appendix b - Winona State University

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WSU INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)
PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES
PURPOSE
It is recognized that the use of live animals is an integral part of the educational and research missions of WSU. All
faculty, students and staff engaging in research, research training (including teaching), experimentation, biological
testing and related activities (including classroom demonstrations) involving live, vertebrate animals housed in campus
facilities or in/from the wild are required to submit a Protocol for Animal Research and/or Teaching Activities prior to
initiating such activities. Purely observational field studies, which do not involve invasive procedures, harm to the
animals, or materially alter the behavior of the animals, do NOT require a protocol. For additional information, refer to
the WSU Regulation 3-32 Assurance of Compliance with the Public Health Service (PHS) Policy on Humane Care and
Use of Laboratory Animals at http://www.winona.edu/faculty/3-32.pdf. The Policy addresses the entire institutional
program of animal care and use, covering animals used in both research and teaching activities. For regulatory
information, refer to the most recent copies of: PHS Policy on Humane Care & Use of Laboratory Animals; Animal
Welfare Act (CFR Title 9, Chapter 1. Subchapter A, Parts 1, 2 and 3); Guide for the Care and Use of Laboratory
Animals (National Research Council); American Veterinary Medical Association (AVMA) Panel on Euthanasia
IACUC REVIEW
The IACUC reviews protocols in accord with two general goals:
1. Scientific reliance on live animals should be minimized.
2. Pain, distress, and other harm to laboratory animals should be reduced to the minimum necessary to
obtain valid scientific data.
The Protocol form is designed to allow for the use of live animals in education and research while ensuring that
regulatory requirements are met. The form provides the IACUC with the necessary information to determine if the use
of animals is justified and pain and distress is justifiable given the nature of the activities. It is also designed to
determine if animals housed on campus will receive appropriate care.
ANIMAL FACILITIES
The approved permanent facilities on campus for mammals and birds are Stark 219 and Phelps 208A. Mammals and
birds may be removed from these facilities for research and teaching activities for no longer than twelve (12) hours.
Other vertebrates (e.g. amphibians, reptiles and fish) may be housed in other rooms on campus subject to inspection
of the facilities by the IACUC.
ANIMAL CARE
Ultimate responsibility for the care of any animal rests with the Principal Investigator (PI), who shall name
another Faculty Designee to be approved by the IACUC. This Designee will assume responsibility for the care
of the animals upon the absence of the PI. If the IACUC receives a report of animals not receiving appropriate
care and determines to the best of its ability that said care is inadequate, the IACUC will assume control of the
animals and may care for or dispose of the animals, up to and including euthanasia, as appropriate. IACUC
emergency / notification procedures are included in an attachment to the IACUC Protocol form and are
updated annually.
INSTRUCTIONS
Complete each item on the Request Form. If an item is not applicable, please indicate this with a response of “NA”.
Do not leave any items blank. Attach additional pages or supporting documentation as needed.
Submit seven (7) copies to the Grants & Sponsored Projects Office, Maxwell 161. Requests will be forwarded to the
full IACUC for review at the next scheduled monthly meeting. Note: The IACUC does not review requests during
summer break.
DECISIONS
The IACUC is a federal regulatory board reporting directly to the President. A protocol approved by the IACUC may be
disapproved by the President. However, a Protocol disapproved by the IACUC cannot be approved by the President
nor any other administrative office on campus. An investigator whose protocol is disapproved by the IACUC will
receive written suggestions for modifying his/her request and may revise and resubmit the protocol and/or request a
meeting with the IACUC to present a further rationale for approval. Research and/or teaching activities involving
animals may not be initiated prior to receiving IACUC approval and the IACUC may advise the President to suspend
any unauthorized activities or activities found to be in violation of the WSU Assurance.
Rev. 8/30/07 -- Page 1 of 7
WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES
I. BACKGROUND INFORMATION
Note: Students must identify a faculty advisor. Attach additional sheets if needed.
A. Investigator/Project Director
Department
Mailing Address
email
Faculty Advisor
Phone
B. Co-Investigator
Department
Mailing Address
email
Faculty Advisor
Phone
Co-Investigator
Department
Mailing Address
email
Faculty Advisor
Phone
Phone
Phone
Phone
C. For projects which involve (or may involve) external funding:
1. Will a proposal for support for this project be submitted to a funding agency?
Yes
No
2. Name and address of person at funding agency and/or other cooperating institution(s) who should
receive notice of WSU IACUC approval (other than the Principal Investigator).
NOTE: Copies of proposals submitted to external agencies must be attached to this protocol.
D. Project Title (Include Proposal Title for externally-funded activities if different.)
E. Inclusive dates of project
to
F. Identification of species and number of animals to be used
1. Species:
2. Common name:
3. Source (name of licensed or authorized vendor or breeder, or indicate if bred in-house):
4. Total number of animals:
G. Project Category – See Following page for category descriptions.
A. (no longer in use)
B.
C.
D.
E.
Page 2 of 7
WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES
The following project category definitions are adapted from the United States Department of Agriculture (USDA)
classifications and examples.
Classification A: This category is no longer in use.
Classification B: Animals being bred, conditioned, or held for use in teaching, testing, experiments, research,
or surgery, but not yet used for such purposes.
Examples:
 Breeding colonies of any animal species 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. Breeding colony includes parents and offspring.
 Newly acquired animals that are held in proper caging and handled in accordance with applicable
regulations.
 Animals held under proper conditions or wild animals that are being observed.
Classification C: Animal upon which testing, research, experiments, or tests will be conducted involving no
pain, distress, or use of pain-relieving drugs.
Examples:
 Procedures performed correctly by trained personal such as administration of electrolytes/fluids,
administration of oral medication, blood collection from a common peripheral vein per standard
veterinary practice or catherization of same, standard radiography, parenteral injections of non-irritating
substances.
 Euthanasia performed in accordance with the recommendations of the most recent American Veterinary
Medical Association (AVMA) Panel on Euthanasia, utilizing procedures that produce rapid
unconsciousness and subsequent humane death.
 Manual restraint that is no 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 the use of appropriate anesthetic,
analgesic, or tranquilizing drug 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 sequella 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.
Note: Protocols for classification E activities must provide a scientific justification to explain why the use
of anesthetics, analgesics, sedatives or tranquilizers during and/or following painful or distressing
procedures is contraindicated.
Page 3 of 7
WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES
II. Animal Care
At WSU, individual researchers and/or faculty advisors are responsible for the care of the animals used in
research and teaching activities. All animals on campus will be housed following standards set forth in the
Public Health Service (PHS) Policy which complies with the Guide for the Care and Use of Laboratory Animals
and the U. S. Department of Agriculture (USDA) Animal Welfare Act. Specific guidelines for lower vertebrates
(e.g. fish, amphibians and reptiles) are not set forth in the Guide nor the Animal Welfare Act. Investigators are
to adhere to guidelines for the care of these vertebrates established by appropriate professional associations.
Activities may not involve species covered by the U.S. Department of Agriculture’s definition of animal.
A. Housing
1. Primary Housing location (Mammals and birds must be housed in Stark 219 or Phelps 208A):
Stark 219:
Phelps 208A:
Specify locale for animals other than mammals or birds:
2. If animals will be removed from primary housing area for research or teaching activities, identify:
Alternate location:
How often the animals will be transported to that location:
How long (at each occurrence) will the be kept at that location:
B. Care standards and responsibilities
1. Standard feeding
Standard water
Standard housing
Yes
Yes
Yes
No (Explain in activities description.)
No (Explain in activities description.)
No (Explain in activities description.)
2. Identify by name the individual responsible for the following activities:
Principal investigator (PI)
Or faculty advisor
Student/staff under
PI/Faculty direction
Arrangements for veterinary care
Bedding (changing and disposal)
Sanitation (cage and facility cleaning)
Waste disposal (waste products/trash)
Temperature/ventilation monitoring
Daily observation and care for animals
Providing for weekend and holiday care
3. Identify the Faculty Desigee who will care for the animals when the PI is not on campus and explain what
arrangements have been made for 24-hours-a-day care when the PI is not contractually obligated to be on
campus.
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WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES
III. ACTIVITIES DESCRIPTION
Attach a narrative addressing each of the following questions.
Purpose: What is the purpose of the research or teaching activities? Provide a 2-3 sentence description of the
research objectives. Unnecessary duplicative research/activities should be avoided.
Research design: Provide a complete description of the experimental design, including descriptions of
experimental injections or inoculations, blood withdrawals, surgical procedures, radiation doses, methods of
restraint and/or other possible stresses (e.g. food or water deprivation, environmental stresses, etc.). Provide
citations for any supporting literature. If using vertebrates in the wild (field study), describe any state or federal
permits required, agency issuing and/or holding the permit(s) and date(s) they were obtained. (The term field
study does not include observational studies which do not involve invasive procedures, harm to the animals,
or materially alter the behavior of the animals. Protocols are not required for observational studies.)
Justification: What is your rationale for using animals? Explain why a non-animal model, such as cell or tissue
cultures or computer simulations or other training aids, is not appropriate.
Species selection: Why is this species the most appropriate selection? The species should be the lowest
possible on the phylogenetic sale.
Number of animals: How did you determine the number of animals to be used? The number of animals
should be the minimum required to obtain statistically valid results. Provide statistical justification, if possible.
Timely intervention: Identify the criteria and processes for intervention and removal of animals from a study.
Minimization of pain and distress: What procedures will be taken to minimize pain and distress? Provide
citations for any supporting literature.
Anesthesia, analgesia, tranquilization or other agents: Identify agents to be used as part of the
experimental design and/or euthanasia, if appropriate. Specify dosage and method of administration. If using a
controlled drug, describe security and tracking procedures and identify any state or federal permits required,
agency issuing and/or holding the permit(s) and date (s) they were obtained
Post research care:
Euthanasia: Provide a complete description of the method of euthanasia to be employed. Investigators
should adhere to the 2000 guidelines of the American Veterinary Medical Association (AVMA) Panel on
Euthanasia. If you require an exception to the AVMA guidelines, provide a justification with literature
citations along with your protocol. Briefly describe carcass disposal procedures.
Maintenance: If animals will be maintained in WSU facilities after the conclusion of the study, indicate
how they will be cared for.
Other: Please specify provision for care.
Note: It is understood that following a field study animals will be released.
Page 5 of 7
WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES
IV. QUALIFICATIONS, EDUCATION AND TRAINING, AND SAFETY MEASURES
A. Qualifications
Describe the training and experience of the PI and Co-Investigator(s) as it relates to the care and handling of
the species of animal to be used and the experimental procedures to be undertaken. If a self-instructive
training program has been completed, please identify the instructional source.
B. Education and Training
1. Describe the education and training that will be provided to students who are conducting research.
2. Please indicate which of the following will be addressed in the training program. Note that depending on
the species of animal or the amount of animal exposure, not all areas will be applicable.
pre-placement medical evaluation
identification of hazards to students and safeguards appropriate to the risks
appropriate testing and vaccinations
training of students regarding their duties, hazards and safeguards
policies and facilities that promote cleanliness
provisions for treating and documenting injuries and illnesses
C. Hazardous agents: Identify any hazardous agents (radionuclides, biological agents, hazardous chemicals
or drugs, recombinant DNA, etc.). Describe any state or federal permits required, agency issuing and/or holding
the permit(s) and date(s) they were obtained. Describe how and when the the WSU Safety Officer will be
notified of potential hazardous waste disposal.
D. Safety Measures
Identify any potential risks and/or hazards (to researchers, students or staff) and identify the procedures to be
followed to mitigate such risks.
Page 6 of 7
WSU IACUC PROTOCOL FOR ANIMAL RESEARCH AND/OR TEACHING ACTIVITIES
Protocol number (to be assigned by the IACUC): _________________
V. Certifications
A. Investigator(s) Certification
Any significant changes in this approved protocol must receive prior approval of the IACUC. The investigator(s)
are responsible for the animals under her/his care and must notify the IACUC of any unanticipated impact on the
animals. Any unanticipated pain, distress, morbidity or mortality should be reported to the IACUC. The IACUC
may request periodic documentation that no changes have occurred.
1. Project Title (include Proposal Title for externally-funded activities if different.)
2. Investigator signature
______________________________
Date:___________________
Co-Investigator(s) signature(s):
______________________________
Date:___________________
Co-Investigator(s) signature(s):
______________________________
Date:___________________
Faculty Advisor signature:
______________________________
Date:___________________
3. Faculty Designee: By signing below, I indicate my agreement to assume responsibility for the care of the
animals covered by this protocol in the event of the absence of the PI.
Faculty Designee:
________________________________________
Date:____________________
B. IACUC Certification -- This certifies the action(s) taken by the WSU IACUC on the above Protocol.
Provides an unqualified approval.
Defers a decision for the reasons described below.
Approves the protocol pending clarification as described below.
Provides a qualified or conditional approval pending satisfaction of conditions described below.
Provides a limited approval as described below.
Disapproves your protocol based on the rationale provided below.
Explanation for above decision
IACUC Chair signature: ___________________________________________
(designee)
Date: __________________
Page 7 of 7
INSTITUTIONAL ANIMAL CARE & USE COMMITTEE
EMERGENCY / NOTIFICATION PROCEDURES
Contact information for the Principal Investigator (PI), his/her Faculty Designee and the required
protocol information must entered below and this sheet must be conspicuously posted on the animal
enclosures so as to clearly identify the animals within..
Protocol number:
Species
--------------------------------------------------------------------------------------------------------------------------------------Any individual who questions whether these animals, covered by the protocol number given above,
are in an emergency situation and/or are not receiving adequate care should notify the individuals
below in the order given.
If the IACUC receives a report of animals not receiving appropriate care and determines to the best of
its ability that said care is inadequate, the IACUC will assume control of the animals and may care for
or dispose of the animals, up to and including euthanasia, as appropriate.
Contacts in order
Day
phone
Evening/weekend Mobile phone
phone
email
1. Principal
Investigator
2. Faculty Designee
3. Any IACUC
member
Richard Deyo
Mark Garbrecht
John Holden
Robin Richardson
457-5667
457-2261
457-5439
457-5128
608.781.1590
--608.799.4137
rdeyo@winona.edu
Mgarbrech@!winona.edu
Jholden@winona.edu
rricharson@winona.edu
Exception
Nothing in this emergency contact procedure shall prohibit an individual from
contacting an IACUC member directly without notifying the PI or the Faculty
Designee if she/he believe such actions are in the best interests of the animals.
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