Institutional Animal Ethics Committee Animal House, School of Biological Sciences, NISER, Bhubaneswar. Summary Sheet (To be filled by Investigator)

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1 Institutional Animal Ethics Committee Animal House, School of Biological Sciences, NISER, Bhubaneswar Name of the Principal Investigator: Designation: Summary Sheet (To be filled by Investigator) Contact No. Title of the Project New/ Ongoing (Tick) If ongoing- Mention the protocol no. assigned New Ongoing Species of Animal Requested Strain/Stock No. Requested No. of animals used if ongoing Species Strain No. Funding Source (Tick) Self/Institutional Collaborative External Grant Name of Funding Agency Protocol no. assigned. For Office use Date of Receiving Date of Approval

2 Form B [per rule 8(a)] Application for permission for Animal Experiments Application to be submitted to sent either to the CPCSEA (address in form A above) or Institutional Animal Ethics Committee (IAEC) 1* Name and address of establishment National Institute of Science Education and Research Bhubaneswar P.O. Jatni, Khurda , Odisha, India 2* Registration number and date of registration Reg. No.-1634/GO/ERe/S/13/CPCSEA Date of Registration -15/10/ Name, address and registration number of breeder from which animals acquired (or to be acquired) for experiments mentioned in parts B & C Details of CPCSEA registered animal breeders should be provided quoting the registration no. Ex: Institute of Life Sciences (An Autonomous Institute of the DBT, Govt.of India) Nalco Square, Chandrasekharpur Bhubaneswar Registration No. - 76/PO/ReBi/99/C PCSEA 4 Place where the animals are presently kept (or proposed to be kept) Provide the address Ex : National Institute of Science Education and Research Bhubaneswar P.O. Jatni, Khurda , Odisha, India Reg. No.-1634/GO/ERe/S/13/CPCSEA 5 Place where the experiment is to be performed (Please provide CPCSEA Reg. Number) Experiments should be carried out only at animal house facility registered with CPCSEA. Experiments cannot be housed or experiments carried out at animal facility other than that inspected and approved by CPCSEA. Ex : National Institute of Science Education and Research Bhubaneswar P.O. Jatni, Khurda , Odisha, India Reg. No.-1634/GO/ERe/S/13/CPCSEA 6 Date on which the experiment is to commence and duration of experiment Post facto approval will not be allowed. Date of commencement can be after the date of approval and not before that. The validity of approval will be for a period of 1 year from the date of approval. 7 Type of research involved (Basic Research/Educational/Regulatory) This point is self explanatory. Mention the type of research. Signature Date: Name and designation of the Investigator Place: Bhubaneswar

3 PART B Protocol form for research proposals to be submitted to the committee/institutional Animal Ethics Committee, for new experiments or extensions of ongoing experiments using animals other than non-human primates. 1. Project / Dissertation / Thesis Title: TITLE SHOULD BE BRIEF AND CONCISE 2. Principal Investigator / Research Scholar / Research Guide /Advisor : a. Name Complete details of PI should be mentioned here b. Designation c. Dept / Div/ Lab d. Telephone No. e. Experience 3. List of names of all individuals authorized to conduct procedures under this proposal Co - guides a. Name Only trained personnel are b. Address authorized to conduct procedures on animals. List of persons c. Experience authorized by PI should be mentioned here 4. Funding source with complete address (Please attach the proof) Self/Institutional, Collaborative, External Grant In case of external govt. or private funding, submit a copy of letter/proof. 5. Duration of the project a. Number of months Mention approximate duration of experiment along with proposed date of initiation. Date of b. Date of initiation (Proposed) c. Date of completion (Proposed) commencement can be after the date of approval and not before that. The validity of approval will be for a period of 1 year from the date of approval, however proposed date of project may be beyond that. Do not mention the duration of your funded project.

4 6. Detailed study plan may be given (Not more than one page) Briefly mention the objective and study plan to achieve those objectives in a simple way. A broad idea of the study plan with animal involvement should be mentioned here. Committee will look into the ethical part of your study plan and not judge the scientific knowledge of the group. Objective of study with reference to animal experiment should be clearly mentioned in a very simple and layman s language as the committee also comprises of people from non scientific background. 7. Animals required a. Species/Common name Details of the animal species along with its common name b. Age / weight / size PI should mention the age and weight range here. c. Gender Sex of animal d. Number to be used (Year-wise breakups and total figures needed to be given) Detailed breakup of animal should be given in this section. The investigator should mention the number of groups in the study and also number of animals in each group. This will help the members to assess the need for required number of animals. Give breakup as mentioned below. Year Group no. Age group No. of animals (control) 6-8 week 15 2(Drug 1) 6-8 week 15 3(Drug2) 6-8 week 15 Total 45 e. Number of days each animal will be housed. Duration of experiment including the acclimatization period f. Proposed source of animals Mention the tentative source from where the animals will be procured. Ex. National Institute of Science Education and Research Bhubaneswar P.O. Jatni, Khurda , Odisha, India Reg. No.-1634/GO/ERe/S/13/CPCSEA 8. Rationale for animal usage

5 a. Why is animal usage necessary for these studies? Mention why the animals usage is necessary in the proposed study. Whether the study can be carried out without animals using in-vitro, in-silico methods etc? If not, mention the need for animals in this study. Provided that replacement alternatives not involving experiments on animals should be given due and full consideration and sound justification must be provided in case alternatives, though available, are not used b. Why are the particular species selected required? Justify why the particular species is selected for experiment. Animals lowest on the phylogenetic scale which may give scientifically valid results should be first considered for any experimental procedure. c. Why is the estimated number of animals essential? The experiment should be designed using minimum number of animals to give statistically valid results at 95% degree of confidence: If more number of animals is requested, then proper justification should be provided. If this is an ongoing project justify why more numbers of animals are required. Also submit a progress report of the previous approved projects. No. of Animals used for the same study d. Are similar experiments conducted in the past? If so, the number of animals used and results obtained in brief. Repetition of experiments should be avoided. If similar kind of study conducted earlier, it should be mentioned here and also the number of animals used and a brief report on the results obtained. Experiments should be performed on an animal /animals for the purpose of advancement by new discovery of physiological knowledge which will be useful for saving or prolonging life or alleviating suffering or for combating any disease whether on human beings or animals. e. If yes, why new experiment is required? Explain f. Have similar experiments been made by any other organization agency? If so, their results in your knowledge. Mention in brief results of similar type of experiment in past. 9. Description of the procedures to be used. List and describe all invasive and potentially stress full non-invasive procedures that animals will be subjected to in the course of the experiments. Furnish details of injections schedule No. of Animals required for ongoing study Justification for more use of animals Substances Doses Furnish details of injectables or test material. Exact Doses of the same to be mentioned here

6 Sites Volumes Blood withdrawal Volume Sites Radiation (dosage and schedule) Route of administration Ex. Oral, IV, IM etc Quantity of test compound to be injected should be mentioned here. Keep in mind that in small animals we can inject only a fixed volume. Like maximum dosing for oral gavage is 10ml/kg Refer to the Standard Operating Procedures for blood withdrawal. The proposed quantity of blood withdrawn from the animal should be mentioned here. Keep in mind the frequency and total blood volume of animals. The route of blood collection should be clearly mentioned here such as retro orbital plexus, tail vein, ear vein etc. Mention if applicable. 10. Please provide brief descriptions of similar studies from invitro /invivo (from other animal models) on same/similar test component or line of research. If, enough information is available, justify the proposed reasons. The point is self explanatory. If similar studies have been carried out then what is the need for new study. 11. Does the protocol prohibit use of anesthetic or analgesic for the conduct of painful procedures (any which cause more pain than that associated with routine injection or blood withdrawal)? If Yes, explanation and justification Experiments involving operative procedure more severe than simple inoculation or superficial venesection shall be performed under the influence of anaesthetic to prevent the animal feeling pain and it shall remain so throughout the experiment. However if use of same will affect the outcome of experiment or may deviate the test results, proper justification should be given. 12. Will survival surgery be done? Survival surgery is defined as any surgery from which the animal recovers consciousness from anesthesia following a surgical procedure If Yes, the following to be described. a. List and description of all such surgical procedures (including methods of asepsis) If any surgery is done on animals, detailed procedure should be given

7 b. Names, qualifications and experience levels of operators Surgeries should be carried out only by a qualified person. Full details of such persons should be mentioned here c. Description of post-operative care Post operative care includes drinking, eating care, pain management(analgesia) and dressing. Detailed procedure about how the animals are taken care after the surgery should be mentioned in detail. d. Justification if major survival surgery is to be performed more than once on a single individual animal. Repeated surgeries on single animal is always discouraged, but may be permitted by IAEC if scientific justification is acceptable. Multiple major survival surgical procedures can be justified if they are related components of a research project, if they will conserve scarce animal resources, or if they are needed for clinical reasons. 13. Methods of disposal post-experimentation a. Euthanasia (Specific method): Only approved methods to be used. See SOP for details. Should be performed by a qualified person. b. Method of carcass disposal : Refer to Biomedical waste guidelines by govt. of India. Also refer to SOP for waste disposal. In case outsourced, mention the name of the qualified agency. Not following the guidelines for disposal is a punishable offence. c. Rehabilitation: This section is not applicable for small laboratory animals. Only for large animals. 14. Animal transportation methods if extra-institutional transport is envisaged If animals are to be transported from other places or breeder facilities, then how these animals are transported (rail/road/air) and type of vehicle and also type of boxes/cages used should be mentioned in detail 15. Use of hazardous agents (use of recombinant DNA-based agents or potential human pathogens requires documented approval of the Institutional Biosafety Committee (IBC). For each category, the agents and the biosafety level required, appropriate therapeutic measures and the mode of disposal of contaminated food, animal wastes and carcasses must be identified) Enclose the permission from IBC.

8 (a) Radionuclides : (b) Microorganisms / Biological infectious Agents: (b) Hazardous chemicals or drugs : (c) Recombinant DNA : (d) Any other (give name) If, your project involved use of any of the above, attach copy of the minutes of IBSC granting approval. It is mandatory to attach the approval letter of Institutional Biosafety committee if the proposal involves any of the above mentioned items are used

9 Investigator's declaration 1. I certify that I have determined that the research proposal herein is not unnecessarily duplicative of previously reported research. 2. I certify that, I am qualified and have experience in the experimentation on animals. 3. For procedures listed under item 11, I certify that I have reviewed the pertinent scientific literature and have found no valid alternative to any procedure described herein which may cause less pain or distress. 4. I will obtain approval from the IAEC/CPCSEA before initiating any significant changes in this study. 5. Certified that performance of experiment will be initiated only upon review and approval of scientific intent by appropriate expert body (institutional scientific advisory committee / funding agency / other body (to be named). 6. Institutional Biosafety Committee's (IBC) certification of review and concurrence will be taken (required for studies utilizing DNA agents of human pathogens). 7. I shall maintain all the records as per format (Form D) 8. I certify that, I will not initiate the study unless approval from CPCSEA is received in wiring. Further, I certify that I will follow the recommendations of CPCSEA. 9. I certify that I will ensure the rehabilitation policies are adopted. Signature Date: Name of Investigator THIS IS A LEGAL DOCUMENT. ALL THE DETAILS SHOULD BE FILLED WITH DUE CARE. MINOR DEVIATION IF ANY SHOULD BE REPORTED TO IAEC. MAJOR DEVIATION IS NOT ALLOWED WITHOUT PRIOR APPROVAL FROM IAEC. INVESTIGATOR SHALL MAINTAIN RECORD OF EXPERIMENTS IN FORM D (AVILABLE WITH ANIMAL HOUSE OFFICE).