RMH trial team, and invited to participate in the trial.
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