FACULTY OF PHARMACY, THE UNIVERSITY OF LAHORE
LAHORE, PAKISTAN
INSTITUTIONAL RESEARCH ETHICS COMMITTEE
Application for approval of a project involving the Use of animals,
and approval as an investigator for the Project.
NOTE:
1. Applications must be word processed or typewritten and forwarded to the Dean, Faculty of Pharmacy (chairman of the committee) for approval.
2. Please direct any enquiries to the Chairman, Institutional Research Ethics Committee, Faculty of Pharmacy, The University of Lahore, Defence road campus, Lahore. Email:
NAME OF PRINCIPAL INVESTIGATOR:
PROJECT TITLE:
Received by Chairman, Institutional Research Ethics Committee
Project File No: …………………………………… Date: ………………….
PROPOSAL
Note: If synopsis has been prepared, then attach the signed copy (from supervisor) of synopsis with this application and write “synopsis attached” to avoid duplication (1.1 to 1.4).
1.1 Project Title
1.2 Scientific or educational aims of the projects
1.3 Description/ Back ground/literature review/ pilot study results (300 words)
1.4 Ethical Implications of the Project
1.5 Duration (Please note ethical clearance can only be given for a maximum period of 3 years.)
Proposed commencement date:
Estimated duration from:
1.6 Investigators Involved in the Project
a. Please list the name of all those who will be involved in the working with live animals on this project.
b. Principal Investigator:
c. Co-Investigators:
2. CLASSIFICATION OF PROJECT
A- Projects requiring animal to be sacrificed for the preparation of the whole animals or tissue specimens.
B- Procedure carried out under anaesthesia and the animal sacrificed without regaining consciousness.
C- Survival after an intervention, which causes minimal stress of short duration (e.g. venepunture,
restraint, and blood vessel cannulation under anaesthesia).
D- Survival after an intervention, which causes major or prolonged stress (e.g. major surgery, prolonged restraint, administration of toxic or painful substances, major behavioural modification).
E- Purely breeding projects.
F- Production of antisera.
G- Teaching purposes.
H- Fieldwork.
Other procedures – please specify.
ANIMALS REQUESTED
Table of Proposed/ requested Animal Usage
(NOTE: Ethical Clearance can only be given for work involving live vertebrates for a maximum period of three calendar years only.)
Species and Common Name / Male / Female / Total No.Grand Total
ANIMALS (Continued)
3.1. SOURCES AND SUPPLY OF ANIMALS
Please indicate/delineate specifically and clearly the expected sources of animals to be used, e.g. from which supplier, place, etc.
3.2 LOCATION OF ANIMALS
a. Please indicate where the animals will be housed during the experimental period.
b. Please indicate type (s) of environmental enrichment to be used for laboratory animals.
c. Who will be responsible for the day-to-day care of animals (including after hours and weekends)?
PERMITS REQUIRED If protected native species, then provide details of appropriate permits held:
Holder:
Issuing Agency: N/A
Date of Issue:
Serial No.:
Period of Validity:
Please explain the basis for selection of the species, and outline the experimental design to justify the number of animals to be used in the project.
NOTE: Project must be design to use the justifiable number of animals to achieve the aims of the investigation.
4. EXPERIMENTAL METHODS
Note: If synopsis has been prepared, then attach the signed copy (from supervisor) of synopsis with this application and write “synopsis attached” to avoid duplication (4.1 to 4.3)
4.1. Procedures to be carried out on the animals
4.2. Surgical procedures to be carried out on the animals
4.3. Experience of the Principal Investigator in these procedures
Principal investigator must be sufficiently experienced in animal handling procedures. Otherwise, he/she will get guidance from, Dean Faculty of Pharmacy / Dr. Arham Shabbir, Associate Professor Faculty of Pharmacy, The University of Lahore, Lahore, Pakistan.
4.4. Anaesthetics
a. Diethyl ether anaesthesia
b. Any other (Specify)
4.5. Neuromuscular Blocking Agents NO
If YES Agent: ______Dose: ______
Route of Administration: ______Duration: ______
Provide justification for use of neuromuscular blocking agents:
4.6. Supervision during experimentation
(Detail the extent and method of supervision of animals during experimentation, including methods to be used for assessing and preventing pain and distress).
4.7. Post-procedural care
(Postoperative care must be such to minimize discomfort and the consequences of any disability from the operative procedure. Post-surgical animals should be euthanized if it is determined that their postoperative condition is causing them to suffer pain or distress needlessly. The immediate recovery from anesthesia should be monitored closely. Animals should be monitored continuously until they are able to maintain sternal recumbency. Rodents should never be returned to regular housing until they are recovered from anesthesia. Following restoration of consciousness, the animal should be examined at least daily for a minimum of ten days. Exposed sutures or staples should be removed within 10-14 days of the surgery).
Principal investigator and Co-PI agree to abide by the mentioned post-procedural care policies.
4.8. Time animals are required to be maintained after the procedures
Animals will be handed over to animal house staff of The University of Lahore upon their discretion to decide.
5. COMPLETION OF PROJECT
If animals are to be sacrificed:
a) state the method to be used;
b) the name of the person performing euthanasia;
a. Principal investigator along with co investigators
c) The method of disposal of euthanasia animals.
d) If animals are not killed, state what happens to them
6. HAZARDOUS MATERIALS
Does the project involve exposure of live animals to any of the following?
6.1 Ionising Radiation YES/NO
If YES, Agent ______
6.2 Carcinogen/ Teratogen YES/NO
If YES, Agent ______
6.3 Pathogenic Organisms YES/NO
If YES, Agent ______
6.4 Other YES/NO
Please give details.
If YES to any above;
(i) Please indicate the health risks to Staff and/or animals involved in the project:
If YES, please complete appropriate forms.
7. GENETIC MATERIALS
7.1 Will you be isolating the DNA YES/NO
7.2 Will you be inserting DNA into live animals YES/NO
8. ANY OTHER COMMENTS
9. DECLARATION BY PRINCIPAL INVESTIGATOR
I hereby declare that I have the appropriate qualifications and experience to perform the procedures described in this project. I further declare that the procedures described in this project do not constitute unnecessary repetition of work previously carried out by other research workers or myself, and that each person engaged in this project has been adequately instructed in, and is competent to perform, procedures that they are to carry out. If they are not already skilled in the procedures, I will be responsible for seeing that they obtain the necessary training in advance, so that each procedure on an animal will be carried out in the most appropriate manner.
______
Signature: Principal Investigator Date
10. CERTIFICATION OF THE REVIEW GROUP
Authorised representative of Institutional Research Ethics Committee
Name: Dr. Arham Shabbir
Signature:
______Date: ______
11. DECLARATION BY DEAN, FACULTY OF PHARMACY
I acknowledge that it is my responsibility to ensure that all members of staff engaged in animal experimentation comply with the conditions laid down by:
Institutional Research Ethics Committee, Faculty of Pharmacy, The University of Lahore
Signature:
______Date: ______