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Who Owns the Animals?

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Title: Who Owns the Animals?


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Who Owns the Animals?
Kathryn Bayne, M.S., Ph.D., D.V.M., DACLAM Senior
Director Director of Pacific Rim
Activities AAALAC International
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Oversight authority
  • OLAW
  • USDA
  • AAALAC International
  • Follows the money trail
  • Covered species on site
  • Follows animal ownership

5
PHS Policy
  • This Policy is applicable to all PHS-conducted
    or supported activities involving animals,
    whether the activities are performed at a PHS
    agency, an awardee institution, or other
    institution and conducted in the United States,
    Commonwealth of Puerto Rico, or any territory or
    possession of the United States.

6
USDA
  • The Animal Welfare Act and accompanying Animal
    Welfare Regulations provide authority (as
    determined by the Secretary) for warm-blooded
    animals
  • In laboratory animal programs, this includes live
    animals used or intended for use in research,
    teaching, testing, or experiments

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AAALAC International
  • All animals used or to be used in research,
    teaching or testing at accreditable units are to
    be included and evaluated. This includes
    traditional laboratory animals, farm animals,
    wildlife, and aquatic animals. Nontraditional
    animals, inclusive of invertebrate species, are
    also included where they are relevant to the
    unit's mission.

9
What does AAALAC visit?
  • If your accredited institution owns animals at
    another accredited institution
  • We will not include those animals in your site
    visit they will be addressed during the other
    institutions visit
  • If your accredited institution owns animals at a
    non-accredited institution
  • You will need to include those animals in your
    Program Description and we will include them in
    the site visit

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  • However, the accredited unit may have a more
    limited contract in which the accredited unit
    owns the animals. In this latter situation,
    AAALAC International considers those facilities
    to be an integral part of the institution's
    animal care program. The services and facilities
    provided by the contractual arrangement must be
    included in the application and annual reports,
    and the facilities will be visited as a part of
    the institution's original and periodic site
    visits to determine compliance with AAALAC
    International standards. Contractual agreements
    made by AAALAC International accredited
    institutions or applicants must provide for the
    inspection of the contracted facilities by AAALAC
    International site visit teams. If the contract
    facility is separately accredited by AAALAC
    International and is currently fully accredited,
    it will not be necessary to visit that facility
    during the site visit.

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What does AAALAC visit?
  • If your accredited institution is involved in a
    collaboration or contract (regardless if the
    performance site is accredited or not), but does
    not own the animals
  • This does not need to be described in the Program
    Description, nor declared as part of your
    accredited unit

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  • Institutions may have contractual arrangements
    for certain aspects of their animal care
    activities with other animal care
    agencies/facilities. In some situations, an
    accreditable unit may issue a comprehensive
    contract whereby the contractor provides most or
    all specified facilities, services, personnel,
    animals, etc., and the animals are owned by the
    contractor. In this situation, AAALAC
    International accreditation does not extend to
    the contracted facilities and their associated
    animal care programs.

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Defining ownership (Websters)
  • Legal right of possession
  • Lawful title to
  • Proprietorship (legal title or exclusive right to
    some property)

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Defining Ownership
  • Shades of Grey

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To define animal ownershipYou may need to get
the lawyers involved
  • due to possibly varying state, municipal, and
    international laws regarding property ownership
    specific to your area

18
How to avoid confusion
  • During the development of a contractual
    relationship, establish who owns the animals
    (e.g., authority for final disposition of an
    animal)
  • If your institution is providing monetary support
    in a collaborative project, use of that money to
    purchase animals should be addressed up front

19
Animal Ownership? Intellectual Property
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Animals at your institution that you dont own
but which may be reviewed by AAALAC
  • Raptors in a rehab program owned by FWS, but used
    for teaching
  • Client-owned animals in maintained in a vet
    school that are used in an IACUC approved protocol

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Animals at your institution that you dont own
but which may be reviewed by AAALAC
  • Agricultural animals whose primary purpose is
    other than teaching or research, but which are
    also used for either of those purposes
  • Animal not owned by accredited unit, but housed
    in close proximity to those that are, and may
    impact well-being of the animals

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Responsibility Accountability
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Contracting OutWhat are the Issues?
Wendy J. Underwood, DVM, MS, DACVIM Director,
Veterinary Resources Eli Lilly and Company
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Introduction
  • Pharmaceutical industry is under increasing
    pressure
  • Increasing federal regulations and guidelines
  • Increasing costs to deliver new molecular
    entities
  • As a result, research institutions are evaluating
    and utilizing contract research organizations
    (CROs)

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Issues
  • Developing an outsourcing strategy
  • Identifying, evaluating and approving CROs
  • Developing policies and procedures for oversight
    and approval of outsourced studies
  • Identifying ongoing outsourced activities
  • Assuring regulatory compliance
  • Identifying the level of institutional oversight
    necessary for contracted animal work

26
Strategies and procedures
  • Utilize only well-established CROs with proven
    records of success that are AAALAC accredited
  • Utilize only local CROs so that investigators can
    oversee studies
  • Utilize CROs with expertise in certain areas
  • Utilize regional CROs with potential research and
    business synergies

27
Who drives the process?
  • Investigator driven
  • Portfolio driven
  • Management driven

28
Each institution should develop its own strategy,
understand its own strategy, and communicate that
strategy prior to launching major outsourcing
efforts.
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Initial steps
  • Establish a centralized process for outsourced
    study approval and administrative management
  • Establish a process for veterinary and management
    approval
  • Ensure proper provision for research animals
  • Ensure alignment with business goals and
    objectives

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Identify key internal resources
  • Routing of study protocols and contracts
  • Initial contact of potential CROs
  • Scheduling of appropriate internal meetings
  • Coordination of CRO communications
  • Development of Statements of Work, Purchase
    Orders, and legal contracts

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Identify a legal gatekeeper
  • Trade secret information
  • Proprietary animal models
  • Contracts should be detailed
  • Ownership of animals
  • Assurance that the CRO will comply
  • Reporting of adverse events

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Centralized database
  • List approved CROs
  • Identify CRO areas of expertise
  • List all outsourced activities
  • Track ongoing outsourced activities

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The institution should develop policies for
outsourced studies!
  • CRO approval criteria
  • Expectations for meeting all local, state, and
    national regulations and guidelines
  • Expectations for the level and extent of
    institutional oversight including
  • Ensuring IACUC review of animal use protocols
  • Ensuring that the 3 Rs have been addressed
  • Ensuring that the use of alternatives have been
    addressed
  • Ensuring that the minimum number of animals have
    been used
  • Ensuring that duplication of studies has not
    occurred.
  • Ensuring appropriate removal from study and
    euthanasia

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Evaluating CROs
  • Develop evaluation criteria for
  • animal care and use program
  • research program

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Evaluation criteria
  • Animal care and use program
  • regulatory status
  • veterinary program
  • animal husbandry
  • physical plant
  • security

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Evaluation criteria
  • Research program
  • organizational structure
  • technical staff capabilities
  • general research capabilities
  • data collection methods and capabilities
  • quality assurance programs
  • records and record retention systems

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CRO specialties
  • Surgical models
  • surgeon qualifications
  • number and location of surgical sites
  • surgeon turnover and training
  • Breeding programs
  • genetic integrity
  • record keeping and animal tracking
  • biosecurity and veterinary care
  • security and transportation

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Many issues arise, but can be addressed!
  • Develop detailed study protocols
  • Clearly state the purpose of the study and study
    objectives
  • Develop sample handling and transport procedures

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Harmonization
  • Determine if exact harmonization of veterinary
    care, surgical and animal husbandry procedures is
    needed between the CRO and the institution. This
    is critical for study success!

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Harmonization details
  • Health status
  • Veterinary program
  • Specific surgical details
  • Husbandry
  • Caging
  • Bedding
  • Water

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Other considerations
  • Pilot or parallel studies
  • Ethical information (3Rs)
  • Biosafety ABSL level 2 or 3?

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Monitoring
  • Who will do the monitoring?
  • Who will report adverse events?
  • Who will oversee
  • Data collection?
  • Study reports?
  • Final study package?
  • Who has final study package approval?

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An informal survey was done for benchmarking
purposes
  • Went to COMPMED, Council, colleagues
  • 32 responses

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Question 1 What type of contracting organization
  • 14 private
  • 11 pharma (6-disc 4-disc/tox 1-ASR)
  • 3 biotech
  • 18 public
  • 4 were vet schools
  • 12 were universities
  • 1 was a hospital
  • 3 mixed

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Q2 Asked if profit, nonprofit, AAALAC, USDA,
etc.
  • 24/32 were AAALAC Accredited
  • 28/32 were USDA registered
  • 20/32 were PHS Assured
  • 30/32 had an IACUC
  • Indicates general compliance
  • Contractors can use this information

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Q3 Is the process official?
  • 14/32 had an official process
  • 13/32 had an unofficial process
  • 5/32 had no process

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Q4 What did the formal approval process include?
  • 2/32 said a thorough process was created and
    required a site visit, but 7/32 said the process
    could be better
  • Other
  • 4-AAALAC, 5-PHS 7-USDA
  • 6-9 policy/guideline based
  • Tox units required official visits and AAALAC
    Accreditation

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Q5 What did the informal process include?
  • 6/32 req AAALAC 18 prefer, 3 dont
  • 16/32 req USDA 3 prefer, 3 dont
  • 11/32 req PHS 4 prefer 4 dont
  • 7/32 req GLP 6 prefer 7 dont
  • Private sector puts more emphasis on USDA and
    GLP, while public sector puts more emphasis on
    USDA and PHS.

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Q6 What official paperwork is required?
  • 6/32 said none
  • 10/32 said official IACUC approval letters by
    both institutions! 9/32 were from Private
    sector!)
  • So, institutions do require some paperwork, and
    the public sector usually requires IACUC
    documentation.

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Q7 If concerned about differing standards for
ACU.
  • 13/14 for-profit said Yes
  • 8/18 not-for-profit said Yes
  • Implies general concern for differing standards
    for animal care and use.

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Q8 Who coordinates contracted studies?
  • 27/32 had an over sight program
  • 9/32 said Lab Animal Management
  • 8/32 said Research Management
  • 10/32 said other, IACUC
  • So, a variety of organizational units
    administrate contracted studies.

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Q9 Is the unit moving toward a more official
process?
  • 18/32 said Yes!
  • 12/14 for-profit private institutions said
    Yes
  • 6/18 not-for-profit public said Yes
  • Interesting! For-profit units also indicated
    (Q7) concern about differing standards.

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Q10 Does lab animal management know the total
number of studies contracted?
  • 14/32 said Yes
  • 9/18 not-for-profit said Yes
  • 5/14 for-profit said Yes

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Q 11 Does the IACUC know the number and type of
studies outsourced?
  • 15/32 said Yes
  • 3/14 of for-profit said Yes
  • 12/18 of not-for-profit said Yes
  • Interesting contrast!

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Conclusions
  • Dont abdicate responsibility for the oversight
    of animal welfare!
  • Establish company policies and/or guidelines
  • Develop database of approved CROs
  • Establish an institutional approval process for
    outsourced studies

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Conclusions (contd)
  • Develop thorough written contracts
  • Create detailed study protocols
  • Perform and validate pilot studies
  • Establish lines of communication
  • Develop a process for study monitoring

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Contracting in Researchto Universities What
are the Issues?
Joseph N. Benoit, Ph.D. Dean, Graduate
School University of North Dakota
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Contracts are partnerships
  • An agreement between two or more parties to do or
    not do something

Contractee (University)
  • Contractor
  • (Industry)

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Understanding the partnership
  • The key to the successful partnership, however
    is the recognition on both sides that
    universities and industry have distinct missions.
    The mission of the university is the pursuit of
    knowledge for its own sake, the best-known
    strategy for innovation and the mission of
    industries is to make money for their
    stockholders, the best known strategy for
    economic progress. In some contexts, these two
    missions can lead to aims that are antithetical.
    In other contexts, both aims can be fulfilled in
    pursuing a common goal, with corresponding
    benefit to society.
  • Zack W. Hall, Ph.D., The Academy and Industry
    A View Across the Divide. In Buying In or
    Selling Out? The Commercialization of the
    American University, D.G. Stein, Ed., Rutgers
    University Press, 2004

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Contractor expectations
  • The party awarded the contract will be able to
    provide the services requested. The contractor
    assumes that the contractee has the expertise and
    infrastructure to perform the work.
  • Contractor also expects to own the product of the
    work conducted by the contractee.

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Contractee views
  • The contractee understands that they will conduct
    the work.
  • The contractee understands that they will be paid
    for the work that is done.
  • The contractee may not fully recognize that their
    ability to to conduct curiosity based research
    may be curtailed by the contract.

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Universities are becoming more entrepreneurial
  • Research generates
  • Money
  • Prestige
  • Intellectual property

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The publics perspective of the university
mission has changed
  • In 1999, North Dakota leaders looked into the
    future and saw challenges and opportunities that
    required immediate action. They committed to
    taking the bold steps needed to improve the
    states economic and demographic picture. These
    leaders believed the North Dakota University
    System to be an integral part of expanding and
    diversifying the states economy and enhancing
    the quality of life for all North Dakotans. As a
    result, profound changes are taking place, many
    of which reflect the growing relationships
    between the NDUS and its many public and private
    partners.
  • North Dakota University System

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What are the issues associated with innovative
university partnerships?
  • Oversight
  • Regulatory compliance
  • Infrastructure
  • Intellectual property
  • Curiosity driven research vs. contract driven
    research
  • Conflicts of Interest and Conflicts of Time

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Oversight of animal care use
  • Contractor or Contractee IACUC?
  • Who owns the animals?
  • Protocol review
  • Search for alternatives?
  • Pain Distress?
  • Use of analgesia?
  • Removal of animals from study?
  • Who provides the veterinary care?
  • Employee health and safety?
  • Semiannual Review?

66
Regulatory compliance
  • USDA
  • Which organization is held accountable for
    deficiencies?
  • Biohazardous Agents
  • Which committee reviews and approves protocol?
  • Pharmaceuticals with unknown properties?
  • Infectious agents?
  • Select agents?
  • Radiation
  • Who reviews?
  • Who monitors?
  • Who disposes?

67
Infrastructure
  • Adequacy of infrastructure to support the
    contract
  • Does the contractor verify that the
    infrastructure exists?
  • Economic benefit to the contractee?
  • Does the contractee overextend their
    infrastructure for financial gain?

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Intellectual property
  • Who owns the data?
  • Where are the data stored and archived?
  • Whose record retention policies govern data
    storage and archiving?
  • What about tissue samples?
  • Curiosity-driven research vs. contract-driven
    research
  • Who owns the idea?
  • Who owns subsequent ideas?
  • Who benefits when new discoveries are made?

69
Academic integrity issues
  • Conflict of interest
  • Conflict of time

70
Successful contracts involve a complex balancing
act
71
Suggested reading
  • Buying In or Selling Out? The Commercialization
    of the American Research University. Donald G.
    Stein, Ed., Rutgers University Press, 2004.
  • The Creation of the Future The Role of the
    American University. Frank H. T. Rhodes, Cornell
    University Press, 2001.
  • Universities in the Marketplace The
    Commercialization of Higher Education. Derek
    Bok, Princeton University Press, 2003.
  • Science, Money and Politics Political Triumph
    and Ethical Erosion. Daniel S. Greenberg, The
    University of Chicago Press, 2001.
  • The Uses of the University. 5th Edition. Clark
    Kerr, Harvard University Press, 2001.

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Neutralizing Dual RegulationsAWRs vs. GLPs
Kathy Laber, DVM, MS, DACLAM Professor Medical
University South Carolina
73
Good Laboratory Practices 21 CFR
  • Implemented in the late 70s
  • In response to the FDA receiving research that
    was poorly conducted
  • Assure quality and integrity of the safety data
    conducted in nonclinical laboratory studies.
  • GLPs originated without animal impact as a
    specific focus/concern

74
Nonclinical studies
  • Part of FDA drug approval process
  • adequate pharmacology/ toxicology drug
    studies using laboratory animals or in vitro
  • supports that its reasonably safe to conduct
    clinical investigations
  • Types of Studies
  • Single/Repeat dose toxicity, Biocompatibility,
    Reproduction/Development, etc..

75
Animal Welfare Act CFR 7
  • Implemented in mid sixties
  • AWRs originated with focus on random origin dogs
    cats, facilities and sanitation
  • Impact was very limited in first 2 decades
  • Impact exploded with1985 amendments
  • Definition of the IACUC
  • Definition of AV /Adequate Veterinary Care

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Intended protocol focus
  • GLP
  • Study Conduct
  • AWA
  • Impact of Study on Animal Welfare

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Critical Player for GLPsStudy director
  • study director has overall responsibility for
    the technical conduct of the study..and
    represents the single point of study control
  • Does NOT MEAN they may disregard AWA, AV, IACUC
  • From 21 CFR Part 58

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Critical player for AWAAttending veterinarian
  • Has authority for activities involving animals
  • Research facility shall assure that the attending
    veterinarian has appropriate authority to ensure
    the provision of veterinary care
  • ..Shall establish programs of adequate
    veterinary care that include
  • daily observation of all animals to assess their
    health and well-being
  • From 9 CFR Part 2

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Regulatory language GLPs
  • Animals may be treated for disease or signs of
    disease provided that such treatment does not
    interfere with the study.
  • Diagnosis, authorization of treatment,
    description of treatment, and each date of
    treatment shall be documented
  • SOPs written for handling of animals found
    moribund or dead during study
  • From 21 CFR Part 58

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Regulatory languageAWA
  • Procedures that may cause more than momentary or
    slight pain or distress will
  • Involve in their planning, consultation with the
    Attending Veterinarian..
  • Animals that would otherwise experience severe or
    chronic pain or distress that cannot be relieved
    will be painlessly euthanized at the end of the
    procedure, or, if appropriate, during the
    procedure
  • From 9 CFR Part 2

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Missing language from both CFRs
  • Useful discussion of End Points
  • GLP driver- Evidence of Product Safety
  • AWA driver- Alleviation of pain/distress
  • Defined Interface between Study Director and
    Veterinarian
  • Study Director (Tox Management) reports to FDA
    and hosts FDA audits
  • Attending veterinarian leads reporting of animal
    use (by pain category) to USDA and hosts USDA
    inspections

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Dueling CFRs
  • Toxicologists and Vets may resort to the use of
    their regulations as hammer
  • Type A personalities- difficult to resist the
    temptation to trump each other with higher
    authority for action/inaction

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Failure to address spirit of GLPs
  • Insufficient safety information to support
    clinical testing
  • Repetition of studies and increased animal use
  • Increased time to make important therapies
    available to the public
  • Increased cost that is forwarded to public

88
Failure to address spirit of AWA
  • Negative impact on animal
  • Unrelieved animal care staff pain/distress
  • Reportable incident to regulatory agencies
  • USDA citation/fine
  • Adverse public relationships

89
AAALACs perspective
  • Goal is avoid /minimize distress and pain in
    concert with sound science
  • References AWA
  • Does NOT reference GLPs

90
AAALACs perspective
  • ..Euthanasia occurred only after receiving
    permission from the study directorcontrary to
    principles of Guide-MUST ensure AV has necessary
    authority to ensure prompt euthanasia.

91
AAALACs perspective
  • study director determined whether or not
    veterinary assessment should occur. The study
    control by the study director does not supersede
    the requirement to assess animals by the
    veterinary staff..attending veterinarian
    MUST..have the oversight authority for aspects of
    animal care and use

92
AAALACs perspective
  • DEFFERED
  • PROBATION
  • INTENT TO REVOKE
  • REVOKE

93
Double-click on image to play
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Solution to challenge
  • TEAM APPROACH TO SAFETY STUDIES
  • COMMUNICATE
  • Avoid GLP (us) versus AWA (them) debate
  • LEARN EACH OTHERS BUSINESS

95
Solution to challenge
  • Pre-emptive strike critical to success
  • Protocol development
  • Diagnosis or treatment is permitted as long
    as it does not interfere with study objective.
    If the treatment interferes, the animal can be
    removed
  • SOP development Study conduct i.e. define
    nursing care

96
Solution to challenge
  • Define endpoints
  • Minimize mortality, opt for human euthanasia
  • Rapid weight loss (15-20)
  • Extended period of weight lossgtemaciation
  • Prolonged lethargy
  • Debilitating/prolonged diarrhea
  • Condition that interferes with animals ability to
    eat/drink i.e. ataxia/weakness
  • Bleeding, marked icterus, anemia

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Research Collaborations at Land Grant
Institutions What are the Issues?
Joseph R. Haywood, Ph.D. Professor and
Chairperson Department Pharmacology
Toxicology Michigan State University
100
Land grant institutions represent a special
challenge
  • Agriculture- and animal science-based education
  • Large numbers of undergraduate students
  • Outreach efforts 4H Clubs, tours
  • Wildlife and natural resources
  • Many species of animals
  • Diversity of funding sources

101
Institutional philosophy
  • USDA intellectual and property ownership
  • AAALAC control
  • PHS money
  • Issues
  • What are the standards of the institution?
  • PHS assurance?

102
Scenarios
  • Taking the bull by the horns
  • Shared ownership of animals
  • Snakes, snakes, snakes What a zoo?
  • No ownership, but faculty involvement
  • Follow the shells Where is the teaching animal?
  • Informal or formal relationships with privately
    owned animals
  • Production animals or teaching animals?

103
Scenarios
  • Out-of-site, out-of-mind
  • Off-site farms
  • Trans-state-genics
  • Large animal transgenics maintained on a private
    farm
  • Large animal antibody-production on a private farm

104
Scenarios
  • Lab for rent the mobile laboratory
  • Lab ownership, but not animals
  • Swimming with the fishes
  • Studies with state-owned wildlife on campus and
    off campus

105
Other known scenarios
  • Spay-neuter clinic
  • Veterinary clinical studies on client-owned
    animals
  • Blood donors
  • Wildlife recovery ward

106
The power of communication
  • Memoranda of Understanding
  • Plan for Adequate Veterinary Care
  • Protocol Review
  • Others
  • Disaster Plan
  • Occupational Health concerns
  • Training issues

107
Practical considerations
  • Think logically and talk it through
  • Dont create problems
  • Not every laboratory has four walls and HVAC
  • What would 60 Minutes ask me?

108
Names, locations, and species were changed to
protect the victims
109
International Research Contracts and
Collaborations InvolvingLaboratory Animals
Dennis M. Stark, D.V.M., Ph.D., DACLAM Executive
Director Veterinary Sciences Bristol-Myers
Squibb Pharmaceutical Research Institute
110
What are the issues?
  • Good science
  • Appropriate animal care
  • Regulatory compliance
  • Institutional standing
  • Planned oversight

111
Why the concern about standards?
  • Legal codes
  • Regulations
  • Ethical codes
  • Cultures
  • Language

112
Due diligence
  • Site visits pre/ongoing
  • Written agreement
  • Legal review
  • IACUC review

113
What needs to be clear?
  • Study design
  • Animal care
  • Veterinary care
  • Roles
  • Intellectual property

114
Contracts, agreements and memos of understanding
  • Delineate who is responsible for what
  • Regulations covering laboratory animal use
  • Inspections/auditing defined
  • Periodic contract, program, and inspection report
    review
  • Notice of changes in accreditation and regulatory
    standing
  • Protocol reviews
  • Ownership of laboratory animals
  • Animal and veterinary care
  • Protect Intellectual Property
  • Confidentiality provisions
  • Security
  • Data/Records/Samples

115
What can we learn from public agencies?
  • Public Health Service
  • The National Institutes of Health
  • National Science Foundation
  • Department of Defense
  • National Academies of Science
  • US Department of Agriculture
  • Organization for Economic Cooperation and
    Development

116
NIH supported activities
  • NIH will not make an award for research involving
    live
  • vertebrate animals unless the applicant
    organization and all performance sites are
    operating in accordance with an approved Animal
    Welfare Assurance.
  • Foreign organizations proposing activities
    involving
  • vertebrate animals are required to comply with
    the PHS
  • Policy or provide evidence that acceptable
    standards for the humane care and use of animals
    will be met.

117
Statement of Compliance with Standards for
Humane Care and Use of Laboratory Animals by
Foreign Institutions
  • In reference to the Public Health Service Policy
    on Humane Care and Use of Laboratory Animals, it
    will comply with laws, regulations, and policies
    regarding humane care and use of laboratory
    animals of the jurisdiction in which the research
    will be conducted.
  • This Institution acknowledges and accepts
    responsibility for the care and use of animals
    involved in activities covered by this Statement
    of Compliance.
  • This Institution is guided by the International
    Guiding Principles for Biomedical Research
    Involving Animals developed by the Council for
    International Organizations of Medical Sciences.

118
International Guiding Principles for Biomedical
Research Involving Animals
  • Basic Principles (XI)
  • Special Provisions
  • Acquisition
  • Transportation
  • Housing
  • Environmental conditions
  • Nutrition
  • Veterinary care
  • Records
  • Monitoring
  • Alternatives

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Resources
  • PHS Policy on Humane Care and Use of Laboratory
    Animals
  • http//grants2.nih.gov/grants/olaw/references
    /PHSPolicyLab Animals.pdf
  • NIH Grants Policy Statement http//grants1.nih.g
    ov/grants/policy/nihgps_2003/NIHGPS_Part5.htm_Toc
    54600087
  • International Guiding Principles for Biomedical
    Research Involving Animals
  • http//www.cioms.ch/1985_texts_of_guidelines.
    htm
  • Application of the OECD Principles of GLP to the
    Organization and Management of Multi-Site Studies
    - ENV/JM/MONO(2002)9
  • www.oecd.org/ehs/
  • International Regulations
  • http//www.aaalac.org/resources/international
    regs.cfm

120
Association For Assessment And Accreditation of
Laboratory Animal Care International
121
Thank you
A sincere thanks to the following who helped with
the research for this talk
  • Kathryn Bayne (AAALAC)
  • Denis Doyle (NIH-OLAW)
  • Betty Goldentyer (USDA)
  • Terrance Hawk (GlaxoSmithKline)
  • Michael Kastello (sanofi-aventis)
  • Hilton Klein (Merck)
  • Dale Martin (sanofi-aventis)
  • Timothy Morris (GlaxoSmithKline)
  • Edward Mundy (NSF)
  • Mary Newman (BMS)
  • Mary Pat Nowack (NAS)
  • Gregory Reinhard (Merck)
  • James Swearengen (AAALAC)
  • Robert Trotta (BMS)
  • Axel Wolf (NIH OLAW)
  • Joanne Zurlo (NAS-ILAR)

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Contact AAALAC Internationalaccredit_at_aaalac.org
www.aaalac.org301.231.5353
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