Form Version: March 18, 2016

Drexel UniversityInstitutional Animal Care and Use Committee

Application to Use Animals in Research and Teaching (Form must be typed for submission)

Assurance # A3222-01 USDA Registration # 23R-0180Please see application instructions for more information on completing this form.

1. Title of Your IACUC Study

2. Financial Sponsor of the Study

3. Principal Investigator (must be faculty, postdoctoral fellow, medical/dental resident or visiting scientist)

3a. Name

3b. Academic Rank

3c. Department

3d. Mail Stop or Address

3e. Work Phone

3f. Home Phone

3g. Cell Phone Number

3h. E-mail Address

4. Faculty Sponsor (for postdoctoral fellow, medical/dental resident or visiting scientist)

4a. Name of Faculty Sponsor

4b. Academic Rank

4c. Department

4d. Mail Stop or Address

4e. Work Phone Number

5. Responsible Persons authorized to make research decisions in the absence of the principal investigator (if none, enter none in the Name column)

Name Work Phone NumberAfter Business-hours Phone

Number

6. Review Status of Protocol (please check a, b, or c)

6a. Completely new protocol6b. Re-submission due to three completed years of the study

If 6b is yes – Protocol Number:

6c. This protocol is exactly same as the protocol # shown, except for a change of sponsor

and/or title. (For any other minor changes, you must submit an explanatory memo to the IACUC chairperson)If Question 6c is yes:

Protocol Number

Sponsor changed to / from

Title changed to / fromPI or Faculty Sponsor SignatureDate

If 6c is yes, you do NOT need to complete the rest of this form

7. Approval Period: Check the number of years from the approval date that you want this protocol active

One year Two years Three yearsNote: The approval date will be assigned as the date of the IACUC meeting the protocol was approved

8. Non Scientific Summary: In language understandable to a high school senior, briefly describe the goals and significance of this study (this should be similar to language used in a news article in USA Today).8a.Goals

8b.Significance

8c.Provide a simple chronological outline or what will happen to the animals in this study. Do not give details; use a flow chart if necessary (e.g. animals arrive, so many days later surgery takes place, so many days after surgery they are euthanized).

8d.If this protocol is a renewal, provide a brief summary of the animal experiments conducted on this protocol since it was last approved.

9. Animal model:

9a.Why is it necessary to use laboratory animals rather than in vitro methods, human studies, computer models or other methods?

9b.Why is the animal species you have chosen most appropriate for your study?

10. Number of Animals Requested: Please list below the total number of each species to be used in your study for a three year

period.Species Name (e.g. rat)Strain/Stock (e.g. Tac: N(SD) fBR)Number to be purchasedNumber resulting from in house births (including fetuses > Embryonic day 16 )Number being transferred from another studyNumber studied or collected in fieldTotal number of animalsAge or weightHousing site (Center City, Queen Lane, Calhoun)Usage Site (Building & Room #)

Use table below if more space is neededSpecies Name (e.g. rat)Strain/Stock (e.g. Tac: N(SD) fBR)Number to be purchasedNumber resulting from in house births (including fetuses > Embryonic day 16 )Number being transferred from another studyNumber studied or collected in fieldTotal number of animalsAge or weightHousing site (Center City, Queen Lane, Calhoun)Usage Site (Building & Room #)

11. Justification of Animal Numbers: Justify why you need the number of animals listed in question 10. Show the experimental groups to be used in your study and the number of animals in each group. In your justification, use power analyses, previous publications of similar work, or other means. IMPORTANT: You must justify all animals in the study, including those used for breeding and those unused. Please be sure that the numbers of animals requested in 10, justified in 11, classified in 18 (total across the 3 categories), and euthanized or otherwise disposed of in 25 are the exact same total.

12. Maximum Number of Cages: What is the maximum number of cages you anticipate using for each species at any one time?

13. Special Care for Animals: Will your research or the genetic composition of the animal lead to a condition that requires special care, such as a barrier housing, special diet, food or water restriction, limitation of environmental enrichment, or single housing of social species? If yes to any of these, check yes, and answer the sub-questions. Otherwise check no and go on to item 14.

Yes No

a. Who will provide this care?

b. In the space below, describe the care required. In addition, if deprivation and/or restrictions of ad libitum food or water is required, describe the duration, extent, and the reason for the reduction, as well as the monitoring methods used to insure the well-being of the animal.

c. If your protocol precludes the use of environmental enrichment, justify the reason(s) for the exclusion. NOTE: According to the Guide for the Care and Use of Laboratory Animals (NRC 2011) animals should be provided with environmental enrichment that promotes the expression of species-typical behaviors and psychological well-being through physical exercise, manipulative activities and cognitive challenges. For further information, see the IACUC Policy for Animal Enrichment.

d. Will any portion of the protocol require that animals be singly housed? If yes, provide a rationale as to why this is required. NOTE: This does not apply to temporary single housing following surgery during the immediate post-operative period. (According to the Guide for the Care and Use of Laboratory Animals (NRC 2011) single housing of social species should be the exception and justified based on experimental requirements.)

14. Non-ULAR Facilities and Animal Transportation:a. Will any animals be kept out of the ULAR facility for more than

12 hours? Yes No

If yes, provide scientific justification for that need in the space below.

b. Will you be transporting live animals between buildings for any reason? Yes No

If yes, indicate where (to / from), how and why transport will occur. Note that ULAR must be notified prior to transport and approve the animal transportation conditions. See Policy for Transport of Animals.

15. Second Use of Animals: Have any of the animals to be used in your study been used for Ye No

any other research or teaching protocol (other than breeding) within or outside of this s

university?If yes, in the space below please explain and justify why they will be used again.

16. Animal RestraintWill any animal be kept awake and restrained for more than 60 minute?

Yes No

If yes describe and justify. See Policy for Transport of Animals for more information.

a. Justification

b. How long will the animal(s) need the special procedures?

c. Describe the special conditions / procedures needed:

17. Pain Relief: Complete the table below for any anesthetic, analgesic, tranquilizer or neuromuscular blocking drugs used

Species

Experimental group

Drug Name (generic)

Induction Dose (mg/kg, %gas)Maintenance Dose (mg/kg,

%gas)Frequency of use (e.g. every 4

hours)Route of Administration

VolumeIf the volume is a dilution,

please enter the dilution factor and the diluent.

a. Will you be using a volatile anesthetic agent? Yes No

If yes, in the space below please describe the precautions you will take to scavenge waste anesthetic gases.

b. Indicate the method you will use to ensure that the animals are properly anesthetizedToe Pinch

Palpebral Reflex

Reaction to Incision

Blood Pressure

Other Please describe:

c. Will you be using neuromuscular blocking drugs Yes No

If yes, in the space below please justify their use and explain how you will ensure that the animals are adequately anesthetized and not just paralyzed.

18. Pain or Distress:a. Would any surgical or nonsurgical procedures described in this

protocol, if performed without anesthesia, analgesia, or tranquilization, cause more than momentary or slight pain or distress?

Yes No

b. Complete the following table regardless of answer to 18.a.. Please see IACUC Policy Assigning Pain and Distress Categories on IACUC Protocols for assistance.

Category C(former Drexel A)

No Pain or Distress

Category D(former Drexel B)

Pain or Distress will be alleviated by drugs or other

means

Category E(former Drexel C)Pain or Distress will

not be alleviatedSpecies

Number of animalsHow long after the procedure will relief be needed?

c. If there will be intentionally unalleviated pain or distress, please provide in the space below scientific justification why this is necessary for your research.

d. If you indicated that you will be alleviating pain or distress, when will this occur?When first noticed

Before surgery begins

Immediately after surgery

Before surgery ends

Other

Please specify:

e. If applicable, please describe your protocol for monitoring the pain, distress, health, and well-being of your animals.

i. Monitoring method

ii. Frequency

iii. Criteria for removing animals from study

iv. disposition of removed animals

v. Responsible individual

19. Search for Alternatives to Procedures which may cause Pain and Distress

If you have indicated that animals in your study will experience pain or distress, even if it will be fully alleviated, indicate which source for alternatives you used and fill in the requested information for each.

Used Source Date of Search

Years Covered by

Search Keywords usedAGRICOLA Data Base (National Agricultural Library)

MEDLINE Data Base

CAB Abstracts Data Base

TOXLINE Data Base

BIOSIS Data Base

ATLA (Alternatives to Laboratory Animals, Journal) Issues Used:

Animal Welfare Information Center (Tel. 301-504-6212)

State information requested from AWIC:

Direct contact with colleagues or other sources

Indicate the source and substance of the information:

Results of Search:

I have considered alternatives to the use of animals in my study. In addition, I have also considered alternatives to procedures that might cause more than momentary pain or distress, and I have not found any such alternatives. I have used the above methods and sources to search for alternatives.

Initials: Date:

20. Other Agents used during your research (excluding antigens for antibody production, anesthetics, analgesics, tranquilizers, and neuromuscular blocking drugs)

a. List any drug, cell line or vehicle used in this study (do not include antigens for antibody production, anesthetics, analgesics, tranquilizers or neuromuscular blocking drugs)Species/StrainExperimental GroupDrug, cell line or vehicle name (generic)Vehicle (for research agents only)Dose (ml/Kg or mg/kg)Frequency and length of administration (e.g. 2x per day for 4 days)Route of AdministrationVolume used (if appropriate)Procedure (e.g. surgery, label)

Use spaces below if extra space is needed (e.g., more than four agents are used)Species/Strain

Experimental GroupDrug, cell line or vehicle name (generic)Vehicle (for research agents only)Dose (ml/Kg or mg/kg)Frequency and length of administration (e.g. 2x per day for 4 days)Route of AdministrationVolume used (if appropriate)Procedure (e.g. surgery, label)

b. Are there any known adverse effects of the agents listed at the dose level and frequency used in this study? Yes No

If yes, in the space below describe the adverse effects and include possible treatment or why a treatment cannot be used.

c. Will non-pharmaceutical grade medication such as antibiotics, anesthetics, analgesics or experimental compounds be used in protocol activity?

Yes No

If yes, indicate the type of medication, justify usage and describe how the medication will be prepared, sterilized, labeled with expiration date, and stored. For further information, see the IACUC Policy for use of Non-Pharmaceutical Grade Drugs – Cocktails.

21. Non-Surgical Procedures:a. Will any animal undergo a nonsurgical procedure? Yes No

If yes, in the space below describe your nonsurgical procedures in a stepwise fashion.

b. Will a breeding colony be maintained? Yes No

If yes, describe the reason for maintaining a breeding colony. Discuss the breeding scheme, weaning age, duration for which animal will be used for breeding, etc. Describe the genetic monitoring program. Indicate how samples are collected for genotype determination. Indicate method of individual animal identification. The Guide for the Care and Use of Laboratory Animals (NRC2011) space recommendations allow for one male and one female with a litter to be maintained in a standard shoebox mouse cage. If you plan to utilize trio breeding, provide justification for this increased density including management techniques which will allow pups to develop to weaning without any detrimental effects for the mother or litters. See the IACUC Breeding Policy for more information.

c. Will you be obtaining blood samples (other than during terminal procedures)? Yes No

If yes, complete the following table:Experimental Group Amount of Blood

Removed Sampling Frequency

Sampling Site

Method(e.g., I.V., post-orbital

(ml) bleeding, etc.)

22. Survival Surgerya. Will survival surgery be conducted on any animals? Yes No

If yes, complete the table below, and answer all other questions that pertain to survival surgery.

Species/Strain # having only one survival surgery

# having more than one survival surgery

Building Room Group Identification

If more than one survival surgical procedure on the same animal is performed, provide scientific justification below:

b. Describe the aseptic technique you will follow:i. How will the animal be prepared for aseptic surgery?

ii. What procedures will the surgeon use to prepare himself/herself for aseptic surgery?

iii. How will the instruments be prepared for aseptic surgery? (Sterile instruments must be used for each animal).

c. Survival surgery description:Describe the major steps in your survival surgical procedure. Indicate which group will undergo survival surgery. Remember to indicate the site of the incision, major intraoperative steps and how the incision will be closed. Describe how inter-operative recordkeeping will be recorded.

How will the animal’s body temperature be maintained during surgery?

23. Postoperative and Postanesthesia Care

Answer these questions only if an animal will undergo survival surgery or general anesthesia for any survival purpose. (NOTE: In addition to completing this form, the IACUC requires that you complete Surgical and Postoperative Care forms for all survival surgery. Sample forms are available in every Drexel aseptic surgical suite and in the University Laboratory Animal Resources office.)a. Where will the animal be kept (room/building) until it recovers from anesthesia? (NOTE:

Recovery implies that the animal is awake enough to maintain sternal recumbency.)

b. How often will the animal be observed until it recovers?

c. Who will observe the animal until it recovers? [Supply name(s)]

d. How will postoperative/post-anesthesia body temperature be maintained?

e. If the animal will not be kept in its own cage until fully recovered, explain why.

f. If skin sutures or clips are used, when will they be removed? (Note: Do not use absorbable sutures for skin closure unless they are subcutaneous).

g. Describe procedures and information included in post-operative monitoring records.

24. Non-survival Surgery:a. Will any animals undergo nonsurvival surgery? Yes No

If yes, please complete the table below.

Species / StrainQuanti

ty# of previous

surgeries Group Identifier

Location(Campus and Room

#)

b. Briefly describe your non-survival surgical procedure.

25. Disposition of Animalsa. Will you euthanize animals for any reason? Yes No

If yes, please complete the table below.

Species / StrainNumber to be euthanizedPrimary procedure (e.g., overdose, cervical dislocation)Dose (mg/kg or % gas)Agent (generic name)Route of administrationVolume (ml or ml/kg)

Drexel University has a “double kill” policy. Please describe your second procedure.

b. Will you perform cervical dislocation or decapitation without anesthesia? Yes No

If yes, provide scientific justification in the space below.

For animals euthanized by decapitation, indicate the type of instrument used (e.g., guillotine, scissors) and indicate the frequency at which instruments are sharpened. (Note: records of sharpening should be maintained.)

c. No euthanasia of animals: Complete the following table for animals that will not be euthanized during or at the conclusion of your study.Species / Strain Number not Euthanized Group Identification Disposition

d. The progressive deterioration of an animal’s health leading to its death is not considered an appropriate endpoint for an experiment. In the space below, provide scientific justification if such death is to be used as an endpoint.

e. Number inconsistencies are among the most frequent problems in IACUC protocols. Confirm that you have verified that the number being euthanized or disposed of

Confirmed:

(in item 25) includes all the animals (used or unused, whether bred, ordered, or transferred in) and is the same as the total number in items 10, 11, and 18?

26. Genetic Alterations:a. Is there any change in the animals’ genome that may result in

an adverse effect on the animal? Yes No

If yes, please describe the adverse effect in the space below.

27. Safety:Prior to beginning experimentation with animals administered biohazards, investigators will notify ULAR staff.a. Will hazardous agents (agents requiring University Biosafety

Committee review) be used with or administered to the animals?

Yes No

If yes, please describe in the space below:

What is the University Biosafety Committee approval status?

Application submitted, approval

pendingApproval received

b. Will radioactive materials be used with or administered to the animals? Yes No

What is the Radiation Safety Committee approval status?

Application submitted, approval

pendingApproval received

c. Will x-rays imaging (radiographs, fluoroscopy, CT, etc.) be performed on the animals? Yes No

If yes, please describe in the space below, including x-ray equipment to be used and who will operate it:

28. Microbial Status:Will you be using cells, cell extracts, tissues, or nonsterile biological fluids from any source that will be introduced into animals?

Yes No

If no, skip to question 29.

a. Source of cells, cell extracts, tissues, or non-sterile biologic fluids (human or indicate species):

b. The microbial status of my cells, cell extract, tissues, or nonsterile biological fluids is:

c. The microbial status was determined on (date):d. The method used for determination was:

29. Personnel Experience, Training and Occupational Health Certification:a. Please complete the following table by listing the certification dates for you and your staff.

Also remember that the IACUC must be notified of ANY change in personnel or procedures.

Name

CITIBase

Module

CITIAseptic Surgery

CITI Reducing Pain &

Distress in Laboratory Mice

& Rats

CITISpecies Module

ULARSpecies Specific Training

Occupational Health(Annual Physical)

If species specific training has been completed, please attach the species specific certification form for all individuals listed in 29a.

b. In the table below describe the responsibilities and experience each person has with the animal research techniques to be performed in THIS study.

Name Responsibilities Experience Pertinent to the Proposed Study

c. People will be trained in your research techniques using:

Euthanized Animals Yes No

Live Animal Yes No

Model Animal Yes No

30. Assurance Statement:

I certify that I have provided an accurate description of the animal care and use to be followed in the proposed research or teaching activity; that I will notify the Institutional Animal Care and Use Committee (IACUC) in writing of any changes in this protocol and will await IACUC approval before proceeding with animal research/teaching. I understand that failure to report to the IACUC changes in this protocol may place the institution and investigator in violation of Federal and University regulations.

I certify that I will abide by the provisions of the Public Health Service's Guide for the Care and Use of Laboratory Animals (most recent version), all federal, state and local laws and regulations, and any institutional policies regarding the use of animals in teaching and research. I assume full responsibility for compliance with such regulations for all personnel involved with this protocol.

I certify that this protocol does not unnecessarily duplicate previous experiments.

Principal Investigator’s Signature Date:

Faculty Sponsor’s Signature Date: