Application for Approval of a Project Involving the Use of Animals, and Approval as an Investigator for the Project

Transcription

1 ANIMAL ETHICS COMMITTEE UNIVERSITI SAINS MALAYSIA Application for Approval of a Project Involving the Use of Animals, and Approval as an Investigator for the Project NOTE: 1. Please complete the application form in accordance to the Animal Ethics Committee Guidelines. Incomplete application will result in the return of the application and delay in the granting of the approval. 2. Attach a copy of the proposal (research / elective / teaching / other). 3. Application must be word-processed or typewritten and forwarded to the Chairperson, Animal Ethics Committee (AEC), School of Pharmaceutical Sciences, Universiti Sains Malaysia, USM, Penang. 4. Please submit the application and direct all enquiries to the following address: (a) Secretary I, Animal Ethics Committee, School of Pharmaceutical Sciences, USM Main Campus, Penang Attn to: Mrs Salida Ibrahim Tel: (6) ; Fax(6) salida@usm.my (b) Secretary II, Animal Ethics Committee, Office of Research Platform, USM Health Campus, Kubang Kerian, Kelantan Attn to: Mr Tengku Ahmad Damitri Al-Astani Tengku Din Tel: (6) ; Fax: (6) ; damitri@kb.usm.my TYPE OF APPLICATION: [ Please tick ( / ) ] RESEARCH ( ) / ELECTIVE ( ) / TEACHING ( ) / OTHER ( ) Please specify: Please tick this section If teaching / elective project, state course name and code: NAME OF PRINCIPAL INVESTIGATOR / CO-ORDINATOR / CHAIRPERSON: _ Please state name of the PI not the student s name (See Section 1.7) SCHOOL / CENTRE: Name of your school / centre PROJECT TITLE: Title of your project / research Received by Secretary, Animal Ethics Committee

2 AEC File No: Date: 1. PROPOSAL 1.1 Project Title: Can be similar to your research grant s project title or a part of the grant, elective project, mini project, teaching course etc 1.2 Project Objectives: Aims of your project. It can be divided to general objectives and specific objectives 1.3 Summary of the Project (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 1.4 State the Ethical Implications of the Project: 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 1.5 Explain why techniques, which do not use animals, have been rejected as unsuitable. Explanation should give clear reasons why the techniques which do not use animals have been rejected and it is recommended to put related references to support your statements 1.6 Duration (Please note that ethical clearance can only be given for a maximum period of 3 years starting from the commencement date. The AEC should be informed in writing the actual date of commencement of the project.) Proposed commencement date : Estimated duration from : dd/mm/yyyy to: dd/mm/yyyy Please put the estimated duration correctly Maximum period is 3 years. However extension of the duration will be given due to the acceptable reasons

3 1.7 Investigators / Co-ordinators / Chairperson: Please list the names of persons responsible in handling animals. No. Name Dept/ School Investigators / Co-ordinators / Chairperson I/C / Passport No. Contact No. Signature & Date Please ensure that this section is signed by the persons listed Students who involved in the project should be listed 2. CLASSIFICATION OF PROJECT ( Please circle one or more ) A. Project requiring animals to be sacrificed for the preparation of the whole animals or tissue specimens. B. Procedure carried out under anaesthesia and the animals sacrificed without regaining consciousness. C. Survival after an intervention, which causes minimal stress of short duration (e.g. venepuncture, brief 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 and major behavioural modification). E. Purely breeding projects. F. Production of antisera. G. Teaching purposes. H. Fieldwork. I. Other procedures please specify: You can circle one or more response in this section. It depends on the project itself

4 3. ANIMALS REQUIRED 3.1 TABLE OF PROPOSED ANIMAL USAGE: (NOTE: Ethical Clearance can only be given for work involving LIVE VERTEBRATES for a maximum period of three calendar years only.) No. Scientific and Common Name Male (No.) Female (No.) Total (No.) Grand Total Please write the correct Scientific and Common Name of the animals required. No. of animals required should be justified and sample size calculation or relevant information to justify the number of animals to be used must be included 3.2 SOURCES OF ANIMALS: (Address of Source / Supplier:) Please write the correct address for the source or supplier of the animals The source or supplier can be either local or international Local source such as ARASC, USM Main Campus/Health Campus For international supplier, you have to make sure that the animal support / facility in USM know that you are bringing animals from that supplier and details information must be provided 3.3 LOCATION OF ANIMALS: (Please indicate where the animals will be housed during the experimental period) 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 animal to your lab or transit room to run your experiment. Therefore those locations / labs should be recorded. 3.4 ENVIRONMENTAL ENRICHMENT: (Please indicate type(s) of environmental enrichment (special / specific) to be used) Environmental Enrichment is something that you introduce to facilitate / comfort the animals. This is to ensure the wellness of the animals is taken care of Wrong environmental enrichment: (These are basic necessity not environmental enrichment) - Food & drink - Bedding - Cages Example of the environmental enrichment are : - giving toys, tunnels to the animals - giving extra hiding places - giving shredded paper for the purpose of nesting specific material for bedding

5 3.5 CARE OF ANIMALS: (State the name and contact address of the persons responsible for the daily care of animals (including after office hours, weekends and public holidays)) Please state the name of the persons that responsible to take care of the animals Research team members (one or two names) need to be state Name of the LARUSM or Animal House staff is not mandatory but is recommended to include in the list 3.6 PERMITS REQUIRED: (If protected native species, provide details of appropriate permits held) Holder : Issuing Agency : Date of Issue : Serial No. : 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 3.7 JUSTIFICATION: (Please explain the basis for selection of the species and justification for the number of animals to be used.) Please provide sample size calculation and enclosed related references Please consult our Statistician before submit the application Please provide flow chart of your study (detail with the animals to be used) NOTE: Minimum number of animals to be used to achieve the objectives of the project. 4. EXPERIMENTAL METHODS 4.1 Procedures to be carried out on the animals: (Please circle) (a) Surgery: YES / NO (If YES, answer 4.2 and 4.3) (b) Anaesthesia: YES / NO (If YES, answer 4.4 and 4.5) (c) Other: YES / NO (If YES, answer 4.6 and 4.7) Please circle the related procedures and continue with the section mentioned Please provide flow chart of your study 4.2 State surgical procedures to be carried out on the animals: Surgical procedures to be carried out should be clearly explained 4.3 Name the person(s) having experience in performing the procedures: Persons that will perform the procedure must be listed

6 4.4 Anaesthetic to be used: Name : Dose : Route of Administration : Duration : Clinical signs to ensure anaesthesia are adequate: Anesthetic and Neuromuscular Blocking Agent to be used must be correct and please consult persons in ARASC,USM 4.5 Neuromuscular Blocking Agent to be used: YES / NO If YES, Agent: Route of Administration: Dose: Duration: Justification for use of neuromuscular blocking agent: 4.6 Outline the procedure: Outline of the procedure to be carried out should be clearly explained 4.7 Name the person(s) having experience in performing the procedure: listed Name the person (s) having experience in performing the procedures should be 4.8 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). 4.9 Post-procedural care: (Detailed arrangements made by the investigators for immediate and continuing post-operative and / or post-procedural care, including details of restraint, housing and analgesics to be used). Please provide the details needed 4.10 Post-procedural survival time for the animals: (hours / days / months / years) Please provide the details needed 5. COMPLETION OF PROJECT 5.1 Animals to be sacrificed: YES / NO If YES, (i) state the method to be used: (ii) The method to be used must be explained in detail. name of the person performing euthanasia: Name of the correct persons performing the euthanasia must be provided.

7 (iii) method of disposal of euthanized animals: Disposal method must be clearly explained (iv) If animals are not sacrificed, state what happen to them: 6. HAZARDOUS MATERIALS Does the project involved 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; Please indicate the health risks to human and / or animals involved in the project: Fill this section if related to your project 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 Fill this section if related to your project

8 8. ANY OTHER COMMENTS Fill this section if you want to add any additional comments or input regarding your project 9. DECLARATION BY PRINCIPAL INVESTIGATOR / COORDINATOR / CHAIRPERSON: I hereby declare that I and / or co-investigators / co-coordinators / vice chairperson have the appropriate qualifications 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 Animal Ethics Committee USM. 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 Please ensure this section is signed by the Principal Investigator / Coordinator / Chairperson 10. CERTIFICATION OF THE AEC ( Chairperson / Authorised Representative ) Name : Signature : Date : No need to fill this section