IACUC Instructions for Protocol Submission
Principal Investigator

The protocol, c.v., and appropriate supporting literature must be typed. Handwritten
protocols will not be reviewed by the IACUC.

Submit the protocol to your Department Chair, who will sign it and forward it to the
IACUC.

All correspondence related to the protocol will be addressed to the Department Chair.

One form can be used for multiple species. When completely different procedures are
planned for different species, then multiple forms and protocols should be submitted.

If the animal procedures are identical, one protocol can be used to support several
research projects or classes.

The title of the protocol may be included in the IACUC minutes, which, if requested, are
available to the public. Therefore, the title should not contain proprietary or other
confidential information.

If the protocol includes proprietary information, the PI should notify the IACUC via the
Chair in writing. The IACUC will seek legal counsel and notify the PI via the Chair
before responding to any request for release of this information.
Department Chair

The Department Chair will keep a copy of the protocol's first page (Statement of
Assurances) before the protocol is forwarded to the IACUC.

The Department Chair obtains all appropriate signatures before submitting the protocol to
the IACUC.

The third and fourth pages, items 2-7, which contain animal care information for the
appropriate animal technician, should be forwarded by the Department Chair to the
technician, and should not be released to anyone else.
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California State University, Sacramento
Institutional Animal Care and Use Committee Protocol
Statement of Assurances
COURSE/PROJECT: _________________ DURATION: ______ EXPIRES: ______
1.
University Assurances for the Humane Care and Use of Vertebrate Animals
PRINCIPAL INVESTIGATOR/COURSE INSTRUCTOR STATEMENT:
I have read and agree to abide by California State University, Sacramento’s and related
guidelines as contained in A Manual for Facilities and Care of Animals Used in
Research and Instruction. I further agree to abide by any IACUC decisions related to
this protocol. The project will be conducted in accordance with the NIH Guide for the
Care and Use of Laboratory Animals except as explained below. I will abide by all
federal, state, and local laws and regulations governing the use of animals in research and
teaching. I will advise the Institutional Animal Care and Use Committee in writing of
anything other than minor changes in the procedures described in this protocol.
____________________________________ ____________________
Principal Investigator/Instructor
Title/Rank
_________
Date
DEPARTMENT CHAIR/DEAN/DIRECTOR STATEMENT:
The personnel conducting this project are appropriately qualified and trained in the
subject area under study. Personnel with substantial animal contact may be required to
participate in a medical surveillance program as proscribed by Environmental Health and
Safety (EHS).
______________________________________________
Department Chair (Dean/Director if applicable)
__________
Date
The Department Chair is to keep this page on file (do not release or forward this
page.)
Note: Copies of the NIH Guide and the university’s Manual may be obtained from the
Office of Research Administration, campus zip 6111 or research@csus.edu.
Page 2 of 11
COURSE/PROJECT: _________________ DURATION: ______ EXPIRES: ______
2.
Personnel Information:
Principal Investigator/Instructor: _______________________________________
Phone: __________ Department: _______________ E-mail: _______________
Co-Investigator: ___________________________________________________
Phone: __________ Department: _______________ E-mail: _______________
Technician: _______________________________________________________
Phone: __________ Department: _______________ E-mail: _______________
Student(s): _______________________________________________________
Phone: __________ Department: _______________ E-mail: _______________
Student(s): _______________________________________________________
Phone: __________ Department: _______________ E-mail: _______________
3.
Location of animal housing (building and room or vivarium): ______________
a. overnight: ________________________
b. day use only: _____________________
4.
Abstract of research/teaching plan for use by the animal facilities staff. (Give a
brief layman’s description of the procedures employed on the animals in this
project.)
5.
Exceptions, if any, to NIH Guidelines
6. Are there special requirements for maintaining the animals?
[ ] NA
[ ] Yes
[ ] No
If Yes, indicate your requirements below. If you have no special requirements,
animals will be maintained according to the standard operating procedure
approved by the IACUC as specified in this protocol.
a. Temperature (oF): o___; humidity (%): %___; hrs. light: ____; hrs. dark: ____
b. Caging: type: __________________________ size: ____________________
filter tops? ____________ cage changes per week: __________________
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c. Bedding/litter: type _____________________________________________
autoclaved? ___________ bedding changes per week: ______________
d. Type of water (e.g., sterile, deionized, acidified, tap):____________________
7.
e.
Diet and feeding requirements: What diet? ____________________________
If other than ad lib feed and water, state amounts: ___________________
f.
Other special instructions for animal care staff:
Special requirements (Check all applicable boxes): [ ] NA Reason: _________
__________________________________________________________________
Instructions for Disposition Instruction for Disposition Pest control
of Sick Animals
of Dead Animals
Requirements
[ ] Call Investigator
[ ] Clinician to treat
[ ] Terminate
[ ] Call Investigator
[ ] Clinician to treat
[ ] Bag for disposal
[ ] None
[ ] Pest Strip
[ ] Pyrethrin
Specify _________
The Department Chair is to forward these two pages to appropriate department
animal technician only (not to be released or forwarded to any one else).
Page 4 of 11
California State University, Sacramento
PROTOCOL FOR THE HUMANE CARE AND USE OF LIVE ANIMALS
(12/2012)
Federal animal welfare regulations require that the Institutional Animal Care and Use Committee
(IACUC), MUST review and approve all activities involving the use of live “covered” animals
PRIOR to their initiation. This includes animals used or intended to be used in research, tests
(including teaching and production), or experiments. Protocols must be reviewed every six
months, approved yearly, and (if the research or instruction is to continue) re-written every
three years.
1.
Protocol Title (should be descriptive of the animal use activity):
2.
Project Duration (3 years unless otherwise specified):
3.
Principal Investigator/Study Director:
Department:
c.v. Included?
Yes____
No____
Others involved in procedural activities using live animals: (students, technician, others)
a.
Name:____________________________________________________________
Department:_______________________________________________________
c.v. Included?
b.
Yes____
No____
Name:____________________________________________________________
Department:_______________________________________________________
c.v. Included?
4.
Section 2.31(e)(1)
Yes____
No____
Primary species to be used:__________________________
Number of animals to be used:________________________
Are special permits needed?
Yes____
No____
Sex:____
Age or Weight
Range:______________________
Secondary species to be used:_________________________
Number of animals to be used:________________________
Are special permits needed?
Yes____
No____
Sex:____
Age or Weight Range:__________________
Page 5 of 11
5.
Methods used to validate this research, training, or testing protocol.
a.
Commonly accepted procedure (textbooks, etc.):
b.
Expert review (consultant, when, etc):
c.
Collaboration with colleagues (who, date, etc):
d.
Educational seminar covering this subject (what, date, where):
e.
Databases searched, literature reviewed:
Date:
Years covered:
KeyWords/Category:
6.
As per Section 2.31(d)(i)(ii)(iii),(e)(2) answer the following:
a.
The protocol is necessary and is refined as much as possible and does not
duplicate previous work:
Yes____
No____
Explain:
b.
The principal investigator has searched for the replacement of animals and the
use of animals is appropriate:
Yes____
No____
Explain:
c.
The principal investigator has searched for the lowest animal species available:
Yes____
No____
Explain:
d.
The number of animals to be used has been reduced as much as possible:
Yes____
No____
Explain:
e.
A search was conducted for alternatives to painful procedures (acute and chronic)
and alternatives are not available:
Yes____
No____
Explain:
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7.
Section 2.31(e)(3)(4): Provide a complete description of the proposed use of animals in
the space below:
a.
Will the animals be exposed to radioactive materials, infectious agents, or known
carcinogenic or highly toxic chemicals which may pose a risk to personnel or to
other animals? Section 2.31(c)(1)
Yes____
No____
If yes, explain risk and safety procedures to be followed by laboratory personnel
(for infectious agents also indicate the appropriate biosafety level):
b.
Will unanesthetized animals be catheterized, intubated or have blood collected?
Yes____
No____
If yes, describe (method, amount, frequency):
c.
Will animals be anesthetized or tranquilized during the study other than for
surgical procedures?
Yes____
No____
If yes, describe:
d.
Will unanesthetized animals be restrained by chairs, slings, tethers, stanchions or
other devices?
Yes____
No____
If yes, explain
 Method of restraint:
e.

Duration of restraint:

Frequency of restraint:

Observation during restraint:
Will animals be deprived of food or water for greater than 24 hours?
Yes____
No____
If yes, explain. Provide justification and description of monitoring procedures:
f.
Are surgical procedures employed?
Yes____
No____
If no, go on to “g”. If yes, complete this section. (All survival surgery must be
performed using aseptic procedures, including surgical gloves, masks, sterile
instruments, and aseptic techniques. Major survival surgery on non-rodents,
including rabbits, must be conducted in an aseptic surgical suite location in the
Page 7 of 11
animal facility. Non-major survival surgery, and all surgery on rodents, may be
performed outside of the surgical suite but must be performed using aseptic
procedures). Section 2.31(d)(2)(ix)
(1)
Check the statement that describes your project:
___
Non-survival surgery (animals are euthanized under
anesthesia without regaining consciousness.
___
Minor survival surgery.
___
Major survival surgery (penetration and exposure of a body cavity, or
resulting in a permanent impairment of physical or physiological
functions).
(2) Describe surgical procedure:
(3) Location where surgical procedures will be performed:
(4) Preoperative care, anesthesia, and monitoring/supportive care during surgery
and post-operative care. Procedures are to be determined and performed in
consultation with the Campus Veterinarian.
a) Preoperative care (type, dose, route of administration of antibiotics,
sedatives, medications prior to induction of anesthesia or any special care
such as fluids, fasting, etc.):
b) Anesthesia/analgesia (type, dose, route of administration of anesthetics,
analgesics or sedative/tranquilizing agents employed to prevent pain and
distress during surgery):
c) Monitoring and supportive care during surgery (fluids, oxygen,
antibiotics, etc.):
d) Post-operative support care and drug therapy (fluids, antibiotics,
analgesics, etc., including route of administration, frequency and dose.):
g.
Section 2.31(e)(5) euthanizing animals? Yes____
No____
If yes, describe procedure. Include method, product, dose, and route of
administration.
If no, describe the disposition of the remaining animals:
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Does the procedure meet the recommendations of the AVMA Panel on
Euthanasia? (www.avma.org)
Yes____
No____
8.
Section 2.31(1)(iv)(B) The attending veterinarian, or designee, was consulted in the
planning of these potentially painful/distressful procedures.
_____________________________________
Signature of Campus Veterinarian
9.
__________________
Date
Principal Investigator Statement of Assurance: Please check the appropriate answer
(Note: A negative answer to any statement requires a detailed, written explanation):
a.
Section 2.31(1)(iv)(A)(C): The procedures are designed to assure that discomfort
and pain to animals will be limited to that which is unavoidable for the conduct
of scientifically valuable research, including provision for the use of analgesic,
anesthetic, and tranquilizing drugs where indicated and appropriate to minimize
discomfort and pain to animals (unrelieved pain/distress must be justified for
scientific reasons and should continue for only the necessary period of time).
Yes____
No____
b.
Section 2.31(d)(1)(iv)(c) Paralytics will not be used without appropriate
anesthesia.
Yes____
No____
c.
Section 2.31(d)(1)(v) Animals that would otherwise experience severe or
chronic pain/distress that cannot be relieved will be euthanized at the end of the
procedure, or if appropriate, during the procedure.
Yes____
No____
d.
Section 2.31(d)(1)(vi) The animal’s living conditions, including housing,
feeding, and non-medical care, will be appropriate for the species, contribute to
their health and comfort, and will not deviate from USDA standards.
Yes____
No____
e.
Section 2.31(d)(1)(vii) Medical care for animals will not be withheld and will be
available and provided or supervised as necessary by a qualified veterinarian.
Yes____
No____
f.
Section 2.31(d)(1)(viii) Personnel conducting animal procedures will be
appropriately qualified and trained in those procedures and the training and
qualifications of such personnel have been appropriately documented.
Yes____
No____
g.
Section 2.31(d)(1)(x) No animal will be used in more than one major operative
procedure from which it is allowed to recover unless scientifically justified or
required as a veterinary procedure.
Yes____
No____
Page 9 of 11
_____________________________________
Signature of Principal Investigator
Page 10 of 11
__________________
Date
10.
To be completed by the IACUC Chair or designee. The Principal Investigator or
committee member who is involved in the activity may NOT review or vote on the
approval of the project. Assuming a committee quorum is present, a majority of those
members in attendance may approve the activity at the meeting. Section 2.31(d)(2)
a.
Protocol Name/Number:_____________________________________________
b.
Date:_______________
*c.
Designated Member(s):
Yes____
No____ Section 2.31(d)(2)
d.
Protocol Approved:
Yes____
No____ Section 2.31(d)(4)
e.
Annual Review Approved:
Yes____
No____ Section 2.31(d)(5)
f.
Signature of reviewer(s). (Can be chair or designee).
g.
__________________________
___________________________
__________________________
___________________________
__________________________
___________________________
__________________________
___________________________
USDA Reporting Category (Annual Report APHIS Form 7032) Section 2.36
(to be completed by Campus Veterinarian)
_______ Column C – No Pain/Distress.
_______ Column D – Pain/Distress relieved by use of drugs or other means.
_______ Column E – More than momentary pain or distress that is unalleviated
by drugs or other means due to experimental necessity.
h.
Department Chair notified in writing on _____________ Section 2.31(d)(4)
(The Department Chair may forward this page to the Principal Investigator.)
i.
Reason for non-approval noted below (notify investigator in writing) Section
2.31(d)(4)
j.
Conditions of Approval/Modifications
(The Department Chair is to be notified of any conditions or modifications. The
Chair, in turn, is to notify the investigator.)
*Designated Member Reviews are limited to non-survival teaching protocols, non-survival
surgical studies and minor modifications of currently approved surgical survivor studies (i.e.
necessary adjustments of drug dosages, changes in medications or anesthesia). All such reviews
will be reviewed at the next scheduled IACUC meeting.
Comments/Notes by Research Administration:
11