Grants & Sponsored Projects

WSU Assurance of Compliance with Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animalsicies Related to Grants & Sponsored Projects

The WSU Assurance of Compliance requires all faculty, students and staff conducting research involving animal subjects to submit a Protocol for Animal Research and/or Teaching Activities form to the Office of Grants & Sponsored Projects for review by the WSU Institutional Animal Care and Use Committee (IACUC) prior to initiation of any such research. The form may be completed online and printed or a hard copy may be secured from the G&SP Office, Somsen 212, ext. 5519, npeterson@winona.edu.  

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Winona State University
ASSURANCE OF COMPLIANCE WITH PUBLIC HEALTH SERVICE POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS

(Approved January 27, 2006 - Currently under review)

Winona State University, hereinafter referred to as institution, hereby gives assurance that it will comply with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, hereinafter referred to as PHS Policy.

I.  APPLICABILITY

This Assurance is applicable to all research, research training, experimentation, biological testing, and related activities, hereinafter referred to as activities, involving live, vertebrate animals supported by the Public Health Service (PHS) and conducted at this institution, or at another institution as a consequence of the subgranting or subcontracting of a PHS‑conducted or supported activity by this institution.

Faculty, staff and students at WSU may conduct research and/or teaching activities with laboratory-bred rats and mice, birds and lower vertebrates (fish, amphibians and reptiles).  Activities may not involve species covered by the U.S. Department of Agriculture’s definition of animal. 

II.  INSTITUTIONAL POLICY

1. This institution will comply with all applicable provisions of the Animal Welfare Act and other Federal statutes and regulations relating to animals.
   
   
2. This institution is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training."
   
   
3. This institution acknowledges and accepts responsibility for the care and use of animals involved in activities covered by this Assurance.  As partial fulfillment of this responsibility, this institution will make a reasonable effort to ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance as well as all other applicable laws and regulations pertaining to animal care and use.
   
   
4. This institution has established and will maintain a program for activities involving animals in accordance with the Guide for the Care and Use of Laboratory Animals (Guide).

III.  INSTITUTIONAL PROGRAM FOR ANIMAL CARE AND USE

1. The lines of authority and responsibility for administering the program and ensuring compliance with this Policy are:
   
   
   
   
   
   
   
   
   
   
   
   
    
2. The qualifications, authority, and percent of time contributed by the veterinarian(s) who will participate in the program are: 
   
   The veterinarian must be licensed in the State of Minnesota or Wisconsin.  S/he is a full, voting member of the IACUC.  S/he may advise individual researchers on appropriate animal care and may communicate directly with the President on issues of concern. 
   
   The veterinarian is specifically required to participate in the semi-annual facilities’ inspections.  Species currently used in research at this institution include laboratory-bred rats and mice, birds and “cold-blooded” vertebrates.  Since these animals require relatively little specialized veterinary care, the percentage of the veterinarian’s time dedicated to the program beyond IACUC membership will be minimal.  When the IACUC veterinarian is not available, the principal investigators have the expertise to provide adequate care.  Other local veterinarians may be consulted by the principal investigator, as needed. 
   
   
3. This institution has established an Institutional Animal Care and Use Committee (IACUC), which is qualified through the experience and expertise of its members to oversee the institution's animal program, facilities, and procedures.  The IACUC consists of at least five members, and its membership meets the composition requirements set forth in the PHS Policy at IV.A.3.b.  Attached is a list of the chairperson and members of the IACUC and their names, degrees, position titles, specialties and institutional affiliations.  See attached.
   
   
4. The IACUC will:
   
   
   1. Review at least once every six months the institution's program for humane care and use of animals, using the Guide as a basis for evaluation.  The IACUC procedures for conducting semiannual program evaluations are: 
      
      A program review is conducted once a semester using the attached Semiannual Program Review Checklist.  The review is conducted during a regularly scheduled IACUC meeting.  Deficiencies are discussed and corrective actions to be taken are identified.
      
      
   2. Inspect at least once every six months all of the institution's animal facilities, including satellite facilities, using the Guide as a basis for evaluation.
      
      The IACUC procedures for conducting semiannual facility inspections are: 
      
      All facilities housing animals used in research or research training are inspected once each semester.  Inspections are conducted during a regularly scheduled IACUC meeting.  After the inspection, IACUC members individually submit observations and recommendations to the IACUC Chair who compiles a report for IACUC review at their next scheduled meeting.   Deficiencies are discussed and corrective actions identified.
      
      
   3. Prepare reports of the IACUC evaluations as set forth in the PHS Policy at IV.B.3. and submit the reports to the President and Vice President for Academic Affairs.  The IACUC process for developing reports and submitting them to the Institutional Official is:
      
      At the end of each semester, a program review and animal facilities inspection report is completed. The report identifies deficiencies and corrective actions taken in both areas and may make recommendations for additional corrective actions.  Any minority viewpoints are appended to the formal report.  The report is submitted to the President and Vice President for Academic Affairs.  Copies of the report are filed in the office of the IACUC Compliance Officer (the Director of Grants & Sponsored Projects).
      
      
   4. Review concerns involving the care and use of animals at the institution.  The IACUC procedures for reviewing concerns are: 
      
      Any person may submit a request for IACUC action on suspected violations of the animal care policy.  Upon notification, the IACUC will immediately initiate an investigation of the suspected violation.  A report of the IACUC findings will be prepared (including minority opinions) and will include recommended actions.  The report will be forwarded to the President and Vice President of Academic Affairs through the President’s designee on the IACUC (IACUC Administration Representative).  If appropriate, copies of the report will be sent to the Office of Laboratory Animal Welfare and other relevant granting agencies.  A copy of the report will be kept on file in the offices of the Compliance Officer and the IACUC Chair and copies will be forwarded to affected parties.  If warranted, the University will take action to suspend the project and may require termination of the project.  In extreme cases, the University may place permanent restrictions on an individual’s ability to use or handle animals at WSU.
      
      
   5. Make written recommendations to the President and Vice President for Academic Affairs regarding any aspect of the institution's animal program, facilities, or personnel training.  The procedures for making recommendations to the Institutional Official are: 
      
      Written recommendations may be made in the end-of-the-semester program review and facilities inspection reports or in investigatory reports.  The IACUC may also make written recommendations at any other time, as needed.  All written recommendations are prepared by the IACUC Chair and reviewed by the full ICUC. 
      
      
   6. Review and approve, require modifications in (to secure approval), or withhold approval of those activities related to the care and use of animals as set forth in the PHS Policy at IV.C.  The IACUC procedures for protocol review are: 
      
      All university staff, faculty and students planning to initiate a teaching or research project that involves the use of animals are required to submit the Protocol For Animal Research and/or Teaching Activities prior to the initiation of any project. Seven copies of the protocol must be submitted to the Compliance Officer (the Director of Grants & Sponsored Projects).  The Compliance Officer reviews the protocol for completeness, assigns a tentative protocol number and distributes the request to all members of the IACUC.  The IACUC Chair schedules a meeting to review the protocol and notifies the principal investigator of the time and meeting place.  Principal investigators are invited to attend the meeting to answer questions IACUC members may have during the review process, but they are asked to excuse themselves while IACUC deliberations take place. The committee has the option of rejecting, accepting or requiring revision and resubmission of the protocol. Action on a protocol may be taken if a quorum is present at the meeting.  Decisions require a majority vote.  The IACUC Chair will have 10 working days to notify the investigator(s) of the IACUC decision.  Proposals from investigators seeking external funding will receive appropriate written verification of approval/rejection from the IACUC office for inclusion in their application.    
      
      All academic departments housing animals on campus for educational display purposes only (not to be explicitly used for research and/or teaching activities) are required to submit by September 30 each year, a memo indicating the animals are for display only.  The memo should state:  1) the species and number of animals, 2) the location of the animals, and 3) who is responsible for their care.
      
      
   7. Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities as set forth in the PHS Policy at IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are:  
      
      Written descriptions of proposed changes are submitted to the IACUC Compliance Officer for distribution to the IACUC members.  Depending on the scope of the change, a complete copy or portions thereof of the original protocol request may also be distributed with the description of the proposed change.  The IACUC Chair places review of the proposed change on the next meeting agenda.  The committee has the option of accepting or rejecting the change in the format presented or to require amendments be made to portions of the original protocol or to require submission of a new protocol.  Action may be taken if a quorum is present at the meeting.  Decisions require a majority vote.  The IACUC Chair will have 10 working days to notify the investigator(s) of the IACUC decision.   
      
      
   8. Notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval as set forth in the PHS Policy at IV.C.4.   The IACUC procedures to notify investigators and the institution of its decisions regarding protocol review are: 
      
      With regards to approvals or withholding of approvals, the IACUC Chair transmits the action of the IACUC to the principal investigator via completion of the certification section on the prescribed protocol form.  The certification section provides for unqualified approval, deferral, approval pending clarification, qualified or conditional approval, limited approval or disapproval, all with explanation(s) as appropriate.  A complete copy of the protocol and signed certification is returned to the principal investigator and another signed copy is filed with the IACUC Compliance Officer.  With regard to modifications, the IACUC CHAIR transmits the decision of the IACUC to the principal investigator via email and hard copy notification.  A copy is filed with the IACUC Compliance Officer.
      
      
   9. Conduct continuing review of each previously approved, ongoing activity covered by PHS Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with the PHS Policy at IV.C. 1-4. at least once every three years.  The IACUC procedures for conducting continuing review are:  
      
      The IACUC Compliance Officer notifies principal investigators of upcoming review dates and requests submission of a Project Status Report on the prescribed form.  The Project Status Report form and the original protocol request are reviewed by the full IACUC at its next regularly scheduled meeting.   If the protocol to be reviewed was submitted on a protocol request form that is not longer in use, the principal investigator will be requested to forego submission of a Project Status Report and instead will be requested to re-submit the protocol using the current form.  The committee has the option of accepting or rejecting the Project Status Report or re-submitted protocol.  Action may be taken if a quorum is present at the meeting.  Decisions require a majority vote.  The IACUC Chair will have 10 working days to notify the investigator(s) of the IACUC decision.   
      
      
   10. Be authorized to suspend an activity involving animals as set forth in the PHS Policy at IV.C.6.  The IACUC procedures for suspending an ongoing activity are: 
       
       The President’s designee on the IACUC (IACUC Administration Representative) is authorized to recommend and initiate actions to suspend activities.  (See section D.4.)
       
       
5. The individual(s) authorized by this institution to verify IACUC approval of those sections of applications and proposals related to the care and use of animals is/are the The Director of Grants & Sponsored Projects, who also serves as a non-voting member of the IACUC and as the IACUC Compliance Officer, is authorized to verify IACUC approval.
   
   
6. The occupational health and safety program for personnel who work in laboratory animal facilities or have frequent contact with animals is: 
   
   Risk assessment for on campus labs indicates minimal risk since only lab-bred rats and mice and birds are permitted in these facilities.  Faculty are responsible for providing occupational health and safety instructions to students.  All students are instructed as to the importance of personal hygiene and lab attire appropriate to the work being done.  Smoking, drinking, eating, etc. is prohibited in all labs.  Chemical hoods are available as appropriate.  Eyewash facilities are in all labs along with first aid materials.  Hazardous materials are appropriately disposed of and appropriate containers are stored and disposed of according to environmental regulations.
   
   Risk of exposure to biological hazards in field research is minimal since activities may only involve fish, amphibians and reptiles.  In review of protocols involving field research, the IACUC will expect principal investigators to address issues of water safety and hazards in the field, document the safety of equipment and procedures, and provide evidence that appropriate instructions in health and safety will be provided to student participants.
   
   Prior to engaging students in research activities, faculty will screen students via a self-assessment of general health status.  Students should complete a form which allows/prompts them to identify preexisting conditions which may put them at risk (e.g. allergies, asthma, chronic health issues, etc.) and affirms current tetanus inoculation.  Faculty should instruct students on procedures and for reporting injuries e.g. bites.
   
   
7. The total gross number of square feet in each animal facility (including each satellite facility), the species of animals housed therein and the average daily inventory of animals, by species, in each facility is provided in the attached table.  See attached table.
   
   
8. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is:
   
   All principal investigators are required to document training and expertise relevant to research proposed in protocols submitted to the IACUC.  For example, protocols involving surgery, invasive procedures, anesthesia, etc., are only approved for principal investigators who have documented their training and expertise in these methods.  To assure the currency of faculty expertise a resource center will be established in the library and maintained by the IACUC. 
   
   The training of students who will work with animals is the responsibility of the principal investigator.  In behavioral research this will require the review of APA guidelines and procedures for the use of animals in research and specific instruction by the research supervisor on the procedures to be used in the research project.  Individuals supervising students involvied in more invasive procedures will document how the students will be trained in the protocol request.

IV.  INSTITUTIONAL STATUS

As specified in the PHS Policy at IV.A.2, as Category 2, all of this institution's programs and facilities, including satellite facilities, for activities involving animals have been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months in accord with IV.B.1. and 2. of the PHS Policy, and reports prepared in accord with IV.B.3. of the PHS Policy.

All IACUC semiannual reports will include a description of the nature and extent of this institution's adherence to the Guide.  Any departures from the Guide will be identified specifically and reasons for each departure will be stated.  Reports will distinguish significant deficiencies from minor deficiencies.  Where program or facility deficiencies are noted, reports will contain a reasonable and specific plan and schedule for correcting each deficiency.   Semiannual reports of the IACUC evaluations will be submitted to [insert name or title of the Institutional Official signing the Assurance].   Semiannual reports of IACUC evaluations will be maintained by this institution and made available to the Office of Laboratory Animal Welfare (OLAW) upon request.  The most recent semiannual report of the IACUC is attached.

V.  RECORD KEEPING REQUIREMENTS

1. This institution will maintain in the Office of the Compliance Officer for at least three years:
   
   
   1. A copy of this Assurance and any modifications thereto, as approved by PHS.
      
      
   2. Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations.
      
      
   3. Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld.
      
      
   4. Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the President and the Vice President for Academic Affairs.
      
      
   5. Records of accrediting body determinations.
      
      
2. This institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional three years after completion of the
   activity.
   
   
3. All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner.

VI.  REPORTING REQUIREMENTS

1. At least once every 12 months, the IACUC, through the Institutional Official, will report in writing to OLAW:
   
   
   1. Any change in the status of the institution (e.g., if the institution becomes
      accredited by AAALAC or AAALAC accreditation is revoked), any change in the description of the institution's program for animal care and use as described in this
      Assurance, or any changes in IACUC membership.  If there are no changes to report, this institution will provide OLAW with written notification that there are no changes.
      
      
   2. Notification of the dates that the IACUC conducted its semiannual evaluations of the institution's program and facilities (including satellite facilities) and submitted the evaluations to the President and Vice President for Academic Affairs.
      
      
2. The IACUC, through the Institutional Official, will provide the OLAW promptly with a full explanation of the circumstances and actions taken with respect to:
   
   
   1. Any serious or continuing noncompliance with the PHS Policy.
      
      
   2. Any serious deviations from the provisions of the Guide.
      
      
   3. Any suspension of an activity by the IACUC.
      
      
3. Reports filed under VI.A. and VI.B. above shall include any minority views filed by members of the IACUC.

VII.  INSTITUTIONAL ENDORSEMENT AND PHS APPROVAL

A.  Authorized Institutional Official

Name:

Title:

Address:

Phone:

Fax:

Signature:

Date:

 

B.  PHS Approving Official

Name:

Title:

Address:

Phone:

Fax:

Signature:

Date:

 
C.  Effective Date of Assurance:

D.  Expiration Date of Assurance:

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MEMBERSHIP OF THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE            Date:

NAME OF INSTITUTION:  Winona State University
ASSURANCE NUMBER:

Chairperson Name, Title, and Degree/Credentials		Business Address, Phone, Fax, and Email of Chairperson
Name: Frances Ragsdale		Address: Biology Department, Winona State University, Winona, MN  55987
Title: Professor
Degree/credentials:  PhD, Biology		Phone:507.457.5462		Fax:507.457.5681	Email:fragsdale@winona.edu
Name of Member/Code*	Degree/Credentials		Position Title			PHS Policy Membership Requirements**
Deyo, Richard	PhD, Psychology		Professor			Scientist
Jannik, Nancy	PhD, Geoscience		Associate Vice President for Academic Affairs			Scientist
Peterson, Nancy Kay	MPA, Public Admin		Compliance Officer			Non-voting
Ragsdale, Frances	PhD, Biology		Associate Professor			Scientist, IACUC Chair
Dan Scheid	PhD, Philosophy		Professor			Non-scientist
Randall Snell	DVM		Veterinarian			Veterinarian
Wilson, Edward	PhD, Biology		Assistant Professor			Scientist
(vacant)						Non-affiliated member
*Names of members, other than the chairperson and veterinarian, may be represented by a number or symbol in this submission to OLAW.  Sufficient information to determine that all appointees are appropriately qualified must be provided and the identity of each member must be readily ascertainable by the institution and available to authorized OLAW or other PHS representatives upon request. **PHS Policy Membership Requirements: Veterinarian  - a veterinarian with direct or delegated program responsibility. Scientist  - a practicing scientist experienced in research involving animals. Nonscientist  - a member whose primary concerns are in a non-scientific areas (e.g. ethicist, lawyer, member of the clergy). Non-affiliated member     - a member who is not affiliated with the institution in any way other than as a member of the IACUC, and who is not a member of  the immediate family of a person who is affiliated. This member is expected to represent general community interests in the proper  care  and use of animals and should not be a laboratory animal user.  A consulting attending veterinarian may not be considered  non-affiliated . NOTE:  Nonvoting members must be so identified

 

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FACILITY AND SPECIES INVENTORY                                                       Date:

NAME OF INSTITUTION:  Winona State University
ASSURANCE NUMBER:

Laboratory, Unit, or Building*	Gross Square Feet (including service areas)	Species Housed in Unit (use complete common names)	Approx. Average Daily Inventory
Stark Hall Facility 219	606	rats
		mice
Phelps Hall Facility 208A	182	rats
		chicks
SLC - 2nd floor hallway		Cuban Night Anole a and b	2
		Chinese Water Dragon	1
		Green Iguanas	2
Greenhouse		Convict Cichlids	120
SLC – 232		Guppies	40
		Firemouth Cichlids	1
SLC – 234		Boa	1
		Siamese Fighting Fish	30
SLC – 238		Standing Day Geckos	3
SLC – 264		Standing Day Geckos	2
		Leopard Geckos	2
		African Clawed Frog	1
		Terrestrial Frog	1
		Convict Cichlids	20
		Guppies	21
		Green Anoles	2
SLC – 291		Brown Anoles	1
		Plecostoma	2
		Siamese Fighting Fish	1

*Institutions may identify animal areas in any manner, e.g., initials, ID number, etc.  However, the name and location must be provided to OLAW upon request.

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SEMIANNUAL PROGRAM REVIEW CHECKLIST – Page 1 of 1
DATE:		*A	M	S
1.  IACUC Membership and Functions
- at least 5 members, appointed by CEO
- members include veterinarian, scientist, non-scientist, and non-affiliated non-lab animal user
- responsible for oversight and evaluation of institution's program
- reports to Institutional Official (IO)
- conducts semiannual evaluations of institutional animal care and use program
- conducts semiannual inspections of institutional animal facilities
- reviews and investigates concerns about animal care and use at institution
- procedures for review, approval and suspension of animal activities
- procedures for review & approval of significant changes to approved activities
- policies for special procedures (e.g. restraint, multiple survival surgery, fluid restriction)
2.  IACUC Records and Reporting Requirements
Reports to Institutional Official (IO)
- reports of semiannual program reviews & facility inspections are submitted to IO
- include minority IACUC views
- describe departures from Guide or PHS Policy and reasons for departure
- distinguish significant from minor deficiencies
- include plan and schedule for correction of each deficiency identified
Reports to Office of Laboratory Animal Welfare (OLAW)
- reports include any minority IACUC views
- annual report to OLAW documents program changes & dates of IACUC semiannual review
- promptly advises OLAW of serious/ongoing Guide  deviations or PHS Policy noncompliance
- promptly advises OLAW of any suspension of activity by the IACUC
Records
- minutes of IACUC meetings and semiannual reports maintained for 3 years
- IACUC review documentation maintained for 3 years after end of study
- IACUC review of activities involving animals includes all required information
3.  Veterinary Care (See also next section - Veterinary Medical Care)
- institutional arrangement for veterinarian with training or experience in lab animal medicine
- veterinary access to all animals
- provision for backup veterinary care
- must provide guidance on handling, immobilization, sedation, analgesia, anesthesia, euthanasia
- must provide guidance/oversight on surgery programs and oversight of postsurgical care
- veterinary authority to oversee all aspects of animal care and use
	*A = acceptable; M = minor deficiency; S = significant deficiency (is or may be a threat to animal health or safety)