IACUC Animal Protocol Writing Workshop 101

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IACUC Animal Protocol
Writing Workshop 101
How to Write an Effective and
Successful Animal Activity Protocol:
Hands On Training
A Good Sources of Information

Working with the IACUC: Writing an Animal Protocol
AALAS Publication: American Association for Laboratory Animal Science
www.aalas.org “Bookstore” link

How to Write an Application Involving Research Animals
www.niaid.nih.gov/ncn/clinical/researchanimals/tutorial/index.htm

Guidelines for the Care and Use of Mammals in Neuroscience and
Behavioral Research
ILAR Publication: Institute for Laboratory Animal Research
www.national-academies.org/ilar
Protocol Form
6 sections

General information

Number of animals

Surgical and non-surgical procedures

Alternative considerations and literature search

Statement of Assurances

IACUC actions
1.
Name
Principal Investigator
Susan Warren, Ph.D.
Title
Associate Professor
Dept
Anatomy
Ext/pager
X4-1671
email
swarren@anatomy.umsmed.edu
Must be full-time UMC faculty
(Instructor – Professor)
Other Personnel
Name
Eddie Perkins
Name
Title
grad student
Title
Dept
Anatomy/Neurosurgery
Dept
Ext/pager
X4-1671
Ext/pager
email
Name
email
Olga Golanov, MD
Name
Title
research tech
Title
Dept
Anatomy
Dept
Ext/pager
email
Post Doc
X4-1662
undergraduate student
Ext/pager
email
Identify all persons associated with the animal work. This information
assists the LAF and IACUC in contacting knowledgeable persons to
answer questions/concerns relative to the animal experimentation.
For access to the animal facility, all personnel working on this protocol
must be listed.
Laboratory Personnel Training
Certification
Have all the individuals listed above submitted their
completed training requirements registration form?
Yes
No
If no, you must complete
the IACUC Mandated online training requirement
(www.researchtraining.org)
And complete the IACUC Training Registration Form
Project Title
This title will be used in the IACUC database to
identify the project. (may be the same as the
grant title)
The title should briefly state procedures to be
carried out and the animal species to be used.
Project Title - Examples
Tissue Harvest in Rats
Health Monitoring of Guinea Pigs
Production of Transgenic and Gene Knockout
Mice
Evaluation of Drugs for Osteoporosis in
Squirrel Monkeys
Breeding protocol for AXt-1a knockout mice
4.
Proposal is
New - designation of a de novo submission
Revision of Existing Protocol - designation of
amendments/revisions to the protocol. Any
“revised” information should be easily
identified [highlighted, bold, italics,
colored font]
3 year Full Submission
designation of a previously approved protocol
that must be re-written after three years
Needs to include Appendix K
5.
Outside Contracts?
Will any “outside” contracts be used in this study that
involve live animals (antibody production, toxicology
screening, subcontracts with other facilities, etc)?
No
Yes (provide information on the level of involvement)
Mark YES if any non-UMC entity will be involved in any animal care
and use activities. Examples include housing your animals at another
institution for specialized procedures, use of a contract toxicology
research lab, antibody production techniques by another lab, etc.
6.
Funding Source
This question aids the IACUC and LAF in
allocation of resources.
In times of lean animal housing space, the LAF
will further give top priority to those extramurallysupported protocols.
Generally, the IACUC does not attempt to
provide scientific review of a protocol, yet is
obligated to provide some level of scientific
review for those departmentally-funded protocols
lacking any peer review.
6.
Funding Source
Title: Grant Application Title
Grant
Funding Agency: NIH, NSF, American
Heart, etc
Covered Dates: 11-01-04 thru 1-31-07
Departmental Funds
Has this proposal received any peer review?
YesNo
Pending
7.
Procedure Category
Acute (anesthesia without recovery or euthanasia)
Acute procedures not only refer to an anesthesia without recovery, but
also those studies where no advance forms of animal manipulations
have occurred.
Examples include
animal sacrifice
tissue collection
terminal surgical procedure
7.
Procedure Category
Survival
Survival procedures not only include survival surgical procedures but
any animal manipulations that may be conducted on the animal.
Examples include



any type of dosing (oral, feeding, injections,
topical, gavage, etc)
sample collection (blood, urine, CSF)
behavioral experimentation (swim test, radial
arm maze, single unit recording)
8.
Dates of Study
A.
Anticipated start date of study: 2-23-04 thru 1-31-07
B.
Study Duration (maximum 3 years): 2 years
Response assists the LAF in planning/coordinating
space for the study.
9.
Animal Requirements
Species
Strain/
Stock
Sex
rat
SD
mouse
C57BL/6
Source
Total for
Project
Average
daily census
male
213
13
female
113
21
List all animals required to complete the study.
Animal numbers must be calculated for a period of three years.
Complete all columns of the chart.
If using nonhuman primates, must complete Appendix A.
If using time pregnant animals, must complete Appendix B.
If using animals from an in-house breeding program, must complete
Appendix B.
10.
Breeding Program
Will animals be involved in a breeding program at
UMMC or will time-pregnant animals be used?
•No
•Yes (provide information in Appendix B)
Mark YES for any study proposal involving animal mating or for
proposals utilizing time-pregnant animals. Must also include
Appendix B.
11.
Potential Hazards
Yes
A
No
Pending
Chemical toxins in bedding/cages/carcasses?
Reviewed by Risk Mgmt?
B
Radioisotopes in bedding/cages/carcasses?
Reviewed by Radiation Safety?
C
Infectious agents or recombinant DNA usage?
Reviewed by Biohazards Committee?
If YES, provide specific details of specialized animal husbandry, care,
cleaning, or decontamination procedures, especially identifying responsible
parties.
11.
Potential Hazards
Specific check boxes are included for chemical, radioisotopes,
and/or infectious agent exposures in research animals. Boxes
should be checked where appropriate and the proposal must be
reviewed by the responsible oversight group. IMPORTANTLY,
any YES answers must also include specific details of any
specialized animal care procedures to be used, paying particular
attention to occupational safety of animal caretakers. The
explanation should state type of exposures, personal protective
equipment to wear, decontamination procedures, and any other
relevant information.
12.
Animal Husbandry
Standard
Non Standard
Feeding
High/low sodium
chow; beef fat
Watering
sweetener/
alcohol/water
restriction
Caging/Housing
Metabolic cages/
single housing
following surgical
implants
12.
Animal Husbandry
Standard:
•
•
•
Standard methods for UMC include
ad lib access to water
LAF feeding of commercial diets
conventional housing
12.
Animal Husbandry
Nonstandard: Examples include
providing limited access to water
limited quantities of water
feeding specialized diets (e.g., high fat, High/Low
sodium)
feeding specialized amounts
“unconventional” housing (metabolic cage, single
housing)
behavioral manipulation of environment (e.g.,
changes in light-dark cycle)
13.
Housing
Will animals be housed outside of the LAF for greater than 12 hours?
No
Yes
Note:
Where?
If yes, provide complete explanation and justification for any de-
centralized animal housing.
Mark YES for any proposal that requires an animal to be maintained in a
laboratory/testing location in excess of 12 hours. Any location
maintaining animals for greater than 12 hours will be considered as a
housing location and must be maintained in accordance with the USDA,
OLAW, and AAALAC. The IACUC will need to provide approval for such
sites.
14. Objectives in lay terminology
In non-technical/lay terminology, what is the
objective of the experiments proposed in this Animal
Activity Protocol? (i.e. Response should be written in
non-scientific language, as though explaining the study
to a high school student.
Why
are the experiments proposed?
What
knowledge do you hope to achieve?
Generally,
single sentence explanations for these
types of questions will suffice
14. Objectives in lay terminology
Important to write response in non-technical, lay
language. Imagine this response presented to a local
news media. Ideally, this response will highlight a
particular human/animal problem that the study
seeks to investigate.
•How
will the use of animals help you investigate this
particular problem?
•What
answers do you anticipate from the proposal?
15.
Rationale
A. What is the rationale for using the particular
animal species noted in #9?
This question seeks to understand why a particular animal is
noted in #9. Literature searches provide numerous examples of
appropriate animal models for specific types of studies. This
response should support the animal species noted in #9. Cost
alone should not be a reason for choosing a particular animal
species.
B. What is the rationale for using animals rather
than using non-animal models?
This question seeks to understand if all in vitro, inanimate models
have been considered. In many cases, in vitro methodologies may
exist that could support the study, yet will not provide the level of
understanding required to meet the objectives. If in vitro methods
are being used in conjunction with animal, state that also.
16.
Brief Outline
Provide a general description of the animal
procedures included in the experimental design.
Briefly
outline the proposed animal manipulations
and provide a time-line of events.
Note
that specific details about methods and
procedures will be required in the appropriate
appendix (see list below)
Verbatim
descriptions from a grant submission
are not acceptable and will not be reviewed.
16.
Brief Outline
Appropriate responses to this question will briefly outline all
animal manipulations. This question also contains a check
list of related appendices (A through K). Investigators will
note that many specific details of surgical procedures,
sample collection, administration of test compounds,
antibody production, etc will necessitate completion of the
appropriate appendices.
An important consideration for inclusion is a
time-line of events. This time-line helps the
IACUC clarify the proposed work.
16.
Brief Outline
For example, a study seeks to feed an experimental diet to rabbits then surgically
instrument each animal with telemetry devices. Following the surgery, the
animals will be monitored for 4 weeks and intermittent urine/fecal samples will be
collected.
Diet 1
2 weeks
6 week
old rabbits
Diet 2
2 weeks
Surgical
manipulations
4 weeks
Urine/fecal
sample
Sacrifice
Example Answer







In this response, #16 would include information about the diet,
especially if potential nutrient deficiencies were anticipated. General
information about the surgical procedure would be included.
Likewise, any information about urine/fecal collection methods
would need to be a part of the response (metabolic cage,
catheterization, litter pan retrieval, etc).
A probable time-line might be:
Experimental diet (4 weeks) →Telemetry implant (1 day) → Monitor
(4 weeks) → behavioral test (forced swim) → euthanasia
Additionally, the following appendices must be included:
Appendix C [Surgery]
Appendix D [Biological samples]
Appendix F [Administration Test Compound (diet)]
Appendices
Appendix A
Environmental Enhancement/Enrichment
Appendix B
Breeding Programs
Appendix C
Surgery & Management of Surgical Pain & Distress
Appendix D
Collection of Biological Samples
Appendix E
Antibody Production
Appendix F
Administration of Drugs/Test Compounds
Appendix G
Prolonged Physical Restraint
Appendix H
Multiple Major Surgical Procedures
Appendix I
Food and /or Fluid Restriction
Appendix J
Animal Pain and/or Distress
Appendix K
Progress Report
Check and complete only those appendices that apply to the animal
manipulations in your experimental design.
17. Justification of Animal Number
The total number of animals needed to complete item #16 should be
explained in this response. Likewise, this number should match the
requested number provided in #9.
It is often beneficial to include a flow diagram or
chart/table that defines the animal use.
Break numbers down into number of animals/group,
number of groups, number of replicates, etc.
Any animals needed for pilot work or training new
technical personnel should be accounted for.
Responses should have some statistical merit.
18. Location and Transportation
A. Indicate room(s) where animal procedures will be
conducted.
This response is noted in the IACUC database as
the experimental area.
Semi-annual program reviews will include this
location into subsequent inspections.
Likewise, affirmative answers to #13 (Housing)
should also be listed in this response.
18. Location and Transportation
B. Studies involving animal transportation to locations other than
the housing area must identify the animal transport device, the
nature of shrouds used to cover the transport device, and
describe the route of transport
Numerous laboratories are required to remove their animals from
the LAF environment to their respective labs. The method and
route of transport should be courteous to Medical Center
visitors/patients, conscious of occupational exposures, and
respectful of those opposing the use of animals in research. All
animal movement must occur in appropriate restraint boxes/cages
and with a concealment shroud/drape. Consult LAF SOPs for
descriptions of routes of appropriate animal transportation.
19A.
Euthanasia
A. At what point in the proposed experiments will animals
normally be euthanized (experimental end-points)? Or
at what point will any individual animal be euthanized?
This response would correlate with the experimental end
points described in #16. The question seeks to clarify
the IACUC’s understanding of when any particular
animal will conclude the study.
19B.
Euthanasia
B. What criteria will be used to determine if an animal is to
be euthanized prior to, rather than at, the anticipated endpoint of an experiment? Note: Contact LAF, ext.4-1385, for
recommendations on the assessment criteria.
The appropriate response will articulate potential adverse
consequences or effects of the experiment. Investigators should list
potential surgical complications, adverse effects of drug/diet
administration, or failure to manage pain and distress. Specific,
objective criteria may also be incorporated (e.g., 20% loss in body
weight, hematocrit falls below 25%, creatinine levels above 2.5 mg/dl,
etc) to note when an animal is removed from the study.
19C.
Euthanasia
C. If proposing a natural death (or death due to
manipulations), explain and justify.
This type of scenario is described as “death as an endpoint”.
These studies must firmly justify the scientific need to allow an
animal to advance through a potentially painful/distressful terminal
event. Unless information to the contrary is known, it is assumed
that all “death as an endpoint” studies will result in some level of
pain and/or distress to the animal while in the moribund state.
Ideally, some definitive, objective criteria can be used to “measure”
when an animal can be removed. For example, in a model of renal
failure, perhaps BUN levels >100 coupled with Cr values >3.5 are
indicative of end-stage kidney disease and will provide the
necessary endpoints. Likewise, in an oncology study, perhaps
tumor growth beyond a specific size could be used.
20.
Euthanasia Procedures
What procedures will be used to euthanize the animals?
Note: Secondary methods are recommended to ensure
death. (Consult Section VII of the LAF Training and
Procedural Manual for appropriate methods of
euthanasia.)
Procedures must be consistent with the 2000 Report of
the AVMA Panel on Euthanasia [copy located in the LAF
Training & Procedural Manual]. Likewise, secondary
methods should be proposed to ensure and/or guarantee
death. Secondary methods are typically those involving
exsanguination, pneumothorax, or tissue harvest.
Assurances
Institutional requirement for all persons to be registered
and known by the health services organization.
Have all personnel received a medical evaluation
from UMC Student/Employee Health?
Have all personnel become familiar with the LAF
Training & Procedural Manual?
Assurances
The LAF Training and Procedural Manual is jointly
produced by the LAF and the IACUC. The manual is
designed to answer many commonly asked questions
and address particular areas related to animal-based
research programs at UMC.
Each Principal Investigator is issued a copy of the
manual. The manual should be available to all
research personnel in the laboratory in an effort to
foster a better understanding of animal care and use
programs.
Assurances
To comply with the USDA’s Animal Welfare Act [9
CFR, part 2, Section 2.31 (d)(1)(ii) and (iii)] you must
complete a written NARRATIVE of the sources you
consulted to determine whether or not alternatives
exist to procedures that may cause pain and distress.
Likewise, this search will ensure that the proposed
studies are not unnecessarily duplicative.
Assurances
Review of the available resources and previous
experiments have determined that the proposed
activity is not unnecessarily duplicative of
previously reported activities?
The question seeks to prompt the investigator to
conduct a literature review and assure the IACUC
that the proposal does not duplicate existing
work.
Appendix A: Environmental Enhancement/
Enrichment
Enrichment Techniques
Are there any enrichment forms/techniques that are included in this protocol? YES NO
Description
Describe the above techniques
No Enrichment?
Are there any forms of enrichment/enhancement that should not be used in this study? YES
NO
Justification for exemption
YES
NO
If YES, provide complete justification for this exemption
Appendix B: Breeding Programs
Complete Appendix B for all proposals planning on establishing a breeding colony or for
those studies utilizing time-pregnant animals. Studies incorporating breeding programs
or offspring from time-pregnant animals will be required to report annual production
(number of offspring used) at the time of IACUC protocol annual renewal.
1. Description
Provide a specific description of the type of breeding program to be utilized
(harem, monogamous pair, etc).
2. Personnel Responsible
Identify personnel responsible for the breeding program.
3. Records
Identify personnel responsible for maintaining breeding program records.
Appendix B: Breeding Programs
4. Adults
How many adults will be utilized in this breeding program?
5. Final Disposition of Adults
What is the final disposition of these adults at the conclusion of their
breeding program?
6. Offspring
How many offspring are anticipated from each breeding or time-pregnancy?
7. Final Disposition of Offspring
What is the final disposition of any offspring not utilized in the experimental
program?
Appendix C
Surgery & Management of Surgical Pain and
Distress
1.
A Complete description of surgical procedure
Surgical site preparation
The surgical site will be shaved, cleansed with soap,
swabbed with alcohol and bathed in providine solution
Surgical approach
A midline incision will extend from brow ridge to the
occipital protuberance. The skin and underlying muscle will
be reflected. A bilateral craniotomy will be made 3 mm from
the midline using a hand-held drill equipped with a ¼” burr.
Any unique or special
techniques
An ICV cannula, having an internal diameter of 0.25 mm,
will be implanted via a craniotomy into the underlying
lateral ventricle and cemented to the skull using dental
acrylic and stainless steel screws.
Wound closure method, suture
materials, and suture removal
plan
Wound will be closed in layers. Vicryl suture will be used
for muscle. Silk sutures will be used for skin. Skin sutures
will be removed 7-10 days post-operatively
Appendix C Item 2A: Formulary
Agent
Dose
Pre-anesthetic
ketamine HCL
Atropine sulfate
Acepromazine
Xylazine
10mg/kg
Anesthetics
Analgesics
Antibiotics
Frequency/Duration
im
once for cage
removal
sodium
pentobarbital
Isoflurane
iv,
inhalant
1 time for
induction; 2-5
hours
Sensorcaine
Carprofen
buprenorphine
im, sub q 1x for 2-3 days;
1x every 12 hours
Ibuprophin
Fluid/blood
replacement
Route
5% lactated
ringers
Appendix C: Anesthesia
2b. Anesthesia
Who will conduct the anesthesia procedure(s)?
List Individual(s) by name
2c. Anesthesia criteria
What criteria will be used to assess anesthetic depth and how will this
be monitored?
toe pinch, reduced/absent corneal reflex, withdrawal reflex
3. Experience/training
Describe the training/experience, including species of animals, of
personnel conducting the anesthetic procedure?
List individual named in #2B and indicate level of training, number
of years actively involved in procedure, and what species he/she
has worked
Appendix C: Surgical Procedures
4. Surgical procedure
Who will conduct the Surgical procedure(s)?
List individual(s) by name
5. Experience/training
Describe the training/experience, including species of animals, of
personnel conducting surgical procedures?
List individual named in #4 and indicate level of training, number
of years actively involved in procedure, and what species he/she
has worked.
6. Location of procedures
Where will the surgical procedures be conducted?
Indicate Room in which dedicated space for surgical procedures
is located, e.g., LAF procedure room, R-717, N-412.
Criteria for Assessing Level of Anesthesia









Respiration rate
Heart rate
ECG
Toe pinch
Tail pinch
Corneal reflexes
Color of mucous membranes
Muscle relaxation
Other


Pulse oximeter
respirometer
Appendix C: Post-operative Care and
Emergencies
7. Experience/training
Who will conduct and document post-procedural animal care? (post-op
analgesia, nursing care, etc.) Include a plan of monitoring frequency,
duration and intervals of post-op analgesia, nursing care, etc.?
List Individual responsible
Indicate a plan for monitoring - twice daily for the first three days;
three times per week for the duration of the recovery period
8. Emergency Contacts
Emergency contact (pager/phone number) for evenings or weekends
concerning post-operative complications.
Provide a named individual(s) and appropriate phone/pager
numbers
Appendix D: Collection of Biological Samples
from the Live Animal
Biological samples include blood collection, urine collection, ascites, cerebrospinal fluid, biopsy, etc. Appendix D is
completed for all sample collections from live animals (excludes sample collection at necropsy.
Indicate the body fluid or material to be collected.




Indicate the method and site of collection.
Indicate the volume of fluid or material to be collected.
Indicate the frequency of collection.
Will the animal(s) be anesthetized or sedated during this procedure?
YES NO
Agent
Dose
Route
Frequency/Duration
Appendix E: Antibody Formation / Tumor Induction /
Hybridoma & Ascites
Indicate what antigen will be used.
Indicate what vehicle/adjuvant will be used:
initial immunization:
subsequent immunizations:
anticipated complications/side effects:
Indicate sites for immunization:
Indicate route of administration:
What is the total and per site injection volume?
What is the frequency/duration of immunization (e.g., 1 injection every 2 weeks
for 3 injections)?
Appendix E: Antibody Formation / Tumor Induction /
Hybridoma & Ascites
ASCITES PRODUCTION
Fluid accumulation associated with ascites/hybridomas should not become
greater than 10% of body weight. Animals should be euthanized if they become
moribund.
Indicate the maximum volume of ascites fluid to be collected per sampling
(ml/mouse) and the method of collection (skin prep, gauge needed, gravity vs
suction, etc)
Indicate the number of fluid collections and anticipated frequency of collection.
Describe procedures used to care for and monitor the health of animals with
ascites and the point of euthanasia.
Appendix F: Administration of Drugs/Test Compounds
All agents listed in Animal Activity Protocol question #11 (Potential Hazards to personnel or other animals) must be listed in this section.
Additionally, other experimental (Test) compounds used in the study should be noted. This section is not for the listing of veterinary
pharmaceuticals (antibiotics, anesthetics, analgesics).
1. Provide the Following Information
Agent
WGA-HRP
BDA
Dose
Volume
Vehicle
Route
Frequency
20% solution
0.01-0.05 ul
sterile water
one time
4% solution
0.1-0.5 ul
sterile water
one time
BDNF
MK801
2. Describe any potential adverse side effects that may result from the administration of this material. If
agents are unknown or their potential side effects are not documented, provide a reasonable estimate of
the effects of the general class of chemicals (e.g., cmpd may have sedative properties, cmpd will likely
produce diarrhea, etc). No adverse affect anticipated. We will consult with the veterinary staff should
unanticipated problems arise.
3. What special procedures do animal care personnel and veterinary caregivers need to assume when
working with these animals or their bedding/cages? These compounds pose no threat to the health and
welfare of the animal care staff.
Appendix G: Prolonged Physical Restraint
Justify the need for prolonged physical restraint.
Why you need to employ restraint – safety of the animal during procedure;
training
Describe the restraint device: Tether, harness, primate chair
Describe how the animal(s) will be adapted to the restraint device.
Detail the time frame for adaptation to device; detail any
rewards/encouragements used to achieve compliance
What is the duration of a restraint period?
Daily – indicate the total numbers of hours/day
Long term - weeks/ months
Appendix G: Prolonged Physical Restraint
Are animals monitored during the restraint period? Yes No
If YES, describe who and document procedures
How often?
Are there any anticipated problems as a result of the restraint
device (e.g., skin lesion from harness, moist dermatitis, etc)
Indicate plan for monitoring and detail procedure for
corrective measures
Appendix H: Multiple Major Survival Surgical
Procedures
A major surgical procedure is defined as a surgical intervention that penetrates
or exposes a body cavity (peritoneal, thoracic, cranium) or produces substantial
impairment of physical or physiologic function. Multiple major procedures are
those whereby an animal will regain consciousness after each procedure.
Procedures must be described in Appendix C. A major surgery followed by a
second procedure where the animal is sacrificed is not considered in
multiple major surgical procedures.
Justify the need for multiple major surgical events in a single animal.
Need for sequential administration of tracer materials; need to instrument animal proir to
manipulations
What is the time interval between the surgical events?
Day to weeks to months
Appendix I: Food and/or Fluid Restriction
1.
Will FOOD or FLUIDS be restricted?
Justify the need to restrict food and/or fluid.
2.
Check all methods that will be used to ensure
adequate nutritional intake and hydration
FREQENCY OF CHECKS
METHOD
Body weight
Urine output
Fecal output
BUN
Hct
Food intake
Appendix I: Food and/or Fluid Restriction
3.


4.

Restriction protocols typically base the restriction amount relative to a
baseline, (free-choice consumption) parameter (body weight, intake
amount).
What will this restriction amount use as the baseline?
What is the maximum % restriction for any animal?
Growing animals must be frequently re-assessed to ensure normal
growth patterns.
What provisions will be made for these animals to assure that their
nutritional needs are maintained?
5.
The Animal Welfare Act states that if “water is not continually available, it must be
offered to them as often as necessary to ensure their health and well-being, but no less
than twice daily for at least 1 hour each time, unless otherwise required by the
attending veterinarian”.

Will animals be provided unrestricted access to water/fluids twice
daily for at least 1 hour each time? Yes
No
If NO, explain and justify
Appendix J: Animal Pain and/or Distress
1.
Justify the scientific need to withhold appropriate drugs or induce the
pain/distress.
2.
What is the duration of time that an animal may experience this
pain/distress.
3.
Describe non-pharmaceutical means to alleviate pain/distress (soft bedding,
social housing, supplemental heat, etc).
4.
Describe situations where an animal may be removed prematurely from a
study.
Appendix J: Animal Pain and/or Distress
NON-SURGICAL PAIN/DISTRESS
5.
Describe those proposals whereby animals are likely to
experience more than momentary pain or distress as a result
of manipulations or procedures (noxious injections, tumor growth,
sequelae to compound administration, etc).
6.
Will any anesthetics, analgesics, or tranquilizing drugs be
used to reduce this pain or distress?
7.
What non-pharmaceutical measures will be used to minimize
discomfort, distress, pain, or suffering (e.g., fluids, supplemental
heat, soft bedding, etc)?
Criteria used to Assess
Pain/Distress/Discomfort








Loss of appetite
Loss of weight
Restlessness
Abnormal resting posture
Licking, biting, scratching, shaking
Failure to show normal patterns of inquisitiveness
Failure to groom
Guarding
Criteria used to Assess
Pain/Distress/Discomfort
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Loss of mobility
Red stain around eyes (rats)
Unresponsiveness
Self-mutilation
Labored breathing
Other
Appendix K: Progress Report
This appendix must accompany every 3 year
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