Background

According to the Guide for the Care and Use of Laboratory Animals (pgs. 33, 34):

"Continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies." "PAM [Post approval monitoring] helps ensure the well-being of the animals and may also provide opportunities to refine research procedures. Methods include continuing protocol review; laboratory inspections (conducted either during regular facilities inspections or separately); veterinary or IACUC observation of selected procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections and assessments."

Scope

Wayne State University's PAM program is part of the Office of Research Integrity and implemented by the IACUC, and/or Research Compliance Specialist. The primary goal of the PAM program is to foster a positive research culture by striving to establish a collaborative/collegial, educational partnership with PIs to promote and ensure 1) animal welfare, 2) protocol compliance (i.e. accurate and consistent adherence to the approved protocol), 3) high quality research, and 4) exchange of information (e.g. new policies, regulations, and guidelines that may affect protocol compliance and/or laboratory best practice).

Factors that may be monitored include, but are not limited to: examination of surgical areas, use of appropriate aseptic technique, review of anesthetic and surgical records, the number of animals used, proper training and continuing education of personnel, observation of other procedures being performed, maintenance of accurate records, and use of approved analgesia and anesthesia.

General Responsibilities

The IACUC will:

• Review all protocols after a three-year approval period as new submissions. Using the eProtocol system, expiring protocols can be cloned to facilitate resubmissions.
• Inspect animal facilities, including satellite facilities and animal use sites every six months. This will include an inspection of the facility and may also include the review of animal care, procedure or training records with individual Principal Investigators and/or laboratory staff.

The Senior Research Compliance Specialist will:

• Select active protocols for monitoring. Protocols may be selected based on specific protocol criteria, or on a random basis. In addition, for-cause monitoring may occur due to animal welfare or non-compliance concerns.
• Coordinate a visit to the laboratory with the PI and laboratory personnel.
• Work with the PI and laboratory personnel to review protocols and observe animal research activities according to the laboratory schedules.
• Provide a brief summary of findings to the IACUC, and when necessary resolve any areas of potential concerns with the IACUC.
• Provide a written summary to the PI with recommendations and support as required to ensure compliance with the approved protocol, applicable IACUC guidelines, and federal regulations and guidelines. Summary may include recommendations for additional monitoring, training, and/or requirement for an amendment to the protocol.

The Principal Investigator must:

• Provide access to all locations where animals are being used to the IACUC for semi-annual inspections and respond to deficiencies as requested by the IACUC.
• Submit protocol for a Continuing Review (CR) annually for review, if applicable per funding (e.g. VA or DOD funding.)
• Submit a new protocol after the three-year approval period for review by the IACUC.
• Respond to the Sr. Research Compliance Specialist request for PAM
• Participate in the PAM process
• Provide information to the Sr. Research Compliance Specialist as requested
• Allow Sr. Research Compliance Specialist to observe procedures as requested
• Schedule a protocol review with Sr. Research Compliance Specialist if requested and provide appropriate room and conference table to accommodate the procedure. The review should include all available laboratory staff with live animal responsibilities on the protocol.
• Incorporate changes in procedures and/or protocols as required by the IACUC or Sr. Research Compliance Specialist within four (4) weeks of receipt of PAM summary.

Approved: June 2019

Revision approved: October 2022