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Attending Veterinarian. Facility Manager. Animal Care Staff. Principal Investigator ... The IACUC and attending veterinarian's relationship with the P.I. is key to ... – PowerPoint PPT presentation

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Well-trained andmotivated personnel can often
ensure high-quality animal care.
5
Training hits
  • 64 Guide for the Care and Use of Laboratory
    Animals
  • 36 Institutional Administrators Manual for
    Laboratory Animal Care and Use
  • 35 Institutional Animal Care and Use Committee
    Guidebook
  • 22 Biosafety in Microbiological and Biomedical
    Laboratories
  • 17 Guidelines for Research Involving Recombinant
    DNA Molecules
  • 3 PHS Policy on Humane Care and Use of Laboratory
    Animals
  • 7 Animal Welfare Regulations, 9CFR, Part 3

6
AAALAC identified training deficiencies
(mandatory/suggestion)
  • Year IACUC OHSP Personnel
  • 1998 9/6 3/2 1/1
  • 1999 10/5 4/6 1/4
  • 2000 5/4 7/3 0/4
  • 2001 4/0 4/5 5/3
  • 2002 3/3 4/2 1/4

7
Many deficiencies and suggestions for improvement
in other areas are related to inadequate
training.
8
Institutions should develop and embrace a culture
of training, inclusive of administrators,
compliance staff, IACUC, veterinary staff, animal
care staff, and research staff.
9
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10
The AAALAC International Program Description
  • Describe the training, certification level and
    type, and experience of animal care personnel.
  • Describe the continuing education opportunities
    provided to animal care personnel.

11
The AAALAC International Program Description
  • Describe the personnel training for specific
    procedures
  • use of hazardous agents in animals
  • educational program(s) to inform personnel about
    zoonoses, personal hygiene and other occupational
    health and safety considerations

12
The AAALAC International Program Description
  • Describe the personnel training for specific
    procedures
  • training and experience of personnel performing
    surgery
  • training and experience required to perform
    anesthesia
  • training and experience of personnel carrying out
    euthanasia procedures

13
Animal care staff
  • Husbandry personnel
  • Supervisory personnel
  • Management personnel

14
Animal care staff
  • Veterinarians
  • Veterinary technicians
  • Surgical technicians and support staff

15
Animal care staff
  • Technical support staff
  • Research staff providing husbandry

16
Assignments may be specific, or one person may
wear many hats.
17
Types of animal care programs
  • Large versus small
  • Focused versus diverse

18
Training requirements
  • Regulations and guidelines
  • Specific species training
  • Specific task training

19
Continuing education/retraining important.
20
Mechanisms to implement training
  • Condition of employment
  • Prior to facility/animal access

21
Training development/documentation
  • Training coordinator
  • Facility management
  • Veterinary staff
  • Other specialists (biosafety officer, etc.)

22
Regulations/guidelines/animal welfare basics
  • Web-based training
  • Generic (VA, etc)
  • Institution specific
  • Seminars
  • Publications
  • Videotapes

23
Specific species/task training
  • AALAS classes and certifying exams (ALAT, LAT,
    LATG).
  • AALAS Certified Manager of Animal Resources
    (CMAR) exams.
  • Institute for Laboratory Animal Management (ILAM)
    educational program and certification.

24
Specific species/task training
  • Web based training
  • Textbooks, videos
  • Training manuals, SOPs
  • On job training

25
A combination of methods often helps reinforce
training and accommodates different types of
learners.
26
Continuing education/retraining
  • National, district and branch AALAS meetings.
  • Other professional meetings and sponsored
    seminars (AAALAC, LAMA, SCAW, etc).
  • Reviewing SOPs.
  • Reviewing web-based training.

27
Case studies
  • Immune compromised mice housed in sterile
    microisolator cages being changed by animal
    facility personnel on open bench.
  • Animal care staff working in animal rooms in
    street clothes.
  • Animal care staff dumping cages in dirty
    cagewash no dump station in room and no PPE
    being worn.

28
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29
Institutional responsibilities
  • Each institution should establish and provide
    resources for an animal care and use program that
    is managed in accord with this Guide and in
    compliance with applicable federal, state, and
    local laws and regulations . . .
  • Guide for Care Use of Laboratory Animals

30
Organizational structureresearch perspective
31
Organizational structure university perspective
32
IACUC charge
  • AWRs and PHS Policy require institutions to
    ensure that people caring for or using animals
    are qualified to do so.
  • Guide for Care and Use of Laboratory Animals

33
Guide recommendations(personnel qualifications
and training)
  • There are a number of options for the training
    of technicians. Many states have colleges with
    accredited programs in veterinary technology
    (AVMA 1995) most are 2-year programs that result
    in associate of science degrees, and some are
    4-year programs that result in bachelor of
    science degrees. Nondegree training, with
    certification programs for laboratory animal
    technicians and technologists, can be obtained
    from the American Association for Laboratory
    Animal Science (AALAS). There are commercially
    available training materials that are appropriate
    for self-study (Appendix B). Personnel using or
    caring for animals should also participate
    regularly in continuing-education activities
    relevant to their responsibilities. They are
    encouraged to be involved in local and national
    meetings of AALAS and other relevant professional
    organizations. On-the-job training should be part
    of every technician's job and should be
    supplemented with institution-sponsored
    discussion and training programs and with
    reference materials applicable to their jobs and
    the species with which they work (Kreger 1995).
    Coordinators of institutional training programs
    can seek assistance from the Animal Welfare
    Information Center (AWIC) and ILAR (NRC 1991).
    The Guide to the Care and Use of Experimental
    Animals by the Canadian Council on Animal Care
    (CCAC 1993) and guidelines of some other
    countries are valuable additions to the libraries
    of laboratory animal scientists (Appendix B).

34
Guide recommendations(personnel qualifications
and training)
  • There are a number of options for the training
    of technicians. Many states have colleges with
    accredited programs in veterinary technology
    (AVMA 1995) most are 2-year programs that result
    in associate of science degrees, and some are
    4-year programs that result in bachelor of
    science degrees. Non-degree training, with
    certification programs for laboratory animal
    technicians and technologists, can be obtained
    from the American Association for Laboratory
    Animal Science (AALAS). There are commercially
    available training materials that are appropriate
    for self-study (Appendix B). Personnel using or
    caring for animals should also participate
    regularly in continuing-education activities
    relevant to their responsibilities. They are
    encouraged to be involved in local and national
    meetings of AALAS and other relevant professional
    organizations. On-the-job training should be part
    of every technician's job and should be
    supplemented with institution-sponsored
    discussion and training programs and with
    reference materials applicable to their jobs and
    the species with which they work (Kreger 1995).
    Coordinators of institutional training programs
    can seek assistance from the Animal Welfare
    Information Center (AWIC) and ILAR (NRC 1991).
    The Guide to the Care and Use of Experimental
    Animals by the Canadian Council on Animal Care
    (CCAC 1993) and guidelines of some other
    countries are valuable additions to the libraries
    of laboratory animal scientists (Appendix B).

35
Guide recommendations(occupational health
safety of personnel)
  • Personnel should be trained regarding zoonoses,
    chemical safety, microbiologic and physical
    hazards (including those related to radiation and
    allergies), unusual conditions or agents that
    might be part of experimental procedures
    (including the use of genetically engineered
    animals and the use of human tissue in
    immunocompromised animals), handling of waste
    materials, personal hygiene, and other
    considerations (e.g., precautions to be taken
    during personnel pregnancy, illness, or decreased
    immunocompetence) as appropriate to the risk
    imposed by their workplace.

36
The organizational structure of universities can
make compliance challenging
IACUC Focus Group
37
Who trains the trainees?
38
Training tiers
39
Administration
  • Research administrator
  • Focus on compliance (regulatory perspective)
  • Interested in education
  • Academic administrator
  • Focus on education
  • Interested in compliance (academic integrity)

40
Principal investigator
  • Professor
  • Dedicated teacher
  • Dedicated to research
  • Believes in academic freedom
  • Often believes that regulatory compliance is an
    obstruction to academic freedom

41
Research staff
  • Laboratory manager
  • Empowered by the P.I.
  • Directs day to day operation of the lab
  • Career employee
  • Most knowledgeable of regulations
  • Laboratory technicians
  • Entry level position
  • Frequently have other career aspirations
  • Regulations learned from lab manager or PI
  • Student assistants
  • Gaining experience to increase competitiveness
    for professional school
  • Need to work
  • Follow directions
  • Least knowledgeable of regulations
  • Met the professor once

42
Trainees
  • Postdoctoral fellows
  • U.S. citizens foreign nationals
  • Well trained in research methodologies
  • Highly motivated
  • Moderately knowledgeable of regulations
  • Graduate students
  • U.S. citizens and foreign nationals
  • Focus is on studies
  • Learning the ropes and pushing the limits
  • Marginally knowledgeable of regulations
  • Undergraduate students
  • Want to learn
  • Naïve
  • No knowledge of regulations

43
Gradients in training exist
44
Guide recommendations
  • An occupational health and safety program must be
    part of the overall animal care and use program
    (CDC and NIH 1993 CFR 1984a,b,c PHS Policy).
    The program must be consistent with federal,
    state, and local regulations and should focus on
    maintaining a safe and healthy workplace. The
    program will depend on the facility, research
    activities, hazards, and animal species involved.
    The National Research Council publication
    Occupational Health and Safety in the Care and
    Use of Research Animals (NRC In press) contains
    guidelines and references for establishing and
    maintaining an effective, comprehensive program
    (also see Appendix A). An effective program
    relies on strong administrative support and
    interactions among several institutional
    functions or activities, including the research
    program (as represented by the investigator), the
    animal care and use program (as represented by
    the veterinarian and the IACUC), the
    environmental health and safety program,
    occupational-health services, and administration
    (e.g., human resources, finance, and
    facility-maintenance personnel). Operational and
    day-to-day responsibility for safety in the
    workplace, however, resides with the laboratory
    or facility supervisor (e.g., principal
    investigator, facility director, or veterinarian)
    and depends on performance of safe work practices
    by all employees.

45
Building a culture of compliance
  • Administration
  • IACUC
  • Professors
  • Staff
  • Trainees

46
Building a culture of compliance administrative
buy-in
Research Officer Academic Officers must
understand the importance of compliance. IACUC
can be instrumental in educating the
administration.
47
Building a culture of compliance IACUC
facilitation
IACUC should be knowledgeable of the regulations
responsible for advocating best practices to
both administrators and professors. Educate
rather than Train.
48
Building a culture of compliance IACUC
facilitation
49
Building a culture of compliance professorial
buy-in
Let the Professor Teach. Educate rather than
Train.
50
Building a culture of compliance encouraging
professorial buy-in
Get the students to ask the Professor to teach a
course. Educate rather than Train.
51
Building a culture of compliance encouraging
academic administrative buy-in
Academic affairs will support course development
and delivery. Educate rather than Train.
52
Building a culture of compliance closing the loop
Use the Chief Academic Officer to gain support of
the President Educate rather than Train.
53
Take home messages
  • Strict interpretation of the Guide may be not
    always capture students among those who require
    training.
  • Goal of training animal users may be accomplished
    under the academic affairs mission of the
    university.
  • Resources for training may not have to come from
    the research office.

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55
Roadmap
  • Why is IACUC training important?
  • What needs to be included in the training?
  • How do we go about training the IACUC?
  • Resources.

56
Why is IACUC training important?
  • Understand responsibilities and importance of the
    role of the IACUC.
  • Facilitate conduct of required functions.
  • Ensure checks and balances.
  • Distribute responsibilities in the animal care
    program.
  • Limit regulatory burden.
  • Enhance interactions with investigators.
  • It is required.

57
The regulations
  • It shall be the responsibility of the research
    facility to ensure that all scientists, research
    technicians, animal technicians, and other
    personnel involved in animal care, treatment, and
    use are qualified to perform their duties
  • USDA 2.32(a)

58
The regulations
  • This responsibility shall be fulfilled in
    part through the provision of training and
    instructions to those personnel.
  • USDA 2.32(a)

59
The Guide
  • Personnel caring for animals should be
    appropriately trained and the institution
    should provide for formal or on-the-job training
    to facilitate effective implementation of the
    program and humane care and use of animals.
  • The Guide, p. 13

60
The Guide
  • It is the institutions responsibility to
    provide suitable orientation, background
    materials, access to appropriate resources, and,
    if necessary, specific training to assist IACUC
    members in understanding and evaluating issues
    brought before the committee.
  • The Guide, p. 9

61
Roadmap
  • Why is IACUC training important?
  • What needs to be included in the training?
  • How do we go about training the IACUC?
  • Resources.

62
What should be included in the training?
  • IACUC Procedures
  • Expectations and responsibilities
  • Description of the Animal Care Program
  • Processes
  • Regulations and Policies
  • Semi-annual review
  • Protocol review
  • Review of concerns
  • Suspend activities
  • Specific Issues
  • Humane Endpoints
  • Pain and Distress
  • Justification of numbers of animals
  • Many others

63
Roadmap
  • Why is IACUC training important?
  • What needs to be included in the training?
  • How do we go about training the IACUC?
  • Resources.

64
Approaches to training
  • Orientation
  • On-going
  • E options
  • Publications
  • Conferences
  • Customized workshops

65
Orientation for new members
  • Overview of requirements and expectations.
  • Provide copies of
  • The Guide, Animal Welfare Act and Regulations,
  • PHS Policy, US Government Principles.
  • Institutional policies.
  • Institutional protocol form and written
    description of this process.
  • Review role of the attending veterinarian, IACUC
    staff, institutional official, and faculty.

66
A continuous process
  • On-going
  • Review specific requirements for both the IACUC
    and animal welfare concerns
  • Inspections
  • Environmental enrichment
  • Review institutional policies
  • You should have some
  • They should be reviewed periodically
  • Use scenarios
  • Lab Animal
  • IACUC 101

67
Electronic materials
  • E options
  • OLAW tutorial
  • grants1.nih.gov/grants/olaw/tutorial/index.htm
  • VA Office of Research and Development
  • www.researchtraining.org
  • www.iacuc.org
  • List-servs IACUC-Forum, CompMed, IACUC Talk
  • E-newsletters AMP Digest, NABR E-clips

68
Publications
  • Lab Animal
  • Contemporary Topics
  • ILAR Journal
  • Animal Lab News

69
Conferences
  • IACUC 101
  • PRIMR ARENA spring conference
  • AALAS National meeting
  • SCAWs IACUC-Advanced
  • SCAW December conference
  • State society conferences NJABR, MiSMR, NCABR,
    TSBR, and others

70
Custom workshops
  • Tailored to your facility.
  • Optimal if a major upheaval in your program.

71
Remember
  • Keep training on the front burner.
  • Assess the level of need individualize.
  • Dont forget the community representative.
  • Make it easy.

72
Roadmap
  • Why is IACUC training important?
  • What needs to be included in the training?
  • How do we go about training the IACUC?
  • Resources.

73
Core materials for IACUC training
  • Institute of Laboratory Animal Resources,
    National Research Council. Guide for the Care and
    Use of Laboratory Animals (National Academy
    Press, Washington, DC, 1996).
  • Animal Welfare Act as Amended (7 USC, 2131
    et.seq.).http//www.aphis.usda.gov/ac/awapdf.pdf.
  • Animal Welfare Regulations, 9 CFR Ch. 1,
    Subchapter A (1999 edn). Animal and Plant Health
    inspection Service, USDA. http//www.aphis.usda.g
    ov/ac/9CFR99.html.
  • Public Health Service. Policy on Humane Care and
    Use of Laboratory Animals (Washington, DC, 1986).
  • USDA Animal and Plant Health Inspection Animal
    Care Policy Manual. http//www.aphis.usda.gov/ac/
    polman.pdf.html.

74
Core materials for IACUC training
  • Health Research Extension Act of 1985 (P.L.
    99-158), November 20, 1985-Animals in Research.
    http//grants1.nih.gov/grants/olaw/references/hrea
    1985.htm.
  • Interagency Research Animal Committees. U.S.
    Government Principles for the Utilization and
    Care of Vertebrate Animals Used in Testing,
    Research, and Training (Office of Science and
    Technology Policy, Washington, DC, 1985).
  • Federation of Animal Science Societies. Guide for
    the Care and Use of Agriculture Animals in
    Agricultural Research and Teaching (Savoy, IL,
    1999).

75
Core materials for IACUC training
  • Beaver, B.V. et al. 2000 Report of the AVMA Panel
    on Euthanasia. J. Am. Vet. Med. Assoc. 218,
    669-696 (2001).
  • Institute of Laboratory Animal Resources,
    National Research Council. Occupational Health
    and Safety in the Care and Use of Research
    Animals (National Academy Press, Washington, DC,
    1997).
  • ARENA/OLAW Institutional Animal Care and Use
    Committee Guidebook, 2nd edn (2002).

76
Thanks!
  • Molly Greene
  • Mary Lou James

77
Other resources
  • AAALAC International
  • www.aaalac.org
  • The Connection (Winter/Spring 2002 Seeds for a
    Successful Program IACUC Training)
  • American Association for Laboratory Animal
    Science
  • www.aalas.org
  • Animal and Plant Health Inspection Service
    Animal Care
  • http//www.aphis.usda.gov/ac
  • Animal Welfare Information Center
  • www.nal.usda.gov/awic
  • Information Resources for Institutional Animal
    Care and Use Committees
  • 1985 1999, AWIC Resource Series No. 7,
  • http//www.nal.usda.gov/awic/pubs/IACUC/iacuc.htm
  • CompMed
  • E-mail listserv_at_listservaalas.org

78
Other resources
  • IACUC-Forum
  • IACUC-Forum, a closed listserv where issues
    relating to laboratory animal research may be
    discussed privately among members of the
    listserv. Visit www.iacuc.org for details.
  • IACUC Talk
  • http//www.scaw.com/forum.html
  • IACUC.ORG
  • www.iacuc.org
  • IACUC Resource Page
  • www.labanimal.com/iacuc/iacuc.htm
  • OLAW conferences
  • http//grants.nih.gov/grants/olaw/worshop.htm
  • OLAWs IACUC Guidebook
  • http//grants.nih.gov/grants/olaw/iacuc_guidebook/
    iacuc_guidebook.htm
  • OLAWs PHS Policy Tutorial

79
Other resources
  • PRIMR / ARENA annual meeting
  • Public Responsibility in Medicine and Research
    (PRIMR) and Applied Research Ethics National
    Association (ARENA) annual IACUC meeting. Visit
    http//www.primr.org/conferences.html
  • Protocol Review
  • A monthly column n Lab Animal magazine edited by
    Jerald Silverman, www.labanimal.com
  • Articles
  • IACUC Training From New-Member Orientation to
    Continuing Education. Lab Animal 31 26, 2002
  • The IACUC Handbook
  • April 2000, Jerald Silverman, Mark A. Suckow,
    Sreekant Murthy, CRC Press. 59.95. Visit
    www.crcpress.com to order.
  • ResearchTraining.org, www.researchtraining.org

80
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81
Agenda
  • Characteristics of ag programs
  • The Three Tier approach
  • Ag specific training
  • Examples of training materials
  • Case Studies

82
Characteristics of ag programs
  • Most Land Grant Universities some Pharma
  • Veterinary schools, animal science depts
  • Experimental stations remote, isolated
  • Autonomous, independent
  • Highly skilled technicians and herdsmen
  • Most have been around a long time
  • Students

83
The training approach
  • The Three Tier approach
  • 1 Overview
  • Laws and regs and institutional
    responsibilities
  • 2 Species specific training
  • 3 Hands On training
  • Another tier?
  • Ag specific training needs

84
The objective of Tier 1 overview of Laws and
Regs
  • Provide a basic understanding
  • That many laws and regulations exist wrt to
    research animals.
  • That some of them apply to research agricultural
    animals.
  • That an appropriate Animal Care and Use Program
    is important!

85
The objective of Tier 1 overview of Laws and
Regs
  • To do
  • Let them know that training is required
    (regardless of level of expertise).
  • Set the stage for an environment of compliance.
  • Let them know why compliance is important.

86
The Regs! Animal Welfare Act
  • 9CFR
  • USDA/APHIS
  • History Pepper the Dalmatian!
  • Does not cover rats mice (bred for research)
    or farm animals used for food or fiber
  • Does cover farm animals used for teaching or for
    biomedical research
  • Institutional responsibilities

87
Overview the Regs!
  • Public Health Service Policy
  • Make sure herdsmen understand that
  • the Policy applies to any research institution
    receiving funding from NIH
  • the Policy applies to all vertebrate animals.

88
Overview the regs!
  • AAALAC
  • Not regulatory but voluntary
  • Covers all animals in a Program
  • But what the heck is a Program???

89
The overview The program of animal care and
use
  • Provide information on exactly what a Program
    is!
  • Institutional Policies
  • Stress the importance of Institutional Oversight
    for animal care and use!
  • Animal Environment, Housing
  • Most Ag folks know about this

90
The overview The program of animal care and use
  • Veterinary Care
  • Tell them about the roles and responsibilities of
    the AV!
  • Discuss the importance of teamwork
  • Physical Plant
  • May or may not apply

91
The overview the GuidesWhat are the standards?
92
Tier 2 Species specific training
93
Tier 2 Species specific training
  • Swine
  • Dairy
  • Beef
  • Sheep and Goats
  • Poultry

94
Tier 2 species modules content
  • Breeds
  • Classification (species, genus)
  • Nomenclature (freemartin)
  • Uses in research
  • Main biological characteristics
  • Behavior
  • General husbandry
  • Space requirements
  • Procurement
  • On Arrival examination
  • Technician responsibilities
  • Nutrition
  • Basic handling and restraint
  • Identification
  • Animal Health/Common Diseases
  • Euthanasia

95
Tier 2 species modules the trainer
  • Identified most qualified technician/herdsman
    per species.
  • Asked him/her to develop the module.
  • Provided presentation skills.
  • That technician became the trainer for that
    particular species.
  • Trainer presentation skills and efforts were
    recognized by supervision and reflected on
    performance management.

96
Tier 3Hands On training
97
Tier 3 Hands On training
  • Herd health SOPs
  • Dehorning
  • Piglet processing
  • Foot Trimming (all species)
  • Castration
  • Euthanasia (captive bolt)
  • Heat check for dairy
  • Artificial insemination
  • Routine health treatments
  • Mastitis
  • Hypocalcemia
  • Anemia

98
Tier 3 Hands On training
  • Aseptic technique
  • Surgical principles
  • Specific surgical procedures
  • Rumen cannulation
  • Abomasal cannulation
  • Vascular access
  • Research techniques
  • Handling and restraint
  • Bleeding and injection techniques
  • Anesthesia and analgesia

99
Ag specific training!!!
  • Zoonoses and biosafety
  • Recognition of pain and distress in ag animals
  • Ag animal environmental enrichment
  • Necropsy room safety

100
Readily available trainingFASS Training
  • Federation of Animal Science Societies
    (www.fass.org)
  • Beef Cattle
  • Dairy Cattle
  • Swine Training
  • Horse Training
  • Ag Guide

101
Available video tapes
  • National Institute Animal Agriculture (NIAA)
  • Swine Handling and Transport
  • Cattle Handling and Transport
  • Understanding Dairy Cattle Behavior to Improve
    Handling and Transport

102
Lots of other sources of training material
  • AAALAS
  • National Practitioner Organizations
  • AABP, AASV, AADP.
  • National Producer Organizations
  • National Cattlemans Beef Association
  • Temple Grandin (www.grandin.com)
  • American Farm Bureau
  • AVMA
  • AWIC
  • Land Grant University agricultural program
    websites

103
Case study 1
  • Large Land Grant University, USA
  • Mandatory inadequate veterinary care
  • Problem an inadequate understanding of
  • the role of the veterinarian in research,
  • the regulations and how they are applied to
    agricultural research
  • and what constitutes an animal care and use
    program
  • Solution (in part) Tier 1 training

104
Case study 2
  • Large Land Grant University, USA
  • Mandatory lack of or inadequate personnel
    training
  • Problem long term very experienced herdsmen who
    do not understand the need for training
  • Solution
  • Tier 1 training
  • Tier 2 training
  • Herdsman as the trainer

105
Case study 3
  • Land Grant University, USA
  • Mandatory inappropriate euthanasia (swine,
    cattle)
  • Problem lack of understanding of appropriate
    euthanasia techniques
  • Solution
  • Tier 3 SOP discussion and hands on training for
    euthanasia techniques (electrocution, carbon
    dioxide, captive bolt..)

106
Questions?
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108
Industrys unique challenges
  • Slides prepared by
  • Michael Ballinger, DVM, DACLAM
  • Director, Global Animal Resources, Amgen
  • President, Council on Accreditation, AAALAC
    International

109
What is industry
  • Vendors
  • Contract Research Organizations (CRO)
  • Biotech companies
  • Pharmaceutical/vaccine companies
  • The challenges vary with various industry sectors

110
Industry environment/challenges
  • Generally risk averse.
  • Business model includes regulatory compliance
    (FDA, EPA, OECD, ISO, DOD).
  • Business model includes accreditation, (AAALAC
    International).
  • Cost/benefit ratio analysis evaluated for
    programs.
  • Must have business case for education training.

111
Business case for training
  • Is it mandated by law or regulation?
  • Will it protect the companys resources?
  • Will it make us more competitive?
  • Will it improve the data?
  • How important is it for the company to project
    competence?
  • How important is it to convey that animal welfare
    is important?

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Training by job category
  • IACUC member training.
  • Animal care staff training.
  • Research science staff training.
  • Personnel at risk for research hazards.
  • Awareness/training of the companies rank and
    file.

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IACUC training
  • Animal Welfare Act compliance sells need.
  • 1996 Guide provides specific expectation.
  • Support for regular travel to IACUC conferences
    is generally available.
  • Many organizations now bring the trainers in
    to maximize return on investment.

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Animal care staff training
  • Well defined training programs are common.
  • Documentation often excellent, especially if
    GLP.
  • AALAS certification often endorsed and
    financially supported.
  • May be requirement for advancement.
  • ILAM CMAR support is common.

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Training for science staff
  • Business case not as obvious.
  • Qualified versus Trained.
  • Who is ultimately responsible for qualification
    of research staff?
  • What cost center should support it?
  • IACUC may demand demonstration of proficiency
    but should they require training?

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Environmental health and safety training
  • Strong business case for adequate occupational
    health safety resources.
  • Strong business case for hazard abatement.
  • Formal courses readily available.
  • Combining animal use training with other
    required training (i.e. EHS) will increase
    efficiency and may increase effectiveness.

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GLP versus non-GLP
  • GLP animal users take training very seriously,
    but focus is not animal welfare.
  • Well-documented.
  • Humane issues not always a key component.
  • FDA assumes adequate animal care/welfare.
  • USDA focus on welfare, not on study design.
  • Mandate and oversight comes from GLP compliance
    (QA) organization, not IACUC.

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Research and non-GLP
  • Company culture may hinder new demands for
    mandated training and especially needless
    documentation.
  • Perhaps an over reaction to GLPs dont apply
    here.
  • Procedural training with humane focus evolved
    long after GLPs in most companies.

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Industry examples of approaches
  • Risk-based prioritization for hands-on training
    and/or proficiency demonstration.
  • Concentrate on recognizing pain/distress and
    reporting problems.
  • Track proficiencies in a central training
    record.
  • Internal awareness programs for rank and file
    culture of care (Aventis, Charles River).
  • Integrated Needs-Based Training ProgramsAttend
    Seminar tomorrow 800 am!!

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