Postapproval monitoring (PAM) ensures that research is being carried out in the manner that was originally approved by the IACUC and many institutions employ PAM as a self-auditing mechanism to check on compliance. A well-run PAM program can also lead to improved animal welfare, science, and collaboration among departments in the animal care and use program. Having a robust framework for conducting PAM promotes education, transparency, and communication between researchers and the institution.
On December 5, PRIM&R hosted a webinar to provide strategies, resources, and solutions to common challenges for animal care and use professionals interested in implementing or improving PAM at their institutions. Speakers included David Cannon, CPIA, director of the IACUC office at the University of Alabama Birmingham, and Sandy Wilkins, LVT, CPIA, RLATG, IACUC research liaison at Michigan State University.
After the webinar, presenters responded to some of the attendee questions that time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand.
Should the individual conducting PAM be an IACUC member?
David Cannon (DC): Whether or not someone is an IACUC member isn’t as important as the insight the process will provide to the IACUC about how animal care and use is occurring at your institution. Having said this, it could be advantageous to have the monitor appointed to the IACUC; it is then possible to say that the IACUC is conducting the continuing review or aspects of the semiannual inspection process.
Sandy Wilkins (SW): At our institution the postapproval monitor is an IACUC member, conducting all semiannual inspections with a dedicated individual from environmental health and safety who also is a member of the IACUC. They are the “boots on the ground” for the IACUC, and report monthly at IACUC meetings on findings, issues, and/or concerns.
If noncompliance is found by PAM, what’s next?
SW: We work with the investigator and staff to correct any noncompliance found. At the weekly Oversight Group meeting, the postapproval monitor consults with the IACUC chair, attending veterinarian, and IACUC administrator to discuss findings and what the next course of action will be. Findings of noncompliance are reported to the IACUC at the monthly meeting..DC: This is why it is important to have a written process in place to lay out “what’s next” and remove ambiguity while you are investigating potential noncompliance. A written process also allows the individual conducting PAM to talk knowledgeably to all parties and communicate in clear and concise terms.
Do you have any recommended strategies for improving PAM programs at your institution?
SW: We encourage a team approach to improving programs that includes communication with supervisory, veterinary, and the IACUC. Ongoing evaluations, such as unanticipated events and amendments to active protocols, are key to a successful program. Treat investigators as a resource, and assist them in understanding what is meant by compliance in animal use activities.
DC: As we discussed in the webinar, you should have in place some basic tools for performing PAM, such as a written description for protocol monitoring, standardized checklist for audit visits, and some kind of tracking system to use the data you collect in some meaningful way for future use. Any time you’re following a new written process, perform several monitoring visits and then review your process to be sure what you have written is actually what you are doing, and the checklist should help keep you on track with your written process if the checklist was developed correctly.
What model of PAM do the two of you currently use at your institution?
SW: Michigan State University uses a hybrid model. A dedicated individual, who is an IACUC member, performs all semiannual facility and laboratory inspections with a representative from environmental health and safety and also other IACUC members. PAM is under the IACUC office and serves the committee and the investigators as a resource and educator, rather than as “the police”. The postapproval monitor also participates in the weekly management team meetings to facilitate interaction between animal care staff and the IACUC staff.
DC: Any mature PAM program will use the resources available to them as we do at the University of Alabama at Birmingham. To carry this PAM program maturity a step further, a well-functioning animal care and use program must develop an atmosphere of compliance that takes in the animal care staff, IACUC, and researchers. When you have all three working for the same compliance goals, you have the best opportunity to improve animal welfare and research quality.
PRIM&R thanks Mr. Cannon and Ms. Wilkins for sharing their expertise.
The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (PDF) and send it to firstname.lastname@example.org.