protocol review
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© 2014 Nature America, Inc. All rights reserved.
IACUC should consider asking Hodges to carry out a pilot study, with veterinary oversight, to test the monitoring system and to allow the IACUC to review how he is addressing any welfare issues. The review of the pilot study data by the team (IACUC, v eterinarians and researcher) should allow for the d evelopment of a m onitoring s trategy that allows the e xperiment to be carried out while ensuring that the rats’ welfare is protected. Once the study is approved, periodic monitoring of the research records by the IACUC will provide continued assurance that the welfare needs of the animals are being addressed. 1. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington, DC, 2011). Zitzow is Veterinarian, Animal Resources Center, and Associate Professor, Department of Surgery, and Langan is Attending Veterinarian and Director, Animal Resources Center, and Associate Professor, Department of Surgery at The University of Chicago, Chicago, IL.
Response Clarity for humane intervention points Michael W. Brunt, MSc, RMLAT, CMAR
Efficient and clear communication is of p articular importance when p rincipal i nvestigators, attending v eterinarians (AVs) and IACUCs are d etermining humane intervention points and adequate m onitoring procedures for animals p articipating in research protocols. Hodges’ elaborate remote monitoring and drug-delivery mechanism was shown to be effective through v alidation at his previous institution. But an action plan for u nexpected events that might occur during the monitoring period has not been adequately defined. The AV would be the ideal person to develop this action plan in c ollaboration with Hodges. The Guide for the Care and Use of Laboratory Animals1 states, “The p rimary focus of the veterinarian is to oversee the well-being and clinical care of animals used in research, testing, teaching, and production. This responsibility extends 392 Volume 43, No. 11 | november 2014
to monitoring and promoting animal well-being at all times during animal use and during all phases of the animal’s life.” In this situation, d efinition of humane intervention points will be critical. Once specific clinical risks are identified (e.g., high or low blood glucose concentrations, high or low heart rate, etc.), limits must be set to determine when e uthanasia will be required. If Hodges plans to use remote monitoring systems, then he should be expected to return to the facility i mmediately to treat or e uthanize any a nimals reaching these humane i ntervention points. Hodges’ “one-man operation” may not be appropriate for extended m onitoring periods. The IACUC, the AV and Hodges should identify the adverse events that are most likely to be seen, the experimental time points at which they are likely to be seen and the level of pain or distress expected to result from these. This information may be available from p revious studies, enabling Hodges to carry out a risk assessment to determine an a ppropriate monitoring interval that will allow early detection and prompt resolution of the majority of adverse events. If the information is unknown, then Hodges should carry out a pilot study to identify the most critical time period for animal monitoring, as well as the incidence and severity of adverse events. Once a plan has been approved by the IACUC, postapproval monitoring should be i mplemented in the early stages of study execution, and the observations of this monitoring should be used to determine whether adjustments should be made to the monitoring protocol to ensure that a nimals are not experiencing unnecessary pain or distress. This should be a c ollaborative effort between the IACUC, the AV and the investigator. Although Hodges’ monitoring device represents a refinement to one aspect of postsurgical monitoring, the IACUC’s concerns surrounding humane i ntervention points are also valid. This scenario represents on opportunity for Hodges and the IACUC to work together to improve animal wellbeing and build trust within the Great Eastern University community. A collegial, cooperative and consultative approach is needed in this situation to exploit the benefits of Hodges’ monitoring procedures and alleviate the concerns of the IACUC.
1. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington, DC, 2011). Brunt is a Campus Animal Facilities Project Manager, University of Guelph, ON, Canada.
Response Proceed, but cautiously Jo Ann Henry, LATG, CPIA, Gordon Roble, DVM, DACLAM & Jaclyn Steinbach, BVetMed (Hons) MRCVS
Members of an IACUC are generally f amiliar with reviewing protocols that test new technologies such as surgical i nstruments and implants. For s tudies involving untested devices, IACUCs will typically require intensive m onitoring and early endpoints to minimize any potential pain or distress experienced by the a nimals used. Novel monitoring equipment and technologies used to assess at-risk a nimals warrant additional caution during IACUC review. Hodges is on a t echnological cutting edge by proposing use of i ndwelling c annulas, electrodes and a camera to monitor and infuse his d iabetic rats remotely using a smart phone. Although this is a laudable goal, the study design does not address certain factors that need to be considered by the IACUC. The Guide for the Care and Use of Laboratory Animals1 states that the IACUC should evaluate the criteria and process for timely intervention during the protocol review process. Monitoring procedures and humane endpoints should be based on the specific parameters of the individual p rotocol. If Hodges or other appropriate personnel, such as animal care staff or other technical staff, can respond to adverse events or other developments within a reasonable time-frame, then off-site monitoring may be f easible. But without the ability to intervene as necessary, monitoring alone will accomplish nothing. Removing animals from the study does not adequately resolve welfare concerns. If Hodges means removal from the study to include euthanasia, then the capability for remotely initiating appropriate euthanasia should be considered. www.labanimal.com
protocol review
t emperature is more useful clinically than interval monitoring. These topical deliberations by the IACUC can lead to an appropriate understanding, implementation and evaluation of the technology used in Hodges’ study, with benefits for the animal care and use program of Great Eastern University. Web- and audio-enabled cameras are commonly used to monitor the well-being of both research and companion animals and currently serve in an adjunct role to on-site monitoring. Hodges’ system could enable more frequent monitoring of animals. The IACUC should be careful not to penalize Hodges and should
make certain it is not increasing m onitoring requirements unnecessarily. Great Eastern University and Hodges are poised to take this technology from cutting edge to mainstream, but all parties should proceed with caution.
Volume 43, No. 11 | november 2014 393
1. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington, DC, 2011). Henry is Compliance Coordinator, IACUC, Roble is Program Director Post-Doctoral Training Program in Laboratory Animal Medicine, Division of Laboratory Animal Resources (DLAR), and Steinbach is Veterinary Resident in Laboratory Animal Medicine, DLAR, at NYU Langone Medical Center, New York, NY.
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© 2014 Nature America, Inc. All rights reserved.
Additional information should be rovided to the IACUC regarding Hodges’ p previous results using similar t echnology. What is the anticipated failure rate of the monitoring equipment, cannula and e lectrode? What will Hodges do if he c annot access the camera when he is off-site? This method of monitoring and treating the a nimal may be better utilized after the i nitial, critical period. Rather than basing the m onitoring on a time interval, perhaps the system should be set to issue an alert when certain physiologic parameters change. Real-time monitoring of blood g lucose levels, heart rate or body
LAB ANIMAL
npg
© 2014 Nature America, Inc. All rights reserved.
IACUC should consider asking Hodges to carry out a pilot study, with veterinary oversight, to test the monitoring system and to allow the IACUC to review how he is addressing any welfare issues. The review of the pilot study data by the team (IACUC, v eterinarians and researcher) should allow for the d evelopment of a m onitoring s trategy that allows the e xperiment to be carried out while ensuring that the rats’ welfare is protected. Once the study is approved, periodic monitoring of the research records by the IACUC will provide continued assurance that the welfare needs of the animals are being addressed. 1. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington, DC, 2011). Zitzow is Veterinarian, Animal Resources Center, and Associate Professor, Department of Surgery, and Langan is Attending Veterinarian and Director, Animal Resources Center, and Associate Professor, Department of Surgery at The University of Chicago, Chicago, IL.
Response Clarity for humane intervention points Michael W. Brunt, MSc, RMLAT, CMAR
Efficient and clear communication is of p articular importance when p rincipal i nvestigators, attending v eterinarians (AVs) and IACUCs are d etermining humane intervention points and adequate m onitoring procedures for animals p articipating in research protocols. Hodges’ elaborate remote monitoring and drug-delivery mechanism was shown to be effective through v alidation at his previous institution. But an action plan for u nexpected events that might occur during the monitoring period has not been adequately defined. The AV would be the ideal person to develop this action plan in c ollaboration with Hodges. The Guide for the Care and Use of Laboratory Animals1 states, “The p rimary focus of the veterinarian is to oversee the well-being and clinical care of animals used in research, testing, teaching, and production. This responsibility extends 392 Volume 43, No. 11 | november 2014
to monitoring and promoting animal well-being at all times during animal use and during all phases of the animal’s life.” In this situation, d efinition of humane intervention points will be critical. Once specific clinical risks are identified (e.g., high or low blood glucose concentrations, high or low heart rate, etc.), limits must be set to determine when e uthanasia will be required. If Hodges plans to use remote monitoring systems, then he should be expected to return to the facility i mmediately to treat or e uthanize any a nimals reaching these humane i ntervention points. Hodges’ “one-man operation” may not be appropriate for extended m onitoring periods. The IACUC, the AV and Hodges should identify the adverse events that are most likely to be seen, the experimental time points at which they are likely to be seen and the level of pain or distress expected to result from these. This information may be available from p revious studies, enabling Hodges to carry out a risk assessment to determine an a ppropriate monitoring interval that will allow early detection and prompt resolution of the majority of adverse events. If the information is unknown, then Hodges should carry out a pilot study to identify the most critical time period for animal monitoring, as well as the incidence and severity of adverse events. Once a plan has been approved by the IACUC, postapproval monitoring should be i mplemented in the early stages of study execution, and the observations of this monitoring should be used to determine whether adjustments should be made to the monitoring protocol to ensure that a nimals are not experiencing unnecessary pain or distress. This should be a c ollaborative effort between the IACUC, the AV and the investigator. Although Hodges’ monitoring device represents a refinement to one aspect of postsurgical monitoring, the IACUC’s concerns surrounding humane i ntervention points are also valid. This scenario represents on opportunity for Hodges and the IACUC to work together to improve animal wellbeing and build trust within the Great Eastern University community. A collegial, cooperative and consultative approach is needed in this situation to exploit the benefits of Hodges’ monitoring procedures and alleviate the concerns of the IACUC.
1. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington, DC, 2011). Brunt is a Campus Animal Facilities Project Manager, University of Guelph, ON, Canada.
Response Proceed, but cautiously Jo Ann Henry, LATG, CPIA, Gordon Roble, DVM, DACLAM & Jaclyn Steinbach, BVetMed (Hons) MRCVS
Members of an IACUC are generally f amiliar with reviewing protocols that test new technologies such as surgical i nstruments and implants. For s tudies involving untested devices, IACUCs will typically require intensive m onitoring and early endpoints to minimize any potential pain or distress experienced by the a nimals used. Novel monitoring equipment and technologies used to assess at-risk a nimals warrant additional caution during IACUC review. Hodges is on a t echnological cutting edge by proposing use of i ndwelling c annulas, electrodes and a camera to monitor and infuse his d iabetic rats remotely using a smart phone. Although this is a laudable goal, the study design does not address certain factors that need to be considered by the IACUC. The Guide for the Care and Use of Laboratory Animals1 states that the IACUC should evaluate the criteria and process for timely intervention during the protocol review process. Monitoring procedures and humane endpoints should be based on the specific parameters of the individual p rotocol. If Hodges or other appropriate personnel, such as animal care staff or other technical staff, can respond to adverse events or other developments within a reasonable time-frame, then off-site monitoring may be f easible. But without the ability to intervene as necessary, monitoring alone will accomplish nothing. Removing animals from the study does not adequately resolve welfare concerns. If Hodges means removal from the study to include euthanasia, then the capability for remotely initiating appropriate euthanasia should be considered. www.labanimal.com
protocol review
t emperature is more useful clinically than interval monitoring. These topical deliberations by the IACUC can lead to an appropriate understanding, implementation and evaluation of the technology used in Hodges’ study, with benefits for the animal care and use program of Great Eastern University. Web- and audio-enabled cameras are commonly used to monitor the well-being of both research and companion animals and currently serve in an adjunct role to on-site monitoring. Hodges’ system could enable more frequent monitoring of animals. The IACUC should be careful not to penalize Hodges and should
make certain it is not increasing m onitoring requirements unnecessarily. Great Eastern University and Hodges are poised to take this technology from cutting edge to mainstream, but all parties should proceed with caution.
Volume 43, No. 11 | november 2014 393
1. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington, DC, 2011). Henry is Compliance Coordinator, IACUC, Roble is Program Director Post-Doctoral Training Program in Laboratory Animal Medicine, Division of Laboratory Animal Resources (DLAR), and Steinbach is Veterinary Resident in Laboratory Animal Medicine, DLAR, at NYU Langone Medical Center, New York, NY.
npg
© 2014 Nature America, Inc. All rights reserved.
Additional information should be rovided to the IACUC regarding Hodges’ p previous results using similar t echnology. What is the anticipated failure rate of the monitoring equipment, cannula and e lectrode? What will Hodges do if he c annot access the camera when he is off-site? This method of monitoring and treating the a nimal may be better utilized after the i nitial, critical period. Rather than basing the m onitoring on a time interval, perhaps the system should be set to issue an alert when certain physiologic parameters change. Real-time monitoring of blood g lucose levels, heart rate or body
LAB ANIMAL
