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Version: V04Effective Date: 30 May 2017Document Number: NTU-IACUC-SOP-1.1-F01Document Name: NTU-IACUC AUP Application Form

Research Integrity and Ethics OfficeReg. No. 200604393R

Nanyang Technological UniversityINSTITUTIONAL ANIMAL CARE AND USE COMMITTEE

(NTU-IACUC)

Application for Approval of Animal Use Protocol (AUP)

1. Please refer to the NTU-IACUC Policies for Special Procedures before submitting this application.

2. In order to perform its obligations in accordance with the NTU-IACUC Policies for Special Procedures, NTU-IACUC needs a complete description of the proposed animal use and care. Incomplete application will be returned to the applicant resulting in delay in the granting of approval.

3. Email the completed form in MS Word format, together with the soft copy of required documents, if any, to the IACUC Secretariat ([email protected]). Hand-written documents will not be accepted for review.

4. Any changes to the approved Animal Use Protocol (AUP) (procedure, species, personnel, etc.) must be documented through submission of an Amendment Form and approved by the NTU-IACUC before implementation.

a) Any SIGNIFICANT changes to an approved project in progress (e.g. the inclusion of new procedures involving potential pain, surgery or anaesthetization, or a change in Principal Investigator or course director) require IACUC review (and approval) prior to initiation.

b) Any NON-SIGNIFICANT changes to an approved project in progress (e.g. increase in number of animals used within 20%, changes in location of experiment or changes in personnel) require administrative review (and approval) prior to initiation.

5. Approval of AUP will be for a maximum of 3 years. Extension can only be granted one time for a maximum of 6 months with the approval of the NTU-IACUC. Following this, a new application is required. Extension requests submitted at least 30 days before expiry date of the protocol can be done via a minor amendment. A new application will need to be submitted for extension requests made after the expiry of the approved protocol.

6. For animal deliveries please ensure Facilities Director is informed.

7. NTU-IACUC meetings are held on the first Friday of a month, though schedules may change. If there is a change in meeting date or time, the IACUC Secretariat will contact you to inform you of the change if you are scheduled for presentation. All applications and amendments are to be submitted by the 2nd day of a month if they are to be reviewed at the following month’s IACUC meeting. All reviews are on a first

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Official Use Only

Protocol No.:

Approval Date:

Expiry Date:

mailto:[email protected]



come, first served basis. For queries on meeting schedule, please contact the IACUC Secretariat.

8. PIs are required to be present at the IACUC review in person. Any application where the PI is unable to be present in person will not be reviewed at that meeting, even if it was pre-scheduled.

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Animal Use Protocol (AUP) Application FormThis completed Animal Use Protocol (AUP) Application needs to be submitted to and approved by the NTU-IACUC prior to commencement of the animal study.

Application No.:

Date Status Remarks Signature

1st Draft received by IACUC Secretariat

1st Draft pre-reviewed by attending vet

1st Draft soft copy returned to PI for modifications

1st Draft soft copy with amendments returned to IACUC Secretariat

2nd Draft pre-reviewed by attending vet

2nd Draft submission to IACUC for approval

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Official Use Only

Protocol No.: Approval Date: Expiry Date:

Protocol No.:

Draft:Changes on this

page: Y / NResearch Integrity and Ethics Office

Reg. No. 200604393R

AUP Application Type New Submission Renewal

Application Number of Protocol to be Renewed:

SECTION 1a: PRINCIPAL INVESTIGATOR/COURSE INSTRUCTOR Principal Investigator here refers to the main person responsible for the care and use of animals in this protocol (i.e. not necessarily be the grant holder).

Full Name: Tel: Academic Title: Fax: Department: Mobile: Email: Experience or trained working with animals? Please tick.

YES*NO#

*Please provide evidence, include certificate of training, publication involving animal studies.#Provide tentative date for training (dd-mmm-yy).

SECTION 1b: DESIGNATED EMERGENCY CONTACT(S)

Full Name Mobile phone Email

SECTION 1c: CO-INVESTIGATOR(S)/RESEARCH ASSISTANTS List the names of all other individuals (besides the PI) authorised to conduct procedures involving animals under this protocol. *Please provide evidence, include certificate of training, publication involving animal studies.#Provide tentative date for training (dd-mmm-yy).


YES*NO#

Full Name: Tel: Academic Title: Fax: Department: Mobile:



Email: Experience or trained working with animals? Please tick.

YES*NO#


YES*NO#

SECTION 1d: OCCUPATIONAL HEALTH AND SAFETY Tetanus and Hepatitis B vaccinations are compulsory for personnel working with rodents. Have all personnel been vaccinated?

Yes No. They will all be vaccinated by (dd/mm/yy):

SECTION 2: PROJECT TITLE

2a. Project Title (In lay terminology, please give a descriptive title of your research project or course taught):

2b. Please specify the type of AUP application (☒all that apply):

Research Pilot studyBreeding protocolTeachingOthers Please specify:

2c. Proposed length of study using animals (dd-mmm-yy):Each protocol is only valid for 3 years.

Start date: End date:

SECTION 3: FUNDING

Grant type:Grant title:

Others:

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*Funding status: Awarded PendingGrant awarded

date:Grant expiry

date: * Please check the appropriate box.

SECTION 4: Research Animal Requirements

Please provide a summary of the research animal requirements. All fields are compulsory.

Common Animal Name:

Species:

Age at acquisition:

Weight at acquisition (metric):

Total Quantity required (includes breeding animals and

animals to be bred):No. housed at any one time (please check if sufficient room is available

in the facility with lab manager):

Source of Animals*: Local Overseas

Source Address:

Location of housing*: NTU ARF L1 NTU ARF L2 NIE

Novena, CSB L19 Others:

Other descriptions:

* Please select where applicable.

BREEDING PLAN (If any)Determine the number of breeding pairs you need to supply sufficient mice for your experiments. The following links may help you:http://jaxmice.jax.org/support/husbandry/colonySizeWkSht.pdfhttp://www.bu.edu/orc/files/2013/06/JaxColony_Management_brdng.pdf

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http://www.bu.edu/orc/files/2013/06/JaxColony_Management_brdng.pdf

http://jaxmice.jax.org/support/husbandry/colonySizeWkSht.pdf



SECTION 5: LAY DESCRIPTION

Provide a typed abstract of 250 words or fewer in simple language. Outline the objectives of the project, the experimental approach, and the significance of the expected results to human and/or animal health.

List of specific objectives of project:

Abstract of 250 words or less in simple language:

Flowchart of experimental procedures and timelines:

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Significance of expected benefits to humans or animals:

SECTION 6 (a-d): JUSTIFICATION OF ANIMAL USE AND THE THREE R’s

The IACUC requires “that animals should be used only if the researcher’s best efforts to find an alternative have failed”. The three Rs (Replacement, Reduction and Refinement) are the cornerstone of ethical animal research, and NTU-IACUC requires investigators to implement the 3Rs when they are preparing to use animals for scientific or teaching purposes.

6a. Are there alternative non-animal methods used by other investigators for the type of work proposed in this AUP (e.g. tissue cultures, in vitro monoclonal antibody, computer model, etc)? If yes, describe why these alternatives are not appropriate for this project.

6b. Why must animals be used in these experiments (☒ all that apply)?

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This is a study of animal behaviour

This phenomenon under study cannot be reproduced in vitro

This is a pre-clinical study of the in vivo effectiveness of a treatment or procedure

This is for teaching

Others (elaborate in the space below)

6c. What characteristics of this/these species make them appropriate for the proposed study? These might include structural, behavioural, physiological, biochemical, or other features or considerations (such as availability of species-specific reagents, or the use of well-established model) which make the model compatible with the research objectives. Cost is not a primary consideration.

6d. Reduction, replacement and refinement: How have you considered the 3Rs?

(i) Reduction: How have you attempted to reduce the number of animals? Please describe.

(ii) Replacement: Have you considered statistical models in vitro work, instead of using animals etc.? Please describe.

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(iii) Refinement: Have you considered pilot studies, how have you refined any surgical procedures or other manipulations? Please describe.

SECTION 7: CLASSIFICATION OF PAIN/DISTRESS

Please check one ☒ to classify the pain/distress to the animals to be used in this study.

7a. Classification

Classification 1:

NO pain, distress, or use of pain-relieving drugs. Routine procedures (e.g. injections, tattooing, blood sampling) should be reported with this classification.

No. of animalsRemarks

Year 1 Year 2 Year 3

Classification 2:

Accompanying pain or distress to the animals for which appropriate anaesthetics, analgesics, or tranquillising drugs will be used.

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Classification 3*:

Accompanying pain or distress to the animals for which the use of appropriate anaesthetics, analgesic, or tranquillising drugs would have adversely affected the procedures, results, or interpretation of the research, experiments, surgery, or tests. A brief explanation of the procedures producing pain or distress in these animals and the reasons such drugs were not used can be given in part 7b.



Classification 4:

Animals being bred, conditioned, or held for scientific activities at each facility but not yet used for research purposes.



Total number of animals to be used per

year:

*7b. (only for Classification 3)An explanation of the procedures producing pain or distress in these animals and the justification for not using appropriate anaesthetic, analgesic or tranquilising drugs must be provided below. Why must anaesthetics and/or analgesics not be used? Please justify.

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7c. Please justify the number of animals used as stated in section 7.a. Provide a breakdown of how the total numbers are arrived at and demonstrate the distribution of animal numbers in different procedures. (E.g. 6 animals x 2 treatments x 2 replicates = 24 animals). If statistics are used (e.g. 2 test, Fisher’s Exact test, Student’s t-test, ANOVA), please describe the statistical analysis.

7d. Are pregnant animals used? If yes, please describe how you will take care of the offspring.

SECTION 8: SURGICAL/NON-SURGICAL INTERVENTION AND PAIN MANAGEMENT

8a. Give details and description of the surgical procedures and pain management during, and/or after surgical intervention. Please specify the anaesthetic, analgesic, antibiotic and other drugs used in pain management.

8b. Methods of Induction and Maintenance of Anesthesia ( Not applicable)

No. Method Agent Used Dosage Route of Administration

i. Tranquilization

ii. Induction

iii. Maintenance

iv. Analgesia

v. Antibiotics

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8c. Survival Surgery Considerations

i. Has adequate consideration been given to anaesthesia and analgesia (pre- and post-operation)?

ii. Are all surgical instruments and consumables available?

iii. How are surgical instruments sterilised and how is the sterility maintained?

iv. Has adequate consideration been given to asepsis? Describe the method(s) for sterilising the surgical site and instruments.

v. How is the site closed (including all layers)? Describe sutures used and suture method.

vi. Where will the procedure be conducted?

vii. If clips or non-absorbable sutures are used, when will they be removed?

viii. Describe the relevant experience and training to qualify operator in performing this surgery.

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ix. How will the animals be monitored over the 72 hours post-surgery? How will records of this monitoring be carried out?

8d. Post-operative Plan: ( Not applicable)

Duration of post-operative care: *Hours / Days / Weeks* Please delete where appropriate

Please specify the agents that will be used for post-surgical care.No. Agent Drug Name Dosage (mg/kg)

i. Antibiotics

ii. Analgesics

iii. Other agents

8.e Give details of the non-surgical procedure and pain management during, and/or after the procedure in live animal studies. Please specify the anaesthetic, analgesic, antibiotic and other drugs used in pain management.

8.c List all procedures, manipulations, and/or measurements that will be performed on the animals. Include post-operative care, specify analgesics & anaesthetics with dosages and routes of administration, and special procedures used.

No. *PROCEDURES ^FrequencyNo. of

animals involved

Pain/distress classification(1, 2, 3 or 4)

i.

ii.

iii.

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If you need more space for animals involved, please insert new rows.*Including physical or chemical restraint, blood sampling, injection of compounds, e.g. antibiotics, chemicals, etc.^If the same procedure is repeated on the same animal.

SECTION 9: EXPERIMENTAL AND/OR ANIMAL USE ENDPOINT When experimental procedures produce animals that may become ill, it is necessary to define an endpoint to ensure that an experimental animal's discomfort, pain and/or distress is terminated, minimized or reduced.

9a. Indicate any clinical conditions or abnormalities expected or that could arise as a result of the proposed study or teaching exercise (e.g. behavioural changes such as increased grooming, vocalization or postural changes, or physical abnormalities such as anorexia, dehydration, diarrhoea, etc.)

9b. In terms of species-specific behavioural changes and physiological signs, list the criteria that will be used to trigger the decision to remove an animal from the teaching exercise or experiment, or to terminate the teaching exercise or experiment. If necessary, consult the Attending Veterinarian for further advice.

9c. Humane End points of the experiment:

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Please identify end points of the experiment with justification. Tumour size (specify growth in cm). Weight loss (more than 20% of bodyweight over 1 week OR no more than 10% over 24

hr) Inability to drink or eat. Abnormal behavior such as vocalization, CNS signs, shivering, immobility, inactivenessClinical symptoms (e.g. lameness, ruffled fur/coat, dyspnea, vomiting, edema,

discharges) Signs of Toxicity Wound infection/dehiscence(breakdown) Vomiting of blood (Haematemesis) Severe bleeding Severe or chronic pain Others._______________

Comments:

SECTION 10: ANIMAL DISPOSAL

10a. Indicate how carcasses are to be discarded of after completion of the project/research.Euthanasia [☒ select preferred technique(s)]:

Anaesthetic overdose. Agent:

Cervical dislocation*

Exsanguination (under anaesthesia)

Decapitation*

CO2

*Please provide justification(s) for using physical methods of euthanasia, and state the location where it will be done:

10b. Please specify the method of carcass disposal. (Include method of disposing contaminated organs/tissues):

SECTION 11: HAZARDOUS AGENTS & MATERIALS

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Specify each agent/material to be used and hazardous dosage:

Potential Hazard to Animals NoneBiological ChemicalCarcinogenDrugIonizing RadiationOther (i.e. allergen)

Potential Hazard to Humans NoneBiological ChemicalCarcinogenDrugIonizing RadiationOther (i.e. allergen)

11a. Have you conducted risk assessments (RA) for your project using the Workplace Risk Assessment System (WRAS)? Please attach as appendices.

Yes

No. I will submit by (dd/mm/yy):

11b. Describe potential health risks to animals or humans. Specify any special animal care required because of the hazard(s) involved. Specify precautions to be taken by personnel. Specify any special containment requirements (i.e. storage, waste/disposal requirements, etc).

SECTION 14: SIGNATURES Your signature indicates that (check each box where applicable before signing):

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NOTE: If a Biosafety and/or Radiation Safety risk assessment is required then a separate application must be submitted to the relevant bodies.



1

Animals used in this research or teaching project will be cared for in

accordance with the principles contained in Guide for the Care and Use of Laboratory Animal (8th Edition)

http://oacu.od.nih.gov/regs/guide/guide.pdf

2You have considered alternative procedures that do not involve the use

of living animals.

3You will use the minimum number of animals consistent with objectives

of described research/teaching program.

4 You have carefully selected the species that you propose to use.

5

You will use techniques and facilities that are in accordance with the

Guide for the Care and Use of Laboratory Animal (8th Edition)


6 You will notify the IACUC of any revisions to this AUP.

7You will keep copies of all approved AUPs, revisions and amendments

in an accessible file.

8 This project has been reviewed for scientific merit.

9The consultant Attending Veterinarian has been contacted for

consultation prior to AUP submission.

10

Animals housed in other Satellite Rooms

Animals from external sources need to be quarantined or housed

according to the revised guidelines on animal quaratine.

11 Animals housed in Animal Facility

Approval from the IACUC is valid for a period of three (3) years. If required, AUP must be renewed after the expiry date even if no revisions are made. At the end of the animal experiment, a closure report of the animal use is to be for IACUC review.

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AUP form completed by:

Email address :

Principal Investigator’s signature Date signed

Supervisor’s signature and stamp Date signed

FOR IACUC OFFICE USE ONLYDecision of NTU Institutional Animal Care and Use Committee (IACUC)

☐ Approved☐ Approved Pending Minor Modification☐ Withhold Approval Pending Justification and Clarification

This AUP form has been reviewed by the IACUC, and is approved based on the information provided

_________________________________________________________________________Name and Signature of IACUC Chair / Deputy Chair* Date

Date of AUP Approval:

*Please delete accordingly

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