Policy on the Humane Care & Use of Animals in Research & Instruction

1.00 Purpose

The purpose of this policy is to ensure that all authorized use of non-human animals for research and/or instruction at CSU Monterey Bay or through the University Corporation adheres to strict ethical guidelines and is consistent with applicable laws designed to protect the welfare of those animals and the health of people working with those animals.

This policy reflects the University's commitment to the principles, goals, and ideals described in the CSUMB Vision Statement and its core values.

2.00 Overarching Policy Statement

California State University Monterey Bay (CSUMB) and the University Corporation at Monterey Bay (Corporation) recognize that the proper care and management of animals used in research, instruction, or display is essential to the wellbeing of the animals, to the validity of research data, to the quality of instruction, and to the health and safety of those caring for and using animals.

Therefore, it is the policy of CSUMB and the Corporation that all care and use of animals for research, instruction, or display shall conform to applicable laws, rules, and regulations of the United States Government and the State of California designed to protect the welfare of those animals and the people who work with them. Furthermore, all such care and use must be performed in compliance with strict ethical and professional standards for the humane treatment of animals in each of the fields or disciplines involved in the specific research projects or instructional activities.

To ensure these standards, the University President will, as mandated by the Health Research Extension Act of 1985 (Public Law 99-158) and the Animal Welfare Act (Public Law 89-544 as amended), appoint an Institutional Animal Care and Use Committee (IACUC), constituted in accordance with law and qualified through the training and expertise of its members, to oversee the institution's animal care and use program, university animal-care facilities, and all animal-related activities.

3.00 Scope

Operationally, this policy pertains primarily to the care and use of non-human vertebrate species used for research, instruction, or display conducted at or under the auspices of CSUMB or the Corporation. In addition, the purview of this policy may extend but is not limited to the university-related use of certain invertebrate animals including cephalopods, venomous species that are of concern to human health and special status species, as determined by the Institutional Animal Care and Use Committee (IACUC). For a current list of covered species please visit the IACUC website or contact the IACUC Coordinator.

The CSUMB Institutional Official (see section 6.20) reserves the right to modify the policy identified herein to comply with federal and state law.

Principal Investigators may voluntarily submit a protocol for IACUC review and approval even if not required to do so by this policy.

Although humans are biologically classified as vertebrate animals, this policy explicitly excludes human research subjects, which are covered under the CSUMB Policy on Human Subjects in Research. It also excludes pets, pests, and other animals, unless they are being used in connection with academic teaching, research, or display.

4.00 References

The references used in developing this policy include the most recent versions of:

Animal Welfare Act (Public Law 89-544 as amended)
The Guide for the Care and Use of Laboratory Animals (National Academy Press)
Public Health Service Act (Public Law 99-158, 1985)
ICSUAM Policy Section 1100

Also included as references are applicable provisions and regulations of the:

Endangered Species Act (Public Law 93-205, 1972)
Marine Mammal Protection Act (Public Law 92-522, 1972)
State of California Departments of Health Services, Fish & Wildlife, and Agriculture
Other applicable state, federal, or international regulations for special status species.

5.00 Definitions

Animal means any live or dead non-human member of the kingdom Animalia that is acquired, used, or held for intended use in a sanctioned University or University Corporation activity.

Activity means any University or Corporation-supported or authorized project, whether publicly funded, privately funded, or unfunded, involving the use of animals or animal tissues for purposes of research, field studies, experimentation, teaching, demonstration, training, display, or related academic purpose.

Disturbing means activities which materially alter an animal’s behavior including but not limited to deployment of recording equipment in relatively close proximity, baiting, and track plates. Disturbing is not limited to negative impacts on covered species.

Endangered Species means those species defined in the Endangered Species Act (16 U.S.C. 1531 et seq.) and as it may be subsequently amended.

Field Study means a study conducted on free-living wild animals in their natural habitat. However, this term excludes any study that involves an invasive procedure, harms, or materially alters the behavior of an animal under study.

Facility refers to any and all buildings, laboratories, rooms, enclosures, property, vessels, or vehicles under the administrative control of CSUMB or designated off-campus locations used to support animal housing or an activity.

Handling means petting, feeding, watering, cleaning, manipulating, loading, crating, shifting, transferring, immobilizing, restraining, treating, training, working and moving, or any similar activity with respect to any animal.

Personnel refers to any CSUMB faculty member, research affiliate, employee, volunteer, contractor, or student who is involved with the handling of an animal for purposes of a sanctioned University or Corporation activity.

Principal Investigator within the context of this policy, is the person responsible for protocol submission, for adherence to the protocol once approved, for compliance with this policy and all applicable laws and regulations, and for oversight of all personnel involved in the execution of the protocol.

Protocol refers to a written description of the proposed activities involving animals submitted to the IACUC for review.

Quorum means a simple majority (i.e. more than half) of the IACUC members.

Special Status Species refers to those species that are listed by state, federal, or international governments as endangered or threatened, and species that have been assigned other special status by federal, state, or local government.

Tissue means any part of an animal, including (but not limited to) blood, hair, bone, shell, feathers, scales, excrement, or secretions, that are acquired, including those opportunistically attained in the field or acquired from a scientific or other archive.

6.00 Animal Care and Use Policy Oversight

Humane care, use, and treatment of animals for all activities is a university-wide responsibility. It is the policy of CSUMB to comply with all federal, state, and other regulatory requirements that pertain to the acquisition, care, handling, and treatment of animals used for purposes of authorized academic activities, including instruction, research, and display.

6.10 University President

As CEO, the University President must provide assurance that all animals associated with sanctioned academic activities are receiving humane care and are used and treated in accordance with professionally acceptable standards.

6.20 Institutional Officer

Formally appointed by the University President, the Institutional Official (IO) is the designated senior official with authority to administer the institution’s program of animal care and use, and to implement changes necessary to ensure compliance with all applicable regulations governing the care and use of animals. The IO will rely on the IACUC to oversee the institution’s animal program, activities, and facilities; to identify and report program deficiencies; to develop plans to correct any such deficiencies; to address concerns that may arise with regard to the institution’s care or use of animals; and to make recommendations for improvements in the institution’s program of animal care and use.

6.30 Institutional Animal Care & Use Committee (IACUC)

The IACUC is a federally mandated administrative committee composed of representative persons, including a licensed veterinarian, who are qualified by experience and expertise to oversee the University’s animal care and use program. No activity covered by this policy may proceed without prior review and current written approval of the IACUC. While an administrator may terminate an activity approved by the IACUC, federal law mandates that no one, including the IO or University President can authorize an animal activity without IACUC approval. The composition, appointment, authority, and responsibilities of the IACUC are described in this policy.

7.00 Principles for the Use of Animals

Principal Investigators shall ensure that the following principles [1] are adhered to:

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;
Activities 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 an activity 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;
Activities 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 un-anesthetized 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 activity or, if appropriate, during the activity;
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;
All personnel shall be appropriately qualified and experienced for conducting activities with 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 the principle that 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, by an appropriate review group such as an IACUC. Such exceptions should not be made solely for the purposes of teaching or demonstration.
It is the responsibility of the Principal Investigator to ensure that all permits and permissions are acquired if necessary to engage in animal-related research, instruction, display, or other covered activities.

Faculty must demonstrate appropriate and documented training for all individuals handling animals.

8.00 Activities

The privilege of using animals for research, teaching, and display is accompanied by both ethical and legal responsibilities to use them appropriately, both scientifically and humanely. Activities involving the use of covered species must be led and/or supervised by an established faculty member or the Campus Veterinarian. Individual faculty members who use animals in their research or teaching (including those whose research consists of field activities involving animals) are, by law, accountable for conforming to the basic regulations and policies governing animal use on this campus.

8.10 Contact with Live Vertebrate Animals

IACUC review and approval is required for all activities that materially alter the behavior of animals under study. These include noninvasive capture and release, measuring variables (e.g. weight and length), sampling blood, and reviewing other general health indicators. Implementation of animal identification methods (e.g. tattoos, ear tags, radio-collars and surgically implanted transmitters), trapping, transporting, or housing requires IACUC review, approval, and oversight.

8.20 Activities Involving Fertile Eggs

IACUC review and approval is required for all handling of vertebrate fertile and unfertilized eggs, except unfertilized eggs from domesticated animals for food production.

8.30 Samples of Live or Deceased Vertebrate Animal Tissue

IACUC review and approval is required for ordering or bringing onto campus covered species, tissues, blood, organs, or samples of any size and use of any of the above in the field or at collaborating institutions including voucher and museum collections. Additional review requirements may be imposed by outside institutions for the handling or transfer of animals or their parts.

8.40 Observational Activities Involving No Contact with or Disturbance of Covered Species

IACUC requires the review and approval of observational activities that involve contact or disturbing a covered species. As defined in this policy, disturbing is any activity that materially alters the behavior of the animal. Review and approval of observational activities that do not involve contact or disturbing covered animals is not required. In addition, it is the responsibility of the Principal Investigator or instructor to ensure that all permits and permissions are acquired if necessary to gain access to the study location.

8.50 Activities Involving Covered Invertebrate Species

IACUC review and approval is required for all activities involving covered invertebrate species. A complete list of covered invertebrates is available at the CSUMB-IACUC website. Other invertebrate studies do not require IACUC review and approval.

8.60 Live Animal Used for Display

IACUC review and approval is required for all activities involving the display of any covered animal or animal tissue.

9.00 IACUC Composition & Governance

9.10 IACUC Composition

The IACUC committee shall consist of not less than five members, and shall include at least:

One Doctor of Veterinary Medicine (Campus Veterinarian), with training or experience in laboratory animal science and medicine, who has direct or delegated program authority and responsibility for activities involving animals at the institution;
One practicing scientist (Scientist) experienced in research involving animals;
One member whose primary concerns are in a nonscientific area (Non-scientist) (for example, ethicist or lawyer); and
One individual who is not affiliated with CSUMB in any way other than as a member of the IACUC (Community Representative), and is not a member of the immediate family of a person who is affiliated with the institution.

Any individual who meets the requirements of more than one of the categories detailed above may fulfill more than one requirement. However, no committee may consist of less than five members and no more than three members shall be from the same administrative unit.

9.20 Appointments

The IO, after consultation with the IACUC Chair shall submit to the President a slate of recommended individuals to replace outgoing IACUC members. The President shall appoint the new members for terms not to exceed three years.

9.30 IACUC Coordinator

The IO shall provide an IACUC Coordinator to the IACUC.

9.40 Governance

An IACUC Chair and an IACUC Vice-Chair shall each be elected for a three-year term at the first IACUC meeting following a vacancy or expiration of term.

9.50 Quorum

No official business, i.e. approval of protocols, can be done unless there is a quorum.

9.60 Regular Meetings

The IACUC shall meet to review protocols and to tend to other business. Regular monthly meetings will be scheduled at the start of each term. Regular monthly meetings may be cancelled if there is no business to transact.

9.70 Semi-Annual Business

In addition to its regular meetings, the IACUC shall meet at least once every six months to review the institution’s animal care and use program and to inspect the animal facilities. These meetings and inspections may be conducted immediately preceding or immediately following a regularly scheduled IACUC meeting.

9.80 Record Keeping

IACUC shall maintain the following records:

A copy of the Assurance which has been approved by the Public Health Service (PHS) (if applicable);
Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations;
Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was given or withheld;
Records of semiannual IACUC reports and recommendations (including minority views) as forwarded to the IO; and
Records of accrediting body determinations.

All records shall be maintained for at least three years; records that relate directly to applications, proposals, and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be accessible for inspection and copying by authorized government officials at reasonable times and in a reasonable manner.

9.90 Reporting Requirements

At least once every 12 months, the IACUC, through the IO, shall report in writing to authorized government officials as required by law:

any change in the University's program or facilities which would place the University in a different category than specified in its Assurance;
any change in the description of the University's program for animal care and use as required by law;
any changes in the IACUC membership; and
notice of the dates that the IACUC conducted its semiannual evaluations of the University's program and facilities and submitted the evaluations to the IO.

The IACUC, through the Institutional Official, shall promptly provide authorized government officials with a full explanation of the circumstances and actions taken with respect to:

any serious or continuing noncompliance with this Policy;
any serious deviation from the provisions of the Guide;
any suspension of an activity by the IACUC

Reports filed under federal law shall include any minority views filed by members of the IACUC

10.00 Policy Implementation & Individual Responsibilities

In order to insure proper implementation of this policy, areas of responsibility are hereby designated for those persons engaged in activities involving animals as subjects and for those persons involved in the administration of this policy.

10.10 University President

The University President is charged with the overall administrative responsibility for implementing and maintaining a university animal care and use program to assure that all humane, ethical, and legal requirements are met.

10.20 Institutional Officer

The University President will appoint a designated administrator to serve as the Institutional Official (IO), currently the Provost, who will maintain the authority to administer the institution’s program of animal care and use, and to implement changes necessary to ensure compliance with all applicable regulations governing the care and use of animals. The Institutional Official will rely on the IACUC to oversee the University's animal program, activities, and facilities; to identify and report program deficiencies; to develop plans to correct any such deficiencies; to address concerns that may arise with regard to the University's care or use of animals; and to make recommendations for improvements in the University's program of animal care and use.

10.30 College Deans

Deans (or appropriate cognizant administrators) shall review and approve applications for use of covered species in research and instruction prior to their submission for consideration by the IACUC.

Deans (or appropriate cognizant administrators), through appropriate procedures established within their respective departments/units, shall review research protocols for ethical considerations and for scientific and/or educational merit.

In conjunction with the PI, Deans (or appropriate cognizant administrators) shall report promptly to the IACUC any serious or continuing non-compliance with the requirements of this policy or the determinations of the IACUC.

To facilitate the review of research and instructional protocols involving the use of covered species, Deans (or appropriate cognizant administrators) are expected to attend IACUC meetings when requested by the IACUC.

10.40 Department Chairs

Department Chairs (or appropriate cognizant administrators) shall review and approve applications for use of covered species in research and instruction prior to their submission for consideration by the IACUC.

Department Chairs (or appropriate cognizant administrators), through appropriate procedures established within their respective departments/units, shall review research protocols for ethical considerations and for scientific and/or educational merit.

In conjunction with the PI, Department Chairs (or appropriate cognizant administrators) shall report promptly to the IACUC any serious or continuing non-compliance with the requirements of this policy or the determinations of the IACUC.

To facilitate the review of research and instructional protocols involving the use of covered species, Department Chairs (or appropriate cognizant administrators) are expected to attend IACUC meetings when requested by the IACUC.

10.50 IACUC

IACUC shall review at least once every six months the University's program for humane care and use of animals; receive appropriate training to be IACUC members; oversee at least once every six months all of the University's animal facilities and submit reports evaluating these facilities to the IO; make recommendations to the IO regarding any aspect of the University's animal program, facilities, or personnel training; review and approve, require modifications in (to secure approval) or withhold approval of proposed sections of applications or protocols related to care and use of animals, as specified by the Animal Welfare Act and Guide for the Care and Use of Laboratory Animals; and review concerns of the care of animals under the care of the University. Finally, IACUC will work to ensure a safe working environment in each animal use proposal and as part of the semiannual program evaluation.

10.5.1 IACUC Chair

The IACUC Chair has the responsibility for overseeing the coordination and implementation of effective, efficient systems for protocol review and program review by the IACUC in compliance with the Public Health Services (PHS) policy and the Animal Welfare Act. Specifically the Chair will work to ensure that the IACUC has a quorum present at all meetings, declare the loss of a quorum resulting in the end of official business if a sufficient number of members depart or are otherwise absent, prepare and/or oversee the preparation of meeting minutes, agendas, and reports and submit appropriate documents to the IO in accordance with PHS policy and the Animal Welfare Act; report to the IO any activities which have been suspended by the IACUC for non-compliance as required by PHS policy; ensure the establishment of a written system of communication for the IACUC with the investigators concerning the approval status of protocols and the steps necessary to secure approval; stay abreast of the most recent regulatory trends and interpretations; oversee in facility inspections; and ensure regular communication with the IO, Attending Veterinarian, and IACUC Coordinator.

10.5.2 IACUC Vice-Chair

The IACUC Vice-Chair will perform the chair’s roll if the chair is unavailable.

10.5.3 Campus Veterinarian

The Campus Veterinarian will be appointed by the University President and will have delegated responsibility for the health of all animals involved in teaching and research. The Campus Veterinarian will have unlimited access to all animal facilities with due respect for the demands of research in progress and will approve all training programs for animal users. The Campus Veterinarian has the authority to suspend any activity involving animals when the health of the animals or investigators is deemed to be inappropriately at risk, including those activities with a protocol approved by the IACUC.

10.5.4 IACUC Coordinator

The IACUC coordinator (IC) shall serve as the first and primary contact point for inquiries and submissions to the IACUC. The IC shall forward applications to IACUC members for review; assign designated reviewers for protocols, advise PIs, educate and support IACUC members, PIs and others regarding the IACUC process. The IC is charged with maintaining the record-keeping of the IACUC. Responsibilities shall include maintaining: (1) minutes of IACUC meetings, including records of attendance; (2) records of applications, protocols, inspections, and proposed significant changes in the care and use of animals in protocols, including whether IACUC approval was given or withheld; (3) records of any IACUC reports and recommendations forwarded to the IO.

10.5.5 Compliance Officer

The Compliance Officer will facilitate the protocol completions, ensure procedures are being followed, coordinate inspections; ensure inspections and training records are forwarded to the IACUC coordinator. The positions of compliance officer and coordinator may be held simultaneously by the same individual.

10.60 Principal Investigators

Principal Investigators (PI) must follow the procedures and guidelines set forth by the IACUC and accept the responsibility that all animal use will be in accordance with the policies and regulations set forth in this document.

10.70 Other Individuals with Animal Care Responsibilities

Protocols can only be submitted by the PIs, as approved by a College Dean or other appropriate administrator. Undergraduate and graduate students may not submit applications independent of PIs or instructors and must be trained appropriately.

11.00 Procedures

All animal activities must be approved by the IACUC before the study or activity begins. Protocol application submissions must be reviewed, approved, and submitted by a PI, course instructor, or by the Campus Veterinarian. The appropriate submission form must be submitted and cannot be modified or otherwise altered. To ensure adequate time for review it is recommended that all animal care and use protocols be submitted 60 days prior to the initiation date of the proposed activity or 30 days prior to submissions for external funding. In an effort to expedite the protocol review process, pre-review of the protocol application by the IACUC Coordinator or Campus Veterinarian before formally submitting materials for IACUC consideration is recommended.

All activities and classroom exercises involving animals, regardless of prior approval, must be reviewed by the IACUC annually. Reviews at shorter intervals may be required by the IACUC for externally funded projects or for classroom projects where the curriculum has undergone significant modification.

11.10 Protocol Submission

The PI must provide a detailed description of the animal use activity and must include the following information in the animal care and use application:

identify all species and approximate numbers to be used;
complete description of the proposed use of animals;
a description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically or instructionally valuable work using the categories of pain and distress available at the IACUC website or from the coordinator;
a description of any euthanasia method to be used;
all facilities and research localities;
all scientific and husbandry procedures to be conducted on live covered animals with due consideration of the provisions set forth by this policy;
all relevant Federal and State collection or handling permits with attachments as required; and
other information as deemed necessary by the IACUC during the initial review of the protocol application. For example, to maintain IACUC approval of field activities, the PI is responsible for ensuring that all permits are kept current and that copies thereof are provided to the IACUC Coordinator to be included in the protocol file.

Animal Care and Use Protocol Review forms are available on the CSUMB-IACUC website.

11.20 Categories of Pain and Distress

The categories of pain and distress are based on the Animal Welfare Act and the Office of Laboratory Animal Welfare (OLAW). For detailed descriptions of the categories and procedural considerations involved with each, refer the CSUMB-IACUC website.

11.30 Protocol Review Process and Timeline

Proposed protocols will be assigned a protocol number and categorized into the correct review process by the IACUC Coordinator (IC).

Each IACUC member will receive and review appropriate animal protocols. Upon reviewing each protocol, the IACUC members will provide in writing to the IC by the date specified comments, concerns, and suggestions about the protocol, including, if deemed necessary, a request for full IACUC review.

If a full IACUC review is requested or required, the IACUC will meet in a timely fashion to approve, approve with modification, or disapprove the protocol. Approval, specification of modifications for approval, or disapproval by full IACUC review will require a majority (i.e. more than half) of the IACUC quorum.

The IACUC may solicit ad hoc reviewers with specific expertise to assist in protocol reviews on a case-by-case basis. Ad hoc reviewers may participate, but not vote, in the designated reviews.

If no member of the IACUC requests a full IACUC review, the IC will notify the IACUC Chair, who will designate at least two qualified IACUC members to review the protocol, address any comments, concerns, and/or suggestions from the IACUC members, and approve, require modifications needed for approval, request a full IACUC review, or disapprove the protocol. Absent a request for full IACUC review, when the designated reviewers are satisfied the protocol meets review standards, the reviewer(s) will approve the protocol. No member of the IACUC may participate in the review or approval of a protocol in which the member has a conflicting interest except to provide information requested by the IACUC; nor may a member who has conflicting interest contribute to the constitution of a quorum.

11.40 IACUC Approval

A complete listing of protocols approved by the designated reviewer(s) will be made an agenda item at the next regular meeting of the IACUC. Only a convened quorum of the IACUC membership may consider the suspension of a previously approved protocol, and the required vote is a majority of the quorum.

If a protocol is not approved, the PI may appeal to the IACUC by appearing at the next scheduled IACUC meeting. The Committee will reconsider the protocol and re-vote, according to the rules above. The result of the post-appeal vote will be final. Additionally, the IO shall have the authority to deny approval for an animal-related activity to be conducted regardless if IACUC approval is previously obtained.

Once approved, no changes in the approved animal use protocol may be made without prior written approval by the IACUC, except particular incidents where the immediate well-being of the animal is at stake. If emergent problems or proposed procedural changes that may affect the conditions of the project or the health and well-being of the animal, IACUC must be notified immediately.

11.50 Facilities Inspections

At minimum the IACUC shall assemble a subcommittee of at least 2 persons within its membership to conduct a semi-annual inspection (at least once every six months) of all University facilities using the Animal Welfare Act and Guide for the Care and Use of Laboratory Animals as a basis for its evaluation and prepare a written report for full committee review.

11.60 Training

All individuals involved in animal activities and members of the IACUC must be appropriately trained in the relevant regulations and use of animals in activities covered in this policy. Re-training at a minimum of every three years. Resources are available for training on the IACUC website and by contacting the IC.

11.70 Reporting of Concerns

Complaints or concerns regarding animal use and care at CSUMB may be filed anonymously by contacting the IACUC Chair, the campus veterinarian, the IO, or the compliance officer in person or in writing. The identity of the complainant will be held in confidence up to the fullest extent permitted under the law.

Complaints shall be investigated by at least two members of the IACUC. Review of complaints shall be made a matter of record and shall be reported to the IACUC in writing.

If the investigation reveals information that requires full IACUC review, the complainant and the investigator may be asked to meet with the IACUC. The IACUC may consider a wide variety of actions following such a meeting, including termination of an approved protocol.

12.00 Approval and Suspension

12.10 Unapproved Submissions

The IACUC reserves the right to de-activate submissions that have not achieved approval within 3 monthst ime.

12.20 Protocol Approval Limits

An individual animal care and use protocol shall not be granted IACUC approval for a period that extends beyond three years before full re-submission is required.

12.30 Protocol Suspensions

If an approved protocol is suspended due to a serious violation of University policy and principles for use of animals the Institutional Official will notify appropriate federal authorities, as required by federal guidelines, in writing regarding the issues involved and their resolution.

12.40 Protocol Renewal

Animal protocol activities beyond the three-year approval period must be resubmitted for IACUC review and approval before the approved protocol expires. All animal care and use protocols approved for greater than one year must be fully reviewed and re-approved by the IACUC annually based on the protocol anniversary date. Failure to comply with IACUC requests for conducting an annual review of an ongoing protocol will result in immediate revocation of institutional approval to continue the use of animals for that project. At the discretion of the IACUC, a shorter project approval period from that which the PI requested or additional project monitoring requirements may be imposed.

13.00 Continuous Renewal

This policy shall remain in effect for ten years from its effective date to determine its effectiveness and appropriateness. The policy may be revised as needed.

s/ President Eduardo M. Ochoa

Effective Date: December 11, 2017

Certification of Process

Reviewed by: The Institutional Animal Care and Use Committee, Provost, Policy Facilitation Team, Division of Science and Environmental Policy, Student Affairs Leadership Team, Associated Students, Postgraduate Studies and Research Committee, Educational Policy and Planning Committee, Corporation at Monterey Bay, Academic Affairs Council, Academic Senate, and ASEC.

[1] For guidance throughout these Principles, CSUMB relies on the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences.

Policy