1. Purpose: To provide written guidelines for the KSU Institutional Animal Care and Use Committee (IACUC). This is a guide to assist the IACUC in its statutory responsibility and/or oversight of the KSU animal care and use program.
a. Committee: The KSU Institutional Animal Care and Use Committee (IACUC).
b. Institutional Official (IO): The individual with authority to commit resources and make decisions for the Institution regarding the animal care and use program. At KSU, the Vice President for Research is the IO.
c. IACUC Members: Appointed by the IO with representation from university administrative or academic units. Members are responsible for executing appropriate duties of the IACUC. Authority to appoint members delegated in writing from the President (CEO) of the University.
d. IACUC Consultant (non-member): A consultant is defined as an expert available to assist the IACUC in matters that may require technical or specialized expertise not resident on the committee. Consultants may be asked to review proposals or protocols or assist in other activities of the IACUC as needed - at the request of the Chair, the attending veterinarian, and/or the URCO. Some consultants may be engaged on a one-time or ad hoc basis, or they may be identified as a regular contributor or resource for the committee. Unless they are formally appointed as a voting member, consultants are not voting members and do not contribute toward a quorum. Consultants do not routinely review IACUC proposals unless requested by the Chair, the attending veterinarian, and/or the URCO.
e. Designated Reviewer: Appointed by the Chair or the URCO (delegated from Chair) to review a USDA Pain Category B/C proposal for the IACUC. The designated reviewer can recommend approval, disapproval, or full committee review. Regardless of the recommendation, the results of the review will be available to the full committee, and read into the minutes of the committee.
f. Administrative Unit: The major administrative unit for IACUC purposes will be defined as the Colleges, i.e. College of Agriculture, College of Veterinary Medicine, College of Arts and Sciences, etc.
g. Pain Category: The categorization of pain and distress determination for animals used in research, testing, and teaching programs. KSU is required by federal law to provide information on pain categories in our annual report to the USDA at the end of the federal fiscal year. The PI is generally the most knowledgeable person regarding the consequences of study on his/her animals, and is responsible for making an estimation of the numbers of animals in each pain category and reporting them to the IACUC.
Pain Category B - Animals being bred, conditioned, or held for use.
Pain Category C - No or momentary pain and/or distress.
Pain Category D - Alleviated pain and/or distress.
Pain Category E - Unalleviated pain and/or distress.
h. University Research Compliance Office (URCO): Along with other duties, the URCO is responsible for regulatory oversight of the IACUC and campus animal care and use programs.
i. Chair: Chairperson of the KSU Institutional Animal Care and Use Committee (IACUC)
j. Full Committee Review: Proposals reviewed by a quorum of the convened IACUC committee, usually involving those with animals listed in Pain Category D and/or E. Any committee member may request full committee review for any proposal to use animals.
k. Sub-Committee Review: For special purposes, the Chair may request that certain proposals be reviewed by a small group of committee members (no less than 2) with input as appropriate by all committee members. Ordinarily, all members are offered the opportunity to participate in any subcommittee review.
l. Designated Review: Mechanism for reviewing Pain Category B or C proposals - if there is not a request for full committee review from a member. The Chair or his/her designee appoints a member (designated reviewer) to review the proposal for the committee. The designated reviewer can recommend approval as written, approval pending resolution of stipulations, or disapproval. The Cahir is the final approval authority. Results of all designated reviews are documented in minutes of the full committee.
m. Stipulations: During proposal review by a designated IACUC member or by the convened committee, there are usually questions or clarifications needed. Stipulations are formal requests to the PI to address those IACUC questions or issues. Stipulations must be adequately answered and if appropriate, changes made to the proposal, prior to final proposal approval by the Chair.
n. Modifications/addenda: Modifications are changes to an approved IACUC protocol. All modifications must be reviewed and approved by the IACUC prior to implementation by the PI. Modifications are categorized as Minor (can be approved by the Chair), or Major (must be considered and approved by the committee). The Chair makes the minor vs. major determination on a case-by-case basis. Documentation of all modifications is maintained with the original approved protocol.
o. Home Page/Website: The URCO has developed and maintains a comprehensive website that supports the animal care and use program. The site contains significant information and resources for IACUC members, researchers, educators, or any other person involved or interested in animal care and use activities. The website contains the IACUC application, online training, occupational health information, and pertinent links to many other technical and regulatory sites, etc.
a. IACUC Composition: The IACUC is composed of at least one representative from each major administrative unit (college) of the University that uses animals in the animal care and use program. The President (CEO) of KSU has delegated in writing, the authority to appoint IACUC members to the IO. The Institutional Official (Vice President for Research) signs the appointment for committee members, and they serve for an indefinite period, usually three years. The IO may appoint additional members based upon statutory requirements, programmatic emphasis, or desired expertise needs. Since the IACUC is a Presidential Committee at KSU, the Faculty Senate annually reviews and approves committee appointments. A basic listing of general categories or affiliation of committee members is listed below. Committee membership and specialty participation is subject to adjustment at the discretion of the IO. (An individual member may represent more than one category of member, i.e., veterinarian and representative of the College of Veterinary Medicine).
College of Human Ecology
College of Veterinary Medicine
College of Agriculture
College of Arts and Sciences
Non-affiliated, non animal user (may be the nonscientist)
Attending Veterinarian (may be one of the college members)
Nonscientist (may be one of the college members)
Scientist (may be one of the college members)
Alternate (person identified to serve as an alternate at a committee function for a specific person).
Specialty Expertise/Consultants* (as available or needed):
Pain and Distress Management
Information management/literature search specialist
Executive Secretary (non-voting)
* =may be a voting or a non-voting member depending on appointment by the IO
4. IACUC Meetings: The IACUC will usually meet in full committee the first and third Thursday of each month. The meetings will usually be scheduled for 3:00 PM. The committee must have a quorum present to hold a meeting (more than half). At the discretion of the Chair, the IACUC may use subcommittees to review and/or recommend approval of animal care and use activities.
5. IACUC Review: IACUC members receive all animal care and use proposals for preliminary review prior to the scheduled meeting.
a. USDA Pain Category D and/or E Proposals: All Pain category D and/or E proposals will be reviewed in a convened, full committee meeting. PI's will be invited to attend full committee meetings when their proposal is to be reviewed. If a quorum is not achieved, the review will be postponed until the next meeting with a quorum.
b. USDA Pain Category B or C Proposals: A "designated reviewer" may review Pain Category B or C proposals for the committee. During preliminary review, members may have questions about the Category B or C proposal. If so, they should write their questions on the proposal cover page for the assigned designated reviewer to address with the PI. If the member wants to be informed of the PI's response to his/her question, he/she should so indicate on the proposal cover sheet with the question(s). If the member believes that the answers to the question are a condition for approval, and wants to know the answer to the questions PRIOR to approval of the proposal, he/she should so indicate on the proposal cover sheet sent to the URCO. If no member recommends full committee review, the IACUC Chair or the URCO (chair has delegated authority to the URCO in writing) assigns a "designated-member reviewer" with appropriate technical expertise to carefully review and evaluate the proposal. If the designated reviewer recommends approval, the Chair may approve the proposal. If members or the designated reviewer have concerns about the proposal, they may recommend full committee review, in which case, the proposal will be reviewed at the next scheduled IACUC meeting. For the record, a listing of the protocols approved by designated review will be available for the full committee at the scheduled meetings.
6. IACUC Semiannual Inspections: The committee will conduct semiannual reviews of program and facilities using standardized OLAW checklists designed for that purpose. Semiannual reviews will be scheduled (if possible), for the second or third week of April, and the second or third week of October of each calendar year. Subcommittees may assist in performing the program review and facilities inspection (as many members as possible will be encouraged to participate in the program review and inspection of facilities). Subcommittee will report findings and results to the full committee in meeting. The committee will consider the report of the results of the review and inspection, and vote on findings and recommendations for the report to the Institutional Official. Any minority or dissenting opinions will be included in the report. All members of the committee will sign and date the final report. Results and recommendations will be forwarded to the Institutional Official and maintained for review by appropriate oversight entities.
7. IACUC Reports and Records:
a. Semiannual Review of Program and Inspection of Facilities:
b. Minutes of IACUC Meetings
c. Protocol Records and Changes to Protocols
f. Annual Reviews
g. Training Records
h. Membership Records and Qualifications
i. Correspondence Records
8. Animal Care and Use Complaints: It is the statutory responsibility of the IACUC to investigate complaints or concerns about the animal care and use program from any individual(s), to include employees or persons in the general community. Complaints may be handled in a confidential or anonymous manner if requested by the originator. The Chair will decide on a case-by-case basis how to proceed based upon the content and context of the complaint or concern. Regardless, the Chair will ultimately report to the full committee and the IO any formal complaints and the results of any IACUC investigation. The IO will originate required reports to funding agencies, OLAW, or the USDA, as appropriate. There are signs posted prominently in animal use areas informing individuals of the mechanisms and contact information to voice concerns or complaints about animal use at KSU.
9. Suspension of Activities: The IO has statutory authority to suspend animal care and use activities if it determines that a situation is severe enough to warrant it. Any suspension of animal care and use activities (initiated in response to a humane issue), would necessarily be coordinated between the IO and the IACUC. This action represents a serious step that requires formal reporting to appropriate regulatory authorities and funding agencies.
10. Changes to Protocols/Activities: The Chair will make the determination whether a proposed change to an activity or protocol is minor or significant/major. Regardless of the determination and level of review by the Chair, all approved changes or modifications are documented in the minutes at a full committee meeting. A document entitled "Modifications to Approved IACUC Activities" is provided on the KSU IACUC web page to help clarify how the IACUC might categorize various activities as a significant vs. a minor modification.
a. Significant/Major Modifications: The PI must submit information that completely explains the proposed changes to the approved animal care and use activity. If the proposed modification is part of a Pain Category D or E protocol, the proposed change will be reviewed in committee. If it is a modification to a Pain Category B or C protocol that does not change the pain category, a designated reviewer can review it.
b. Minor Modifications: Upon determination by the Chair, the PI may submit a memo to the IACUC describing in detail the proposed minor modification. If adequately presented by the PI, the Chair may approve a minor modification.
11. Annual Review of Activities: The URCO / IACUC will perform a formal review of ongoing activities at least annually. The review will be coordinated by the URCO and use a formal annual review form. Results of the ongoing annual reviews will be reported to the committee on a monthly basis. Animal care and use activities are approved for a period of three years. Activities cannot be extended past the 3-year expiration date. At the end of that period if the activity is not completed, the PI must submit a new Proposal Application with the Renewal box checked, that will be reviewed in the same way as a new proposal.
12. Meetings: The full committee will meet the first and third Thursday of each month as appropriate if there is new business or compelling old business. PI's must submit a completed IACUC Application for Approval form to the URCO by close of business on the Friday two weeks before a scheduled meeting. This is essential so that the URCO can copy and distribute the proposal to members in time for them to review prior to the meeting. Delivery of a completed proposal well before the deadline will considerably facilitate the administrative process, and ensure that the review takes place on time.
Order of business for convened meetings will generally proceed as follows:
a. The Chair will convene the meeting
b. Administrative announcements.
c. Review of minutes
d. Review of proposals
1) New Proposals (Pain Category D and/or E - Proposal Advocate): Principal Investigators with proposals to be reviewed will be invited to committee meetings. If they do not attend, the Chair or other designated representative will briefly explain the proposal to the committee. Questions, discussion and a vote will ensue. A simple majority of a quorum is required for approval. Possible outcomes would be:
Approved, no stipulations (proposal approved, no further action from PI.)
Approved, with stipulations (committee approves, pending resolution of stipulations prior to final approval.
Deferred, with stipulations (committee wants to review stipulations in a convened meeting, and then re-vote)
Disapproved (Committee feels the proposal is flawed and must be resubmitted with considerable revision to be considered again).
2) New Proposals (Pain Category B or C - Designated Reviewer): The Chair relays the results of all designated reviews of proposals during the previous period, usually monthly, or since the last meeting for the committee. If there are no questions or objections, the approval(s) is read into the minutes of the meeting.
e. Old business
f. Other New business
g. Chair ask for motion to adjourn
h. Meeting adjourn
13. Special Subcommittees: In some instances, it may be appropriate to utilize special subcommittees of the IACUC. Examples where subcommittees might be useful include investigation of animal care and use complaints, evaluation of complex or problematic proposals or issues, or review of proposed activities that need expedited review because of unusual time constraints or circumstances, etc. The use of subcommittees for IACUC business will be at the discretion of the Chair, and the Chair will convey all activities and/or findings to the full committee. If appropriate, the Chair may use a consultant to assist the subcommittee in technical or specialized review, deliberations or investigations. Consultants cannot vote on an activity unless the IO has formally appointed them a voting member of the committee. No IACUC members will be purposely excluded from special subcommittees, and when feasible all members will be invited to participate in activities of special subcommittees.
14. Use of Telecommunications for IACUC Meetings: The traditional convened meeting, physically attended by IACUC members, provides the optimal forum in which to conduct full committee review of proposals and consider potential suspensions. Introduction and integration of new members to the Committee is also most effectively accomplished during physically-convened meetings. However, OLAW recognizes that some forms of telecommunications facilitate the conduct of business, reduce regulatory burden, are standard practice in many forums, and enhance flexibility without compromising the quality of deliberation and interaction. The IACUC chairperson, as the appointed leader of the committee, bears some responsibility for holding committee meetings in a manner that encourages participation and facilitates interaction among members. Methods of telecommunications (e.g. telephone or video conferencing) are acceptable for the conduct of official IACUC business requiring a quorum, provided the following criteria are met:
a. All members are given notice of the meeting
b. Documents normally provided to members during a physically-convened meeting are provided to all members in advance of the meeting
c. All members have access to the documents and the necessary technology to fully participate
d. A quorum of voting members is convened when required by PHS Policy
e. The forum allows for real time verbal interaction equivalent to that occurring in a physically-convened meeting (i.e. members can actively and equally participate and there is simultaneous communication).
f. If a vote is called for, the vote occurs during the meeting and is taken in a manner that ensures an accurate count of the vote. A mail ballot or individual telephone polling cannot substitute for a convened meeting.
g. Opinions of absent members that are transmitted by mail, telephone, fax or e-mail may be considered by the convened IACUC members but may not be counted as votes or considered as part of the quorum.
h. Written minutes of the meeting are maintained in accord with PHS Policy, IV.E.1.b.
15. Program of Attending Veterinary Care Surveillance: The IACUC has adopted a formal attending veterinary care surveillance program providing for visits to animal care and use facilities on campus. A veterinarian or a certified American Association of Laboratory Animal Science (AALAS) animal technician under the authority of the IACUC will perform the attending care visits. During attending care assistance visits, the visitors will monitor research animal health and well-being, husbandry, sanitation, and other pertinent aspects of animal care and use. Additionally, they will strive to assist personnel with animal care and use issues, procedures, and training, etc. The frequency of assistance visits to individual animal care and use areas will be based on animal use activity and need, but will usually occur once a month.
If significant issues or problems are identified during visits, the attending veterinarian and/or university veterinarian will perform appropriate follow-up actions. If warranted, the university veterinarian and/or attending veterinarian will refer significant findings to the IACUC for additional consideration and/or formal action by the committee.
Prepared by University Research Compliance Office (785-532-3224)
Modified 14 May 2008