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Abstracts from the Fifth Annual Poster Sessions
presented at the 2009 IACUC Conference 

1. Meeting Responsibilities: The Institutional Animal User Education and Training Program at the University of Saskatchewan*
2. IACUC Oversight of Collaborative Work with the Private Sector and Federal Agencies
3. Laboratory Animal Coordinator Certification Program – A Unique Method for Standardizing Training at A Large Academic Institution
4. MONiTOR: Monitoring Of Novartis’ in vivo Techniques, Operations, & Research*
5. Post Approval Monitoring: 3 Years in Review
6. Random Source (Class B) Dealer Activities: October 31, 2007- November 1, 2008*

*Poster selected for presentation at a moderated abstract discussion.

Abstract #1*
TitleMeeting Responsibilities: The Institutional Animal User Education and Training Program at the University of Saskatchewan
Author(s)Amanda Plante, UCACS Education and Training Committee, University of Saskatchewan
AffiliationUniversity of Saskatchewan, Saskatoon, Saskatchewan, Canada

Required Training
The Canadian Council on Animal Care (CCAC) Guidelines on the National Institutional Animal User Program (1999) mandate that “All personnel involved with the use of animals in research, teaching and testing must be adequately trained in the principles of laboratory animal science and the ethical issues involved in animal use”. “All personnel” includes principal investigators, graduate students, research technical staff, post-doctoral fellows, animal care staff, etc. It is the Principal Investigator’s responsibility to ensure only trained personnel work with animals. It is the Institution’s responsibility to provide appropriate training, and document that training.

Description of the Education and Training Program
At the University of Saskatchewan, the University Committee on Animal Care and Supply (UCACS) Education and Training program designed to meet the CCAC guidelines consists of:

  • On-line UCACS Animal Care Course – The on-line course is presented using the Blackboard® platform. Four sections (laboratory animals, fish, wildlife, and farm animals) are available. Users have the flexibility in choosing the section that is most applicable to their research and the ability to fulfill their training requirements at a time and place that is most convenient to their schedules. Graduate students using animals in their research must complete the web-based Animal Care Course, in addition to taking an Introduction to Ethics Integrity Course, which covers academic ethics, including integrity, conflict and intellectual property.
  • Practical Skills Training – The UCACS offers several practical skills training workshops on a regular basis including: Basic Rodent Handling (half day), Introduction to Rodent Anesthesia (full day), and Basic Surgical Skills (full day). As of April 2008, a new Advanced Rodent Techniques workshop has been developed and added to the course offerings. Special topics workshops (e.g. wild bird bleeding and cattle low stress handling) are also organized periodically upon request.
  • One-on-one training is provided, as required, by contacting the UCACS Education and Training Facilitator.
  • Documenting Education and Training – Each person involved with the care and use of animals for research, teaching and testing, and who is associated with an animal use protocol must complete an Education and Training Data Form (ETDF). The ETDF is used by the University to document the training and practical skills of all those individuals involved in animal research and teaching at the University.
  • Monitoring Procedures – Ensuring that all personnel have the required training is monitored through the work of the Research Ethics Office and the UCACS Animal Research Ethics Board (AREB) during regular committee meetings. The Research Ethics Office also maintains a close link to Research Services to ensure that no research grant/contract funding is released to a principal investigator until all required ethics approvals are in place.

New Policy
Effective January 1, 2009, approval of an animal use protocol (new or annual review), by the AREB requires (or is conditional upon) successful completion of the UCACS Animal Care Course by all personnel listed on the protocol, including the principal investigator. Any new personnel added to a currently approved protocol must complete the on-line course before beginning any work with animals.

Next Steps and Future Plans
Minor revisions to the on-line course will be made on an on-going basis. A systematic review and course updates are planned every two years. Currently, the UCACS Education and Training Committee (ETC) is developing a shortened version of the on-line course that can be completed by licensed veterinarians. As required by the CCAC, training must be updated every 5 years and to accommodate this, the ETC will develop a renewal or “refresher” on-line course as part of the program. As well, the ETC is considering a half day workshop that researchers can attend in order to upgrade their training. The on-line course will be further enhanced to provide readily available reference tools applicable to various areas of research. Additional modules specific to the University of Saskatchewan will also be developed.

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Abstract #2
TitleIACUC Oversight of Collaborative Work with the Private Sector and Federal Agencies
Author(s)Kathy Partin, Ph.D.; Laura Martin, BS; William Moseley, MA
AffiliationResearch Integrity and Compliance Review Office, Colorado State University, Fort Collins, CO
Academic research institutions are actively seeking research collaborations with the private sector and federal agencies, allowing them to broaden their discovery mission and enhance their ability to undertake interdisciplinary projects. Institutions may need to prepare for such endeavors with a concerted re-calibration of several offices, including the CEO/IO, research administrators, grant and contract managers, protocol review committees, compliance officers, ethicists, academic entrepreneurs and research investigators. The expansion of the research endeavor can place the IACUC in the position of needing to review new types of protocol activity, submitted by traditional investigators but also collaborators from outside their institutions. Strategies that enable the IACUC to monitor an animal care program that goes beyond traditional boundaries are needed. Colorado State University (CSU) has explored implementing new training in different areas of research, developing new ways to write and submit animal protocols, and defining new ways to think about who can serve as an investigator. This poster will address how the IACUC, IO, administrative staff, and PIs worked with the current system and policies as well as discuss future considerations and actions needed for successful collaborations.

Contact:
Laura Martin
Senior IACUC Coordinator
Research Integrity and Compliance Review Office
Colorado State University
Fort Collins, CO 80523

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Abstract #3
TitleLaboratory Animal Coordinator Certification Program – A Unique Method for Standardizing Training at A Large Academic Institution
Author(s)Tracy Heenan, DVM, CPIA
AffiliationUniversity of North Carolina at Chapel Hill
Funding/SponsorUniversity of North Carolina at Chapel Hill
Getting a Handle on Research Personnel Training:
Large, decentralized institutions with numerous investigators and research personnel using laboratory animals benefit from a uniform and consistent method for training personnel in the proper handling techniques. When thousands of individuals are involved in animal research at an academic institution, it is often physically impossible for the personnel within the IACUC or Animal Resource Division to train, observe, and certify every animal user in every technique described in the animal use application. The Laboratory Animal Coordinator Certification Program is one successful method for uniformly training research personnel.

Laboratory Animal Coordinator Certification Program Specifics:
Every Principal Investigator with an active animal use application appoints a Laboratory Animal Coordinator or LAC. The LAC is an IACUC-trained and certified member of the research team who is responsible for coordinating animal activities in the laboratory and who is responsible for training other members of the laboratory in proper animal handling. The LAC should be a permanent employee, someone who will be with the laboratory on a long term basis rather than a student. The LAC must attend formal training and be certified during that training session by an IACUC or Animal Resource Division representative to ensure that the LAC is appropriately qualified and experienced for conducting procedures on living animals. Training and certification includes all routine handling techniques and routine procedures that are performed as part of an approved application (i.e., common anesthetics, injections, blood withdrawal, oral gavage, euthanasia, aseptic technique, etc.)

Laboratory Coordinator Responsibilities:
After the LAC is officially certified, the coordinator is then approved to train and certify other individuals in the lab in each of the routine procedures that will be conducted by that person. The LAC is also responsible for coordinating animal activities within the laboratory and for ensuring that personnel handling animals in the lab are familiar with any aspects of the animal application in which they will be involved. Once the LAC certifies a member of their research team, the LAC sends the IACUC documentation of the certification.

Although it is the investigator that is ultimately responsible for activities conducted in the laboratory, the certified laboratory animal coordinator is the “hands-on” person in the lab who will work with other lab members and the IACUC to ensure that all individuals who handle animals on the project are qualified to conduct procedures according to regulatory expectations. The LAC also assists with keeping all lab personnel apprised of new policies and guidelines. The Laboratory Animal Certification Program is a successful method for consistently training large numbers of animal handlers, especially in a decentralized university setting.

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Abstract #4*
TitleMONiTOR: Monitoring Of Novartis’ in vivo Techniques, Operations, & Research
Author(s)David DeOrnellis, BS, RLATg, CPIA and Colleen Cody, BS
AffiliationNovartis Institutes for BioMedical Research, Inc.
Background
In vivo research at Novartis Institutes for BioMedical Research (NIBR) Cambridge is regulated by various entities, including the United States Department of Agriculture (USDA), the Public Health Service (PHS), and the Cambridge Commissioner of Laboratory Animals. Adherence to the guidelines described in the Guide for the Care and Use of Laboratory Animals is required under the PHS Policy for the Humane Care and Use of Laboratory Animals, the City of Cambridge Municipal Code, and is the basis for accreditation by the Association for the Assessment and Accreditation of Laboratory Animal Care (AALAC), International. In addition to these regulations and guidelines, in vivo research at NIBR Cambridge is conducted according to the Novartis Global Animal Welfare Standards and currently accepted industry standards and best practices, in a manner that surpasses regulatory requirements, applying the most stringent regulations to all research and laboratory animal species.

According to federal regulations, the Institutional Animal Care and Use Committee (IACUC) is responsible for overseeing all aspects of the Animal Care and Use Program (the Program). In addition, the Animal Welfare Act (AWA) requires the IACUC to conduct “continuing review” of IACUC-approved activities. However, the AWA does not specify the manner in which this is to be accomplished.

Hypothesis
The NIBR Cambridge IACUC ensures in vivo research conducted at NIBR Cambridge is consistent with the relevant regulatory requirements and guidelines through a comprehensive compliance and post-approval monitoring program encompassing all components of in vivo research (i.e., husbandry, veterinary care, and experimental procedures).

Methods
Monitoring Of Novartis’ in vivo Techniques, Operations, & Research (MONiTOR) is an active, dynamic, and comprehensive program for monitoring compliance of NIBR Cambridge in vivo research. MONiTOR is unique due to the incorporation of all aspects of in vivo research in its scope, including the conductance of technical animal procedures, the operational aspects of vivarium management, and experimental procedures. MONiTOR is a fully integrated system that recognizes the importance of compliance at all levels of in vivo research in ensuring the welfare of the animals used for research at NIBR Cambridge, from husbandry to research-related procedures.

MONiTOR is designed to create and sustain a Culture of Compliance at NIBR Cambridge using a multi-tiered approach to compliance monitoring. MONiTOR is conducted at all levels of in vivo research, including the IACUC members, Animal Welfare Compliance staff, Laboratory Animal Services staff, and Principal Investigators and research staff. MONiTOR is conducted proactively using Facility Audits and Protocol Audits. MONiTOR uses a collaborative approach to 1) identify actual and potential non-compliances, in order to prevent occurrences and reoccurrences, 2) appropriately modify policies, procedures, and protocols, and 3) facilitate the conductance of in vivo research at NIBR Cambridge. This collaborative approach places an emphasis on training rather than reporting.

Poster
The poster for this abstract will describe MONiTOR’s multi-prong approach to compliance monitoring and discuss the implications for programmatic improvements.

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Abstract #5
TitlePost Approval Monitoring: 3 Years in Review
Author(s)Carolyn Malinowski, MS, RLATG, CMAR, CPIA
Sue Kallay, BS, RLATG, CPIA
AffiliationNorthwestern University
Overview
Post Approval Monitoring (PAM) Programs are a new and growing trend in the laboratory animal field. PAM is a program through which an IACUC/Institution can ensure and document program integrity, compliance with regulations and guidelines, and adherence to protocols. Although they are not required by any regulations, PAM Programs are recommended and looked upon favorably by AAALAC International and all regulatory agencies. At Northwestern University, the PAM Program was developed and implemented about 3 years ago. During this time, the program has rapidly expanded and become its’ own entity. Since initiation, over 50 PAM visits have been conducted and detailed records have been maintained. This poster details the experiences at Northwestern and the most common findings during PAM visits.

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Abstract #6*
TitleRandom Source (Class B) Dealer Activities: October 31, 2007- November 1, 2008
Author(s)Gary P. Goldberg DVM, DACLAM
AffiliationUSDA/APHIS/Animal Care
Funding/SponsorUSDA/APHIS/Animal Care

OVERVIEW OF RESEARCH

Background
In response to an inquiry from the Institute of Laboratory Animal Resources, a study of the current acquisition and disposition practices of the Random Source (Class B) Dealers was initiated.

Methods
This review included sources of acquisition such as from private individuals, municipal pounds or shelters, and from other licensee or registrants. The disposition of these animals was categorized as to individuals, other licensee/registrants, or to research facilities. Furthermore, those animals sold to research facilities were categorized as Academic (hospitals, colleges, universities, etc), Federal Research Facilities (DoD, VA, NIH, FDA etc.), Laboratory (Contract, Diagnostic, etc.), or Manufacturers (Pharmaceuticals, Chemicals, etc.). In order to estimate the teaching use of the random source animals, the records of random source dogs and cats were surveyed for campuses where U.S. Medical Colleges, U.S. Veterinary Colleges, and U.S. Veterinary Technician Schools were located.

Results
Acquisition and Disposition Data for Random Source (Class B) Dealers will be presented. The results will differentiate the numbers of Random Source Animals that are acquired from Private Owners vs. Municipal Pounds/Shelters vs. Other USDA Licensees/Registrants. Of major interest is the Disposition of the Random Source (Class B) Animals. The number of Animals that are sold, traded, or donated directly to Research Facilities vs. that are sold, traded, or donated to wholesale pet dealers or other Random Source (Class B) Dealers will be presented. Of the those Random Source Animals sold, traded, or donated to research facilities, the lack of sale, trade, or donation to the pharmaceutical industry becomes quite evident. With the estimate of numbers of animals sold to Academic Research Facility Campuses that have Medical Colleges, Veterinary Medical Colleges, and Veterinary Technical Schools, the predominance of the number of institutions and the usage data by campuses that have Medical Schools clearly dominates the disposition of Random Source (Class B) Animals. The fact that only one Veterinary Technical School is currently using Random Source (Class B) Animals will be clearly demonstrated.

Discussion
This survey of Random Source Dogs and Cats provides the basis for rational discussion of the present and future use of these animals in Biomedical Research. According to the Principle III of the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, “The animals selected for a procedure should be of appropriate species and quality and the minimum number required to obtain valid results.(3)” the In the past, the need for larger sized dogs of random source and short haired cats of random source, i.e. hybrid genetic background had been proposed. These requirements often had been weighed against the variation in source and preventative veterinary medical care. Since these animals have been acquired through donation by individuals, municipal pounds, and other dealers, cost has also been part of the decision making process despite the fact that cost should not be a primary decision for selection of animals for research, testing, or teaching. Currently, a number of Purposebred (Class A) vendors have developed animals meeting these standards and have provided inbreeding coefficients in some cases.

Conclusion
With the number of Random Source (Class B) Dealers decreasing in past, should we encourage or discourage this regulated entity? Should editors of journals and grant reviewers require the identification of Random Source Animals in the Materials and Method sections of research studies? Future presentations will discuss the breeds that Random Source (Class B) Dealers use, the costs of regulation, and the comparison of net worth/endowment size of the institution vs. the use of Random Source (Class B) Dogs and Cats.

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*Poster selected for presentation at a moderated abstract discussion.