Protocol Compliance Monitoring
PERFORMANCE STANDARD: The goal of compliance monitoring is to work with, and in support of, the research staff member, and to confirm accurate and consistent protocol performance in a collegial and unobtrusive manner. According to the “Guide for the Care and Use of Laboratory Animals (8th Ed.)”:
Continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies. Post-approval monitoring (PAM) helps ensure the well-being of the animals and may also provide opportunities to refine research procedures; PAM programs are more likely to succeed when the institution encourages an educational partnership with investigators. A well designed PAM program can benefit the research process by supporting:
- The Institution by reducing non-compliance
- The Researchers by helping them avoid distractions and consumption of resources to resolve issues of non-compliance
- The Animals which receive better treatment during all phases of a research protocol, and
- The Science which will be more consistent and of a higher quality
BACKGROUND: Post-approval monitoring of Institutional Animal Care and Use Committee (IACUC) protocols is performed to provide assurance to regulatory agencies and the BU IACUCs that animal experiments are performed in accordance with approved IACUC protocols. The Protocol Assurance Liaison (PAL) confirms consistency and accuracy of approved protocols and practice.
• IACUC: The PAM program should be considered an extension of the oversight and educational functions of the IACUC.
• Principal Investigators (PIs) and laboratory staff: Works with the PAL to observe and confirm monitoring procedures with the approved protocol.
• Veterinarians and husbandry staff: Provides medical and day-to-day care for animals and special veterinary services in support of the approved protocols in collaboration with the researchers and IACUC.
• PAL: Works with the PI and laboratory staff to observe activity, prepare accurate reports, and provide recommendations for maintaining compliance, and endeavors to provide training and assistance if needed.
• Manager, IACUC: Provides operational oversight and management of the Protocol Assurance Liaison (PAL) and the compliance monitoring program, assures the IACUC receives reports or updates on items of concern, and provides support as required to assure compliance.
Selection of Protocols for Review:
A. All active protocols involving the use of exemptions to social housing of animals, involve the Category E designation and all USDA-covered species will be monitored at least once annually, and more frequently at the discretion of IACUC and veterinary personnel.
B. Approximately one-third of the protocols involving less invasive procedures will be monitored at least once annually and more frequently at the discretion of IACUC and veterinary personnel. Therefore all protocols will be monitored at least once every three years.
C. In general, the Protocol Assurance Liaison (PAL) or designee will schedule monitoring sessions with the Principal Investigator or other laboratory personnel in advance. However, the PAM program reserves the right to perform monitoring without prior notice.
Process of Monitoring:
A. The PAL shall normally notify the PI that the protocol will be monitored and attempt to make an appointment for routine visits. Follow-up non-compliance visits may or may not be scheduled.
B. The PAL may bring a veterinarian, a member of the IACUC or an external consultant if the IACUC deems it necessary.
C. The PI and all laboratory staff working on the protocol will be expected to be present for the visit and to participate in providing information to the PAL as requested. The PI or PAL may invite the veterinary or husbandry staff to participate in providing information to the PAL if appropriate.
D. The PAL may use a standardized checklist for the activity review or another form approved by the IACUC Manager.
E. During each monitoring session, the PAL will compare procedures conducted in the laboratory with those described in the approved protocol. All procedures described in the approved protocol must be carried out in accordance with applicable IACUC guidelines and federal regulations and guidelines. Documented departures of the procedures performed in the laboratory from the protocol and applicable guidelines and regulations will be brought to the attention of the Principal Investigator. Such departures may include:
- Personnel who are performing procedures are not listed in the approved protocol.
- Procedures that are performed in the laboratory but not listed in the approved protocol.
- Anesthetics, analgesics, tranquilizers, antibiotics or other medications used in the animal procedures that are not noted in the protocol, are different from those listed in the protocol, or are not used in accordance with the protocol.
- Procedures listed in the protocol to promote animal welfare (e.g. post-operative monitoring procedures) that are not being performed as approved in the protocol.
- Survival surgery that is not being performed aseptically.
- Euthanasia procedures that are employed differ from those listed in the protocol and/or a method for ensuring euthanasia (e.g. after CO2 exposure) is not employed.
F. Other issues of concern may include:
- Laboratory personnel appear to lack the necessary training to appropriately perform procedures as described in the protocol.
- Supporting documentation for animal care, post-operative care or other study procedures is incomplete or unavailable.
- Conditions are not safe for humans and/or animals.
- Outdated materials (drugs, suture, etc.) are used.
- Equipment (e.g. anesthetic vaporizers) in use is not calibrated or certified.
- There is evidence of animal misuse, mistreatment or neglect.
G. Process of Sharing Information Concerning the Review:
- When possible, the PAL will discuss monitoring results, including any and all departures noted by the PAL, with the Principal Investigator and other laboratory personnel before leaving the laboratory. The discussion will include formulation of a corrective action plan (acceptable to the PAL) to be implemented by the PI, as needed.
- The PAL will send a written report of the monitoring results, including any and all departures from the protocol or applicable guidelines or regulations, and any corrective action plan with deadlines, to the Principal Investigator, laboratory personnel, IACUC Chair, IACUC Manager and Attending Veterinarian. If no departures are noted, the PI will receive a congratulatory report.
H. Process of Follow-up:
- The PAL will follow up on any issues that require corrective action. The PAL will attempt to support the laboratory corrective action by providing or scheduling required training and / or assistance with form preparation (Amendment submission).
- On occasion, additional monitoring sessions may be part of the follow-up to assist with and ensure proper corrective actions.
- Corrective actions may include, for example:
- Modifying an existing protocol,
- Reverting to the procedures which are already listed in the approved protocol
- Training or re-training
- Monthly reports of visits conducted, including status of corrective actions, and follow-up visits, will be reviewed at each scheduled IACUC meeting. Corrective action plans will be included in the monthly review until all corrections are completed.
- Issues of veterinary care that pose an immediate threat to animal welfare will be referred to the Attending Veterinarian or another veterinarian for immediate resolution.
- Any departures from the approved protocol, the Guide, or AWA regulations that may constitute significant, serious or continuing violations will be immediately reported to the IACUC Manager.
J. Process of Addressing Concerns:
- Investigators who disagree with monitoring results, corrective action plans and/or recommendations may appeal to the IACUC.
- A copy of the final monitoring report, including a record of all corrective actions, will be kept in the protocol file.
- The information concerning departures from approved protocols or applicable regulations and guidelines will be recorded for use as institutional trending or follow-up.
PERSONNEL PROTECTIVE EQUIPMENT (PPE): The Protocol Assurance Liaison (and other visitors) shall wear the PPE prescribed for the specific activity or laboratory.
BU IACUC Approved: Revised October 2012