Post Approval Monitoring
The IACUC has an obligation set forth by NIH OLAW and USDA APHIS to oversee and continually review all aspects of the institution’s animal program. Methods of review include semiannual evaluation of USC’s program for the humane care and use of animals, semiannual facility and laboratory inspections, continuing review of animal use protocols, and post approval monitoring of animal activities.
Post approval monitoring (PAM) is an opportunity for the IACUC to follow up with researchers after initial protocol approval to observe activities and serve as a resource to the research community. The PAM process is meant to be a collegial experience with a focus on education and an exchange of information.
The primary goals of PAM:
1. Ensure animal welfare
2. Foster a culture of care for animals, staff, and science integrity
3. Refine experimental techniques
4. Document evidence of good performance and adherence to IACUC protocols and policies
PAM at USC is largely proactive and curiosity driven but may also include for-cause audits.
Monitored activities may include:
– Observation of select procedures or surgeries
– Assessment of animal well-being after disease/injury/condition induction
– Training in specialized animal handling or care
– Submission of a progress report on research outcomes by the PI to the committee
– Review of documentation
– Screening for pathogen contamination in cell lines and biological materials used in vivo
The spirit of PAM is to observe and assess animal research as it is occurring in real time and encourage transparency between the researcher and the IACUC. The PAM process should not be initiated by the PI simply to remove the monitoring requirement.
Additional Information
During the protocol review process, any IACUC member or ad hoc consultant may recommend an animal activity for post approval monitoring. Activities that generally get flagged include:
– Animal models or procedures novel to USC
– Multiple major survival surgeries
– Procedures where analgesics are withheld with scientific justification
– Surgeries with USDA regulated species
– New surgeons
– Procedures where there is increased risk for animal welfare impact
Once the protocol is approved, a monitoring flag is placed on the protocol identifying the activity to be monitored and the action required by the PI.
The PI or research staff may also request PAM voluntarily when they wish to receive guidance on a procedure or need help troubleshooting unexpected or adverse effects in an experiment.
For-cause PAM may be required as a result of animal welfare concerns raised by an individual or as a corrective action for noncompliance with the IACUC.
Research staff should be familiar with their IACUC approved animal use protocols as they are written in iStar and have all the necessary equipment and materials for the animal activity to be monitored. Ensure materials are not expired and animals are housed on the correct protocol.
When ready to be monitored, contact the individuals named in the monitoring flag or the DAR Animal Research Integrity Specialists to schedule. Anticipate providing dates 1-2 weeks in advance for monitoring.
If the researcher requires training to perform the procedure to be monitored, clarify this need ahead of the monitoring.
Remember, PAM is intended to be a review of animal research in action. Do not schedule a demonstration or “dress rehearsal” simply to get the monitoring flag removed. The IACUC wants to see your procedures performed for, and follow the animals through, your actual experiment.
After a PAM activity, the Animal Research Integrity Specialist (or designee) will send a summary of findings to the researcher(s) involved and the PI.
Findings generally fall into the following categories:
– No issues found or recommendations made
– Recommendations for refinement
– Items requiring action (e.g.: protocol amendment)
The Specialist will also file a report in iStar summarizing the monitored activity, findings, and recommendations. PAM reports are associated with the PI’s relevant protocol(s).
PAM reports may be discussed at an IACUC meeting where the committee may make further recommendations to the PI, continue the PAM requirement, or close monitoring.
PAM usually goes well. Researchers are skilled and knowledgeable about their experiments and come prepared with good questions and a willingness to refine techniques.
Some areas that often require some improvement to meet USC standards include:
– Aseptic technique (e.g.: sterile draping, aseptic skin preparation, maintaining sterile fields)
– Suturing skills
– Surgical and post-operative record keeping
– Animal monitoring and assessment of humane endpoints
– Housekeeping items (e.g.: checking expiration dates, maintaining organized and clean work spaces)
– Protocol adherence (e.g.: deviation in time points, surgical approach)
If you need help in any of these areas, the DAR Animal Research Integrity Specialists are available to provide training or guidance.
Frequently Asked Questions
If a monitoring flag is placed on your protocol, yes, you are required by the IACUC to complete PAM for the listed activity.
In iStar, you will see a red box at the top of your protocol home page that indicates monitoring is required and what you need to do to complete the monitoring. You will also receive automated email reminders from iStar.
You are being flagged for PAM because the IACUC has an interest in the work that you are performing. PAM is most often initiated for procedures novel to USC or procedures that have a risk of impacting animal welfare. The IACUC wants to check in to make sure the animals do well, and you have resources on hand in case refinements must be made to improve animal welfare.
Primarily the DAR Animal Research Integrity Specialists who are Registered Veterinary Technologists and have extensive experience in laboratory animal medicine. DAR Clinical Veterinarians or other IACUC members may also be involved with PAM.
No, there is no deadline to complete PAM. The first time the PI plans to perform the flagged procedure is when PAM must be initiated.
The IACUC understands that protocols may be approved before funding is secured or that research trajectory may change. The monitoring flag remains on the protocol until the PI is ready to begin the flagged work.
To be successful, researchers must demonstrate knowledge of their approved IACUC protocols, perform experiments and procedures as they are written in the protocol, and be considerate of animal welfare.
It is possible for animal complications to arise during the monitoring process and still have a successful PAM. It is important that the researcher work closely and collegially with the persons performing the PAM to troubleshoot the complication and find possible solutions or refinements.
The researcher and procedure are evaluated on a holistic level given the details and events within the visit.
iStar sends automated reminders about PAM flags. A reminder is also sent whenever a change to the protocol is approved (e.g.: amendment or renewal). You only need to act on the reminder if you are ready to begin the flagged activity.
If you do not have plans to perform the flagged activity, then the PAM flag remains until you are ready to perform the activity or until that activity is removed from the protocol.
If you perform the flagged activity without notifying the Animal Research Integrity Specialists so they may observe, then you may be found in noncompliance with the IACUC.
You are recommended to amend your animal use protocol to reflect your new research plans.
The monitoring flag will remain on the protocol until the activity is either completed or has been removed from the protocol.
PAM reports may be assigned to multiple protocols. If the procedures are the same and performed in the same manner, one PAM may apply to multiple protocols. If different individuals will be performing the procedure, the IACUC or Animal Research Integrity Specialists may ask to observe each individual separately.
Absolutely! DAR Animal Research Integrity Specialists are valuable resources. You are highly encouraged to reach out to them with your animal research questions and to have them run through or troubleshoot procedures with you.
Email the IACUC at iacuc@usc.edu