Monitoring & Oversight - Animal | Research Administration / CTSI

Mission

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 safety 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 safety 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, safety 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 safety events and protocol deviations.

Refer to the Reporting and Resources section for more information.

FAQs

Is Oversight and Outreach a part of the IACUC?

The Oversight & Outreach Office is independent of the IACUC and reports directly to the Assistant Dean of Regulatory Affairs and Research Integrity.

How do I report animal welfare concerns?

Should you have a concern or question about the welfare of any animal, contact your supervisor and/or the principal investigator of the research project. You may also contact the:

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

What is a "PAM" Review?

A Post Approval Monitoring review (PAM review) is a review of the work being done on an approved IACUC protocol. It is performed to provide assurance to regulatory agencies that studies are conducted in a manner that is consistent with the approved protocol. These reviews are used by the IACUC to ensure that animal activities approved by the IACUC are conducted according to applicable external regulatory rules and Wake Forest SOPs (SOP 23). A PAM review is also a good time for O&O staff to provide one-on-one training/updates on regulatory or policy changes to your team as well as answer any of your questions. In addition, procedures that are currently being done as part of the protocol will be observed to confirm that they are being done as described in the protocol.

What do I do if there are health complications (anticipated or unanticipated) affecting the animals in my research?

The Animal Resources Program provides clinical veterinary assistance for any animal health and welfare concerns. Vet staff is available 24 hours daily for clinical emergencies. Contact information is posted next to all phones in vivarium hallways. O&O staff can assist you with any required reporting of unexpected safety events or protocol deviations involving animal health/welfare. Detailed information, including FAQs for specific SE guidance, can be found on the Reporting Procedures page.

What is AALAC and why do we need AAALAC certification?

AAALAC International (AAALAC) is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. While mandated external oversight is provided by the USDA, OLAW and AAALAC, nearly 1,000 companies, universities, hospitals, government agencies and other research institutions in 46 countries have chosen to become AAALAC accredited, demonstrating that they meet the minimum standards required by law, and are also going the extra step to achieve excellence in animal care and use.

Many funding agencies, including the DOD, VA, NASA and NIH, consider AAALAC accreditation a sign of commitment to excellence.

Why do the regulations and policies keep changing?

Federal regulations and policies actually have not changed all that frequently. However, publications such as The Guide for the Care and Use of Laboratory Animals are periodically revised and updated. Guidance on the interpretation of regulations by governmental agencies such as OLAW and USDA will change over time as areas of interest shift and priorities change. O&O and the IACUC monitor these changes and accordingly the IACUC will adjust our institution’s policies to maintain compliance and high standards. The IACUC Board votes on any changes in standard operating procedure.

How will I be notified of any policy changes?

All animal users should receive the quarterly IACUC Animal Welfare Newsletter. This contains announcements and instruction on a variety of topics. In addition, the IACUC Director sends out emails notifying animal users of any important or impactful information.

Do I need to scrub and wear surgical gloves if I am doing rodent surgery?

Yes. IACUC SOP 13a specifically addresses surgical procedures in rodents. Aseptic technique requires that the surgeon scrub and wear a fresh pair of sterile surgical gloves for surgery on each rodent (SOP 13a, page3).

Which forms do I use to keep surgery or procedural notes?

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.

What do I do with expired drugs?

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

Why do I count pre-weanling rodents?

At WF, any animal that exists counts against the animal number approved in the protocol. Thus, if an animal is ordered or is born here, even if it may not survive until experimentally used (due to illness, breeding problems, or not suitable genotype/sex), or is used prior to weaning, it is counted as part of your approved animal numbers.

How do I get specialized training for specific biomethodology procedures like tail vein injections, gavage, anesthesia or intubation?

Animal Laboratory Training is required and provided through online training modules, hands-on training and periodic presentations. Specialized training can be arranged through WF Training Coordinator, Amanda Dillard (adillard@wakehealth.edu). She can meet with researchers or arrange veterinary assistance with new techniques or refresher training.

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