Navigating an IACUC Inspection of Research Laboratories

The Process

• 1-3 weeks prior to an inspection, the OACUW office will contact the Principal Investigator (PI) to schedule a visit.
• On a mutually agreed date and time frame, teams of two or more IACUC members will conduct an inspection of the laboratory.
• The PI or a person authorized by the PI should be present to provide the inspectors with an overview of the research, and a description of animal procedures used in the studies.
• After the inspection, a communication would be sent to the PI outlining the inspection findings and possible violations of regulatory policies.
• The PI will have 10 days to respond to the IACUC in writing with a plan to correct observed violations.
• The IACUC sends semiannually records of all laboratory inspections to the Institutional Official.

Examples of Questions asked by IACUC Inspectors

Note: It is IACUC policy to conduct inspections in a collegial, non-adversarial manner. Collegial cooperation is expected from PIs and their staffs. If the PI cannot be available for the inspection, a staff person authorized by the PI should be present. The person should be familiar with the research activities of the laboratory and should be able to describe animal procedures and to answer inspectors’ questions.

1. Is laboratory personnel wearing appropriate attire (e.g., a laboratory coat) while in the laboratory?

2. What animal species are used in the studies?

3. If genetically modified mice are used, do they have a normal or pathologic phenotype? How are animals with a pathologic phenotype monitored for pain and distress?

4. If live animals are brought to the laboratory, how are they transported, handled, and what procedures are performed on them? How long are they kept in the laboratory?

5. Are all IACUC-approved protocols available to laboratory staff? Is the staff familiar with the provisions described in the approved protocols (e.g. use of an aesthetics and analgesics, health monitoring of animals, humane endpoint criteria, etc.)?

6. Who is responsible for monitoring the health conditions of experimental animals after a procedure? How often are animals weighed? Is body condition checked and are body condition scores recorded as described in the approved IACUC protocols?

7. Are all areas used for procedures, such as euthanasia or surgery, clean and clutter free?

8. Are surgeries conducted in a dedicated area (at the time of surgery) of the laboratory? Is the area clean, clutter free and situated in a quiet part of the laboratory away from personnel traffic?

9. What anesthetics are used for painful procedures?

10. Is isoflurane administered via a precision vaporizer? Is the vaporizer certified periodically?

11. If isoflurane is administered with the “open drop” method (Isoflurane in a jar), is the procedure done in a fume hood?

12. How are the animals euthanized? Where is euthanasia carried out?

13. If CO₂ is used for euthanasia, is the gas tank equipped with a flow meter? Is tank the properly secured?

14. If animals are housed in a satellite room outside the central Vivaria, does the PI have IACUC permission to keep animals in such a facility?

15. How are animal carcasses discarded?

16. Are hazardous agents (e.g., toxins, carcinogens) used in the study? What SOPs are followed to handle and use the agents, and what Personal Protective Equipment (PPE) is used?

17. Are bio-hazardous agents (potentially infectious) used in the study? What SOPs are followed and what PPE is used?

18. Are controlled substances (e.g., Ketamine, Buprenorphine) used? Where are controlled they stored? Are logs of drug usage maintained?

19. Are all drugs administered to animals of pharmaceutical grade, and not expired?

20. What is the reason for administering chemical grade compounds? How are they prepared and stored? Are the storage vessels marked with an expiration date?

21. Are all animals weighed periodically as a part of a health-monitoring program? Is body condition checked periodically, and are the body condition scores recorded?

22. Who would be responsible for determining that the clinical condition of an animal are such that the animal should be removed from the study and humanely euthanized?