Business Policies and Procedures Manual
Chapter 45: Research

Research and Teaching Activities Involving Animals

BPPM 45.45

For more information contact:
   Office of Research Assurances
   509-335-7951
   iacuc@wsu.edu or iacuc.wsu.edu

1.0  Overview and Purpose

Research and teaching activities involving animals directed by Washington State University (WSU) must comply with federal and state statutes, regulations, ethical principles, and University policies. This section provides an overview of the oversight and requirements related to the use of animals in research and teaching activities at WSU or under the direction of WSU personnel.

The overall intent of the policies described in this section is to:

  • Ensure the humane care and use of animals involved in WSU research and teaching activities;
  • Ensure compliance with all regulations, policies, and standards put in place to protect animal welfare; and
  • Ensure the public’s trust in WSU.

2.0  Applicability

This policy applies to all faculty, staff, volunteers, visiting scholars, and students (i.e., anyone acting as an agent of WSU) conducting research and teaching activities involving animals.

3.0  Roles and Responsibilities

3.1    Institutional Animal Care and Use Committee (IACUC)

The Institutional Animal Care and Use Committee (IACUC) is a WSU presidential committee charged with:

  • Assessing and overseeing the WSU Animal Care and Use Program (ACUP), facilities, and procedures;
  • Reviewing and approving, requiring modifications to secure approval, or withholding approval of proposed research and teaching activities involving animals;
  • Advising the Institutional Official (IO) on matters related to animal care and use at WSU.

The IACUC ensures that procedures with animals minimize pain and distress and procedures involving more than momentary pain and distress are conducted using appropriate sedation, anesthesia, and analgesia. The IACUC confirms that:

  • Living conditions for the animals are appropriate;
  • Proper medical and veterinary care is available; and
  • Personnel are appropriately trained.

In fulfillment of this mission, the IACUC is guided by the following statutes, regulations, policies, and ethical principles. (See also Section 6.2.)

Deviations from the above standards for scientific reasons must be in writing and approved by the IACUC.

The IACUC functions independently and reports to the Vice President for Research. The IACUC is part of the ACUP and is supported by the Animal Welfare Program (AWP) Office within the Office of Research Assurances (ORA).

3.2    Institutional Official/Vice President for Research

Once appointed, IACUCs report to a senior administrator known as the Institutional Official (IO). At WSU, the Vice President for Research is the IO. The IACUC’s authority to review and approve protocols is independent of the IO, who may not overrule an IACUC decision to withhold approval of a protocol.

The IO:

  • Is the signatory official on the WSU Animal Welfare Assurance agreement with the U.S. Department of Health and Human Services (HHS) and the Research Facility Registration with the U.S. Department of Agriculture (USDA);
  • Has authority to appoint the IACUC;
  • Has operational authority over the ACUP; and
  • May delegate this operational authority to qualified individuals in the Office of Research (OR), ORA, Office of the Campus Veterinarian (OCV), and the AWP.

3.3    Offices of Research (OR) and Research Assurances (ORA)

The OR, ORA, IACUC, Environmental Health and Safety (EHS), and the AWP have operational authority to develop and implement the subordinate policies and standard operating procedures (SOPs), including the IACUC Policies, Guidelines, and SOPs that outline how the ACUP meets the regulations and guidelines detailed in the above referenced documents. (See also Section 6.1.)

3.4    Individuals Conducting Research and Teaching Activities Involving Animals

All faculty, staff, volunteers, visiting scholars, and students (anyone acting as an agent of WSU) conducting research and teaching activities involving animals under the direction of WSU must comply with federal and state statutes, policies and regulations, and University policies. (See Section 6.2.) Activities must be conducted in accordance with the IACUC-approved Animal Subjects Approval Form (ASAF) and pertinent IACUC policies, guidelines, and SOPs unless a deviation is approved in the ASAF. (See Section 6.1.)

Principal investigators (PIs) and departments are responsible for ensuring that students who use animals to gather data gathered for theses and dissertations are fully informed of and comply with IACUC review requirements. A failure to obtain appropriate IACUC approval may make it impossible for the Graduate School to accept theses or dissertations involving animal research conducted without approval.

4.0  Requirements

4.1    Compliance with Guiding Regulatory Documents

4.1.a    Activities Covered by the Animal Welfare Assurance Agreement

In compliance with the terms of the WSU Animal Welfare Assurance with the HHS, the IACUC and ACUP are guided by the following regulatory documents when the institution is engaged in research and teaching activities involving animals supported by:

  • HHS;
  • National Science Foundation (NSF);
  • National Aeronautics and Space Administration (NASA); or
  • Another agency with a memorandum of understanding (MOU) with Office of Laboratory Animal Welfare (OLAW).

The guiding regulatory documents are:

4.1.b    Activities Not Covered by Animal Welfare Assurance

When the institution is engaged in research and teaching activities involving animals that are not covered by the terms of the Animal Welfare Assurance or covered by the Animal Act and Regulations, the IACUC ensures the application of equivalent protection using:

The term “taxon” is defined as a level of biological classification, e.g., kingdom, subspecies.

4.1.c    Activities Involving Regulated Activities

In compliance with USDA-APHIS (USDA-Animal and Plant Health Inspection Service) as a registered research facility, when the institution is engaged in research and teaching activities involving USDA-regulated activities the IACUC and ACUP are guided by The Animal Welfare Act and Regulations.

4.2    AAALAC Accreditation

WSU is committed to maintaining Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) accreditation for the entire ACUP. AAALAC conducts triennial site visits to ensure the institution’s ACUP is meeting the standards outlined in the Guide, the Ag Guide, and state and federal policies and regulations. The IACUC, through its policies, practices, semi-annual inspections, and reports, helps ensure these standards are met for all research and teaching activities involving animals that are directed by WSU personnel.

4.3    Appointment Authority/Terms and IACUC Composition

The President has the authority to appoint the IACUC. The President has delegated the authority to appoint the IACUC to the Vice President for Research. Appointment authority remains in effect until revoked in writing by the President or until the end of the term specifically designated.

Members, including chairs, are generally appointed for terms of one to three years. However, members appointed mid-year may have varied terms of appointment. Some members, including the WSU Attending Veterinarian, may receive ex-officio appointments that are linked to their positions at WSU. The terms of appointment, including voting or alternate status and member expectations, are to be outlined in the member appointment letter.

Note: Attorneys from the Attorney General’s Office, WSU Division, attend and participate in IACUC meetings solely as legal advisors and may not participate in votes or count towards quorum.

The IACUC must consist of at least five members with varying backgrounds to ensure it is qualified through the experience and expertise of its members to oversee the institution’s animal program, facilities, and procedures.

Membership is to include, but not be limited to the following:

  • A chairperson;
  • One doctor of veterinary medicine, 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;
  • At least one practicing scientist;
  • At least one member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, and member of the clergy);
  • At least one individual who is not affiliated with the institution in any way other than as a member of the IACUC and is not a member of the immediate family of a person who is affiliated with the institution;
  • A scientist who has experience in agricultural animal research or teaching involving agricultural animals;
  • An animal, dairy, or poultry scientist who has training and experience in the management of agricultural animals; and
  • A veterinarian who has training and experience in agricultural animal medicine and who is licensed or eligible to be licensed to practice veterinary medicine.

Note: An individual may fill more than one role, provided that there are no less than five members.

No member may participate in the initial or continuing review of any project in which that member has a conflicting interest (financial or otherwise), except to provide information requested by the IACUC. See EP27 and IACUC Policy #2.

The IACUC may, at its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IACUC. These individuals may not vote with the IACUC.

4.4    Required Functions of the IACUC

As an agent of the institution, the IACUC must:

  • Review at least once every six months the institution’s program for humane care and use of animals;
  • Inspect at least once every six months all of the institution’s animal facilities (including satellite facilities);
  • Prepare reports of the IACUC evaluations and submit the reports to the Institutional Official;
  • Review and, if warranted, investigate concerns involving the care and use of animals involved in WSU research and teaching activities;
  • Make recommendations to the IO regarding any aspect of the institution’s animal program, facilities, or personnel training;
  • Review and approve, require modifications to secure approval, or withhold approval of proposed research and teaching activities involving animals;
  • Review and approve, require modifications to secure approval, or withhold approval of proposed significant changes (amendments) regarding the use of animals in ongoing activities;
  • Suspend an activity involving animals when it is determined that the activity is not being conducted in accordance with the Animal Welfare Act, the Guide, the Animal Welfare Assurance, the approved ASAF, or applicable University or IACUC policies;

    • Note: IACUC suspension must occur at a convened meeting with a vote of the majority; and

  • Develop IACUC policies, guidelines, and SOPs to help ensure the ACUP is meeting the standards outlined in this document.

4.5    Research Project Review

4.5.a    IACUC Approval

Faculty and staff must submit an ASAF to the AWP and receive approval from the IACUC prior to initiating any research or teaching activities involving animals. The ASAF application and submission is conducted via the MyResearch portal. The protocol and amendment review process is detailed in IACUC Policy #2. Protocol approval is valid for a three-year period; a complete review (de novo) and approval by the IACUC is required every three years to keep a protocol active.

4.5.a.i     Amendment Review

The IACUC must review and approve all significant changes (as described in IACUC Policy #24) to currently approved ASAFs prior to implementation. Review of nonsubstantive changes to a protocol may be delegated to qualified individuals within the AWP (see IACUC Policy #24, Section D: Administrative Amendments).

4.5.a.ii     IACUC Review Outcomes

When reviewing an ASAF or amendment to an ASAF, the IACUC has the authority to:

  • Approve;
  • Require modifications to secure approval; or
  • Withhold approval.

A vote to withhold approval may only occur at a convened meeting. If the IACUC votes to withhold approval, the PI is provided written notification of the IACUC’s decision along with the reasons for denial. The PI is offered an opportunity to respond in person or in writing to request that the IACUC re-consider the decision based on any additional information provided. (In-person response may be conducted face-to-face or through videoconference, e.g., Zoom.)

Note: The IACUC’s authority to review and approve protocols is independent of the IO. Any project that has approval withheld by the IACUC may not be approved by the institution. However, a project that is approved by the IACUC may be subject to approval by other oversight committees and is potentially subject to disapproval by the University.

4.5.b    Exempt Research

If faculty believe their research or teaching activity involving animals is exempt from IACUC review (see IACUC Policies #7 and #40), they are required to provide a written project summary to the AWP Office for determination; e-mail iacuc@wsu.edu. If determined to be exempt, an exemption letter will be provided. Nonexempt projects require submission of an ASAF and IACUC approval before project initiation.

4.5.c    Temporary Pause

The Vice President for Research, IACUC Chair, Director of the ORA, and Assistant Director of the Animal Welfare Program each have the authority to temporarily pause any research project:

  • When an adverse event or alleged significant noncompliance has occurred; and
  • When there is reason to believe that continuation of the research may lead to:
    • Further animal welfare issues; or
    • Continuing noncompliance.

The WSU Attending Veterinarian has full authority to immediately suspend animal activities that are inconsistent with adequate animal care or include protocol deviations that have a negative impact on the animal. The Attending Veterinarian’s authority is further defined in BPPM 45.42.

When a research project is paused, it must not resume until such a time as the Attending Veterinarian, IACUC, or IACUC chair have reviewed and determined that it is safe to resume.

4.6    Training

All personnel engaged in research and teaching activities involving animals must be appropriately trained to perform their assigned tasks.

All personnel listed on an approved ASAF are required to take the following courses:

  • Principles of Animal Care and Use (PAC) training. 

    • PAC training expires after three years, at which point Refresher: Principles of Animal Care must be taken to update it.

  • Occupational Health Training – Animals (OHT-A) for the species associated with the protocols that the personnel will be working under.

    • OHT-A training must be updated every three years.

The IACUC may establish additional requirements for training depending on the nature of the activity and an individual’s background and experience. For a complete list of training requirements, see the IACUC Training webpage and review IACUC Policy #20.

5.0  Procedures

The IACUC policies, guidelines, and SOPs, which are incorporated herein by reference, contain detailed procedures for ensuring the ACUP is meeting the standards outlined in this document. (See Section 6.1.) They also include the handling of investigations (IACUC Policy #27) and required reporting of:

  • Protocol deviations;
  • Noncompliance; and
  • Unanticipated adverse events.

6.0  References and Resources

6.1    Application Forms and Additional Resources

The IACUC website contains links to the online ASAF application and information, including IACUC policies, guidelines, SOPs, and other guidance documents regarding the conduct of research and teaching involving animals.

6.2    Related Statutes, Regulations, Policies, and Guidelines

The following statutes, regulations, policies, and ethical principles apply to research and teaching activities involving animals:

7.0  Assistance

For questions, contact the Animal Welfare Program, Office of Research Assurances; telephone 509-335-7951; e-mail iacuc@wsu.edu.

Refer to the Office of Research Policies for an overview list of policies and guidelines related to the conduct of research.

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Revisions:  June 2023 – new policy (Rev. 612).