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 II
I
Registration of
clinical trials I
These forms are
suitable for research to be conducted either at Alfred Health alone or at
more than one institution. If the research is to be conducted at more than
one institution, researchers are advised to consult those institutions'
HRECs about their application and submission requirements./p>
NEAF National is
suitable for projects using the National Ethics Application Form (NEAF)
but not using the Victoria Government Streamlining Ethics
Review of Multi-Site Clinical Trials "NEAF
Streamlined" system.
NEAF National is an
alternative to the
CAF.
The research may be a
clinical trial, but typically will not be commercially sponsored and
is more likely to be student, epidemiological or allied health research or
surveys, focus groups or program evaluations.
When completing the
NEAF online, researchers will also be prompted to complete an online Site
Specific Assessment (SSA) form. This form is not required for NEAF
National. Instead, please submit the
Alfred Specific Form
(ASF).
NEAF
Must be
completed and accompanied by a protocol or project proposal
Form (you will need
to log in to start using and saving a NEAF form)
Note:
If you need to make an application on both NEAF (www.neaf.gov.au)
AND the NSW, QLD or Victorian state health systems (http://www.ethicsform.org/au), it is recommended that you create your application in www.neaf.gov.au first as
this data can be imported into the
www.ethicsform.org/au directly. It is not
possible to import proposals from
www.ethicsform.org/au into
www.neaf.gov.au.
Demonstration pro-forma NEAF applications specific to particular kinds
of research/issues are available for instructional purposes
on clinical research, research involving ATSI participants and research
involving children, e.g.,
Consent pro-forma application
Further information about the NEAF and using it
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 October 2010
(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
Procedure 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:
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This page was last
modified on
27/04/12
© The Alfred 2000 - 2012
E-mail: research@alfred.org.au