To encourage animal care and use professionals in the PRIM&R community to submit a poster abstract for our upcoming 2016 IACUC Conference, we’ve created a retrospective of the poster abstracts selected for the 2015 IACUC conference. Read on to be inspired to submit your own work. Learn more about the 2016 IACUC Conference Poster Presentation Program.
Post-Approval Monitoring: Making it Stick
Michelle Martin BES, RVT, RLAT; Emi Yano, PMP, B.Ed; Rhain Louis, BSc, MSc
University of Toronto
There was a lack of monitoring and review of animal research after the approval phase. We developed and successfully instituted a post-approval monitoring/review program that is fair, comprehensive, and provides value to both researchers and research administrators.
The post-approval review (PAR) program at the University of Toronto was developed in response to a need to evaluate the conduct of animal-based research projects after approval. Before the program was created, there was no formal mechanism in place to perform randomized, in-depth audits of research after approval. As a large, decentralized institution with ~200 PIs submitting approximately 500 animal use protocols to five IACUCs, it was recognized that a formal system was required to systematically and fairly assess the work done after approval and ensure compliance with the regulations, as well as provide value to the PIs in the sharing of information and best-practices. The PAR program was developed after a detailed review of similar programs at peer institutions was undertaken, and the program was designed to avoid issues that were seen in other programs. The PAR program has been underway for less than two years, and during that time 91 labs have been audited by a single full-time staff member who coordinates the program. The program has been found to be well-received by researchers, and it has afforded compliance staff the opportunity to efficiently find and correct minor issues before they escalate. Due to its design, the program is well-suited for implementation at a diverse range of institutions.
In the Canadian context, post-approval monitoring is an emerging regulatory requirement, but across the country there are few well-developed programs. The program at U of T is robust, well-functioning, and highly efficient. It may be of interest to other institutions that are in the midst of designing their own PAR program.
Postural Movements of Rabbits in Variable Height Caging
Curtis Schondelmeyer; Laura Fontaine; N. Reynolds; K. Yip; Amy Schade
Toxikon Corporation
The “Guide for the Care and Use of Laboratory Animals” 8th edition recommends that the minimum space for rabbit caging as 16in (40.5cm) in height. This recommendation is increased from the 14in height recommendation of the 1996 “Guide” publication and the same height requirement of the Animal Welfare Act. Currently we have several cages that are 15.125 inches for rabbit housing.
The “Guide for the Care and Use of Laboratory Animals” 8th edition recommends that the minimum space for rabbit caging as 16in (40.5cm) in height. This recommendation is increased from the 14in height recommendation of the 1996 “Guide” publication and the same height requirement of the Animal Welfare Act. This change appears to be intended to allow less restricted vertical space for the rabbits. It is unclear, however, if this less restricted vertical space actually makes a change in rabbits postural movements depending on this small change. In addition the scientific basis for this recommendation is unclear. Our hypothesis was that rabbits housed in cages less than 16 inches would not have different postural movements then those housed in cages greater than 16 inches. The study examined two caging types, stainless steel rabbit cages with 15.125 inch cage height and stainless steel rabbit cages with 17 inch cage height. While the rack dimensions did differ between the two caging types, the individual cages on the rack were identical except for the interior height. The postural movements of both New Zealand White (NZW) and Dutch belted (DB) rabbits sitting with ears up, sitting with ears down, reclining, rearing/sitting vertical, and those rabbits whose ears were touching the top of the cage were examined. There was a significant relationship between the proportion of NZW rabbits that sat with their ears up in the 15.125 inch cages (χ2 (1, N = 1,661) = 4.797, p = 0.029), and a significant relationship between the proportion of NZW rabbits that sat with their ears down in the 17 inch cages (χ2 (1, N = 1,661) = 7.339, p = 0.007) . When examining the DB breed, there was a significant relationship between the proportion of rabbits that sat with their ears up in the 17 inch cages (χ2 (1, N = 355) = 5.822, p = 0.016). There were no DB rabbits reported as having the ears touching the top of the cage in either cage type. Like the NZW, there were no significant differences in the relationship between cage type and the proportion of rabbits reclining or rearing. In addition, there was no difference in the relationship between cage type and the proportion of rabbits sitting with ears down.
“Readiness Rounds”: Involving the Technical Staff in Post Approval Monitoring
Josh Folden, RALAT, BS; Marcy Brown, BS, MA, CPIA
Pfizer Inc.
There is an expectation that institutions using animals in research, teaching and testing will have a Post Approval Monitoring (PAM) program of some sort. The Guide for the Care and Use of Laboratory Animals states “Continuing IACUC oversight of animal activities is required by federal laws, regulations and policies. A variety of mechanisms can be used to facilitate ongoing protocol assessment and regulatory compliance. Post-approval monitoring (PAM) is considered here in the broadest sense, consisting of all potential types of protocol monitoring following initial protocol approval by the IACUC. PAM helps ensure the well-being of the animals and may also provide opportunities to refine research procedures. Methods include continuing protocol review; laboratory inspections (as part of regular facilities inspections or conducted separately); veterinary or IACUC observation of select procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections and assessments. The IACUC, veterinary, animal care and compliance staff may all conduct PAM, which may also be used as an educational tool.” And, if an institution is PHS-Assured, there is also an expectation for PAM. Although PHS Policy does not explicitly require a comparison between procedures described in the approved protocol against the manner in which they are conducted, according to OLAW’s FAQ G6, there is an expectation that the IACUC is responsible for program evaluations, review of protocols, reporting noncompliance, ensuring that personnel are appropriately trained, and addressing concerns involving the care and use of animals at the institution, all part of monitoring animal care and use. Finally, in keeping with its emphasis on performance standards, AAALAC also notes that PAM programs may vary from reliance on existing activities already performed by the IACUC to very extensive supplemental audits of protocols and the entire program conducted by compliance staff. “Some institutions have developed PAM programs with dedicated staff that physically monitor procedures and practices associated with animal use protocols. This is one acceptable method that institutions may elect to adopt, but it is not a federally mandated requirement.” In fact, many institutions do not have the resources necessary to have dedicated PAM personnel or a formal PAM program. For example, while Pfizer, Inc. is committed to complying with all laws, regulations and accrediting standards related to the use of animals in research, we do not have dedicated PAM personnel. However, we maintain a robust PAM program using, a “hybrid” PAM approach with a team made up of animal technicians, IACUC members, and regulatory compliance personnel. At least 2 IACUC members perform the procedure review part of the PAM program, while related components of the entire animal care and use program are monitored by a multi-disciplinary team of individuals, including animal and veterinary technicians as well as regulatory compliance personnel.
METHODS/APPROACH: As part of the hybrid PAM Program, the Readiness team conducts weekly “Readiness Rounds” during which all areas in the vivarium are inspected on a rotating basis, ensuring that all animal holding and procedure rooms, storage space, cage wash areas and halls are inspected monthly. The standards used for the assessment include the Animal Welfare Act & Regulations, the Guide for the Care & Use of Laboratory Animals (2011), AVMA Guidelines for the Euthanasia of Animals, Pfizer Corporate Policy #901, CM Standard Operating Procedures, Pfizer La Jolla IACUC Guidelines, Pfizer Global IACUC Guidelines, and our EH&S Laboratory Safety Inspection Checklist. After each inspection, a Readiness Rounds form is completed; any findings are assigned to the responsible individuals to be completed by a reasonable due date based on task. RESULTS/OBSERVATIONS: “Readiness Rounds” is an effective and efficient process to enhance our PAM program by proactively self-inspecting our facilities with limited resources and no additional staff. We have identified issues that could impact the results of formal inspections and ways to improve our program. Since initiating this “hybrid” Post Approval Monitoring approach, the overall number of weekly inspection findings has steadily decreased and there has been a concomitant reduction in findings on both the IACUC semiannual inspections and quarterly EH&S inspections. This has also provided an opportunity for our animal care technicians to learn more about the assessment/inspection process with the added benefit of increased colleague engagement regarding compliance and inspection-readiness. CONCLUSION: PAM helps ensure the well-being of the animals and may also provide opportunities to refine research procedures. Our “hybrid” PAM approach engages the IACUC, veterinary, animal care, and compliance staff and is an effective and efficient process to meet the expectation for a PAM program with limited resources and no additional staff.
Scripting the Way for Rodent Procedure Recordkeeping Compliance
Erica Armstrong, BS, CPIA; Daphne Molnar MBA, CPIA,CMAR
Vanderbilt University
Documentation requirements for non-USDA and USDA regulated species differ at this institution, USDA record maintenance has been appropriate, but the non-USDA rodent users’ records continue to be inadequate and are a subsequent non-compliance concern.
Training efforts included the implementation of a customized on-line course that highlights the regulatory requirements and basic principles of recordkeeping, an optional didactic lecture, continued education for the IACUC members, and increased attention on records during semi-annual inspections and post approval monitoring visits. Through the combined efforts of education and the required completion of the rodent recordkeeping course prior to protocol approval, post procedural recordkeeping has improved. However, while we have found there are rodent procedure records now present, there is still a need to place greater emphasis on compliance to the ‘Policy on Recordkeeping’, the ‘Rodent Anesthesia, Surgery, and Analgesia Standard Operating Procedure’, and the IACUC approved protocol. While we expected the recordkeeping deficiencies to decrease following the implementation of the required training module, it became apparent that our attention to the specific details and oversight of recordkeeping had markedly increased during this time. As a result, we have scripted a Rodent Procedure Record institutional outreach using research methods from Chip Heath and Dan Heath’s book, “Switch: How to Change Things When Change is Hard”. The Heath’s (2010) presented decades of counterintuitive research in psychology, sociology, and other fields to show how we can effect transformative change using a pattern, or script, to make the changes that matter.
The outreach efforts include a very specific script, scheduled visits to over 200 laboratories, and the use of a newly created ‘Rodent Procedure Record’ form. In the past, we allowed researchers to use a laboratory notebook, a post-procedure analgesia form, or excel spreadsheet. Now, we are changing the requirements, scripting out specifically what we want to see, and providing crystal clear direction…all elements presented in the book, “Switch”, to help with this organizational change effort.
Table Topics: A No-Cost IACUC Member Continuing Education Program
CeCeBrotchie-Fine, MA, CPIA
Novartis Institutes for BioMedical Research
Institutions are required to ensure adequate training for all personnel involved in the use of animals in research, including IACUC members. At many institutions, IACUC members are provided with an orientation to the Committee and may attend a few meetings as an observer prior to being appointed as a member. However, ensuring appropriate continuing education for members can be a challenge. While IACUC administrators and some Committee members may have the opportunity to attend conferences and courses related to IACUC topics, financial and time constraints make it unlikely that all members of an institution’s IACUC would be able to join such opportunities. To address this issue, the Novartis Cambridge IACUC implemented a program called Table Topics; a series of member-provided presentations to enrich the understanding of the Committee as a whole. The program is no-cost and requires a minimum of time during each meeting. The intended result is better engagement of Committee members and awareness about current topics of importance to animal care and use programs.
All IACUC members are required to prepare and provide a presentation to the Committee on a topic relevant to the Committee’s function. Typically, five to 10 minute presentations are given at each monthly meeting, and are followed by five minutes of conversation about the topic. Members are encouraged to choose either a topic that they know little about so that they can benefit from the research process or a topic in which they are expert so that the other members can benefit from their knowledge. To evaluate the program, at the one year anniversary of implementation Committee members were asked for feedback on the overall program. One hundred percent felt that it had been beneficial and provided value to the members, both in presenting and learning from presentations.
The Road to Success: Rolling Out Electronic Animal Study Protocol Software
Paul Mireles, RLATg, CPIA; Mandy Kozlowski, BA, CPIA; Jesse Funk; Russell Greene, BS
Northwestern University
As institutions strive to become innovative in incorporating the opportunities presented by new technologies, the challenges of training faculty, staff, investigators, and animal care personnel can be overwhelming for some institutions. The roll out process for any new software requires a tremendous amount of time and work from all involved parties – reviewers, veterinarians, IACUC staff, and your IT group.
When considering a move to an electronic animal study protocol (ASP) submission system, an in-house system may be created, or there are many choices from system vendors. The route we chose was an off-the-shelf product that in particular allowed our principal investigators (PIs) to create a library for their lab’s substances and procedures. We needed to retrain all those involved with writing and reviewing protocols, reviewers, veterinarians, IACUC staff, PIs, and their lab members and members of the animal care program who need to have access to ASPs. With over 200 PIs and 890-1000 ASPs, we decided to utilize a slow roll out. A concierge approach meant first training personnel from labs submitting a new or de novo ASP and PIs new to the university. This allowed us to spend time not only training each PI and their staff in the creation of their substance and procedure library and overall protocol, but also allowed us time to help with the review process (knowing where to make the changes and how to respond to the committee on the changes made). We retrained IACUC staff on the pre-review process and reviewers on the process they would use. Within the last year we’ve trained about 100 labs, the IACUC staff, reviewers, and members of the animal care program. After an initial protocol is created and approved in the new system, the time need to create subsequent ASPs has been cut in half. Lab staff may easily verify substances and procedures across multiple protocols to avoid noncompliance. The number of modifications needed in order for a protocol to be approved has been reduced.
TESS: Tools to Enhance Surgical Success
Colleen Bennett, MS; David J. Lyons, PhD
Wake Forest School of Medicine
Patient (human or animal) safety and surgical success are the desired outcomes in any Operating Room (OR). Adequate training and technical excellence alone does not guarantee a positive outcome. Instead, errors that contribute to unexpected complications and poor outcomes may stem from breakdowns in communication, leadership and teamwork. The reasons for these breakdowns are varied and may include new/transient team membership, uncertain roles and responsibilities, language barriers, social/professional hierarchies, cultural differences, varied team and individual limitations, etc. In the course of resolving adverse events, we surmised that some of the poor outcomes reported may be due to inadequate pre-planning, lack of communication between surgeon and surgical support staff, and poor situational awareness. In an effort to eliminate or greatly reduce these AEs, we created an error reduction program modeled after standard practices in the human OR. We call this program TESS: Tools to Enhance Surgical Success. TESS is a team-based communication program to eliminate errors in planning and to reduce errors of execution.
TESS is designed for non-rodent operating rooms and it may be particular applicable under conditions of high staff turnover (e.g., due to a large number of fellows, clinicians doing animal research on short term projects) or for staff of varied nationalities where language and cultural differences may exist. TESS is a team-based communication program to eliminate errors in planning and to reduce errors of execution thereby increasing surgical success. TESS requires the engagement of all parties in a process of constant improvement by a) looking for emerging concerns and potential errors in before, during and after the surgery, b) asking questions, making suggestions and voicing concerns, and c) respecting each team members’ expertise, opinions and concerns. The tools of the TESS program are a set of surgical meetings and surgical checklists. The surgical meeting set consists of 1) a PRE-procedure planning meeting 2-3 days before surgery, 2) a TIME-OUT on the day of surgery prior to surgeon scrub-in and 3) a post-op DEBRIEF immediately after surgery. Each meeting has a specific agenda template which can be used to ensure that all necessary items are discussed. Checklist templates have been developed for drug and supply lists and personnel duties. In addition, a Surgical Safety Checklist for use in large animal research ORs was adapted from the World Health Organization (WHO)’s checklist for human ORs. Use of this checklist ensures that appropriate checks and confirmations occur after animal prep, prior to first incision and before leaving the OR. The average non-veterinary animal researchers may not be trained on OR communication practices and we see the TESS program as a teaching opportunity. This can be easily implemented at any institution; the only requirement is time. Direct interaction with a surgical team in real time should yield “buy-in”. Training begins with in an initial meeting with the surgical team to discuss the importance of appropriate OR communication and teamwork. The TESS tools are introduced and discussed. Training continues, in real time, as we work with the surgical team to conduct efficient, productive planning meetings and are present in the OR to facilitate a communication stream. Once this practice has been established, training is complete. Follow up is done via personal communication with individual team members.
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