ºÚÁϳԹÏÍø

• Public Health Service Policy on Humane Care and Use of Laboratory Animals (hereafter “PHS”)
• Guide for the Care and Use of Laboratory Animals (hereafter “The Guide”)
• Animal Welfare Act and Regulations (hereafter “AWAR”)
• Health Research Extension Act of 1985 Public Law 99-158 (hereafter “Animals in Research”)
• “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training”
• Other federal statutes and regulations related to care and use of animals in research and teaching
• the University’s Animal Welfare Assurance with National Institutes of Health Office of Laboratory Animal Welfare

8.3.1 All research sponsored by or conducted at the University involving vertebrate or cephalopod animals, whether funded or un-funded, conducted by faculty, staff, or students using any property or facility owned or controlled by the University, will be conducted in compliance with the PHS Policy, AWAR, and all other applicable federal statutes, regulations, and policies. Research involving vertebrate or cephalopod animals will not be conducted unless federal and policy requirements have been satisfied, and written certification by the University’s Institutional Animal Care and Use Committee (hereafter “IACUC”) is obtained following the IACUC’s review and approval of the research.

8.3.2 All requests for vertebrate or cephalopod animal use will be submitted as a protocol and reviewed by the IACUC.  Research involving animals is not permitted to begin until the IACUC has approved the research protocol.

8.3.3 This policy applies to all research involving vertebrate or cephalopod animals, regardless of sponsorship, if:

8.3.4 The Institutional Official (IO), who may be the Vice President for Research (VPR), is authorized to ensure that all activities using animals at the University are humane and in compliance with all applicable external regulations. As per the federally approved IACUC Assurance, the IO may halt, terminate, or impose sanctions on any animal activity. However, neither the VPR nor IO may approve or reinstate any animal activity without IACUC approval.

8.3.5 If allegations of animal mistreatment or protocol noncompliance are reported, the IACUC will conduct an investigation in accordance with procedures outlined in the University’s Animal Welfare Assurance with the National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW).  Circumstances that will be reported in writing to OLAW by the IO per the University’s Assurance include serious or continuing noncompliance with the PHS Policy; serious deviations from The Guide; and/or IACUC protocol suspensions.

8.3.6 Any person responsible for the design, conduct, or reporting of animal subject research who has an economic interest in, or acts as an officer or director of, any outside entity whose financial interests would reasonably appear to be affected by the research, should be removed from the project due to conflict of interest as provided in Section IV, Chapter 2, of this Handbook.

8.4.1The IACUC aligns with all PHS requirements, and all appointed members shall be University faculty experienced with animal research and regulations. The IO appoints members for a minimum of one-year terms. The IACUC reviews all proposals involving the use of vertebrate or cephalopod animals.  The IACUC meets as needed, generally monthly, for proposal review, policy development, and noncompliance investigations.

8.4.2 The Attending Veterinarian is available to Principal Investigators (PI) for consultation during protocol development. For protocols involving USDA pain category D or E, the PI must consult with the Attending Veterinarian during protocol development.

8.4.3 Protocols are made available for review by all members of the IACUC.    Any member of the IACUC may request full committee review of any  submitted protocol. If full committee review is not requested, one or more members of the IACUC, designated by the chairperson, will have the authority to approve, require modifications (in order to secure approval), or request full committee review of such protocol on behalf of the committee. If a full committee review is requested, approval of the proposed protocol may be granted only after review at a convened meeting of a quorum of the IACUC and with approval of the majority of the quorum present. Any changes to approved protocols (amendments) must be submitted by the PI(s) to the IACUC and are processed in the same manner as described above.

8.4.4 In addition to determining whether the proposal conforms to the University’s Assurance with OLAW, the IACUC will consider each of the following criteria for review prior to approving the use of vertebrate or cephalopod animals in research:

8.4.5 Notification of IACUC action regarding a protocol will be made in writing to the PI(s). These actions include approval, modifications required to secure approval, withhold approval, or defer or table review.  Protocols are approved for a three-year period and are appropriately monitored.

8.4.6 The IACUC shall issue reports to the IO at least once every six (6) months upon completion of the required semiannual evaluations. These reports will be maintained by the IACUC Office and made available to the appropriate federal office upon request. The reports must: contain a description of the nature and extent of the University’s adherence to the Guide, the Animal Welfare Regulations, and the PHS Policy; identify specifically any departures from the provisions of the Guide, the Animal Welfare Regulations, and the PHS Policy; and state the reasons for each departure.  If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule for correcting each deficiency.

(PHS Policy) (based on Public Law 99-158, November 20, 1985, "Animals in Research") administered by the U.S. Department of Health and Human Services, National Institutes of Health

 (Guide) (National Academy Press, 2011, Washington, D.C.)

 [Title 7, United States Code (USC) Sections 2131-2159)]

  [Title 9 of the ] implementing The Animal Welfare Act and administered by the U.S. Department of Agriculture: Animal and Plant Health Inspection Service (APHIS)