Semiannual Program Review

Date Adopted: October 4, 2005

Last Review Date: October 15, 2020

I.  Policy

The Public Health Service [(PHS), PHS policy IV.B.1-8] and the United States Department of Agriculture [(USDA), Title 9, Chapter 1, subchapter A-Animal Welfare] mandate that The University of Montana Institutional Animal Care and Use Committee (IACUC) review the institution's program for the humane care and use of animals at least once every 6 months. The PHS and USDA policies require the use of The Guide for the Care and Use of Laboratory Animals (The Guide) and Title 9: Code of Federal Regulations, chapter 1, subchapter A-Animal Welfare, respectively, as standards for evaluation.

A report of the findings of semiannual IACUC program reviews must be reviewed and approved, minority opinions noted, and deadlines for deficiencies established by the IACUC. A copy of the final report must be provided to the Institutional Official.

II. Procedure

A.  Program review

1.  Timing

a.  Minimum of once every 6 months

b.  May occur independently of semiannual facility inspections

2.  Program review team

a.  Must consist of at least 2 IACUC members (Animal Welfare Regulations)

b.  Participation of Compliance Officer [appointed and supervised by the
     Institutional Official (IO)], Attending Veterinarian (AV), and IACUC
     Coordinator is recommended when possible

c.  No IACUC member may be excluded should he/she wish to participate

3.  Checklist

a.  A blank checklist will be used to guide IACUC members during program
     reviews and will be reevaluated semiannually by the IACUC Coordinator to
     ensure compliance with all federal, state, and institutional guidelines.

b.  One week prior to the review, the IACUC Coordinator should provide
     members of the program review team with a copy of the previous program
     review findings for reference.

c.  Checklist templates available at OLAW sample format

B.  Program review reports

1.  Internal institutional program review reports

a.  Components

1)  Written draft report of program review findings compiled by IACUC
     Coordinator and distributed to IACUC 

2)  Deficiencies identified by the program review designated as minor or
     significant in the draft report. Proposed correction dates for items in
     both categories, reached in consultation with the IACUC Chair and
     AV, included.

3) The report must describe the institution's adherence to the following
    federal guidelines and identify any deviations from them:

a)  Animal Welfare Regulations

b)  PHS Policy

c)  The Guide

4)  Minority views included in the final report.

b.  Review by the IACUC

1)  Revisions or corrections sent to IACUC Coordinator 

2)  Revised draft of the report distributed to IACUC 

3)  Discussion, revision, and approval of report and deficiency correction
     deadlines

4)  The final report signed by a majority of the IACUC present at IACUC
     meeting

5)  The IACUC-approved report forwarded to the IO

c.  Recordkeeping

1)  The final report kept on file for a minimum of 3 years

2)  The final report posted on a password-protected web site

2.  External reporting

a.  Annual reports to OLAW are filed by January 31 of the year following the
      reporting year and include the dates of program reviews.

b.  Significant deficiencies (defined as those that may be a threat to animal
      health or safety) discovered during program reviews must be reported to the
      appropriate agencies (OLAW, USDA, AAALAC) and funding units after the
      program review.

3.  Compliance monitoring

a.  The IACUC Coordinator will forward an updated deficiency correction log on
     a monthly basis to the IACUC until all deficiencies are corrected.

b.  Inability to meet significant deficiency correction deadlines within 15 days of
     the lapsed deadline must be communicated by the IACUC Chair on behalf
     of the IACUC through the IO to appropriate regulatory and funding agencies.