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1. Contacts:
Primary Investigator: This is typically the Principal Investigator (PI) responsible for the research project. The primary investigator must be a UC employee with career employment status.
Please be sure to include an alternate contact. Non UC personnel, graduate students, and residents may be the alternate contact.
Provide an after-hours phone and/or pager numbers for PI and alternate contact. When the investigator or alternate contact person cannot be reached, animals on this project that show evidence of illness or pain, will receive emergency care, including euthanasia, at the discretion of veterinary staff
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Primary Investigator
Name:
E-mail:
Department:
Telephone:
After Hours:
/ Alternate Contact
Name:
E-mail:
Department:
Telephone:
After Hours:
*Primary contact for sick animals
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2. Project Title:
Please limit the title to 60 characters or less.
If the project is funded by a single grant, it is appropriate and helpful to give the protocol the same name as the grant. Teaching protocols should be titled with the name of the course and course number.
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3. Protocol Type:
Select the category or categories that reflects the type of activity you will be conducting.
For breeding and colony management protocols please be aware of the policy on Tissue Collection for Genotyping of Mice and Rats-
You may select more than one.
1) Research
2) Teaching-Non SOVM/VMTH- This will include all courses outside of the School Of Veterinary Medicine
3) Teaching-SOVM/VMTH
4) Herd/Breeding/Colony Management (e.g., maintaining transgenic rodent lines)
5) Field Activity/Research and/or Teaching-include permit number if applicable (e.g., Department of Fish and Game Scientific Collection permit).
It is the PI’s responsibility to ensure they have the proper permits from state and federal agencies before the work begins.
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Research
Teaching - non SOVM/VMTH
Teaching - SOVM/VMTH
Herd/Breeding/Colony Management
Demonstration/Training
Field Activity: Research or Teaching
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4. Species:
Please enter the total number of each species. The protocol can be active for up to 3 years, therefore please include animal numbers for the entire three years.
Source: List all of the potential sources of animals.
Animals Transferred from an approved protocol must be transferred in accordance with the (ATS) Policy
Please enter the total number of each species that will be needed for the protocol. For example, if you are teaching a class once a year and the course requires 20 mice, the total would be 60 for a three year protocol. The total here should match the number justified in section 13e/f.
Source: List all of the potential sources of animals, (e.g., Jackson Labs, field caught, auctions, client animals). If you are using campus-approved vendors such as Jackson Labs or Charles River, you may choose the “Campus Approved Vendor” option. Non-approved sources such as pet stores or other universities will be subject to further review by the Attending Veterinarian’s Office in order to ensure colony health is not jeopardized by introducing animals with unknown health status.
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Common Names / Total Number for Study / Name of Source of the Animals
add or edit Species Information
5. Brief Summary of Procedures:
This should be a short (one or two sentences) description of your project, written in language understandable to non-scientific personnel.
The front page of the protocol is posted on the animal room door and intended to give the animal care staff a brief summary of the project. For example “Upon arrival mice will be fed diets with different fat concentrations. They will be maintained on these diets for up to 1 year and then euthanized for tissue collection”. You do not need to go into detail on how the procedures will be carried out as this is addressed in section 14a “Procedure Details”.
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6. Animal Location(s):
This section is used to identify areas where live animals will be housed or taken for experimentation (e.g., PI laboratory).
The IACUC is required to inspect all areas where live animals are held or used, therefore it is important that this section is accurate.
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Study Area/Laboratory:
This section is used to capture information on areas other than the animal facility that may be used (e.g., PI laboratory, imaging center).
If live animals never leave the animal facility, select “None/Animals Will Not Leave Animal Facility”
If live animals are brought to a laboratory, the IACUC will need to inspect the laboratory on a regular basis according to IACUC policy 04
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Location/Building - Room
add or remove Study Area(s)/Laboratory
Overnight Housing (vivaria):
Please select the vivarium where you plan to house your animals. More than one can be selected if using multiple housing locations. If the housing location is not on the list provided, choose “other animal study areas” and fill in the name of the location. If your study does not require overnight housing, (e.g., field study or clinical trial), select “None/Not applicable”
Vivarium(s)
add or remove Vivaria
Animals will be maintained by:
Indicate whether the daily animal care is to be provided by the vivarium staff, the investigator, a combination of both, or “not applicable” (i.e., select this option for field studies). If animals are investigator maintained, the investigator’s Standard Operating Procedure (SOP) for animal care must be uploaded.
If you will follow the related vivarium SOPs, please choose that option from the pick list.
To upload an SOP click “Edit this section” then choose the “upload” or “add or delete files” option at the bottom of the page.
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/ Vivarium / / Investigator* / / Vivarium & Investigator* / / Not Applicable - (Select only if conducting field studies.)
*If investigator maintained, please upload husbandry Standard Operating Procedures (SOP's) or reference that you will follow vivarium SOP's
7. Special Husbandry Requirements:
Please list any special husbandry requirements. This should include items such as, PI will provide/feed animals when on diet trial, immune-compromised mice requiring special housing, animals will be on a reverse light cycle, special instructions for disposal of dead animals, or restrictions on pest control.
(To insert line breaks or to separate paragraphs, input a double carriage return.)
8. Hazardous Materials:
Identify any hazardous materials that will be used as part of the study. This includes recombinant DNA, Non-infectious viral vectors, human tissue, hazardous chemicals, Infectious agents, Radio-isotopes, etc.
This serves as a safety warning to both the research and animal care staff. The IACUC will not approve protocols that involve hazards until the appropriate “use authorization” or clearances are in place. These include;
- Biological Use Authorization (BUA) for projects involving recombinant DNA, human tissue/cells, viral vectors, infectious agents, etc.
- Radiation Use Authorization (RUA) for use of radioisotopes
- Stem Cell Research Oversight Committee (SCRO) approval for work involving human stem cells
- Clearance by the Chemical Safety Officer for projects involving hazardous chemicals
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Yes - Appendix A in Section 19 will be used to gather details regarding work with hazardous materials when present in a vivarium.
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Type / Material / Location
add or edit Hazardous Materials Information
9. Special Procedures and/or Activities:
Please check all that apply.
Many of these items are considered exceptions to standard practices and therefore require scientific justification. A separate justification box will appear for any that require justification.
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None - No Special Procedures and/or Activities
Anesthetics or Tranquilizers
Survival Surgical Procedures
Terminal Surgical Procedures
If any of the following procedures or activities are checked, please provide a justification where prompted.
Multiple Major Survival Surgical Procedures / Monoclonal Antibody Production by Ascites
Prolonged Restraint / Neuromuscular Blocking Agents
Use of Wire Bottom Cages for Rodents / Deviation from Standard Environmental
Conditions (e.g. lighting, temperature, etc.)
Food or Water Regulation / Deviation from Routine Sanitation Schedule
Death as an Endpoint / Deviation from Normal Space Allocation –
deviation from normal housing conditions
Singly Housed Rodents / Laboratory Housing
Use of Non-Pharmaceutical Grade Drugs
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Justification for Multiple Major Survival Surgical Procedures:
"Major surgery” penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic function. Rodent survival surgeries must be performed aseptically and in accordance with the Guidelines for Survival Surgery in Rodents-
Multiple major survival surgical procedures on a single animal are discouraged but may be permitted if scientifically justified by the user and approved by the IACUC. For example, multiple major survival surgical procedures can be justified if they are related components of a single research project, if they will conserve scarce animal resources or if they are needed for clinical reasons. If multiple major survival surgery is approved, the IACUC will pay particular attention to animal well-being through continuing evaluation of outcomes. Cost savings alone is not an adequate reason for performing multiple major survival surgical procedures. (2011 National Research Council Guide for the Care and Use of Laboratory Animals.)
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Justification for Prolonged Restraint:
Prolonged restraint should be avoided unless it is essential for achieving research objectives and is approved by the IACUC.
When restraint devices are used, they should be specifically designed to accomplish research goals that are impossible or impractical to accomplish by other means or to prevent injury to animals or personnel. (2011 National Research Council Guide for the Care and Use of Laboratory Animals.)
The following are important guidelines for restraint:
- Restraint devices should not to be considered normal methods of housing.
- Restraint devices should not be used simply as a convenience in handling or managing animals.
- Alternatives to physical restraint should be considered.
- The period of restraint should be the minimum required to accomplish the research objectives.
- Animals to be placed in restraint devices should be given training (with positive reinforcement) to adapt to the equipment and personnel.
- Animals that fail to adapt should be removed from the study.
- Provision should be made for observation of the animal at appropriate intervals, as determined by the IACUC.
- Veterinary care should be provided if lesions or illnesses associated with restraint are observed. The presence of lesions, illness, or severe behavioral change often necessitates temporary or permanent removal of the animal from restraint.
- The purpose of the restrain and its duration should be clearly explained to personnel involved with the study.
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Justification for Use of Wire Bottom Cages for Rodents:
The IACUC must review and approve the use of wire bottom cages.
The Guide for the Care and Use of Laboratory Animals recommends the use of solid bottom caging with bedding for rodents (NRC 2011). Approval of the use of wire bottom cages will be determined based upon the scientific justification provided in the animal care and use protocol. Some examples of studies in which wire bottom cages may be scientifically justified include toxicology studies, nutritional studies, metabolic studies, and certain contact studies or medical conditions in which the use of bedding poses a risk to the animal. If wire bottom caging is requested, the duration of use must also be specified.
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Justification for Food or Water Regulation:
“Food or water regulation” refers to short periods of food or water restriction or deprivation which exceeds periods of abstinence in nature.
When experimental situations require food or fluid restriction, at least minimal quantities of food and fluid should be available to provide for development of young animals and to maintain long-term well-being of all animals. Restriction for research purposes should be scientifically justified, and a program should be established to monitor physiologic or behavioral indexes, including criteria (such as weight loss or state of hydration) for temporary or permanent removal of an animal from the experimental protocol (Van Sluyters and Oberdorfer 1991). Restriction is typically measured as a percentage of the ad libitum or normal daily intake or as percentage change in an animal's body weight.
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Justification for Death as an Endpoint:
"Death as an endpoint" refers to acute toxicity testing, assessment of virulence of pathogens, neutralization tests for toxins, and other studies in which animals are not euthanized, but die as a direct result of the experimental manipulation.
If death is an endpoint, explain why it is not possible to euthanize the animals at an earlier point in the study. If you can euthanize the animals at an earlier point, based on defined clinical signs, then death is not an endpoint.
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Justification for Monoclonal Antibody Production by Ascites:
Monoclonal antibodies are exceptionally powerful research tools and have potential clinical uses. Production of Monoclonal antibodies must be performed in accordance with the Monoclonal Antibody Production Guidelines-
Ascites production is initiated by injection of hybridoma cells into the peritoneal cavity. Alternative methods to in vivo production must be considered before any in vivo methods are approved.
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Justification for Neuromuscular Blocking Agents:
It is imperative that any proposed use of neuromuscular blocking drugs be carefully evaluated by the veterinarian and IACUC to ensure the well-being of the animal.
Neuromuscular blocking agents (e.g., pancuronium) are sometimes used to paralyze skeletal muscles during surgery in which general anesthetics have been administered (Klein 1987); because this paralysis eliminates many signs and reflexes used to assess anesthetic depth, autonomic nervous system changes (e.g., sudden changes in heart rate and blood pressure) can be indicators of pain related to an inadequate depth of anesthesia. Acute stress is believed to be a consequence of paralysis in a conscious state and it is known that humans, if conscious, can experience distress when paralyzed with these drugs (NRC 1992; Van Sluyters and Oberdorfer 1991). If paralyzing agents are to be used, the appropriate amount of anesthetic first be defined on the basis of results of a similar procedure using the anesthetic without a blocking agent. Neuromuscular blocking drugs do not provide relief from pain.
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Justification for Deviation from Standard Environmental Conditions:
Include specific deviation requirements from routine husbandry procedures (e.g., long/short light cycle, reverse light cycle or reduced housing temperatures).
Contact proposed vivarium for species-specific standard husbandry procedures.
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Justification for Deviation from Routine Sanitation Schedule:
Include specific deviation requirements from routine sanitation schedule (i.e. cage changes beyond standard procedures).
Contact proposed vivarium for species-specific standard sanitation procedures.
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Justification for Deviation from Normal Space Allocation:
Include specific deviation requirements from the minimum standards requirements (i.e. metabolic cages, reduced space due to need to restrict movement).
Contact proposed vivarium for species-specific standard space requirements.
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Justification for Singly Housed Rodents:
Single housing can be justified based on experimental requirements or veterinary-related concerns about animal well-being. (ILAR Guide)
In these cases, it should be limited to the minimum period necessary, and where possible, visual, auditory, olfactory, and tactile contact with compatible conspecifics should be provided. In the absence of other animals, enrichment should be offered such as positive interaction with the animal care staff and additional enrichment items or addition of a companion animal in the room or housing area.
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Please provide the rationale for singly housing the rodents. Can they have cage enrichment? If no, why?
Justification for Laboratory Housing:
A laboratory housing area is defined as any area that holds animals for greater than 12 hours in non-vivaria space. Laboratory housing must be in performed in accordance with the Laboratory Housing for Research Animals Guidelines and CVS Standards of Care (Husbandry Policies) 30
Typically these are animals that are housed in an investigators lab. A standard operating procedures (SOPs) indicating how the animals will be cared for while in the laboratory must be provided.
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Justification for Use of Non-Pharmaceutical Grade Drugs :
Please provide the agent and a scientific justification for why a pharmaceutical grade alternative cannot be used. When possible, non-pharmaceutical-grade compounds should go through a purification/ sterilization process such as filter sterilization. Use of non-pharmaceutical-grade drugs must be used in accordance with the Non-Pharmaceutical-Grade Drugs and Non-Pharmaceutical-Grade Na Pentobarbital Policies.