Instructions for an Animal Research Or Training Protocol Application

Instructions for an Animal Research or Training Protocol Application

All investigators must meet the legal requirements of the Federal Animal Welfare Act of 1996, as amended to the present. In addition, investigators must comply with Public Health Policy Public Law 99-158 and the Guide for the Care and Use of Laboratory Animals (NIH Publication 86-23. The investigators and the IACUC must observe all applicable laws of the United States Department of Agriculture (USDA).

Handwritten submissions of a protocol shall not be accepted by the IACUC. Recommendation is made to submit one copy of the protocol to the Chairman of the IACUC, Dr. Arthur Freed (X 28742) in the Institutional Review Board office for a preliminary administrative review. The veterinarian will then review the submission from a veterinary medicine perspective. You will be advised of any changes recommended to improve the submission for full member IACUC review. After the administrative and veterinary review (with recommended changes) is performed, re-submit the application with five copies to the chairman. These will be distributed among IACUC members for their study and vote at the next scheduled meeting.

The hospital veterinarian, Dr. Irvin Herling is available on beeper 443-865-1202 for assistance in the preparation of a protocol. You are encouraged to obtain the veterinarian's assistance with respect to medications, dosages and methods of anesthesia, analgesia and euthanasia. All boxes of the application must be filled. If the question is not applicable, indicate by placing the letters "N A" in the box. All animals ordered for an approved protocol will be ordered by the Animal Lab Supervisor (unless other arrangements have been made and approved by the Supervisor.

Please give careful attention to your responses concerning:

Selection of animal species (the smallest species that may be used is preferred)

Use of keywords and literature search (preference is given to two databases such as Med Line and Agricola as a means of substantiating that the proposed work is not a duplicate of other studies). Keyword searches should be separated by semi-colons to delineate one individual search from another.

3.Number of animals needed. Do not overstate or understate your need. Give consideration to the statistical validity of the project.

4.What steps will be taken to minimize or eliminate pain and distress in the animals.

5.Description of plans for adoption of surviving animals.

6.Qualifications of the Principal Investigator and project assistants. All involved persons must be named in the protocol with a description of the training and competency in handling animals' for which the protocol is submitted.

Check with the veterinarian about additional training as may be needed.

Recommendation is also made to review your need for cages with the Animal Lab Supervisor.

Information on the Animal Welfare Act, public health policies in animal care, functions and objectives of IACUCs are available from the Animal Lab Supervisor.

SinaiHospital IACUC Application Page 1

Version 5: 6/29/2010

SinaiHospital IACUC Application Page 1

Version 5: 6/29/2010

DEPARTMENTOFRESEARCH

SinaiHospital IACUC Application Page 1

Version 5: 6/29/2010

Institutional Animal Care & Use Committee

Application for Animal Research or Training in Research Techniques

Protocol No:
Name(s) of Principal Investigators:
Title of Protocol:

1. Brief Description of Proposed Research

Purpose:
Protocol (laymen’s version):
Species:
Type:
Number Needed:

2. Financial Support of the Project: More than one may be chosen for mixed funding

Hospital Cost Private Funding Government Funding

Name(s) of Principal Investigator(s)
Department Assignment
Telephone Numbers at work
Beeper Numbers
Home Telephone Numbers
E-Mail Address
Other contact person Numbers
Sponsor Providing Funding
3. Planned Start Date:

Please take into consideration when ordering and planning your start date that all animals received at Sinai Hospital shall be housed in the facility for a period of not less than 3 days (preferably one week) prior to use in a protocol study.

(All protocols are approved for a time period of one year. If additional time is needed, you must reapply prior to the expiration date of this protocol).

4. Detailed Description of Protocol:

Describe all aspects of the experimental design in sufficient detail to allow the IACUC to evaluate all procedures done to the animal.

If appropriate, you may reference Sections #23 (Description of Survival Surgical Procedures) or #26 (Description of Non-Survival Surgical Procedures).

If a supplement is attached, label attachment "4.Detailed Description of Protocol”, and state "See Attachment."

5. Why must animals be used? Is there no alternative (reference the literature search). Are there alternatives such as phantoms, computer models, training aids etc?

Choice of species. Justify that this is the smallest species that will be effective for study.

7.Breakdown of the Animals Requested:

Species
Strain/Stock
Total Number
Sex
Age or Weight
Housing site
Handling Sites

8.Justification for the Number of Animals Requested for this Study.

9.How many cages are needed for animals in this study?

Requirements for Special Care of Research Animals (e.g. barrier housing)?

Yes No

If yes, attach a description and drawing of the facility

Describe who will provide the care and the type and extent of care needed.

Will animals be removed from the animal care facility for procedures or observation?

Yes No

If yes, state the location(s), reasons for relocation, procedures to be done out of the Animal Lab and the persons who will perform procedures and observations.

Location
Reason
Procedures
Persons

12.Will any animal be kept awake and restrained for long periods of time? Yes No

If yes, describe and justify your restraint procedure.

13.Pain Relief:

The veterinarian should be consulted before completing this section

Will you be using any anesthetic, analgesic, tranquilizer or neuromuscular blocking drugs?

Yes No

If yes, complete the table below.

Species/Strain
Drug Name generic)
Induction Dose(mg/kg or % Gas)
Maintenance Dose (As Above)
Frequency of Use
Administration Route
Volume (ml or ml/kg)

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

If yes, please describe the precautions you will take to scavenge waste gases.

c.Will you be using neuromuscular blocking drugs? Yes No

If yes, explain how you will ensure that the animals are properly anesthetized.

Indicate the method to be used to ensure that animals are properly anesthetized.

Toe Pinch Palpebral Reflex Reaction to Incision

Taking of Blood Pressure Other (Specify)

14.Pain/Distress

Will any surgical or non-surgical procedures described in this protocol, if performed without anesthesia, analgesics or tranquilization, cause more than momentary or slight pain and distress?

Yes No

b.Whether yes or no, complete the table below:

No Pain or Distress / Alleviated Pain or Distress / Unalleviated Pain/Distress
Species/Strain
Quantity
Duration of Relief

c. If there will be intentionally unalleviated pain or distress provide 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?

Before Protocol begins

Before surgery ends

First Noticed

Immediately after surgery

e.Describe your procedure for monitoring the pain, distress, health and well-being of your animals. Include monitoring methods, the frequency of monitoring and names of monitors.

15.Animal Use Alternatives

Describe alternative procedures and methods to minimize animal use

Specify here or attach supplement for above and state "See Attachment"

I have considered alternatives to animal procedures that may cause more than momentary pain or distress, and I have not found such alternatives in the databases listed below:

Database / Dates of Search / Years Covered in Search / Keywords Used*
Agricola
Medline
AWIC**
Other (Specify)

* Type or write the exact string of key words using semi-colons to separate each independent search.

** AnimalWelfareInformationCenter: 301-504-6212

ATTACH THE COMPUTER PRINTOUT FROM EACH DATABASE SEARCHED (SYNOPSIS)

16.Other Drugs or Vehicles Used during Research (excluding anesthetics, analygesics, tranquilizers and neuromuscular blocking drugs).

If this is not applicable, check here

Species/Strain
Generic Drug
Vehicle
Dose(per body weight)
Freq. of administration
Route of administration
Procedure
Any known adverse effects? If so, describe them.

17.Non-Surgical Procedures

Will any animal undergo a non-surgical procedure? Yes No

If yes, describe the procedures in a stepwise fashion.

Describe here or state "See Attachement."

18.Antibody Production

If animals are used to produce antibodies for further study, describe for each species/strain

antigen, adjuvant(if any), dose per site(mg/kg), number of sites, route of administration, number of boosters and frequency of boosters.

Antibody Supplement Attached? Yes No

19.Blood Sampling

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

If yes, complete the table below:

Experimental Group ID / ml of Blood / Frequency / Sampling Site(s) / Method(e.g. IV,Postorbital

Survival Surgery (If non-survival surgery see # 25 below)

Will survival surgery be conducted on any animals? Yes No

If yes, complete the table below:

Species/Strain / # Single Surgeries / # Multiple Surgeries / Location of Surgery

21.Provide justification for requiring more than one surgical survival procedure on the same animal.

If not applicable check here

22.Survival Surgery - Aseptic Technique

Describe the preparation of the animal, surgeon and surgical instruments

23.Description of Survival Surgical Procedures

Describe all surgical procedures in sufficient detail to allow the IACUC to evaluate all procedures done to the animal.

If a supplement is attached, label attachment "23. Survival Surgical Procedures”, and state "See Attachment."

24.Postoperative Care (This section applies only to animals undergoing survival surgery)

Where will the animals be kept until recovered from surgery?

How often will the animals be observed postoperatively (and for how long)?

Who will observe the animals in recovery (Provide Names)?

How will postoperative body temperature be maintained?

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

If skin sutures or clips are used, when will they be removed?

25.Non-Survival Surgery

Will any animals undergo non-survival surgery? Yes No

If yes, complete the table below:

Species/Strain / Quantity / # with Prior Surgery / Location of Surgery

26.Description of Non-Survival Surgical Procedures

Describe all surgical procedures in sufficient detail to allow the IACUC to evaluate all procedures done to the animal.

If a supplement is attached, label attachment "26.Non-Survival Surgical Procedures”, and state "See Attachment."

27.EuthanasiaConsult the veterinarian before completing this section

Will animals be euthanized? Yes No

If yes, complete the table below:

Species/Strain
Number to be Euthanized
Procedure*
Agent
Dose (mg/kg) Route

* Cervical dislocation, overdose, perfusion, exsanguination

Will you perform cervical dislocation without anesthesia? If so, provide justification for doing this.

Yes No

28.Non-Euthanized Animal Disposition (Complete the table below):

Species/Strain / # Animals Not Euthanized / Disposition of Animals*

* If animals are to be adopted, please state your plan

29.Genetic Alterations

Will you be creating; breeding or using genetically altered species? Yes No

If yes, describe the known side effects below:

Do you plan to subject animals to biohazards, radioactive materials, radiation emissions, recombinant DNA?

Yes No

If yes, provide the names of agents, doses and details of exposure below:

31.Special Facilities and/or Equipment Required. If any describe below:

32.Personnel Training

Complete this table to provide information on personnel training in the handling, care and use of animals in research and/or procedure training. Attach curriculum vitae for each person. Include Investigators.

Name of Individual / Prior Training Description
(Include Dates) / Prior Experience
(Include Dates) / Locations

NOTE:MAKE ARRANGEMENTS WITH THE VETERNARIAN FOR TRAINING OR REFRESHER TRAINING IF PERSONNEL ARE LACKING IN CURRENT COMPETENCY.

CHECK HERE IF TRAINING ARRANGEMENTS HAVE BEEN MADE WITH THE VETERINARIAN

Assurance Certification

I certify that I have provided an accurate description of the animal care and use to be followed in this proposed research or teaching activity; that I will notify the Institutional Animal Care and Use Committee in writing before making any changes in this protocol and that I will await the Committee's approval before proceeding with this project.

I understand that failure to report changes to the IACUC and/or the performance of animal activities without Committee approval or beyond the expiration date of an approved protocol may place the institution and myself in violation of federal law.

I certify that I will abide by the provisions of the Sinai Hospital IACUC and Animal Care policies, the USDA regulations and the Public Health Service's "Guide for the Care and Use of Laboratory Animals."

I further certify that this research protocol (if applicable to research) does not unnecessarily duplicate previous experiments.

I will abide by the principals and guides of the Animal Welfare Act.

I understand that any change to or omission from the protocol may leave the IACUC no choice but to suspend the activity and submit report to the USDA.

I assume full responsibility for compliance with the aforementioned polices and regulations for all personnel involved with this protocol.

Principal Investigator's SignatureDate

Co-Investigator's SignatureDate

(If Applicable)

Department Head's SignatureDate

SinaiHospital IACUC Application Page 1

Version 5: 6/29/2010