Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use Summary of a Workshop (2015) / Chapter Skim
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6 Reports from the Breakout Sessions
6 Reports from the Breakout Sessions
Pages 65-80
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From page 65... ...
All workshop registrants were preͲassigned to a group to ensure diversity in perspectives and each group designated a rapporteur who described the performance standard, followed by the process the group used to develop its standard. Each group was assigned one of the following topics: x Personnel training in animal handling and procedures x Workplace safety x Scientific flexibility, or study drift, in animal use protocols x Perioperative surgical management Under each topic, the working groups would address the following: 1.
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From page 66... ...
Measurement criteria included a postͲprocedural monitoring program for both animal care and research staff to establish a process for followͲup monitoring of animals after experiments are completed and for ensuring that staff understand that followͲup process. This group, said Scherrer, wanted to create (a)
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From page 67... ...
There was some discussion, Kennedy said, about outcomes and issues related to poorly trained individuals. The group also discussed ways to reinforce positive behavior and outcomes that reflected specific tasks pertaining to the care and use of laboratory animals.
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From page 68... ...
The report would include information gathered from all involved program components, such as environmental health, occupational safety, and the animal care program. The action plan, explained Dysko, would include efforts to follow up on any reported incidents with retraining, lockout from the facility, or other actions to ensure the laboratory was compliant with all workplace safety codes.
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From page 69... ...
PERFORMANCE STANDARD FOR SCIENTIFIC FLEXIBILITY OR STUDY DRIFT IN ANIMAL USE PROTOCOLS Kent Lloyd, Professor and Head of the Mouse Biology program at the University of California, Davis, and Judy MacArthur Clark served as the rapporteurs for this working group. Lloyd noted that the word "drift" does not appear anywhere in the Guide, while the word "flexibility" appears only five times and never in the context of scientific research or progress.
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From page 70... ...
An important component of this performance standard, then, would be to train the IACUC to think about flexibility in a new way and to train investigators to request realistic and reasonable flexibility in their protocols. Regarding measurement criteria, MacArthur Clark said one approach would be to measure how many trivial amendments are granted with little consideration or debate by the IACUC.
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From page 71... ...
These surveys could also solicit more qualitative views on how well the performance standard is helping researchers deliver their science, making it easier for an animal care technician to protect the welfare of the animals, helping veterinarians feel that they are having an impact, and enabling IACUC members to feel they are spending their time doing something important instead of wasting time processing trivial amendments. Developing the Performance Standard for Scientific Flexibility or Study Drift in Animal Use Protocols Similarly to the other working groups, Lloyd noted the importance of having individuals with diverse experiences contributing to the discussions.
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From page 72... ...
PERFORMANCE STANDARD FOR PERIOPERATIVE SURGICAL MANAGEMENT Randall Nelson, Associate Vice Chancellor for Research and Professor of Anatomy and Neurobiology at the University of Tennessee Health Science Center, served as rapporteur for this working group, which thought there were several reasons for developing a performance standard for perioperative surgical management. The main reason is the lack of specificity in the Guide and the AWR with regard to key elements of perioperative management.
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From page 73... ...
In terms of implementation, Nelson reported that the working group thought monitoring surgical outcomes would identify problems and determine the procedures needing modification to ensure both animal welfare and good science. The working group suggested using a checklist to verify adherence to approved procedures and protocols, and one was supplied to the working group by an online participant listening to this working group's discussions (Figure 6Ͳ1)
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From page 74... ...
74 PERFORMANCE STANDARDS FOR LAB ANIMAL USE minimizing pain and distress, and it should involve not just those working in the laboratory, but also animal care staff, IACUC members, and members of the compliance office. In the case of protocol deviations that warrant reporting, there should be wellͲdefined procedures for disseminating information internally and for reporting it externally.
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From page 75... ...
PERF FORMANCE ST TANDARDS FOR LAB ANIMAL USE R 75 FIGU 6Ͳ1 PostͲapproval monitoring program checklist URE m SOUURCE: Working Group 4 slide
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From page 76... ...
The participants, said Nelson, chose to look beyond what was not in the Guide and in the regulations, and instead used convention, best practice, and professional judgment to develop a performance standard. DISCUSSION Joseph Newsome, Clinical Director of the Division of Laboratory Animal Resources and Associate Professor of Pathology at the University of Pittsburgh, said one theme he picked up on that he had not heard before was the need for wellͲtrained moderators and leaders who can work through the process to develop performance standards.
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From page 77... ...
As a final comment, MacArthur Clark said her group soon realized that depending on hard numbers was not going to provide all the needed metrics and that the qualitative information from surveys combined with quantitative data was the best approach. COMPARING AND CONTRASTING THE WORKING GROUPS' PERFORMANCE STANDARD DEVELOPMENT PROCESS As a final piece of the working group exercise, Mary Ann Vasbinder was tasked by the workshop organizing committee to compare and contrast the process the four teams went through to develop a performance standard.
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From page 78... ...
The groups pointed out the pivotal role of the IACUC in providing leadership and direction for developing and applying performance standards. Not only does the IACUC have to approve performance standards, but it is the collective body that gives an institution the weight to administer and monitor them properly.
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From page 79... ...
Nelson wondered if the problem of limited flexibility rests with proposals being written without getting input from the people who see and care for these animals daily. Kennedy asked Dysko if his IACUC had any facility managers or animal care technicians as voting members, as they may be the ones most likely to suggest where flexibility would be beneficial.
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From page 80... ...
Nelson said there is a need to educate IACUC members and the animal care staff, as well as investigators, about what is acceptable flexibility because they do not know how much flexibility is appropriate and allowable.
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