I What do I need to submit? I
Change to research personnel I
Changes to consent procedures I
Changes to Investigator’s Brochures (IBs) I
What do I need to submit?
Amendment applications must be submitted electronically to
research@alfred.org.au
according to instructions on the
Request for
Approval of Amendments form. We do not require hard copies.
In
order to review an application, the committee members must be able to
understand what changes have been made to a project, which is why documents with changes tracked are required. A document with changes
tracked allows a reviewer to see both the original and the altered text;
therefore clean copies are unnecessary.
Only
relevant documentation is required. Material that is not relevant is not
only a waste of paper but causes confusion for reviewers and ultimately
slows down the entire process, resulting in delays to approval of
amendments.
All amendment applications should be either electronically
signed by the Principal Researcher, or sent from the Principal
Researcher's email address.
Adhering to these guidelines will result in faster and more efficient
processing of amendment applications.
Changes to research personnel
It is common for changes in staff to occur throughout the life of a
project. When new people join your research
team or others leave, please make sure you let the Ethics Office
know.
Use the form below if there have
been any changes to Principal
Researcher/s, Associate Researcher/s, Research Assistant/s, Research
Coordinator/s, Student Researcher/s or any other members of the research
team since the project was approved.
There is no fee for approval of changes to research personnel.
If you would like approval
for changes to other aspects of your project, please submit a ‘Request for
Approval of Amendments’ as detailed on the
Amendments
page.
Changes to consent procedures
(arising from Guardianship & Administration Act changes)
Is
the activity involving participants a medical research procedure
(as currently defined in the Guardianship and Administration Act)?
YES:
- Amendment
application form explaining why the activity is a ‘medical research procedure’ and
which steps in the Act are being proposed.
- Module 1.21 or VSM Section 2 & 3: Complete all
relevant questions.
-
Consent Guidelines for recruiting staff,
detailing procedures for obtaining Person Responsible consent and (if
relevant) recruitment under Procedural Authorization.
-
All appropriate PICFs based on
the Clinical Research Project template.
NO:
- Amendment
application form.
-
Module 1.21(b) or VSM 2.1a)ii): Check “Other” and
give details of next-of-kin/carer acknowledgment in the text box
provided [refer to Module One or VSM Guidelines for further information].
-
Information Sheet** for NOK/Carer
(appropriately worded) based on the Non-Clinical Research Project
template, including a Third Party
Acknowledgment Form and Revocation of Consent Form.
- A
Participant Continuation PICF** if
the participant is likely to regain the capacity to consent while the
research is still under way.
**
Note: there is no specific template provided – please adapt
the wording in the main PICF template. The Clinical Research Project PICF
template, however, has a specific Participant Continuation Consent Form
which can be used.
Changes to Investigator’s Brochures (IBs)
Revised IBs do not need to be submitted as a formal amendment
unless corresponding changes are required to the Participant Information &
Consent Form (PICF).
No
changes to PICF: If the changes to the IB do not require
changes to the PICF, please email the
Request for Review
of Updated Investigator's Brochures form and
attach the core documents
listed below. This will be sent to a reviewer with
pharmacology expertise.
Changes to PICF:
If the PICF needs to be
updated to include information from the revised IB, please email the revised PICF,
amendment application form, and the
following core documents
as a formal Request for Approval of Amendments.
Core Documents:
- Full revised IB
- Summary of changes
(if not included in the revised IB)
- Impact Statement
signed by the Principal Researcher advising whether, or not, the changes
may have an impact on Alfred Health participants
Please note that revised IBs are acknowledged by return email
rather than 'approved', and will not be listed on the Certificate of Approval
of Amendments.
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was last modified on
27-02-12
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