Post-Approval Monitoring (PAM) (IACUC)

Purpose

Boston University (BU) is committed to observing Federal policies and regulations and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International standards for the humane care and use of animals.  The intent of this policy is to describe the post-approval monitoring (PAM) activities in place at BU and the procedures for the PAM of Institutional Animal Care and Use Committee (IACUC) approved protocols. Adherence to this policy is mandatory unless a specific exception has been approved by the IACUC.

Covered Parties

This policy is applicable to all persons responsible for conducting research, teaching, training, breeding, and related activities, hereinafter referred to collectively as “activities”, involving live vertebrate animals conducted at or under the auspices of Boston University.

University Policy

PAM activities are performed to provide assurance to regulatory agencies and the BU IACUC that animal experiments are performed in accordance with approved IACUC protocols. The post-approval monitoring process confirms consistency and accuracy of approved protocols and practices.

Types of PAM Activities:

I. Semiannual Facility Inspections:
These inspections are performed by IACUC members with the assistance of the Animal Welfare Program (AWP) at least every six months. While focused primarily on facilities, these inspections also support protocol compliance review in the following ways: a) mechanism to monitor compliance with facility-related issues regarding equipment and processes, b) monitoring of drug storage and usage, c) monitoring of surgical and procedure logs, d) assessment of protocol personnel’s general knowledge of protocol content, e) monitoring for potential animal health and welfare issues, and f) dissemination of information regarding new policies and reinforcement of “best practice.” Semiannual reports of visits conducted, including corrective actions, are reviewed at a convened IACUC meeting.

II. Ongoing Oversight by the BU Animal Science Center (ASC):
Live vertebrate animals at BU are subject to routine monitoring and evaluation by ASC staff. These include, but may not be limited to daily observations of animal health and welfare.

III. Formal “For Cause” Protocol Monitoring:
“For cause” monitoring may be conducted at any time by the AWP, with or without advance notice to the Principal Investigator (PI) or research personnel when there are any animal welfare or noncompliance concerns.

IV. PAM of IACUC-Approved Protocols:
All active IACUC-approved protocols involving the use of live vertebrate animals are subject to PAM. In general, the AWP will schedule monitoring sessions with the PI or other laboratory personnel in advance. However, monitoring may be performed without prior notice.

All active protocols involving the use of exemptions to social housing of animals, involving the Category E designation and all USDA-covered species will be monitored at least once annually, or more frequently, at the discretion of IACUC or Attending Veterinarian.

All protocols, including field research protocols, will be monitored at least once every three years, or more frequently, at the discretion of IACUC or Attending Veterinarian.

Procedures for PAM of IACUC-Approved Protocols:

A. Monitoring Process:

• The AWP 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.
• The Post-approval monitors (PM) are typically AWP staff and may include ASC veterinarians, IACUC members or external consultants.
• The PI and all staff working on the protocol are expected to be present for the visit and to participate in providing information to the PM as requested. The PI or PM may invite ASC veterinary or husbandry staff to provide information.
• The PM shall wear the PPE prescribed for the specific activity or laboratory.
• During each monitoring session, the PM 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 policies and regulatory requirements.
• When possible, at the completion of the monitoring the PM will discuss the monitoring results, including any departures noted, with the PI and staff. The discussion may include formulation of a corrective action plan (to be presented to the IACUC by the PM) to be implemented by the PI once approved.
• Animal welfare issues will be immediately reported to the IACUC and the AV. The AWP staff will gather information to present to the IACUC for review and, if necessary, further investigation.
• At the discretion of the PM, research procedures may be placed on hold if animal welfare issues are observed. In such cases, the PM will immediately contact the AV.

B. Follow-Up Process:

• A summary of animal welfare concerns and noncompliance and proposed corrective action plan will be reported to the IACUC for review and approval.
• The PM will send a final written report of the monitoring results, including departures from the protocol or applicable regulatory requirements, and corrective action plans, to the PI, the IACUC Chair and the Attending Veterinarian.
• The AWP will follow up on any issues that require corrective action and will attempt to support the laboratory corrective action by providing or scheduling required training or assistance with form preparation (e.g., amendment submission).
• On occasion, additional monitoring sessions may be part of the follow-up to assist with and ensure proper corrective actions.

C. Reporting:

• Issues of veterinary care that pose an immediate threat to animal welfare will be referred to the Attending Veterinarian or another ASC veterinarian for immediate resolution.
• Any departures from the approved protocol, Guide for the Care and Use of Laboratory Animals, Eighth Edition, or Animal Welfare Act regulations that may constitute significant, serious or continuing violations will be immediately reported to the AWP. Such departures will be reported to the IACUC for discussion to determine specific IACUC corrective actions, and whether they are reportable to the Office of Laboratory Animal Welfare (OLAW), United States Department of Agriculture (USDA), or AAALAC.

D. Appeal Process:

PIs who disagree with monitoring results, corrective action plans or recommendations have 10 business days from receipt of the final written report to submit an appeal in writing to the IACUC. The appeal should include the specific provisions being challenged, the reason for the appeal, and the justification for a different outcome.

E. Recordkeeping:

A copy of the final written report, including a record of all corrective actions, will be kept on file by the AWP.  PAM results will be recorded by the AWP for use on institutional trends or follow-up.

Responsible Parties

Principal Investigators are responsible for: preparing and submitting applications; making modifications in applications in order secure IACUC approval; ensuring adherence to approved protocols; ensuring that all personnel have completed required training; and reporting any adverse events to the IACUC.

The Animal Welfare Program and the Institutional Animal Care and Use Committee are responsible for overseeing implementation of and ensuring compliance with this policy.

The Attending Veterinarian has been delegated authority to implement BU’s veterinary care program, and to oversee the adequacy of all other aspects of animal care and use.

Definitions

Attending Veterinarian: is an individual who has received training or experience in the care of the species being attended and who has direct or delegated authority for activities involving animals.

Boston University Animal Science Center (BU ASC): means the animal facility that oversees veterinary medical care and animal care services at BU, and actively participates in all facility design. Day-to-day care of animals and technical assistance are provided by animal caretakers.

Category E procedure: means a procedure that may produce pain or distress lasting for more than a moment, which will not be alleviated through analgesia, anesthesia, or other methods.

Institutional Animal Care and Use Committee (IACUC): means the committee that is responsible for oversight and evaluation of the entire Animal Care and Use Program and its components as described in The Guide for the Care and Use of Laboratory Animals, Eighth Edition. Its oversight functions include review and approval of proposed animal use (protocol review) and of proposed significant changes to animal use; regular inspection of facilities and animal use areas; regular review of the Program; ongoing assessment of animal care and use; and establishment of a mechanism for receipt and review of concerns involving the care and use of animals at the institution.

USDA-regulated species: means any live dog, cat, monkey (nonhuman primate mammal), guinea pig, hamster, rabbit, or such other warm-blooded animal, as the Secretary of Agriculture of the United States may determine is being used, or is intended for use, for research, testing, experimentation, or exhibition purposes, or as a pet; but such term excludes (1) birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research, (2) horses not used for research purposes, and (3) other farm animals, such as, but not limited to livestock or poultry, used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber. With respect to a dog, the term means all dogs including those used for hunting, security, or breeding purposes.

Related Policies and References

Guide for the Care and Use of Laboratory Animals, Eighth Edition

Animal Welfare Act and Animal Welfare Regulations

History

Effective Date: 02/04/2025
Next Review Date: 02/03/2028