Post-Approval Monitoring Program

There are two primary components of the post-approval monitoring plan:

  • Ensure animal health and welfare
  • Protocol compliance
  1. Animal Health and Welfare

Responsible body: CCMS

Purpose: To ensure that animal health and welfare is in accordance with approved IACUC protocols

Monitoring plan:

  • 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.
  1. Post-Approval Protocol Compliance

A. Objective:

    • 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.

H. Reports:

    • 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.