INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)
UCSF POST-APPROVAL MONITORING PROGRAM (PAM) (REVISED MAY 2013)
Program Scope
The goal of the Post-approval monitoring (PAM) program is to support research staff in
conducting procedures in accordance with an approved IACUC protocol and applicable policies
and regulations. PAM is integrated into numerous regulatory functions, including semi-annual
inspections, protocol reviews, and hands-on training requirements. The Training and
Compliance (T&C) unit aims to provide outreach and training to the scientific staff, helping to
create a compliance minded research community.
T&C manages and conducts the following components of the PAM Program:
Protocol reviews
 Survival Surgery Review: education and training through constructive
engagement
On a protocol specific basis, commitments and UCSF Guidelines pertaining to survival
surgery are reviewed in a meeting scheduled with staff involved in surgical and postsurgical care. The Survival Surgery Review is intended to proactively answer
researchers’ questions and address inconsistencies, thus preventing later noncompliances. These small-scale, casual meetings also give laboratory personnel a
direct, known liaison to the IACUC office.
 Formal Protocol Review process
T&C identifies and presents discrepancies or other compliance related protocol findings
to the IACUC during the full committee protocol review. Identifying potential noncompliances prior to protocol approval/renewal allows issues to be addressed early
through education rather than later through mandated retraining.
 Spontaneous protocol reviews: specific reported concerns
Such reviews may be promoted by receipt of a complaint, an Animal Care and Use
Concern Reporting Form, the IACUC, LARC or laboratory staff. These may be
conducted by T&C, or, if veterinary expertise is required, will include a LARC
veterinarian. The extent and content of the audits will vary depending on the specific
protocol being audited, but may include meetings with PI’s/lab staff to discuss
procedures, reviews of medical or surgical records, and/or procedure observations.
 Focused protocol audits: a closer look at high-risk categories
Each year, a designated “high-risk” group of approved protocols is chosen by the IACUC
to be examined more closely by T&C. Audits may include protocol review, discussion of
procedures with lab personnel in person or by e-mail, procedure observations, medical
record review, or other applicable contact with labs and PI’s.
Procedure Observations
 T&C staff, frequently accompanied by a LARC veterinarian, visits labs to observe
personnel perform animal procedures. This may be IACUC-mandated in response to a
lab’s non-compliance, to address IACUC members’ concerns about animal welfare
during/after a new or unusual procedure, or to provide feedback on lab personnel’s
ability to perform the procedure independent of LARC/IACUC oversight.
IAC26 (5/2013)
Inspections
 Semi-annual inspections
Teams comprised of T&C staff, LARC veterinarians, and IACUC members inspect all
LARC centralized spaces and USDA animal use areas in the spring and fall each year,
using the Guide as a resource. These teams also inspect select animal use areas
outside LARC space, including behavioral testing, survival surgery, and animal housing
locations. T&C generally conduct semi-annual inspections of all other rodent use
locations outside of LARC space, and may be accompanied by LARC veterinarians
and/or IACUC members.
 Mock USDA inspections
During quarters which the semi-annual inspections do not occur, T&C conducts mock
USDA inspections, visiting all USDA covered species locations and using the same
criteria as is used during the semi-annual inspections.
 Quarterly Inspections of Hunter’s Point Animal Facility
Inspections of this facility occur during the regular semi-annual inspections by IACUC
members. During the alternate quarters when semi-annual inspections do not occur,
T&C conducts facility inspections using the Guide as a resource and the semi-annual
inspection checklist. EHS or LARC staff, or IACUC members may assist T&C with these
inspections.
 Initial inspections of non-LARC housing, surgery, and behavior areas
When protocols include new requests to house animals, perform survival surgery, or
conduct behavioral studies outside of LARC space, T&C coordinates inspections of
these spaces. The inspection team may include IACUC members and LARC
veterinarians in addition to T&C staff. The inspection team evaluates the
appropriateness of the space for the designated use, the need to use space outside the
vivarium, and meets with lab personnel who will be responsible for the animals.
Protocol expiration tracking
 When protocols expire, T&C communicates with the laboratory to ensure any study
related animal work will discontinue, and that routine care will continue to be
administered. Suggestions for animal transfer or donations are provided when the
protocol will remain inactive, otherwise the animals are transferred to the LARC holding
protocol until the expired protocol is renewed. T&C request an acknowledgment of any
electronic communications to ensure compliance.
The PAM program efforts may shift on an annual or semi-annual basis depending on the needs
of the University, the Institutional Animal Care and Use Program, and the identification of new
risk categories to animal welfare and or protocol compliance. Program integrity resides in
successful post-approval monitoring, with which UCSF researchers can work toward the
common goal of advancing health worldwide.
IAC26 (5/2013)