Jawatankuasa Penjagaan dan Penggunaan Haiwan Institusi USM (JKPPH USM) USM Institutional Animal Care and Use Committee (USM IACUC) CHECKLIST OF ANIMAL ETHICS APPLICATION, PLEASE TICK ( ) IN THE BOX BELOW Penyelidik Utama: Principle Researcher/Teacher Please state name of PI not student s name No. DOCUMENTS 1 Borang Permohonan Kelulusan Etika (Haiwan) Animal Ethics Approval Application Form 2 Cadangan Penyelidikan Research Proposal APPLICANT PLEASE TICK ( ) IACUC USM PLEASE TICK ( ) 3 Tandatangan Penyelidik Utama/Pengajar Principle Researcher/Teacher signature 4 Tandatangan Penyelidik Bersama Co-researchers signature 5 Carta Alir Flow chart Please tick this 6 Tarikh Memulakan Penyelidikan Date of the project starting 7 Dokumen-dokumen tambahan yang berkaitan (jika ada) Additional related documents (if any) Please sign here (PI) Tarikh: (Tandatangan Penyelidik) (Tandatangan Penerima) (Date) (Researcher signature) (Recipient signature) Submitted date IACUC
Office Use Only Proposal Received Date IACUC File No. Received by USM Institutional Animal Care and Use Committee APPLICATION FOR APPROVAL OF A PROJECT INVOLVING THE USE OF ANIMALS NOTE: 1. Please complete the application form in accordance with the Guidelines for the Care and Use of Animals for Scientific Purposes (available at http://www.research.usm.my). Incomplete application will result in the return of the application and delay in the granting of the approval. 2. Attach all relevant documents based on the checklist. 3. Please refer to Appendix A for guideline in fulfilling the form. 4. Application must be word-processed and forwarded to the Chairperson, Institutional Animal Care and Use Committee (IACUC), Health Campus, Universiti Sains Malaysia (USM), 16150 Kubang Kerian, Kelantan. 5. Please submit the SOFTCOPY of application and the checklist from the following email jkpph@usm.my 6. Please submit the signed HARDCOPY to the Secretary, Institutional Animal Care and Use Committee (IACUC), Division of Research & Innovation, Health Campus, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan. Tel:09-767 2366, Fax:09-767 2351 7. If a proposal is requested to be presented at the USM IACUC Meeting, attendance of the Principal Investigator or Co-researcher (non-student) is compulsory. NAME OF PRINCIPAL ANIMAL RESEARCHER/TEACHER Please state name of the PI not the student s name SCHOOL / CENTRE PROJECT TITLE FOR ANIMAL STUDY TITLE OF THE GRANT/PHD/MASTER PROJECT (if different from above) Name of your school/department/unit Can be similar to your research grant's project title or part of the grant Title of your research grant (i.e short term/ru/frgs
SECTION 1: ADMINISTRATION 1.1 TYPE OF APPLICATION (Please tick [ ] one or more) (a) Research i Fundamental research Please tick this section ii iii iv v Applied research Applied animal model mimicking human disease Applied animal model mimicking the veterinary disease Toxicology study (b) Teaching (c) Others (Please specify) (e.g. Breeding, standard operating procedure) 1.2 LIST ALL PERSON INVOLVED IN THE PROJECT (including principal researcher)* No. Name School / Department Role/ Contribution I/C / Passport No. Contact [Email & H/P] Signature & Date (a) (b) (c) -Please ensure that this sections is signed by the persons listed -Student who involved in this project must be listed (d) (e) *Please ensure that this section is signed by the persons listed *Students involved in the project should be listed
1.3 DURATION OF ANIMAL STUDY Please note that ethical clearance can only be given for a maximum period of 3 years (research) and 3 years (teaching) starting from the approval date Proposed commencement: Date: Month: Year: Expected completion: Date: Month: Year: 1.4 ANIMAL(S) REQUESTED -Please put the estimated duration correctly -Maximum period is 3 years. However extension of the duration will be given due to the acceptable reasons 1.4.1 No. 1. 2. 3. Scientific / Common Name Strain Name (Indicate With an (*) If Genetically Modified) No. of male (Age / Weight) No. of female (Age / Weight) Total (No.) Dropout (%) Please write the correct scientific & common name of the animals required. No. of animals required should be justified & sample size calculation or relevant information to justify the number of animals to be used must be included Grand Total -Please write the correct address for the source or supplier of the 1.4.2 Source of animals animals Please state the supplier of the animals use for the experiments -The source of supplier can be either local or international -Local source such ARASC, USM main campus -For international supplier, you have to make sure that the animal support/facility in USM know that you are bringing animals from the supplier and details information must be provided 1.4.3 Location of animals Please indicate all the locations at which research using animals will be conducted and housed Location of animals can be more than one location. Please identify all those locations. For example: - You maybe keep your animals in ARASC but at the same time you may bring the the animal to your lab or transit room to run your experiment. Therefore those locations / labs should be recorded. -Need to discuss with animal facility
1.4.4 PERMITS REQUIRED: (Please tick [ ]) (YES / NO ) if YES please provide details of appropriate permits held (a) Holder: (b) Issuing Agency: (c) Date of Issue: (d) Serial No.: (e) Period of Validity: Usually this section is not filled by the applicants because till now there is no research related to this protected native species -However, maybe your project is related with this kind of species -Therefore please provide the details requested -Example of the protected native species : (i) Macaca fascifularis -Need to comply with any applicable laws-reseachers full responsibility 1.5 HEALTH AND / OR SAFETY RISK 1.5.1 (a) Does the project involve procedures or agents that might pose a health risk to other animal and / or personnel? (Please tick [ ]) (i) Ionizing Radiation : YES NO ii) Carcinogen / Teratogen: YES If Yes, please state the agent: If Yes, please state the agent : (iii) Pathogenic Organism : (iv) Others : YES NO YES If Yes, please state the agent : If Yes, please state the agent : NO NO (b) If YES to any of the above, please explain the risk and describe the precaution that will be taken. -The use of any agents that might pose a health risk must be declared -Appropriate SOP and facility need to be in placed (c) Describe the facilities available.
1.5.2 CLASSIFICATION OF PROJECT Please tick [ ] one or more to indicate the category that best describes all procedures to be carried out on the animals in the project A B C D E A project requiring animals to be sacrificed for the isolation of embryo and tissue/organ specimen. The procedure to be carried out under anaesthesia and the animals to be sacrificed without regaining consciousness. Survival after an intervention, which causes major or prolonged stress (e.g. major surgery and prolonged restraint). Survival after an intervention, which causes minimal stress of short duration (e.g. venepuncture, brief restraint and skin irritation). Animal behavior experiments, including pain assessment. F G H I J K L Infective or biohazard experiments. Genetic modification of animals. Toxicity studies. Purely breeding projects. Production of antisera. Blood vessel cannulation Other procedures Please specify. You can tick one or more response in this section. It depends on the project itself SECTION 2: JUSTIFICATIONS FOR THE USE OF ANIMALS IACUC must be satisfied that the use of animals is justified, based on whether the scientific or educational value of the work outweighs the potential impact on the animal being used 2.1 PROJECT SUMMARY (a) State the objective of the project Aims of your project. It can be divided to general objectives and specific objectives (b) Provide a brief background of the study (not more than 250 words).
-Summary of the Project should give a brief introduction and an overview of your study. It is best to include the background of the study and justification of the study (c) Provide flowchart of the study and indicate the number of animals to be used in the flowchart (Attached as an appendix) -Study flowchart need to clearly present what is happening to animals from the beginning to the end of the project & over what time sequence -Animal grouping & their different treatment received (d) Justify the number of animals requested based on statistical calculations, guidelines, published study or other methods Please provide sample size calculation and enclosed related references -Please consult our Statistician before submit the application (e) Justify the choice of species / strain of the animals to be used (provide references) Please provide the details needed
(f) State the housing and husbandry for special requirements (if applicable) Caging or housing Maximum per cage Please provide the details needed Special care Diet Environmental enrichment 2.2 ETHICAL IMPLICATION OF THE PROJECT Identify all factors/procedures that may have an impact on an animal s well being i.e any activities not part of the ordinary husbandry Ethical Implications of the project is something that will give / create something bad or negative to the animals and handler himself. For example: Introduce stress to the animals create new environment which will harm/cause discomfort to the animals / handler and precautions needed whatever treatment or intervention you give to the animals what will happen to the animals during and after the study any alteration of treatment or long restrain procedure any alterations of feeding & drinking any procedure i.e / anesthesia / surgery / euthanasia 2.3 REPEATED USE OF ANIMALS, Please tick [ ] Have any of the animals been the subject of a previous research or teaching activity? NO Please provide the details needed YES, (if YES, please explain why it is necessary to reuse the animals)
SECTION 3: PROJECT DETAIL Procedures to be carried out on the animals 3.1 ANAESTHESIA Will anaesthesia be used in the experiment (except for euthanasia) (Please tick [ ]) Yes No Anesthetic and Neuromuscular Blocking Agent to be used must be correct and please consult persons in ARASC,USM (if YES, please complete the table below) (a) Please complete the table below for each anaesthetic agent or mixture used (please duplicate the table for different groups/species/ Agent name Route of Administration Please provide the details needed Dose/volume Duration (explain in instruction) (b) Describe how will you monitor recovery from anaesthesia: (c) Clinical signs to ensure anaesthesia is adequate: 3.2 NEUROMUSCULAR BLOCKING AGENT Will Neuromuscular Blocking agent be used in the experiment, (Please tick [ ]) Yes No (if YES, please complete the table below) Agent Dose/volume Route of administration Justification for use of neuromuscular blocking agent 3.3 SURGERY
(a) Will surgery be performed during the experiment, (Please tick [ ])) Yes No Surgical procedures to be carried out should be clearly explained (if YES, please complete the table below) Describe in detail, the surgical procedures to be carried out on the animals Outline of the procedure to be carried out should be clearly explained Name the person identified to perform the procedure Persons that will perform the procedure must be listed Is the person familiar with the procedure (Please tick [ ]) Trained Yes No 3.4 OTHER INTERVENTIONS Please justify the intervention to be performed in the experiment Outline the procedure: State the person identified to perform the procedure: - Other intervention includes Toxicology, drug treatment (substance, volume, route, frequency of treatment, local & systemic effects, anaesthesia or analgesia, restrain). - Blood/body fluid collection (volume, route, frequency, anaesthesia or analgesia, restrain) - Diet/water modification (type, amount, effect) - Tumour/neoplasia induction (method, site, endpoint, monitoring) 3.5 GENETIC MODIFICATION OF ANIMALS
(a) Does the project involve the use or creation of genetically modified (GM) animals e.g.: transgenic, knockout, or mutant animals (Please tick [ ]). Yes No Fill this section if related to your project (if YES, please complete the table and section below). Animal Species & Strain (Common name) Name and function of genetic modified Phenotype of animals Please provide the details needed (b) If application for the creation of animals, please state the method/used that will be used. The method to be used must be explained in detail (c) Provide details of the breeding and maintenance of the GM line. Please include personnel and facility involved.
SECTION 4: HUSBANDRY & MONITORING (a) Who will carry out the daily husbandry and monitoring of animal, including weekends and holiday? Provide name and contact number. -Name of the correct persons performing the daily husbandry and monitoring of animal must be provided. Please provide contact number. -Research team members (one or two names) need to be stated -Name of the ARASC or Animal House staff is not mandatory but is recommended to include in the list (b) Monitoring during and after procedures/interventions; List specific signs to be monitored and their frequency. Please provide the monitoring checklist you will use to record these observations. Please provide the details needed SECTION 5: FATE OF THE ANIMALS (a) What is the maximum period of time that an individual animal or a group of animals will be used in this project? (b) If animals are to be sacrificed, please fill the table below: Method Agents Route of administration The dosage used The person performing the procedure (c) What will be the method of disposal of euthanized animals? Disposal method must be clearly explained (d) If animals are not sacrificed, state what happen to them?
SECTION 6: DECRALATION BY PRINCIPAL RESEACHER/TEACHER I hereby declare that I and co-researcher have the appropriate qualification and experience to perform the procedures described in this project. I am familiar with the provisions of the USM rules and regulation in animals for the care and use of Animals for Scientific Purposes; and accept responsibility for the conduct of the experimental procedures detailed above; in accordance with the requirement of the rules and regulation laid down by the USM Institutional Animal Care and Use Committee. 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 carried 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 of Principal researcher/teacher : Date : Official stamps: SECTION 7: CERTIFICATION FROM IACUC (CHAIRPERSON / AUTHORISED REPRESENTATIVE) Name : Position : Signature : Date :