There are two primary components of the post-approval monitoring plan:
- Ensure animal health and welfare
- Protocol compliance
- Animal Health and Welfare
Responsible body: CCMS
Purpose: To ensure that animal health and welfare is in accordance with approved IACUC protocols
- All experimental animals will be monitored daily by CCMS husbandry staff for evidence of illness or injury.
- Animal undergoing procedures that may have a high risk of morbidities or severe debilitation will undergo additional monitoring as outlined below.
- The IACUC will make the initial determination of placing a protocol on a more intensive post-approval monitoring plan.
- Likewise, any protocol yielding a large amount of sick reports by CCMS staff will be reported to the IACUC for placement on the more intensive monitoring program.
- Protocols referenced in c and d above will be added to a spreadsheet database maintained by the IACUC and provided to CCMS.
- CCMS veterinary technicians will inspect on a monthly basis animals on the protocols database.
- Sick or injured animals found on these rounds will be reported to the Veterinarians and cross-referenced on the spreadsheet (e.g. for humane endpoint compliance, etc.).
- Veterinarians will communicate with PIs regarding animal health issues, and report to the IACUC at a convened meeting for any necessary further action.
- Post-Approval Protocol Compliance
- To ensure that allprocedures (including euthanasia) and testing (e.g., behavioral testing) on animals are conducted in accordance with approved IACUC protocols throughout the duration of a study through its completion.
B. Responsible body: IACUC
C. Inspectors: IACUC members and a Compliance Coordinator (CC) will be responsible for implementing the two components of the post-approval monitoring plan.
D. Components of the Post-approval Monitoring Plan:
- Semi-annual inspections. Federally mandated semi-annual IACUC inspections of laboratories (where procedures are done on animals) will be carried out by IACUC members.
- Inspections/Interviews by the Compliance Coordinator (CC): Periodic inspections of laboratories will be conducted by the CC.
E. Inspections process:
- IACUC Inspectors and/or the CC will interview PIs and personnel responsible involved in the study.
- IACUC Inspectors and/or the CC will inspect areas of the laboratory where procedures are performed on animals as well as CCMS procedure rooms.
F. Subjects monitored: Examples of information gathered during these inspections will include, but will not be limited to:
- Procedures conducted on live animals anywhere in the vivarium (procedure-and animal-rooms)
- Euthanasia performed in the laboratory or in the vivarium
- Use of anesthesia and analgesia, and pertinent records.
- Monitoring plans of the health conditions of genetically modified animals.
- Weight and body condition score records
- Training of laboratory personnel.
- Housing of animals in laboratories.
- When requested by the committee or judged necessary by the Veterinarians or the CC, the CC (or a member of the veterinary staff) will observe research staff performing animal procedures. Results of this observation will be reported in writing to the IACUC.
G. Monitoring frequency:
- Inspections will be conducted semi-annually by teams of IACUC members, as required by federal regulations
- The CC will conduct inspections and interviews according to a schedule determined at a regular IACUC meeting.
- The IACUC will determine which protocols will be placed on a special monitoring list and provide the list to the CC and to the veterinary staff.
- The CC schedule will be flexible but should not duplicate or overlap with the semi-annual inspections.
- The CC inspection frequency will be based on a ranking of protocol according to the level of pain and distress involved in the study:
- Class 1 studies (see Note below): Every two years
- Class 2: once a year
- Class 3 and above: twice a year or more frequently as recommended by the veterinary staff.
Note: Studies involving immediate sacrifice and tissue collection are to be considered class 1 only if the animals involved do not have a pathologic phenotype and have a normal life span. Studies involving immediate sacrifice and tissue collection of genetically modified animals with pathologic phenotypes or shortened life span are to be classified at level 2 and above, depending on the nature of the pathology.
- Written reports of the inspection findings will be generated by IACUC inspectors and by the CC.
- Reports will be submitted to and reviewed by the IACUC at a convened meeting.
- After review of the records, the IACUC will recommend appropriate action(s) to correct compliance violations.
- Serious instances of non-compliance will be investigated by the IACUC and addressed according to existing policies.
- Findings of the overall post-approval monitoring program and corrective actions plans will be included in the semi-annual reports to the IO.