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Policy Contact: Division of Research and Economic Development

1. Purpose

   For both humanitarian and scientific reasons, the University is committed to ensuring that animals involved in research and teaching receive humane care and treatment. This policy sets forth the guidelines to follow regarding institutional animal care and use.

2. Policy
   1. The United States Public Health Service (PHS) and the U.S. Department of Agriculture (USDA) require that when working with vertebrate animals, individuals are trained in their care and use in research and in educational or training programs. Specifically, when conducting vertebrate animal research, important principles to follow include:
      1. Weigh the use of animals against the potential benefits gained;
      2. Use the minimum number of animals possible to obtain valid results;
      3. Reduce the amount of pain and distress experienced by animals used in experimentation; and
      4. Seek alternatives to using vertebrate animals, such as using computer modeling, in vitro procedures, or invertebrates when appropriate.
   2. This policy applies to all research and teaching using vertebrate animals conducted at the University, including those sponsored and paid for by non-University organizations, or by University faculty, staff, or students when acting as representatives of the University at off-campus locations. It also applies to the Agricultural Experiment Station and individuals acting as representatives of the Agricultural Experiment Station at off-site locations.
   3. The University recognizes the classification of animal use in research and teaching into three (3) categories for the purpose of specifying the standards for animal care and use:
      1. Biomedical Research and Teaching: research and teaching whose goal is to generate or communicate knowledge that will contribute to improving the health and well-being of humans and/or animals. For biomedical research and teaching, the University endorses three (3) standards for animal care and use: 1) the , 2) the , and 3) the (the Guide). These documents will apply to those species specified in each document. Anyone conducting biomedical research and teaching with a vertebrate species not covered by these documents should work closely with the University’s Institutional Animal Care and Use Committee (IACUC) and the University Veterinarian (UV) to develop appropriate guidelines for the particular species.
      2. Agricultural Research and Teaching: research and teaching whose goal is to generate or communicate knowledge that will contribute to the improvement of commercial food or fiber production from animals. For agricultural research and teaching, the University endorses the standards for animal care and use contained within the (Ag Guide), prepared by the Federation of Animal Science Societies.
      3. Field Research and Teaching: research and teaching whose goal is to generate or communicate knowledge that will contribute to our understanding of animals living in the wild. This category is limited to animals that will be collected from or manipulated in the field, or whose behavior in the field will be substantially modified. If wild animals are captured and brought into the laboratory for study, all use conducted in the laboratory will be subject to the standards for biomedical research and teaching. For field research and teaching, the University endorses the standards for animal care and use contained within the following documents and any subsequent revisions:
         1. For mammals: ;
         2. For birds: ;
         3. For amphibians and reptiles: ; and
         4. For fishes: .
   4. The University endorses the 2020 Edition of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, or any subsequent revision.
   5. The University shall implement an Institutional Animal Care and Use Occupational Health and Safety program, incorporated herein as an Appendix.
   6. Research and teaching not clearly identifiable as agricultural or field research and teaching will be classified as biomedical.
   7. The Vice President for Research and Economic Development, or successor, shall serve as the Institutional Official (IO) and bears ultimate responsibility for the University's animal care and use program (hereinafter "Program"). Oversight for the Program is vested in the UV, the IACUC, and supporting personnel identified below. In keeping with federal regulations, the IACUC shall consist of no fewer than five (5) individuals, including the Chair, UV, one individual whose interests are primarily non-scientific, and one individual not affiliated with the University and who is not a laboratory animal user.
      1. The Vice President for Research and Economic Development, or successor, will designate a Chair from the University members. The Chair shall serve as champion and spokesperson for animal care and use and the IACUC. The Chair shall convene and preside over meetings, make initial determinations to declare proposals as exempt from the policy, arrange for designated member review (DMR) of protocols as outlined in the Guide, and oversee all written communication between the IACUC and the Principal Investigator (PI). A vice- chair shall be assigned by committee consensus on an as needed basis.
      2. The UV shall serve as the Attending Veterinarian (AV) and shall have the authority to direct staff to carry out activities related to maintaining optimal animal care. The duties of the UV, in addition to sitting on the IACUC, include at a minimum the following:
         1. Work with the IACUC to develop institutional guidelines and programs concerning veterinary care for animals used in research or teaching and to assure compliance of animal facilities with the requirements of the Animal Welfare Act, applicable state and local laws, PHS Policy, the Guide, and any organization that has accredited the Program.
         2. Aid PI in project design, identifying potential risks and hazards.
         3. Suggest possible alternatives to procedures that potentially increase risks to human health and safety or animal welfare.
         4. Facilitate compliance with federal, state, and local regulations, policies, and protocols.
         5. Assist PI with questions pertaining to training requirements.
         6. Confer with the Vice President for Research and Economic Development, or successor, on matters of animal care and use in research and teaching.
         7. Provide information as needed for the safety and protection of personnel as it relates to occupational health hazards. Coordinate occupational health efforts with University Environmental Health and Safety.
         8. Assist in the preparation of reports and statements as requested or required by various regulatory or accreditation agencies.
         9. Provide veterinary consulting on animals being used in a research or teaching project.
      3. The Program Director for Research Integrity and Compliance (PDRIC) or successor shall serve as a liaison between the IACUC and the Vice President for Research and Economic Development, or successor, and will coordinate IACUC activities with other compliance requirements and committees. The PDRIC will monitor compliance with provisions for departing PIs. In consultation with the Chair and UV, the PDRIC will ensure that all members of the IACUC are appropriately trained, file annual updates and other reports to the USDA and PHS, maintain registration with these agencies, monitor federal and state regulations, and suggest revised policies, procedures and guidance documents to remain in compliance with those regulations. Additionally, the PDRIC shall review and lead revisions of the Program annually.
      4. IACUC member candidates may be nominated by the Dean from each of the colleges that use vertebrate animals for research or teaching, and/or by current members. Members will be appointed by the Vice President for Research and Economic Development, or successor, after consultation with the UV, the Chair, and others.
      5. No more than three (3) members shall be from the same administrative unit at the departmental or school level of the University. Committee composition shall be structured to reflect the types of research generally conducted at the University.
      6. Committee members shall be appointed to three (3) year terms. Committee member terms will be staggered in order that continuity can be maintained. Committee members may be reappointed to additional terms, as needed, and if willing to continue service.
      7. The committee, through the Chair or the UV, may seek the advice of experts in other disciplines to assist in the review of protocols on an ad hoc basis, as necessary. These individuals shall not have voting privileges.
      8. An administrative assistant to the IACUC shall schedule meetings, take minutes in conformity with Robert's Rules of Order, and assist in preparing reports and maintaining records. These records shall include a current roster of all committee members, files of all projects, and records of all correspondence between the PI and the committee. Files shall be destroyed three (3) years after expiration of the protocol.
   8. The IACUC shall meet as necessary to conduct business, generally once per month. Minutes of the previous meeting and materials for review will be made available to each member prior to the meeting. A quorum, which shall consist of a simple majority (over half of the voting members on the committee) will be required to conduct business. Members may participate via video or teleconferencing. Other IACUC responsibilities are to:
      1. Recommend policies and procedures concerning the use, care, housing, and disposal of vertebrate animals held or used for research, teaching, or other activities;
      2. Review applications for protocol approval, including an Occupational Health and Safety Program (OHSP) Project Risk Assessment (PRA), and other documents specified in the OHSP (see Appendix);
      3. Specify appropriate related training for PI and participants if training or training documentation is inadequate;
      4. Maintain documentation of personnel training for proper use and care of animals;
      5. Conduct IACUC semi-annual Program evaluations, including facilities inspections;
      6. Facilitate compliance with federal, state, and local Program requirements during reviews and inspections;
      7. Coordinate the animal care and use of Programs, including related communication, and maintain appropriate information and documentation related to Program training.
      8. Review concerns involving the care and use of animals in University activities;
      9. Make written recommendations to the Vice President for Research and Economic Development, or successor, regarding any aspect of the Program, facilities, or personnel training;
      10. Review and approve, require modifications in (to secure approval), or withhold approval of those activities related to the care and use of animals as set forth in the PHS Policy. This approval will be evaluated based upon information provided by the PI in the Animal Use Proposal.
      11. Notify PIs and the University 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.
      12. When necessary, initiate steps to suspend institutional approval for an activity involving animals as set forth in the PHS Policy, and suspend an activity.
   9. All activity that involves the use of vertebrate animals requires the submission of the Animal Use Proposal. Activity that may be determined to be exempt from Full Committee Review (FCR) may include wild animal studies done on free-living wild animals in their natural habitat, activity with no intervention (observation only), activity that does not involve an invasive procedure, and activity that does not harm or materially alter the behavior of the animals under study. Activity conducted by or under the control of another organization where the University only provides labor is also excluded.
   10. Research involving animal care that falls under certain categories of research will be deemed exempt from FCR but not from this policy. PIs may not make a unilateral determination of a project’s exempt status and must submit the Animal Use Proposal for review. IACUC Chair and the UV will make the determination jointly as to exempt status. Activity that may be deemed exempt includes livestock or poultry undergoing standard agricultural husbandry practices or intended for use in improving animal nutrition, breeding, management, or production efficiency; and activity for improving the quality of food or fiber, when methods causing no greater than slight or momentary pain or distress are employed.
   11. If a proposal does not involve animals in pain category E, major survival surgery, or particularly risky procedures, it is eligible for DMR. All members will be provided information regarding the protocol, with the opportunity to request FCR. If FCR is not called for, the Chair will appoint one or more members to review the proposed research with the authority to approve, seek modifications to secure approval, or request FCR. A protocol may not be disapproved using DMR.
   12. Research involving animal care that is not exempt from this policy and is not eligible for DMR will be reviewed at a convened IACUC meeting. At a minimum, both DMR and FCR will ensure that:
       1. The procedures with animals avoid or minimize discomfort, distress, and pain to animals and are consistent with sound research design;
       2. If procedures cause more than momentary or slight pain or distress to the animals, the procedures will be performed with appropriate sedation, analgesia, or anesthesia; or a written scientific justification for not including these items will be provided in the proposal;
       3. If procedures involving unrelieved severe or chronic pain must be used, the animal will be painlessly euthanized at the end-point established in the approved IACUC protocol.
       4. Living conditions of the animals are appropriate for their species and contribute to their health and comfort.
       5. Feeding and nonmedical care are directed by a faculty or staff expert and/or veterinarian experienced in the proper care, handling, and use of the species being maintained or studied.
       6. Medical care for the animals is available and provided as necessary by a qualified veterinary technician or veterinarian.
       7. Personnel conducting procedures on the species being maintained or studied are appropriately qualified and trained in the procedures.
       8. The method(s) of euthanasia to be used is consistent with AVMA guidelines.
   13. A protocol under review shall be deemed approved by FCR if accepted by a majority of voting members in attendance. The committee may require modifications to the protocol prior to approval. The Chair, or designee(s), and the UV shall jointly determine if the modifications follow committee requirements or should be taken back to the full committee for final approval. The committee may require the resubmission of a protocol before any action is taken or may withhold approval of any research, with detailed comments/reasons provided to the PI.
   14. A PI may appeal a decision of the IACUC within two (2) weeks of notification by the Chair. The appeal process is as follows:
       1. The PI must submit an appeal in writing to the Chair, identifying specific points of disagreement with the Committee’s decision, reasons for disagreement, and the desired outcome of the appeal.
       2. A quorum of the committee will hear (or read) the appeal from the investigator, discuss any concerns with the appealer, and determine an outcome.
       3. The investigator can appeal to the IACUC for a second hearing if:
          1. There was pertinent information that was available at the time of the initial hearing, but was not presented to the IACUC, or
          2. Policies and/or procedures were not adhered to during the first hearing.
       4. If the investigator is dissatisfied with the result, further reconsideration of the matter may be requested by appealing to the Vice President for Research and Economic Development, or successor, in writing. Such written requests must be filed with the IACUC administrative assistant within ten (10) days of the IACUC reconsideration decision.
       5. The Vice President for Research and Economic Development, or successor, will meet with the IACUC for further discussion, if warranted. The Vice President for Research and Economic Development may review committee decisions, impose additional modifications, or disapprove research activity approved by the committee. The Vice President for Research and Economic Development or any other official may not approve animal research activity that the committee has disapproved.
   15. In accordance with PHS Policy, no member of the IACUC may be involved (except to provide information requested by the committee) in the review or approval of a project in which they have been or expect to be engaged or have a direct interest. The individual may not be counted toward a quorum for the project under consideration.
   16. Any changes in protocols must be reported to and approved by the IACUC prior to initiation. The only changes that can be made without prior consent are those necessary to eliminate apparent immediate hazards to animals. Initial review of proposed changes is conducted by the Chair. An increase of less than 10% in previously approved animal numbers for non-USDA species may be handled administratively by IACUC Chair without additional consultation or notification.
   17. Application for changes will be reviewed by UV. If UV approves the changes, IACUC Chair reviews the application for changes. UV and Chair jointly determine if the requested changes are minor or significant. If the changes are deemed significant the Chair distributes application for significant changes to IACUC. If no IACUC member requests FCR within 48 hours, the changes are reviewed by DMR. Examples of significant changes include but are not limited to changes:
       1. from non-survival to survival surgery;
       2. resulting in greater pain, distress, or degree of invasiveness;
       3. in housing and/or use of animals in a location that is not part of the animal program overseen by the IACUC;
       4. in species;
       5. in study objectives;
       6. in Principal Investigator;
       7. that impact personnel safety; or
       8. other changes deemed significant by UV or Chair.
   18. Projects will be approved for up to three (3) years. Annually, PIs shall be required to submit a continuing review and update that provides information on the status of the project (including information such as percent complete, not yet started, ongoing, temporarily stopped) and certifying that no changes have been made. Project extensions are allowed after protocols undergo a de novo review using FCR or DMR procedures, as appropriate. The committee may review activities more frequently, as they determine necessary, and conduct, or direct others to conduct, random audits of any approved project or laboratory facilities. To begin a triennial de novo review, a new protocol request must be submitted prior to the (3) year expiration date to keep the study active.
   19. During the process of initial or continuing review of an activity, material provided to the IACUC shall be considered privileged information and the committee shall assure the confidentiality of the data contained therein.
   20. The PI is responsible for full compliance with the federal regulations, the Guide, and this policy. With regard to animal care and use, these responsibilities include but are not necessarily limited to the following:
       1. Submitting completed Animal Use Proposals, including PRA, for approval;
       2. Designing research, education, and outreach projects involving animals and preparing complete protocol requests to IACUC for review and approval. With input from the UV, completing PRA to assess if the intended projects pose potential health risks to the participants (See Appendix). If necessary, the PI will consult with Environmental Health and Safety to verify whether PPE is required. Institutional biosafety policy requirements shall be met and documented in the PRA;
       3. Ensuring participants review PRA and conform to OHSP requirements (see Appendix) before beginning work on an approved protocol;
       4. Ensuring all participants complete required training;
       5. Reporting on the progress of the research;
       6. Filing all necessary project extensions; and
       7. Project close-out if departing the University prior to protocol expiration.
   21. University faculty and staff may serve as PIs. Graduate students must name a faculty advisor as PI who will provide oversight. Individuals who are not University employees may serve as PIs if they are sponsored by a University administrator, faculty or staff member, or are under contract to use University facilities.
       1. PIs departing the University must inform IACUC through IACUC processes prior to their departure date to facilitate the management of ongoing protocols and animals. All existing protocols under a departing PI must be closed and arrangements made for the transfer or disposition of animals under the protocol(s), or the protocol must be transferred to another PI as provided for in this policy.
       2. The supervisor of the departing PI is responsible for ensuring that the departing PI has either closed or reassigned to another PI all active IACUC protocols, and that protocol reassignment or closure is documented in Human Resources employee exit materials.
   22. In accordance with federal regulations, the University will promptly report to USDA or the National Institutes of Health Office of Laboratory Animal Welfare and other appropriate federal agency officials the following:
       1. Failure to correct significant deficiencies found during semi-annual inspections and Program review; and
       2. Serious or continuing noncompliance with the federal regulations or the requirements or determinations of the IACUC.
   23. Individuals are encouraged to report concerns regarding noncompliance to IACUC, including questionable use of animals or conditions affecting animal care or use. The University and federal policy prohibit reprisal against anyone who reports a potential concern involving animal care and use.
   24. When alleged incidents of noncompliance are reported, the IACUC will follow written procedures to resolve the concern. The PI will receive a notification of the allegation and any IACUC action, and an investigation of the alleged violation will be initiated by the IACUC Chair. If there is found to be animal suffering, the UV may immediately suspend the activity and euthanize the animal(s) in question. The PI will be given the opportunity to address the committee.
       1. The IACUC may use one of several options to resolve the issue, including:
          1. An immediate corrective response as appropriate and sufficient;
          2. A timeline for corrective action; and
          3. Suspension of the activity.
       2. If the PI is a member of the Department of the IACUC Chair, the Vice President for Research and Economic Development, or successor, at the request of the Chair, may appoint a vice-chair who will assume responsibility for the proceedings. The PI and all administrators will communicate with the Chair and vice versa, i.e., there will be only one line of communication.
       3. If the IACUC votes by simple majority of the members present to suspend the PI's animal use activity, the Vice President for Research and Economic Development, or successor, will be notified by PDRIC, or successor, in writing within one working day of the meeting. Once PDRIC has informed the Vice President for Research and Economic Development, further communications will be with the Office of the Vice President for Research and Economic Development. The Vice President for Research and Economic Development will notify the PI and other individuals and regulatory authorities as appropriate.
       4. If an activity is suspended, subsequent meetings of the IACUC will determine if the PI has met the stipulations assessed by the committee and will vote on lifting the suspension. The Vice President for Research and Economic Development, or successor, will be notified of the results of this meeting immediately in writing by the Chair, and the PI will be notified.
       5. PDRIC, or successor, will notify the Vice President for Research and Economic Development, or successor, of alleged incidents of noncompliance and of the IACUC response in writing within five (5) business days of IACUC decision. IACUC decisions to suspend the activity, however will be transmitted according to this policy. The Vice President for Research and Economic Development will meet with the IACUC for further discussion, if warranted. The Vice President for Research and Economic Development may review committee decisions, or impose additional actions. The Vice President for Research and Economic Development or any other official may not overrule IACUC action on noncompliance events.

3. Responsible Administrator

   The Vice President for Research and Economic Development, successor, or designee is responsible for the annual and ad hoc review of this policy. The University President is responsible for approval of modifications to this policy.

Approved by President on 09/16/2014. Revised; Approved by President on 01/03/2020. Revised; Approved by President on 10/16/2020. Revised; Approved by President on 03/08/2026.

Source: Animal Welfare Act (Public Law 89-544 and subsequent amendments); ; ;

Associated Forms: SDSU Occupational Health and Safety in the Care and Use of Animals Programs (OHSP) (see Appendix),