The purpose of the Animal Oversight & Outreach Program is to improve the quality of animal research through education, training, and post approval monitoring of research studies. This program is intended to be collegial, proactive, not punitive, and focuses on educating investigators and research staff about their ethical and regulatory responsibilities in the conduct of research. The program also manages the reporting of adverse events and the investigation of noncompliance incidents.
What is the relationship between the IACUC and the Oversight & Outreach Program (O&O)?
The IACUC and O&O are both components of the Animal Welfare Program. The O&O is charged with evaluating and enhancing animal research through education, training, and monitoring. The IACUC is charged with reviewing and overseeing animal research to ensure animals are always treated ethically and humanely. The feedback received from Oversight & Outreach reviews provides a way for the IACUC to improve these activities.
Post Approval Monitoring (PAM) Reviews
Post approval monitoring (PAM) reviews are performed to provide assurance to regulatory agencies and the IACUC that animal experiments are performed in accordance with approved IACUC protocols. A PAM review will confirm consistency and accuracy of approved protocols and practice. It includes an examination of records, lab facilities and observation of procedures.
The Oversight and Outreach Office ensures institutional compliance through quality assurance, post-approval monitoring (PAM ) reviews, management of adverse events, investigating incidents of noncompliance.
How are protocols chosen for review?
Selection of protocols includes a cross section of species, campuses and departments with an emphasis on:
- Pain category: All active protocols involving procedures with Pain Category E will be reviewed at least once a year.
- Survival Surgery: novel, high risk procedures will be reviewed.
- USDA regulated species.
- Labs with past compliance issues.
What can you expect during a PAM review?
- An appointment will be set up, in advance, between the Oversight & Outreach Specialist, the PI and/or other members of the research team. For Cause reviews may be conducted at any time, with or without prior notice to the PI.
- During the meeting, you will be asked about how the research project is going with regard to animal number, adverse events, etc. Records (training, drug, surgical, post-operative monitoring) will be reviewed for completeness.
- Whatever procedures are currently being done as part of the protocol will be observed to confirm that they are being done as described in the protocol.
- Whenever possible, the Oversight & Outreach Specialist will discuss the results of the review with the PI or research team before leaving the laboratory.
How long will the assessment take?
- If all records are available, the initial review will take approximately one hour. Procedural observations will last as long as the procedure and should be as unobtrusive as possible.
What happens after a PAM review?
- The Oversight & Outreach Specialist will write up a report using the Post Approval Protocol Review Sheet. The report will include a brief description of the observed procedures, any noted deficiencies, suggestions for improvement and any action items that must be addressed. A draft will be sent to the PI for comment.
- The final report will be sent to the PI, IACUC Chair, IACUC Director and Assistant Dean for Regulatory Affairs & Research Integrity. A brief summary will be verbally reported to the IACUC during its monthly meeting.
- The PI has 30 days to respond to any actions that must be taken and submission of any amendments required.
What are the possible outcomes of a PAM Review?
- If fully compliant, no follow up is needed.
- Minor deficiencies and resolutions are reviewed by the IACUC Chair and Vice Chair.
- Serious concerns or incidents of noncompliance are brought before the full IACUC for discussion and resolution.
Researchers are required to promptly report adverse events and protocol deviations.
Oversight & Outreach Office: 336-716-4127
IACUC Office: 336-716-3540
ARP Main Office: 336-713-7394
A confidential Concern Line is also available. WFU Concern Line at 1-877-880-7888 or www.tnwinc.com/Reportline
Many funding agencies, including the DOD, VA, NASA and NIH, consider AAALAC accreditation a sign of commitment to excellence.
For surgical procedures-
- A Surgical Record Form must be used
- An Intraoperative Monitoring Form (if applicable)
- A Post-surgical Observation Form which includes pain scores must be used until the animal is at Stage 0
For procedures which result/ may result in pain or distress, or involve humane endpoints (tumor bearing, infectious disease, radiation studies, etc.)-
- An Animal Welfare Assessment Form and/or a Scoring Rubric must be used.
SOP 13 and 13a indicate which essential information must be recorded. We have a selection of form templates in our Study Management Tools section for both rodent and non-rodent users. Rodent users can also review the Record Keeping presentation. If in doubt, please call the O&O staff.
Expired controlled substances should be stored in the same place as other controlled substances until disposed of through a reverse distributor or DEA agent. Expired controlled substances must be labeled as expired and kept separate from “in date” drugs. This can be as simple as a plastic bag or a box. Contact Environmental Health and Safety for more information (Bill Crouse, 336-716-3029).
Other expired drugs should be disposed of in a timely manner by contacting EH&S