OFFICE FOR
RESPONSIBLE
RESEARCH
USE ONLY
Review Date:
Approval Date:
Continuing Review Date:
Date OSPA Database:
Project Closure Date:
Key Personnel Training:
Committee ID:
Length of Approval:
FULL Committee Review Date:
Date in Compliance Database:
Complete / Date of Completion:
Incomplete
ISU RESPONSIBLE RESEARCH REVIEW FORM USE OF ANIMALS IN RESEARCH
SECTION I: GENERAL INFORMATION
Principal Investigator (PI):
Phone:
Degrees:
Correspondence Address:
Department:
Email Address:
Center/Institute:
College:
PI Level:
Faculty
Staff
Postdoctoral
Graduate Student
Alternate Contact Person:
Email Address:
Correspondence Address:
Phone:
Title of Project:
Start Date for involvement of Animals or Biohazards (mm/dd/yy):
Fax:
KEY PERSONNEL
List all members and relevant experience of the project personnel. This information is intended to inform the committee
of the training and background related to the specific procedures that each person will perform on the project.
NAME
DEGREE
SPECIFIC DUTIES ON
PROJECT
TRAINING & EXPERIENCE RELATED TO
PROCEDURES PERFORMED, DATE OF
TRAINING
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FUNDING INFORMATION
Provide the funding source for the project below. Do not skip this question. If not applicable, please explain under
“Other.”
Internally funded, please provide account number:
Externally funded, please provide funding source and account number:
Funding is pending please provide OSPA Record ID on GoldSheet:
Title on GoldSheet if different from above:
Other:
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SCIENTIFIC REVIEW
Yes
No
Has or will this project receive peer review?
If “yes,” please indicate who did or will conduct the review:
If a review was conducted, please indicate the outcome of the review:
COLLECTION OR RECEIPT OF BIOLOGICAL SAMPLES
Will you be: (Please check all that apply.)
Yes
No Receiving samples from outside of ISU? See examples below.
Yes
No Sending samples outside of ISU? See examples below.
Examples include: genetically modified organisms, body fluids, tissue samples, blood samples, and pathogens.
If you will be receiving samples from or sending samples outside of ISU, please identify the name of the outside
organization(s) and the identity of the samples you will be sending or receiving outside of ISU:
SECTION II: APPLICATION FOR INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)
APPROVAL
Yes
No Does this project involve live vertebrate animals? If “no” is checked, you don’t need to answer the
questions in SECTION II.
SECTION III: APPLICATION FOR INSTITUTIONAL BIOSAFETY COMMITTEE (IBC) APPROVAL
Yes
No Does this project involve any of the following: Recombinant DNA (including transgenic animals);
human, plant or animal pathogens; biological toxins; or administration of experimental biological
products? If “no” is checked, you don’t need to answer the questions in SECTION III.
SECTION IV: ENVIRONMENTAL HEALTH AND SAFETY INFORMATION (EH&S)
Yes
No Does this project involve laboratory chemicals, human cell lines or tissue culture (primary OR
immortalized), or human blood components, body fluid or tissues? If “no” is checked, you don’t need to
answer the questions in SECTION IV.
ASSURANCE





I certify that the information provided in this application is complete and accurate and consistent with any
proposal(s) submitted to external funding agencies.
I agree to provide proper surveillance of this project to ensure that the health and welfare of animal subjects are
protected. I will report any problems to the appropriate compliance review committee(s).
I certify that this project does not unnecessarily duplicate previous experiments involving animals.
I agree that modifications to the originally approved project will not take place without prior review and approval
by the appropriate committee(s), and that all activities will be performed in accordance with all applicable federal,
state, local and Iowa State University policies.
I will follow applicable biosafety level requirements, comply with all shipping requirements and required waste
management practices.
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
I will ensure that all personnel have appropriate training. including but not limited to: biosafety principles and
techniques, accidental spills, shipping regulations, proper handling of biohazardous materials and waste
management, animal welfare regulations, and human subject regulations training.
CONFLICT OF INTEREST
Yes
No Will you or any member of your research team have an actual or potential conflict of interest?
Yes
No If yes, have the appropriate disclosure forms been completed?
SIGNATURES
Signature of Principal Investigator
Date
Signature of Department Chair
Date
FOR OFFICE FOR RESPONSIBLE RESEARCH /IACUC USE ONLY:
Project approved (date:
Project not approved (date:
)
)
IACUC Approval Signature
Date
FOR OFFICE FOR RESPONSIBLE RESEARCH /IBC USE ONLY:
Initial action by the IBC :
Project exempt. Date: _____________
Project approved. Date: _____________
Project not approved. Date: _____________
Project referred to the full committee. Date: ____________
Pending further review. Date: _____________
Follow-up action by the IBC:
Signature of IBC Chair
Date
PLEASE NOTE: Any changes to an approved protocol must be submitted to and approved by the appropriate
committee(s) before the changes may be implemented.
SECTION II: APPLICATION FOR INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
APPROVAL
STUDY OBJECTIVES
Provide an overall summary of the project and briefly explain in language understandable to the general public the
specific aim(s) of the study.
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BENEFIT
Explain in language understandable to the general public how the information gained in this study will benefit human
or animal health, the advancement of knowledge, and/or serve the good of society. This information is intended to inform
the committee why it is important to conduct this study.
PART A: SPECIES
Table 1:
Genus/Species
or Common
Name
Strain,
Subspecies or
Breed
Total*
Number to
Be Used in
Entire
Project
Humane Use Category
In B
In C
In D
In E
Approximate
Age, Weight
or Size
Sex
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*You must include the total number of each species that you anticipate will be used during the entire project. This
includes any animals that will be purchased as extra animals or that are started on the study but removed before
completion.
PAIN OR DISTRESS CLASSIFICATION AND CONSIDERATION OF ALTERNATIVES
A) If animals in this project will be in category D, you must provide a written narrative below of the sources consulted
to determine whether or not alternatives exist to procedures that may cause pain or distress. At a minimum you must
include: the names of the databases searched; the date the search was performed; the period covered by the search; and
the key words and/or the search strategy used; potential alternatives and why they were not appropriate.
B) If any animals in this project will be in category E, an explanation of the procedures producing pain or distress in
the animal and the justification for not using appropriate anesthetic, analgesic or tranquilizing drugs must be provided
below. This information is required to be reported to the USDA, will be available from the USDA under the Freedom
of Information Act, and may be publicly available through the Internet via the USDA’s website. At a minimum, you
must include: the names of the databases searched; the date the search was performed; the period covered by the
search; the key words and/or the search strategy used; and potential alternatives and why they were not appropriate.
USDA PAIN OR DISTRESS CLASSIFICATION AND EXAMPLES
Classification B: Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery,
but not yet used for such purposes.
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Examples:
 Breeding colonies of any animal species (USDA does not require listing of rats, mice, or birds) that are held in legal
sized caging and handled in accordance with the Guide for the Care and Use of Laboratory Animals and other
applicable regulations.
 Newly acquired animals that are held in proper caging and handled in accordance with applicable regulations.
 Animals held under proper captive conditions or wild animals that are being observed.
Classification C: Animals upon which teaching, research experiments, or tests will be conducted involving no pain,
distress, or use of pain-relieving drugs.
Examples:
 Procedures performed correctly by trained personnel such as the administration of electrolytes/fluids, administration
of oral medication, blood collection from a common peripheral vein per standard veterinary practice (dog cephalic,
cat jugular) or catheterization of same, standard radiography, parenteral injections of non-irritating substances.
 Euthanasia performed in accordance with the recommendation of the most recent AVMA Guidelines on Euthanasia,
utilizing procedures that produce rapid unconsciousness and subsequent humane death.
 Manual restraint that is not longer than would be required for a simple exam.
Classification D: Animals upon which experiments, teaching, research, surgery, or tests will be conducted involving
accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs will
be used.
Examples:
 Surgical procedures conducted by trained personnel in accordance with standard veterinary practice such as
biopsies, gonadectomy, exposure of blood vessels, chronic catheter implantation, laparotomy or laparoscopy.
 Blood collection by more invasive routes such as intracardiac or periorbital collection from species without a true
orbital sinus such as rats and guinea pigs.
 Administration of drugs, chemicals, toxins, or organisms that would be expected to produce pain or distress but
which will be alleviated by analgesics.
Classification E: Animals upon which teaching, experiments, research, surgery, or tests will be conducted involving
accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing
drugs will adversely affect the procedures, results, or interpretation of the teaching, research, experiments, surgery, or
tests.
Examples:
 Procedures producing pain or distress unrelieved by analgesics such as toxicity studies, microbial virulence testing,
radiation sickness, and research on stress, shock, or pain.
 Surgical and postsurgical sequelae from invasion of body cavities, orthopedic procedures, dentistry or other hard or
soft tissue damage that produces unrelieved pain or distress.
 Negative conditioning via electric shocks that would cause pain in humans.
Table 2:
SOURCES OF SPECIES
Procured through Laboratory Animal Resources
Iowa State University breeding colony or herd
Privately owned
Transferred from another study.
NUMBER OF EACH SPECIES
NUMBER:
IACUC LOG NUMBER:
NUMBER:
NUMBER:
IACUC LOG NUMBER:
Other – List other Source
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Captured from the wild
NUMBER:
PERMITS REQUIRED:
1) Preferred housing location(s) and any special housing, caging, or bedding needs. If animals will be housed
outside of an ISU-approved housing facility for more than 12 hours, please provide the alternate housing location,
including the building and room number.
2) Location(s) where procedures will be conducted including where surgery will take place:
3) Please indicate what will happen to the animals at the end of the project. Please designate the number of animals
for each category.
Slaughtered. Number:
Sold. Number:
Returned to colony, herd, or owner. Number:
Transferred to another project. Number:
Please provide log number and Principal Investigator:
Other. Number:
Please specify:
Euthanized. Number:
Please specify how the carcass will be disposed of following euthanasia.
Can be rendered
Must be incinerated
Other. Please specify:
Please specify who will dispose of the carcasses.
Disposed of by key personnel.
Disposed of by LAR personnel.
Collected by Environmental Health and Safety
Other. Please specify:
PART B: RATIONALE FOR ANIMAL USE
4) Explain your rationale for using live animals and why the species proposed is appropriate for this study.
5) What alternatives to use of live animals have been considered, and why were they not appropriate? This
question is designed to inform the committee of the alternatives that were considered, why it was determined that they
were not useful for this study, why a species lower on the phylogenetic scale could not be used, if methods have been
incorporated into the study to reduce animal numbers or refine techniques, and an explanation of those methods.
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6) Describe how the number of animals needed for the study was determined. The Guide recommends that the
number of animals should be the minimum number required to obtain statistically valid results. A power analysis is
strongly encouraged to justify group sizes when appropriate. Note: this question overlaps with other questions but is
needed for clarification and documentation purposes.
PART C: DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES
Please do not respond to any questions with the statement “industry practice” as the community and nonscientist
members of the committee will not be familiar with industry practice and will not have the information necessary
to vote.
7) Briefly explain the experimental design and specify the treatments (including nutritional manipulations) and the
number of animals per treatment group. This description should allow the IACUC to understand the experimental
course of an animal from its entry into the experiment to the endpoint of the study.
8)
Yes
No Will this project involve injections, inoculations or drugs? (Note: this question overlaps with #9
but is required for clarification.) If “yes,” please provide the information below for all substances that will be
administered.
Substance
Dose
Schedule
Route of Administration
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9)
Yes
No Will this project involve administration of substances to animals that have not been approved
for marketing by the FDA/USDA-APHIS? If so, please describe your plan for conforming with requirements of the
FDA and USDA under 21 CFR 511 (New Animal Drugs for Investigational Use) and 9 CFR 309.17 (Livestock Used
for Research).
This information is intended to inform the committee if the study is in support of an application for marketing
approval for a new drug, if a “slaughter authorization” is required from the FDA (i.e., the animals must be held for a
set period specified by the FDA), and if the animals may be rendered or must be incinerated. If the FDA has issued a
“slaughter authorization,” attach it and any other applicable communications from the FDA with your application.
10)
Yes
No Will this project involve blood draws? If “yes,” please describe below including volume,
frequency, withdrawal sites, and methodology. (Note: this information overlaps with Question 9, but a follow-up
is needed for clarification.)
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11)
Yes
No Will this project involve radiation or isotope administration? If “yes,” please explain below
and include doses and schedules.
12)
Yes
No Will this project involve restraint of the animals for procedures included in the protocol (e.g.,
metabolism cages/stalls, chutes, stanchions, manual restraint, etc.)? If “yes,” please explain below including the
length of time and how animals will be restrained for procedures included in the protocol. Prolonged restraint must
be justified with appropriate oversight to ensure that the potential for pain and/or distress is minimized. Also
describe any sedation, acclimation, or training to be utilized.
13)
Yes
No Will this project involve animal identification methods (e.g., ear tag, tattoo, collar, cage card,
implant, etc.)? If the answer is “yes,” please explain the method(s) to be used.
14)
Yes
No Will this project involve other non-surgical procedures (e.g., husbandry procedures, tail
biopsies, etc.)? If “yes,” please specify below.
15)
Yes
No Will the animals in the study experience any resultant effects from the procedures in this study
(e.g., pain or distress, ascites production, etc.)? If “yes,” please explain below, and explain to what extent affected
animals will be treated.
16)
Yes
No Will this study involve other potential stressors (e.g., food or water deprivation, noxious
stimuli, environmental stress)? If “yes,” please explain below and include the procedures to monitor and
minimize distress. If a study is USDA Humane Use Category E, indicate any non-pharmaceutical methods to
minimize pain and distress. Please note that a monitoring log must be kept in each room.
17)
Yes
No Will this study involve the administration of tumor cells, biologics, infectious agents,
radiation or toxic chemicals that have the potential to be lethal or cause significant symptomatology? If “yes,”
the experimental endpoint criteria (e.g., tumor size, percentage body weight gain or loss, inability to eat or drink,
behavior abnormalities, clinical symptomatology, or signs of toxicity) MUST be specified below. Also list the
criteria to be used to determine when euthanasia is to be performed. Use of a moribund state or death as an
endpoint must always be scientifically justified.
18) Indicate how the animals will be monitored during the project, including criteria used to determine when an
animal should be removed from the project. Please be specific, and do not list categories such as “general
health.”
SPECIES
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PARAMETERS TO BE
MONITORED
FREQUENCY OF
MONITORING
PERSON RESPONSIBLE FOR
MONITORING
8
Add New Row
NOTE: A copy of the monitoring records must be kept in the animal facility/room.
19) Please specify the experimental endpoint criteria (e.g., tumor size, percentage body weight gain or loss, inability to
eat or drink, behavior abnormalities, clinical symptomatology, or signs of toxicity). Also list the criteria to be used
to determine when euthanasia is to be performed. Use of a moribund state or death as an endpoint must always be
scientifically justified.
20) Veterinary care. Please indicate desired plan of action in case of animal illness (e.g., initiate treatment, call
investigator prior to initiating treatment, euthanize). Please include the veterinarian responsible for providing
care and the names of project personnel authorized to approve medical treatment or euthanasia.
*Please note: if none of the individuals listed below can be contacted in a timely manner, the decision to treat
or euthanize animals will be made by the LAR veterinary staff.
21) Will this study involve euthanasia of animals?
Yes
No
If “yes,” please describe the method of euthanasia below. You must justify any methods not fully approved by
the AVMA Guidelines on Euthanasia.
If “no,” please describe the method of euthanasia that will be used, should the need arise for euthanasia to alleviate
unrelieved pain and distress (e.g., animal has not or will not recover with treatment). You must justify any methods
not fully approved by the AVMA Guidelines on Euthanasia. If euthanasia will need to occur, please indicate the
individual(s) that will perform euthanasia and the training/experience the individual(s) has with euthanasia.
PART D: SURGERY
Yes
No Will this project involve surgery on animals? If “yes,” please complete all of the questions in
Part D: Surgery.
22) Specify and describe the surgical procedure(s) to be performed. Include preoperative procedures (e.g., fasting,
analgesic loading), monitoring, and supportive care during surgery. Include the aseptic methods to be utilized. This
question overlaps with Question 9 but is required for clarification.
23)
Yes
No Will the surgery be a survival surgery? If “yes,” please describe postoperative care required,
frequency of observation, and identify the responsible individual(s). Include detection and management of
postoperative complications during work hours, after hours, and on weekends and holidays.
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24)
Yes
No Will more than one major survival surgery be performed on an animal while on this study?
Major survival surgery is defined as surgery that penetrates and exposes a body cavity or produces substantial
impairment of physical or physiologic functions (e.g., laparatomy, thoracotomy, craniotomy, joint replacement, or
limb amputation). If “yes,” please justify below.
25)
Yes
No Will major survival surgery be performed on any animal prior to being placed on this
study? If “yes,” please explain below.
26)
Yes
No Will paralytic agents be used during surgery? If “yes,” please describe how ventilation will be
maintained and how pain will be assessed. Note: Paralytic agents cannot be used without an anesthetic agent.
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SECTION III: APPLICATION FOR INSTITUTIONAL BIOSAFETY COMMITTEE APPROVAL
Yes
No Will this project involve any of the following: (i) recombinant DNA (including transgenic animals); (ii)
human, plant or animal pathogens; (iii) biological toxins; or (iv) administration of experimental
biological products? If the answer “yes” is checked, please proceed to PART A: TRANSGENIC
ANIMALS. If “no” is checked, please proceed to Section IV.
In addition to the Key Personnel listed in Section I, all personnel with project roles requiring review by the Institutional
Biosafety Committee (IBC) must be listed. List all personnel that contribute to the project described in the application,
along with their relevant experience and training. This information is necessary to inform the IBC of the experience,
background, and training of the investigators and personnel relevant to each project during its review.
NAME
DEGREE
SPECIFIC DUTIES ON
PROJECT
TRAINING & EXPERIENCE RELATED TO
PROCEDURES PERFORMED/DATE OF
TRAINING
PART A: TRANSGENIC ANIMALS
Yes
No Will this project involve the use of transgenic animals? If “no” is checked, please proceed to PART B:
EXPERIMENTAL BIOLOGICAL PRODUCTS.
Yes
No Will this project involve breeding transgenic animals at ISU? If the answer “yes” is checked, you must
also submit a Breeding Colony Form.
1) Describe how these animals are genetically altered.
2) Please indicate how these animals will be procured. This information is intended to inform the committee if animals
will be purchased from a vendor, transferred from another institution, or produced here at ISU.
3) NIH Guidelines require that transgenic animals must be individually marked (e.g., ear notch, toe clip, etc.) within 72
hours after birth if size permits. If size does not permit, their container should be marked. Describe the marking
system that will be used to individually identify all transgenic animals in this project and any resulting offspring.
4) Describe the type and frequency of evaluations to be performed on the animals in this project.
PART B: EXPERIMENTAL BIOLOGICAL PRODUCTS
Yes
No
Will this project involve use of unlicensed experimental biological products in animals? If the answer
“no” is checked, please skip to PART C: RECOMBINANT DNA.
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5) Please describe how you will comply with requirements of the FDA and USDA under 9 CFR 103.2 (Disposition of
animals administered experimental biological products or live organisms) and 9 CFR 309.17 (Livestock used for
research).
PART C: RECOMBINANT DNA
Yes
No
Will this project involve recombinant DNA? If the answer “no” is checked, please skip to PART D:
INFECTIOUS AGENT OR BIOLOGICAL TOXIN USE.
6)
Please describe the source of the DNA including the type of organism, species, strain, cultivar/cell line.
7)
Please describe the nature of the inserted DNA sequences, including regulatory or coding region, entire genome,
synthetic antisense sequences, etc.
8)
Please describe the recipient organism(s) for the DNA. Specify the type of organism, species, strain, cultivar/cell
line, origin, etc.
9)
List vectors to be used, such as expression vectors, and briefly specify their purpose.
10)
Yes
No
Will there be a deliberate attempt to express a foreign gene?
If “yes,” describe how expression of the inserted DNA sequences will result in differences from the non-modified
parental organism (e.g., morphological or structural characteristics, physiological activities and processes, growth
characteristics). Indicate possible toxicity or other hazards, if any:
PART D: INFECTIOUS AGENT OR BIOLOGICAL TOXIN USE
Yes
11)
No
Will this project involve human, animal or plant pathogens, or biological toxins? If the answer is “yes,”
please complete all of the questions in this section.
Please list the infectious agents or biological toxins to be used and check appropriate categories:
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INFECTIOUS AGENT OR BIOLOGICAL
TOXIN
HUMAN
HAZARD
ANIMAL
HAZARD
PLANT
HAZARD
IF PLANT
PATHOGEN, IS
IT
(Answer Yes or (Answer Yes or (Answer Yes or INDIGENOUS
TO IOWA?
No)
No)
No)
(Answer Yes or
No)
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12) If this project will involve infectious agents or biological toxins that affect humans, please describe symptoms,
severity of disease, vulnerable populations, and mode of transmission (fecal-oral, direct contact, aerosol, etc.).
13)
Yes
No If you will be using a human infectious agent or biological toxin, is a vaccine available?
If a vaccine is available, all potentially exposed personnel must be informed of the potential hazards and benefits
and offered the option of receiving the vaccine. Vaccinations may be obtained at Occupational Medicine office
(294-2056).
If a vaccine is available, list dates and type of vaccination for all potentially exposed personnel:
NAME
VACCINATION(S)
DATE(S) RECEIVED
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For any potentially exposed personnel not receiving available vaccination(s), please attach a completed and signed
Decline of Immunization Form.
14)
Yes
No Will this project involve the use of Select Biological Agents
(www.ehs.iastate.edu/publications/selectagents.pdf)?
14a)
Yes
No If Select Agents will be used, have all requirements of the University Biological
Research Security Plan been met?
All possession and use of Select Biological Agents requires special registration that must be done through the
University Biosafety Officer (294-5359).
PART E: BIOSAFETY CONTAINMENT LEVEL
If you have indicated “yes” to Part A, B, C, or D, please complete the following.
15) Please check the federal guidelines applicable to the proposed project. The IBC Administrator (294-5412) can assist
you in determining the proper guidelines. All guidelines are also available on the Internet.
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For recombinant DNA and/or transgenic animals, refer to the NIH Guidelines for Research Involving
Recombinant DNA Molecules. Please list the specific guidelines under section III to be followed for this project
in the box below:
Please indicate proposed biosafety containment level(s) to be used in this project. Refer to the NIH Guidelines for
Research Involving Recombinant DNA Molecules.
rDNA Biosafety Level 1 (BL1)
rDNA Biosafety Level 2 (BL2)
rDNA Biosafety Level 3 (BL3)
rDNA Animal Biosafety Level 1 (BL1-N)
rDNA Animal Biosafety Level 2 (BL2-N)
rDNA Animal Biosafety Level 3 (BL3-N)
rDNA Large Scale Biosafety Level 1 (BL1-LS)
rDNA Large Scale Biosafety Level 2 (BL2-LS)
rDNA Large Scale Biosafety Level 3 (BL3-LS)
rDNA Plant Biosafety Level 1 (BL1-P)
rDNA Plant Biosafety Level 2 (BL2-P)
rDNA Plant Biosafety Level 3 (BL3-P)
For human pathogens or toxins, refer to the CDC publication Biosafety in Microbiological and Biomedical
Laboratories (www.cdc.gov/OD/ohs/biosfty/bmbl5/BMBL_5th_Edition.pdf). Please list the specific safety and/or
containment practices to be followed for this project:
Please indicate proposed biosafety containment level(s) to be used in this project. Refer to Biosafety in
Microbiological and Biomedical Laboratories.
Biosafety Level 1 (BSL-1)
Biosafety Level 2 (BSL-2)
Biosafety Level 3 (BSL-3)
Animal Biosafety Level 1 (ABSL-1)
Animal Biosafety Level 2 (ABSL-2)
Animal Biosafety Level 3 (ABSL-3)
For animal-only pathogens or toxins, there are currently no applicable regulatory guidelines. Please contact the
University Biosafety Officer (294-5359) for assistance with the development of prudent guidelines specific to the
animal-only pathogen or toxin used in this project. Please list the specific safety and/or containment practices to
be followed for this project:
Please indicate proposed biosafety containment level(s) to be used in this project. Refer to Biosafety in
Microbiological and Biomedical Laboratories.
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Biosafety Level 1 (BSL-1)
Animal Biosafety Level 1 (ABSL-1)
Animal Biosafety Level 1 with special practices to prevent spread to other (susceptible) animals in the
facilities (ABSL-1+)
16)
Yes
No
Are any federal permits required for this project? This information is intended to inform the
committee if any federal import, export, transport, or field-test permits or letters of notification
are required. If the appropriate permits have already been obtained, please list the applicable
permit numbers:
Permit:
Permit:
Permit:
The Department of Environmental Health and Safety (EH&S) can assist you in determining permit requirements and
obtaining any necessary permits. Permit requirement information is available on the Internet. Please submit permits to
the EH&S Permit Specialist, 294-5359.
17) Describe the specific decontamination method(s) to be used for all biohazardous waste (except animal carcass
disposal) and contaminated equipment. Decontamination methods may include autoclaving, chemical disinfections,
etc. If a chemical disinfectant is used, state type and concentration. Please refer to the EH&S Sharps and
Biohazardous Waste Policy (http://www.ehs.iastate.edu/publications/policies/sharps.pdf) and the Sharps and
Biohazardous Waste Disposal Flow Chart (http://www.ehs.iastate.edu/publications/policies/sharpsflowchart.pdf) for
assistance.
TYPE OF WASTE/EQUIPMENT
DECONTAMINATION/DISPOSAL METHOD
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PART F: PROCEDURES FOR LABORATORY SAFETY AND EXPERIMENTAL PROCEDURES
18) Please check all of the personal protective equipment required for work in the laboratory.
face shield/goggles/safety glasses (specify the type protection and when it will be used):
shoe covers
lab coat
gloves
head cover
mouth/nose covering (specify the type and when it will be used):
other (specify):
19) Please list any special precautions, in addition to the personal protective equipment and the regulatory guideline
requirements that may be employed in the laboratory for safety and waste handling. If this question is not applicable,
please indicate N/A.
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PART G: STUDY LOCATION INFORMATION
20) Please list the location(s) where the project will be carried out. Include all laboratory and animal facilities as well
as field locations and greenhouses.
BUILDING, FIELD LOCATION OR GREENHOUSE
ROOM NUMBER IF APPLICABLE
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21) List locations of biological safety equipment (e.g., biosafety cabinet, autoclave). Include most recent certification date
for biosafety cabinets. Please enter “failed” if the cabinet did not pass certification testing.
BIOLOGICAL SAFETY
EQUIPMENT USED
BUILDING
ROOM
NUMBER
CERTIFICATION DATE
(Required only for biosafety
cabinets.)
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PART H: PROJECTS INVOLVING ANIMAL STUDIES
22)
Yes
No
Does this project involve animals? If the answer is “yes,” please complete all of the questions in
this section.
At the project’s termination the animals will be:
Note: If multiple categories are checked, designate the number of animals for each category.
Slaughtered
Sold
Returned to colony, herd, or owner
Transferred to another project (if yes, give log # and investigator):
Other (specify):
Euthanized
Specify how the carcass will be disposed of following euthanasia.
Can be rendered
Must be incinerated (Per ISU EH&S Sharps and Biohazardous Waste Policy, all sheep and goats and
any animals infected with human pathogens must be incinerated.)
Other (specify):
Please describe how the carcass will be disposed (e.g., PI will euthanize, place carcass in the freezer and
LAR will take carcass to the incinerator, etc.).
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23)
Yes
No Will this project involve the use of infectious agents or biological toxins in animals? If the answer
is “yes,” please complete all of the questions in this section. Please specify all animal species that are affected by this
infectious agent or biological toxin and describe the expected clinical signs, severity of the disease, and mode of
transmission (e.g., fecal-oral, direct contact, aerosol, etc.).
24) Please check all personal protective equipment required in animal facilities:
face shield/goggles/safety glasses (specify the type protection and when it will be used):
boots/shoe covers
coveralls/lab coat
rain suit
gloves
head cover
mouth/nose covering (specify the type and when it will be used):
other (specify):
25) Please describe any special precautions to be used in the animal facility: (e.g., shower in/out). If this question is not
applicable, please indicate N/A.
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SECTION IV: ENVIRONMENTAL HEALTH AND SAFETY
Yes
No Will this project involve any of the following: human cell or tissue cultures (primary OR immortalized),
or human blood components, body fluids or tissues? If the answer is “yes,” please proceed to Part A:
Human Cell or Tissue Cultures.
PART A: HUMAN CELL OR TISSUE CULTURES
Yes
No Will this project involve human cell or tissue cultures (primary OR immortalized cell lines/strains)?
1) Please list the specific cell lines/strains to be used, their source, and description of use.
CELL LINE
SOURCE
DESCRIPTION OF USE
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Yes
No Have the human cell or tissue cultures been documented to be free of bloodborne pathogens? If “yes,”
please fax or attach copies of the documentation. If “no,” please complete this section.
2) Please refer to the ISU “Bloodborne Pathogens Manual,” which contains the requirements of the OSHA Bloodborne
Pathogens Standard. Please list the specific precautions to be used for this project below (e.g., retractable needles will
be used for blood draws):
Anyone working with human cell lines/strains who has not been documented to be free of bloodborne pathogens is
required to have Bloodborne Pathogen Training annually. Current Bloodborne Pathogen Training dates must be
listed in Section I for all Key Personnel. Please contact Environmental Health and Safety (294-5359) if you need to
sign up for training and/or to get a copy of the “Bloodborne Pathogens Manual.”
PART B: HUMAN BLOOD COMPONENTS, BODY FLUIDS OR TISSUES
Yes
No Will this project involve human blood components, body fluids or tissues? If “yes,” please answer all of
the questions in the “Human Blood Components, Body Fluids or Tissues” section.
3) Please list the specific human substances used, their source, amount, and description of use.
SUBSTANCE
E.g., Blood
SOURCE
Normal healthy
volunteers
AMOUNT
2 ml
DESCRIPTION OF USE
Approximate quantity, assays to be done.
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4) Please refer to the ISU “Bloodborne Pathogens Manual,” which contains the requirements of the OSHA Bloodborne
Pathogens Standard. Please list the specific precautions to be followed for this project.
Anyone working with human blood components, body fluids or tissues is required to have Bloodborne Pathogen
Training annually. Current Bloodborne Pathogen Training dates must be listed in Section I for all Key Personnel.
Please contact Environmental Health and Safety (294-5359) if you need to sign up for training and/or to get a copy
of the “Bloodborne Pathogens Manual.”
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