Policies and Procedures

University of Idaho
Institutional Animal Care and Use Committee (IACUC)
Procedures
(Last Updated May/27/2010)

Introduction
IACUC Procedures
IACUC Protocols
Standard Operating Procedures
Appendices

Introduction
1. Description
  The Institutional Official (IO) is the VP for Research and Economic Development. This position is authorized on behalf of the University of Idaho’s President to ensure that all programmatic and regulatory requirements of animal activities are met.
  
  IACUC committee oversight and support is provided by the Office of Research Assurances. The Office of Research Assurances Manager is a standing ex-officio member of the IACUC. The Campus Veterinarian housed within the Office of Research Assurances also serves as a standing member of the IACUC.
  
  The Institutional Animal Care and Use Committee (IACUC) oversees “animal activity” in all research, teaching, demonstration and testing performed on University owned property or engaged in by University personnel. University owned property excludes land and facilities leased to third parties for commercial enterprise purposes.
2. Structure
  Members are appointed to three year terms by the Institutional Official (IO). To provide the necessary expertise and continuity members may serve successive terms with reappointment by the IO. Three positions are standing member appointments by job description: 1. The Manager of the Office of Research Assurances (Chief Research Compliance Officer) [ex-officio non-voting member], 2. The Campus Veterinarian [voting member] and 3. The LARF manager [voting member].There are not less than seven voting members including the Campus Veterinarian; the Manager of the Laboratory Animal Research Facility; a public member who is not employed by the UI, is not a laboratory animal user, is not an immediate family member of an individual affiliated with the UI, and is not a practicing scientist experienced in research involving animals; one member of the faculty or staff with responsibilities involving the utilization of animals in teaching or research from each of the following - the College of Agriculture and Life Sciences, the College of Natural Resources, the College of Science, and one member at large. The public member/non-scientist position may be fulfilled by two individuals at the discretion of the IO. Alternates that meet the criteria for each of the specified positions may be appointed by the IO. The IO may remove and replace a committee member at any time when the IO has determined that the member is unwilling or unable to perform committee member functions.
3. Functions
  The IACUC advises the Institutional Official regarding all aspects of the University of Idaho animal care and use program through the Office of Research Assurances Manager. In addition the IACUC performs the following functions:
  1. Reviewing, at least once every six months, the University’s program for the humane care and use of animals and the status of the institution’s animal facilities, including satellite facilities, laboratories and areas where survival surgery is conducted. The IACUC procedures for conducting semiannual program reviews are as follows:
    1. The IACUC chair appoints a subcommittee of not less than two voting members to develop a preliminary program review report using the OLAW sample document program review checklists for “Institutional Policies and Responsibilities” and “Veterinary Medical Care” as the basis for the review.
    2. The full committee reviews the preliminary report and amends or accepts the report.
    3. The amended full committee report is signed by a majority of voting IACUC members and includes any recommended changes in procedures, staffing, financial support, or veterinary medical care, and all dissenting opinions.
    4. The signed report is supplied to the Institutional Official. The Institutional Official either directly allocates resources or works with other administrative units to ensure that any programmatic or facility deficiencies are corrected in a timely fashion.
    5. OLAW is notified of any significant or ongoing uncorrected deficiencies that have been identified along with a plan for their correction as identified in section III.D.4.e and VI.B of this assurance.
    6. One or more IACUC members inspect a facility. No member is denied participation in the inspection of a facility. For any facility where Animal Welfare Act regulated activities occur, two or more voting members of the committee must participate in the facility review process. Members with a conflict of interest may not be the sole inspector or contribute to the minimum of two voting members for facilities housing AWA regulated activities. A conflict of interest is any member that manages the facility being inspected or materially participates in a project conducted at the facility, with the exception of the Attending Veterinarian that provides veterinary expertise and/or procedural training as part of a study. The Attending Veterinarian is deemed to have a conflict of interest if acting as the principal investigator or co-investigator on a project conducted at the facility under review.
    7. All items identified in the OLAW “Sample Semiannual Facility Inspection Checklist” are reviewed at each facility. A modified checklist is used for aquaculture and agricultural research facilities where appropriate.
    8. Written reports of inspection findings are drafted and sent to the responsible facility managers. Reports include suggestions for improvement of non-violations, and distinguish significant and minor deficiencies as identified in the Guide and Ag Guide. A date for correction of deficiencies is included.
    9. Draft reports are distributed to the full IACUC for review and amendment or approval. The final IACUC approved reports are sent to the Institutional Official. If changes were made to the original reports facility managers are supplied an updated copy of the report.
    10. Written plans for correction of any deficiencies noted are submitted by facility managers to the Institutional Official for review and then shared with IACUC members for evaluation and further recommendations to the Institutional Official.
    11. Follow-up inspections are conducted to ensure correction of all significant and minor deficiencies noted in the inspection reports.
  2. Prepare reports of the IACUC evaluations as set forth in the PHS Policy IV.B.3 and submit the reports to the Institutional Official. The IACUC procedures for developing reports and submitting them to the Institutional Official are as identified in parts III.D.1 and III.D.2 of this Assurance.
  3. Review concerns involving the care and use of animals at the Institution. The IACUC procedures for reviewing concerns are as follows:
    1. The University of Idaho has a 1-800 hotline for reporting compliance matters. This number is 1-800-775-1056. Opportunities to report concerns informally are provided during ongoing meetings between the Vice President for Research, the Chief Research Compliance Officer, and faculty and staff. Concerns may also be reported directly to any facility manager or IACUC member. Additionally, regular meetings between the Campus Veterinarian and animal management staff encourage reporting of all concerns. Posters that provide contact information for the Chief Research Compliance Officer are posted in a variety of areas across campus. Concerns are taken seriously and are investigated. In all cases, the individual reporting the incident is assured protection from reprisal.
    2. Information Gathering and Committee Assessment
      
      The committee Chair, Campus Veterinarian, Chief Research Compliance Officer or other pertinent party will provide the committee with factual information on the incident as soon as those facts are identified. The individuals(s) involved will be given ample opportunity to explain the circumstances from their point of view.
      
      Committee notification occurs in a timely manner and includes the type of incident (e.g., unapproved procedures, housing violations, lack of skill/training, neglect, unnecessary or excessive use of animals) and details of the specific events (e.g., species, procedures performed, adverse effects, individuals involved).
      
      Committee members then consider the following questions in determining what actions to take.
      1. In what humane use category would the procedures have been?
      2. What were the adverse effects on the animals being used?
      3. Might the adverse effects have been prevented if the procedures had been reviewed by the IACUC and the veterinary staff?
      4. Was medical intervention by the veterinary staff required?
      5. Were the individuals involved aware that IACUC approval was required before performing the procedures?
      6. Has the investigator repeatedly violated IACUC policies? Were the previous violations the same or different than the current action?
      7. Was it necessary for the IACUC to intervene to temporarily or permanently interrupt the activities?
      8. Was there intent to circumvent committee authority?
    3. After considering the above questions, the committee members assess the incident for the following:
      1. Have the actions jeopardized the health or well-being of the animals being used or resulted in animals being harmed or dying?
      2. Is there evidence that the investigator and/or his or her staff disregarded the institutional animal care and use policy in order to perform procedures without obtaining approval from IACUC?
    4. Committee Actions
      
      The IACUC will notify the Institutional Official and those individuals involved of findings in writing. Judgment is rendered on a case-by-case basis. The following actions are representative of possible actions. Other actions may also be taken as appropriate to remedy situations.
      1. Issue a notification of a finding of no wrong doing, with or without accompanying suggestions for changes in procedures.
      2. Issue a written warning to the individual(s) with a copy to the individual(s) departmental chair.
      3. Require investigators and/or staff to complete additional training.
      4. Make other appropriate stipulations to ensure that standards are met. These might include but are not limited to increasing the number of inspections or requiring changes in protocol procedures.
      5. Suspend the project in question until deviations can be remedied.
      6. Permanently revoke approval for the project in question.
      7. Suspend or revoke all animal care and use privileges for the investigator and/or his staff.
    5. The Institutional Official, OLAW and any funding agencies supporting affected projects will be provided a full explanation of the circumstances and actions taken in the following situations.
      1. Any serious or continuing noncompliance with the PHS Policy
      2. Any serious deviation from the provisions of the Guide or Ag Guide
      3. Any suspension or revocation of an activity by the IACUC
  4. Make written recommendations to the Institutional Official regarding any aspect of the Institution's animal care and use program, facilities, or personnel training. Recommendations may also be made verbally or in writing through the IACUC Chair, Chief Research Compliance Officer or Campus Veterinarian
  5. In accord with the PHS Policy IV.C.1-3, the IACUC shall review and approve, require modifications in (to secure approval), or withhold approval of PHS-supported activities related to the care and use of animals. The IACUC procedures for protocol review are as follows:
    1. Requirements for Protocol Submission
      1. Any PHS funded project utilizing live, vertebrate animals must have an approved animal care and use protocol in place prior to the initiation of the project. One protocol may be used for all animal procedures in a grant, including when more than one species is required for the project, as long as the protocol specifies the procedures to be performed, on which animals the procedures will be performed, and the number of each species to be used.
      2. A protocol must be submitted and approved for all covered activities in which an investigator is involved at off-campus sites, such as other institutions, in the field, or in other countries. This includes projects where the University investigator is not the awardee of the grant. In general, any activity where an investigator is acting as an agent of the University or the investigator could be listed as an author on published work requires prior IACUC approval.
      3. The Campus Veterinarian, IACUC Chair and Chief Research Compliance Officer determine if a protocol is required in unclear circumstances, with a bias towards protocol submission and review. When the details of animal work on any grant proposal are not identifiable at the time of award, the funding agency will be notified and if applicable funds accepted under a Restricted Award.
      4. Vertebrate wildlife must be included if the exhibition of their normal species-specific behavior is compromised. This includes any animal that has been trapped or penned inside its normal range and intentional herding of animals in an open range.
      5. The IACUC will review protocols for invertebrate animal use upon the request of an investigator. Routine submission of protocols for invertebrate animals is not required.
    2. Exemptions From Review
      1. Retrospective literature studies of projects where animals were used.
      2. Obtaining tissues from animals at slaughter where animals are not being euthanized specifically for the purpose of obtaining the tissues.
      3. Surveys of animal health and/or production data from third parties where the data was obtained for some other purpose.
      4. Processing samples as a service where animal products (hair samples, blood samples, other sources of DNA, etc.) are submitted for analysis and a report of results returned to the party requesting the analysis. If the test itself involves the use of live animals a protocol must be approved for the testing procedure.
      5. Only data analysis is being provided where the University employee or student has had no involvement in study design or collection of samples.
      6. The project is being funded, designed and implemented by Idaho Fish & Game where only population management procedures are being conducted. Population management procedures may include capturing and transportation of animals or any health monitoring procedures deemed necessary by IF&G where publication of data obtained for research purposes is not part of a research trial. University provided personnel may not receive academic credit for the activity.
    3. Investigator Assurances.
      1. All protocol forms must be signed by the principal investigator. This signature binds the investigator in an agreement to comply with all University policies regarding animal care and use. This includes but is not limited to:
        
        compliance with all policies of the IACUC and any animal facilities used,
        
        completion of any training requirements set forth by the IACUC, and
        
        responsibility for the actions of all individuals who are named in the protocol as co-investigators or personnel on the project as it relates to the well-being of the animals used.
        
        Failure to comply with any University policy regarding animal care and use may result in immediate loss of animal care and use approval, denial of access to facilities, and notification of funding agencies of withdrawal of approval for animal care and use
      2. Acceptable signature formats include original written signatures, faxed copies of original written signatures, email originating from the investigator’s institutional email account, and investigator actions taken in a secure online records system that uniquely identifies the individual taking the action.
      3. Signature authority may be delegated for one or more protocols by the principal investigator to one or more people. Acceptable signature requirements for signature delegates are the same as for principal investigators.
    4. Distribution of Materials
      1. New protocols, requests for significant changes to existing protocols, and any other materials for IACUC review are distributed via electronically to all voting committee members.
      2. Paper or fax copies are sent to those members lacking adequate computing resources to evaluate electronic versions of review materials.
    5. Meetings and Attendance
      1. The IACUC meets monthly to conduct review of new protocols, significant changes to previously approved protocols, and any other business of the IACUC requiring committee action.
      2. Committee actions require a quorum. A quorum is a simple majority (greater than half) of voting members. Only voting members present may contribute to a quorum.
      3. Alternate committee members are available for all committee membership positions. Alternates fulfill the same membership role on the committee as the person for whom they are substituting including full voting rights. Alternates only have a vote when the member they are alternate for is not present. Protocols and other materials for action by the committee are provided to alternates only when the regular committee member is not available.
      4. Each member is trained as to conflict of interests as they relate to their voting capacity on the IACUC. It is understood that when there are conflicts of interest the committee member will abstain from the vote due to conflict of interest. A conflicted member many contribute to the quorum for action to be taken.
      5. All committee actions are the result of a simple majority vote of the voting members present.
    6. Review Criteria
      1. Review is based on those items identified in part IV.C. of the Policy.
      2. The IACUC relies on external funding agencies to provide adequate scientific review. Scientific merit of internally funded and non-peer-reviewed projects is determined by the IACUC. If the IACUC determines it does not have the expertise to adequately review a protocol, the protocol is sent to outside consultants for scientific review. Outside consultants cannot vote on protocol approval by the IACUC.
      3. The Campus Veterinarian is available for assistance in selection of anesthetics, analgesics, euthanasia methods, or other aspects of project design and protocol completion.
      4. Protocols using radioactive materials require prior approval from the Radiation Safety Committee (RSC).
      5. Protocols using recombinant DNA or infectious agents require prior approval from the Institutional Biosafety Committee (IBC).
      6. All protocol listed personnel must complete appropriate IACUC training as defined in III.G of this document.
      7. All protocol listed personnel must be enrolled in an occupational health program as defined in III.E of this document prior to participation in the project.
      8. Only PHS Assured institutions may act as performance sites for PHS funded activities where animal work may be performed.
        
        The OLAW published lists of assured domestic and foreign institutions is consulted prior to issuing subcontract awards.
        
        The IACUC of the performance site institution is responsible for review and approval of protocols, and ensuring compliance with all aspects of the PHS Policy at the performance site.
        
        Written documentation of performance site IACUC approval is required before funds are released.
      9. Organizations providing custom antibody production or other custom services where live animals are used must be PHS Assured institutions. The contracting organization’s IACUC is the IACUC of record
    7. Protocol Review Process
      1. Protocols may be reviewed via full committee review or designated member review. The default protocol review process is full committee review.
      2. Protocols are pre-reviewed by IACUC staff upon receipt for completeness. The PI is notified of any recommended or required changes or any additional information that is needed before the committee will review the protocol.
      3. Full Committee Review (FCR)
        
        Completed protocols are distributed with supporting documentation (proposals, permits, etc.) as appropriate to the committee prior to the scheduled IACUC meeting. Documentation is provided in electronic or paper format as needed. Protocols are compared to funding proposals for inclusiveness and compliance with institutional policies and procedures.
        
        Investigators are welcome at IACUC meetings to discuss their protocols or other animal care and use concerns. IACUC meetings are open to members of the public.
        
        Four categories of action may be taken by the committee on any protocol submission.
        
        Approval Withheld. The committee deems the project inadequate to warrant the use of animals. This may be due to flawed science, poor experimental design, or lack of ethical justification for approval. Investigators may not proceed with the project.
        
        Tabled. The committee deems the protocol to have insufficient or unclear information for adequate review. The investigator will be notified of the committee's deliberations and requirements for further review. Investigators may not proceed with the project.
        
        Modifications Required to Secure Approval. The committee deems the protocol to have sufficient ethical and scientific merit to warrant approval, but minor point(s) require clarification before full approval will be granted. Investigators may not proceed with the project until all minor points have been clarified and approved by IACUC staff, and they assign a status of Approved to the protocol.
        
        Approved. The committee deems the protocol acceptable as submitted or amended. Investigators may proceed with the project as facilities and animal availability allow.
      4. Designated Member Review
        
        New protocols and requests for significant changes to existing protocols involving minimal or no unrelieved pain or distress may be reviewed by designated member review (DMR) at the Chair’s discretion. All forms and review content are the same as for full committee review.
        
        Members are given 5 business days from the time of distribution of materials to call for FCR. Email replies, phone replies, fax and original written replies are all acceptable. If a member fails to respond after 5 business days they are considered to approve DMR of the protocol or amendment. Members are informed of this policy during new member training.
        
        Members may request additional information be provided and reported back to committee members or be reviewed and approved by the designated reviewer. If any voting member requests FCR, the protocol is placed on the agenda of the next convened meeting of a quorum of the IACUC. If no voting committee member requests FCR, the designated reviewer’s recommendation is carried out.
        
        The Chair appoints one or more qualified IACUC members to review the request, or seeks comments from a qualified outside reviewer. If an outside reviewer was appointed, the Chair acts as the designated reviewer.
        
        The designated member reviewer may
        
        approve the protocol or significant change as submitted,
        
        require modifications to the protocol or significant change in order to secure approval, or
        
        refer the protocol to the full committee with or without modifications for FCR.
        
        IACUC members are informed of the reviewer’s comments and recommendations at its next meeting
    8. Recording Committee Actions
      1. Documentation is maintained with the protocol and in meeting minutes for all deliberations and committee actions regarding the protocol.
      2. The IACUC is informed at each meeting of the results of all DMRs since the previous meeting.
      3. Minutes of meetings are reviewed and approved by a quorum of members present at subsequent meetings.
  6. 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 IV.C. The IACUC procedures for reviewing proposed significant changes in ongoing research projects are as follows:
    1. All significant changes in ongoing research project must be reviewed and approved by the IACUC prior to their implementation. Significant changes include but are not limited to:
      1. Changes in the objectives of a study;
      2. Changes from non-survival to survival surgery;
      3. Changes that increase the degree of invasiveness of a procedure or discomfort to an animal;
      4. Changes in species;
      5. Changes in the approximate number of animals used;
      6. Changes in the principal investigator;
      7. Changes in anesthetic agent(s), the use or withholding of analgesics, or methods of euthanasia, and
      8. Increases in the duration, frequency, or number of procedures performed on an animal.
    2. The following changes are considered protocol refinements requiring prior IACUC notification and administrative approval:
      1. Changes in personnel other than the PI;
      2. Changes from survival to non-survival surgery;
      3. Changes in procedures or housing
        
        that decrease the degree of invasiveness of a procedure or discomfort to an animal;
        
        that decreases the duration, frequency, or number of procedures performed on an animal.
        
        addition of environmental enrichment methods for non-behavioral or stress evaluation studies.
    3. The IACUC Chair and Campus Veterinarian make a joint determination in cases where it is unclear as to whether a significant change is being requested requiring committee review.
    4. Annual protocol renewal forms include a request for proposed significant changes in procedures and/or personnel.
    5. A written or email request for substantive changes in a protocol may be submitted at any time during the year for review. Requests must include the same information as required for new protocol submission.
    6. Requests for significant changes are reviewed using the same criteria and processes as identified for new protocol submissions.
  7. 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 IV.C.4. The IACUC procedures to notify investigators and the Institution of its decisions regarding protocol review are as follows:ecisions regarding protocol review are as follows:
    1. The principal investigator is notified in writing or verbally of its decisions. Verbal decisions are always followed up with written authorization. Written authorization may be in printed letters, email, or within electronic IACUC records systems. Any of these forms of notification of a committee action of Approved authorizes initiation of the project.
    2. Copies of minutes of the IACUC meetings are made available to the Institutional Official. Matters with a potentially significant impact are also discussed with the Institutional official. As appropriate written reports are provided to the Institutional Official.
  8. 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 IV.C.1-4 at least once every three years. The IACUC procedures for conducting continuing reviews are as follows:
    1. i. Protocol Review
      1. A protocol may be renewed with annual updates for a total duration of three years (two annual updates) from the original approval date.
      2. A new protocol form must be submitted for projects requiring longer than three years to complete. The protocol is then reviewed for approval under a new protocol number using the same criteria as a new submission.
      3. Approaching annual renewal and three year expiration reports are run monthly and sent to investigators and grant management staff. Investigators are notified approximately 90, 60, and 30 days prior to expiration of the protocol, and immediately following protocol expiration.
    2. Expired Protocols
      1. Live animals present at the time of protocol expiration are transferred to holding protocols for the facility in which they are housed.
      2. The Office of Sponsored Programs is notified when protocols expire.
        
        PHS funds may continue to be used for basic husbandry of any animals currently on holding protocols.
        
        PHS funds are frozen for research activities involving the use of animals until an appropriate renewal or resubmission has been completed and approved by the IACUC.
    3. Additional procedures to ensure ongoing compliance with approved protocols include but are not limited to:
      1. Animal study areas and all satellite facilities are inspected not less than once every 6 months as described under III.D.2. Additionally, the Campus Veterinarian, the Chief Research Compliance Officer, and the Industrial Hygienist make announced and unannounced visits to laboratories for informal assessments of procedures.
      2. As part of the mandatory training for all personnel listed on animal care and use protocols, personnel are encouraged to contact the Campus Veterinarian, the IACUC Chair, any IACUC member, and facility managers at any time during study performance
        
        for clarification on animal care, appropriate animal use procedures, and compliance with IACUC policies and procedures,
        
        reporting adverse events,
        
        unanticipated situations arise when conducting studies where additional veterinary support, animal care and use assistance, or animal care training may be needed.
      3. Instructions for reporting animal welfare concerns, requesting veterinary care, and contacting emergency services for safety or physical plant issues are posted in all animal facilities.
      4. Animal purchases and acquisitions must be placed through the facility manager. The facility manager verifies that an IACUC approved protocol is in place that covers the species and numbers of animals being requested prior to placing animal orders.
      5. Preventive health programs are in place at all animal facilities including but not limited to:
        
        IACUC approved vendor selection
        
        Animal health reports and/or veterinary health certificates are reviewed by facility staff for each shipment of animals. The attending veterinarian is notified of any potential infectious diseases or other problems that occur with individual shipments.
        
        Verification that all required state and federal regulatory permits are in order.
        
        Quarantine of incoming animals specific to the species, source of origin, and intended housing site and use.
        
        Vaccination and parasite control programs are implemented when available and warranted.
        
        Water quality testing is routinely performed for aquatic housing at a frequency dependent on the type of housing and the species being housed.
        
        Animal housing areas are cleaned at a frequency and in a manner designed to prevent influential exposure to infectious agents and toxic irritants.
      6. Written records are maintained for daily observation; animal feeding; facilities cleaning; all animal purchases, transfers and euthanasia; and all animal research procedures including surgery and anesthesia.
      7. Routine announced and unannounced visits are made by the veterinary staff, Office of Research Compliance staff, and Environmental Health & Safety personnel to each animal facility, satellite facility, and study area for assessing animal care, investigator procedures, physical plant status, and reviewing facility management procedures and usage of required PPE. Facility and investigator records may be reviewed at any time.
      8. Animal facility managers and animal care staff monitor on a daily basis the health and well-being of all animals housed at the facility, the adequacy of housing and husbandry being provided to animals, and the skills and procedures implemented by investigators, providing assistance and training when required. The attending veterinarian for the facility is contacted if significant or ongoing health concerns are identified.
      9. Any significant deviations from IACUC approved protocols or significant animal health events as determined by the attending veterinarian for the facility are reported to the IACUC for investigation and review as specified in III.D.4 and VI.B of this assurance.
  9. Be authorized to suspend an activity involving animals as set forth in the PHS Policy IV.C.6. The IACUC procedures for suspending an ongoing activity are as follows:for suspending an ongoing activity are as follows:
    1. The Campus Veterinarian may immediately halt any experimental activity if animals are in immediate harm. The IACUC will convene to review the situation or a formal complaint by another party in a timely manner. After following the complaint review process as specified in III.4.a of this Assurance, the IACUC may:
      1. Restart the activity,
      2. Require modifications of procedures, additional training, or increased IACUC and/or investigator monitoring of the protocol activities as conditions of reinstatement of the activity, or
      3. Permanently suspend the activity.
    2. The Institutional Official is notified in writing of committee actions where suspension of an activity occurs. A complete report including committee recommendations is provided.
    3. OLAW and the funding agency for the project will be notified within 10 working days of the suspension of any activity governed by that agency. Reasons for the suspension and conditions for the suspension being removed will be included in the notification.
4. The occupational health and safety program for personnel working in laboratory animal facilities or have frequent contact with animals is as follows:
  1. Program Management
    1. The Industrial Hygienist in Environmental Health & Safety (EHS), the Campus Veterinarian, and Human Resources manage the program.
    2. Written laboratory safety plans are in place in all laboratories. Plans include work practices, procedures, and policies to ensure that employees are protected from all potentially hazardous materials in use in their work area. MSDS sheets are posted in each laboratory.
    3. Projects and positions that include exposure to live or dead animals, animal tissues, or animal excrement where recombinant DNA or infectious agents are reviewed and approved by the Institutional Biosafety Committee (IBC). Biosafety manuals are in place in all laboratories monitored by the IBC. All personnel working in the laboratory must read and sign the manual.
  2. Personnel Covered
    1. All University employees coming in contact with live or dead animals, animal tissues, or animal excrement as a result of their normal duties may participate in the Animal Workers Medical Surveillance Program (AWMSP).
    2. All of the medical procedures performed as part of the program may be denied by the employee unless required as indicated in regulation or by the IACUC, IBC, Radiation Safety Committee (RSC), or Environmental Health & Safety (EHS).
    3. Students enrolled in courses where potential animal health risks may occur are provided information on the risks to which they may be exposed. Appropriate personal protective equipment (PPE) as described for employees is provided to mitigate those risks.
    4. Individuals listed on protocols that are not University employees must provide documentation of inclusion in their home institution’s occupational health program. If no such program exists they are treated as students enrolled in a class.
    5. Volunteers are treated as students enrolled in a class.
  3. Hazard Identification and Risk Assessment
    1. Hazard identification and risk assessment are performed jointly by EHS personnel (Industrial Hygienist, Hazardous Material Specialist, etc.), the Campus Veterinarian, and when appropriate the IBC, RSC, health care providers, and personnel involved.
    2. Relative risk is determined by completing job hazard analysis forms that include evaluation of
      1. the properties of the physical, chemical, and infectious hazards identified,
      2. the intensity and frequency of exposure,
      3. the animal species used,
      4. the procedures being performed,
      5. the study location,
      6. the facilities at the study location, and
      7. the age, pregnancy status, and immune status of the employee.
    3. Assessment by Position for Permanent Personnel
      1. The work environment of facilities maintenance and animal facility staff positions is examined by EHS personnel and the Campus Veterinarian.
      2. Direct consultation occurs with investigators, staff, and staff supervisors involved regarding the duties each will conduct.
    4. Assessment at the Time of Protocol Review
      1. During protocol review an initial assessment is made by the Campus Veterinarian and the IACUC as to whether significant risks (zoonotic diseases, infectious or toxic agents, etc.) to employees may exist.
      2. If significant health risks exist the Industrial Hygienist that administers the program is notified. Hazard analysis and risk assessment is performed and mitigating procedures identified before protocol approval is granted.
      3. Signed AWMSP participation or declination forms for all University employees listed on a protocol must be provided before protocol approval is granted. All personnel choosing to participate in the program are contacted by the Industrial Hygienist to conduct a job hazard analysis and determine whether referral to a health care provider will occur.
    5. Relevant information from the hazard analysis and risk assessment is supplied to health care providers.
  4. Personnel Training
    1. A combination of online courses, video tapes, live seminars, and hands-on training labs are provided.
    2. The Campus Veterinarian and EHS personnel provide training sessions on zoonotic diseases, chemical safety, physical hazards, allergies, appropriate preventive methods (includes personal hygiene), handling of waste materials, safety procedures for use of special equipment and precautions taken during pregnancy, illness or immune suppression.
    3. American Biological Safety Association animal handling videos are used for training as appropriate for animal work with infectious agents.
  5. Personal Hygiene
    1. Clothing appropriate to the study location, procedures being conducted, and hazards identified must be worn.
    2. Sinks with soap are available in all study areas. All personnel are encouraged to wash between handling different groups of animals and prior to leaving the facility.
  6. Facilities, Procedure and Monitoring
    1. Projects that include work with either recombinant DNA or infectious agents must be reviewed and approved by the IBC prior to IACUC approval.
      1. A Biosafety manual is developed from a risk assessment to mitigate the risks associated with the project activities. All personnel in the laboratory must read and sign the manual.
      2. All sites where IBC regulated activities occur are inspected by the IBC upon receipt of a Memorandum of Understanding and Agreement (MUA), and periodically throughout the project.
    2. IACUC Monitoring
      1. The Campus Veterinarian provides ongoing facilities monitoring and in conjunction with the animal facility managers develops SOP’s for activities at each animal facility.
      2. The IACUC inspects all animal facilities and study areas not less than every six months as identified in III.D.2 of this document.
    3. Fire, electrical, and general safety inspections are conducted according to state and federal code.
  7. Animal Experimentation Involving Hazards
    1. If the use of hazardous materials is identified in animal care and use protocol review, approval is received from the IBC, RSC, or EHS prior to protocol approval.
    2. Procedures requiring animal biosafety level containment are conducted in facilities and using practices that meet Biosafety in Microbiological and Biomedical Laboratories (BMBL) criteria and where appropriate meeting the NIH Recombinant DNA Guidelines.
    3. Protective clothing and equipment is provided for all employees when indicated based on risk assessment or regulations.
      1. Personnel working with Peromyscus sp. of unknown Hantavirus status or are at high risk of Hantavirus exposure in the field must wear HEPA-filtered respiratory protection while at risk. National Center for Infectious Diseases recommendations for preventing Hantavirus disease is followed.
  8. Medical Evaluation and Preventive Medicine for Personnel
    1. Following review of a completed job hazard analysis form, medical consultation with a health care provider is scheduled for the employee if deemed appropriate by the Industrial Hygienist.
    2. Health care providers are contracted providers or the employee’s personal health care provider based on location. The physician and Industrial Hygienist jointly make a final determination of what preventive measures are required for participation in the proposed projects.
    3. Physical examinations are provided. Additional testing is based upon the risk assessment and consultation.
    4. Serum samples for storage or serologic testing are collected on an as needed based on consultation between the employee and his/her physician. Samples are maintained by the health care provider. Potential titers include rabies, toxoplasmosis, Q-Fever, and psittacosis.
    5. Tuberculosis testing, stool sample examination for parasite detection, and other diagnostic tests are provided as determined by the Industrial Hygienist and health care provider.
    6. Vaccinations are provided by health care providers after individual consultation between the employee and their health care provider.
      1. All covered personnel are offered immunization for tetanus.
      2. Individuals working with wild carnivores and other species at high risk of carrying rabies (skunks, wild canines and felines, bats, etc.) are offered immunization against rabies. The University reserves the right to deny participation to any individual refusing rabies prophylaxis.
      3. Employees participating in any work that falls under the OSHA Blood Borne Pathogen standard (non-human primate potentially infectious material) are offered Hepatitis B vaccination. No live human primate work is performed at UI facilities.
    7. All personnel that utilize respiratory protection undergo cardio-pulmonary function testing at the discretion of health care providers. Decisions are made based on a health history and risk assessment.
  9. Reporting and Treating Injuries
    1. First aid kits are maintained in each laboratory and study area. Required contents are specified by EHS.
    2. In the event of accidental injury basic first aid is administered as identified in the laboratory’s biosafety manual. Employees are then referred or transported to a health care provider for examination and treatment.
    3. The mechanism for reporting accidents and gaining treatment is the same as for any other occupational injury in the University. Once emergency medical needs have been addressed, a word related accident report form is submitted to EHS for review. EHS may require changes in physical plant, materials and methods, or training before continuing with the activities that resulted in injury or exposure.
  10. Special Precautions for Personnel Working With Non-Human Primates. The University of Idaho has no facilities for housing non-human primates. The employee is required to follow the health program established at any PHS Assured primate facility with which the employee is working. If no such program exists the CDC guidelines for Cercopithecine Herpes Virus (Herpes B) are followed to prevent exposure and in the event of a potential exposure.
5. Training and Instruction
  1. All investigators and staff participating in projects covered by this Assurance must complete one of the following training methods:
    1. Seminar provided by the Campus Veterinarian covering :
      1. the Laboratory Animal Welfare Act and its amendments
      2. the Guide for the Care and Use of Laboratory Animals
      3. humane methods of animal maintenance and experimentation
      4. alternatives to the use of animals in research, testing and teaching including refinement, reduction and replacement;
      5. proper use of anesthetics, analgesics, and tranquilizers; methods to report deficiencies in animal care and treatment; services available through the National Agricultural Library and the National Library of Medicine.
    2. Online training through in house and third party IACUC approved courses
  2. All personnel are provided with a copy of the ACUC’s Policies and Procedures Manual.
  3. Additional training is required based on the species of animals used and the procedures to be performed. This may include any of the following resources:
    1. Video tapes on the proper care and use of laboratory animals
    2. Wet labs on handling, bleeding, anesthesia, surgery and other techniques.
    3. Training modules produced by commercial vendors or internally such as the Federation of Animal Science Societies modules covering general animal care and use requirements and relevant species-specific modules when applicable.
  4. A course on Laboratory Animal Science is available through cooperation with Washington State University (7 miles away).
  5. The Campus Veterinarian or other approved trainers verify the Principal Investigator has the necessary skills to perform the activities approved in a protocol. Additional training is provided where needed. The principal investigator is responsible for providing training to all personnel listed on their protocols.
  6. A database of mandatory training satisfactorily completed by all users, including dates of training, is maintained by the IACUC. Training is verified for all personnel prior to be added to a protocol. The principal investigator is responsible for maintaining documentation for all personnel training performed by them or their staff on their studies.
  7. IACUC members complete online training that explains their responsibilities as an IACUC member as well as ongoing training at IACUC meetings. Each member is provided a copy of the IACUC Policies and Procedures Manual and the Guide at the start of their term, and other relevant professional society animal care and use statements as needed. An initial and ongoing opportunity to ask questions and meet individually with the Campus Veterinarian or the Chief Research Compliance Officer is also provided.
IACUC Procedures
1. Confidentiality of Information
  
  The IACUC views all information submitted to the committee by an investigator as confidential for the safety of all individuals involved in the project and for preservation of proprietary information. According to the AWA, all individuals who serve as members of an IACUC must be given the opportunity to review all requests for animal use before approval may be granted. The IACUC requires each committee member to review all protocols prior to the committee meeting at which they will be discussed. Each member is given a copy of the protocol submissions to be reviewed. Committee members are to treat the protocols as confidential and destroy the material when the review process is completed. In compliance with federal regulations, ORA maintains one copy of all protocols submitted and OSP maintains their associated grant proposal on file until three years after the last activity on the protocol. After this period, the protocol and all correspondence regarding the protocol may be destroyed. A computerized database which contains minimal information for appropriately tracking annual renewals and expiration notices is also maintained using the same criteria.
2. Animal Procurement
  Animals may not be procured for, or transferred to, personnel who do not have IACUC approval. Animal procurement and disposition must be in accordance with Purchasing Services (APM 60.44) and IACUC policies and procedures.
3. Euthanasia
  All euthanasia methods must be in compliance with the current AVMA Panel on Euthanasia. Deviations from this panel report must be scientifically justified in the protocol and may require approval from the USDA and NIH.
  
  Most facility technicians are skilled at performing euthanasia. The method chosen should not interfere with any post mortem procedures implemented. The Campus Veterinarian is also available for consultation on selection of euthanasia method. Acceptable methods of euthanasia are those that initially depress the central nervous system to ensure insensitivity to pain. For this reason, anesthetic agents are generally acceptable. Mammals and birds can be killed quickly and humanely by intravenous or intraperitoneal injection of an overdose of barbiturates. Physical methods of euthanasia (decapitation, pithing, pneumothorax with injectable anesthetics, removing the heart) may be used for euthanasia of already anesthetized animals. Cervical dislocation of small rodents and rabbits must be performed under anesthesia unless there is scientific justification for not using anesthesia. Carbon dioxide in precharged, uncrowded chambers is satisfactory for several different species and relatively inexpensive.
  
  Every attempt should be made to perform euthanasia on animals in a manner that minimizes reactions among other living animals. Proper euthanasia technique should include a follow-up examination to confirm the absence of a heartbeat, which is a reliable indicator of death. Monitoring respiration is not sufficient. In some animals, particularly under deep carbon dioxide anesthesia, heartbeat can be maintained after visible respiration has ceased, and the animal might eventually recover. When any doubt occurs, a pneumothorax will ensure that the animal will not recover.
4. Animal and Animal Waste Disposal
  
  All dead animals, animal tissues and animal wastes are considered biomedical waste and must be disposed according to University policy as established by the Safety Office. For animal protocols falling under the NIH recombinant DNA Guidelines animal carcasses must be disposed of in accordance with the specified NIH requirements and be approved by the Institutional Biosafety Committee (IBC). The LARF has an incinerator for university wide use on small animals. The capacity of the incinerator is limited. Please make arrangements with the LARF director before bringing carcasses to the facility.
5. Consequences of Non-Compliance With IACUC Policies
  
  In the event of non-compliance with IACUC policies, the IACUC may revoke animal care and use privileges for the investigator and his/her staff. If the non-compliance is in violation of PHS policy, OLAW will be notified of the non-compliance and actions taken by the IACUC to correct the situation. If the animal species involved is covered by the AWA, the USDA-APHIS Animal Care will also be notified. Reinstatement of animal care and use privileges is dependent upon future compliance with IACUC policies, demonstration of assurance that such violations will not recur, and will not be granted until OLAW and USDA provide approval if needed. OLAW and USDA may impose further sanctions, including but not limited to withdrawal of funding for the investigator, withdrawal of federal funding from the University, fines and/or criminal prosecution of the parties involved.
IACUC Protocols
1. General Information
  A protocol for animal care and use is a form which the IACUC has developed for adequately reviewing requests for animal care and use. Any projects which involve animal activities must have an approved animal care and use protocol in place prior to the initiation of the project. One protocol may be used for all animal procedures in a grant as long as all procedures are specified in the protocol form. One protocol may be used if more than one species is required for the project as long as the protocol specifies the procedures to be performed on which animals and the number of each species to be used. Wildlife animals must be included if the exhibition of their normal species-specific behavior is compromised. This includes any animal that has been trapped or penned inside its normal range. Intentional herding of animals in an open range is also considered intruding on their species-specific behavior.
  
  The IACUC also requires a protocol to be submitted for all covered activities in which an investigator is involved at off-campus sites, such as other institutions, in the field, or in other countries. This includes projects where the University investigator is not the awardee of the grant. In general, any activity where an investigator is acting as an agent of the University or the investigator could be listed as an author on published work requires prior IACUC approval. The Campus Veterinarian may be consulted to determine if a protocol should be submitted. The IACUC will review protocols for invertebrate animal use upon the request of an investigator. Routine submission of protocols for invertebrate animals is not required.
  
  Each funding agency sets its own requirements for when a request for funding must have IACUC approval - at submission, before review, before release of funding, or no review requirement. It is the investigator's responsibility to ensure compliance with the funding agency's requirements. Writing "Pending" in the space for IACUC approval on grant application forms may or may not be acceptable. In all cases where live animals are used, the University requires an animal care and use protocol be approved prior to receipt of funding or initiation of a project.
  
  Protocols are effective for one year from the original approval date. A protocol may be renewed with annual updates for a total duration of three years (two annual updates). ORA will make every effort to send annual renewal notices and three year expiration notices to all investigators approximately two months prior to expiration of the protocol. However, it is the investigators responsibility to monitor protocols and maintain compliance. Procedures must not be performed on any project which has expired until an appropriate renewal has been completed and approved by the IACUC.
  
  Some projects may require longer than three years to complete. A new protocol form must be submitted for approval under a new protocol number. The first page of the protocol includes a space to indicate the protocol number of the previously approved project. This section must be completed, with the addition of any proposed changes to the previously approved protocol. All protocol forms must be signed by the principal investigator, (electronic signatures are acceptable for all but FDA regulated protocols). This signature establishes the investigator as the legally responsible individual under the AWA and University policy. It also binds the investigator in an agreement to comply with all University policies regarding animal care and use. This includes but is not limited to:
  1. compliance with all policies of the IACUC and any animal facilities used,
  2. completion of any training requirements set forth by the IACUC, and
  3. responsibility for the actions of all individuals who are named in the protocol as co-investigators or workers on the project as it relates the well-being of the animals used.
2. The Protocol Review Process
  A copy of the current protocol form may be obtained from the ORA website. A detailed explanation for completing the form is included with the protocol. The protocol form must be fully completed in written type format and signed by the principal investigator before it will be accepted for review. The instruction section, and the surgery form if no surgeries are to be performed, should not be submitted with the completed protocol for review.
  
  The facility manager at the desired housing site should always be contacted for space and animal availability during the desired project period, as well as for current pricing information. IACUC approval does not ensure availability of animals, housing or per diem rates. Any special requirements of the project must be worked out with the facility manager and the campus veterinarian prior to implementing the project. A copy of the IACUC policy and procedures manual for each facility may be obtained from the manager of the facility. Any deviations from the IACUC approved procedures of the facility must be specified in the protocol. The campus veterinarian may be contacted for assistance in selection of anesthetics, analgesics, euthanasia methods, or other aspects of completing the protocol form.
  
  The IACUC meets monthly, normally in the week following the second Tuesday in the month. The exact day and time vary with the schedules of committee members. To allow for adequate time for distribution of protocols to committee members and protocol review, the electronic protocol must be submitted to iacuc@uidaho.edu by the close of business on the second Tuesday of the month. A form submitted without a detailed project description will not be reviewed by the committee. Investigators are always welcome at IACUC meetings to discuss their protocols or other animal care and use concerns.
  
  Regulations require review based on both ethical value and scientific merit. The IACUC relies on external funding agencies to provide adequate scientific review. Internally funded, non-peer-reviewed projects may be sent to outside consultants for scientific review if the IACUC determines it does not have the expertise to adequately review the project. Outside reviewers cannot vote on protocol form approval by the IACUC. The investigator will normally be contacted for a list of suggested reviewers. This can result in delays in approval. Investigators should plan ahead when submitting protocols for review.
  
  The PI will be notified in writing within one week of the IACUC's meeting of its decision. All committee actions are the result of a majority vote of the members present. Four categories of action may be taken by the committee on any protocol submission.
  - Approval Withheld. The committee deems the project inadequate to warrant the use of animals. This may be due to flawed science, poor experimental design, or lack of ethical justification for approval. Investigators may not proceed with the project.
  - Tabled. The committee deems the protocol to have insufficient or unclear information for adequate review. The investigator will be notified of the committee's deliberations and requirements for further review. Investigators may not proceed with the project.
  - Modifications Required to Secure Approval (MRSA). The committee deems the protocol to have sufficient ethical and scientific merit to warrant approval, but minor point(s) require clarification before full approval will be granted. Investigators may not proceed with the project until all minor points have been clarified and approved by IACUC staff, and they assign a status of Approved to the protocol.
  - Approved. The committee deems the protocol acceptable as submitted or amended. Investigators may proceed with the project as facilities and animal availability allow.
  For all protocols that are determined to fall under category MRSA above The Campus Veterinarian or other reviewer designated by the committee may grant full approval based on satisfactory clarification of all questions raised in the Modifications Required to Secure Approval decision.
  
  Protocols only receive approval when a majority of a quorum votes for approval.
3. Guidelines for Review of PHS Applications and Proposals
  In order to approve protocols or proposed significant changes in ongoing activities, the IACUC will conduct a review of those sections related to the care and use of animals and determine that the proposed activities are in accord with regulations and University policy unless acceptable justification for a departure is presented. Further, the IACUC will determine that the activity conforms with the institution's NIH assurance statement and meets the following requirements:
  1. Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.
  2. Procedures that may cause more than momentary or slight pain or distress to the animals will be performed with appropriate sedation, analgesia, or anesthesia, unless the procedure is justified for scientific reasons in writing by the investigator and approved by the IACUC.
  3. Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be painlessly sacrificed at the end of the procedure or, if appropriate, during the procedure.
  4. The living conditions of animals will be appropriate for their species and contribute to their health and comfort. The housing, feeding, and non-medical care of the animals will be directed by a veterinarian or other scientist trained and experienced in the proper care, handling and use of the species being maintained or studied.
  5. Medical care for animals will be available and provided as necessary by a qualified veterinarian.
  6. Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures. Approval will not be granted unless the principal investigator and all personnel listed on the protocol have completed the University's animal care and use training seminar.
  7. of euthanasia used must be consistent with the recommendations of the current AVMA Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator.
4. Changes in Procedures, Animal Numbers, or Species
  Under regulations and University policy, the investigator is required to submit proposed changes in protocols for IACUC review prior to the changes being implemented. A memo detailing the proposed changes and the reasoning for the change must be submitted to the IACUC for review. In extenuating circumstances, such as when a delay until the next committee meeting is not possible, the Campus Veterinarian should be contacted directly.
Standard Operating Procedures
Appendices
1. Acronyms
  1. AAALAC - Association for Assessment and Accreditation of Laboratory Animal Care International
  2. AALAS - American Association of Laboratory Animal Science
  3. IACUC - Animal Care and Use Committee
  4. APHIS - Animal Plant Health Inspection Service; see USDA-APHIS
  5. AVMA - American Veterinary Medical Association
  6. AWA - Animal Welfare Act
  7. AWIC - Animal Welfare Information Center
  8. CSREES - Cooperative State Research, Education and Extension Service
  9. DHHS - Department of Health and Human Services
  10. ESA - Endangered Species Act
  11. ESU - Evolutionary Significant Unit
  12. IACUC - Institutional Animal Care and Use Committee
  13. ILAR - Institute for Laboratory Animal Research
  14. LARF - Laboratory Animal Research Facility
  15. NIH - National Institutes of Health
  16. OPRR - Office for Protection from Research Risks
  17. PHS - Public Health Service
  18. PI - Principal Investigator
  19. SBOE - State Board of Education
  20. SCAW - Scientists Center for Animal Welfare
  21. URO - University Research Office
  22. USDA - United States Department of Agriculture
  23. USDA-APHIS - USDA Animal Plant Health Inspection Service
  24. USDA-AC - USDA Animal Care
  25. USDA-ARS - USDA Agriculture Research Service
  26. USDA-IES - USDA Investigative & Enforcement Services
  27. USDA-REAC - USDA Regulatory Enforcement for Animal Care (changed to Investigative & Enforcement Services)
2. Definition of Terms
  For the purposes of this manual, unless the context otherwise requires, the following terms, abbreviations and acronyms, shall have the meanings assigned to them in this section. The singular form shall also signify the plural and the masculine form shall also signify the feminine. Words undefined in the following sections shall have the meaning attributed to them in general usage as reflected by definitions in a standard dictionary.
  - Animal: an animal includes any living warm-blooded or cold-blooded vertebrate species, and all dead animals specified in subchapter A, part 1 of the AWA, which are used in research, testing or teaching; this includes: all university owned vertebrate animals; any other vertebrate animals housed in University facilities for the purposes of teaching, research, or testing; and any wildlife which have had their ability to exhibit normal species-specific behavior compromised, including range of migration
  - Animal Activity: Animal activity means teaching, research, demonstration or testing procedures using live or dead animals that are performed on University owned property or engaged in by University personnel. University owned property excludes land and facilities leased to third parties for commercial enterprise purposes.
  - Animal Welfare Act (AWA): the Act as defined in title 9, subchapter A of the Code of Federal Regulations
  - Ag Guide: Guide for the Care and Use of Agricultural Animals in Agriculture Research and Teaching; the Ag Guide was produced by the Consortium for Developing a Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching; copies may be obtained from the Federation of Animal Science Societies
  - Animal and Plant Health Inspection Service (APHIS): APHIS is the branch of the USDA responsible for setting and enforcing USDA policy on the care and use of AWA covered species
  - Department of Health and Human Services (DHHS): the principal agency of the U.S. government for protecting the health of all Americans and providing essential human services
  - Euthanasia: the humane killing of an animal, i.e., as rapidly and painlessly as possible
  - Facility: animal housing area which may be one or more rooms or buildings
  - Facility Manager: the person in charge of all daily activities at an animal facility
  - Grant Proposal: the application and all supporting documents submitted to a funding agency; also includes any detailed project description for pilot studies, graduate and undergraduate student projects, etc.
  - Guide: Guide for the Care and Use of Laboratory Animals; the Guide was prepared by the Committee on Care and Use of Laboratory Animals of ILAR for NIH; copies may be obtained from NIH
  - Institutional Animal Care and Use Committee (IACUC): the University of Idaho's IACUC as defined in the Faculty-Staff Handbook
  - National Institutes of Health (NIH): One of eight health agencies of the Public Health Service which, in turn, is part of the DHHS comprised of 24 separate institutes, centers, and divisions
  - NIH Assurance Statement: a general policy statement on how NIH guidelines are implemented at the University of Idaho
  - Office for Protection from Research Risks (OPRR): The office in the Division of Animal Welfare at NIH responsible for ensuring institutions are in compliance with NIH guidelines for animal care and use
  - Personnel: Personnel includes all University employees, students, and volunteers working on University sanctioned activities.
  - Principal Investigator (PI): The primary person in charge of a project which uses animals; normally the awardee of a grant or a faculty member
  - Protocol Form: The IACUC form which must be completed for using animals in research, teaching or product testing
  - Public Health Service (PHS): One of the four Operating Divisions of the DHHS responsible for setting guidelines for PHS funded studies which use animals
  - Quorum: A simple majority of the voting members of the IACUC
  - Regulations: Those portions of IACUC policies and procedures which are mandated by federal, state, or local laws and ordinances; federal laws and ordinances include the AWA, PHS Policy, Health Research Extension Act of 1985, U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in testing, research, demonstrations and training
  - University Policy: Those portions of IACUC policies and procedures which are not mandated by law, but are required by the IACUC and the Institutional Official; policy is subject to change, but deviation from policy is only allowed with prior consent from the IACUC or Institutional Official.
3. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
  
  The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible Institutional official shall ensure that these principles are adhered to:
  1. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et. seq.) and other applicable Federal laws, guidelines, and policies(1).
  2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
  3. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
  4. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
  5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents.
  6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
  7. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.
  8. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals.
    Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.