Date Approved__________ Animal Research Protocol

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A.

B.

Date Approved__________

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Animal Research Protocol #_____________

University of the Sciences in Philadelphia

ANIMAL RESEARCH PROTOCOL FORM

(Please Type your responses in

BOLD

12-point font)

Project Title:

Principal Investigator:

Department:

Building and office number:

Office Phone: EMERGENCY Phone:

C.

Location of Research Lab where animal work will be carried out:

This protocol is:

Circle/Bold one - 1. New 2. Revised Protocol #

D. List all personnel using animals in this project (principal investigator, co-investigators, graduate students, technicians, under-graduate students). List their experience and/or training using laboratory animals:

Name Title Experience/training using animals and the techniques involved in the protocol

Office phone

Emergency #

E. Estimated dates protocol will be in effect (no more than 3 years).

From: To:

F. Per AAALAC's recommendation – IF APPLICABLE: attach section of grant that deals

with the planned use of animals and, justification for the use of vertebrate animals, to this

protocol (ex. use section 2F of NIH grant). Even with the submission of the grant pages,

you must continue to complete the rest of this protocol form in detail.

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G. All animals to be used in this project.

1.

2.

3.

4.

5.

6.

Species and Strain:

Number (for the entire project):

Sex:

Weight/Age:

Duration of Stay:

Vendor:

Special maintenance requirements:

H. Describe in LAY TERMINOLOGY the overall purpose of this project. (Attach separate pages if necessary)

1. In clear language, justify the USE of animals.

2. Justify the CHOICE of SPECIES.

I.

3. Justify the NUMBER of animals.

In LAY TERMINOLOGY, describe your protocol in detail and sequence of events (attach a separate sheet as necessary).

Are there alternatives to the use of live animals? (check one): ______ YES

_____NO

Please describe what alternatives exist and were considered instead of live animals.

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1.

2.

What reasons did you have for rejecting them? If specific references support your reasons for rejection, please include them here.

If specific alternatives to live animal use do not exist, this should be stated and justified appropriately.

K. Enter the total number of animals in the categories that best describe your proposed animal experiments.

NO PAIN (C) PAIN & DRUGS (D)

Animals will not experience pain or distress for which pain relieving drugs would be given

Animals might experience pain or distress in which tranquilizers, analgesics, or anesthesia will be used. in human or veterinary medicine.

# Animals: # Animals:

PAIN - NO DRUGS (E)

Animals might experience pain or distress in which tranquilizers, analgesics, or anesthetics CANNOT be used due to study complications.

# Animals:

1. Are animals listed in category D? _______Yes _______No

If you answered yes, give the following information and also answer section K.c. below: a. Tranquilizer:

Event/Procedure:

Number of Animals:

Dose:

Route:

How will its effect be monitored? b. Analgesic (mg/kg):

Event/Procedure:

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2.

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Number of animals:

Dose:

Route:

How will its effect be monitored? c. Anesthesia (mg/kg):

Event/Procedure:

Number of Animals:

Dose:

Route:

Maximum duration of anesthesia:

How will the depth of anesthesia be measured?

What indicators will be used to provide supplemental doses?

Are animals listed in category E? _______Yes ________No

If you answered yes, give the number of animals and justify why pain-relieving drugs cannot be used. Also answer section K.c. below.

3. A LITERATURE SEARCH MUST BE COMPLETED for animals listed under

USDA categories D or E. Search for an alternative procedure; we must provide proof that a painful or distressful procedure cannot be eliminated. ALSO, if the painful or distressful procedure cannot be eliminated, a refinement to the technique being used must be searched for.

Date Search Conducted: ________________________________________

Application Procedure: ________________________________________

Databases Searched: ___________________________________________

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Range of Years Searched: ______________________________________

Keywords used: ______________________________________________

Specify the following information: L.

1. Will radioisotopes be used

In-Vivo

? Yes ( ) No ( )

Specify Isotope:

Specific Activity:

In Vivo Only

Dose:

Route:

Frequency:

Species:

Method of carcass disposal:

Method of waste disposal:

Precautions:

Approval of Radiation Safety Officer ______________________________

(Signature required with protocol submission)

2. Will infectious agents be use

In-Vivo

? Yes ( ) No ( )

Specify Organism:

Dose:

Route:

Frequency:

Species:

Method of carcass disposal:

Method of waste disposal:

Precautions:

Approval of Biohazards Control Officer_____________________________

(Signature required with protocol submission)

3. Will carcinogenic agents be used

In-Vivo

? Yes( ) No ( )

(defined by National Toxicology Program or IARC)

Specify Agent:

Dose:

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Route:

Frequency:

Species of animal:

Method of carcass disposal:

Method of waste disposal:

Precautions:

Approval of Hazardous Materials Officer ____________________________

(Signature required with protocol submission)

4. Will toxic agents be used

In-Vivo

? Yes ( ) No ( )

Specify Agent:

Dose:

Route:

Frequency:

Species of animal:

Method of carcass disposal:

Method of waste disposal:

Precautions:

Approval of Hazardous Materials Officer _______________________________

(Signature required with protocol submission)

5. Will human tissues or fluids be used

In Vivo

? Yes ( ) No ( )

Specify tissue or fluid:

Method of carcass disposal:

Method of waste disposal:

Precautions:

IRB Approval Date and Number:

(Attach a copy of the IRB Approval Letter)

Approval of Safety Officer:

(Signature required with submission)

M. Will controlled substances be used In-Vivo? Yes ( ) No ( )

Substance:

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N. Euthanasia Method:

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The Animal Care Committee follows the guidelines established by the American

Veterinary Association Panel on Euthanasia. Copies of this document are available from the Vivarium supervisor (x 8975).

O.

Method of Euthanasia:

Survival surgery: Will you be performing SURVIVAL surgery?

__________Yes ___________No

If you answered yes, please answer all of the questions below. Attach additional pages if necessary.

1. Describe all surgical procedures, including antibiotics and any other drugs to be used (list anesthesia and analgesics under section K.a.1, 2, and 3). Note:

Paralytic agents may not be used without the concurrent use of anesthetic.

2.

3.

4.

Describe the aseptic technique to be used by the surgeon.

State the steps taken to prepare the animal for surgery.

State the room number where surgery is to take place. Describe the location for the surgery. Describe the techniques used to disinfect the location of the surgery and to sterilize all instruments.

5. Describe the immediate and long-range post-operative care for animals undergoing survival surgery. Include arrangements for outside of working hours, holidays, and weekends.

Non-survival surgery: Will you be performing NON-SURVIVAL surgery?

____________Yes ____________No

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If you answered yes, please answer the following questions. Attach separate pages if necessary.

1.

Describe the surgical procedure in detail including all anesthetics and analgesics that are used. (Make sure to include the anesthetics and analgesics in section K.a.1,2, and

3)

2.

State the room number where the surgery is performed. Describe the location of the surgery and the steps taken to disinfect the location and all instruments.

3.

Describe the aseptic technique to be used by the surgeon.

4.

State the steps taken to prepare the animal for surgery.

Feed and/or Water Restriction: Will you be water and/or feed restricting your animals?

___________Yes ___________No

If you answered yes, please provide greater details involving the need to feed/water restrict the animals.

1.

Scientific justification:

2.

Length of the restriction period:

3. How are the animals monitored during the restriction?

4.

How are you ensuring the animals receive proper hydration/ nutrition during the restriction:

5.

What criteria is used to remove animals from the study early should you find they are not receiving proper nutrition/ hydration:

Prolonged Restraint: Will you need to restrain your animals for a prolonged period of time (description is below)? _____________Yes ____________No

If you answered yes, please provide greater details for special restraint devices used or prolonged restraint that is not for routine physical exams or blood withdrawal.

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1.

Scientific justification:

2.

Restraint device to be used:

3.

How are the animals acclimated to the restrainer:

4.

How long is the acclimation period:

5.

How are the animals monitored during the entire restraint period:

S. Describe any painful procedures, methods of restraint or natural/experimental diseases that may result in acute or chronic discomfort, distress or pain to the animals.

I certify that I will humanely treat all animals that are being used in my experimental protocol.

FUTHERMORE, I will follow and ensure conformity to the NIH Guidelines, Standard Operating

Procedures of the Vivarium, and the Animal Welfare Act. I also certify that this protocol does not unnecessarily duplicate previous experiments.

________________________________________________

Principal Investigator Date

Animal Research Protocol Reviewed and Approved By:

______________________________

Chairperson, Animal Care Committee/Date

______________________________

Consulting Veterinarian/Date

_____________________________

Vivarium Supervisor/Date

_____________________________

Animal Care Committee Member/Date

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