Application to Use

ADMINISTRATIVE COVER SHEET FOR AN

APPLICATION TO USE ANIMALS IN RESEARCH, TEACHING OR TESTING

THAT INCLUDES EUTHANASIA PROCEDURES ONLY

Yale University

Institutional Animal Care and Use Committee (IACUC)

FOR OFFICE USE ONLY

IACUC PROTOCOL NUMBER: ______

IACUC Approval has been granted for the project described in this document

Original Approval Date:______

Approval Period:

______

FromTo

Please submit this form electronically as a single .pdf document to the IACUC e-mail at. (Paper submissions will not be accepted).

This application covers only procedures that involve euthanasia of an animal prior to removal of tissue or other manipulations.

CHECK ONE: New Application

3 Year Renewal - Be sure to include any modifications to procedures when completing the new application. Please provide the previously assigned IACUC protocol number:

TITLE OF PROJECT:

PRINCIPAL INVESTIGATOR (PI) INFORMATION: (If not Yale Faculty, include a Yale Faculty sponsor, see Question #4) Please indicate how you prefer to be contacted: Fax E-mail

PI Name: Department:

Work Address:

Work Phone:FAX #: Emergency phone (after hours) #:

Pager #:E-mail Address:

CONTACT PERSON FOR PAPERWORK ISSUES(if other than PI): N/A

Please indicate how person prefers to be contacted:Fax E-mail

Name: Department:

Work Address:

Work Phone: FAX #:

E-Mail Address:

YALE FACULTY SPONSOR: (required if PI is not Yale faculty):N/A

Please indicate how person prefers to be contacted:Fax E-mail

Name: Department:

Work Address:

Work Phone: FAX #:

E-Mail Address:

QUALIFICATIONS AND TRAINING OF PERSONNEL:

Please list all personnel** who will be working with or handling live vertebrate animals associated with this protocol:

**For each individual, including the PI who is listed above, download and complete a separate Qualification of Personnel Form and submit it with this protocol application. Please note, approval will not be granted without these forms. If you downloaded the New Application Pack from the Website, a Qualification of Personnel form is included.

FUNDING (Check all that apply):

Intramural Funding: (e.g. Departmental funds, personal funds, various donors/gifts, etc.) Protocols funded by the Departmentor any non-peer reviewed source require Department Chair signature (Section 11 in this application).

Extramural Funding: Please provide the following information for extramural funding that has been or is expected to be funded (e.g. fundable score, JIT, IACUC congruency approval required prior to proposal submission, etc).

AGENCY/
SPONSOR / PI OF AWARD / AGENCY AWARD NUMBER / IRES
PROPOSAL NUMBER / TITLE

OFF SITE RESEARCH (OTHER THAN VA CONNECTICUT HEALTH CARE SYSTEM):

a)Do any of the funding sources listed (question 6) involve Yale University-managed funds for the use of live vertebrate animals at a site other than Yale? YES NO

b)Please indicate the funding source(s) that will support this work:

c)Please indicate the name and location of the institution where this work will be conducted:

d)Does the offsite facility have an Animal Assurance with OLAW? YES NO

e)Is the offsite facility AAALAC Accredited?YES NO

APPLICATION TO USE
ANIMALS IN RESEARCH, TESTING OR TEACHING
FOR EUTHANASIA PROCEDURES ONLY
Yale University
Institutional Animal Care and Use Committee / OFFICE USE ONLY
Protocol Number:______
Approval Period:
______
FromTo

This application covers only procedures that involve euthanasia of an animal prior to removal of tissue or other manipulations.

PI NAME: DEPT.: WORK PHONE:

TYPE OF PROJECT (please check one): Research Teaching/training Testing

All sections of the application must be completed within the form field provided. If a specific section of this application does not apply to your project, please indicate that it is not applicable (NA). If attachments are necessary to provide a response to a specific section, the attachment must be clearly referenced under the appropriate section and the section number noted on the attachment.

SECTION 1 RELEVANCE OF RESEARCH

Provide a brief synopsis of the research or teaching project, and of its overall objectives and intended benefits to humans, animals and/or the advancement of scientific knowledge. This section should be understandable to a general reader at an 8th grade level.

SECTION 2 ANIMALS REQUESTED

Using the table below:

a) List all live vertebrate animals to be involved in this project. List separately any special strains (e.g. nude, genetically altered), pregnant animals and offspring.

b) The total number of animals should be stated for the duration of the project (a maximum of 3 years).

FYI: Animals used in euthanasia only projects are automatically placed in USDA Category C by the IACUC Office.

SCIENTIFIC & COMMON NAME / STRAIN/STOCK / SEX / AGE OR WEIGHT / TOTAL # REQUIRED

SECTION 3 JUSTIFICATION FOR THE USE OF ANIMALS

a)Provide the rationale for the use of live vertebrate animals in this research project:

b)Explain why each species was specifically chosen for the proposed project (cost of the animal should not be the sole factor for the choice):

SECTION 4 APPROPRIATENESS OF ANIMAL NUMBERS

a)Describe in detail the basis upon which the total number of animals was determined and how the number is appropriate for the goals of the project.

b)List the experimental groups (including control groups), the number of animals in each group and the dependent variable(s) to be measured. Include details of multiple time points and drug doses where applicable. Describe how the group sizes were determined.

c)A power analysis or other statistical justification should be used when appropriate. Where the number of animals required is dictated by other than statistical considerations (such as the amount of tissue needed, period of viability, etc.), justify the number of animals requested on this basis. Provide this for the duration of the project or a maximum of 3 years whichever is less.

Note:All animals involved in the project must be included in the protocol and justified. This includes not only experimental animals, but also donor animals, breeding pairs, pregnant mothers, and offspring that cannot be utilized because of genotype/phenotype, sex, etc.

SECTION 5 ANIMAL USE LOCATIONS (only provide locations where live vertebrate animals will be used or housed):

LOCATION: BUILDING / ROOM #:
Housing (if known):
Experimental Work:

a) Will the PI or laboratory staff be responsible for animal husbandry? YES NO

If “Yes,” provide information on feeding (frequency and type of food), cage type and size, and cleaning schedule, veterinary care and emergency procedures. Include in this a confirmation that a daily log will be maintained in order to comply with federal requirements that animals must be observed on a daily basis, including weekends and holidays:

b) Does the protocol call for non-standard caging (i.e. wire bottom, metabolic) to be used?

YES NO If “Yes” please indicate the length of time the animals will be housed in these non-standard cages and provide justification as to why this type of caging is necessary:

c) Does the protocol call for solitary isolation of social species (e.g. NHP, dogs)?

YES NO If “Yes” please indicate the length of time the animals will be isolated, justification for this type of housing and include plans for enhanced environmental enrichment.

SECTION 6 REQUEST FOR HOUSING EXCEPTION

Will animals be housed out of the animal facility for greater than 12 consecutive hours?

YES NO If Yes, provide the following information (please refer to the IACUC Policy on Housing of Animals Used in Teaching, Research and Training):

a)If more than one species is noted on the protocol, indicate which animal(s) will be kept out of the animal facility longer than 12 hours.

b)How long will animals be kept out of the animal facility?

c)Justify why animals need to be kept outside of the animal facility.

d)Identify the site where animals will be kept (Building/Room #).

e)How often will animals be monitored and what care will they receive?

f)Will animals be housed in cages other than those provided by YARC? If yes, please detail and describe the cages to be used.

g)If animals will be kept in the laboratory for 12 hours or longer, provide an SOP on feeding (frequency and type of food), cage type and size, and cleaning schedule, veterinary care and emergency procedures. Include confirmation that a daily log will be maintained in order to comply with federal requirements that animals must be observed on a daily basis including weekends and holidays.

SECTION 7 DISPOSITION of Animals at End of Project/EUTHANASIA

Will YARC or VCS be performing euthanasia for any animals involved in this protocol according to an IACUC approved SOP (Refer to the IACUC approved SOP forVeterinary Clinical ServicesEuthanasia or contact Regulatory & Safety Services at to be sure): YES NO

A Yes answer with no additional information in this section will be interpreted as YARC or VCS performing all euthanasia.

If your laboratory will be performing euthanasia independently or in addition to YARC or VCS, please describe in detail the euthanasia procedures (physical or chemical) to be used for each species. State whether the method(s) used is consistent with the recommendations of the AVMA (American Veterinary Medical Association) Guidelines on Euthanasia. If not, present a justification for deviating from the recommendations.

If chemical agents will be used for euthanasia, please complete the table below.

AGENT / DOSE (mg/kg body weight) / ROUTE / SPECIES

Physical methods such as cervical dislocation and decapitationin the absence of anesthesia are not considered an acceptable means of euthanasia, unless required for the scientific goals of the project and should be completely justified below:

Regardless of the method used, please indicate how death will be confirmed. Choose one of the following:

Rigormortis (occurs in 10 minutes)

Removing vital organ

Create pneumothorax

Absence of cardiovascular function

Other (Please describe):

Note: Expired drugs should not be used in live vertebrate animals. Use of selected expired drugs in non-survival procedures may be acceptable with prior IACUC approval. Only medical grade drugs should be used unless they are unavailable, or scientific justification is provided for use of non-medical grade drugs. Controlled drugs must be secured and logged appropriately. Registration and licensing from the State of Connecticut Department of Consumer Protection (860-566-4490) and the United States Department of Justice Drug Enforcement Administration is required for their use. EHS has fact sheets available for distribution, if needed call 785-3550.

The use of ether is generally prohibited. If ether as an anesthetic is required, justification for its use must be provided and a “Request to Use Hazardous Agents” form must also be completed.

SECTION 8 HAZARDOUS AGENTS (i.e. Radioactive Substances, Radiation Devices such as Irradiators or X-ray Producing Equipment, Lasers, Hazardous Biological Agents (including tissue of human origin and all Biosafety Level 2 and above agents), Biological Toxins, Toxic Chemicals (LD50<50 mg/kg), Mutagens, Carcinogens , Reproductive Toxins, and Ether.

Will hazardous agents be used in vivo as part of the animal protocol? YES NO IfYes, please attach aRequest to Use Hazardous Agents form.

Reminder: the use of hazardous agents in animals may only be initiated after approval from IACUC/OHS, YARC, and Environmental Health & Safety (EHS).

SECTION 9 RECOMBINANT DNA

Will project involve the creation of transgenic rodents? NO YES (If yes, complete A thru D below)

Will your rodents be made by the Yale Transgenic Mouse Service or other entity, or purchased from a company (i.e. you supply the inserted gene or purchase an animal containing the gene)?

NO YES

If Yes, your transgenic rodent experiments are exempt from rDNA registration.

Will your experiments involve the creation of your own BSL-1 transgenic or knock-out rodents?

NO YES; if yes, please complete the following:

Host Species: ______

Inserted DNA:______

Method of DNA Insertion:______

* Biosafety Level 1 transgenic animal experiments (NIH rDNA Guideline Section III-E) such as electroporation, direct inoculation into an embryo, and other methods that do not involve biohazards may be initiated once this form has been completed and you have received formal Yale IACUC authorization.

Will your experiments involve the creation of transgenic animals other than rodents?

NO YES

If Yes, please complete a Yale Biological Safety Committee Registration of Recombinant DNA Experiments form (available at: If you have already completed a Registration of Recombinant DNA Experiments form, what is your rDNA registration number: ______

Will your rDNA animal experiments involve the use of a biohazard, such as an oncogene, human or animal pathogen, or the use of a defective pathogen vector?

NO YES

SECTION 11 DEPARTMENTAL APPROVAL Required only if the animals will be used in teaching or training or if the animal research will be supported by departmental or non peer-reviewed funding. The Department Chair must read the protocol and sign below indicating department approval before IACUC approval may be granted. Note: If the Department Chair is also an investigator on the protocol, this approval must be obtained from the next highest level of administrative authority not involved in the project.

“I have read the Application to Use Animals, and find this research to be appropriate in design and that the investigator (or faculty sponsor) is competent to perform (or supervise) this study. My signature below denotes departmental approval of this study as submitted.”

______

Typed NameSignatureDate Signed

Department ChairDepartment Chair

INVESTIGATOR’S ASSURANCE

For the Application to Use Animals in Research, Teaching, or Testing

That Includes Euthanasia Procedures Only

Yale University

Institutional Animal Care and Use Committee (IACUC)

By virtue of submitting this application I, the Primary Investigator, ensure the following:

I agree to abide by PHS policy, USDA Regulations, the National Research Council Guide for the Care and Use of Laboratory Animals, all federal regulations, and policies of Yale University governing the use of animals in research, teaching and testing.

I will permit emergency veterinary intervention, even if it could compromise my experiments, for animals showing evidence of pain or illness not addressed specifically in the approved protocol, in addition to appropriate veterinary care as prescribed for individual species. I understand that it is my responsibility to provide current and updated emergency contact information if veterinary intervention will compromise my experiments.

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 animal handling, procedural techniques, administration of anesthesia, analgesia and euthanasia to be used in this project, and all are aware of the hazards involving the use of live animals and tissues. Personnel will be allowed adequate time to obtain training necessary for this project.

I ensure that copies of the approved protocol will be made available to all laboratory personnel.

I assure that all personnel, including myself will follow the recommendations of the University’s Occupational Health Program.

I certify that the information provided within this application is accurate to the best of my knowledge. 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 animal use in such funding proposal is identical in principle to that contained in this application.

I certify that all personnel in this project will attend the mandatory IACUC/YARC Orientation.

I am aware that the use of hazardous agents in animals may only be initiatedafter approval from IACUC/OHS, YARC, and Environmental Health & Safety (EHS).

FOR PROJECTS INVOLVING DOGS OR NON-HUMAN PRIMATES:

I am aware that an institutional plan for exercise of dogs is required by USDA standards (9CFR Part 3, Subparts A and D). I will consult with the attending veterinarian during the planning of these activities.

I am aware that an institutional plan for the psychological well being of non-human primates is required by USDA standards (9CFR Part 3, Subparts A and D). I will consult with the attending veterinarian during the planning of these activities.

CONSIDERATION OF UNNECESSARY DUPLICATION:

I certify that I have consulted the following sources and, to the best of my knowledge, the experiments described in this protocol do not unnecessarily duplicate previous experiments or unnecessarily use animals (check all applicable sources):

National Agricultural Library Library of Congress Medline

Other (Please specify):

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Application to Use Animals in Research, Teaching or Testing that includes EUTHANASIA ONLY

Rev. 12/1/10 IACUC Office