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IACUC Animal Protocol Writing Workshop 101

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Title: IACUC Animal Protocol Writing Workshop 101


1
IACUC Animal Protocol Writing Workshop 101
  • How to Write an Effective and Successful Animal
    Activity Protocol Hands On Training

2
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/tu
    torial/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

3
Protocol Form
  • 6 sections
  • General information
  • Number of animals
  • Surgical and non-surgical procedures
  • Alternative considerations and literature search
  • Statement of Assurances
  • IACUC actions

4
1. Principal Investigator
Must be full-time UMC faculty (Instructor
Professor)

5
Other Personnel
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.

6
Laboratory Personnel Training Certification
7
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.

8
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

9
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
10
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.      
11
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 extramurally-supported
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-fund
ed protocols lacking any peer review.

12
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?
  • Yes No Pending


13
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

14
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)

15
8. Dates of Study
  • 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.
16
9. Animal Requirements
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.
17
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.

18
11. Potential Hazards
19
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.
20
12. Animal Husbandry
21
12. Animal Husbandry
  • Standard Standard methods for UMC include
  • ad lib access to water
  • LAF feeding of commercial diets
  • conventional housing

22
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)

23
13. 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.
24
14. Objectives in lay terminology
25
14. Objectives in lay terminology
26
15. Rationale
27
16. Brief Outline
28
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.
29
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.
2 weeks
Diet 1
Surgical manipulations
6 week old rabbits
4 weeks
Diet 2
2 weeks
Urine/fecal sample
Sacrifice
30
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)

31
Appendices
Check and complete only those appendices that
apply to the animal manipulations in your
experimental design.
32
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.

33
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.

34
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.
35
19A. Euthanasia
  • 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 IACUCs
    understanding of when any particular animal will
    conclude the study.

36
19B. Euthanasia
B. What criteria will be used to determine if an
animal is to be euthanized prior to, rather than
at, the anticipated end-point 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.
37
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 gt100
coupled with Cr values gt3.5 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.
38
20. Euthanasia Procedures
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.
39
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?

40
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.
41
Assurances
To comply with the USDAs 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.
42
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.
43
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


44
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.
45
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?
46
Appendix C Surgery Management of Surgical
Pain and Distress
1. A Complete description of surgical procedure
47
Appendix C Item 2A Formulary
48
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
49
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.
50
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

51
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
52
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

53
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)?      
54
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.
55
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
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.
     
56
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      
57
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
58
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
59
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
60
Appendix I Food and/or Fluid Restriction
  • 3. 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?   
  •   
  • 4. 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


61
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.    
62
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)?
63
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

64
Criteria used to Assess Pain/Distress/Discomfort
  • Loss of mobility
  • Red stain around eyes (rats)
  • Unresponsiveness
  • Self-mutilation
  • Labored breathing
  • Other

65
Appendix K Progress Report
This appendix must accompany every 3 year Full
Submission
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