Animal Care and Use Review Form
Office use only
Protocol #
Date Approved
Date Expires
The University of Iowa
Animal Care and Use Review Form
University policy and federal regulations require a review of
projects for humane treatment and safe use of vertebrate animals in
research and teaching by all University of Iowa staff on or off
campus. At the University of Iowa, the review is conducted by
the Institutional Animal Care and Use Committee (IACUC). The U.S.
Public Health Service requires verification of IACUC approval of
animal care and use for funded projects before monies will be
released for use. For projects funded by non-PHS agencies;
verification of IACUC approval of animal care and use generally
must occur within 60 days after submission of an application or
proposal. Six weeks is required to process this application. Please
complete all parts of the attached form. Additional information to
clarify some questions can be accessed by clicking on the icon
adjacent to the question. This application must be completed on a
word processor, and submission must include a signed hardcopy and
computer file (Word, Word Perfect or Adobe). E-mail the file to
[email protected]. For externally sponsored projects, please provide
a hardcopy of the Research Plan portion of the grant/contract
application. Please return the signed hardcopy of this form and the
Research Plan portion of the grant/contract to the OAR, 400 Medical
Laboratories. This document is best viewed in “Print Layout”. It is
recommended, that first-time users of this form schedule an
appointment with the IACUC coordinator by sending an e-mail to
[email protected] or calling 5-7985.
I.Principal Investigator:
Name
Department
Campus Address
Telephone #
E-mail address
Lab phone
Lab Address(Building, Rm#)
Please copy and paste this table to add additional
personnel.
Co-Investigator(s):
Name
Department
Campus Address
Telephone #:
E-mail address
Please copy and paste this table to add additional
personnel.
II.Project Information:
Project title: (Use the same title as the grant application; For
Center, PPG, or Training Grant, use subproject title.)
Grant Application Deadline
Project Start Date
III. Funding Information: Answer all Three Questions Yes or
No
Yes
No
External funding expected: (Please provide a hard copy of
research plan portion of grant)
Yes
No
Research Plan attached: If not attached please explain:
Yes
No
Internal funding expected;(If YES, Departmental review and
assurance are required [see VII])
Funding Agency Name
Funding Agency Number (if known)
IV. Type of project:
Yes
No
New Project
Yes
No
Renewal
Previous ACURF#
Yes
No
Duplicate Submission
Previous ACURF #
Yes
No
Instructional project
Yes
No
Part of training grant:
Program Dir.
Yes
No
Part of center or program project;
Program Dir
V. SPECIAL CONCERNS
Answer ALL of the following:
Please read the material hyperlinked to any positive
response:
Yes
No
Instructional use of animals (teaching course or training
class)
Yes
No
Survival surgery
Yes
No
Hazardous chemicals, Biological agents, Recombinant DNA
(including production of transgenic animals), other biohazardous
agents
Yes
No
Death as an endpoint (i.e. LD50, tumor growth).
Yes
No
Custom antibody production by outside vendor
Yes
No
Production of monoclonal antibodies using ascites method
Yes
No
Use of Complete Freund's Adjuvant
If you answer yes to any of the above questions click on the
associated link to obtain additional information
VI. PROJECT DESCRIPTION
1.If this is an initial application summarize in language that a
high school student can understand, the aims and objectives of this
project including its long‑term goals and briefly explain the
relevance this work will have to human or animal health, the
advancement of knowledge or the good of society. The grant
abstract may not be used. If animals in this proposal will be used
for instructional purposes also list the course objectives. If the
answer is longer than one page the contents in the box often will
not all appear. To enter a longer answer click in the box, then go
to the top menu, click on “Table” then click on “Convert” and then
click on “Table to text”.
If this is a renewal application summarize in language that a
high school student can understand, what was learned during the
initial approval and explain how the results influence the
continuation of the project. Briefly explain the relevance this
work will have to human or animal health, the advancement of
knowledge or the good of society. The grant abstract may not
be used. If animals in this proposal will be used for instructional
purposes also list the course objectives. If the answer is longer
than one page the contents in the box often will not all appear. To
enter a longer answer click in the box, then go to the top menu,
click on “Table” then click on “Convert” and then click on “Table
to text”.
QUESTIONS SPECIFICALLY MANDATED by Regulations
2.a. You must perform database searches unless compelling
justification can be made without it. A standard literature search
is the usual method to demonstrate this project is not
“unnecessarily duplicative” and to search for “alternative
experimental approaches.” To search for alternatives, match the
basic problem under investigation (e.g, heart failure,
hypertension, arrhythmia) to terms or phrases like “animal testing
alternatives”, simulations, in vitro, or cell culture. If a
database search was performed please answer ALL four of the
following questions.
Database(s) Searched:
Date of Search (must be within two months of submission)
Years Searched (range):
Search Terms and/or Search Strategy
b. If a literature search is NOT performed, provide a narrative
to justify why this project is not duplicative and that no
acceptable alternatives are available.
c. Comment upon the potential application of any identified
alternatives.
d. Describe what consideration has been given to the following
alternatives :
-Reducing the numbers of animals required
-Modifying a procedure to lessen or eliminate pain or distress
to the animal
-Use of a non-mammalian or invertebrate species
-Use of a non-animal system (cell or tissue culture, computer
model, mathematical model, etc.)
3.Is this project unnecessarily duplicative?
No
Proceed to Question 4.
Yes
Proceed to Question 4.
PERSONNEL:
4. Personnel: Please provide the following information for all
personnel involved in this project who will handle animals,
including investigators, technicians and students. Describe the
relevant training and experience of each person. If personnel do
not have experience, describe how they will be trained.
Participation in the University Employee Health Clinic ((UEHC)
Clinic A; Boyd Tower; 356-3632) program for animal users is
determined on a case by case basis for all persons having any
contact with animals or animal tissues. List all individuals having
contact with animals, the species involved and a brief description
of the degree of contact (e.g. rodents, less than 2 hours/week).
Include their University address, phone number, e-mail address, so
that they can be contacted by the UEHC regarding enrollment in the
program.
Principal Investigator/Coinvestigators: Please complete for each
investigator listed in I. (first page)
Name:
Describe Training:
Has this person taken the University online training module on
Policies/Regulations? (
Yes
No
Describe related experience with techniques Proposed:
Describe how individual will be trained if no prior relevant
training or experience
Is this person performing surgery?
Survival Surgery
Nonsurvival surgery
Not Applicable
Describe exposure to each species that will occur during
performance of this proposal.
Please copy and paste this table to add additional
investigators
Technical Personnel
Name:
Address:
Dept:
Phone #:
E-mail address:
Describe Training:
Has this person taken the University online training module on
Policies/Regulations?
Yes
No
Describe related experience with techniques Proposed:
Describe how individual will be trained if no prior relevant
training or experience
Is this person performing surgery?
Survival Surgery
Nonsurvival surgery
Not Applicable
Describe exposure to each species that will occur during
performance of this proposal.
Please copy and paste this table to add additional
personnel.
NOTE: All personnel are required to take the Online course for
“Policies/Regulations” and pass the associated quiz.
(http://courses2.uiowa.edu:8900/public/AUEC/index.html)
ANIMAL Information
5.
Animal species (common name)
Strain (if applicable)
Describe the biological characteristics of each species that are
essential to the proposed study
Please copy and paste this table to add additional
species/strains.
Guidelines for proper nomenclature:
6.a.Approximately how many of each species will be used?
You must include the total number of each species to be used over
the three year duration of this proposal. This approval is for a
maximum of three years. Do not count rodents that are not weaned.
[NOTE: U.S. Government Principles for the Utilization and Care of
Vertebrate Animals used in Testing, Research, and Training: III.
The animals selected for a procedure should be of an appropriate
species and quality and the minimum number required to obtain valid
results.
Species/
Strain
Total
Please copy and paste this table to add additional
species/strains.
b.Describe how the number of animals needed for the study was
determined. When appropriate, provide the number and type of
experimental and control groups in each experiment, the number of
experiments planned, and the number of animals in each group. The
Guide states that whenever possible, the number of animals
requested should be justified statistically. A power analysis is
strongly encouraged to justify group sizes when appropriate. If the
answer is longer than one page the contents in the box often will
not all appear, to solve this problem click in the box then go to
the top menu, click on “Table” then click on “Convert” and then
click on “Table to text”.
c.What is the source of the animals?
Yes
No
Via the OAR
Yes
No
Breeding colony in house
d. Are Transgenic Animals utilized in this study?
No
Proceed to Question 7.
Yes
e.Does expression of the transgene/knockout phenotype result in
pain/distress?
No
Proceed to Question 7.
Yes
It is mandatory that you answer Question 23 even if you answer
Yes to Question 18 or 20.
7.Will the animals used in this study be subjected to any of the
following:
Yes
No
The animal(s) utilized in this study will have already been used
in a previous study (non-naïve animals)?
Yes
No
The same animal(s) used in this study may be used in a
future?
If yes to either of the above, please explain.
Note: Prior Committee approval is required for each of the
above.
8.Animal Housing Location:
Yes
No
University of Iowa Animal Care Unit
Yes
No
Veterans Administration Research Facility
Yes
No
Other: Please describe
9. Will animals be kept outside of the OAR animal quarters for
longer than 12 or 24 hours
No; Proceed to next question
> 12 hours
Building and Room #
> 24 hours
Building and Room #
If housed outside of OAR for > 24 hours please justify this
requirement:
10.Will any special housing conditions be required for this
project (lighting, feed, special caging, biological containment,
etc.)?
No; Proceed to Next Question
Yes
Please Specify
11.Do you request that rodents be housed in wire bottom
cages?
No or Not Applicable; Proceed to Next Question
Yes; Please Justify
12.Do you request that nonhuman primates be excluded from the
University of Iowa’s “Psychological Enrichment Program”? This
program is designed to provide an enriched environment including
social interactions among primates in use at the University.
No or Not Applicable; Proceed to Next Question
Yes; Please Justify
13. Do you request that dogs be excluded from the University of
Iowa’s “Canine exercise Program”?
No or Not Applicable; Proceed to Next Question
Yes; Please Justify
HAZARD USE
14.Does this study utilize rDNA in vivo AND the animals are
returned to the Animal Care Unit after exposure?
No or Not Applicable; Proceed to Next Question
Yes; Specify rDNA
If yes, please complete and submit rDNA application to the
Health Protection Office, available online or contact the Health
Protection Office (HPO) at 335-8501. If an approval has already
been received, please note approval:
rDNA approval number
NOTE: If rDNA is used AT ALL (whether in animals or not) it’s
use must be approved by the Institutional Biosafety Committee
(IBC). Approval of this Animal Care and Use form does not approve
the use of rDNA. rDNA use can only be approved by the IBC which is
coordinated through the Health Protection Office (335-8501).
15.Are any of the substances listed in 15.a. used in this
project?
No or Not Applicable; Proceed to Question 16.
Yes; Please complete 15a. & 15.b.
a.
Substance
Specify Substance
Human blood, blood products, tissues
Animal cells or extracts (from sources outside the OAR barrier
facility)
Non-sterile biological fluids
Other Biological agents (other than rDNA, e.g. infectious
agents)
Carcinogens
Hazardous chemicals
Radioactive materials
b. Are any of the substances listed in 15.a. introduced into
animals that are returned to the Animal Care Unit ALIVE:
No or Not Applicable; Proceed to Question 15.e.
Yes; Please complete 15.c.
c. Please complete and attach a containment protocol to this
ACURF. Prior to initiation of this protocol, inform the OAR when
use of the hazardous agent/material is pending to ensure the
protection of OAR personnel. Forms are available at :
Have you appended a containment protocol?
Yes; Proceed to Question 15.e.
NO; Please complete 15.d.
d.If a containment protocol is NOT necessary please provide your
rationale:
e. Could any of the hazardous substances listed in
15.c.contaminate Animal Caging?
No; Proceed to Question 16.
Yes; Please complete 15.f.
f.If NOT already described in a submitted containment protocol
(15.c.) please describe how you will decontaminate caging or
equipment before returning it to the Animal Care Unit.
EXPERIMENTATION
16.Describe fully the method of euthanasia that will be employed
for each species.
a.Method
Species
Chemical Agent
Not applicable:
Dose
Route
Physical Method
Not applicable:
Please copy and paste this table to add additional
methods/species.
b.Scientific justification must be provided to perform
euthanasia by a Physical method in an UNanesthetized or UNsedated
animal.
Not applicable (Proceed to Question 17.
Scientific justification
17.Are tissues collected before euthanasia? If tail samples are
taken for genetic analysis please indicate here and review IACUC
guidelines
No; Proceed to Question 18.
Yes; Please list tissues harvested
18.Is the “only” procedure: euthanasia performed followed by
harvest of tissues?
No; Proceed to Question 19.
Yes; You are finished; you do not need to complete the rest of
the form
19.Will any procedures (surgical or non-surgical) require
anesthesia?
Anesthetic dosages can be found at this link
No; Proceed to Question 20.
Yes
a. Preanesthetic agent(s), dosage and route
Species
Drug (e.g. Atropine)
Dosage (mg/kg)
Route (IV, IM, SQ, IP)
Please copy and paste additional tables if needed.
b. Anesthetic agent(s), dosage and route
Species
Drug (e.g. Pentobarbital)
Dosage (mg/kg)
Route (IV, IM, SQ, IP)
Please copy and paste additional tables if needed.
c. For prolonged procedures how will anesthesia be
maintained?
d.How many times will anesthesia be required for each animal
during the study?
e.Describe the methods used to monitor the state of anesthesia
and general well being:
f.Will paralytic agents be employed?
No; Proceed to 19.g.
Yes; Name of agent
Explain why it is necessary to use this agent
Explain how the animals will be monitored to insure adequate
anesthesia
g.Is the proposed postprocedural and postanesthesia monitoring
in accordance with IACUC recommendations?
Yes; Proceed to 20.
No; Specify the procedures that will be utilized below
20.Is the “only” procedure performed the harvest of tissue
and/or body fluids under anesthesia followed by euthanasia?
No; Proceed to Question 21.
Yes; You are finished; you do not need to complete the rest of
the form
21.Will antemortem blood samples be taken?
No; Proceed to Question 22.
Yes
Species
Route
Amount
# of collections
Interval between collections
Will blood collection be performed under anesthesia?
Yes; Anesthesia should be described in answer to Question
19.
No
Please copy and paste additional tables if needed.
22.Is any procedure (including survival surgery) likely to cause
pain or distress (e.g. any procedures that would reasonably be
expected to cause pain or distress in a human)? Common analgesic
dosages can be found at this link Do not provide anesthetic
regimens; these are already described in Question 19.
No; Proceed to Question 23.
Yes
Species
Identify Painful Procedure
Methods to alleviate pain/distress
Justification for not providing relief from pain/distress
Please copy and paste additional tables if needed.
23.Are there predictable adverse pre- or post‑procedural events
that may occur?
No; Proceed to Question 24.
Yes; Please describe event below and indicate how it will be
humanely managed to minimize discomfort to the animal
Please copy and paste additional tables if needed.
24.Will food and/or water be restricted?
No; Proceed to Question 25.
Yes
What is restricted?
Food
Water
Species
Length of restriction
Interval between restrictions
Monitoring during restriction
Justify restricting food and/or water
Please copy and paste additional tables if needed.
25.Will animals be restrained by tethers, stanchions, metabolism
cages, etc.?
No; Proceed to Question 26.
Yes
Species
Method of restraint
Duration of restraint
Frequency of restraint
Monitoring during restraint
Acclimation of animal to restraint
Justify restraint
Please copy and paste additional tables if needed.
26. Will survival surgical procedures be employed?(Disruption of
any integumentary surface of a living animal by any means other
than a hypodermic needle, biopsy needle, ear punch, or tail snip is
considered surgery. All surgical procedures must be described
in Question 27.)
NOTE:If survival surgery is performed it must be done using
aseptic technique. Provide a description of the surgery in your
answer to Question 27; describe the anesthetic regimen in your
answer to Question 19 and describe your analgesic regimen in your
answer to Question 22.
No; Proceed to Question 27
Yes; Proceed to 26.a.
a. Will “multiple” survival surgeries be performed on the same
animal?
No; Proceed to Question 26.b.
Yes; You must provide a detailed scientific justification as
required by Federal regulations
b. Where will the survival surgery be performed?
Bldg:
Room:
c.Describe the postoperative care, fluids, physical support
methods and postoperative monitoring given to the animals.
Species
Monitoring provided
Please copy and paste additional tables if needed.
d.Is the proposed postprocedural and postanesthesia monitoring
in accordance with IACUC recommendations?
Yes;
No; Specify below the procedures that will be utilized
Please copy and paste additional tables if needed.
e. How are the instruments sterilized?
Steam Sterilization
Ethylene oxide
Chemical sterilization
Please answer next the question in the table and review IACUC
guidelines
Name of sterilant
f. How do you insure that proper sterilization has occurred
(check all that apply)
All sterilization is performed by University Hospitals Central
Sterilizing
Integrator strips on inside of steam/ethylene oxide sterilized
pack
Indicator on outside of steam/ethylene oxide sterilized pack
g.Does the surgeon utilize the following during surgery?
Yes
NoSterile gloves
If NO Why Not?
Yes
No
Sterile gown
If NO Why Not?
Not required for rodent/ectotherm surgery
Other reasons
Yes
No
Face mask
If NO Why Not?
27.For each distinct procedure, describe the manipulations that
will be performed (including surgery) and the order in which they
will be performed. Include time frames and intervals for the
sequence of procedures. Unless listed elsewhere in this document,
describe all drugs (including test substances) administered during
the study as well as the dosage, route, and frequency. Procedures
that will be performed after the animal has been euthanized need
not be described. (Describe the procedures in enough detail so that
reviewers will be able to determine what is actually being done to
the animal. You DO NOT need to re-describe in detail procedures
addressed in previous Questions (e.g anesthesia, euthanasia) If the
answer is longer than one page the contents in the box often will
not all appear. To enter a longer answer click in the box, then go
to the top menu, click on “Table” then click on “Convert” and then
click on “Table to text”.
II. Assurances and Approvals
(Signature of Departmental Executive Officer)
(“Per signature not acceptable)
(Date)
If this project will not receive external peer review prior to
beginning work with animals, the DEO must designate an individual
or committee for scientific review and assurance of this ACURF.
This person/committee member cannot be involved in this
project.
(Signature Certifying Scientific Review and Approval)
(Date)
The policies and procedures of the University of Iowa, the AWA
and the PHS apply to all activities involving live vertebrate
animals performed at or by the personnel of this Institution.
Therefore, no activities involving the use of these animals are to
be initiated without prior written approval by the University
Animal Care and Use Committee (IACUC).
The undersigned is familiar with the AWA and the PHS Policy on
Humane Care and Use of Laboratory Animals by Awardee Institutions,
the NIH Guide for the Care and Use of Laboratory Animals and the
University Guidelines, and agrees to abide by the Principles for
the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training contained in this document. I assure that I
will obtain IACUC approval prior to significant changes in the
protocol. I assure that students, staff, and faculty on the
project are qualified or will be trained to conduct the project in
a humane and scientific manner. Any change in the care and
use of animals involved in this protocol that would affect their
welfare will be promptly forwarded to the IACUC for review.
Such changes will not be implemented until the Committee's approval
is obtained. Animals will not be transferred between
investigators without prior approval.
(Signature of Principal Investigator)
("Per" Signature not acceptable)
(Date)
Approvals
Refer to IACUC
Signature
Date:
Administrative Approval
Duplicate Submission
Approved by Full IACUC at convened meeting
Date:
Signature
Date:
Veterinary Review Complete
Refer to IACUC
Signature of Veterinarian
Date:
Approved
Refer to IACUC
Signature of Designated Reviewer
Date:
Comments of University Reviewers:
INFORMATION AND INSTRUCTIONS FOR THE
ANIMAL CARE AND USE REVIEW FORM (ACURF)
Please complete all parts of the attached form. This application
must be completed on a word processor, and submission must include
a signed hardcopy and computer file (Word or Word Perfect format).
E-mail the file to [email protected]. Please return the signed
hardcopy to the OAR, 400 Medical Laboratories. The reviewers would
also appreciate the formatting of your answers in a manner that
allows for ease of review (i.e. boldface). Please note: Six weeks
is required to process each application.
University policy and federal law require a review of projects
for humane treatment and safe use of vertebrate animals. At
the University of Iowa, the review is conducted by the University
Institutional Animal Care and Use Committee (IACUC).
Principal investigators and course directors must obtain
approval from the IACUC before initiating any research, testing or
instructional project involving the use of live vertebrate
animals. (The U.S. Public Health Service requires
verification of IACUC approval of animal care and use for funded
projects before monies will be released for use. For projects
funded by non-PHS agencies; verification of IACUC approval of
animal care and use generally must occur within 60 days after
submission of an application or proposal. Projects with multiple
components, such as Program Projects, may require several
ACURFs. IACUC approval must also be obtained prior to
significant changes in previously approved protocols.
The maximum period of approval is three years. (An annual
review of your approved protocol is also required utilizing the
Annual Review Form, which will be sent to you 60 days prior to the
annual date.) Prior to initial IACUC review, an approval number
will be assigned to the project. No project involving the use
of vertebrate animals may be initiated without approval by the
IACUC, including projects where animals are not directly purchased
(e.g. wild trapping, in‑house breeding, field observation).
The Office of Animal Resources (OAR) may be contacted for
guidance in selecting analgesics, anesthetics, methods for
euthanasia, nursing care techniques, etc. The OAR maintains a
repository of information on veterinary medicine, laws and
standards, and many aspects of the humane care and use of
animals. OAR professional and technical staff are available
for training and instruction of groups or individuals in animal
manipulations. Instructional Material is available on the OAR
Home Page:
http://research.uiowa.edu/animal
Please note that approved and funded (or activated) ACURFs are
available for public inspection (Iowa Public Records Act, Chapter
22, Iowa Code). In order to ensure that the information contained
in this form is not misinterpreted, it is imperative that
significance, aims and procedures of your protocol be in terms
which are understandable by the lay public. Your attention to this
will greatly facilitate the dissemination of accurate information
concerning the essential role of animals in research and teaching.
Be assured also that you will be contacted before any information
concerning your project is released. It is also advised and
encouraged that information supplied to the public and to the news
media be made available with the assistance of the Health Science
Relations Office 335-8037 or University Relations Office
335-0557.
If you have concerns regarding the security of the animals or
the animal facilities, contact OAR at 335-7985 or Department of
Public Safety at 335‑5027.
UNIVERSITY OF IOWA PRINCIPLES
FOR THE CARE AND USE OF LABORATORY ANIMALS
(Adapted from the U.S. Government Principles for the Utilization
and Care of Vertebrate Animals Used in Testing, Research, and
Training)
I.The transportation, care and use of animals must be in
accordance with the Animal Welfare Act and other applicable federal
and state laws, guidelines, and policies.
II.Procedures involving animals should be designed and performed
with due consideration of their relevance to human or animal
health, the advancement of knowledge, or the good of society.
III.The animals selected for a procedure should be of an
appropriate species and quality and the minimum number required to
obtain valid results. Alternative methods such as
mathematical models, computer simulation, and in vitro biological
systems must be considered.
IV.Proper use of animals, including the avoidance or
minimization of discomfort, distress, and pain when consistent with
sound scientific practices, is imperative. Unless the
contrary is established, investigators must consider that
procedures that cause pain or distress in human beings may cause
pain or distress in other animals.
V.Procedures with animals that may cause more than momentary or
slight pain or distress should be performed with appropriate
sedation, analgesia, or anesthesia. Surgical or other painful
procedures must not be performed on unanesthetized animals
paralyzed by chemical agents.
VI.Animals that would otherwise suffer severe or chronic pain or
distress that cannot be relieved must be painlessly euthanized at
the end of the procedure or, if appropriate, during the
procedure. UI veterinarians have the authority to euthanize
animals whose welfare is seriously threatened. The action
will follow contact or several efforts to contact the responsible
investigators.
VII.The living conditions of the animals should be appropriate
for their species and contribute to their health and comfort.
Normally the housing, feeding, and care of all animals used for
biomedical purposes must be directed by a veterinarian or other
scientist trained and experienced in the proper care, handling, and
use of the species being maintained or studied. In any case,
veterinary care shall be provided.
VIII. Investigators and other personnel shall be appropriately
qualified and experienced for conducting procedures on living
animals. Adequate arrangements shall be made for their
in‑service training, including the proper and humane care and use
of laboratory animals.
IX.Where exceptions are required in relation to the provisions
of these Principles, the decisions should not rest with the
investigators directly concerned but should be made, with due
regard to Principle II, by an appropriate group such as an
institutional animal research committee. Such exception
should not be made solely for the purpose of teaching or
demonstration.
16
(Revised 1 6/11/03) Please download the latest form at
http://research.uiowa.edu/animal/?get=forms
