ANIMAL SUBJECTS APPROVAL FORM INSTRUCTIONS
California State University, Northridge, Institutional Animal Care and Use Committee (IACUC)
INSTITUTIONAL APPROVAL FOR THE USE OF VERTEBRATE ANIMALS
IN RESEARCH AND/OR INSTRUCTION
PLEASE TYPE ALL RESPONSES AND OBTAIN ALL REQUIRED SIGNATURES (last page of form)
PRIOR TO PROTOCOL SUBMISSION. APPEND ADDITIONAL PAGES AS NECESSARY TO
ANSWER EACH QUESTION COMPLETELY. INCOMPLETE FORMS WILL BE RETURNED
WITHOUT ACTION.
POLICY
California State University, Northridge, requires Institutional Animal Care and Use Committee (IACUC)
approval for the use of all vertebrate animals in research and instruction. For any use of animals to be approved,
the IACUC must receive complete and convincing evidence that such is consistent with the mission of the
University, the principles and practices of the CSUN Guide for Facilities and Care of Animals Used in
Research and Teaching, the specifications of the NIH Guide for the Care and Use of Laboratory Animals, and
the highest applicable medical and humane standards.
IACUC approval:
 is limited in time; it may be granted for a period not to exceed twelve (12) months;
 is renewable for an additional two (2) years (on a yearly basis), after which a new protocol must be
submitted;
 is not transferable;
 is based on the original submission; modifications in the approved use of animals may not be initiated
without prior IACUC approval.
PROCEDURES
The following procedures are to be employed in securing approval for all uses of vertebrate animals at CSUN:
1. Applicants are invited to request a copy of the following documents from Research and Sponsored Projects
(UN 275, x2901):
a. CSUN Guide for Facilities and Care of Animals Used in Research and Teaching
b. NIH Guide for the Care and Use of Laboratory Animals
c. IACUC Policies and Procedures/Application Form for Institutional Approval for the Use of
Vertebrate Animals in Research and/or Instruction.
Applicants should carefully review the content of these documents.
2. Applicants should complete the “Animal Subjects Approval Form,” obtain the necessary signatures, and
submit the original to the Research and Sponsored Projects Office. In addition, please email a copy as an
attachment to daniel.rastein@csun.edu. Please type all responses. Incomplete applications will be
returned to the applicant without action.
3. The IACUC will communicate its response to the applicant no later than thirty (30) days after receipt. The
response may be (1) approved, (2) disapproved, or (3) modifications requested.
Approvals will be for the period indicated on the application up to a maximum of twelve (12) months. Upon
the termination of an approval, applicants may apply for a renewal by completing an Animal Protocol
Renewal Request form. Protocols may be renewed for two (2) additional years (on a yearly basis), after
which a new protocol must be submitted. Modifications may be submitted to the IACUC on a Protocol
Revision Form.
4. Applicants may appeal decisions of the IACUC within forty-five (45) days. Appeals should be addressed, in
writing, to the Chair of the IACUC. Individuals appealing these decisions may be invited to address the
IACUC personally.
ANIMALS COVERED: All live vertebrate animals used by employees, faculty, and students of California State
University, Northridge.
WHO SHOULD COMPLETE FORMS: The Animal Subjects Approval Form and/or renewal request form
needs to be submitted by employees and faculty planning to use animals. Forms can be downloaded from the
Research website.
ANNUAL REVIEWS: If you plan to conduct a multiple year project, you are required to submit annual renewal
requests for your protocol.
RELEASE OF CONFIDENTIAL INFORMATION: The Federal Welfare Act, Section 27, states that it is
unlawful for any member of an Institutional Animal Committee to release any confidential information
including: trade secrets, processes, operations, style of work, apparatus, confidential statistical data, or income
information. Please identify confidential information you have included in this form by circling the item
number.
APPENDICES: Please complete any attached appendices as applicable to your protocol.
ANIMAL SUBJECTS APPROVAL FORM
California State University, Northridge
Institutional Animal Care and Use Committee (IACUC)
Please answer all questions completely, obtain the necessary signatures, and turn in the original to: Office of Research and Sponsored
Projects, UN 265. You must also email a copy of your protocol as an attachment to daniel.rastein@csun.edu. For questions, call the
Research Office, (818) 677-2901. Please type all responses.
Last name (PI cannot be a student)
First name
Department
Mail code
Telephone
FAX
Email
Title of project
Funding agency (if any)
Proposed start date
mm/dd/yy
Proposed end date (approvals are for 1 year)
mm/dd/yy
Species
Please check all boxes that apply to your study.
Type of protocol:
New
Continuation
Type of project:
Research
Teaching
Pilot
Type of study:
Breeding
Acute
Chronic (Recovery surgeries are considered chronic.)
Is this an observational/behavior study only?
Yes
No
Is this a field study?
Yes
No (If other species are involved, describe steps to minimize harm to them on separate page.)
Is confidential information contained in this project or form?
Yes
No (If yes, see instructions on pages above.)
RESEARCH PROCEDURES
Type A Procedures
No animal distress or pain
during research protocol and
no anesthesia, analgesia, or
distress relief needed (e.g.,
observational studies, handling
captive animals in a class).
Type B Procedures
Type C Procedures
Minor animal distress or pain during
research protocol not relieved by
anesthesia, analgesics, or other
pharmacological agents (e.g., trapping
and handling wild animals, toe or ear
clipping, blood drawing).
Type D Procedures
Moderate distress or pain during
research protocol even if anesthesia,
analgesics, or other pharmacological
agents are used to relieve distress for
some of the protocol (e.g., surgery
employing pain-relieving/reducing
pharmacological agents).
Severe distress or pain during research
protocol even if anesthesia, analgesics, or
other pharmacological agents are used to
relieve distress for some of the protocol
(e.g., research conducted on pain/stress in
which no pain-relieving/reducing
pharmacological agents are employed).
ANIMAL NUMBERS AND CARE
Species and/or Strain of Animal
No. Animals involved in
Research Procedures
(see above)
A
B
C
D
Animal Care
Building &
Room
Arrival
mm/dd/yy
No. of
cages
Animals
per cage
Days of
care
Reuse/
Euthanize
Total
animals/yr
List source(s) (e.g., vendor name) for all vertebrate animals involved in this study. For wild animals, list state or federal
collecting/possession permit numbers.
If animals are to be taken to another room(s) for preparations and procedures, please indicate location(s).
Building and Room Number(s):
Are there any specific requirements for care or cleaning for the animals involved in this study?
If yes, please describe.
FOR IACUC AND RESEARCH OFFICE USE ONLY
Disposition:
• Approved
Chair, IACUC, or Institutional Official
Yes
Date received
• Approved as amended
• See attached memo
Date
• Other
No
1.
DESCRIPTION OF PROJECT
Please provide a nontechnical description of the project (research or teaching) and its potential value, bearing in mind that the IACUC
membership includes faculty not engaged in animal research, administrative personnel, and community volunteers. Please use language
understandable to the layperson to indicate the overall purpose, goals, and significance of your project. If this study duplicates another
study, state why it is necessary.
2.
SUPPORTING LITERATURE
The USDA requires that you to name two or more databases and references describing the use of the vertebrate animal model(s) you have
selected, if appropriate, and/or to support your justification for the use of vertebrate animals for your project. In addition, please indicate
whether non-animal models have been developed in your area of research, and if so, describe why they cannot be used to meet your goals.
3.
Please indicate whether your procedures with animals will include any of the following.
(1) Restraint (including handling)?
Yes
No Type?
(2) Food restriction?
Yes
No Duration?
(3) Water restriction?
Yes
No Duration?
(4) Injection?
Yes
No Route and agent?
(5) Tumor growth? Such as occurs following a specific treatment and/or injection of tumor cells or monoclonal antibody-producing
hybridomas.
Yes
No (Please sign agreement in Vivarium office.)
(6) Blood collection?
Yes
No If yes, indicate volume, frequency, and drawing location in box below. Please
check with Vivarium veterinarian for guidelines.
(7) Chemical agents? (e.g., adjuvants)
Yes
No
(8) Radioactive material?
Yes
No Radiation Safety Permit #
(9) Biohazardous materials?
Yes
No Biological Safety Approval?
(e.g., infectious agents, mutagens, carcinogens, recombinant DNA, etc.)
(10) Other invasive procedures?
Yes
No (Please explain fully in question 4.)
Yes
No
a. For each chemical, radioactive, or biohazardous agent, list the (1) agent, (2) dose/kg body mass, (3) route of administration, and (4)
frequency of administration. Please list only one agent per line.
b. What are the potential health risks to humans and/or animals for each of the agents listed above? Be specific.
c. Will the animals housed in the Vivarium or will staff/personnel be exposed to any of the above agents? Explain.
d. Describe special animal care requirements relating to the use of any of the above hazardous materials. Are there any special containment
facility requirements?
e. Describe special precautions for animal handlers, including researchers and/or Vivarium staff.
f. Describe waste and animal disposal requirements.
4.
PROCEDURES TO BE PERFORMED
For each species, describe the procedures to be performed on live vertebrate animals indicating:
a. the type(s) of procedure(s) (treatments, surgery, tissue collection, injections, behavioral tests, etc.);
b. the number of procedures to be performed on each animal and what endpoints will be established;
c. expected effect of each procedure on the animal, including but not necessarily restricted to pain and discomfort;
d. whether and when the animal will be euthanized during or following the procedures;
e. drugs administered, including frequency and dose, and biohazardous materials if used;
f. for animals brought into the Vivarium, either originally from a vendor or the wild, or after a procedure in another location, note the
duration of quarantine/isolation and criteria for return to the Vivarium.
5.
NUMBERS
Indicate the number of animals you plan to use for each experimental procedure, justified according to accepted statistical principles. For
breeding protocols, please indicate how many litters/clutches will be required to produce adequate numbers for your studies. Please indicate
the maximum number you plan to generate by breeding and whether this number is different than the number that you plan to use for
experiments. Numbers here must match those listed on the first page.
6.
PAIN AND/OR DISCOMFORT
a. Will the animals be exposed to uncomfortable or painful stimuli or procedures?
Yes
b. Will the pain or discomfort be minimized by the use of anesthetics and/or analgesics?
Yes
(Analgesics must be used following recovery surgery unless sufficient justification is provided.)
No
No
If the answer to either (a) or (b) above is yes, please indicate the following:
1. Anesthetic to be used?
2. Dose?
3. Route of administration?
4. Frequency?
1. Analgesic to be used?
2. Dose?
3. Route of administration?
4. Frequency?
c. Are you using neuromuscular blocking agents (NMBA)?
Yes
No
Are you combining NMBA with general anesthesia?
Yes
No
(If the answer is yes to either question above, see Vivarium for agreement.)
1. What kind of NMBA?
2. Dose?
3. Frequency?
4. Route of administration?
5. Name of anesthetic?
6. Monitoring equipment?
BP
EEG
Other
d. In the event that you are unable to relieve pain or suffering, please indicate by your initials below that you agree to euthanize the
animal(s) immediately or contact the Vivarium veterinarian.
Initial here (typed OK): ________
(In the event that an animal held in the Vivarium is experiencing severe distress or is moribund and the PI or his/her designee(s) cannot
be reached, the animal may be euthanized by the Vivarium veterinarian or Vivarium staff in consultation with the veterinarian.)
7.
EUTHANASIA
Euthanasia must be conducted in accordance with the Guidelines on the Panel of Euthanasia of the AVMA. Please list acceptable
method(s) of euthanasia that will be used in this study for each species and check appropriate box(es) below. If you are uncertain about the
suitability of a particular euthanasia method, consult the Vivarium veterinarian.
CO2
Agent, dosage, and route?
Other, describe
Chemical overdose
8.
TRAINING AND EXPERIENCE WITH VERTEBRATE ANIMALS TO BE USED IN THIS STUDY
Who will perform procedures?
Faculty
Student(s)
Who will supervise procedures?
Faculty
Vivarium
technician(s)
Others (e.g., veterinarian, non-CSUN faculty or
technicians; specify below)
Others (e.g., veterinarian, non-CSUN faculty or
technicians; specify below)
Name of supervisor(s):
Please list the names of all individuals who will come into contact with the animals involved in this project, and indicate their past training
and experience with the species to be used. Also, indicate whether these persons have received training by the Vivarium, including relevant
IACUC training materials. Note that all employees working with vertebrate animals must receive appropriate training. Faculty who have
had previous training at other institutions must attest to receiving such training. In addition, faculty are responsible for assuring appropriate
training for their staff and students. Faculty who house animals in the Vivarium are required to document their training and that of their
staff and students. This documentation must be placed in the Training Logs located in the Vivarium. Training materials are available from
the Vivarium and from the Office of Research and Sponsored Projects.
9.
EXPERTS
Please list one or more experts whom the IACUC may contact who are familiar with the experimental procedures proposed in this study
and who could offer an opinion regarding the appropriate use of vertebrate animals for this project. Faculty or a veterinarian would be
appropriate. Indicate whether you would allow this/these expert(s) to review this form.
10.
SUMMARY OF QUALIFICATIONS
Please attach a copy of your current résumé/CV (or if currently on file in the Office of Research and Sponsored Projects,
please indicate).
Principal Investigator Assurance: I agree to abide by the Guide for the Care and Use of Laboratory Animals, the USDA
Animal Welfare Regulations (CFR 1985) and Public Health Service Policy on Humane Care and Use of Laboratory Animals
(1996) and the CSUN’s policies governing the use of vertebrate animals for research, testing, teaching, or demonstration
purposes. I also certify that the proposed studies do not represent unnecessary duplication of experiments. I will permit
emergency veterinary care to animals showing evidence of pain or illness, if the desired effect(s) of the above-approved
techniques are not achieved. The information provided above is accurate to the best of my knowledge. No deviation from
Type C or D procedures (where proposed), will be attempted without prior written approval from IACUC. Appropriate space
and funding are available for this study. The use of non-animal alternatives has been considered and found unacceptable at
this time. I declare that all procedures involving live vertebrate animals will be performed under my direct supervision or
under that of another qualified scientist as listed above. Technicians or students who will be involved have been trained in
proper procedures in animal handling and in any invasive procedures or euthanasia to be used in this project.
Principal Investigator (PI cannot be a student)
Approvals:
Date
Signatures certify that adequate space, food/housing resources, supervision, maintenance equipment, and
training in handling of this/these particular species will be available. Signatures below needed only if
animals will be housed in the Department of Biology Vivarium.
Chair, Department of Biology
Date
Vivarium Technician
Date