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
How to Write an Effective and Successful Animal Activity Protocol: Hands On Training
AALAS Publication: American Association for Laboratory Animal Science
www.aalas.org “Bookstore” link
ILAR Publication: Institute for Laboratory Animal Research
Must be full-time UMC faculty
(Instructor – Professor)
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.
Will any “outside” contracts be used in this study that involve live animals (antibody production, toxicology screening, subcontracts with other facilities, etc)?
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.
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.
Response assists the LAF in planning/coordinating space for the study.
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.
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.
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.
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.
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.
Check and complete only those appendices that apply to the animal manipulations in your experimental design.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Identify personnel responsible for maintaining breeding program records.
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?
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?
Surgery & Management of Surgical Pain and Distress
1. A Complete description of surgical procedure
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
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
4. Surgical procedure
Who will conduct the Surgical procedure(s)?
List individual(s) by name
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.
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
Indicate what antigen will be used.
Indicate what vehicle/adjuvant will be used:
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)?
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.
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.
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
Are animals monitored during the restraint period? Yes No
If YES, describe who and document procedures
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
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
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
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.
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)?
This appendix must accompany every 3 year Full Submission