Fillable VIRGINIA STATE UNIVERSITY Submission Procedures: Submit the completed (Virginia State University)

Fill Online, Printable, Fillable, Blank VIRGINIA STATE UNIVERSITY Submission Procedures: Submit the completed (Virginia State University) Form

Use Fill to complete blank online VIRGINIA STATE UNIVERSITY pdf forms for free. Once completed you can sign your fillable form or send for signing. All forms are printable and downloadable.

VIRGINIA STATE UNIVERSITY Submission Procedures: Submit the completed (Virginia State University)

On average this form takes 43 minutes to complete

The VIRGINIA STATE UNIVERSITY Submission Procedures: Submit the completed (Virginia State University) form is 16 pages long and contains:

  • 0 signatures
  • 0 check-boxes
  • 172 other fields

Country of origin: US
File type: PDF

U.S.A. forms for Virginia State University

BROWSE VIRGINIA STATE UNIVERSITY FORMS

Related forms
Fill has a huge library of thousands of forms all set up to be filled in easily and signed.
Fill in your chosen form
Sign the form using our drawing tool
Send to someone else to fill in and sign.
find another form
 
1
VIRGINIA STATE UNIVERSITY
Petersburg, Virginia 23806
FOR IACUC USE
Review Month:
Protocol Number:
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
ANIMAL PROTOCOL REVIEW QUESTIONNAIRE
Submission Procedures: Submit the completed signed questionnaire to the IACUC Office, P O Box
9407. The IACUC has established a review cutoff date of 5 business days to complete the review of a
protocol. Please call the IACUC Office for additional information.
ADMINISTRATIVE INFORMATION:
(1) TITLE OF PROJECT:
(2) PERSONNEL: Principal Investigator and Co-Investigators:
Name
Role on Protocol
Department
P. O. Box
Phone
Email
a)
b)
c)
d)
(3) FUNDING AGENCY: _______________________ SUBMISSION DATE: _____________
(4) REVIEW STATUS:
Initial Review Revised Submission
(If this is an annual renewal, please use the IACUC Annual Renewal Form.)
(5) PURPOSE OF THE STUDY:
Provide a brief summary in commonly understood terms describing the purpose, hypothesis, and
importance of the study. Remember that a layman or USDA inspector may review your proposal and
that not all members of the IACUC are familiar with your area of research.
2
(6) RATIONALE FOR USING ANIMALS:
Describe the potential benefits to be gained in either improved medical care of humans or animals or the
contribution of new scientific information.
(7) SPECIES JUSTIFICATION:
State why the animal species selected represents the best model to test the hypothesis of the study.
(8) ALTERNATIVES TO ANIMAL USE:
A search in at least two databases is required to determine that alternatives are not available and/or are
scientifically unacceptable. Database names, key words, dates searched and date search was performed
are required plus at least one additional database. For USDA covered species (gerbils, hamsters, rabbits,
cats, dogs, ruminants, pigs and primates), an Agricola (http://agricola.nal.usda.gov/) search is required.
For non-USDA covered species (rats, mice, birds), appropriate databases may include PubMed
(http://www.pubmedcentral.nih.gov/), Norina (http://oslovet.veths.no/NORINA/), Ovid
(http://www.ovid.com/site/index.jsp?top=1), Google (http://www.google.com/), Biosis Previews
(http://www.biosis.org/ ), CAB Abstracts (http://www.cabi-
publishing.org/AbstractDatabases.asp?SubjectArea=&PID=125), SCISEARCH
(http://library.dialog.com/bluesheets/html/bl0034.html), CRIS (http://cris.csrees.usda.gov/) or others as
applicable.
Key words that must be used in the search include: “alternative(s),” species proposed (dog, cat etc.) and
experimental procedure. Other terms may be searched as applicable.
(9) UNNECESSARY DUPLICATION:
Provide written assurance that the animal experimentation does not unnecessarily duplicate previous
experiments. If there is duplication, state why duplication is necessary.
Provide a description of how the P.I. accessed the pertinent literature (sources, key words, dates).
(10) PROCEDURES INVOLVING ANIMALS:
A. Describe all experimental procedures to be done to live animals, including anesthesia, surgeries,
blood volume to be drawn, etc. Use as much space as necessary.
B. Do you intend to breed animals?
If Yes, list the species. You are responsible for submitting the number of animals bred to
the IACUC on the first day of each month.
3
C. List All Drugs to be Used:
Species
Agent
Purpose
Dose
Route
a)
b)
c)
d)
e)
D. Will any non-pharmaceutical grade compounds be used?
If "Yes," include a scientific justification of why use of this compound is necessary:
E. Will this study involve prolonged restraint of unanesthetized animals?
If "Yes," provide a description of the restraint method/procedure and scientific justification for
its use:
F. Will the animals be deprived of water? Withholding water for the immediate pre-surgical period
(rodents up to 8 hours and non-rodents up to 12 hours) need not be described.
If "Yes," provide a description of the method of deprivation and monitoring of animal welfare along with
a scientific justification for water restriction.
G. Will the animals be deprived of food? Withholding food for the immediate pre-surgical period
(rodents up to 12 hours and non-rodents up to 24 hours) need not be described.
If "Yes," provide a description of the method of deprivation and monitoring of animal welfare along with
a scientific justification for food restriction.
H. Will the animals undergo multiple major survival surgeries?
If "Yes," provide scientific justification for multiple survival surgeries.
I. Endpoints: What clinical criteria or specific observations might be anticipated that would result in
premature euthanasia? Example: 20% loss in body weight; severe, unrelievable pain; animal expected to
die within 24 hours, moribund. (Death as an endpoint is strongly discouraged and must be justified.)
4
J. Euthanasia: Will euthanasia be carried out?
If "Yes," provide information below. Please use the most recent AVMA panel
on euthanasia for guidance (www.AVMA.org/resources/euthanasia.pdf) Note:
cervical dislocation and decapitation without anesthesia requires scientific justification.
Species
Agent/Method
Dose
Route
a)
b)
c)
d)
e)
If "No," describe disposition of animal(s) at conclusion of the study.
(11) ALTERNATIVES TO PAINFUL PROCEDURES:
A search in at least two databases is required to determine that alternatives to painful procedures are not
available and/or are scientifically unacceptable. Database names, key words, dates searched and date
search was performed are required plus at least one additional database. For USDA covered species
(gerbils, hamsters, rabbits, cats, dogs, ruminants, pigs and primates), an Agricola
(http://agricola.nal.usda.gov/) search is required. For non-USDA covered species (rats, mice, birds),
appropriate databases may include PubMed (http://www.pubmedcentral.nih.gov/), Norina
(http://oslovet.veths.no/NORINA/), Ovid (http://www.ovid.com/site/index.jsp?top=1), Google
(http://www.google.com/), Biosis Previews (http://www.biosis.org/ ), CAB Abstracts
(http://www.cabi-publishing.org/AbstractDatabases.asp?SubjectArea=&PID=125), SCISEARCH
(http://library.dialog.com/bluesheets/html/bl0034.html), CRIS (http://cris.csrees.usda.gov/) or others as
applicable.
Key words that must be used in the search include: “alternative(s),” “pain,” species proposed (dog, cat
etc.) and experimental procedure. Other terms may be searched as applicable.
(12) TOTAL NUMBER OF ANIMALS REQUESTED FOR THE ENTIRE PROJECT PERIOD:
By law, the number of animals requested can be approved for a maximum of 3 years only, but reviews
are mandated annually.
CLASSIFICATION OF ANIMAL USAGE: The USDA requires all animal usage to be classified
according to one of the following types:
Type C: Procedures involve no pain or distress (e.g., routine blood sampling without surgery
from a superficial vein or routine injections IV, IM, subcutaneous or IP or euthanasia following
AVMA panel on euthanasia guidelines.)
Type D: Procedures involve pain or distress, but the pain is relieved by appropriate drugs (e.g.,
surgery under anesthesia with pain relieving drugs postoperatively.)
5
Type E: Procedures involve pain or distress and they are not relieved by drug administration. If
you classify your procedures as Type E, you must write a statement giving careful scientific
justification for withholding such drugs.
Species
Number
Classification Type
Age or Weight
Sex
a)
b)
c)
d)
e)
(13) CONSULTATION WITH VETERINARY STAFF. It is mandated that investigators
consult with the facility veterinarian during preparation of this application before IACUC review for
Type D and Type E protocols.
Name the veterinarian consulted ______________________ Date ________________
(14) PLEASE PROVIDE THE FOLLOWING INFORMATION REGARDING
HOUSING AND ANIMAL USE:
(a) Housing Location:
If OTHER, fill in text box. Describe the housing if animals will remain longer than 12 hours. Please list
the location where the animals will be held. Indicate what provisions you will make for animal care
(regulated light, heat, humidity, room air changes, and cage cleaning) if you plan to exceed the above
time limit:
(Note: The IACUC requires the area to pass inspections prior to animals being housed and must be
allowed access to inspect the housing location after it is approved.)
(b) Will animals be used outside of the vivarium?
If YES, describe location of animal use (building, floor and room number) and procedure(s)
performed on animal. Please describe the housing conditions for the animals if they will
remain longer than 12 hours:
(c) Housing duration?
(d) Do animals need exemption from cage space requirements per NIH Guide for the
Care and Use of Laboratory Animals?
If YES, provide scientific justification:
6
(e) Do animals need exemption from enrichment per NIH Guide for the Care and Use of
Laboratory Animals and the Animal Welfare Act?
If YES, provide scientific justification:
(f) Do animals need exemption from exercise (dogs) per NIH Guide for the Care and Use
of Laboratory Animals and the Animal Welfare Act?
If YES, provide scientific justification:
(15) JUSTIFY THE NUMBERS OF ANIMALS TO BE USED:
The IACUC needs assurance that the minimum number of animals that will ensure a statistically sound
investigation is being requested. "Past experience" and "previously published" literature are not, in
themselves, an adequate justification.
(a) Has a biostatistician been consulted?
If "Yes," include memo from the biostatistician detailing the statistical analysis to be used and sample
size calculations and skip item (b).
(b) Specify the experimental design and indicate how you arrived at the number of
animals you propose to use:
(c) Provide a table summarizing animal use for each proposed experiment:
7
(16) QUALIFICATIONS OF INVESTIGATORS:
List only the personnel performing animal procedures and indicate for each individual their duties and
their previous experience in the procedure or how they will acquire the necessary training. Experience
should be described with the specific species and procedures described in this application.
Procedure to be Done
Name of Individual
Individual’s previous experience
with this procedure in this species
a)
b)
c)
d)
e)
(17) Infectious, Toxic Agents or Biohazards: Identify any agent(s) to be used that is harmful
to humans or other vertebrates.
A. Radioactive Materials: It is strongly encouraged to discuss possible hazards
with Animal Facility Management BEFORE starting the experiment.
1. Are radioactive materials given to animals?
2. If "Yes," identify the isotope(s) to be administered:
Half-life:
3. Is the isotope a gamma emitter?
4. If "Yes," describe how animals in adjacent cages will be protected.
5. Describe any precautions which must be taken because of isotope excretion and
respiration.
6. Who will be responsible for insuring that these precautions are taken properly?
7. How will the radioactive carcasses be disposed?
8
8. Approved by Radiation Safety Officer
_______________________________________ ____________________
(Name) (Date)
B. INFECTIOUS AGENTS: It is strongly encouraged to discuss possible
hazards with Animal Facility Management BEFORE starting the experiment.
1. Are infectious agents given to animals?
2. Identify the Infectious Agents and describe safety precautions needed:
3. If "Yes," describe how the condition of the animal will be monitored
throughout the experiment and safety precautions needed.
4. Has the Institutional Biosafety Committee approved the use of these materials?
C. CARCINOGENS: It is strongly encouraged to discuss possible hazards with Animal
Facility Management BEFORE starting the experiment.
1. Are known carcinogens/mutagens/reproductive hazards to be given to the animals?
2. If "Yes," Identify and describe the carcinogens/mutagens/reproductive hazards
being used.
3. If "Yes," describe how the condition of the animal will be monitored throughout
the experiment.
4. Has Environmental Health and Safety approved the use of these agents?
9
D. TOXIC AGENTS: It is strongly encouraged to discuss possible hazards with
Animal Facility Management BEFORE starting the experiment.
1. Are toxic agents to be given to the animals?
2. If "Yes," identify toxins and describe safety precautions needed.
3. If "Yes," describe how the condition of the animal will be monitored
throughout the experiment.
E. BIOHAZARDOUS MATERIALS: It is strongly encouraged to discuss possible
hazards with Animal Facility Management BEFORE starting the experiment.
1. Are biohazardous materials to be given to the animals?
2. If "Yes," identify the biohazard. Describe how the condition of the
animal will be monitored throughout the experiment and safety precautions
needed.
3. If the biohazard is greater than risk group 2, has the Institutional
Biohazard Committee approved the use of these materials?
(18) Good Laboratory Practice:
GLP relates to compliance with special reporting requirements established by the Food
and Drug Administration (FDA) for the testing of new drugs and devices.
1. Is this project subject to compliance with FDA standards?
10
(19) THIS PROTOCOL NEEDS TO BE REVIEWED IN USE EVERY 6
MONTHS. Has this protocol been reviewed in the last 6 months for new and improved
methods? Attach search.
(20) SIGNATURES
The use of animals for research, education or other purposes requires prior approval of a specific
protocol by the IACUC in accordance with Public Health Service (PHS) policy, the Health Research
Extension Act (PL99-158) and New World Laboratories, Inc. policy. Please complete all items in the
animal protocol review questionnaire and attach this assurance page.
Principal Investigator Assurance: The Principal Investigator is responsible for the humane use of
research animals, and is accountable for the completeness and accuracy of the information offered on the
attached protocol review questionnaire. While the care and use of animals may be delegated to other
persons, this responsibility cannot be delegated. Only one PI may be identified for each project. The
Principal Investigator must sign the following statement of assurance:
The proposed investigation involves the use of animals. I am submitting this form with a description of
my protocol prepared in accordance with New World Laboratories, Inc. policy for the humane care and
use of laboratory animals. I am responsible for:
1. Conducting activities involving animals in accordance with all provisions of the
Animal Welfare Act, the U.S. Government Principles Regarding the Care and Use
of Animals, the Guide (Guide for the Care and Use of Laboratory Animals, U.S.
Dept. of Health and Human Services, Public Health Service, NIH), the PHS
Policy on Humane Care and Use of Laboratory Animals and the CCF PHS
Assurance Statement:
2. Insuring that protocols involving animals are submitted to the Institutional Animal
Care and Use Committee for review and approval before the activity begins;
3. Submitting an annual protocol form to the IACUC;
4. Reporting, promptly to the IACUC proposed significant changes in my research
activity involving animals. Such changes shall include differences in species and
number of animals used in the project, changes in surgical and anesthetic
methods, change of PI, and changes in the method of euthanasia;
5. Reporting promptly to the IACUC any serious or continuing deviation from the
provisions of the Guide, PHS Policy or Animal Welfare Regulations.
Principal Investigator Signature
_______________________________________ ____________________
(Name) (Date)
Download
Save PDF to desktop
Email
Email completed PDF
Send for Signing
Email for others to sign
Print
Print document
Choose a Field
Click on a field and
select the person that should complete it
Want to add a signature?
You can add a signature field
and assign it to someone else
to sign
Choose a Field
Click on a field and
select the person that should complete it

VIRGINIA STATE UNIVERSITY Submission Procedures: Submit the completed (Virginia State University)

This document is locked as it has been sent for signing.

You have successfully completed this document.

Other parties need to complete fields in the document. You will recieve an email notification when the document has been completed by all parties.

This document has been signed by all parties.

Completed 1 September 2020

Message

View Audit Log
Print With Audit Log
Duplicate Document