USDA Animal and Plant Health Inspection Services (APHIS) Guidlines

Institutional Animal Care and Use Committee (IACUC) Guidelines

Note: These guidelines are not meant to replace the Animal Welfare Act (AWA), regulations or standards.

1. Membership of IACUC: 2.31 (a)(b) and 2.33 (a)(3)
   
   • 3+ members appointed by CEO. Includes at least one nonaffiliated person, one veterinarian, and a chair.
     
     

2. Program Review and Facility Inspection: 2.31 (c)(1) and (c)(2)
   • At least once every 6 months by at least two IACUC members

   
   

3. Program Review and Facility Inspection Reports: 2.31 (c)(3)
   • IACUC majority reviews, signs and submits to Institutional Official.
   • Contains minority view.
   • Identifies departures from regulations or standards and reasons.
   • Distinguishes significant from minor deficiencies.
   • Provides reasonable and specific plan and schedule and reasons.
   • Nonadherence to plan of correction for significant deficiencies reported within 15 business days to APHIS and any Federal funding agency.

   
   

4. Review/Investigate Complaints About Animal Care: 2.31 (c)(4)
   • Complaints may be from the public or from facility personnel [refer also to 2.32 (c)(4)].

   
   

5. Recommentations Concerning Animal Care Program: 2.31 (c)(5)
   • To Institutional Official about animal care and use program, facilities, or personnel training.

   
   

6. Review of Protocols: 2.31 (c)(6) and 2.31 (d)(1-5) and (e)
   • Review of ongoing protocols no less than once a year.
   • All IACUC members given list of proposed protocols prior to review.
   • Full committee (quorum) can be convened at request of one member.
   • IACUC reviewer must have no conflict of interest with protocol.
   • May use nonvoting consultants.
   • No study is to begin before IACUC review and approval.

   
   

7. Review Significant Changes to Approved Protocol: 2.31 (c)(7) and (d)(8), 2.31 (e)
   • IACUC must preapprove signinficant changes to protocol.

   
   

8. Authorization to Suspend a Protocol: 2.31 (c)(8) and (d)(6), 2.32 (d)(7)
   • IACUC can suspend approved protocol with majority vote of convened quorum.
   • Report suspensions to APHIS and any Federal funding agency.

   
   

9. Field Study Exemption From Protocol and Faculty Review: 2.31 (c)(2) and (d)(1)
   • Part 1 defines a field study as using free-living wild animals in a natural habitat without invasive procedures, harm or altering of behavior.

   
   

10. Assurances and/or Statements Required in Written Protocols: 2.31 (d)(1) and (e)

    All Proposed Animal Activities

    • Procedure does not unnecessarily duplicate previous experiments.
    • Animals' living conditions are appropriate.
    • Medical care is available for the animals. (also 2.33)
    • Qualified and trained personnel are involved with procedures. (also 2.32)
    • Discomfort, distress and pain are minimized.
    • If used in two major surgeries, animal is not allowed to recover (unless justified).
    • Description of preoperative and postoperative care.
    • Survival surgery is conducted aseptically in dedicated facilities.
    • Rationale for species and number of animals.
    • Rationale for using animals.
    • Complete description of proposed use of the animals.
    • Complete description of procedures designed to assure that discomfort and pain are minimized.
    • Complete description of method of euthanasia.
      All Proposed Animal Activities With Potentially Painful Procedures 2.31 (d)(1)(i-iv)
    • Discomfort, distress and pain are minimized.
    • Method used, alternative information sources searched with a written list of parameters used for the search.
    • Procedure does not unnecessarily duplicate previous experiments.
    • Use of proper drugs for relief of pain/distress. No paralytics without anesthesia.
    • Attending veterinarian is involved in planning. (also 2.33)

    
    

11. IACUC Records: 2.35 (a)(1-3)
    • Minutes, proposed activities or significant changes, approvals or disapprovals of protocols, and semiannual reports with recommendations.

    
    

12. Exceptions to Regulations and Standards: 2.36 (b)(3)
    • IACUC-approved exceptions to regulations and standards attached to annual report (APHIS Form 7023).

The U.S. Department of Agriculture (USDA) prohibits discrimination in its programs on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, and marital or familial status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (braille, large print, audiotape, ect.) should contact the USDA Office of Communitcations at (202) 720-5881 (voice) or (202) 720-7808 (TDD).

To file a complaint, write Secretary of Agriculture, U.S. Department of Agriculture, Washington, DC 20250, or call (202) 720-7327 (voice) or (202) 720-1127 (TDD). USDA is an equal employment opportunity employer.

Issued Auggust 1995