1. IACUC EVALUATIONS Program Reviews & Facility Inspections William R. Parlett, Jr., DVM, DACLAM Compliance Officer (Contractor) Office of Laboratory Animal Welfare NIH, DHHS

2. IACUC EVALUATIONS Program Review Program Review Facility Inspection Facility Inspection Reports of Evaluations Reports of Evaluations

3. IACUC EVALUATIONS At least Once Every Six Months At least Once Every Six Months IACUC May Determine the Best Means…. IACUC May Determine the Best Means…. –The Guide –USDA Regulations –PHS Assurance

4. IACUC EVALUATIONS IACUC May Invite Ad Hoc Consultants to Assist IACUC May Invite Ad Hoc Consultants to Assist IACUC Remains Responsible IACUC Remains Responsible –For the Evaluations –For the Reports

5. IACUC EVALUATIONS OLAWs Interpretation OLAWs Interpretation –IACUC Function / Responsibility –Committee Members Should Be Involved in the Process –No Member May be Involuntarily Excluded

6. IACUC EVALUATIONS - Program Guide and CFR Guide and CFR Program Components to Consider Program Components to Consider –IACUC Membership and Functions –IACUC Records and Reporting Requirements –Husbandry & Veterinary Medical Care –Personnel Qualifications and Training –Occupational Health and Safety

7. IACUC EVALUATIONS – Facilities George, can I pet the bunnies? Lennie Of Mice and Men John Steinbeck John Steinbeck

8. IACUC EVALUATIONS – Facilities Animal Facility – Any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation. Animal Facility – Any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation.

9. IACUC EVALUATIONS – Facilities Satellite Facility – any containment outside of a core facility or centrally designated or managed area in which animals are housed for more than 24 hours. Satellite Facility – any containment outside of a core facility or centrally designated or managed area in which animals are housed for more than 24 hours.

10. IACUC EVALUATIONS – Facilities Animal Housing Animal Housing Feed, Water, and Bedding Feed, Water, and Bedding Cage Washing & Storage Cage Washing & Storage Surgery and Surgical Support Surgery and Surgical Support Procedure Areas and Laboratories Procedure Areas and Laboratories Storage and Mechanical Areas Storage and Mechanical Areas

11. IACUC EVALUATIONS - Reports Description of Adherence to the Guide and PHS Policy Description of Adherence to the Guide and PHS Policy Identify Departures and State the Reasons Identify Departures and State the Reasons Distinguish Significant v. Minor Deficiencies Distinguish Significant v. Minor Deficiencies

12. IACUC EVALUATIONS - Reports Reasonable and Specific Plan and Schedule Reasonable and Specific Plan and Schedule Identify AAALAC Accredited Facilities Identify AAALAC Accredited Facilities Signatures of a Majority of the Members Signatures of a Majority of the Members Minority Views Minority Views

13. IACUC EVALUATIONS - Reports Upon Completion of Evaluations Upon Completion of Evaluations Submit to Institutional Official Submit to Institutional Official Maintained by Institution Maintained by Institution Made Available to OLAW upon Request Made Available to OLAW upon Request

14. IACUC EVALUATIONS Use of AAALAC Site Visit for Evaluations Use of AAALAC Site Visit for Evaluations –Report Must be Compliant with PHS Policy –Report must be Endorsed by IACUC as the Official Report and Must be Submitted to IO –Must be Compliant w/USDA Regs (if applicable) e.g., at least two (2) IACUC Members e.g., at least two (2) IACUC Members

15. IACUC EVALUATIONS Areas of Concern Areas of Concern –Lack of Required Contents, e.g. Checklist Only –Checklist Faux Pas –Limited Participation - Veterinarian &/or Chair –Missing Signatures / No Indication of Committee Input or Review

16. IACUC EVALUATIONS Areas of Concern Areas of Concern –No Indication of Submission to IO –Timeliness (Evaluations and/or Reports) –Reporting Channels –Years of No Deficiencies

17. IACUC EVALUATIONS Areas of Concern Areas of Concern –Significant (major) v. Not Significant (minor) –Program Review v. Facility Inspection –No Animals, No Inspection, No Documentation –Missed Areas

18. IACUC EVALUATIONS Questions Questions –OLAW Staff –http://grants.nih.gov/grants/olaw/olaw.htm

19. IACUC EVALUATIONS Thank You