I
Use of Alfred services I
Legal and regulatory
requirements I Nursing Research I
I
Research involving
Caulfield Hospital I
External applicants I
Ethics Committee fees I
I
Registration of
clinical trials I
The Victorian
Government Streamlining Ethical Review of Multi-Site Clinical Trials
("NEAF Streamlined") system is suitable for multicentre
clinical trials that
are eligible to undergo a single review by a CCHRE accredited HREC
(http://www.health.vic.gov.au/cchre/).
These trials are
typically commercially sponsored or sponsored by a collaborative group.
Researchers will normally be approached to submit under this system by a
commercial sponsor or a collaborative group, who will provide instructions
about the application process.
Before embarking upon
their applications, researchers will need to consult Angela Henjak, Ethics
Officer, Alfred Hospital on 9076 8825 or
a.henjak@alfred.org.au about
their eligibility to use this system at Alfred Health and, if eligible, to
obtain submission instructions.
Please also familiarise yourself with our
SERP Guide.
Please refer to the
application instructions:
http://www.health.vic.gov.au/cchre/applications/applications_how_to.htm
NEAF and Site Specific Assessment (SSA)
Must be completed
Form
Victorian-Specific
Module (VSM)
Must be completed
Form
VSM Guidelines
Research
involving ionising radiation - if required
Alfred Specific Form (ASF)
Must be completed
Form
Participant Information and
Consent Forms
If required, choose from the following templates:
Participant Information and Consent Form -
Health and/or social science - Version October 2010 (72KB, MS Word)
Participant Information and Consent Form
- Clinical drug/device - Alfred Version July 2011 (145KB, MS Word)
Participant Information and Consent
Form - Clinical non drug/device - Alfred
Version October 2010 (126KB, MS Word)
Participant Information and Consent Form Recommended Wording
for Specific Procedures and Situations
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Use of Alfred services
Please note that where Alfred services are
being used in the course of the study, a declaration will need to be
signed by the relevant Resource Centre Manager. This applies to routine
tests as well as additional tests.
Resource Centre Declaration forms and
information are provided below. These are to be completed where
applicable.
Legal and regulatory requirements
See Legal and regulatory requirements.
Nursing Research
All nursing
research applications need to be submitted to the Nursing Research and
Access Committee prior to submission to the Ethics Committee. Please click
here for further information.
Research involving Caulfield Hospital
All
applications involving Caulfield Hospital resources, staff or patients
need to be submitted for authorisation by the relevant Directors prior
to submission to the Ethics Committee. Please refer to the
Caulfield Hospital Research Governance Authorisation to Conduct Research
Guideline for further information (and the corresponding application
form 'Notice
of Intention to Conduct Research at Caulfield Hospital') on the
Alfred Health intranet. Please contact Nicole Austin at
n.austin@cgmc.org.au if you do
not have access to the intranet.External applicants
If you are an applicant who is not a staff
member of The Alfred you must include at least
one senior member of staff on the research team.
Ethics
Committee fees (Ethics infrastructure fees)
Fees apply for certain
categories of applications. For full details, see
Fees.
Registration of clinical trials
The International
Committee of Medical Journal Editors (ICMJE) has adopted a policy that the
member journals will only consider publication of clinical trials if the
trial has been registered in a World Health Organisation (WHO)-accredited
clinical trial registry. Trials can be registered with: