Download animal use protocol form

Institutional Animal Care & Use Committee
Van Etten 468
Telephone Number: (718) 430-3572
Fax Number: (718) 430-3467
Website: Institutional Animal Care and Use Committee
GENERAL INSTRUCTIONS FOR ANIMAL USE PROTOCOL FORM
1.
READ ALL INSTRUCTIONS BEFORE PREPARING YOUR ANIMAL USE PROTOCOL, AS FORMS
THAT ARE INCOMPLETE WILL BE RETURNED.
2.
A SEPARATE PROTOCOL IS REQUIRED FOR EACH SPECIES OF ANIMAL.
3.
FOR CONTRACT ANTIBODY SERVICES, USE SHORTER CONTRACT ANTIBODY SERVICE
PROTOCOL FORM: Contract Antibody Protocol
4.
THE ANIMAL USE PROTOCOL FORM MUST BE TYPED. HANDWRITTEN FORMS WILL NOT BE
ACCEPTED.
5.
PLEASE ANSWER ALL ITEMS COMPLETELY.
6.
THE SPACE PROVIDED ON THE FORMS IS NOT INTENDED TO LIMIT THE LENGTH OF THE
ANSWER. WRITTEN ANSWERS SHOULD BE BRIEF BUT AS LONG AS NECESSARY TO
ADEQUATELY AND COMPLETELY ANSWER THE ITEM. ADD PAGES, IF NEEDED.
7.
IF ADDITIONAL TEXT PAGES ARE ATTACHED TO THIS FORM, PLEASE LABEL THE ANSWERS
TO SPECIFIC ITEMS WITH THE ITEM NUMBER FROM THE FORM.
8.
YOU MUST COMPLETE ALL PERTINENT APPENDICES AND ATTACH THEM TO THIS FORM.
THE APPENDICES MAY BE DOWLOADED FROM THE IACUC WEBSITE LISTED ABOVE.
9.
IN THE EVENT YOU ARE USING MORE THAN ONE CORE FACILITY AT EINSTEIN, YOU MUST
COMPLETE A SEPARATE APPENDIX 6 FOR EACH CORE FACILITY.
10.
IF YOU HAVE COMPLETED APPENDIX 8, BE SURE TO ATTACH THE APPROPRIATE SOPS AND
HAZARDOUS SIGNS. PROTOCOLS THAT ARE MISSING SOPS AND HAZARDOUS SIGNS WILL
NOT BE APPROVED.
11.
YOU MAY SUBMIT THE INITIAL PROTOCOL BY E-MAIL TO: [email protected].
12.
DO NOT SUBMIT SIGNATURES UNTIL YOU HAVE BEEN REQUESTED TO SUBMIT SAME. You
will receive and e-mail requesting signatures and providing you with a signature sheet.
13.
YOU MUST RETAIN ONE ELECTRONIC VERSION OF THIS FORM, IN THE EVENT YOU ARE
ASKED TO REVISE THE FORM.
14.
IF YOUR PROTOCOL IS APPROVED, YOU MUST MAINTAIN A COPY OF THE FINAL APPROVED
VERSION IN YOUR LABORATORY.
Animal Use Protocol Form
[1]
ANIMAL USE PROTOCOL
This box is for IACUC Office Use Only.
Please do not enter any information in this box.
Received:
Protocol Number:
Delegated Review List:
Assignment:
Full Review
RSC Meeting:
IACUC Meeting:
Review Letter(s):
Revision(s)
Date Tabled:
Delegated Review
Date Assigned to
Delegated Reviewer(s):
Reviewer(s):
Annual Renewal 2:
Approved:
Annual Renewal 3:
GENERAL PROTOCOL / CONTACT INFORMATION
A. Principal Investigator Information:
Name:
Academic Title:
Department:
Mailing Address:
Office Location:
Laboratory Location:
e-mail:
Office phone:
Laboratory
phone:
B. Protocol Information:
Protocol Title:
Species:
Is this project ongoing?
Campus where study will be
conducted:
Only one species may be listed.
Yes. Provide Protocol number:
.
No. Provide anticipated start date:
Einstein
MMC
[2]
.
YU
C. Peer-review Information:
Have these studies been or will they be peer-reviewed for scientific merit by a granting agency? Check Yes
OR No below and provide appropriate information.
No. Provide information below:
1. How will study be funded:
Yes. Provide information below:
1. Name of Agencies:
2. At time of submission have any of these agencies funded this proposal? Check one.
No.
Yes. Provide name of funding agency(ies):
D. Departmental/Laboratory Information:
D1. Department Administrator
Name:
Mailing Address:
Telephone Number:
e-mail:
Fax:
E. Personnel and Qualifications. In the table provided on the next page, provide name(s) of all individual(s)
who will work with the animals in this study. THE TABLE MUST INCLUDE THE PRINCIPAL INVESTIGATOR,
EVEN IF HE/SHE WILL NOT BE HANDLING THE ANIMALS. For all personnel listed, describe their
education and relevant experience with experimental animals. (The information you provide here must enable
reviewers to determine that personnel listed are qualified to accomplish the procedures and manipulations of
animal subjects described in the protocol skillfully and humanely.) Please note that in order to for this protocol
to be approved, the personnel listed must have completed all mandatory training pertinent to this animal use
protocol.
List of IACUC Training Sessions (CONSISTS OF TWO PARTS):


CITI Training Modules.
Face to Face Training Sessions. Below is a list of the face to face training sessions.
Training
Session #
Training Session Title
1
New User’s Orientation to Research Animal Use at EINSTEIN
Mandatory for all.
3
Rodent Survival Surgery – Principles and Practices
Mandatory if performing rodent survival surgery.
4
Safe and Humane Rodent Handling, Anesthesia, Analgesia and Euthanasia
Mandatory if this is the first time you will be handling rodents at Einstein.
5
Non-Rodent Survival Surgery
Mandatory if performing non-rodent species survival surgery.
1B. If anyone in the NEXT table does not have experience, who will provide training?
[3]
YOU MUST FILL IN ALL INFORMATION.
1. Principal Investigator
Name:
E-mail Address:
Degrees:
Years of Experience:
Does this person have experience relevant to handling and
experimental manipulation of animal species as described in this
protocol?
Will this person handle live animals under this protocol?
Will this person be performing survival surgery?
Yes
No
Yes
Yes
No
No
2. Lab Manager/Person to Contact if PI is not Available
Name:
Role in Study:
Degrees:
E-mail Address:
Does this person have experience relevant to handling and
experimental manipulation of animal species as described in this
protocol?
Will this person handle live animals under this protocol?
Will this person be performing survival surgery?
Years of Experience:
Yes
Yes
Yes
No
No
No
3. Laboratory Personnel
Name:
Role in Study:
Degrees:
E-mail Address:
Does this person have experience relevant to handling and
experimental manipulation of animal species as described in this
protocol?
Will this person handle live animals under this protocol?
Will this person be performing survival surgery?
Years of Experience:
Yes
Yes
Yes
No
No
No
4. Laboratory Personnel
Name:
Degrees:
Role in Study:
E-mail Address:
Years of Experience:
Does this person have experience relevant to handling and
experimental manipulation of animal species as described in this
protocol?
Will this person handle live animals under this protocol?
Will this person be performing survival surgery?
[4]
Yes
No
Yes
Yes
No
No
5. Laboratory Personnel
Name:
Role in Study:
E-mail Address:
Does this person have experience relevant to handling and
experimental manipulation of animal species as described in this
protocol?
Will this person handle live animals under this protocol?
Will this person be performing survival surgery?
Degrees:
Years of Experience:
Yes
No
Yes
No
Yes
No
6. Laboratory Personnel
Name:
Degrees:
Role in Study:
E-mail Address:
Does this person have experience relevant to handling and
experimental manipulation of animal species as described in this
protocol?
Will this person handle live animals under this protocol?
Will this person be performing survival surgery?
Years of Experience:
Yes
Yes
Yes
No
No
No
If you need additional sheets, please download: IACUC Forms
OVERVIEW
1. Purpose (Narrative).
1A. Briefly describe the purpose of the study, the hypothesis, how you are testing the hypothesis
(number & species of animal, brief test description, and the expected outcome in lay terms (understood by
someone with undergraduate level education, who is not a specialist in the field). DO NOT extract language
from your grant application – keep this brief and simple, as if you are attempting to provide an encapsulated
description to a group of basic science students. Limit this description to 1-2 simple paragraphs.
1B. If this is a continuation of an ongoing study, you must include a brief report of progress made in the
previous three year study.
1C. Define the experimental groups, based upon your hypothesis and experimental goals. Clearly
indicate what will happen sequentially to each experimental group of animals so that reviewers can readily
[5]
visualize what each group of animals will experience (please provide timeline for all procedures performed
in each experimental group; a chart or figure to explain the timeline). Describe the sequence of the
procedures/manipulations and time line in hours, days, weeks or months for each experimental group. Indicate
if particular groups of animals are expected to experience pain or distress or develop disease due to these
procedures or genotype, and what will be done to reduce stress and pain. Do not describe details of these
procedures here; details should be provided in other appropriate sections of this form.
2. Justification of Animal Use. Your description must include answers to items 3A and 3B.
2A. Why must a living animal be used in this study or teaching demonstration instead of in vitro
resources such as cell lines or computer simulation models?
2B. Why was this animal species/strain/genotype selected for study, rather than a phylogenetically
“lower” and presumably less sentient species? Describe the characteristics of each animal species/strain/or
genotype that justify your selection of this animal model for the proposed study. (Consider such characteristics
as genotype, body size, data from previous studies, or unique anatomic or physiologic features.)
ANIMAL SUBJECT DESCRIPTION
3. Strain and Source of Species. A separate table should be provided for each animal strain from separate
sources. Note: The total number requested must match the explanation of animal provided in below in item 5.
Strain(s)
Source
Strain 1:
Bred at Einstein (by PI or personnel)
Obtain from Another Scientist
Purchased (Commercial Source)
Strain 2:
Bred at Einstein (by PI or personnel)
Obtain from Another Scientist
Purchased (Commercial Source)
Strain 3:
Bred at Einstein (by PI or personnel)
Obtain from Another Scientist
Purchased (Commercial Source)
Total Number of Animals Requested for 3 Year Period:
(Total number above must match number explained in item 5 below.)
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4. Explanation of Animal Numbers. A clear explanation for the total number of animals requested for this
study (in item 3 above) MUST be provided so that reviewers understand the experimental use of the animals.
Note:
 You MUST present ALL experimental groups or sampling scheme IN TABULAR OR OUTLINE FORM
with the number of animals of each strain, etc provided for each group.
 A complete explanation must include a statement that explains why a specific experimental group
sample size was chosen.
 PROVIDE A SUPPLEMENTAL PAGE IF NEEDED.
 Statistical arguments (Power analysis) should be used whenever possible.
 Protocols involving breeding to produce the animals to be used in experiments must account for the
breeders and the total production, including surplus animals and those discarded because of unwanted
genotype.
 For an examples of how you should provide this information, please visit:
http://www.einstein.yu.edu/uploadedFiles/MouseHouse/Calculating%20Animal%20Numbers.pdf
Explanation:
ANIMAL HUSBANDRY AND CARE
5. Special Husbandry, Handling, Hazards, Etc. All husbandry and care practices must meet standards
described in the Animal Welfare Regulations and the Guide for the Care and Use of Laboratory Animals.
Specific exceptions can be requested (in writing) and are granted by the Institutional Animal Care and Use
Committee only when specific scientific justifications are provided or by the veterinarian for medical reasons.
This includes housing outside the Institute for Animal Studies primary housing facilities, deviations from
standard practices in animal health monitoring, diet, cage, environmental control, exercise (where required),
environmental enrichment, and means of identification.
Will animals require special husbandry or handling practices and procedures? (CHECK ONE)
No. Proceed to item 6.
Yes. Complete Appendix 1 and proceed to 6.
6. Animal Housing Location Requested.
6A. Campus Where Animals Will be Housed (check all that apply then go to 6B):
Einstein (complete table below)
Montefiore
Yeshiva University
Not Required
For Animals Housed At Einstein Only
6B. Where in the IAS would you like your animals housed? (check all that apply then go to 6C)
Chanin
Kennedy Center
Ullmann Building
Price Center
6C. What type of housing are you requesting? (check all that apply then go to 6D)
Barrier
Isolator (“Bubble)
Conventional
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6D. Are you requesting housing outside the IAS for more than 12 hours?
No. Go to 6F
Yes. You must include location below:
Building:
Room No:
6F. Are you requesting housing outside the IAS for more than 24 hours?
No. Go to 7.
Yes. This is satellite housing You must include location below (which
must be approved by the IACUC), then to go to 7.
Building:
Room No:
NOTE: Satellite housing outside IAS Animal Facility, must be inspected and approved by the IACUC.
Please attach letter and/or e-mail approving this location for satellite housing.
7. Breeding of Animals. Are all the animals described in items 3 and 4 (above), only being bred to be given
to other investigators and/or be used under a different approved animal use protocol? (No other experimental
procedures will be performed by you on these animals other than breeding).
No. Proceed to 8.
Yes. See “Note” below.
Note: If all the animals under this protocol are being bred to be given to other PI(s) and/or to be used
under a different approved animal use protocol, you only need to complete items 9, 12 and 20 of this
form.
8. Collaborative or Contractual Arrangements. Will this project involve a collaborative or contractual
arrangement in which live animals will be housed at, transferred to, or have procedures performed at another
institution in order to complete the goals of this study?
No. Proceed to item 9.
Yes. Complete items 8A and/or 8B.
8A. Information regarding collaborative/contractual institution of facility:
Name of collaborative/contractual institution or facility:
Is the facility AAALAC accredited?



Yes
No
Unknown
For collaborative arrangements, a copy of the approval letter from the Institutional Animal Care and Use
Committee at the collaborating or recipient institution indicating the dates and duration of approval
must be provided.
Copies of other approvals, permits, etc., necessary to complete the study must also be provided (e.g.
Environmental Health and Safety, Biosafety, etc.)
Proceed to Item 10.
8B. Information regarding commercial contract facilities. What type of service will be performed?
Surgical models (surgery performed prior to
purchase of animals). Name specific surgical
procedure below.
Other. Name procedure below.
[8]
Procedure:
If this protocol involves contract antibody services,
complete and submit the animal use protocol form entitled “Contract Antibody Production”
EXPERIMENTAL PROCEDURES
9. Animal Procedures Locations. Provide the buildings and laboratory room numbers (including animal
facility procedure rooms) where animal procedures will be performed.
ATTENTION: “CLEAN” BARRIER RODENTS MAY NOT RETURN TO THEIR HOUSING AREAS AFTER
TRAVELING TO LABORATORIES OR CORES LOCATED OUTSIDE THE BARRIER. IF ANIMALS NEED
TO RETURN TO IAS ANIMAL FACILITY, YOU MUST MAKE REQUEST ISOLATION SPACE. PLEASE
COMPLETE: REQUEST ISOLATION SPACE FROM
Check all that apply
Investigator laboratory
Fill Information
Building:
Room Number:
Specify Procedure(s):
IAS Sterile Surgery
Ullmann 1005
Kennedy Center B35/36
Specify Procedure(s):
IAS Procedure Room
Ullmann 1005
Price Center
Specify Procedure(s):
IAS Animal Housing
Building:
Room Number:
Specify Procedure(s):
Other (Specify)
Building:
Room Number:
Specify Procedure(s):
10. Test Substances. Radioisotopes, toxic, antigenic, pharmacological, infectious, carcinogenic, other types of
substances, biomaterial or cells administered to live animals are considered test substances. Will test
substances be administered to animals? {“Test substances” do not include anesthetics, fluids, or antibiotics,
given SOLELY to support the animals’ health independently of the experimental goals} (CHECK ONE)
No. Proceed to item 11.
Yes. Complete Appendix 2 and proceed to 11.
11. Specimen Collection. (All body fluids and tissues are considered specimens).
collected before death?
No. Proceed to item 12.
Will specimens be
Yes. Complete Appendix 3 and proceed to 12.
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12. Monoclonal Antibody Production. Will animals be injected with hybridoma cells to generate ascites for
monoclonal antibodies on-site?
No. Proceed to item 13
Yes. Complete Appendix 4 and proceed to 13.
13. Animal Surgery. Will surgery be performed as part of the experimental protocol?
No. Proceed to item 14.
Yes. Complete Appendix 5 and proceed to 14.
14. Core Facilities at Einstein. Will any core facilities at Einstein (other than the Behavioral Core) be
involved in these studies?
No. Proceed to item 16.
Yes. Complete Appendix 6 and proceed to 15.
Note: You must obtain a signature from the Core Facility on Appendix 6.
If you are using more than 1 Core Facility, you must complete a separate Appendix 6 for each Core.
15. Behavioral Core Facility at Einstein. Will the Behavioral Core at Einstein be involved in these studies?
No. Go to item 16.
Yes. Complete Appendix 7 and attach “Core User
Form”. PLEASE CONTACT THE BEHAVIORAL
CORE TO OBTAIN THE CORE USE FORM.
16. Other Experimental Procedures. Will animals be subject to experimental procedures not described
above?
No. Proceed to item 17.
Yes. Complete Appendix 7 and proceed to 17.
SPECIAL CONSIDERATIONS OF REGULATORY OR VETERINARY CONCERN
17. Clinical Illness in Animals (for TUMORS, fill out item 18). Will genetically induced conditions
(spontaneous mutation, targeted mutation, transgene, aging, etc.), or experimental procedures cause animals
to show any clinically apparent disease or phenotype, (Except tumors)? (Is it possible that animals will become
sick and/or die as a result of experiments and procedures?) Note: If survival surgery will be performed, you
must check the Yes box and complete items 17A-17D for possible post-operative complications.
No. Proceed to item 18.
Yes. See “NOTE” below and answer 17A – 17D.
NOTE: Animals that have an expected abnormal phenotype should be flagged with an expected phenotype
card to alert the care staff. These pink phenotype cards can be obtained from IAS in consult with veterinary
staff. Animals receiving surgery must have a post-surgery monitoring card affixed to the cage until full
recovery & sutures are removed.
17A. Describe what clinical signs may be seen (this can be based on published or known phenotypes,
or what MAY BE ANTICIPATED based on the human condition being modeled). Protocols involving surgery
should discuss possible surgery associated complications such as wound infection. If a procedure has an
anticipated morbidity or mortality rate associated with it, this must be described.
Potential for animals to die from manipulations.
Potential dehydration.
Animals expected to become moribund.
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Animals expected to lose weight.
Other (you must describe):
17B. Describe how frequently animals will be checked/monitored and specifically state monitoring
procedures including how said monitoring will be documented (weighing, blood test, etc). It is the responsibility
of the PI to require their staff to monitor any treated or manipulated animal that may not be normal or may have
complications or post-treatment effects on A DAILY BASIS. See “NOTE” below.
NOTE: The IAS veterinary staff must be consulted for assistance with implementation of monitoring
documentation (Pink monitoring documentation cards to be affixed to each cage).
Monitoring Procedure
Blood Test
Body Weight
Physical Activity
Clinical Signs
Other (you must describe):
Frequency
Daily
Twice Weekly
Other (describe below)
Daily
Twice Weekly
Other (describe below)
Daily
Twice Weekly
Other (describe below)
Daily
Twice Weekly
Other (describe below)
Describe “Other”:
17C. What will you do (PLAN OF TREATMENT/ACTION) if animals exhibit any of the above clinical
problems (from 17A)? (Describe any special nursing care or treatment. Describe your criteria for deciding
whether to treat or euthanatize a sick animal.)
NOTE: This information MUST be on pink phenotype card placed on cage. Consult with the IAS veterinary
staff to obtain the appropriate card.
Criteria
Treatment (if any)
17D. At what timepoint, humane endpoint and/or clinical signs will animals be euthanized?
18. Tumors. Will experimental animals have tumors induced by injection of tumor cells, treatment with
carcinogens, or are they expected to develop tumors due to genetic manipulations?
NOTE: Animals expected to develop tumors (abnormal phenotype) must be flagged with an expected
phenotype card by the PI’s staff to alert the care staff. These pink phenotype cards can be obtained from IAS
in consult with veterinary staff.
Yes. Answer 18A – 18H.
No. Proceed to item 19.
18A. At what age or time after treatment are tumors likely to begin to develop (i.e. within 2 weeks, 6
months, etc.)?
18B. Describe the target organs or locations where tumors may develop, including potential
metastases.
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18C. Will the tumor be multinodal or single?
Multinodal
Single
18D. How often will animals with signs of tumor burden be checked (this must be daily when the tumor
is approaching a defined endpoint (either size, ulceration, interference with normal function, or signs of
excessive tumor burden).
Please note that once animals develop tumors, they must be monitored on a daily basis.
18E. Describe how the animals will be monitored for overall health and for tumor progression, including
both externally visible and/or internal tumors. NOTE: if tumors are expected to be large or ascites will be
produced, loss of body weight may not be the best method of monitoring the animals’ condition. Consider an
alternative method such as body condition score. Consult the IAS veterinary staff for assistance with
developing a body condition scoring system.
18F. Describe what sign(s) or system(s) will be used to decide whether to euthanize animals.
18G. Will animals be euthanized and tumors harvested as soon as they are detected?
No. Complete item 18G(i) and proceed to 18H.
Yes. Proceed to 19.
18G(i). Describe when the animals will be euthanized and/or tumors will be harvested after
detection and explain why this endpoint was chosen.
When:
Why:
18H. If detectable tumor mass becomes larger than: 1cm diameter (in mice, small rats, gerbils,
hamsters), 2cm diameter (in large rats [>200 g], guinea pig), 3cm diameter (in adult rabbits), interfere with
postural adjustments, or become necrotic or ulcerated, can / will the animals be euthanized?
No. Complete item 18H(i).
Yes. Proceed to 19.
18H(i) Explain below on scientific grounds why and for how long animals must be kept alive,
and provide all other information in table.
Scientific Justification:
Define monitoring frequency:
Describe supportive nursing care:
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19. Death Endpoint. Does this study involve measurements of survival / mortality rates, lethal doses, or time
to death data? (Is death an endpoint, that is are any animals expected to die as a result of experiment or
during monitoring stage of the study without intervention, e.g. euthanasia?) Note: Euthanasia is not a death
endpoint.
No. Proceed to item 20.
Yes. Answer item 19A through 19C.
19A. What type of death endpoint study is this?
LD50
Time to Death
Other (specify):
19B. Explain on scientific grounds why an earlier (less severe) endpoint, such as illness (morbidity), or
loss of weight (e.g. > 25% body weight) is not acceptable.
Scientific grounds:
NOTE: Animals nearing death endpoint are expected to be checked frequently, at least 2 times per day
(morning & afternoon). Even in death endpoint studies, animals are expected to be routinely euthanized if
found to be moribund.
19C. Will animals be immediately euthanized if they are found to be moribund (death within the next 8 –
12 hours expected with a high degree of certainty)?
No. Complete 19C(i).
Yes. Proceed to 20.
19C(i). Why will animals not immediately be euthanized if found moribund?
Explain:
EUTHANASIA OR OTHER DISPOSITION OF ANIMALS
20. Euthanasia. Will animals be euthanized during or at the completion of this study?
No. Proceed to item 21.
Yes. Answer 20A-20E
NOTE: For guidance on acceptable methods of euthanasia, refer to the most current Report of the AVMA
Guidelines on Euthanasia.
20A. List the name(s) of person(s) who will perform the euthanasia and indicate if they are
trained.
Name
Yes
Yes
Yes
Yes
Yes
Trained
No
No
No
No
No
If no, by whom will they be trained?
20B. Method of euthanasia. (List ALL methods that will be used. Specify the secondary techniques
and type of animals (i.e. neonate, dam, etc.) if more than one will be euthanized.
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20B(i) Will it be by chemical method alone?
No. Go to 20B(ii)
Chemical Agent
Isoflurane Overdose
Ketamine/Xylazine Overdose
Carbon Dioxide
Other. Describe:
Yes. Describe in table below. Answer 20B(i)(a)
Dose
Route
To Effect
Inhalation
NOTE: FOR USING CO2, CO2 MUST BE DELIVERED BY COMPRESSED GAS CYLINDER INHALED
ROUTE) TO EFFECT (DOSE). THIS IS THE ONLY APPROVED METHOD FOR USING CO2. CO2
GENERATED BY DRY ICE IS NOT AN ACCEPTABLE METHOD, AS PER THE CURRENT AVMA PANEL
OF EUTHANASIA.
20B(i)(a). How will death be ensured?
REQUIRED (see below)
CHECK ALL THAT APPY BELOW
Lack of Heartbeat for one minute
Cervical Dislocation
Lack of Response to Stimulus (e.g. toe pinch)
Blanching of the eye ball (pale globe, indicating no
blood is flowing through the eye)
Lack of Respiration for one minute
Decapitation
20B(ii) Will it be by combination of chemical and physical method?
No. Go to 20B(iii)
Sedative/Anesthetic/Analgesia
Yes. Describe in table below. Then proceed to 20B(iii)
Dose
Route
Physical by
Decapitation
Cervical Dislocation
Other (describe below)
Describe Physical Method:
20B(iii) Will it be by physical method alone?
No. Proceed to 20C.
Cervical Dislocation
Thoracotomy
Describe “Other”:
Yes. Describe in table below and complete 20B(iii)(a).
Then proceed to 20C.
Physical Method Alone
Decapitation
Other (describe below)
20B(iii)(a) Cervical dislocation or decapitation without anesthesia, carbon dioxide overdose of
animals other than small rodents are NOT currently recommended by the AVMA Panel on Euthanasia. If these
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methods are proposed, they must be justified scientifically, with full literature references. (MUST ALSO BE
SPECIFICALLY ADDRESSED IN ITEM 24 BELOW.)
Scientific justification:
20C. Will all experimental groups be euthanized in the same manner:
No. Complete table below. Then proceed to 21.
Yes. Proceed to 21.
Group(s)
Method of Euthanasia
Chemical Method
Chemical & Physical Method Combined
Physical Method Alone
Chemical Method
Chemical & Physical Method Combined
Physical Method Alone
Chemical Method
Chemical & Physical Method Combined
Physical Method Alone
Group 1
Group 2
Group 3
MANDATORY CONSIDERATIONS
21. Consideration of Alternatives. You are required by federal law and EINSTEIN policy to declare if any
procedure to be employed has the potential to cause more than momentary or slight pain or distress and
document that a good faith effort to consider alternatives less painful or distressful procedures. (The U.S.
Dept. of Agriculture has determined that surgery or perfusion conducted under anesthesia is a potentially
painful procedure.)
21A. Please provide a narrative description (below) of the methods and sources used to determine that
suitable alternatives (to each potential painful procedure, e.g. a different procedure, or method) were not
available or applicable to this study. The following information must be included.
Databases and Resources used (check any that were used below):
AGRICOLA database
MEDLINE database
AWIX TOXLINE database
BIOSIS database
Scientific Journals
Scientific Meetings
Altweb
AWIC
CAB Abstracts database
Other Database:
Scientific Discussions
NORINA
When using databases, identify the search terms, years covered, and date of the search below.
Date that literature search was
performed:
Objective of search:
Years covered by the search:
Search terms (keywords). If
surgery is being performed,
include if any alternative or
less invasive procedures in
Search terms (keywords):
You must include the key
words “alternative, animal
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model, and the
painful/distressful procedure
you are performing.
Narrative (must address each
procedure explicitly):
EINSTEIN POLICIES AND FEDERAL REQUIREMENTS
22. Volatile Anesthetics. Will volatile anesthetics (i.e. isoflurane,) be used?
No. Proceed to item 23.
Yes. Answer items 22A and 22B.
22A. Indicate location(s) where the agent will be used:
Building
Chanin
Forchheimer
Kennedy Center
Price Center
Ullmann
Other. Specify:
Room Number
22B. Will this agent be used in a fume hood at this location?
No. Proceed to 22C.
Yes. Proceed to 23.
22C. Will anesthetic machine (e.g. IAS portable unit) with carbon canister scavenging system attached
be used?
No. Proceed to 22D.
Yes. Proceed to 23.
22D. If fume hood will not be used, describe the waste gas scavenging system that will be used and
how it will be checked to ensure it is working properly. NOTE: Anesthetic machines rented from the IAS
includes carbon canister system monitored by IAS clinical services.
Describe:
NOTE:
 CARBON CANISTER SYTEMS MUST BE MONITORED BY WEIGHT WITH EACH USE AND
DISCARDED WHEN SATURATED.
 SAFEY MUST APPROVE LOCATION(S) OF FUME HOOD(S) OR THE SCAVENGING SYSTEM BY
SIGNING THE SIGNATURE PAGE. VOLATILE ANESTHETICS CANNOT BE UTILIZED IN
BIOSAFETY CABINETS UNLESS THE CABINETS HAVE DUCTED EXHAUST, OR A SCAVENGING
SYSTEM IS IN USE.
23. Flammable Anesthetics. Will ether or any other flammable anesthetic agent be used in any portion of
these animal studies?
No. Proceed to item 24.
Yes. Proceed to 23A and 23B.
[16]
23A. Indicate location(s) of the flame and explosion proof fume hood where it will be used.
Building
Chanin
Forchheimer
Kennedy Center
Price Center
Ullmann
Other. Specify:
Room Number
23B. Will animals that are euthanized with ether be stored in a refrigerator while they de-gas?
No. Proceed to item 24.
Yes. Proceed to item 23A(i).
23A(i) Give location of the explosion-proof refrigerator:
Building
Chanin
Forchheimer
Kennedy Center
Price Center
Ullmann
Other. Specify:
Room Number
NOTE: Safety must approve locations flammable anesthetics are used by signing the signature page,
ITEM II. Please obtain Safety signature on protocol form.
24. DEA CONTROLLED SUBSTANCES. Are DEA controlled substances being used in this protocol?
Controlled Drugs. All drugs used in this study that are classified by the DEA as controlled substances must be
stored, used and accessible only in accordance with DEA regulations. Your signature on the signature page
indicates that you are aware of this and will adhere to it
No.
Yes. Complete 24A.
24A. Provide licensee under which research is performed (person listed below must also be listed
under personnel):
Type
Federal DEA
NY State DEA (For Non-MD Only)
Name of Licensee
Number
NOTE: CONTROLLED DRUGS MUST BE KEPT UNDER DOUBLE LOCK. (A LOCKED BOX WITHIN A
LOCKED DRAW OR CABINET OR A PERMANENT SAFE IS ACCEPTABLE). ALSO, A CONTROLLED
DRUG LOG MUST BE KEPT WITH THE CONTROLLED SUBSTANCE. THE DRUG LOG MUST INCLUDE
LOT NUMBER, BOTTLE NUMBER, DATE USED, AMOUNT USED, SPECIES USED UPON, AMOUNT
REMAINING, AND INITIALS OF INDIVIDUAL THAT USED CONTROLLED SUBSTANCE.
FOR
ADDITIONAL INFORMATION REGARDING THIS MATTER, PLEASE VISIT THE FOLLOWING WEBSITE:
http://www.health.state.ny.us/professionals/narcotic/
[17]
25. Human Tissues (Reminder). Any work involving human patient samples in animals must have approval
by the Committee on Clinical Investigations (CCI). Does this study involve human tissues?
No. Proceed to 26.
Yes. Proceed to 25A.
25A. Have you obtained CCI approval?
No. Please contact CCI and proceed to item 26.
Yes. Attached CCI approval letter to protocol.
Proceed to 26.
26. Stem Cell Research (Reminder). Any work involving human embryonic stem cell research in animals
must have approval by the Embryonic Stem Cell Research Oversight Committee (ESCRO). Does this study
involve stem cell research in animals?
No. Proceed to 27.
Yes. Complete 26A.
26A. Have you obtained ESCRO approval?
No. Please contact ESCRO and proceed to 27.
Yes. Proceed to 27.
REMINDER: ANIMALS USED FOR STEM CELL RESEARCH MAY NOT BE BRED.
27. APPENDICES CHECKLIST ATTACHED (please check appropriate boxes and GO TO ITEM 28)
Appendix 1 – SPECIAL HUSBANDRY PRACTICES
Appendix 2 – TEST SUBSTANCES
Appendix 3 – SPECIMEN COLLECTION PRIOR TO EUTHANASIA
Appendix 4 – MONOCLONAL ANTIBODY COLLECTION
Appendix 5 – SURGERY
Appendix 6 – CORE FACILITIES (MAY NOT BE USED FOR BEHAVIORAL CORE)
Appendix 7 – OTHER EXPERIMENTAL PROCEDURES OR BEHAVIORAL CORE
Appendix 8 – BIOSAFETY/CHEMICAL SAFETY PRECAUTIONS (If you completed Appendix 8
YOU MUST ATTACH all appropriate SOPs and Hazardous Signs)
28. SIGNATURES: Please do not submit at this time. Signatures will be required on the final
version of the animal use protocol. You will receive an e-mail (along with a signature sheet)
requesting signatures on the final version of the animal use protocol. Please note that the
protocol will not be approved until all original signatures are on file on the final version of the animal
use protocol.
[18]
APPENDIX 1
SPECIAL HUSBANDRY PRACTICES
1. Special Husbandry: Check and describe all nonstandard practices or procedures (examples listed
below). Then go to 2.
Check
Duration of
special husbandry
Description of Procedure
Approximate number of
animals requiring
specialized husbandry
at any given time
Nonstandard caging (indicate below):
wire bottom
metabolic chamber
Other (specify):
Special Feed (indicate below):
special formula
powdered food
medicated feed
Limited or restricted feed
Medicated water/Special treated
Limited or restricted water
Exemptions from standard cage maintenance
Non-standard temperatures
Non-standard light cycle
Housing outside animal facility > 12 hours
Housing in “satellite animal facilities”
Tethering or prolonged restraint
Indicate type:
Restricted environmental enrichment
Exercise program
Restricted observation
Special monitoring or nursing care
Weaning rodents beyond 21 days of age
Biosafety in Animals (see also Appendix 8)
(If study includes the use of an agent that is
hazardous or potentially harmful that is classified
as: ABSL-2, ABSL-3, CSL-2, RS-1A, RS-1B, and/or
RS-2 you MUST complete this row.)
Other (indicate below):
Indicate type:
2. Justification. Describe below exactly what is being done and explain briefly the rationale for each
type of special husbandry requested in previous table. Provide response below then go to 3.
[19]
Response:
3. Personnel performing special husbandry: Will you or your staff be performing the special
husbandry?
No. Go to 4.
Yes. Complete information below then go to 4.
Name of Individual(s) Performing Special Husbandry
Work Phone #
After Hours Phone,
Pager or Beeper #
4. Special Husbandry Cards: You are required to affix the appropriate “Special Husbandry Card” to
all cages. These cards are custom designed. Please consult with veterinary staff of the Institute for
Animal Studies (IAS) to make arrangements in advance of beginning a study that requires special
husbandry to prepare the “Special Husbandry Card” (X3220). By checking below, you acknowledge
that you have read this statement and that you will contact the veterinary staff in order to obtain the
appropriate “Special Husbandry Card”. Check the box below.
I have read the above statement and will contact the veterinary staff to obtain the “Special
Husbandry Card” once I have received written notification from the IACUC that this
protocol has been approved.
[20]
APPENDIX 2
TEST SUBSTANCES
1) Classes of test substances or other materials:
Class Description
Class Description
A
Radioisotope
G
Pharmacological agent
B
Infectious agent
H
Adjuvants
C
Carcinogen
I
Antigenic substance
D
Toxic chemical
J
Biomaterial
E
Human material
K
Recombinant Genetic material (vectors)
Other (describe):
F
Tissues/cells
L
The letter of the Class identified above should be listed in column 2 in table below.
2) List the test substances or other material to be administered to the animals.
Substance Name
Class
(See
above)
Is test substance
hazardous or
potentially infectious
to humans or
animals?
No
No
No
No
No
Dose
Dose Schedule (You must
include route, frequency
and maximum dose per
animal)
Yes
Yes
Yes
Yes
Yes
If any test substance is hazardous or potentially infectious to humans or animals,
you must complete Appendix 1 and 8.
3) NOTE: Cells and biologicals to be injected into rodents should be free of contamination with adventitious infectious
agents. Otherwise, these materials could introduce infectious agents into our rodent populations. Please provide source
below:
Primary Human Tumor
Rodent Cell Line Propagated in Cell Culture
Human Cells Propagated in Tissue Culture
3A. Are any of the biologicals listed above derived from rodents (e.g. mouse hybridoma /monoclonal antibody) or
have rodent biologicals been used in the production or maintenance of these materials (e.g. human cells incubated with
media containing mouse serum), or have any of these biologicals been passaged in rodents (e.g cell lines that can only
be maintained in vivo)?
No. Proceed to item 4.
Yes. Answer 3B and 3C.
Appendix 8.
You must complete
3B. Have these materials been tested and found to be free of exogenous infectious agents?
No
Yes. Please provide date and method of testing:
Unknown
. Proceed to item c.
3C. Have these materials been passaged ONLY in animals known to be free of exogenous infectious agents?
[21]
Yes. Proceed to 4.
No. See note below.
N/A (not passaged.). Proceed to 4.
Unknown. See note below.
YOU MUST CONTACT DR. L. HERBST, DIRECTOR OF THE INSTITUTE FOR ANIMAL STUDIES, AT EXTENTION:
3571 OR 8553, FOR FURTHER INFORMATION ABOUT SPECIAL ISOLATION CONDITIONS OR TESTING
REQUIRED TO USE THESE MATERIALS PRIOR TO USING THEM IN RODENTS.
4) Will any the test substance(s) cause clinical signs, pain, or distress to the animal?
No
Yes. Answer 4A and 4B.
4A. Describe what signs are expected. Your answer below must be consistent with your response from items 16
and 17 from main protocol form.
Signs:
4B. Describe what measures will be taken to alleviate or minimize these affects. Your answer below must be
consistent with your response from items 16 and 17 from main protocol form.
Measures that will be taken:
[22]
APPENDIX 3
SPECIMEN COLLECTION PRIOR TO EUTHANASIA
1) Invasive Procedures. Will invasive procedures be employed to collect tissue or body fluids from the live
animals during this experimentation? (Any procedure that penetrates a body orifice, the skin, or a hollow
visceral organ is invasive.) Answer YES only if animals survive after the collection.
NOTE: If tissue collection is done as a part of a terminal procedure or after euthanasia, answer NO.
No. Proceed to item 5.
Yes. Characterize the procedures below and answer
items 2-4.
Tissue / fluid
collected
Method of Collection
1
For
Genotyping
Ear Punch (preferred)
Tail Biopsy (may require
anesthesia
Toe Clipping
2
3
Ascites
Blood
Collection
Urine
Feces
Tissue
Other. Describe below. Fill in each column.
4
5
6
7
Amount or
volume
collected per
sample
Age and
Frequency of
sampling
Maximum
number of
samples that
will be
collected
If performing blood collection, bleeding of the animal must be controlled by using pressure. Also, silver
nitrate is available through the Institute for Animal Studies, Ullmann 1005.
2) Will tail biopsy samples be collected more than once?
No.
Yes. If Yes, you must provide rationale in 2A.
(Please visit see: Policy # 2011-2 Tail Clipping Mice and Rats for Genotyping)
2A) Rationale:
3) Will samples for Genotyping be collected by more than one method?
No.
Yes. If Yes, you must provide rationale in 3A.
3A) Rationale:
4) Will these procedures be performed under anesthesia?
No.
Yes. If Yes, complete table below and items 4A
and 4B.
[23]
Procedure
from item 1
above
1
2
3
4
5
6
7
Anesthetic Drug
Dose
Route of
Administration
4A) Describe the method of restraint used to execute this task for all procedures where surgical planes
of general anesthesia are not induced.
Method of
Restraint:
4B) Will any procedure cause more than momentary pain or distress (anything more than a needle
prick)? Will these procedures be performed under anesthesia?
No.
Yes. If Yes, answer 4C.
4C) If anesthesia will not be used, and the procedure will cause more than momentary pain or distress,
provide a scientific justification for omission of anesthetics or pain-relieving agents?
Scientific
Justification:
5) Non Invasive Procedures. Will noninvasive procedures be employed to collect tissue or body fluid from the
live animals (for example, metabolic cages for urine or feces collection)?
No.
Yes. If Yes, complete 5A.
5A) Briefly describe the non-invasive procedure, the specimens, and how they will be collected below.
Response:
[24]
APPENDIX 4
MONOLCONAL ANTIBODY PRODUCTION BY THE ASCITES METHOD*
Directives from NIH require the IACUC to critically evaluate the proposed use of the mouse ascites method because this
method causes discomfort, distress, or pain and because practical in vitro alternatives exist in many experimental
applications without compromising the aims of the study.
The following items are designed to facilitate your justification for needing to use the ascites method.
1) Have you completed Appendix 2 and 3 to describe the cell lines, procedure, and ascites tapping schedule that will be
used?
Yes
No. Please go back and complete Appendices 2 and 3.
2) What other methods or in vitro alternatives to live animals which could avoid or minimize discomfort have been
considered? Why are they NOT suitable for use (check all that apply)?
a) In vitro culture (hollow fiber / “Techno mouse”) - check all that apply:
Monoclonal cell line grows slowly and production in vitro is not feasible.
Attempts at use of this monoclonal cell line for in vitro production have failed.
Antibody isotype required is not produced well in vitro.
Amount of antibody required for experiments makes in vitro production not practical.
Other. Please provide details below.
Details:
3) Phage display (genetic technique):
Monoclonal antibody producing cell line already exists.
Phage reagents could not be used for planned experiments (i.e. in vivo work)
Other. Please provide explain below.
Explanation:
4) Will any adjuvant be used?
No.
Yes. If Yes, complete information below.
4A. Check which one will be used:
Pristane
Freund Complete/Incomplete
Other:
4B. Please provide justification below.
Justification:
4C. Describe any clinical signs below.
Clinical signs:
4D. How are clinical signs managed? Your response here should be consistent with your response under item 16
of main protocol form.
Management of Clinical Signs:
[25]
4E. Humane endpoints/criteria for euthanasia. Your response here should be consistent with your response
under item 16 of main protocol form.
Response:
[26]
APPENDIX 5
SURGERY
Policy Statement
I. EINSTEIN Institutional Animal Care and Use Committee (IACUC) policy and Federal regulations require:
A) For non-mouse, non-rat, USDA-regulated species that written records be kept of surgery and intraoperative
monitoring data. These are part of the documentation of adequate veterinary care. These records must be
maintained for the life of the study at minimum and must be readily available for inspection.
B) The written plan for post-operative care (items 12 and 13 above) be followed precisely. For all mammalian
species, written records MUST be kept to document that the post-operative medications and care were given.
These records must be maintained for the life of the study at minimum and must be readily available for
inspection by the Committee and USDA Inspectors.
1) List Surgeon(s) below (If performing survival surgery, individuals listed here MUST have attended IACUC training
session related to performing survival surgeries. If they have not attended the mandatory training sessions, this protocol
will not be approved until such time as said training has been completed):
Surgeon
Work Phone Number
After Hrs Phone #, pager or beeper
1A. Will survival surgery be performed?
No. Go to 2.
Yes. Complete item b.
1B. Have all the surgeons listed above attended the mandatory IACUC training session on survival surgery? (As
noted above, all the surgeons performing survival surgery must complete the training related to this procedure).
No. Please have surgeon(s) register for training. 1
Yes.
2) Description of Surgery. Describe each of the surgical procedures below in detail (in chronological order so that it is
clear what is being done and how it is done). A separate description (Appendix 5) is needed for each type of
procedure. When multiple procedures are performed on an animal, please describe the sequence and timing of these
procedures so that it is clear what is happening to the animals during the study. Provide supplemental pages if needed. *
Detailed descriptions of surgeries involved in the production of transgenic and knockout founder mice are not required if
EINSTEIN Transgenic and Gene Targeting Facility will perform these procedures following their standard protocol.
2A. Procedure (provide detailed description):
Description:
2B. Preoperative procedures:
2B(i) Will animal be fasted prior to surgery?
Yes. If Yes, for how long prior to surgery?
No.
Duration:
1
To register for training, please visit the “MouseHouse” website.
[27]
2B(ii) Will animals be held off water prior to surgery?
Yes. If Yes, for how long prior to surgery?
No.
Duration:
2C. Paralyzing Agents. These agents do not block pain sensation. Federal regulations prohibit the use of these
agents without general anesthesia.
2C(i) Will paralyzing agent(s) be used?
No.
Yes. Answer items 2C(i)(a) and 2C(i)(b).
2C(i)(a) Why is it necessary to use a paralyzing agent?
Reason:
2C(i)(b) Explain how the depth of anesthesia will be monitored while paralyzing agent is being
administered.
Will be Monitored as follows:
2D. Anesthesia:
2D(i) List who will be responsible for administering anesthesia:
Name
Work Phone Number
After Hrs Phone #, pager or beeper
2D(ii) Will preanesthetic be administered?
No.
Yes. Complete information below.
Drug
Preanesthetic
Dose
Route
2D(iii) Will preemptive analgesic be administered?
No.
Yes. Complete information below.
Drug
Preemptive Analgesic
Dose
2D(iv) Provide information regarding induction of general anesthesia.
[28]
Route
Induction
Dose
Drug
Route
2D(v) Provide information on anesthesia maintenance.
Maintenance
Dose
Drug
Route
2E. Preparation of Animal. Check the procedures that will be performed.
Clip Hair
Scrub site. Provide disinfectant(s) which will be used to
prepare skin for aseptic surgery:
Place I.V. Catheter
Other. Describe below.
Description:
2F. Describe incision in animal, including location.
Description:
Location of Incision:
2G. Describe Operation/Manipulation.
Description:
2H. Intraoperative monitoring of animal’s condition. Indicate the specific methods you will use to monitor the state
of anesthesia and general well being. A complete description will include the name of the monitoring tests, when and how
often they will be used. Note: If a paralyzing agent will be used (see item 2 below), special methods must be used to
monitor adequacy of anesthesia since those that rely on a movement response to stimulus will be useless.
Check
All that
Apply
Method
Frequency
Toe pinch (withdrawal reflex)
Heart rate
Respiratory rate
Corneal touch (blink reflex)
Other (describe):
Must be at least every 10 minutes.
Must be continuously.
Must be continuously.
Provide frequency:
Provide frequency:
2I. Suture for closing incision.
2I(i) What type of suture will be used to close incision?
Suture type:
2I(ii) Size of the suture?
Size:
[29]
2J. Will animal survive after surgery?
No. Complete item i) below.
Yes. Skip item to j) below.
2J(i) How will animal be euthanized?
Method of Euthanasia:
2K. How long will animal survive after surgery?
Animal will survive for:
2L) Will multiple survival surgery be performed?
No. Go to m.
Yes. Complete information below.
21L(i) Description of multiple survival surgeries:
2nd Surgery
Explain procedure:
Interval between each successive surgery:
Scientific justification for performing more than one procedure in a single animal:
Location where this procedure will be performed. Provide building and room location.
3rd Surgery
Explain procedure:
Interval between each successive surgery:
Scientific justification for performing more than one procedure in a single animal:
Location where this procedure will be performed. Provide building and room location.
3) Surgery Location. Where will surgery be performed? (Check ALL that apply)
Check Below
Kennedy B36
Ullmann 1005
Hood with Barrier
Provide Information
Building:
Laboratory Area
Provide Information
Building:
Montefiore Medical Center
Provide Information
Building:
Room #:
Room #
Room #
NOTE: Area within the laboratory must not be used for any other purpose except surgery when procedure is
being performed.
4) Aseptic Surgery. All survival surgery must be performed aseptically.
4A. What method(s) will be used to sterilize surgical instruments, implanted materials and packs prior to surgery?
[30]
Method(s):
4B. Current EINSTEIN policy on surgery allows the re-use of surgical instruments in a single surgery session
(day) for rodent surgery only. However when reusing instruments in a single surgery, you may use the same instrument
on up to 5 animals within three hours. After that you must obtain new surgical instruments. Once it is opened, will the
same instrument pack or any of the surgical instruments be used on more than one rodent during a surgery session?
No
Yes. If Yes, complete table below.
4B(i) What method(s) be used to disinfect or sterilize surgical instruments that will be used between
animals during session?
Hot bead sterilizer
Cold Sterilizer (i.e.
Other (describe):
Dipped in 70% alcohol for 15 minutes followed by
rinsing in sterile saline/irrigating solution
4C. The following additional aseptic techniques must be used.
**
For Rodents (Rat & Mice)
REQUIRED:
 Sterile Gloves**
 Clean Gown/Laboratory Coat
 Sanitize Hand
 Face Mask
 Drapes
Clean Non-Sterile Gloves may only be used if
exposed tissue will not be touched (i.e. micro surgical
procedure)
For USDA Covered Species
REQUIRED:
 Sterile Gloves
 Full Surgeon Scrubs
 Mask
 Cap
 Surgical Drape
5) Post-Operative Monitoring. This will require that animals be identified using pink post-operative monitoring cards
available through the Institute for Animal Studies outside Ullmann 1003.
5A. Describe physical support methods (i.e. a source of heat to help maintain body temperature.
Description:
5B. Post-operative drugs: analgesics, antibiotics, fluids (also see item 4 below):
Name Drug / Fluid
Dose
Dose Schedule (You must include route, frequency,
duration or maximum number of doses)
6) Post-operative analgesia. Post-operative care MUST include assessment of the animal for pain and discomfort
including specific criteria for determining if the animal is uncomfortable or painful. Post-operative drug therapy should
include routine administration of an analgesic or a contingency plan with specific criteria for your decision to give or
withhold analgesia. It is generally considered preferable to err on the side of providing an analgesic that may not be
needed than to withhold one. For all procedures that constitute more than a minor surgery, analgesics should be
administered. Current veterinary standards indicate that pre-emptive analgesic use provides superior analgesic effect.
[31]
Therefore, the appropriate dose of analgesic should be administered prior to making the incision (ideally during the
anesthesia induction stage).
Preemptive analgesics are preferred for pain management and are generally effective with a single pre-operative dose.
Post operative care must include assessment of pain and discomfort. Must include assessment of pain in conjunction
with veterinary staff to determine use of additional analgesic.
6A. Will analgesic be administered in the operative period (pre-emptive or gas anesthetic)?
Yes, routinely an initial dose is given then subsequent treatments are based upon assessment of the animal’s
condition.
Describe below specific behaviors or symptoms, which will be used as criteria to identify a painful animal who will
be given the analgesic as indicated above. The description must include the monitoring schedule.
Description:
MEDICAL RECORD MUST INCLUDE NOTATIONS AS TO ANIMALS CONDITION TO SUPPORT DECISION TO
CONTINUE OR DISCONTINUE A TREATMENT
No, analgesics will not be given because the surgical procedure is minor, and animals return to normal activity,
eating and drinking within a few hours of this surgical procedure. Animals are checked twice per day following
surgery for two days. If, however, animals have not returned to normal activities within the first 12 hours, they will
be provided analgesic or euthanized.
No, analgesics cannot be given because the use of any analgesic will interfere with the objectives of this
experiment. The use of an analgesic is contraindicated because:
Provide reason:
Please scientifically justify how analgesics will interfere with experimental objectives. Below. Please provide
published references to support your claim if possible. This should also be included in search for alternatives in
item 21 of main form.
Scientific Justification:
6B. What criteria will be used to determine whether a post-operative animal should be euthanatized rather than
treated?
Criteria:
6C. Who will be responsible for postoperative care?
Name
Work Phone Number
After Hrs Phone #, pager or beeper
NOTE: To assist you in monitoring post-operative animals, all animals (including rodents) should have a post-surgical
card placed on their cage. Post-operative treatments and observations may be recorded on this card.
7) Suture Removal. Skin incisions generally heal within 10-14 days. Skin sutures or wound clips should not be left in
place beyond 2 weeks following surgery as they act as a foreign body, becoming a source of irritation and infection.
7A. Will skin sutures or wound clips be removed within 10 post surgery?
No. Answer 7B(i) AND 7B(ii) below.
Yes. Got to 8..
[32]
7B. Removal of skin sutures later than 10 days.
7B(i) When will sutures be removed?
Skin sutures will be removed:
(ii) Why must sutures be removed later than recommended?
Reason:
[33]
APPENDIX 6
– For Behavioral Core Use Appendix 7
FOR USE OF EINSTEIN CORE FACILITIES
IF MORE THAN ONE CORE FACILITY WILL BE USED, A SEPARATE APPENDIX 6 MUST BE COMPLETED FOR
EACH CORE FACILITY.
1) Indicate below which Core Facility will be used (should coincide with information from item III from main protocol form).
Also, please obtain a signature for the Core Director and/or designated core facility representative to acknowledge that
they have been consulted.
Indicate Core Facility
Acknowledgement that Core Facility
has Reviewed this Appendix (Provide Signature)
Choose One
The Core Facility should include any additional comments in this space:
2) Who will be responsible for animals during the time core services will be provided? (Check one)
The Core Facility. Provide their protocol number then go to item 1B. CORE’S APPROVED ANIMAL USE PROTCOL
NUMBER:
The Principal Investigator and/or Laboratory Personnel. Read note below and go to item 3.
PLEASE NOTE THAT IF CORE FACILITY WILL NOT BE RESPONSIBLE FOR ANIMALS DURING THE TIME CORE
SERVICES ARE PROVIDED, THEN ALL THE PROCEDURES THAT WILL BE PERFORMED BY THE PRINCIPAL
INVESTIGATOR AND/OR THE LABORATORY PERSONNEL MUST BE DESCRIBED IN THE MAIN PROTOCOL FORM
AND THIS APPENDIX.
3) If Core will be responsible, please attach a copy of your agreement with Core Facility and/or documents from the Core
Facility regarding their standard operating procedures.
Are documents attached?
Yes.
No. If you have not attached documents, please provide
explanation below.
3B) Explanation why forms have not been attached.
Explanation:
4) Describe any and all procedures to be performed in Core Facility not covered in other appendices. Check below
Non -noxious Testing
Potentially Stressful
Positive reward conditioning
Morris water maze
Open field behavior
Imaging procedures
Electrophysiology (ECG,
EMG)
Metabolism Cage
MRI
Radiography
EEG,
Addiction
/
drug
withdrawal
Tail Cuff Blood Pressure
Measurement
Restraint device – Prolong
> 30 minutes
[34]
Noxious Testing
Stress induction (cold, footshock, restraint) (radiography,
MRI)
Negative conditioning (footshock)
Tail flick test
Seizure induction
Irradiation
Microdialysis
MicroPET
If something other than those items listed above, please describe below.
Other. Describe:
5) Indicate location where procedure will be performed.
Location:
6) Provide frequency of test sessions.
Every day.
Every other day.
Every two days.
Other. Indicate frequency:
6) Provide duration of each test session.
Duration:
7) Indicate maximum number of test sessions on each animal.
Maximum number:
8) Total duration of other experimental procedures.
Hours:
Days:
Weeks:
Months:
Other:
9) Describe the parameters of each procedure and expected outcome. (Test parameters include the stimulus, stimulus
intensity, stimulus duration). Include the “readouts”, the physical or behavior modifying characteristics of the stimulus or
material administered or withdrawn.
Parameters:
10) Will any procedure cause more than momentary pain or discomfort?
No.
Yes. Complete items and b below.
10A) Describe below the procedures or methods used to minimize pain and discomfort or explain why such
methods cannot be used. You must include this search for alternatives in item 21 of main protocol form.
Description:
10B) Define specific humane criteria for removal of an animal from a potentially painful or stressful procedure
such as failure to succeed in a specified time, signs of exhaustion, inappropriate reactions, etc.
Define:
11) Describe the methods for monitoring the condition of the animal during and after the procedure.
Methods:
12) Provide the names and phone numbers of the person(s) who will perform these procedures and are responsible for
monitoring the condition of the animals.
[35]
Name
Work Phone
[36]
After hours phone, pager or beeper #
APPENDIX 7
OTHER EXPERIMENTAL PROCEDURES
REMINDER: FOR EINSTEIN’S BEHAVIORAL CORE YOU SHOULD COMPLETE THIS APPENDIX AND YOU WILL BE
REQUIRED TO ATTACH THE “CORE USER FORM” WHICH YOU SHOULD OBTAIN FROM BEHAVIORAL CORE
1) Describe any and all procedures not covered in other appendices. Check below
Non -noxious Testing
Potentially Stressful
Positive reward conditioning
Morris water maze
Open field behavior
Addiction / drug withdrawal
Imaging procedures
Tail Cuff Blood Pressure
Measurement
Electrophysiology (ECG, EEG, EMG)
Metabolism Cage
Restraint device – Prolong >
30 minutes
MRI
Radiography
MicroPET
If something other than those items listed above, please describe below.
Other. Describe:
Noxious Testing
Stress induction (cold, footshock, restraint) (radiography, MRI)
Negative conditioning (footshock)
Tail flick test
Seizure induction
Irradiation
Microdialysis
2) Indicate location where procedure will be performed.
Location:
3) Provide frequency of test sessions.
Every day.
Every other day.
Every two days.
Other. Indicate frequency:
4) Provide duration of each test session.
Duration:
5) Indicate maximum number of test sessions on each animal.
Maximum number:
6) Total duration of other experimental procedures.
Hours:
Days:
Weeks:
Months:
Other:
7) Describe the parameters of each procedure and expected outcome. (Test parameters include the stimulus, stimulus
intensity, stimulus duration). Include the “readouts”, the physical or behavior modifying characteristics of the stimulus or
material administered or withdrawn.
Parameters:
8) Will any procedure cause more than momentary pain or discomfort?
No.
Yes. Complete items and b below.
8A) Describe below the procedures or methods used to minimize pain and discomfort or explain why such
methods cannot be used. You must include this search for alternatives in item 21 of main protocol form.
[37]
Description:
8B) Define specific humane criteria for removal of an animal from a potentially painful or stressful procedure such
as failure to succeed in a specified time, signs of exhaustion, inappropriate reactions, etc.
Define:
9) Describe the methods for monitoring the condition of the animal during and after the procedure.
Methods:
10) Provide the names and phone numbers of the person(s) who will perform these procedures and are responsible for
monitoring the condition of the animals.
Name
Work Phone
After hours phone, pager or beeper #
11) Are you obtaining services from Einstein’s Behavioral Core?
No.
Yes. You must attach the “Core User Form” signed by
the Core Director OR the Director’s Assignee. You can
obtain the form from the Behavioral Core.
[38]
APPENDIX 8
BIOSAFETY/CHEMICAL/RADIATION SAFETY PRECAUTIONS
This section of the protocol form refers to the use of: potentially hazardous chemicals,
biological materials (infectious agents, human tissues or cells), recombinant plasmid / viral
vectors, and radioisotopes in animals. Please read the instruction below for completing this
appendix:
 List all substances from Appendix 2 (Test Substances) from main animal use protocol that are
considered hazardous or potentially harmful in this appendix.
 To expedite the review and approval of this appendix, you must attach (when available – see
below) sufficient information on the hazardous agents listed in the table.
 Please complete as much information as you can in ALL the columns in the table, as missing
information will delay the review process of the animal use protocol by the IACUC and EH&S.
 You MUST complete and attach a Standard Operating Procedure (SOP) for each of the
hazardous agent(s) listed in item 1, Summary Table classified as: ABSL-2, ABSL-3, CSL-2, RS1A, RS-1B, and RS-2. You may download some SOPs from the IACUC website (List of
Hazardous Agents). If there is no SOP on IACUC website, you are required to complete an SOP
(see item 3 below).
 YOU MUST contact the IAS Facilities Manager, [email protected], and inform IAS
before initiating any studies using the Hazardous Agents listed below.
 You MUST complete and attach a Hazard Sign for each of the hazardous agent(s) listed in the
table classified as: ABSL-2, ABSL-3, CSL-2, RS-1A, RS-1B, and RS-2. Signs will be laminated
and affixed to the door by the IAS animal care staff when experiments start. You may download
sign from item 4 below.
1. Summary Table: Please list all agents that are potentially hazardous below.
YOU SHOULD PROVIDE ALL INFORMATION IN EACH COLUMN
Hazardous Agents
Problem Cause if Human
Exposed
Animal Safety Protocol
(attached)
Check Appropriate
Boxes Below
ABSL-1
ABSL-2
ABSL-3
CSL-1
CSL-2
RS-1A
RS-1B
RS-2
[39]
Bedding
changed by:
IAS
Laboratory
Specific Holding time (IF
ANY) for:
For
animals:
For
cages:
ABSL-1
ABSL-2
ABSL-3
CSL-1
CSL-2
RS-1A
RS-1B
RS-2
ABSL-1
ABSL-2
ABSL-3
CSL-1
CSL-2
RS-1A
RS-1B
RS-2
ABSL-1
ABSL-2
ABSL-3
CSL-1
CSL-2
RS-1A
RS-1B
RS-2
Bedding
changed by:
For
animals:
For
cages:
For
animals:
For
cages:
For
animals:
For
cages:
IAS
Laboratory
Bedding
changed by:
IAS
Laboratory
Bedding
changed by:
IAS
Laboratory
2. Standard Operating Procedures (SOP) – MUST BE ATTACHED TO PROTOCOL.

You must complete and attach an SOP for each of the hazardous agent listed in the table
classified as: ABSL-2, ABSL-3, CSL-2, RS-1A, RS-1B, and RS-2 which you may download
from the IACUC website.

If you were unable to locate an SOP on the IACUC website for any of the hazardous agents
listed in the table above, then you must:
o Search Material Safety Data Sheets (MSDS) and attach. MSDS are available through
the website of the Department of Environmental Health and Safety (EH&S).
o Download, complete and attach the appropriate Animal Safety Protocol(s), based upon
the information you have provided in column 3 of the table above, from:
SOP Templates
(Click link below)
Animal Biosafety Level 1
Animal Biosafety Level 2
Animal Biosafety Level 3
Examples
Adeno-Associated virus, E. coli non-pathogenic strains, B. subtilis, S.
cerevisiae)
Pathogens/parasites that have some risk of transmission among
animals and to humans, viral vectors, human tissue.
Pathogens that have risk of transmission to humans by aerosol.
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Animal Chemical Safety Level
1
Animal Chemical Safety Level
2
Radiation Safety Level 1A
Radiation Safety Level 1B
Radiation Safety Level 2
Chemicals/toxins that are low toxicity and not excreted as active
metabolites in urine or feces.
Chemical/toxins that have active metabolites excreted in feces urine
or residual in carcass.
Non-terminal studies with “long-lived” radioisotopes.
Any
radioisotopes with long half-lives, such as H-3 and C-14 with
concentrations in the animal greater than 0.05 microcuries per gram
that are used in animals that are maintained for a period after
treatment.
Non-terminal studies with “short-lived” radioisotopes. Radiation Any radioisotopes with short half-lives, such as I-125, I-131, Tc-99m,
P-32, S-35, and Cr-51 that are used in animals that are maintained
for a period after treatment.
“Long-lived and Short-lived” radioisotopes. Terminal procedures
[radioisotopes used in animals in the laboratory as part of a terminal
experiment in which the animals are killed within 12 hrs of treatment.
4. Hazardous Signs for agents classified as ABSL-2, ABSL-3, CSL-2, RS-1A, RS-1B, and RS-2
MUST BE ATTACHED TO THIS PROTOCOL (IAS will affix on door(s) where animals are housed).
Complete, print and attach the appropriate sign (which provide necessary instructions regarding
signage for your animal room). You may download the appropriate sign below:
Biohazard Signs:
Chemical Hazard Signs:
Radioactive Material Signs:
Hazardous Signs
ABSL2
RSL1A
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ABSL3
CSL2
RSL1B
RSL2