Animal Care and Use Program Guide

Boise State University is committed to ensuring the humane and ethical care and use of animals in its research and academic activities. The university strives to advance scientific knowledge, teaching, and research while balancing the use of animals that contribute to these endeavors. The Animal Care and Use Program Guide is intended to serve as a reference and guide to the university’s policies, program, processes and procedures when it comes to research, teaching, and testing involving animals. The university’s program is guided by a number of regulatory obligations and sponsor/agency/organizational requirements/guidelines such as, but not limited to:

• Guide for the Care and Use of Laboratory Animals (the Guide)
• Animal Welfare Act (AWA)
• Public Health Service (PHS) Policy
• American Veterinary Medical Association (AVMA) Guidelines on Euthanasia

Boise State University is responsible for the review of all activities involving animal use and the procurement, handling, and care of animals used of research, training, or testing if:

• the research, training, and testing is conducted under the auspices of the university, no matter of funding sources, or
• the research, training, and testing is conducted under the direction of any faculty, student, staff, or agent of the university in connection with his/her university responsibilities, or
• the research, training, and testing is conducted under the direction of any faculty, student, staff, or agent of the university using any property or facility of the university.

The responsibility for compliance with federal, state or university regulations concerning activities involving the care and use of animals rests with the President of Boise State University. The President delegates this authority to the Vice President for Research and Economic Development (VPRED) to serve as the Institutional Official (IO).

Protocols that have been approved by the IACUC may be subject to further appropriate review and approval by the institution. If the IACUC approves a protocol, the university is not required nor obligated to conduct the activity. The university may not allow the conducting of an activity involving the care and use of animals if it has not been approved by the IACUC. Other committee approvals are the responsibility of the Principal Investigator.

Boise State University concurs with the U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in testing, research and training. The University adopts and ensures that the following principles are adhered to:

• The transportation, care, and use of animals shall be in accordance with the Animal Welfare Act (AWA) and other applicable laws, guidelines, and policies.
• 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.
• 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.
• 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.
• 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.
• Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly euthanized at the end of the procedure or, if appropriate, during the procedure.
• The living conditions of animals should be appropriate for the 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.
• 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 provision 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 purpose of teaching or demonstration.

The Vice President for Research and Economic Development (VPRED) shall:

• Ensure compliance with all applicable laws and policies;
• Appoint an institutional animal care and use committee (IACUC) with appropriate administrative support;
• Have sufficient administrative and operational authority to develop administrative procedures necessary to implement the Boise State Institutional Animal Care and Use Program Guide;
• Review the composition of the IACUC membership, in consultation from the IACUC Chairperson and the Director of Research Compliance;
• Perform all necessary reporting requirements including to the appropriate officials for any noncompliance with laws and policies including any corrective or remedial action taken;
• Give proper administrative and operational authority to commit institutional resources to ensure compliance;
• Ensure that all personnel involved in animal care, treatment, and use are qualified to perform duties, and that training and instruction in specific areas are provided to those personnel;
• Review qualifications of personnel to ensure they can fulfill their responsibilities; and
• Ensure that the University maintains records for the specific time period as required.

The Office of Research Compliance (ORC) provides administrative support and oversight of the IACUC and of the animal care and use program. ORC also helps guide Principal Investigators through the IACUC processes. ORC is responsible for:

• Coordinating the protocol review process and IACUC meetings;
• Serving as a liaison between the IACUC and Principal Investigators;
• Recording meeting minutes;
• Serving as the official record keeper for IACUC documents;
• Developing IACUC processes and guidance;
• Coordinating Post Approval Monitoring, program reviews, and facility inspections; and
• Assisting in ensuring appropriate animal care training for IACUC members, Principal Investigators, and personnel.

The IACUC is responsible for the assessment and oversight of the university’s animal care program, which includes:

• Reviewing activities involving animal care and use by approving, not approving, or requiring modification of activities to ensure compliance with regulatory obligations and university policies and programs;
• Reviewing any allegations and concerns of noncompliance or concerns, and if applicable, suspending or terminating activity approved based upon non-compliance with regulatory obligations and university policies and programs;
• Conducting program review and facility inspections;
• Reporting approval status in accordance with agency requirements;
• Reporting non-compliance to the VPRED (through ORC) and appropriate agencies as required; and
• Make written recommendations to the IO regarding any aspects of the University’s animal use and care program, facilities, or personnel training.

• IACUC members should make every effort to attend and actively participate in all regularly scheduled meetings, promptly conduct complete reviews of protocol, and participate in facility and program reviews.
• Committee members must also recognize the sensitive nature of the IACUC activities and maintain confidentiality.
• Come to meetings prepared to discuss agenda items and protocols
• Complete training and stay current

Principal Investigators (PI) are responsible for:

• Informing the IACUC of their work with animals;
• Not beginning covered activities until reviewed and approved by the IACUC.
• Ensuring animals under their control have proper care, food, water, and housing. Supervise animal care in all areas under his/her jurisdiction.
• Ensuring personnel conducting activities covered by an IACUC protocol are identified on the protocol;
• Ensuring personnel complete applicable training including laboratory/group specific training;
• Ensuring all personnel have been informed of potential hazards and risk involving handling or capture of specific species;
• Ensuring personnel have been properly trained for safety procedures and reporting requirements for bites, exposures, incidents, etc.; and
• Ensuring personnel are wearing appropriate clothing, shoes, and personal protective equipment.

PI Eligibility

The IACUC follows the eligibility requirements under University Policy 5020 – Principal Investigator Eligibility. An individual requiring a PI exception for a project with no external funding must contact the IACUC Coordinator for instructions and the ORC PI Exception Form. An individual external to the University may be a PI; however, a review fee may apply.

Key Personnel are individuals carrying out research, teaching, or testing activities with animals or an individual overseeing an activity with animals in an academic setting. A PI is considered Key Personnel. Key Personnel are responsible for:

• Conducting activities in a safe manner and following IACUC procedures and protocols;
• Reporting incidents to their supervisor/PI and/or the IACUC;
• Reviewing and understanding the IACUC protocol, its scope and requirements; and
• Completing applicable general and lab/group specific training.

Chair

A knowledgeable and effective leader is crucial to an effective IACUC. The Chair will be responsible for all activities of the IACUC including, but not limited to: (a) schedule meetings; (b) set the agenda for meetings; (c) ensure that a quorum of the IACUC is present and declare the loss of a quorum resulting in the end of official business; (d) ensure all members have a copy of the protocol to be reviewed; (e) moderate the meetings; (f ) keep records of activity; (g) by written letter of acknowledgment, inform the PI of the IACUC’s decisions regarding his/her protocol; (h) sign, approve, and send the required reports to the IO; (i) report to the IO any activities that been suspended by the IACUC for noncompliance; ( j) approve the minutes of meetings, (k) keep abreast of new regulations and trends; (l) evaluates and champions policy and practices to improve the animal care program; and (m) call emergency meetings when necessary.  The Chair may delegate, in writing, one or more of these activities to other members or staff.

Attending Veterinarian

The IACUC must include at least one member who is a Doctor of Veterinary Medicine ideally with training or experience in laboratory animal science and medicine who serves as the Attending Veterinarian (AV).  The AV must have direct or delegated program authority and responsibility for activities involving animals at the university.  They must be able to provide critical review of the protocol for veterinary care issues.

Nonaffiliated member

The IACUC must include at least one member who is not affiliated with the university in any way (aside from the committee) to represent general community interests. An informed nonaffiliated member can bring significant value to the committee by bringing a non-institutional perspective to the research endeavor. This member has equal status to every other committee member, and should be provided the opportunity to participate in all aspects of the IACUC functions. This member shall not be: (a) a member of the immediate family of a person who is affiliated with the University; (b) a laboratory animal user; or (c) a person with financial interest in the facility, such as an animal supplier.

Scientist

The IACUC must include at least one practicing scientist experienced in research involving animals, whose primary concerns are in a scientific area. The principal role of the scientist is to ensure that the interests of scientific colleagues are being fairly represented in the review process, and to aid in the IACUC’s assessment of relevance, validity, and technical aspects of the protocol submitted for approval. This individual can also bring to the IACUC a better understanding of the selection, use, and limitations of animal models, and certain aspects of experimental design. The scientist can also bring perspectives on how to best launch new initiatives to engender the support of the scientific community and others involved in the care and use of animals.

Nonscientist

The IACUC must include at least one member from a nonscientific area (e.g., ethicist, lawyer, member of clergy, health and safety, human resources) and have no obvious connections to any area of science. This role is to further the diversity of the IACUC and add to the balance of foils for the scientist members who may have a vested interest in the promotion of animal studies.

Vice Chair

The IACUC may designate a current member to serve as Vice Chair, who will serve in the absence of the Chair at a convened meeting.

Non-voting members

Participants, whose roles are administrative, operational, or consultative to support the IACUC, are identified by the ORC. These non-voting members include: (1) the animal facility staff, (2) the Coordinator for Research Compliance and other ORC staff serving as advisory, and (3) consultants or individuals with expertise in specific areas, when requested by the IACUC to attend a meeting.

Alternate Members

Alternate members may be designated for any member to serve as an alternate in the regular members place.  An alternate must serve in the role as the regular member (e.g. Scientist).  An alternate cannot count towards quorum or vote if their designated member is present.

Membership shall consist of no fewer than five members with varying backgrounds and meeting the minimum types/roles requirements.  A member may fulfill more than one requirement.

The VPRED appoints each member typically to a four-year term and these terms are staggered as best as possible to ensure committee continuity.  The VPRED may reappoint members to additional terms.  Members serve at the discretion of the VPRED and may be removed or replaced at any time.  The VPRED, in consultation with the IACUC Chair and ORC, annually reviews the IACUC membership to ensure appropriate committee representation and composition and commitment of its members.  The review may include, but is not limited to:  attendance, timely submission of comments, training completion, and participation in scheduled meetings. The VPRED shall appoint one member of the IACUC to serve as Chair.

The University offers protection for its employees and authorized volunteers who are sued for duties and actions performed in the course of their employment and in good faith under the University’s liability and workers’ compensation insurance.

IACUC Members who are not employees of Boise State are considered authorized volunteers and are required to fill out an Authorized Volunteer Services Agreement Form. The signed forms will be kept on file within the Office of Research Compliance. In the event of a claim, the Office of Risk Management and Insurance will request the signed Authorized Volunteer Services Agreement Form from the Office of Research Compliance.

Any testing, research, or instructional use of live vertebrates by Boise State faculty, researchers, affiliates, staff, or students requires the submission of an IACUC protocol. The protocol must be fully approved before an animal user may acquire, house, or manipulate animals.

Any observation-only field study conducted on free-living wild animals in their natural habitat does not require the submission of a protocol to the IACUC. Any field study that will disturb or increase the stress level of the animal; involves an invasive procedure; materially alters the behavior of the animal; or has the potential to cause harm or accidental injury to the animal will require the submission of a protocol.

The IACUC or ORC must be consulted as to whether a project requires IACUC review. This cannot be done by a PI or Key Personnel. A PI should reach out to the IACUC Coordinator to determine the best mechanism to provide a description of the activities.

Pre-Review

The Office of Research Compliance (ORC) receives all protocols submitted for IACUC review through an electronic protocol management system (InfoEd). ORC performs initial review for completeness and assigns a protocol number or a sequential submission number. ORC, and if appropriate the Chair and/or AV, works with the PI to address any issues found in the pre-review. ORC may perform an Administrative review for minor changes (e.g. personnel, funding sources) or ORC assigns review to the Chair to call for Full Committee Review (FCR) or Designated Member Review (DMR).

Full Committee Review (FCR)

The IACUC convenes meetings on a regular basis (typically monthly) to review submissions requiring full committee review (FCR) and other committee business. Additional meetings may be convened if the need arises.

IACUC members are notified at least one week in advance that a new protocol has been submitted for review.

The IACUC may use electronic telecommunications to conduct business at convened meetings as per the Guidance on Use of Telecommunications for IACUC Meetings under the PHS Policy on Humane Care and Use of Laboratory Animals (NOT-OD-06-052).

Quorum Requirement

A quorum is defined as a majority (greater than 50%) of the voting members of the IACUC. Therefore, a protocol is approved only if a quorum is present AND if more than 50% of the quorum votes in favor. PHS policy and AWR require that in order to suspend an activity, the IACUC must review the matter at a convened meeting of a quorum, and the suspension must be approved by a majority vote of the quorum present. For reasons other than conflict of interest, an abstention from voting does not alter the quorum or change the number of votes required.

Motions

After a submission is discussed and reviewed, a Member must call for a motion. A motion should be one of the following:

• Approve;
• Send the submission back to the PI for modification with the modifications to be reviewed and approved by FCR;
• Send the submission back to the PI for modification with the modifications to be reviewed and approved by DMR;
• Send the submission back to the PI for modification with the modifications to be reviewed and approved by Administrative Review;
• Table; or
• Not approve (or terminate or suspend approval).

Voting

Each Member has one vote and no proxy votes are allowed. Members must vote for, vote against, or abstain from voting on a motion. A Member choosing to vote against or abstain from the vote may request their reason be noted in the minutes.  Member alternates may vote if the primary member is not present.

Minutes

Meeting minutes provide a summary of the committee’s business and deliberations.  They are drafted by the IACUC Coordinator and the previous meeting’s minutes are reviewed at the subsequent meeting.

The minutes must include records of attendance. Although members may arrive late or leave during a meeting, a member is generally marked as either present or absent. An exception would be when a member leaves the meeting room during discussion of a protocol on which that member is a participant. If an IACUC member steps outside during a vote of their protocol, this does not reduce the quorum nor change the number of votes required – this member’s vote is an automatic abstention.

Minutes should also document activities such as corrections or approval of previous minutes, presentations of programs, policy, facility and compliance reports; and outcome and decisions on policies, protocols and amendments. Deliberations need to, as a minimum, summarize the key points discussed prior to a committee decision

Designated Member Review (DMR)

DMR consists of review by at least one member of the IACUC designated by the IACUC Chair and qualified to conduct the review. The designated member reviewer(s) have the authority to approve, require modifications in (to secure approval) or request FCR. Prior to designated member review, protocol submissions are sent electronically, or by hard copy if requested, to all committee members for review for a minimum of 3 business days. Any committee member has the authority to request the protocol be reviewed by the FCR during this period.

DMR Subsequent to FCR

DMR may also be used subsequent to FCR when there are outstanding concerns with a submission determined at a committee meeting.  Investigator responses and modifications to secure approval are reviewed by DMR if included in the motion to require modifications (to secure approval). The FCR motion must pass unanimously to use DMR as any member can request the modifications to secure approval be reviewed by the full committee at the next meeting.

Administrative Review

ORC may review updates, renewals (if sponsor/agency required), and modifications for:

• Key personnel
• Funding source
• Contact information
• Locations already under the review/inspection of IACUC
• Confirm minor changes are made as requested under FCR or DMR
• Modifications not considered “significant changes” to a protocol

New Protocol (Initial Application)

A new protocol requires either FCR or DMR review.  Submissions for activities continuing beyond a previous approval are treated as new (de novo) submissions.

Modification

The PI must seek approval for any changes or additions to previously approved activities. This includes changes in personnel, funding sources, locations, species, animal numbers, or activities/procedures.  ORC may administratively review modifications that are not considered “significant changes”.  The IACUC Chair calls for FCR or DMR for significant changes.

Significant Changes

Significant changes to a protocol include changes to:

• Objectives of the protocol or research;
• Degree of invasiveness;
• Species;
• Anesthetic agents or methods of euthanasia;
• PI;
• Facility for housing or care of animals not part of the animal program overseen by the IACUC;
• Impact personnel safety; or
• Number of animals to be used more than 10% increase.

Annual Renewal

Renewals are only required if deemed necessary by a sponsor/agency.  The IACUC Chair calls for FCR or DMR.

Final Report (Close this Protocol)

The PI should submit a final report to close the protocol if the protocol is within its approval period and the activities will not continue.  ORC reviews administratively and reports on the next meeting agenda.

ORC, in coordination with the Chair, notifies the PI regarding the IACUC’s determination of their protocol indicating its approval status, and if applicable, requirements to secure approval.

If the IACUC votes to not approve (withhold), suspend, or terminate a protocol, ORC must immediately notify the VPRED.  If the IACUC decides to withhold approval of an activity, it shall include in its written notification, a statement of the reason(s) for its decision and give the investigator an opportunity to respond in person or in writing.

Each approved protocol typically has a three-year life cycle.   PIs are sent annual check-ins to remind them to update their protocol as needed unless a sponsor/agency specifically requires annual renewals for continuing review. The IACUC may approve protocols with shorter approval periods and may stipulate the protocol cannot be renewed meaning a new protocol application must be submitted for review. Modification approval does not change the protocol’s approval period.

If the activities are not complete by the third year, the PI is required to submit a new protocol application for review and approval.  The new protocol MUST be approved prior to expiration of the previously approved protocol to avoid a gap in approval.

In order to approve new protocols or proposed significant changes for ongoing projects, the IACUC shall conduct a review of those components related to the care and use of animals and determine that the proposed protocol is in accordance with mandated requirements. In making this determination, the IACUC shall confirm that the protocol will be conducted in accordance with the Animal Welfare Act insofar as it applies to the project, and that the protocol is consistent with the Guide, unless acceptable justification for a departure is presented. Further, the IACUC shall determine that the protocol conforms and meets the university’s requirements.

• Protocol is written in a language understandable by the lay public as to the purpose and relevance of the project.
• Justification for (a) using animals and (b) rationale for the number and selection of species;
  • Replacement or utilizing non-animal models or different species is not feasible;
  • Assurance that studies or research is not duplicative;
• Procedures with animals will avoid or minimize discomfort, distress, and pain to the animals, consistent with sound research design.
• 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 PI.
• Animals that would otherwise experience severe or chronic pain or distress that cannot be relieved will be euthanized at the end of the procedure or, if appropriate, during the procedure.
• 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 facilities staff experienced in the proper care, handling, and use of the species being maintained or studied.
• Medical care for animals will be available and provided as necessary by a qualified veterinarian.
• Personnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures.
• Occupational health and safety issues are addressed for safe working environment
• Methods of euthanasia will be consistent with the recommendations of the AVMA Guidelines on Euthanasia unless a deviation is justified for scientific reasons in writing by the PI.
• Records of individual surgical procedures will be kept; documenting procedures used and animal’s responses from pre to post-operative period. Medical progress records during wound healing, suture removal, and the final disposition of animals are also necessary. A surgical log will be kept and made available for audit.

The IACUC Chair may appoint subcommittees, as deemed appropriate, to facilitate the business of the IACUC. All members of subcommittees shall consist of members in good standing. Subcommittees shall report directly to the IACUC with recommendations or reports. No actions may be taken by the subcommittee without prior approval of a majority of the quorum at a convened IACUC meeting.

ORC and the IACUC Coordinator provide administrative and operational support for the IACUC including:

·        Determining research protocols and non-regulatory review in consultation with the Chair;

·        Taking minutes of the IBC meetings and maintain appropriate records;

·        Advising faculty, staff and students in preparation of protocol applications;

·        Providing education and program guidance to the University community regarding the IACUC;

·        Implementing and maintaining the IACUC Program Guide in consultation of the VPRED and IACUC;

·        Ensuring each Member receives agenda and protocol applications with sufficient time for review prior to meetings;

·        Tracking pending, approved and not approved IACUC protocols and animal care program standard operating procedures;

·        Maintaining the IACUC membership roster and updates roster information;

·        Maintaining the registrations of the IACUC with regulatory and accreditation organizations;

·        Serving as a liaison between the IACUC and PIs to facilitate communication and efficient reviews; and

·        Coordinating Post Approval Monitoring (PAM), program reviews, and facility inspections.

ORC maintains submission documents and all related supplemental materials for a minimum of three years after the protocol is closed. Meeting agenda, minutes, and IACUC Member rosters will remain on file in ORC as a permanent record of the committee’s activities. A curriculum vitae or resume of active Members of the IACUC will be maintained in the ORC and will be updated in content as necessary. Policy guidance and forms will be disseminated from and stored in ORC until replaced by new and/or revised documents.

The PI is responsible for maintaining project data according to university requirements and/or the terms and conditions of any sponsor and key personnel training records.  The PI must keep records of individual surgical procedures documenting procedures used and animal’s responses from pre to post-operative period. Medical progress records during wound healing, suture removal, and the final disposition of animals are also necessary. A surgical log must be kept and made available.  The PI must store these records in a secure location.

A conflict of interest arises when financial, professional, or other personal considerations compromise, or have the appearance of compromising, an individual’s judgment in the review, design, conduct, or reporting of research. Activities involving biohazardous materials are subject to the University Policy 1110 – Interest and Commitment Policy.

If a PI has disclosed a potential conflict of interest related to activities, the IACUC Coordinator will refer the case to the University Conflict of Interest Officer. The Conflict of Interest Officer will refer the case to the University Conflict of Interest Committee as appropriate. The Conflict of Interest Committee will review the disclosure, and consider the potential conflict of interest. The IACUC Coordinator will collect the information necessary to fully inform the IACUC of any proposed management plans. The IACUC will carefully consider specific mechanisms to minimize the potential adverse consequences of the conflict.

A Member must not provide review or vote on an application if they are an investigator on the application or have any other conflict of interest with any person or entity connected to an application. The Member must make any conflict of interest known to the IACUC through the IACUC Chair and/or IACUC Coordinator. The Member is not required to identify the exact nature of the conflict of interest. The fact that an application is submitted by another PI from the Member’s department or area does not, in and of itself, constitute a conflict of interest.

The Member with conflict may participate in the discussion to answer the IACUC’s questions regarding the application under review to the same extent as any PI may provide to the IACUC. The Member will be recused for the IACUC’s deliberation and vote. Failure to abide by these provisions may be cause for removal of a Member from the IACUC.

The IACUC provides continuing review of approved protocols through Post Approval Monitoring (PAM).  PAM is important to ensure protocols are being followed, animals are receiving appropriate care, and to identify potential areas of improvement.  PAM takes the shape of formal inspections and documented assessments as well informal observations by animal care staff and the AV over the course of a regular day.  Conduct continuing review of previously approved ongoing protocols.

The IACUC must fulfill its regulatory responsibilities to inspect animal housing areas (facility) at least once every six months to evaluate compliance. The facility inspection is performed with at least two members, and no member may be excluded should he/she wish to participate.

The IACUC must also review its animal care and use program every six months. The program reviews are scheduled to occur at a convened monthly meeting. The program review is conducted with a quorum of members.  A copy of the prior program report is provided to each member prior to the current review and inspection.

The semiannual IACUC report summarizes the program review and facility inspection for the VPRED.  The report must:

·        Indicate whether or not any minority views filed and must be included in report;

·        Be signed by a majority of the IACUC involved in the inspection;

·        Identify deficiencies as either minor or significant (a significant deficiency is one that is or may be a threat to the health and safety of the animals); and

·        Include a reasonable and specific plan with a schedule of dates for correcting each deficiency.

The PI must provide a copy of the Unanticipated Events/Incident Report to the IACUC, who shall promptly report to IO a full explanation of the circumstances and actions taken with respect to:

• Any serious or continuing non-compliance;
• Any serious deviation from the provisions of the GUIDE or AWA; or
• Any suspension of an activity by the IACUC.

If a serious violation of harm or a threat to the health and wellbeing of the animal is involved, immediate action will be taken by the Chair or the Attending Veterinarian. The Chair or the Attending Veterinarian has the authority to stop or terminate the activity directly involved. When this happens, they will notify the IO and the ORC Director as soon as possible to determine if an investigation is necessary. A special session may be called for the IACUC to convene and take over the jurisdiction of the research. The IO, in consultation with the IACUC and ORC Director, shall review the reason for the suspension, take corrective actions and provide a written report of the action to OLAW, appropriate sponsored agency, Dean, Chair and PI.

Boise State is committed to providing a safe and productive working environment for all employees and volunteers under the animal care program through the university’s Occupational Health and Safety Program.  The basic elements of a program includes hazard identification and risk assessment, personnel training and protection, written procedures and policies regarding hazard use and monitoring, and medical evaluation and preventive medicine.

The OHSP applies to all individuals working within Boise State animal facilities who are involved in the direct care of vertebrate animals and their living quarters, and those individuals who have direct contact with animals, their viable tissues, body fluids or wastes.

The extent and level of participation of personnel in the program is based on the hazards posed by the animals and materials used, the exposure intensity, duration, and frequency, the susceptibility of the personnel, and the history of occupational illness and injury in the particular workplace. At a minimum, participants must complete training (e.g. CITI Program) prior to personnel working with animals in research and complete an OHSP Animal Contact Assessment form.  Individuals with significant animal contact must also complete a health history evaluation through the University’s occupational health service provider.  This evaluation assesses the individual’s animal contact and associated hazards with their health history to determine any restrictions or controls that must be in place (e.g. tetanus vaccination, personal protective equipment).  The university’s provider also determines frequency of review.

The Attending Veterinarian (AV) has final authority and responsibility to insure that the IACUC program of veterinary care is adequate.

The Boise State University IACUC provides the AV the authority to oversee the adequacy of all aspects of animal care and use of animals used in research, training and teaching, the authority to oversee the adequacy of all aspects of animal care and use of animals, and the authority to ensure that adequate veterinary care including pre and post procedural or surgical care, in accordance with current established practices, is provided at all times. The AV has the responsibility of providing guidance to PIs, as well as, guidance and support to the IACUC.

The AV retains the authority to immediately access the medical records of animals used for research, training and teaching, and access to care given to animals.

Adequate veterinary care consists of appropriate method to: identify possible disease or disease control methods for animals being housed in facility; manage protocol-associated potential disease; provide consultation for anesthesia and analgesia; observe and/or consult with surgery, including pre and post surgical care; assess animal well-being by observation and/or communication with animal facility staff if warranted, for signs of illness, injury or abnormal behavior; and oversee aspects of sanitation practices, zoonosis control, and hazard containments.

The AV is actively involved in the review of all protocols and projects, and in the inspection of facilities and review of institutional programs involving animals in research, testing and teaching. The veterinary care program is a continuing institutional responsibility to foster and support enhancement of the program through the identification and adoption of techniques, procedures, and policies that improve laboratory animal health and well-being.

The isolation, quarantine and stabilization programs for newly arrived animals are necessary to provide time to assess their health status, allow them to recover from the stress of shipment, and an opportunity to adapt to their new environment. The extent of these programs depends on several factors, including species and source of the animals, as well as their intended use. For some animals, such as rodents obtained from reliable sources for which health status is known, visual inspection on arrival may suffice. For species such as nonhuman primates, farm animals, wild animals, random source dogs and cats, and non-specific pathogen free rabbits and rodents, appropriate quarantine and isolation procedures must be employed.

Preventive medicine programs such as vaccinations, ecto- and endoparasite treatments and other disease control measures should be initiated according to currently acceptable veterinary medical practices appropriate to the particular species and source. Only animals of defined health status should be used in research and testing, unless a specific, naturally occurring or induced disease state is being studied. Systems should be established to protect animals within the institution from exposure to diseases. Transgenic and mutant animals may be particularly susceptible to diseases and may require special protection to ensure their health. Systems to prevent the spread of disease may include facility design features, containment/isolation equipment, and use of standard operating procedures. Training of animal care and research staff is essential to prevent the spread of animal diseases.

Daily observation of all animals by a person or persons qualified to verify their well-being is required. It is not necessary for a veterinarian to personally make this assessment each day. However, at a minimum, a trained paraprofessional or technician must observe each animal every day, and there must be a timely and accurate method for conveying information regarding animal health, behavior, and well-being to the AV.

Disease surveillance is a major responsibility of the veterinarian and should include routine monitoring of colony animals for the presence of parasitic, bacterial, and viral agents that may cause overt or inapparent disease. Additionally, cells, tissues, fluids, and transplantable tumors that are to be used in animals should be monitored for infectious or parasitic agents that may cause disease in animals. The type and intensity of monitoring necessary will depend upon professional veterinary judgment and the species, source, use, and number of animals housed and used in the facility.

Diagnostic laboratory services must be available and used as appropriate. Laboratory services should include necropsy, histopathology, microbiology, clinical pathology, serology, and parasitology, as well as other routine or specialized laboratory procedures as needed. It is not necessary that all of these services be available within the animal facility if other laboratories with appropriate capabilities are available and used.

Animals with infectious disease must be isolated from others by placing them in isolation units or separate rooms appropriate for the containment of the agents of concern. In certain circumstances, when an entire group of animals is known, or thought to be exposed or infected, it may be appropriate to keep the group intact during the time necessary for diagnosis and treatment, for taking other control measures, or for completion of a project.

The AV must has the authority to use appropriate treatment or control measures, including euthanasia if indicated, following diagnosis of an animal disease or injury. If possible, the AV should discuss the situation with the PI to determine a course of action consistent with experimental goals. However, if the PI is not available, or if agreement cannot be reached, the AV has the authority to act in order to protect the health and well-being of the institutional animal colony. The AV’s authority should be exercised with the concurrence of the IACUC and the IO.

Adequate veterinary care includes providing guidance to animal users and monitoring animal use to assure that appropriate methods of handling and restraint are being used and to ensure proper use of anesthetics, analgesics, tranquilizers, and methods of euthanasia. Written guidelines regarding the selection and use of anesthetics, analgesics and tranquilizing drugs and euthanasia practices for all species used must be provided and periodically reviewed by the AV. Guidelines may be developed in-house or provided by specific references to the current veterinary literature. In addition, the AV or trained professionals should provide formal or informal instruction in the proper use of such agents and euthanasia procedures.

The AV has the responsibility and authority to assure that handling, restraint, anesthesia, analgesia, and euthanasia are administered as required to relieve pain and such suffering in research animals, provided such intervention is not specifically precluded in protocols reviewed and approved by the IACUC. The AV must exercise good professional judgment to select the most appropriate pharmacologic agent(s) and methods to relieve animal pain or distress in order to assure humane treatment of animals, while avoiding undue interference with goals of the experiment.

A program of adequate veterinary care includes the review and approval of all preoperative, surgical, and postoperative procedures by a qualified veterinarian. The institution bears responsibility and must assure, through authority explicitly delegated to the veterinarian or to the IACUC, that only facilities with programs appropriate for the intended surgical procedures are utilized, and that personnel are adequately trained and competent to perform the procedures. The veterinarian’s inherent responsibility includes monitoring and providing recommendations concerning preoperative procedures, surgical techniques, the qualifications of institutional staff to perform surgery, and the provision of postoperative care.

Adequate veterinary care includes responsibility for the promotion and monitoring of an animal’s well-being before, during, and after experimentation or testing. Animal well-being includes both physical and psychological aspects of an animal’s condition evaluated in terms of environmental comfort, freedom from pain, and distress and appropriate social interactions, both with conspecifics and with man. The veterinarian must have the authority and responsibility for making determinations concerning animal well-being and assuring that animal well- being is adequately monitored and promoted. The veterinarian must exercise this responsibility in review of animal care and use protocols, and must have the authority to remove an animal from an experiment which is adversely affecting its well-being beyond a level reviewed and approved by the IACUC. The following examples represent how this responsibility can be met:

• Ensuring the adequacy of the physical plant, caging, and ancillary equipment.
• Developing, implementing, and monitoring sound animal care (husbandry) programs including such areas as sanitation, nutrition, genetics and breeding and vermin control.
• Establishing an acclimatization program to adapt animals to either short-term or long-term restraint procedures.
• Improving and enriching an animal’s environment to minimize the development of physical or behavioral abnormalities.
• Providing appropriate opportunities for human-animal socialization and acclimatization to the research environment or procedures.
• Performing periodic physical and clinical evaluations appropriate for the species and the experimental situation.
• Providing pre-procedural and post-procedural care in accordance with current established veterinary procedures.