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ANIMAL CARE AND USE PROTOCOL

PROTOCOL # 00-000APPROVED:EXPIRES:

OFFICE USE ONLY

PRINCIPAL INVESTIGATOR AND GENERAL PROTOCOL INFORMATION This submission is a (check [X] one):

[ ] New Study[ ] Renewal: Previous protocol: [# ] Expires [DATE][ ] Amendment - Complete Amendment Record below

Project Title:

Project Type [ ] Breeding [ ] Contract [ ] Field [ ] Research [ ] Teaching(Check [X] one): [ ] Other, please describe _

Funding Source(s): _Grant Title(s): _

Principal Investigator Name: Position (check [X] one): [ ] Tenure track/clinical professor [ ] Research Scientist [ ] Lecturer [ ] Emeritus [ ] IUB DVMOnly individuals of the above ranks may serve as a PI. All electronic protocol submissions must be generated by or copied to the PI.

Email: _Department: _Phone: _ *Emergency after-hours phone: _ Campus Address: _

Co-PI (if applicable): _Position (check [X] one): [ ] Tenure track/clinical professor [ ] Research Scientist [ ] Lecturer [ ] Emeritus

[ ] Postdoctoral Fellow [ ] Visiting Scientist [ ] Research Associate [ ] Graduate Student [ ] Technician

Email: _ Department: _Phone: _ *Emergency after-hours phone: _Campus Address: _

Does this study involve live animal use at another campus or institution? [ ] yes [ ] noIf yes, please explain: _

PI Signature Page

OFFICE USE ONLY

BIACUC Chair or Authorized SignatureApproved on:

Conditions or modifications:

BLOOMINGTON INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (BIACUC) # 00-000-00

The signature on this form demonstrates the responsibility of the Principal Investigator, and if applicable, the co-PI for all activities and personnel related to this study or class.

I assure the safe and ethical conduct of all research conducted with animals and that the research complies with the IUB’s Letter of Assurance to OLAW and all applicable state and federal laws governing animal welfare.

I assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of valid scientific research or teaching and that this study does not unnecessarily duplicate previous research or experiments.

I will provide veterinary-approved anesthesia and analgesia for procedures that cause pain, distress or discomfort to animals.

All research personnel listed on the protocol must have completed the IACUC-required CITI online training and have been medically cleared by the Occupational Health and Safety group prior to participating in animal-related activities.

I will directly inform all project personnel of the IACUC-approved procedures and methods prior to their participation in animal-related activities. The approved protocol and all amendments will be read by and will be readily available to project personnel.

I certify that all experiments involving live animals will be performed under my supervision or that of another qualified scientist.

I will ensure that appropriate licenses and permits for collecting wild animals have been obtained before conducting animal activities.

I assure that the animal use section of any associated grant accurately reflects the animal use. I understand that noncompliance with the laws, regulations, policies, and guidelines can result in the suspension of approved activities for conducting animal research, teaching, and testing. Noncompliance with the care and use of animals in research, teaching and testing can jeopardize the IUB’s ability to procure external and internal research funding and may be reportable to the USDA, OLAW and the NIH.

PI Signature:

Date:

Co-PI Signature:

Date:

(This page may be submitted separately, in PDF format.)

BIACUC Protocol Version: September 2018


PROTOCOL SUMMARY AND PROCEDURES/EXCEPTIONS

This application consists of two parts: The following REQUIRED sections (1-8), and the additional sections (A-I). Your answers to the required sections will determine if additional sections are applicable and require completion.

REQUIRED SECTIONS

Amendment Record (for amendments only)

1. Animal Requirements & Husbandry

2. Rationale for Involving Animal Subjects

3. Purpose of Proposed Research

4. Description of Experimental Design and Animal Procedures

5. Experimental Manipulations

6. Assurance that Proposed Work Does Not Unnecessarily Duplicate Previous Research

7. Teaching Proposals

P. Project Personnel

ADDITIONAL SECTIONS

A. Surgery

B. Anesthesia

C. Minimization of Pain and Discomfort

D. Experimentally Induced Disease or Condition -

E. Euthanasia

F. Hazardous Substances

G. Breeding, Ordering, or Using Pregnant Animals

H. Standard Operating Procedure (SOP) for Investigator Maintained Animals

I. Pain & Distress Rating Scale Template

J. Field Study



AMENDMENT RECORD a. To submit an amendment to a previously approved protocol, incorporate the requested changes by using the Track

Changes option in this WORD document. If you prefer a different option, highlight changes with different color text or with the highlight tool, ensuring that deleted text is changed to strikethrough.

b. Provide a brief summary of the proposed revision(s) in the section below:

Date Summary

1. _ _

2. _ _

3. _ _

4. _ _

5. _ _

6. _ _

7. _ _

8. _ _

9. _ _

10. _ _



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1. Animal Requirements & Husbandry Note: If ordering or using pregnant females, indicate the number of pregnant females separate from the number of offspring that will be used as subjects. If breeding animals as part of this protocol or ordering pregnant animals for use or to produce litters, complete Section G: Breeding, Ordering, or Using Pregnant Animals

1.A. Species

Scientific name Common nameTotal number of

animals*

Housing area(s)LAR facility or Room # of

PI-managed LabUse areas (include room

numbers)

*If breeding rodents, include an estimate of the number of offspring produced, both those used experimentally and not used experimentally. Include rodents less than 21 days of age.

This data is to be included in Section G.4 OR Section G.5 as well. .

Grand Total of Animal Numbers Requested*:

(*This includes animals transferred from a previous study, another IUB protocol, and offspring produced from breeding activities.)

Are any strains Genetically Modified Animals (GMA)? If yes, please list below.

Species Strain

1.A.1. Are any of the Genetically Modified Animals (GMA) a newly generated line for this study? [ ] Yes [ ] No

If yes, also complete Section D: Experimentally Induced Disease or Condition.

NOTE: Use of genetically modified animals requires IBC approval. See: http://researchcompliance.iu.edu/ibc/index.html

1.A.1.a. If genetically modified animals are to be used, describe any phenotypic consequences of the genetic manipulations to the animals and any special care or monitoring that the animals will require. If this is a newly generated line of GMA or if phenotypic consequences are adverse or unknown, also complete Section D: Experimentally Induced Disease or Condition.

Phenotypic signs identified in GMAs must be listed in the protocol.


http://researchcompliance.iu.edu/ibc/index.html


1.A.2. Renewal Transfer: If this is a three-year renewal, approximately what number of animals will be transferred from the previous protocol? Be sure that the number of animals transferred are included in Table 1.A.

Species currently in use Strain Number of Animals

1.B. Source of Animals

Where will animals be obtained for this study? Check [x] all that apply.

1.B.1. [ ] An LAR-approved vendor

You are free to purchase animals from ANY of the resources on the approved vendor list. The currently approved vendors

listing may be downloaded from the LAR web site: https://lar.indiana.edu/policies-guidelines/index.html

1.B.1.a. [ ] Fish or Frogs

If requesting one of these species, please list the vendor below. Please contact a LAR veterinarian to discuss animal health status, animal housing location, and use of animals The BIACUC is to approve new housing areas before animal activity may commence.

_

1.B.2. [ ] Bred in-house specifically for this protocol. Complete Section G: Breeding, Ordering, or Using Pregnant Animals –(unless animals are bred under another protocol)

1.B.3. [ ] Transferred from another IU protocol: # List all activities and procedures that animals from the above protocol(s) will undergo prior to transferring them.

_

1.B.4. Is the proposed animal a wildlife species? (The population status of a wildlife species is to be considered prior to procurement.)

[ ] No[ ] Yes - Complete Section J: Field Study

1.B.5. [ ] Other, please specify: _

1.C. Transportation

1.C.1 Are animals obtained from a commercial vendor? [ ] Yes [ ] No

If No (animals are not obtained from a commercial vendor), are animals transported to IUB by a commercial animal transport service?


https://lar.indiana.edu/policies-guidelines/index.html


[ ] Yes [ ] No

If No (animals are not transported by commercial animal transport service), please explain how animals will be transported to IUB:

_

1.C.2 If animals are to be transported between buildings within the IUB campus, describe the transportation method. (Please refer to the Transportation of Animals – Guidelines for more details.

(http://researchcompliance.iu.edu/Policies/iacuc/iub/Transportation_of_Animals_Guidelines.pdf)

NOTE: Whenever possible a University-owned vehicle should be used to transport animals. The use of personal vehicles for animal transport is discouraged due to concerns with potential animal biosecurity, safety, health and liability risks for the animals, personnel and Institution. If it is necessary to use a personal vehicle, the following conditions must be met and described below:1. Provide the justification for using a private vehicle.2. The animal enclosures must be appropriately secured to prevent falling.3. Traditional laboratory animals (rodents, rabbits, etc.) should be protected from direct sunlight. 4. Closed vehicles used for animal transport must be environmentally controlled (e.g., heating, ventilation, air

conditioning).5. Plastic or a similarly impermeable material that can be sanitized should be placed under the transport cages/carriers.6. Avoid public areas when possible. When transporting through public areas, animals should be obscured from view by

drapes, shrouds, opaque secondary enclosure, a specialized transport cart or carrier, etc.

_

1.D. Husbandry, LAR-core Facility

Per the 8th edition of the Guide: Social animals should be housed in stable pairs or groups of compatible individuals unless they must be housed alone for experimental reasons or because of social incompatibility.

1.D.1. Will social animals be single-housed for more than 24 hours? [ ] Yes [ ] No [ ] N/AIf yes, provide justification, including reasons related to (1) husbandry, (2) experimental necessity, and/or (3) health, as appropriate. Include the maximum amount of time that animals will be single-housed.

_

1.D.2. Can LAR provide its standard, species-specific enrichment (e.g., Enviro Dry, Nylabones) to all animals in your study (singly-housed or group-housed)?

[ ] Yes [ ] No [ ] N/AIf no, provide justification as described in the BIACUC Policy for social housing and enrichment: http://researchcompliance.iu.edu/Policies/iacuc/iub/Social_Housing_Enrichment_Policy.pdf

_

1.D.3. If LAR staff will not have primary responsibility for daily care, please explain why and complete Section H: SOP for Investigator Maintained Animals:

_

1.D.4. Will animals be kept for 12 hours or more in any area other than a LAR-core housing facility?


http://researchcompliance.iu.edu/Policies/iacuc/iub/Social_Housing_Enrichment_Policy.pdf

http://researchcompliance.iu.edu/Policies/iacuc/iub/Transportation_of_Animals_Guidelines.pdf


[ ] Yes [ ] No

If yes, please list the location (building, room number), number of animals, and provide justification.

_

2. Rationale for Using Animal Subjects

2.A. Explain your rationale for animal use: _

2.B. Describe the characteristics that make this species appropriate for this study or class._

2.C. Justify the number of animals to be used, utilizing at least one of the methods below. [The number of animals should be the minimum number required to obtain statistically valid results.]:

Report numbers of animals needed to achieve statistical significance for activity planned; Citation of previous research that is sufficiently similar in concept and methodology to the present

proposal to make it a reasonable model for sample sizes; Derivation of animal numbers from material needs, with a clear indication as to why the specific amount

of material is needed, and why the number of animals requested is appropriate; Regulatory requirement for the particular species of animal and/or number of animals to be used; Results of a pilot study to estimate the variability in the data before performing statistical analysis.

Note: Actual numbers of animal used in individual experiments are to be included in Section 4.

_

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3. Purpose of Proposed Research Please provide a brief description of your research project in non-scientific, lay person terminology, outlining the purpose of your research and justifying the use of research animals. Include at least one sentence, explaining why the study is important to human or animal health, the advancement of knowledge, or the good of society._

Will this research involve a Pilot Project? A pilot activity is a small scale, preliminary study conducted in order to evaluate feasibility, time, cost, adverse events, and affect size (statistical variability) in an attempt to predict an appropriate sample size and improve upon the study design before performing a full scale project.



[ ] No[ ] Yes (If yes, please describe in Section 4.)


4. Description of Experimental Design and Animal Procedures Include a complete description of animal-related activities and as applicable, timeline of the proposed use of animals, beginning with the time of the animals’ arrival and up to the end of the experiment. Provide a clear understanding of what happens sequentially to each animal or group of animals. In addition to related experimental tables, SOPs, diagrams and/or pictures, include:

Acclimation period before being placed on a study (48 hours required; 3 to 5 days recommended); Potential sequence of potential events, from the time of arrival to the termination or transfer of the

animals; Description of dosing compounds and types of samples obtained (e.g., blood, CSF, tissues, etc.); Details of blood collection, tissue collection, and surgery to be obtained and included in other section of

the protocol; Include humane endpoints; and Include the final disposition of the animals at the conclusion of the study (e.g., euthanasia, transfer to

another protocol, reuse on current protocol. (Reuse may require additional IACUC review and approval.)

NOTE: Details of surgical procedures should be provided in Section A: Surgery

_

5. Use of non-pharmaceutical grade drugs, substances or compounds

Will all chemicals and substances used in animals be of pharmaceutical grade? [ ] Yes [ ] No

Note: Pharmaceutical or USP grade substances are approved by the FDA or have a chemical purity standard established by the U.S. Pharmacopeia. Please reference: http://www.usp.org/ or http://online.pheur.org/EN/entry.htm

5.A. If no, list compounds that are used on this study, which are not available in pharmaceutical grade:

_

5.B. If no, describe methods used to formulate the dose given to animals, ensuring the sterility of the non-pharmaceutical grade compounds. Refer to the BIACUC Non-pharmaceutical grade compound policy for guidance:

http://researchcompliance.iu.edu/Policies/iacuc/iub/Non_Pharmaceutical_Pharmaceutical_Grade_Compounds_in_Research_Animals.pdf

Include details such as grade, purity, sterility, acid-base balance, pyrogenicity, osmolality, stability, side effects, adverse reactions, storage, pharmacokinetics, and vehicles, which are taken into consideration because of the potential for causing pain or distress to the animal.

_




http://online.pheur.org/EN/entry.htm

http://www.usp.org/


5.C. If no, and pharmaceutical grade is available, list each nonpharmaceutical grade compound used and provide scientific justification for their use.

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6. Animal Disposition How will animals be disposed? Check [x]all that apply.

[ ] Adoption (See policy on this at: http://researchcompliance.iu.edu/Policies/iacuc/iub/Disposition_of_Animals.pdf[ ] Euthanasia (complete Section E: Euthanasia below)[ ] Return to colony[ ] Return to the wild [ ] Transfer to different project. Protocol(s) #[ ] Death is to be an endpoint. Provide scientific justification: _[ ] Perfusion (complete Sections A.1 through A.1.c)

[ ] Other (Please explain): _

NOTE: The Institutional Biosafety Committee (IBC) policy prohibits the donation of animal carcasses to outside entities. For more information on this policy, refer to: http://www.researchcompliance.iu.edu/ibc/bio_policies.html

7. Anesthesia and Surgical Activities

7.A. Is surgery to be performed? [ ] Yes [ ] No

If yes, complete Section A: Surgery, Section C: Minimization of Pain and Discomfort, and, if the surgery is survivable, provide an appropriate Post-Operative Monitoring Form (See Section I)

7.B. Are anesthetics to be administered? (Does not apply if anesthesia is used only for euthanasia. Go to Section E.)

[ ] Yes If yes, complete Section B: Anesthesia [ ] No [ ] N/A

7.C. Will animals have or experience any of the following: [ ] Yes [ ] No

A serious or experimentally-induced disease or condition, which may also include genetically modified animals of phenotypic consequences that interfere with the animals’ health and comfort;

More than momentary pain and discomfort (procedures expected to cause pain or distress in a human should also be considered painful to animals);

Food or water withheld;

Prolonged restraint, where an animal is confined or immobilized for extended periods of time;


http://www.researchcompliance.iu.edu/ibc/bio_policies.html

http://researchcompliance.iu.edu/Policies/iacuc/iub/Disposition_of_Animals.pdf


Aversive stimuli

If yes, the following sections may require completion. Consult each section for further information.

Section C: Literature Search - Minimization of Pain and Discomfort ; Section D: Experimentally Induced Disease or Condition;

7.D. Do the activities described in this protocol require the use of hazardous materials, including biological materials, chemicals, and/or radioactive substances? [ ] Yes [ ] No If yes, complete Section F: Hazardous Substances

8. Assurance That Proposed Work Does Not Unnecessarily Duplicate Previous Research

Animal welfare regulations do not allow unnecessary duplication of previous experiments.

Does the proposed research duplicate previous work?

8.a. [ ] Y - The research duplicates previous work. If yes, explain why it is scientifically necessary to replicate the experiment: : _

8.b. [ ] Y – However, this is a teaching activity involving different student groups.

8.c. [ ] N - No, it does not duplicate previous work.




ADDITIONAL SECTIONS – Check [X] each additional section(s) you are completing with this protocol application.

[ ] Section A: Surgery – Complete for either survival or non-survival surgeries.

[ ] Section B: Anesthesia – Complete if using anesthesia or analgesia for either survival or non-survival surgeries.

[ ] Section C: Literature Search - Minimization of Pain and Discomfort – Protocols using USDA-covered species that will experience a painful procedure or technique, or causes a USDA-covered animal to experience distress must include a literature search to demonstrate adherence to the three Rs and minimization of pain and distress.

[ ] Section D: Experimentally Induced Disease or Condition – Including, but not limited to, any procedure that includes more than momentary pain and discomfort, withholding food and/or fluids, prolonged restraint, aversive stimuli, or genetically modified animals with either adverse or unknown phenotypic consequences. This also includes tumor studies or conditions where animals will have serious, naturally-occurring or experimentally-induced conditions.

[ ] Section E: Euthanasia

[ ] Section F: Hazardous Substances – Complete if the proposed study uses any hazardous substances. biological agents, chemical, radioactive, or other hazardous substances.

[ ] Section G: Breeding, Ordering, or Using Pregnant Animals – Complete if ordering pregnant females OR if breeding animals under this protocol.

[ ] Section H: Standard Operating Procedure (SOP) for Investigator Maintained Animals – Complete if animal husbandry will not be provided LAR staff.

[ ] Section I: Post-Operative Monitoring and Assessment Form – If you checked Sections A (survival surgeries only), C, or D, complete this section. This applies to survival surgeries, tumor studies, or animals experiencing serious, naturally-occurring or experimentally-induced conditions. Revise as appropriate for your species and/or procedures.

[ ] Section J: Field Study – Complete if conducting a field study and/or working with wildlife.

[X] Section P: Project Personnel – Complete for ALL persons, including the Principal Investigator, working with animals under this study.




Section A :: Surgery

In compliance with federal regulations (the Animal Welfare Act and Public Health Service Policy), all survival surgery in vertebrate animals must be performed using aseptic procedures, including surgical gloves, masks, sterile instruments and aseptic techniques. Non-rodent mammalian survival surgery must be performed in an operating room used only for surgery. Refer to the BIACUC Surgery Policy: http://researchcompliance.iu.edu/Policies/iacuc/iub/Surgery_General_Policy.pdf

The proposed surgery will be (check [X] Acute/non-survival and/or Survival, as appropriate):

A.1. [ ] Acute/non-survival: The animal will remain anesthetized during the entire procedure and will be euthanized without awakening. Provide the following information and complete Section B: Anesthesia and Section E: Euthanasia

A.1.a) Location (building and room number) where surgery will be performed: _

A.1.b) Describe animal pre-operative preparation, surgical site preparation, and description of procedures to be performed:_

A.1.c) Describe the experimental endpoint:_

A.2. [ ] Survival: The animal will awaken from anesthesia. Major survival surgery is defined by the Guide for the Care and Use of Laboratory Animals as penetrating and exposing a body cavity or producing substantial impairment of physical or physiological function. Complete Section B: Anesthesia, Section C: Minimization of Pain and Discomfort and for USDA-regulated species, the Post-Operative Monitoring and Assessment Form.

Using the definitions from the current edition of the Guide*, is this procedure a major or minor surgery? (Please consult a LAR DVM, if uncertain.)

[ ] Major [ ] Minor

*Minor Surgery: Does not expose a body cavity and causes little or no physical impairment; this category includes wound suturing, peripheral vessel cannulation, and percutaneous biopsy.

*Major Surgery: Penetrates and exposes a body cavity, produces substantial impairment of physical or physiologic functions, or involves extensive tissue dissection or transection.

A.2.a) Location (Building and Room number) where surgery will be performed: _

A.2.b) Describe the surgical procedures. Include pre-operative care of the animal and aseptic preparation of the animal, surgeon, instruments and surgical site. Describe the anatomical location and approximated size of the incision site(s), placement site and size of catheters or implantable devices, all suture material and estimated duration of surgery, including a description of the closure of the surgical site:

NOTE: Silk suture is not recommended to be used to close a skin incision; however, provide justification for use of this suture for the IACUC to consider. _


http://www.nap.edu/catalog.php?record_id=12910

http://www.nap.edu/catalog.php?record_id=12910

http://researchcompliance.iu.edu/Policies/iacuc/iub/Surgery_General_Policy.pdf


A.2.c) Who will be responsible for providing post-operative care?_

A.2.d) Description of post-operative care, including supplemental heat, administration of fluids or analgesics, frequency of animal observations, and all drugs to be administered following surgery. Specify frequency of observation and drug administration in terms of timed intervals (e.g. every 6 hours, NOT 4 times a day)._

A.2.e) Describe the clinical signs that are normally expected in the animals as a result of the procedure(s) (e.g., tumors, surgical wounds, weight loss, behavioral abnormalities, illness, etc.)._

A.2.f) What post-operative complications are reasonably possible and how will they be addressed? _

A.2.g) If multiple major survival surgical procedures (MMSS) will be performed on any animal, justify why this must occur and describe the multiple surgical sequence and timing between procedures._

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Section B :: Anesthesia and Analgesia

Complete this section if anesthesia or analgesia is to be administered. Procedures that cause more than momentary or slight pain or distress to the animal must be performed with appropriate analgesia or anesthesia. The regime should be developed in consultation with an IU veterinarian. Procedures to be conducted without appropriate anesthesia must be scientifically justified.

B.1. Pre-operative regimen: State the length of withholding food and/or water and list pre-anesthetic drugs administered, including dosage and routes of administration.

_

B.2. Anesthetic regimen: Provide a listing of all induction, maintenance, and muscle relaxant drugs, including drug name, dosages, and routes of administration.

_

B.3. Analgesic drugs: Provide the drug name(s), dose(s), volume(s), routes and frequency of administration. If analgesic drugs cannot be administered, provide scientific justification for withholding them and include other measures that will be used to reduce the animal’s distress, discomfort and/or pain (e.g., bedding, heat source, special food, etc. ).

_

B.4. Procedures and methods: Describe procedures that will be used to indicate that an appropriate plane of anesthesia is being maintained. Include the frequency of monitoring the animal, the criteria that will be used to determine if administration of additional anesthetic agent is required, and how records of the anesthetic procedures are kept.



(Reference policy: Anesthesia Monitoring and Record Keeping Policy; http://researchcompliance.iu.edu/Policies/iacuc/iub/Anesthetic_Monitoring_Record_Keeping.pdf)

_

B.5. Gases: If volatile gases (e.g., isoflurane) are to be used, describe the scavenging technique (e.g., charcoal canister, snorkel, fumehood, etc.).

_



Note: IACUC-Approved Drug Formularies

LAR provides formularies (veterinary-approved lists of drug recipes, routes of administration, etc.) for mice, rats, hamsters, rabbits, fish, and birds. These formularies can be found here:

http://lar.indiana.edu/drug-formularies/


http://lar.indiana.edu/drug-formularies/


Section C :: Literature Search - Minimization of Pain and Distress in USDA-covered Animals

Every protocol that involves USDA-covered animals experiencing more than momentary pain or distress must include a literature search to ensure minimization of pain and distress in animals and demonstrate adherence to the Three Rs.

The Animal Welfare Regulations (AWA) require investigators to consider alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, providing a written narrative of the methods used and sources consulted to determine the availability of alternatives. For more information, reference the USDA Animal Care Resource, Policy 12: https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Policy%20Manual.pdf

In 1959, researchers William Russell and Rex Burch published The Principles of Humane Experimental Techniques with the objective of establishing the “…humanist possible treatment of experimental animals.” The authors proposed the principles of the 3R’s: Replacement, Reduction and Refinement. Application of the 3R’s includes:

Replacement – Methods to substitute nonliving materials or in vivo processes to achieve scientific goals. Reduction – Methods to minimize the number of animals used for a study or class. Refinement – Methods to reduce animal pain, discomfort and distress within the study or class.

Perform a literature search to determine if alternatives, especially those supporting refinement, exist.

Please cite specific sources in the table below. You must consult at least two databases. IU Libraries provide access to multiple databases via One Search: http://www.libraries.iub.edu/index.php?pageId=1697&mode=subjectId

In the search strategy, include keywords that are relevant to the procedure(s) and proposed uncomfortable or painful methods. The search may also include drugs and/or compounds administered to the animals as well as alternate experimental designs, housing/restraints modifications, etc.

C.1. REPLACEMENT : If non-vertebrate species, in vitro systems or computer simulation cannot be used, please explain why._

C.2. REDUCTION : Please explain how the number of animals requested fulfills the objective of reduction. _

C.3. REFINEMENT : Please explain methods used to minimize pain, discomfort and/or distress that animals might experience._

C.4. List keywords, which should be specific to the study or class.

_

C.4.a. Date of Search: _

C.4.b. Years Covered by Search: _

C.4.c. Databases Consulted (Two, minimum): _

C.5. Describe the potential alternatives discovered in your search. If you are rejecting any of the alternatives, provide scientific justification for doing so.

_




http://www.libraries.iub.edu/index.php?pageId=1697&mode=subjectId

https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Policy%20Manual.pdf


Section D :: Experimentally Induced Disease or Condition

A Post-Operative Monitoring and Assessment Form (See Section I) must be completed for this protocol and used by lab personnel if the animals have a serious natural or experimentally induced condition.

D.1. Describe the animal’s condition/disease and expected clinical signs. Include how the progression will be monitored and the frequency of observations. Include clinical conditions such as tumors, surgical wounds, weight loss, behavioral abnormalities, illness, etc.

D.2. Endpoint Criteria: What are the specific objective criteria or endpoints for toxicity or euthanasia? Describe the criteria and the intervention used to prevent unnecessary pain and distress. Criteria may include, but are not limited to:

Weight loss beyond a predetermined limit Pain or distress not controlled by with analgesics Loss of normal movement Loss of normal feeding or drinking behavior

Intervention may include, but is not limited to: Euthanasia Discontinuation of a procedure Removal from the study

_

D.3. What measures will be taken to alleviate or minimize pain/distress? (e.g., analgesics, other manipulations)_

D.4. If any methods/techniques listed below will be used, check the appropriate box and provide the requested details.

D.4.a) [ ] Administration of a hazardous/toxic substance: List the substance name, site of administration, volume, and frequency._

D.4.b) [ ] Prolonged restraint: Prolonged restraint is keeping an animal confined or immobilized for time periods in excess of those required for administration of treatments or routine handling procedures. Describe the restraint method, duration, frequency, and acclimatization period for the animal to the restraint device._

D.4.c) [ ] Food/water deprivation: Describe the duration, frequency, extent (total/partial), and methods that will be used to monitor and assess. _

D.4.d) [ ] Abnormal environment: temperature, humidity, light, duration, bedding changes._

D.4.e)) [ ] Aversive stimuli: type and intensity of stimulus, duration, and justification for use._

D.4.f) [ ] Tumor Development _





Section E :: Euthanasia

Consistent with the 2013 AVMA Guidelines for Euthanasia, the BIACUC requires that following euthanasia by CO2, death be confirmed through secondary method such as bilateral pneumothorax, decapitation, or cervical dislocation. Any exception to this requirement must be scientifically justified and approved by the BIACUC. (https://www.avma.org/KB/Policies/Documents/euthanasia.pdf)

E.1. Chemical Method – check[X] all that apply

[ ] Lethal injection using a commercial or laboratory prepared euthanasia solution at the recommended dosage. Specify the name, dose (mg/kg), and route of administration. *_

*Note: For non-pharmaceutical grade compounds to be used for lethal injection, please either reference relevant text in Section 5 OR cut and paste description of its preparation here.

[ ] Inhalation of anesthetic gases. Please specify agent and method of administration: _For inhalation of anesthetic gases, what scavenging technique will be used?

[ ] Charcoal filter[ ] Fume hood[ ] Snorkel system[ ] Other. Please specify: _

[ ] Inhalation of carbon dioxide (rodents, amphibians, birds). Check physical method of assurance below.

[ ] Inhalation of carbon dioxide administered by LAR staff according to the LAR SOP.

E.1.a) If euthanasia is to be induced by a chemical method without a secondary method, describe how death will be assured.

E.2. Physical Method - check[X] all that apply

[ ] Cervical dislocation

[ ] Decapitation

[ ] Bilateral pneumothorax

[ ] Exsanguination

[ ] Perfusion – Fill in Sections A.1 through A.1.c, if using perfusion.

[ ] Other:

E.2.a) If the euthanasia is to be induced by a physical method without the use of anesthetics or sedatives, provide scientific justification: _



https://www.avma.org/KB/Policies/Documents/euthanasia.pdf



SECTION F :: HAZARDOUS SUBSTANCES

Complete this section only if the project requires the use of any of the following agents in live animals, or if any of the agents may pre-exist in the species you are using. Check all agents that apply and identify the agent . Include dose, route, and frequency for treatment, post-mortem handling of animals or tissue, and any other exposure scenario for personnel.

F.1. Use of the following agents requires review by the Institutional Biosafety Committee (IBC) and/or the Biosafety Office ([email protected] ) . Reference: http://www.researchcompliance.iu.edu/ibc/bio_policies.html

If you currently have secured IBC protocol approval for your animal research study, please include the IBC protocol number here:

Check [X] and identify if using any:

[ ] Biological toxin: _[ ] Infectious agent: _[ ] Recombinant DNA: _[ ] Transplantable cell line: _

F.1.a) Level of review – check [X] all that apply[ ] BL1 [ ] BL2[ ] BL3[ ] Not yet determined

F.2. Use of the following requires Radiation Safety Training. Contact the Radiation Safety Officer at 855-3230.

[ ] Radioisotopes: _

F.3. Use of the following agents requires Chemical Safety Training. Contact EH&S 855-6311 for assistance or see http://www.ehs.indiana.edu/lab_safety.shtml. - Check [X] and identify all that apply.[ ] Carcinogens: _[ ] Controlled substances, prescription drugs, or intoxicants: _[ ] Novel substances: _[ ] Reproductive hazards: _[ ] Toxic chemicals: _

F.4. What precautions will be taken to protect personnel involved in the protocol? Describe all personal protective equipment._

F.5. Describe any special waste and/or carcass disposal requirements (carcinogen, biohazard, radiation, etc.)._




http://www.ehs.indiana.edu/lab_safety.shtml

http://www.researchcompliance.iu.edu/ibc/bio_policies.html

mailto:[email protected]


SECTION G :: BREEDING

If more than one species or strain of species is to be bred for this study, complete a separate Section G for each species/strain. If the animals for this study are bred under another protocol, then do not complete this section.

G.1. Species _ Strain _

G.2) Source of breeding stock _

G.3) Mating scheme

State the final disposition of retired breeders (males and females). _

G.4) DO NOT USE IF FILLING IN THE TABLE IN G5:

Total number of animals, including an offspring to be used experimentally, offspring that will not be used experimentally, and adult breeding pair, both experimental and non-experimental: _

Please be sure to include this number in the animal numbers table in Section 1.A.

For Mouse Breeding Only:

We must consider the impact of trio breeding on Guide-issued requirements for cage space and the potential for overcrowding. Per the most recent edition of the Guide:

Consideration of floor area alone may not be sufficient in determining adequate cage size; with some species, cage volume, and spatial arrangement may be of greater importance. Space allocations should be assessed, reviewed, and modified as necessary by the IACUC considering performance indices (e.g., health, reproduction, growth, behavior, activity, and use of space) and special needs determined by the characteristics of the animal strain or species, and experimental use.



Will a single-pair breeding scheme be used? [ ] Yes [ ] No

If 'Yes', describe this scheme and include:

the range of ages during which weaning will occur

the timing of addition and removal of males from the breeding cage

_

Will a trio or multiple-female breeding scheme be used? [ ] Yes [ ] No

If 'Yes', describe this scheme and include:

the range of ages during which weaning will occur

the timing of addition and removal of males from the breeding cage

the reason for retaining multiple female breeders in one cage

the duration of time during which multiple breeding females are kept together in a cage

_

G.5) Please complete the following Mating Scheme Table, if Section G.4 has not been filled in. Click inside the table to activate the cells.

Please be sure to include the total number in the animal numbers table in Section 1.A.

When entering breeding scheme information, be sure to double-click inside the table.



Total Number of Animals for Breeding Scheme

Genotype

100 12.5%

700

880

Enter the number of experimental animals and the approximated percentage of offspring that will be the correct genotype and sex . The estimated numbers of non-experimental animals and the total number of animals (plus 10% for strain maintenance) will be automatically calculated. The total animal number will appear at the under the protocol will appear at the bottom of the table.

Number of Experimental

Animals Required

Percent Offspring of

Correct Genotype/Sex

Number of Non-

experimental Offspring

Generated

Total Number of Animals Needed per

Strain

Indicate KO, KI, TG, or WT -

General Comments

Indicate the number of animals required

Enter approximated percentage

Auto-calculated

Auto-calculated (Total number of animals generated plus 10% for strain maintenance)

EXAMPLE: Estrogen receptor (Esr1)

KI; only female homozygous offspring fr heterozygous breeding will be used



[return to Additional Sections][return to table of contents]

SECTION H :: STANDARD OPERATING PROCEDURES FOR INVESTIGATOR-MAINTAINED ANIMALS

** Animals must be observed daily (365 days a year), including weekends and holidays **

H.1. Person(s) Responsible for Providing Animal Care: _

H.2. Room Number(s)/Building Name: _

H.3. Other Activities Conducted in This Room: _

H.4. Species (List All or Provide Separate SOP for Each): _

H.5. What type of tank, tub, or cage ("primary enclosure") is used for housing?

H.5.a) Materials and construction: _

H.5.b) Size of enclosure and maximum number of animals per enclosure: _

H.5.c) How are feed and water provided within each (bowls, on floor, special devices, etc.)? _

H.6. What methods if any are used to provide or monitor essential levels of the following environmental parameters? _

H.6.a) Temperature? _

H.6.b) Humidity? _

H.6.c) Ventilation? _

H.6.d) Illumination? _

H.6.d) Noise? _

H.6.f) Tank water quality? _

H.7. Behavioral Management

H.7.a) Structural environment: What structural features (e.g., for resting, climbing, perching, hiding) if any are added to enclosures? _

H.7.b) Social housing: Are animals housed singly or in groups; how are social groups maintained? _

H.7.c) Activity: Are animals provided any means of activity outside of enclosure? _

H.8. Food

H.8.a) Type and Source (Vendor and Manufacturer if different) _

H.8.b) Storage: Room number, refrigerated or frozen storage, type of feed container _

Note: Feed must be stored in a covered or sealed container separate from carcasses, tissues or chemicals used for research or cleaning. Containers should be labeled with contents, milling/manufacture date or expiration date if applicable.

H.8.c) Food Preparation: How and where (room # if different from housing area) is food prepared if applicable? _

H.8.d) If live feed is provided, how is it maintained or fortified with additional nutrients? _

H.8.e) How Is Food Provided (Frequency, quantity per animal or ad libitum)? _

H.8.f) Quality Control: How long are feed or supplements maintained? _



H.8.g) What other methods are used to insure adequacy of nutrients? _

H.9. Drinking Water - Source, Treatment and How Provided (Tank water for aquatic species should be described in Section H.5.)

H.9.a) Municipal (tap), well, other? _

H.9.b) Filtered, chemically treated, autoclaved, testing performed, other? _

H.9.c) Bottles, bowls, automatic watering system, other? _

H.9.d) Frequency for replacing drinking water: _

H.10. What type of bedding or substrate, if any, is used?

_

H.10.a) How often is it replaced? _

H.10.b) Where is it? _

H.11. Sanitation

H.11.a) How often is tank water changed and approximately what percentage of water is changed each time? _

H.11.b) Where is soiled bedding or substrate removed? _

H.11.c) How often is the primary enclosure (tank, tub, cage or, if animals are loose in room, entire room) cleaned (as described in section d. below)? _

H.11.d) Primary Enclosure Sanitation

H.11.d)(i) Where are enclosures and caging accessories washed? _

H.11.d)(ii) Hand washing, mechanical/machine washing, or autoclave usage? _

H.11.d)(iii) Duration of exposure to sanitizing/disinfecting agent? _

H.11.d)(iv) Is hot water or steam employed for sanitation? If so, provide temperature if measured: _

H.11.d)(v) Other procedures designed to assure removal of gross soils, disinfection of surfaces, and adequate removal of sanitizing chemicals? _

H.11.d)(vi) Cleaning/Sanitizing Agents Used: _

H.11.e) Cleaning and Disinfection of Secondary Enclosures (Room or Area Where Tanks or Cages are Held)

H.11.e)(i) Animal Room Cleaning Frequency _

H.11.e)(ii) Procedures or Methods (Equipment Used) _

H.11.e)(iii) Sanitizing Agents _

H.11.e)(iv) Support Area Cleaning _

H.11.e)(v) Sanitation of Caging Accessories _

H.11.e)(vi) Procedures and Frequency for Cleaning Feeders and Watering Devices _

H.11.e)(vii) Procedures and Frequency for Enrichment Devices or Other Structural Additions to Enclosures _

H.11.e)(viii) Soiled Bedding and Refuse: How is this handled and discarded? _



H.12. Waste disposal

H.12.a) How are animal carcasses stored or discarded? (i.e., Frozen in sealed bags and request EH&S pick-up at www.ehs.indiana.edu “Request Assistance” or other method) _

H.12.b) Hazardous (and Non-Hazardous) Chemical, Radioactive, and Biological Agents, Waste, and Sharps Disposal (Call EH&S for guidance 855-6311) including Packaging, Labeling, Disinfection (i.e. autoclave, chemical disinfection, etc.), Storage, and Separation from Animals or Feed, Disposal: _

H.13. Pest Control – describe vermin control program

_

H.14. How Is Emergency, Weekend, and Holiday Care Provided?

_

H.15. Identification and Records

_

H.15.a) Methods for identification of each species _

H.15.b) What individual or group records do you maintain for identifying animals and their sources or pedigrees? _

H.16. Breeding Colony Maintenance

H.16.a) What, if any, species, stocks or strains do you produce in-house? _

H.16.b) Describe the breeding scheme used to assure homozygosity of inbred lines or heterozygosity of outbred lines if applicable. _

H.16.c) Do you do any genetic monitoring? If so, what do you test for and how? _

H.17. Security

H.17.a) Who has access to room(s) where animals are maintained? _

H.17.b) How is area secured? _

H.17.c) How do you assure that only authorized people have access to animals under your care? _




http://www.ehs.indiana.edu/


Post-Operative Monitoring and Assessment Form

Animal assessment and scoring is to be documented daily, for a period no less than 10 to 14 days post-procedure. An exception may be granted if the scoring is 0 for 5 consecutive days.

Assessment Category Assessment Score = 0 Assessment Score = 1 Assessment Score = 2 Assessment Score = 3

Attitude and Movement Alert, freely moves about cage Less active, moves around cage only when stimulated

Will not move around cage when stimulated Lying on side

Coat and Posture Smooth coat, not hunched Hunched or ruffled fur Hunched with ruffled fur

Surgical Site Clean and not swollenClear discharge or redness or mild* swelling or occasional

scratching at surgical site

Moderate* swelling and/or redness and pus and/or persistent scratching

at surgical site and/or pressing surgical site to side or bottom of cage

Surgical site open exposing underlying subcutaneous tissues or intra-

abdominal cavity

Appetite Eating and drinking normally Weight decreased by ≤10% compared to pre-surgical weight

Weight decreased >10%, <20%, compared to pre-surgical weight

Weight decreased by ≥20% compared to pre-surgical weight

Respiratory Rate Breathing normally Increased respiratory rate Labored or difficulty breathing Respiratory distress or open mouth breathing

___________Treatment Plan (in consultation with Attending Veterinarian) Scores = 3 in any category: euthanize immediately Scores = 2 in any category: consult with vet Score = 2 for Surgical Site: Administer analgesic & consult with vet Score > 1 in Appetite: Provide easy access to food- moist crushed feed in petri dish Animals will be weighed daily for 14 days; the Attending Veterinarian will be consulted if any weight loss exceeds 10% of the pre-surgical weight

*Mild swelling: Skin around incision raised but no increased tension on sutures; Moderate swelling: Skin around incision raised causing skin tension around sutures or separation of incision

Protocol #: Animal or Animal Group ID:

TIME & DATEATTITUDE AND

MOVEMENT

COAT AND POSTURE

SURGICAL SITE APPETITERESPIRATORY

RATETOTAL SCORE INITIALS ACTION

1.

2.

3.



Protocol #: Animal or Animal Group ID:

TIME & DATEATTITUDE AND

MOVEMENT

COAT AND POSTURE

SURGICAL SITE APPETITERESPIRATORY

RATETOTAL SCORE INITIALS ACTION

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

Date surgery site healed: __________Incision is closed, no redness associated with wound, and no scabbing is present ________________________________________________________



SECTION J: FIELD STUDY DESCRIPTION

J.1. Is the species endangered? [U.S. Fish & Wildlife Service Endangered Species Database]

[ ] Yes [ ] No

J. 2. Will animal care and/or use take place in the wild or at a field site?

[ ] Yes [ ] No

If yes, describe the location(s) where the field study will be performed and/or where captive animals will be housed and used.

_

[The BIACUC recognizes that it is not always possible to predict at the initiation of field studies all potential observation or collection opportunities. PIs must inform the IACUC of new location opportunities as they develop by submitting an amendment.]

J. 2.a. If the study will take place on private land, has the landowner’s permission been obtained?

[ ] Yes [ ] No

J.3. Do you agree to obtain all the required, applicable permits before starting the study?

[ ] Yes [ ] No

J.4. Will animals be captured alive?

[ ] Yes [ ] No

J.5. Describe the method of capture and frequency of trap checks, if applicable.

J.6. If released, where will captured animals be released?

J.7. If not released, what will happen to the animals?

J.8. What precautions are taken to prevent capture of non-target species?

J.9. What is the expected injury or death rate during capture?

J.10. In the event of illness or injury to the animal during capture, how will this be addressed?

J.11. Will a telemetry unit be implanted?

[ ] Yes (Complete J.12)[ ] No


http://www.fws.gov/endangered/


J.12. For Field Studies implanting or attaching a telemetry unit:

Identify who will perform the implant/attachment and list their qualifications: _

Describe the dimensions and weight of the unit; the anatomical site; procedure for removal or likely consequence to the animal if not removed: _

J.13. Will animals be held in captivity for: More than 12 hours (AWA)? [ ] Yes [ ] No

More than 24 hours (PHS)? [ ] Yes [ ] No

J.14. If the answer is YES to either question above, please describe:

The planned duration of captivity The holding facility that you intend to use, including cage size/dimensions Equipment to be used Food/fluid strategies The maintenance for a suitable environmental condition Release procedures, if applicable

Note: A diagram or photograph of equipment and/or the housing/cages may help to clarify the description.

J.15. If applicable, describe how the animal(s) will be transported and under what conditions.

J.16. Non-Target Species: Include any non-study animals affected by this research, including those that may be captured and/or killed or disturbed. If unable to provide a specific list, then you may include a general descriptor such as “all native mammals to the specified area.” The total number may be reported when the procedure has been completed.

Non-target Species Strain Number of Animals

J.17. If IUB veterinary staff will not have primary responsibility for oversight, please describe the arrangement for veterinary medical care. Note that the Attending Veterinarian must be informed of all animal health and welfare concerns.

If no veterinary care will be needed, please explain the circumstances. For example, a field study consisting of only direct, unobtrusive observation of free-ranging animals in their natural ecosystem.

_

Please be sure to fill in Section 6, Final Animal Disposition, and indicate if animals will be released or what the final outcome will be for captive animals.



P: PERSONNEL SECTION:

INSTRUCTIONS: List ALL personnel working with animals on this study (co-investigators, postdoctoral fellows, students, research assistants, and technicians). If conducting highly technical activities (e.g., perfusion, cervical dislocation without anesthesia), please indicate personnel responsible for these activities and include their related training/experience.

PI : _

Responsibilities Check [X] all that apply.

[ ] Anesthesia [ ] Injections [ ] Surgery – survival[ ] Animal Handling [ ] Perfusion [ ] Surgery – non-survival[ ] Euthanasia [ ] Peri- or post-operative monitoring [ ] Decapitation [ ]Additional Responsibilities _

Experience: List individual’s previous training and experience using animals, including species information, identifying procedures and experience level (e.g., how many years). List where PhD was obtained, the year, and area of discipline. Include where and by whom training was provided. _

Training: Indicate who will provide current training and for which procedures. Include the qualifications of the trainer. How will skill level and/or proficiency be determined? What are the qualifications for an individual to work independently? _

BIACUC-CITI courses: https://research.iu.edu/training/citi/index.html Check [X] all that apply.

[ ] Investigators, Staff and Students, Basic Course (All personnel to complete.) [ ] IUEHS Safety & Health for Animal Users Training (All personnel to complete.)

Check species as appropriate:[ ] Working with Rats [ ] Working with Mice[ ] Working with Dogs [ ] Working with Rabbits[ ] Working with Hamsters [ ] Working with Amphibians

Training by Laboratory Animal Resources Personnel:[ ] Aseptic surgery (Required prior to participating in any surgical procedures.)

Medical Clearance to Work with animals: http://healthlinc.org/iusurvey/ - Select “Animal Researcher Survey”[ ] Medical Surveillance Questionnaire and follow-up (All personnel to complete.)

Chemical Safety Training: http://ehs.iu.edu/training/training-schedule.shtml[ ] Laboratory Safety and Chemical Hygiene Training




http://ehs.iu.edu/training/training-schedule.shtml

http://healthlinc.org/iusurvey/

https://research.iu.edu/training/citi/index.html


Name : _ Network ID: _Position : _ Dept/Program: _Responsibilities Check [X] all that apply.


Experience: List individual’s previous training and experience using animals, including species information, identifying procedures and experience level (e.g., how many years). Include where and by whom training was provided._



[ ] Investigators, Staff and Students, Basic Course (All personnel to complete.) [ ] IUEHS Safety & Health for Animal Users Training ( All personnel to complete.)



Medical Clearance to Work with animals: http://healthlinc.org/iusurvey/ - Select “Animal Researcher Survey”[ ] Medical Surveillance Questionnaire (All personnel to complete.)









Name : _ Network ID: _Position : _ Dept/Program: _Responsibilities Check [X] all that apply.


Experience: List individual’s previous training and experience using animals, including species information, identifying procedures and experience level (e.g., how many years). Include where and by whom training was provided. _



[ ] Investigators, Staff and Students, Basic Course (All personnel to complete.)

[ ] IUEHS Safety & Health for Animal Users Training (All personnel to complete.)












Name : _ Network ID: _Position : _ Dept/Program: _

Responsibilities Check [X] all that apply.[ ] Anesthesia [ ] Injections [ ] Surgery – survival[ ] Animal Handling [ ] Perfusion [ ] Surgery – non-survival[ ] Euthanasia [ ] Peri- or post-operative monitoring [ ] Decapitation [ ]Additional Responsibilities _

Experience: List individual’s previous training and experience using animals, including species information, identifying procedures and experience level (e.g., how many years). Include where and by whom training was provided._







Chemical Safety Training: http://ehs.iu.edu/training/training-schedule.shtml [ ] Laboratory Safety and Chemical Hygiene Training








Name : _ Network ID: _Position : _ Dept/Program: _

Responsibilities Check [X] all that apply.[ ] Anesthesia [ ] Injections [ ] Surgery – survival[ ] Animal Handling [ ] Perfusion [ ] Surgery – non-survival[ ] Euthanasia [ ] Peri- or post-operative monitoring [ ] Decapitation [ ]Additional Responsibilities _

Experience: List individual’s previous training and experience using animals, including species information, identifying procedures and experience level (e.g., how many years). Include where and by whom training was provided. _














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