Animal Use Protocol - Hong Kong University of Science and ...

Sample Questionnaire (NOT FOR OFFICIAL USE)

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The Hong Kong University of Science & Technology Animal Experiment Protocol (AEP)

Personnel

Please provide the names of all personnel who will oversee or conduct work under this protocol.

Principal Investigator The Principal Investigator is responsible for all work conducted under this protocol and can edit the information. Last name First name

Co-Investigators The Co-Investigators can edit the information in this protocol. Last name First name

Research Personnel Research Personnel conduct research procedures using animals under this protocol. Last name First name

Student Research Personnel Student Research Personnel conduct research procedures using animals under this protocol. Last name First name


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Signers Individuals listed here are required to sign the protocol. Please select your Head of Department for the approval process. Last name First name

Request Addition of a New User If you are unable to locate a user by using the “Edit Selection“ button above, list that user's ITSC username, e-mail address and which personnel group they belong to in the box below.

ITSC username Email address First name, last name

Department Personnel Group (Co-I/Research Personnel/Student Research Personnel)


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General Information Title Document title:

Protocol Lay Description Provide a brief, lay summary of the project in a manner understandable by a non-scientist.

Proposed location where animals are to be kept:

Place in which experiments will be carried out:


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Species

Please select the species you are using for this protocol. Please note that multiple species may be included on the same protocol.

Species

• Specify Species / Strain to be used on the protocol

• For each of the Species / Strain specified, answer the following questions

Species Justification / Information

Explain why you select the species for use in this protocol.

Animal Source

What is the strain, source, and health status of the animals ? (*)

Animal Characteristics

Describe the animal characteristics (ex. age, weight, size, gender, etc.) of the animals used in this protocol.

Select the strain and breeding lines used on this protocol.

Severity Level Please provide the Severity Level (or Distress Classification) of the Species and its number that applies to this protocol. Severity Level Species Number of Animals

0


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Study Segment A study segment includes all procedures that may be performed on one group of animals from arrival to euthanasia. Protocols may have only one study segment or animals maybe used in more than one segment.

Add Study Segment

To add a new study segment, provide name of the study segment, select the appropriate species, and click “Add”. To change order of study segment use up/down buttons in the study segment list.

Name of study segment :

Species :

Add

Study Segment Species

Study Segments Details

For each of the study segment specified above, answer the following questions.

Species to be used for the Study Segment

Please assign species for study segment.

The species you selected under the Species Tab will be available for selection, below is only an example:

C57BL/6J

Mouse

SD (Sprague Dawley)

Animal Biosafety Level

Please select the animal biosafety level that the study will be conducted. (*)

For information about the BSL levels, please see section 'D. Description of Biosafety Levels' at https://hseo.ust.hk/sm_09_p1.

ABSL-1

ABSL-2

ABSL-3

ABSL-4


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Endpoints

What are the end points for this study segment? (*)

Tumor size

Percentage body weight gain or loss

Inability to eat or drink

Behavioral abnormalities

Clinical symptomatology or signs of toxicity

Other. Please specify

What criteria will you use to determine when euthanasia is to be performed? (Note: Death as an endpoint must always be scientifically justified.) (*)

Animal Monitoring

Please provide details on how animals are monitored by filling in the following table:

Species Parameters Monitored Monitoring frequency Responsibility Person

What, if any, clinical signs or symptoms do you expect the animals to show in response to this particular procedures or manipulations?

Weight loss

Rough hair coat

Hyper/hypoactivity

Diarrhea

Labored breathing

Other. Please describe.

Animal Disposition

Will there be animals that are not euthanized on this study segment?

No – all animals will be euthanized

Yes

If yes, please describe the disposition of animals not euthanized on this study segment.


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Euthanasia

Please list the Drugs/Agents used for Euthanasia by filling in the following table:

Generic Name Brand Name Dose (mg/kg) BW Total Volume Route

Describe the methods of euthanasia that will be used.

Proper Euthanasia requires that two AVMA approved methods are applied to ensure death. If decapitation without prior tranquillization or other not recommended methods of euthanasia are applied, please provide scientific justification.

Breeding

Are you breeding animals under this protocol? (*)

Yes

No

Animal Identification Methods

Describe the method (e.g. ear punch, tattoo, cage card, etc) and age at which animals will be identified. (*)

Use of Visual Media

Will you be using visual media on this study segment? (*)

No

Yes

If Yes, Please describe the extent of use of visual media and assure save storage of that material according to the visual media policy. *

Surgery

Will you be performing surgery on this study segment? (*)

No


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Yes

If Yes, please answer the following questions.

Will you be using paralytic agents during surgery? (*)

No

Yes

If Yes, please describe how ventilation will be maintained and how pain will be assessed. *

Will you be performing multiple major survival surgeries on the same animal? (*)

No

Yes

If Yes, please answer the following questions.

• What kind and how many surgeries are planned on each animal? (*)

• How long will the animal recover between surgeries? (*)

• Please justify why multiple surgeries on the same animal cannot be avoided? (*)

Potential Stressors

Describe the potential stressors that animals may experience during procedures conducted on this protocol. (*)

Study Segment Summary

Briefly explain the experimental design and specify all animal procedures used in this study segment. (*)

Specific procedures to be employed in the study must be described on the “Procedures” tab. The Study Segment Summary should allow the Animal Ethics Committee to understand the experimental course of an animal from its entry into the experiment to the endpoint of the study. A flowchart or ordering the procedures on the “Procedures” tab may be an effective presentation of the planned procedure. A best practice is to provide an acceptable range of the specific items described below to allow flexibility in the use of professional judgment and avoid non-compliance due to work conducted off protocol as a result of overly restricted parameters.


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Study Segment - Number of Animals

Provide the number of animals for each study segment tab below. If the same animals will be used on multiple study segments, you should provide the justification for the first segment, and then select 0 animals for related segments with an explanation. For each of the study segment specified under the Study Segment Tab, answer the following questions.

Number of Animals

Please provide the number of animal. Animal Numbers Justification Provide the scientific justification for the animal numbers required for these studies. (*) Include how the numbers were determined and what criteria were used to determine group size. Be sure to include any literature references, statistical analysis performed (ex. power analysis) as well as provide any previous experience from similar studies. Provide scientific / statistic justification for the animal number and approximate litter size.

Study Segment - Procedures

For each of the study segment specified under the Study Segment Tab, answer the following questions. Procedures List all procedures that will be used for each study segment tab. Click on add/edit below to select pre-determined procedures. Each procedure will correlate with a training competency (assigned on next tab). If you do not see a procedure listed, you may define your own procedure (note there is no automatic link to training and you will need to document additional training details on the next tab). Description of Procedures General descriptions for each procedure chosen are inserted into the text field below. These are the descriptions predetermined by the IACUC. If you make modifications, the changes will be tracked and the revised description will be reviewed by the IACUC for approval.


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Study Segment - Procedures Training Verification

For each of the study segment and per species specified under the Study Segment Tab, answer the following questions. Procedures Training and Responsibilities for Study Personnel Procedures Training is required for all personnel prior to protocol submission and approval. The matrix below shows the current status of Study Personnel Training (Research Personnel, Student Research Personnel, and Animal Care & Veterinary Support Staff). Click the edit selection button(s) on the Personnel tab to add names to the Research Personnel, Student Research Personnel, and Animal Care & Veterinary Support Staff groups. Procedures assigned to the protocol appear in the rows of the table below. For each personnel, check which procedures the will perform on this protocol. Once trainings are selected, click the refresh button below and the training status appears. For each training the table shows if the Research Personnel, Student Research Personnel, and Animal Care & Veterinary Support Staff have completed the training and it has been documented in their tick@lab user profile. The PI is responsible to ensure that all listed personnel have completed the required trainings. Additional Procedure Training Details Provide justification for each Study Personnel regarding the procedure training and qualification.


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Anesthesia/Analgesia

Anesthesia For each procedure on the protocol where anesthesia will be used, select the procedure, species and drug below and provide the concentration, dose, route and duration of effect. Only procedures and species selected on the “Procedures” tab will appear. The appropriate drugs will then appear for selection.

Add new row

Procedure Species Drug Concentration

Dose

Route

Duration of Effect

Analgesia For each procedure on the protocol where analgesia will be used, select the procedure, species and drug below and provide the concentration, dose, route and duration of effect. Only procedures and species selected on the “Procedures” tab will appear. The appropriate drugs will then appear for selection.

Add new row

Procedure Species Drug Concentration

Dose

Route

Duration of Effect


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General Training

Required Basic APCF Traning Select the basic AUP Training for the research.

APCF Workshop Assessment

APCF L Zone Training

APCF J Zone Training

APCF Orientation

Required General AUP Training for Study Personnel General AUP Training is required for all personnel prior to protocol submission and approval. The matrix below shows the current status of Study Personnel Training (PI, Co-Investigator, Research Personnel and Student Research Personnel, and Animal Care & Veterinary Support Staff). Click the edit selection button(s) on the Personnel tab to add names to the PI, Co-Investigator, Research Personnel, Student Research Personnel, and Animal Care & Veterinary Support Staff groups. Then select the relevant trainings in the Required General AUP Training section above. Once trainings are selected, click the refresh button below and a list of required training appears. For each training the table shows if the PI, Co-Investigator, Research Personnel, Student Research Personnel, and Animal Care & Veterinary Support Staff have completed the training and it has been documented in their tick@lab user profile. The PI is responsible to ensure that all listed personnel have completed the required trainings. By clicking the ‘Refresh’ Button below, you will see if the research personnel has taken the training course specified above.

Refresh

Additional General Training Details For each of the Study Personnel, list their responsibilities under this protocol and describe any additional information regarding the training and qualifications of Study Personnel that may be relevant.


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Protocol/Forms Links

Links to Other Protocols or Forms

If this AEP is linked to another HREP, SP, AEP form, please select the appropriate item. If you are unable to find protocol to link, please contact the appropriate Coordinator and ask to be added to the File Access Group. (By clicking the button “Edit Selection”, a window pop up for selection of other forms. Click “+” button to choose. Click “Apply current selection”.)

Edit selection

After selection, the selected linked protocols will be shown :

Number Protocol Title Type of Protocol

Additional Details for Linked Protocols and Forms If you want to discuss additional details regarding any of the links above, please describe them below.


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Rationale/Alternatives Note: Please visit the following websites on the “3Rs Principle” (i.e. replacement, reduction and refinement):

1. “Center for Alternatives to Animal Testing (Altweb)” at http://altweb.jhsph.edu

2. “Fund for the Replacement of Animals in Medical Experiments (FRAME)” at http://www.frame.org.uk/index.htm

3. “Norwegian Reference Centre for Laboratory Animal Science and Alternatives (NORINA)” at http://oslovet.veths.no/NORINA

4. “National Centre for the Replacement, Refinement and Reduction of Animals in Research” at http://www.nc3rs.org.uk

Rationale for Animal Use Explain your rationale for animal use and make an argument why this study does not unnecessarily duplicate or replicate previous experiments done in this lab and by others.

Search Data Add literature search information by filling in the following table.

Add new row

Search conducted

Searched from Searched to DB Title # of hits Keywords

searched

Provide a narrative summarizing the results of the referenced literature searches.

Replacement, Reduction, and Refinement

Provide a clear indication that alternatives to experiments on live animals (i.e. reasons why non- animal models cannot be used) and/or a reduction of the number of animals to be used.


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Refinement Can animals be replaced by the use of appropriate alternative methods such as tissue banks, cell cultures or computer models?

Yes

No

If No, please describe why this is not possible

Can these experiments be refined by employing less stressful/traumatic/invasive methods to achieve the same results?

Yes

No


Can the number of animals be reduced through the use of a different experimental paradigm or better directed questions?

Yes

No


Replacement Explain why animals cannot be replaced with computer models or cell cultures.


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Animal Husbandry/Housing Fluid or Food Restriction

Will Food or Fluids be restricted on this protocol? (*)

No

Yes

If Yes, describe and justify the duration and monitoring method

Deviations from Standard Environmental Enrichment Will there be deviations from standard environmental enrichment on this protocol? (*)

No

Yes

If Yes, describe and justify the type and length of time of deviation

Other Husbandry Deviations or Considerations Will there be other husbandry deviations or special considerations regarding the animal use in this protocol? (*)

No

Yes

If Yes, describe and justify the type of deviation/special consideration and length of time of deviation


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Safety & Hazards

Use of Biologics or Cell Lines Does this protocol use animal derived biologics or cell lines on animals? (*)

No

Yes

If Yes, fill in the list below.

Biologics or Cell Line Source Date, late MAP

test SP Protocol # SP Approval Date Special Precautions

Use of Infectious Agents

List all infectious agents used on this protocol. Be sure that any referenced Safety protocol is selected on the "Protocol Links" tab. Does this protocol use infectious agents on animals? (*)

No

Yes


Infectious Agent SP Protocol # SP Approval Date Containment Level Special Precautions

Use of Genetic Constructs / Recombinant DNA

List all genetic constructs or recombinant DNA used on this protocol. Be sure that any referenced IBC protocol is selected on the "Protocol Links" tab.

Does this protocol use genetic constructs/ recombinant DNA on animals? (*)

No

Yes


Genetic Construct SP Protocol # SP Approval Date Containment Level Special Precautions


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Use of Genetically Engineered Animals

List all genetic constructs for genetically engineered animals used on this protocol. Be sure that any referenced IBC protocol is selected on the "Protocol Links" tab. Will genetically engineered animals be made under this protocol? (*)

No

Yes


Genetic Construct SP Protocol # SP Approval Date Containment Level Special Precautions

Use of Toxic Chemicals List all Chemical Hazards used on this protocol. Be sure that any referenced IBC protocol is selected on the "Protocol Links" tab. Does this protocol use toxic chemicals on animals? (*)

No

Yes


Chemical Name Risk Group MSDS Link Containment Level Special Precautions

Use of Radiation / Radioactivity List all radiological hazards used on this protocol. Be sure that any referenced IBC protocol is selected on the "Protocol Links" tab. Does this protocol use radiation (e.g. caesium source) and/or radioactivity (3H tritium) on animals? (*)

No

Yes


Radopnucleotide Radiation Type Half Life Shielding Special Precautions


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Other Hazards

List all other hazardous substances used on this protocol. Be sure that any referenced IBC protocol is selected on the "Protocol Links" tab.

Describe any additional hazards that apply to this protocol.


Hazard/Agent name Hazardous ? Comments Special Precautions Instruction

Use of Human Derived Agents, Tissues or Cell Lines Does this protocol use human derived agents, tissues or cell lines? (*)

No

Yes

If Yes, answer the following questions.

Describe the use of human derived agents, tissues or cell lines. (*)

Does the described use of human derived agents, tissues or cell lines have an IRB approval or exemption letter? If it does, please attach the IRB approval or exemption letter to this tab. (*)

No

If No, please state why IRB approval is not necessary.

Yes

If Yes, List the IRB Protocol number and date of approval. Be sure that any referenced IBC protocol is selected on the "Protocol/Forms Links" tab. *

A pathogen report is required for all cell lines used in animals. Please attach the report to this tab. Have you attached a pathogen report? (*)

No

Yes


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Waste and Animal Disposal Procedures Describe the practices and procedures required for the safe handling and disposal of contaminated animals and material associated with this study.

Describe methods for removal of radioactive waste and, if applicable, the monitoring of radioactivity.

Additional Safety Considerations Describe any additional safety considerations that apply to this protocol which are not already listed above.


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Transportation

Transportation Will you need to transport animals outside of the animal facility?

No

Yes

If Yes, answer the following questions.

Describe where the animals will be transported. (*)

How will the animals be transported? (*)

Will you be following the Institutional Transportation SOP? (*)

Yes

No

If No, please describe how you will deviate from approved procedures and why this is necessary. *


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PI Certification PI Certification I have provided an accurate description of the proposed Animal Care and Use Protocol and agree to

the following conditions: (*)

• My personnel and I will abide with the Animals (Control of Experiments) Ordinance (Cap. 340) and all pertinent institutional rules and policies governing the use of animals in research, teaching, and testing.

• I certify that I have carried out and documented the results of an appropriate literature search to ensure that the proposed studies do not unnecessarily duplicate previous experiments.

• I certify that I have reviewed the pertinent scientific literature and the sources and/or databases and have found no valid alternative to any procedures described herein which may cause more than momentary pain and all effort will be made to alleviate pain and distress to the absolute minimum consistent with the study objective and best veterinary practice.

• I assure that the named individuals on this project have read and understand the procedures outlined in this protocol.

• I certify that all experiments and surgeries involving live animals will be performed under my supervision or that of another qualified professional listed on this protocol.

• I declare that all personnel having direct live animal contact on this project, including myself, have been or will be trained in humane and scientifically acceptable procedures for the animal handling, administration of therapeutic drugs and euthanasia to be used in this project. Personnel will be allowed adequate time to obtain necessary training for this project and will not begin any procedure with live animals until they have been successfully trained.

• I certify that I will notify the Animal Ethics Committee regarding any unexpected study results that impact the animals. Any unanticipated pain or distress, morbidity or mortality will be reported to Animal & Plant Care Facility and the Animal Ethics Committee and I will permit emergency veterinary care for animals showing evidence of pain or illness not addressed specifically in the approved protocol as well as routine veterinary care as prescribed for individual species.

• If drugs or substances that are classified by the Department of Health as Dangerous Drugs are used in this study, I assure that they will be stored in a locked cabinet and accessible only to authorized persons in accordance with Dangerous Drugs Ordinance (Cap. 134).

• I assure that all personnel working with live animals are aware of the potential hazards associated with the use of live animals and animal tissues.

• I certify that the Safety Panel has approved the use of the test substance(s), if any. I certify that research personnel will abide by all relevant, universal precautions regarding blood-borne pathogens, appropriate biosafety level precautions, radiation safety procedures, and the chemical hygiene plan.

• I certify that the information provided within this application is accurate to the best of my knowledge and that no significant changes will be made without advance approval of the Animal Ethics Committee. I also understand that, should I use the project described in this application as a basis for a proposal for funding (either intramural or extramural), it is my responsibility to ensure that the description of the animal use in such funding proposal(s) is identical in principle to that contained in this application. I will submit modifications and/or changes to the Animal Ethics Committee as necessary to ensure these are approved before initiating these changes.

I certify that the above statements are understood and will be followed.

Animal Use Protocol - Hong Kong University of Science and ...

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