Protocol Amendment Form - Northern Sydney Local Health District

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Animal Ethics Committee
Research Office, Level 13 Kolling Building
Royal North Shore Hospital, Pacific Highway
St Leonards NSW 2065
(T) 02 9926 4590 (F) 9926 6179
E-mail: NSLHD-Research@health.nsw.gov.au
Northern Sydney Local Health District Animal Ethics Committee
Application Form for an Amendment to an Approved Animal Research Project
Instruction for submission
1. Please refer to the Research Office website for meeting dates and submission deadlines.
Applications are tabled for the next upcoming scheduled meeting, per the submission deadline.
2. This form must be completed electronically, handwritten forms will not be accepted
3. Provide a clean and tracked copy (using ‘review’ function in Word) of the revised protocol with this
form
4. Delete red guidance text prior to submission
5. You must submit with one hard copy of your amendment submission (this form and any revised
documents) with signatures and one electronic copy, via email
6. Proposed amendments must not be implemented without prior written approval from the AEC
7. Incomplete submissions may be rejected or delay their review
Mailing address
In Person
Research Office
Kolling Building
Level 13, Kolling Building
Level 4 (ground floor lobby): dial x64590 and staff
Royal North Shore Hospital
St Leonards NSW 2065
from the Research Office will come to collect
Level 13: please leave all mail in the in-tray outside
the main office door
Email the complete application to nslhd-research@health.nsw.gov.au
Subject: AEC Amendment Submission – NSLHD reference
Northern Sydney Local Health District Animal Ethics Committee
Application Form for an Amendment to an Approved Animal Research Project
NSLHD reference:
Project Supervisor/Co
Investigator:
Project Title:
summarise the relevant details relating to the amendment and ongoing
conduct ie safety update regarding xxx; change in sample size;
amendment to drug dosing schedule etc
Description of amendment:
1. Reason/rationale for amendment:
make clear why the amendment is required
2. What are the ethical implications
of the amendment?
3. If additional animals are required how many will be required?
Anticipated Animal Usage per procedure. Please detail all procedures that will be performed.
Please also indicate if multiple groups of animals will be used or if multiple procedures will be performed on the
on experimental group.
1st Animal Group *
2nd Animal Group*
NSLHD AEC Amendment form – March 2015
Always download this form from the Research Office website to ensure it is current
3rd Animal Group*
RESD/14/8997
Page 1 of 3
Species:
Strain:
Sex , Age, Weight:
Common Name:
Group name:
Total Number:
Source of Animals:
Classification of
Procedure: **
See below for guidance
See below for guidance
See below for guidance
Scale of pain: ***
See below for guidance
See below for guidance
See below for guidance
Duration of Pain: ****
See below for guidance
See below for guidance
See below for guidance
4. Guidance regarding classifications
* More than one procedure may be performed on each animal group, please include the number of
animals used in each group AND each procedure.
** Classification of Procedure
*** Scale of Pain
1
Observation involving minor interference
1
Minimal eg. IP or IV injection
2
Animal Unconscious with no recovery
2
Mild eg. Incision
3
Minor conscious procedure
3
Moderate eg. Thoracotomy
4
Minor Surgery with recovery
4
Severe eg. Broken bone
5
Major Surgery with recovery
**** Duration of pain
6
Minor physiological challenge
1
Seconds
7
Major physiological challenge
2
Minutes
8
Death as an end point
3
Hours
9
Genetically Modified Organism production
4
Days
10
Antibody production
Declaration by Animal House Manager
I have discussed this project with the applicant and have indicated that the required animals can be supplied
and/or maintained (cross out if not applicable)
Name
Facility
Signature
Date
Declaration by the Project Supervisor (this section must be signed by the project supervisor who has
overall responsibility for the study)
I agree that the above information is accurate, and that the project will continue in accordance with the original
AEC approved protocol and any approved amendments.
Name
NSLHD AEC Amendment form – March 2015
Always download this form from the Research Office website to ensure it is current
RESD/14/8997
Page 2 of 3
Signature
Date
NSLHD AEC Amendment form – March 2015
Always download this form from the Research Office website to ensure it is current
RESD/14/8997
Page 3 of 3
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