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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

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IACUC Animal Protocol Writing Workshop 101


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iacuc animal protocol writing workshop 101

IACUC Animal Protocol Writing Workshop 101

How to Write an Effective and Successful Animal Activity Protocol: Hands On Training

a good sources of information
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
Protocol Form

6 sections

  • General information
  • Number of animals
  • Surgical and non-surgical procedures
  • Alternative considerations and literature search
  • Statement of Assurances
  • IACUC actions
slide4

1.Principal Investigator

Must be full-time UMC faculty

(Instructor – Professor)

slide5

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.

slide7

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.
slide8

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
slide9

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
slide10

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.

slide11

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-funded protocols lacking any peer review.

slide12

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
slide13

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
slide14

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)
slide15

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.

slide16

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.

slide17

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.
slide19

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.

slide21

12. Animal Husbandry

  • Standard: Standard methods for UMC include
  • ad lib access to water
  • LAF feeding of commercial diets
  • conventional housing
slide22

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)
slide23

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.

slide28

16. Brief Outline

Appropriate responses to this question will briefly outlineall 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.

slide29

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

example answer
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)]
slide31

Appendices

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

slide32

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.
slide33

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.
slide34

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.

slide35

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 IACUC’s understanding of when any particular animal will conclude the study.
slide36

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.

slide37

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.

slide38

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.

slide39

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?
slide40

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.

slide41

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.

slide42

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.

slide43

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
slide44

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.

slide45

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?

slide46

Appendix C

Surgery & Management of Surgical Pain and Distress

1. A Complete description of surgical procedure

slide48

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

slide49

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
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
slide51

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

slide52

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
slide53

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)?

slide54

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.

slide55

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.

slide56

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

slide57

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

slide58

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

slide59

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

slide60

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
slide61

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.

slide62

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
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 discomfort1
Criteria used to Assess Pain/Distress/Discomfort
  • Loss of mobility
  • Red stain around eyes (rats)
  • Unresponsiveness
  • Self-mutilation
  • Labored breathing
  • Other
slide65

Appendix K: Progress Report

This appendix must accompany every 3 year Full Submission